Gene patents have been the most debated matter since years. The economic and policy issues surrounding patents on genes, gene sequences, nucleotide sequences, expressed sequence tags (ESTs), single nucleotide polymorphism (SNPs) have posed the potency  to present unique challenges in science, innovations and legal fraternity around the  globe.

Patent Issues regarding Gene Patents:

A number of gene/DNA sequence patents grew dramatically during the Human Genome project. Researchers have obtained patents for isolating genes or gene sequences that occur in nature. Whether this should be permitted or not is still an open debate since decades.

Generally to seek a patent-protected gene, there are certain issues that a researcher comes across.

(1) Stop or avoid researching the particular gene;

(2) License the rights to research the gene from the patent holder; or

(3) Continue research regardless of legal liability.

Indeed, the choice made is often dependent on the DNA sequence in question and the line of research pursued. Regardless, the exercise of any of these three options could potentially work to reduce fundamental R&D in human genetics.

Considering an instance of gene patent invalidation of Myriad Genetics by US federal court. The American Association of Pathologists and others have challenged several patents relating to the breast cancer genes BRCA1 and BRAC2 held by Myriad Genetics and the University of Utah Research Foundation. BRCA1 and BRCA2 genes are associated with an increased risk of breast and ovarian cancer. The patent claimed products of nature, law of nature and naturally occurring phenomena. The US district court for the Southern District of New York upon decision by Judge Robert Sweet, invalidated Myriad’s patents. The decision that isolated but otherwise unaltered DNA should not be patentable is now being appealed by Myriad.

The US Government stated that:

“The fact that a particular segment of the human genome codes for the BRCA1 protein in a human cell, for example, rather than for adrenaline or insulin or nothing at all, is not within the power of science to alter. Such basic natural relationships may not be the subject of a patent.” (Case 1:09-cv-04515-RWS)

Secondly, it is been argued that Myriad patents and it being the sole provider of BRCA1/2 testing has highly hindered cancer patients to receive cancer genetic testing. It is impeded that genes are the natural heritage of animals and/or human and its use should not be restricted by patent protection.

Indian Patent Laws on genes:

India, like other major countries have immensely involved in various biotech and medical research area, being one of the topmost competitor in commercial market in biological therapeutic and diagnostic domains globally

Section 3(c) of Indian Patent Act, states that “mere discovery of scientific principle or the formulation or the discovery of any living/non living substance occurring in nature” is not considered to be an invention. Pertaining to this law, mere isolation of naturally occurring genes from animal or plant body cannot be patentable.

Accordingly, section 3 (i) define diagnostic methods is not patentable. Further, it explains that in vivo diagnostic methods practiced on human/animal body cannot be patentable but if diagnosis is performed in vitro i.e. on tissue or fluids that have been removed from body are entitled to be patentable in light of inventive measures. Hence, diagnostic methods employing DNA primers or probes or the like that are different from naturally occurring genes/DNA sequences that exhibits modified functions  would be considered as patentable inventions.  Considering Bilski (30 S.Ct. at 3225), new and useful methods of identifying, isolating, or using genes or genetic information may be patented (prohibiting patenting abstract ideas), that are basically man-made transformation or manipulation of the raw materials of the genome, such as cDNAs.

Section 3(j) “plant and animals as whole, seeds and species which involve in its propagation or biological processes are not considered to be patentable”. In addition to this section 3(j) also states that apart from naturally occurring embodies, living entities of artificial origin such as transgenic plants and animals and/or parts thereof are not patentable. Microorganisms are construed to be patentable under section 3 (j). However, section 3(j) and section (c) when combined, states that isolated microorganisms from naturally occurring bodies are not construed to be patentable. Nevertheless, artificially developed genetically engineered microorganisms, vaccines and recombinant DNA are all considered to be patentable.  For instance , as seen in the case law of  Diamond v. Chakrabarty, 447 U.S. 303 (1980), ruled that “anything under the sun that is made by man” is patentable. The Supreme Court established that the man-made products of genetic engineering are eligible for patent protection under 35 U.S.C. § 101. The Patent and Trademark Office responded to Chakrabarty by granting patents on a wide range of engineered DNA molecules and useful genetic methods.

The basic fact about genes/gene products being patentable is that when a genetically engineered gene/DNA/amino acid sequence is novel and holds an inventive step thereby ensuring its industrial application, the patents can be claimed as:

• Gene sequence/amino acid sequence.
• A method of expressing the above sequence.
• An antibody against that sequence/protein.
• A kit made from the antibody/sequence.

In a more brief sense, it should be noted that rDNA, plasmids and process of forming the same are allowed to be patentable under substantive inventive steps employed. Further, unidentified functions of gene/DNA sequences and without any industrial application cannot be construed to be patentable.

One such example of gene patents in India, as seen in Indian Patent No. 243373 (279/MUM/2004) assigned to Sichuan Biotechnology Research Center, discloses artificial gene sequence for encoding recombinant super compound interferon with enhanced activity. The independent claim of the patent states:

1. A method for producing a recombinant interferon for inhibiting HBV-DNA replication as well as secretion of HBsAgs and HBeAg comprising steps of;
   1. Synthesizing and interferon DNA having a sequence as depicted in Fig.1 or 2 designed according to the codon usage;
   2. Placing said interferon DNA in an appropriate host preferably E.Coli and;
   3. Expressing said recombinant interferon in said host having an amino acid sequence encoded by interferon DNA shown in said Fig.1 or 2.

Wherein Fig 1 or 2 is a gene sequence of interferon DNA. (see Patent)

Again looking into Biocon’s story on genes, Using patent information as an integral tool, Biocon determined are as on which the company’s R&D should focus on.One such example is how the company used patent information to gain initial access to the field of human insulin production, where it is now a major player. The product patent on human insulin had long expired, but it was still protected by strong patents on processes of production.

Key take aways:

In most prosecution cases, it is been observed that the examiner objects claims directed towards isolated DNA/gene sequences in context to section 3 (c). Such objections can be dealt sating that the applicant’s/individuals claimed isolated DNA/gene sequence is purely recombinant and in modified form and its functions are not identical to that occurring naturally. But nevertheless, there are certain granted patent claims where isolated DNA/gene sequences are not substantially different from that occurring in nature. Such claims have been granted based on the previous precedence of such issued claims.

About the Author: Ms. Minusmita Ray, a Senior Patent Consultant in Institute of Intellectual Property Research & Development (IIPRD) and can be reached: minusmita@iiprd.com.

1. Cards are already on the table

Google isn’t getting a lost treasure chest filled with unimaginable secrets in this deal. Motorola was and is already actively engaged in patent litigation with a number of parties, including Apple and Microsoft. These actions will continue, according to assertions made by Google during yesterday’s conference call about the acquisition. Google may help Motorola sustain these legal battles, but it won’t necessarily create any new ones; Motorola stood to gain more by asserting its portfolio than Google does, since licensing fees could have benefited the faltering company in the same way they now help Kodak flesh out its bottom line. So it stands to reason that it looked long and hard at its portfolio to see what had the most potential. Even if Motorola hasn’t played all of its patent cards yet, it probably chose the strongest to play first.

A table showing the size of the biggest patent deals and IP portfolios. Source: UBS.

2. Broad licensing limits potential for legal action

Motorola’s patents have another weakness: According to experts like FOSS Patents’ Florian Mueller and industry-watcher Steve Crowley, they are very broadly licensed. What that means is that many of Motorola’s patents are already legitimately licensed by parties involved in the smartphone patent battles, thus limiting their ability to be used as metaphorical intellectual property nukes in a “mutually assured destruction” scenario, as Mueller puts it.

3. These aren’t the patents you’re looking for

Motorola may have a lot of patents thanks to its role as a founder of cellular technology, but they don’t necessarily apply as specifically to newer technology, including smartphones like the iPhone and iPad. Motorola itself talks about its strengths lying more with network technologies and “video compression, decompression and security tech,” and Roughly Drafted points out that Google has been in the Android business longer than Motorola, which should have provided it with more time to acquire patents relevant to defending the platform.

Google may have bought Motorola at least in part for the patents, and it may come out considerably richer in that regard than it was before. But that doesn’t mean it has guaranteed itself immunity from the patent attacks that continue to be directed at Android, and I doubt we’ll see Apple deviate much from its current course in that regard as a result of this deal.

Nokia had been seeking the revocation of European Patent (UK) No. 1 841 268 (‘268 Patent) belonging to IPCom. In addition, by counterclaim, IPCom alleges infringement of 268 in respect of a number of mobile phones sold by Nokia. Nokia denies infringement. The ‘268 patent is itself a patent which was divided out of European Patent No. 1 186 189 (“the parent patent”). Like the parent patent, ‘268 is concerned with managing the problem of contention on a random access radio channel uplink between mobile phones and a network base station.

Regarding the validity of the patent, Judge held that “It is of course always necessary, at the end, to take a step back and ask whether the claim embodies an inventive step, both in the case of the attacks based on specific publications and in the case of the common general knowledge. Nokia submitted that the invention achieved nothing in terms of functionality as compared with, say, IS-95. That is correct as far as it goes, but it does not follow that IPCom’s approach to achieving that functionality is obvious. It is entirely possible that invention lies in achieving the same functionality in a different way. In the end I was not satisfied that any of Nokia’s four starting points rendered IPCom’s solution obvious. It follows that I reject all the attacks on the 268 patent based on obviousness”

Infringement

There is a Product and Process Description for each of 14 types of Nokia device. The High Court held that the ‘268 Patent was infringed by two Nokia devices: “the A1″and “the A2″,but Nokia were granted a declaration of non-infringement in respect of Nokia’s devices, labeled B1,B2,C1,C2,D1,D2,E1,E2,F1,F2,G1 and G2.

High court clearly analysed the infringement by mapping the features of devices A1 and A2 of Nokia with the Independent claim 1 of ‘268. Independent claim1 of ‘268 patent is broken as follows:

[A] Mobile station for operation in a UMTS mobile radio network

[B] in which multiple user classes are distinguished

characterised in that the mobile station is arranged

[C] to read a user class from a SIM card

[D] to receive access threshold value bits and access class information over a broadcast control channel

[E] to determine an access threshold value from the access threshold value bits

[F] to use the access class information relevant for the user class to determine whether

[G] the mobile station is permitted to access a random access channel, for example RACH, independent of the received access threshold value bits

[H] or whether the access permission for the random access channel, for example RACH, is determined on the basis of an evaluation of the access threshold value.

Infringement

• The Nokia device described as A1 operates as follows. The mobile is designed to receive two parameters of relevance. These are the dynamic persistence level, N, and the AC to ASC mapping information.
• Any device operating in accordance with the A1 method must be a member of at least one Access Class (AC). There are 10 normal ACs, numbered from 0-9. Every device must be a member of one of those normal ACs and the number of the particular AC to which the device belongs is stored on its SIM card. There are another 5 special Access Classes (11-15) designated for use by special groups of users such as emergency services and network staff. All access classes may be barred at any time by the network.
• The next thing which it is necessary to understand is how the A1 selects an Access Service Class (“ASC”) which it will use for its access attempt. These ASCs are different from the AC stored on the SIM.. The transmitted data includes an element entitled “AC-to-ASC mapping”. This allocates each AC to an ASC. There are 8 ASCs numbered from 0-7. The mapping is carried out by the device reading the information element (IE) in the System Information Block appropriate to its AC. The way this is done is set out in Table 2 taken from the A1 Product and Process Description. ACs 0-9 look at the first IE in the block, 10 the second, 11 the third and so on.

• Depending on which ASC has been allocated by the mapping process, the device works out a “persistence value” known as P(i), (not the same as the dynamic persistence level, N, sent by the network). The way this is done is set out in Table 1 taken from the A1 Product and Process Description.

•  It can be seen that there is a difference between ASC 0 and the other ASCs. If a device is in ASC 0 the device automatically sets its persistence value, P(i), to 1. This conclusion is arrived at directly from the AC to ASC mapping and not from the other parameter of importance, the dynamic persistence level, N.
• On the other hand, if a device is in one of the other ASCs (1-7), it has to carry out a calculation using the dynamic persistence level, N, sent by the network.
• So P(N) is a function of (i.e. mathematically dependent on) the transmitted dynamic persistence level.
• Devices which are mapped to ASC 0 by the network will automatically pass the persistence test because the random number can never exceed 1. Those devices which are mapped to ASC 1 or higher may or may not pass the persistence test. Whether they pass the persistence test depends on the value N sent by the network.

The judge held that Nokia device A1 in summary held that:

i) the bits used to transmit the dynamic persistence level, N, constitute the access threshold value bits;

ii) the AC to ASC mapping information constitute access class information;

iii) P(N) is an access threshold value which is determined from the access threshold value bits;

iv) the AC to ASC mapping information is used to determine whether the device is in:

a) ASC 0, in which case it is permitted to access the RACH independent of the received access threshold value bits because it has a P(i) value of 1 which is not a function of the persistence level N which is being broadcast by the network; or

b) an ASC other than 0 in which case it must determine access permission on the basis of an evaluation of P(N) which comprises a comparison of P(N) with a randomly generated number.

In the A1device the random number comparison gives a win/lose determination on permission, whereas in the A2 it determines the extent to which permission will be delayed. However, the judge held that, in both cases access permission is determined on the basis of an evaluation of the access threshold value and thus infringing ‘268 patent.

About the Author: Mr. Veera Raghavan, Patent Specialist at IIPRD and can be reached at: Raghavan@iiprd.com

Introduction Facts:

1. EG is among the world’s leading wind turbine manufacturers and had set up EIL in 1995 having 56% stake in the company. After company level disputes EIL litigated against EG with as a result retaining control of EIL and Mr. Mehra remaining the Managing Director of the company.
2. Disputes over certain Licensing agreements led to EIL filing invalidation appeals/revocation petitions at the Intellectual Property Appellate Board for 23 patents (in the name of Mr. Wobben) of EG in Jan 2009. After hearing both parties through October and November, 2010, a bench of the IPAB, consisting of Mr. S. Chandrasekharan sitting as Technical Member and Ms. S. Usha sitting as Judicial Member revoked 12 EG’s patents. Decision of IPAB on the preliminary matters relating to Misc. petitions, dated 27’th July 2010, can be seen here in which IPAB directed miscellaneous petitions to be considered along with the respective original Revocation applications thereby dismissing the writ petition.
3. EG made an appeal against this preliminary order of the IPAB, praying for the Madras High Court to issue a writ of certiorari to strike down the impugned order. Judgment is made available here. The issue at discussion was the whether Mr. Yogesh Mehra, MD, of EIL, had the locus standi to maintain the application for revocation. On the one hand, according to the respondent, Mr.Yogesh Mehra relied on a Board resolution dated 27.04.2007, which according to them authorized him to institute suits and proceedings on behalf of the company. This was contraverted by the writ petitioner EG by stating that the resolution dated 27.04.2007 was void and non-est. The Madras High Court relied on the decision by the Hon’ble Supreme Court in the case of M/s. Fomento Resorts and Hotels Ltd. and specifically took note of the fact that when, there is a possibility of appeal all issues have to be taken up and decided. As the facts of the case clearly indicate that there is a definite possibility of appeal against the decision of the Tribunal and the present writ petition itself is one such illustration. Therefore, court ordered that the Tribunal rightly directed miscellaneous petitions to be considered along with the respective Original Revocation Applications thereby dismissing the writ petition.
4. Substantive disclosures of how the 12 patents were striked down have not been right now made available but one such order was for Patent No. 199045 dated 3’rd December 2010 has been shared by MIPR.
5. Furthermore, even though issues relating to locus standi were raised by the EG’s counsel which discussed on whether Mr. Mehra could be considered as an interested person, our discussion is strictly on the technical side of patent revocation and not on the legalities relating to authorization of Managing Director who has not been duly authorized by the Board of the Indian Company viz. EIL to sign the revocation application and further his ability also to file the affidavit in respect of the revocation application for the revocation of the subject patent..

Analysis of One Exemplary Patent:

Indian Patent No. 199045 (Corresponding WIPO Application can be accessed here)

Abstract:

The present invention concerns a wind power installation having a tower head of the wind power installation, comprising a flange for receiving a connection which is suitable for receiving the tower head ,f the wind power installation. Therefore the object of the invention is to provide a tower of a wind power installation having a flange for receiving a connection, wherein the tower does not suffer deformation in respect of its cross-section, in particular in the region of the flange, by virtue of the inherent weight of the tower, during manufacture and/or transport. A tower of a wind power installation for carrying a tower head of the wind power installation, comprising a flange for receiving a connection which is suitable for receiving the tower head of the wind power installation, characterized in that there is provided a partition or a ring bulkhead in the tower interior at a spacing of between preferably 1.0 m and 7.0 m from the flange, and the partition or the ring bulkhead substantially forms a disc which is connected to the tower wall in the tower interior and passes through the tower.

First Independent Claim as granted:

1. A wind power installation having a tower head of the wind power installation, comprising: a tower for supporting the tower head, the tower having an interior and a flange for receiving a connection that is suitable for receiving the tower head of the wind power installation; and a ring bulkhead in the tower interior at a spacing of between 1.0 m and 7.0 m from the flange, wherein the ring bulkhead substantially forms a disc that is connected to an interior wall of the tower.

Reliance was made on US Patent No. 3,761,067 having cited portions Col 1 (Lines 3-5) disclosing cooling towers, Col 1 (Lines 25-30, and Lines 43-44) for giving relation to the same problem that patent under revocation is attempting to provide a solution for, Col 1 (Lines 46-54) and Col 1 Lines 62-65 disclosing stiffening rings for force distribution, wherein the rings are ring or disc shaped.  ‘067 therefore disclosed the proposed inventive step of the subject patent by disclosing a ring structure in the tower, wherein the ring is disc shaped.

It was furthermore stated that a tower having a flange was already admitted by the Applicant of the patent under contention to be existing in the art and hence made part of the Background section of the patent application by stating that “A flange is usually provided at the end of the tower, in the case of the steel towers. That flange forms the flat support surface of the tower for receiving an azimuth mounting, in which respect ball-type rotational connections as are known in the general art are predominantly used as the azimuth mounting. This is shown in Figure 1.” Hence a flange for receiving a connection of a tower head couldn’t be considered as an inventive step.

Reliance was also made on US Patent No. 1,947,515 titled Elevated Tank wherein Page 2 Lines 90-99 was submitted to have disclosed use of a ring 27 which was riveted or welded circumferentially within the tower.

Reliance was also made on US Patent No. 4,261,931 titled “Cooling tower with fluted wall” discloses with cited portion being Col 5, Lines 30-40 wherein horizontal circular rings were disclosed to withstand the compressive loads.

Reliance was also made on US Patent No. 4,010,580 on similar inventive step grounds.  It was also stated that all the above four cited prior art references have not been discussed or been deliberated before in the prosecution for the corresponding patent in other geographies including US, EP, or India and hence the prior arts are valid and should be considered relevant.

It was finally concluded that “Comparing the inventive features in ’067 patent and the inventive features as construed from the principal claim 1, no difference in the invention claimed in the claim of the impugned patent could be perceived or notices.” It was therefore ordered by Mr. S. Chandrasekharan sitting as Technical Member and Ms. S. Usha sitting as Judicial Member that the application for revocation of patent has been allowed.

6. After having 12 of its patents striked down by IPAB, EG, in Feb 2011, surprisingly filed an appeal before the writ jurisdiction of the Delhi High Court against the Orders of the IPAB striking down 12 patents belonging to Dr. Wobben even though the case would typically have come under the jurisdiction of Madras High Court as IPAB that heard the revocation proceedings was based on Chennai and not in Delhi.

7. In April 2011, it has also been reported that Enercon GMBH has also filed further writ appeals before the Madras High Court against the Orders of the IPAB revoking several of his patents. The appeals have therefore been filed in both the jurisdictions

8. In the latest bit of update on the progress of the case, Enercon GMBH filed applications for withdrawal of three of its appeals for counterclaim against 3 of its revoked patents were accepted by the Delhi High Court. As the appeals against the other 9 revoked patents are going on in Madras High Court, it is quite possible that these 3 withdrawn appeals might get filed at the Madras High Court for consistency and other possible reasons.

About the Author: Mr. Tarun Khurana, Partner and Patent Attorney in Institute of Intellectual Property Research & Development (IIPRD) and can be reached: Tarun@iiprd.com.

The patent act indicates that issued patents are “presumed valid.” 35 U.S.C. § 282. In this case, Microsoft challenged the strength of that presumption — arguing that a low “preponderance” standard for proving invalidity should be sufficient rather than the higher “clear and convincing” standard required by the Court of Appeals for the Federal Circuit. The Supreme Court verdict was “We consider whether §282 requires an invalidity defense to be proved by clear and convincing evidence. We hold that it does.” Microsoft will now likely be forced to pay the $290 million judgment for infringing i4i’s patents.

The Supreme Court has rejected Microsoft’s argument and affirmed the Federal Circuit’s strong presumption of proof. Justice Sotomayor delivered the opinion for seven of the justices. By the time Congress enacted §282 and declared that a patent is “presumed valid,” the presumption of patent validity had long been a fixture of the common law. According to its settled meaning, a defendant raising an invalidity defense bore “a heavy burden of persuasion,” requiring proof of the defense by clear and convincing evidence. That is, the presumption encompassed not only an allocation of the burden of proof but also an imposition of a heightened standard of proof. Under the general rule that a common-law term comes with its common-law meaning, we cannot conclude that Congress intended to “drop” the heightened standard proof from the presumption simply because §282 fails to reiterate it expressly.

The Supreme Court similarly rejected Microsoft’s alternative proposal that the presumption of validity be weakened for validity challenges that were not considered by the USPTO during prosecution of the application. However, the Court did agree with Judge Rich’s American Hoist opinion that “new evidence” of invalidity likely carries more weight than evidence that had been previously considered and rejected by the Patent Office. In what may become the most litigated aspect of the decision, the Supreme Court says:

“Simplifying, if the PTO did not have all material facts before it, its considered judgment may lose significant force. And, concomitantly, the challenger’s burden to persuade the jury of its invalidity defense by clear and convincing evidence may be easier to sustain. In this respect, although we have no occasion to endorse any particular formulation, we note that a jury instruction on the effect of new evidence can, and when requested, most often should be given. When warranted, the jury may be instructed to consider that it has heard evidence that the PTO had no opportunity to evaluate before granting the patent. When it is disputed whether the evidence presented to the jury differs from that evaluated by the PTO, the jury may be instructed to consider that question. In either case, the jury may be instructed to evaluate whether the evidence before it is materially new, and if so, to consider that fact when determining whether an invalidity defense has been proved by clear and convincing evidence. Although Microsoft emphasized in its argument to the jury that S4 was never considered by the PTO, it failed to request an instruction along these lines from the District Court. Now, in its reply brief in this Court, Microsoft insists that an instruction of this kind was warranted. That argument, however, comes far too late, and we therefore refuse to consider it.”

In its opinion, the court acknowledged policy arguments both for and against a strong presumption of validity (Citing Lemley & Lichtman), but in the end decided that it was bound to follow Congress and the common law precedent.

Author – Veera Raghavan Rajendran,
Patent Specialist, IIPRD.
The Author of the Blog can be reached: Raghavan@iiprd.com.

A patent infringement suit filed by Bruce N. Saffran, a New Jersey Radiologist (“Plaintiff”) against Johnson & Johnson (J&J) and Cordis Corporation (“Defendants”) claiming that defendants directly infringed U.S. Patent No. 5,653,760 (filed Aug. 9, 1995) (the `760 patent;) entitled “Method and Apparatus for Managing Macromolecular Distribution”. Defendants’ accused products are the Cypher drug-eluting stents (including the Cypher Select and Cypher Select Plus) for which they were nailed with $482 million verdict. Case ruled in United States District Court, E.D. Texas, Marshall Division.

About the patent ‘760

 The ‘760 patent discloses a medical device preferably drug eluting implantation device used for the treatment of damaged tissues such as cardiac vessels and/or injured bones.

Claim 1 of the patent states:

A flexible fixation device for implantation into human or animal tissue to promote healing of a damaged tissue comprising:

a layer of flexible material that is minimally porous to macromolecules, said layer having a first and second major surface, the layer being capable of being shaped in three dimensions by manipulation by human hands, the first major surface of the layer being adapted to be placed adjacent to a damaged tissue,

the second major surface of the layer being adapted to be placed opposite to the damaged tissue,

the layer having material release means for release of an at least one treating material in a directional manner when said layer is placed adjacent to a damaged tissue, the device being flexible in three dimensions by manipulation by human hands,

the device being capable of substantially restricting the through passage of at least one type of macromolecule therethrough.

Dispute on Claim Elements by both Parties

 Defendants’ Argument on above Court’s statement:

Defendants seek judgment as a matter of law (“JMOL”) that (1) there is no infringement; (2) the patent-in-suit is invalid; (3) there is no willful infringement; and (4) there was not sufficient evidence to support $482 million in damages.

1.      Non-Infringement:

Defendants argue that they did not directly infringe any of the claims of ‘760 patent and states that there is no sufficient evidences to prove Cypher stents infringing Plaintiff’s claimed invention. But the Court based on the five disputed limitation concludes and proves Defendants product infringing Plaintiff’s ‘760 patent. The five points being:

a.     Capable of Being Shaped in Three Dimensions by the Manipulation of Human Hands.

b.     The Layer is “Minimally Porous” to Macromolecules.

c.     The Material Release Means Limitation

d.     The “Device” Being Flexible in Three Dimensions by Manipulation of Human Hands

e.     The Device Being Capable of Substantially Restricting the Through Passage of at least One Type of Macromolecule.

2.      Validity:

Defendants seeks that claims of ‘760 patent is invalid and is rendered obvious in the light of (1) U.S. Patent No. 5,282,823 (“Schwartz”); (2) Schwartz in combination with U.S. Patent No. 5,545,208 (“Wolff”); and (3) Schwartz in combination with Langer, R.S. & Peppas, N.A., Present and Future Applications of Biomaterials in Controlled Drug Delivery Systems, Biomaterials 2:201-14 (1981) (“Langer”). However, Plaintiff provided sufficient evidences that the `760 Patent was not obvious in light of Schwartz, Schwartz in combination with Langer, or Schwartz in combination with Wolff. Hence, the Court DENIES Defendants’ motion for judgment as a matter of law on the grounds of invalidity.

3.      `Willful Infringement:

Due to lack of sufficient proofs/evidence provided by Plaintiff, the Court GRANTS Defendants’ motion for JMOL stating that Defendants did not willfully infringe the ‘760 patent.

4.      Damages:

Defendants seek judgment as a matter of law that they would not award Saffran $482 million in damages arguing that licenses relied on by Plaintiff were improper. But the Court DENIES Defendants’ motion for JMOL and concludes there are sufficient evidence supports to find damages & 482 million.

Conclusion:

From the above law suit it is found that Defendants’ motion for JMOL is GRANTED-in-part and DENIED-in-part. The Court DENIES Defendants’ motion for JMOL on the issues of infringement, validity, and damages because the Court concludes that sufficient evidence supports the jury’s verdict on these issues. The Court, however, GRANTS Defendants’ motion for JMOL on the issue of willful infringement because the Court holds, as a matter of law, that there was no willful infringement. Had, the Defendants’ proposed product been modified in either its structural and/or functional aspects, it would not have infringed Saffran’s claimed invention. But finally due to proper and core analysis on the overall case with substantial evidences, the Court has rendered a justified verdict saving the Plaintiff from heavy damages by awarding him $482 million.

Author – Minusmita Ray,
Patent Consultant, IIPRD.
The Author of the Blog can be reached: Minusmita@iiprd.com.

‘530 Patent:-
The ‘530 patent entitled “Supply items for printers and the like, and method of loading supply items” has a priority date of 31st July 2002. The invention relates to printers, laminators and other equipment to produce data bearing identification. In particular, the invention relates to supply items (Ribbon, webs that carry laminate patches, cleaning tape, holographic overlays, and other exhaustible web materials) in such equipment and to a method for facilitating the loading of the supply item into the equipment.

The patent describes a supply item and a carrier that are modified to facilitate loading of the supply item onto the carrier in the proper orientation, and the carrier can be more easily loaded into the production equipment in the correct orientation.

The supply item 10 includes a print ribbon 12 wound onto a supply cylinder 14. The supply cylinder 14 includes first and second ends 20a, 20b and is generally hollow from the first end to the second end. Likewise, the take-up cylinder 18 includes first and second ends 22a, 22b and is generally hollow from the first end to the second end. Preferably, the ends 20a, 20b, 22a, 22b of the cylinders 14, 18 are designed to facilitate loading of the cylinders 14, 18 onto a carrier 24 in the proper orientation, thereby simplifying ribbon replacement. Mostly a difference in the geometry of the ends of the cylinders 14, 18 is used to achieve the simplified replacement.

With reference to Figures 1, the ends 20a, 20b of the cylinder 14 each define an opening having an area, with the area of the opening at the end 20a being substantially equal to the area of the opening at the end 20b. In addition, the ends 22a, 22b of the cylinder 18 each define an opening having an area. However, the end 22a of the cylinder 18 is closed by a wall 26 that forms part of a cap 28 that is connected to the end 22 of the cylinder 18. An opening 30 is provided in the wall 26. Thus, the area of the opening 30 at the end 22a is different than the area of the opening at the end 22b, and the area of the opening 30 is different than the area of the opening at the end 20a of the cylinder 14. The difference in the geometry of the openings at the ends 20a, 22a of the cylinders 14, 18 limit how the cylinders 14, 18 can be connected to the carrier 24. While the end of the cylinder 18 is described as having an opening 30 with an area less than the opening at the end of the cylinder 14, it is to be realized that the reduced area opening can be provided on the cylinder 14 rather than on the cylinder 18.

The inventive concept of claim 1, after amendment, explains that one end of one of the cylinders of a supply item has a different geometry to that of the other three ends so that the supply item can be correctly loaded onto a carrier having appropriately-shaped spindles.

Obviousness over Fargo Pro-L (US Patent No 5,755,519):

The Fargo Pro-L printer has four hubs, three of which are large and one of which is smaller. The ribbon is supplied on two cylinders. One of the ends of the cylinders is different to the other three ends in that it is fitted with a closely fitting circular insert. This insert has an aperture which is concentric with the circumference of the insert and the inner circumference of the cylinder. The insert contains a number of metal pins disposed in a circle concentric with the aperture. The aperture enables the end of the cylinder with the insert to fit onto the smaller of the four hubs, but is not large enough to fit properly onto the other three hubs.

Difference between ‘530 and Fargo Pro-L:
The differences are that, in Fargo Pro-L the cylinders are directly loaded onto hubs in the printer. On the other hand, in amended claim 1 of ‘530 the cylinders are loadable onto spindles on a carrier, the cylinders have ribs on their interior surfaces and the differences in the ends of the cylinder are capable of limiting how the cylinders can be connected to a carrier.

Defendants Arguments:
Eagle contends that there is a disadvantage with the method of loading the ribbon used in the Fargo Pro-L as it was fiddly to fit the cylinders onto the four hubs inside the printer. A well-known and obvious alternative method of loading a ribbon in 2002 was direct loading onto two spindles in the printer. Once the skilled team decided to adopt the direct loading onto spindles approach, it would have been immediately apparent to them that the cylinders would need to have ribs on the inside so as to enable the spindles to drive the cylinders. At that point they would have arrived at a supply item within amended claim 1, because the geometry of the ends of the cylinders would be capable of limiting loading onto spindles on an appropriate carrier.

Judge dismissed Datacard five arguments that were crucial in determining the obviousness:
First, DataCard argues that the skilled team would have no motive to change from the hub design of the Fargo Pro-L. Judge did not accept this arg. and said that the absence of motive is not conclusive Changing from one well-known ribbon loading arrangement to another one is not something that requires a specific motive, because they are technically obvious alternatives to each other. Furthermore, in the present case there would be a motive, namely the desire for a less fiddly method of loading the ribbon.

Second, the skilled team would have motive not to change it. Judge refused this arg. and said by changing the loading method from hubs to spindles would not necessitate changing the insert, nor prevent the ribbon being identified by means of a Hall Effect sensor.

Third, if the skilled team decided to change from hubs to spindles, it would be into a complete re-design of at least the ribbon-loading aspects of the machine. Judge refused this point by saying if differential geometry of the ends of the cylinders in terms of preventing error loading when combined with suitable hubs would be apparent to the skilled team, then it would not take invention to appreciate that precisely the same advantage could be obtained when replacing hubs driven by means of notches with spindles driven by ribs.

Fourth, judge, for the above reasons, refused to accept Expert witness evidence that the two systems involved a different constructional principle, and therefore a wholesale re-design would be required.

Finally, DataCard submitted that account should be taken of Expert Witnesses evidence in his reports as well as his evidence in cross-examination. Although Judge have taken Witnesses evidence and its reports into account, this does not assist DataCard for the simple reason that in his reports Expert Mr Klinefelter did not consider the case which was put to him in cross-examination.

Obviousness over Brother (US Patent No. 6,257,780):
Judge is of the opinion that the arguments in relation to Brother are similar to those in relation to Fargo Pro-L. So far as amended claim 1 is concerned, Eagle’s case is that an obvious alternative to the different notches on the spools in Brother would be to drive the cylinders by means of ribs inside and to change the geometry of one end in a different way by making one of the apertures of the cylinders smaller than the others. Judge agreed to Eagles argument.

Obviousness over Sharp (Japanese Unexamined Patent Application No. H10-329378):
Sharp is a similar proposal to Brother. Counsel for Eagle accepted that Eagle’s case in relation to Sharp was virtually identical to its case in relation to Brother.

It is seen that the case laws, for obviousness, interpret the evidence and the prior arts from the person who is skilled in the technology. From his point of view Judge questions the Expert witnesses of both the parties. Infact Judge questions the witnesses as to whether the prior art leads a motive to develop to the present patent in question? Whether, skilled team can arrive only to this technology as an alternative to the existing technology in the prior art? and so on. There are certain differences in the degree of obviousness from US courts and English courts point of view. Graham factors, the core factors for finding the obviousness include many factors and are very rigid in nature.

In the next part, we will see the obviousness case of ‘572 patent to assess the degree of obviousness in the UK courts in a detailed manner.

Author – Veera Raghavan Rajendran,
Patent Specialist, IIPRD.
The Author of the Blog can be reached: Raghavan@iiprd.com.

‘803 Patent:

In the ’803 patent titled “System for displaying programming information”, Microsoft claims that defendant is infringing ‘803 patent by way of using, selling, offering for sale, and/or importing products, systems and/or processes in US and within the scope of the ‘803 patent. Such infringement products, services and software’s include defendants TiVo Premiere and TiVo Premiere XL.

‘803 claims a method for retrieving and displaying items of electronic information. The electronic information has a list of programs arranged in categories to which they belong. A category display contains an array of related channels and subcategories contain programs related to that channel. Arrangement is made in a panel to display these categories and sub-categories. User can scroll through the panel and select the category of channel that he wishes to access and watch the information about it. User can also select the desired channel based on the obtained information.

‘314 Patent

In the ’314 patent titled “System and method for secure purchase and delivery of video content programs”, Microsoft claims that defendant is infringing ‘314 patent. Such infringement products, services and software’s include defendants set top box products, services and software.

‘314 patent relates to purchase and delivery of video content via internet. The video content is delivered by secured methods and by using cryptographic methods. Decryption capabilities of data are kept with video merchant. When a buyer asks for a particular video, the decryption capabilities of the video program are downloaded to an IC card, further used to authenticate and decrypt the data. The video can be downloaded and distributed to the user. The IC card uses the decryption capabilities to partly decrypt the video content without exposing the capabilities to decrypt it.

Microsoft claims a system for purchasing video content programs including a merchant computing unit at a video merchant and a purchaser integrated circuit (IC) card that compatibly interfaces with the merchant computing unit. The purchaser selects a video content program and the merchant computing unit downloads decryption capabilities unique to the selected video content program to the purchaser IC card for use in decrypting the selected video content program. These decryption capabilities include a program key unique to a related video content program and a policy concerning decryption protocols.

TiVo has products in set top boxes domain such as TiVo Premiere and TiVo Premiere XL. These products are having features such as

ü      program recording,

ü      on demand video store,

ü      HD user interface,

ü      online or mobile scheduling of video recording, among others

As the concerned patents relate to online video requests and program display systems, which map to TiVo’s products, it would be interesting to see how the case proceeds.

IIPRD would, based on its preliminary analysis, soon be coming up with its own claim mapping for one of the patents with respect to one TiVo’s products to render its brief opinion on level of literal infringement.

Author: Nagraj Mannikeri, Patent Consultant

The author can be reached: iiprd@iiprd.com

In summary the patent discloses, a Multi-node (MN) that connects to an access point for performing communication. The communication may be performed by transmitting and receiving messages between the access point and the mobile device. When the MN moves out of the coverage area of an access point, then a handoff process occurs. During the handoff process, the MN tries to select another possible access point, according to the present invention, by determining speed of the mobile node in the network and by determining a domain of migration of the mobile node.

The Applicant is intended to claim the following:

1. A method for selecting a mobility anchor point for a mobile node in a network, the method comprising:

determining speed of the mobile node in the network; determining a domain of migration of the mobile node; and selecting the mobility anchor point based on the speed and the domain of migration.

Based on quick due diligence, IIPRD identified few prior arts that can be considered material for invalidation on the present patent application. The prior arts include:

1. Mobility anchor point selection based on user mobility in HMIPv6 integrated with fast handover mechanism – Published in 17 March 2005
2. A performance comparison of mobility anchor point selection schemes in Hierarchical Mobile IPv6 networks – Published in 07 October 2005.
3. History based Auxiliary Mobility Management Strategy for Hierarchical Mobile IPv6 networks – Published in 07 July 2005.

Discussing further, part of claim mapping is cited below for the first prior art.

It is further to be noted that there are many valid grounds to reject a patent under section 25 of Indian Patents act, 1970.  Few Important grounds are stated here:

Important Grounds under Opposition to grant of patent:

Section 25 (1) Where an application for a patent has been published but a patent has not been granted, any person may, in writing, represent by way of opposition to the Controller against the grant of patent on the ground –

(b) that the invention so far as claimed in any claim of the complete specification has been published before the priority date of the claim-

(i)  in any specification filed in pursuance of an application for a patent made in India on or after the 1^st day of January, 1912; or

(ii)  in India or elsewhere, in any other document; provided that the  ground specified  in sub-clause (ii) shall not be available where such publication does not constitute an anticipation of the invention by virtue if sub-section (2) or sub-Section(3) of Section 29;

(e) that the invention so far as claimed in any claim of the complete specification is obvious and clearly does not involve any inventive step, having regard to the matter published as mentioned in clause (b) or having regard to what was used in India before the priority date of the applicant’s claim;

Pre-grant Opposition under Section 25(1) (b) (i) and under Section 25 (1) (e) under the grounds that the patent publication in light of the above cited prior art(s) can be rendered non-novel/obvious and hence non-patentable.

We believe that it is the right time to conduct a comprehensive due-diligence to understand the type of patents being filed currently by Indian and International Corporates, analyze the scope of protection that might be accorded from a functional and structure/construction perspective, and also assess the manner in which they might later impact the products/services being launched by Corporates and specially start-ups in the same domain.

Please note that the above analysis and the opinion presented are solely performed by IIPRD professionals and the views are solely their own and not be relied and intended to be legal advice about particular problems and. Corporates who are interested in filing a pre-grant oppositions are advised to carry out further due diligence for the same. For any comments or queries, please mail us to iiprd@iiprd.com.

Author – Veera Raghavan Rajendran,

Patent Specialist, IIPRD.

The Author of the Blog can be reached: Raghavan@iiprd.com.

In the Indian context, even though pre-grant oppositions are not a very common phenomenon right now and are typically restricted to the pharmaceutical sector, mostly because of legacy and “react when you get hit mentality”, the time is not far when Corporates realize the importance that a granted patent could have on the business execution. Such patent might not stop the complete business functioning of a Corporate but sure can make a small dent by a legal suit followed by certain damages or injunctions. Why not take an easier route and be diligent in filing a pre-grant opposition as a proactive step and negate th patent itself in the first place. Any Person, according to section 25 of Indian Patents act, 1970, can apply for a Pre-grant opposition for a published patent application in India.  In the recent past, Potential people (including Potential Infringers!) can file an Pre-grant Opposition under Section 25(1) in the Indian Patent Office against this concerned Patent Application by presenting relevant prior arts/documents based on which this patent can be rendered non-novel/obvious and hence non-patentable. This pre-grant opposition needs to be filed before the grant of this Indian Patent Application.

This article is merely an effort and initiative from IIPRD to randomly pick up recently published Indian patent application and try and understand the chances of getting a valid patent. IIPRD made note of an Indian Patent Application, which has been recently been published in the Indian Patent Journal, relating to a web guide and particularly to a method and system for dynamically presenting a website.

In summary, the patent disclosure relates to a user specifying his initial interests which are collected to generate a preference profile for the website. Given the preference profile, a web guide automatically restructures the website presentation in such a way that the website looks as if it has been ‘made for me’. That is, the presentation of the website is personalized for the user. Unlike conventional personalization which only allows the user to select a background, font color, and other limited choices, the web guide leads navigation of the website. That is, the web guide synchronizes the displayed web content (data, information, etc.) with the specified interests of the user. The web guide further provides the user with queries and prompts based on the user’s preferences, and the returned content is subsequently used to further guide the user in his navigation. These queries and prompts are designed to follow the logic of a human tour guide. That is, the queries and prompts of the web guide focus further searching by providing guidance that is related to the preferences already expressed by the user and thus more likely to be relevant to the user.

The Applicant is intended to claim the following:

1. A server comprising:
computer executable instructions configured to:
present an initial home page, the initial home page including initial preference options;
receive initial preference option data corresponding to the initial preference options;
retrieve select first data based on the initial preference option data; and
structure a first presentation of a website based on the select first data, the first presentation including a closed set of subsequent preference options based on the select first data.

Based on quick due diligence, IIPRD identified few prior arts that can be considered material for invalidation on the present patent application. The prior arts include US Patent publication no. 2008/0209336, US Patent No. 7,353,460 and US Patent No. 7,743,334.

Discussing further, part of claim mapping is cited below for the first prior art.

It is further to be noted that there are many valid grounds to reject a patent under section 25 of Indian Patents act, 1970.  Few Important grounds are stated here:

Important Grounds under Opposition to grant of patent:

Section 25 (1) Where an application for a patent has been published but a patent has not been granted, any person may, in writing, represent by way of opposition to the Controller against the grant of patent on the ground –

(b) that the invention so far as claimed in any claim of the complete specification has been published before the priority date of the claim-

(i) in any specification filed in pursuance of an application for a patent made in India on or after the 1^st day of January, 1912; or

(ii) in India or elsewhere, in any other document; provided that the  ground specified  in sub-clause (ii) shall not be available where such publication does not constitute an anticipation of the invention by virtue if sub-section (2) or sub-Section(3) of Section 29;

(e) that the invention so far as claimed in any claim of the complete specification is obvious and clearly does not involve any inventive step, having regard to the matter published as mentioned in clause (b) or having regard to what was used in India before the priority date of the applicant’s claim;

Pre-grant Opposition under Section 25(1) (b) (i) and under Section 25 (1) (e) under the grounds that the patent publication in light of the above cited prior art(s) can be rendered non-novel/obvious and hence non-patentable.

We believe that it is the right time to conduct a comprehensive due-diligence to understand the type of patents being filed currently by Indian and International Corporates, analyze the scope of protection that might be accorded from a functional and structure/construction perspective, and also assess the manner in which they might later impact the products/services being launched by Corporates and specially start-ups in the same domain.

Please note that the above analysis and the opinion presented are solely performed by IIPRD professionals and the views are solely their own and not be relied and intended to be legal advice about particular problems and. Corporates who are interested in filing a pre-grant oppositions are advised to carry out further due diligence for the same. For any comments or queries, please mail us to iiprd@iiprd.com.

Author – Veera Raghavan Rajendran,

Patent Specialist, IIPRD.

The Author of the Blog can be reached: Raghavan@iiprd.com.

Introduction:

Monsanto’s European patent EP0546090 (‘090) granted on 19 June 1996, discloses “Glyphosate tolerant 5-enolpyruvylshikimate-3-phosphate synthases”, the patent being valid, inter alia, in Netherlands. Glyphosate, a non-selective herbicide, exhibits an anti-growth effect on plants by inhibiting Class I enzyme 5-enol-pyruvylshikimate-3-phosphate synthase (also called ‘EPSPS’). As a result plants die due to its toxic effect.

The patent ‘090 describes a class of EPSPS enzymes i.e. Class II EPSPS enzymes instead Class I which are resistant to glyphosate. Hence, plants containing such enzymes survive the use of glyphosate, and only the weeds get destroyed. The genes encoding these Class II enzymes have been isolated from three different bacteria. Those genes were incorporated into the DNA of a soy plant, called RR (Roundup Ready) soybean plant. As a result, the RR soybean plant produces a Class II EPSPS enzyme called CP4-EPSPS, which is glyphosate-resistant. It thus becomes resistant to the herbicide ‘Roundup’.

Infringement Suit Filed:-

The RR soybean is cultivated on a large scale in Argentina, where Monsanto did not hold any patent protection for his invention. Importing soy meal from Argentina into Amsterdam port on 16 June 2005, 21 March and 11 May 2006 by Cefetra, Vopak and Toepfer had led to a case of Patent infringement and hence Monsanto applied for injunctions against the three before Rechtbank’s-Gravenhage, on the basis of Article 16 of Regulation No 1383/2003, and for a prohibition of infringement of the European patent in all countries in which the patent is valid. Samples of exported soy meal were tested by Monsanto to determine whether they originated from RR soyabeans. Results revealed the presence of CP4-EPSPS in the soya meal and the DNA sequence encoding it.

In turn, Cefetra, supported by Argentine State, argued that Article 53a of the 1995 Law is exhaustive in character, stating that if the DNA present in the soy meal can no longer perform its function in that substance, Monsanto opposing the marketing of the soy meal solely on the ground that the DNA is present in it. It claimed the connection between the limited patentability referred to in recitals 23 and 24 in the preamble to the Directive and the scope of the protection conferred by a patent. Recital 23 in the preamble to the Directive (European Union Law) states that a mere DNA sequence without indication of a function does not contain any technical information and is therefore not a patentable invention. Recital 24 in the preamble to the Directive (European Union Law) indicates that, in order to comply with the industrial application criterion it is necessary in cases where a sequence or partial sequence of a gene is used to produce a protein or part of a protein, to specify which protein or part of a protein is produced or what function it performs. Monsanto argued stating that “The purpose of the Directive is not to limit the protection for biotechnological inventions that exists in Member States neither does it affect the protection conferred by Article 53 of the 1995 Law, which is absolute. A restriction on protection would be incompatible with Article 27 of the TRIPS Agreement”

But, the key statement by Rechtbank’s-Gravenhage (where the case was filed initially) after observing Article 53a(3) of the 1995 Law, like Article 9 of the Directive, stands were:-

-          The DNA/genetic material hold the exclusive right of the proprietor of the patent if the genetic information is found in that material and performs its function therein.

-          This concludes that soy meal being a dead material does not expresses the functional DNA.

Hence, Article 53a(3) of the 1995 Law and Article 9 of the Directive, does not go in favor of Monsanto’s arguments of his patent being infringed and explicitly states that DNA function was observed in the soy plant at the given moment, and it could again express its function when isolated from soy meal and transferred to a living material.

On the above circumstances, the following articles were discussed:-

1.      Article 9 of Directive 98/44/EC of the European Parliament states that the patented product (enzyme and its encoding DNA) is contained in the soy meal, where it does not perform the function for which it is patented, but did perform that function previously in the soy plant, of which the meal is a processed product, or would possibly again be able to perform that function after it had been extracted from the soy meal and inserted into the cell of a living organism.

2.   Article 9 of the Directive effects an exhaustive harmonization of the protection it confers, with the result that it precludes the national patent legislation from offering absolute protection to the patented product as such, regardless of whether it performs its function in the material containing it.

3.      Article 9 of the Directive precludes the holder of a patent issued prior to the adoption of that directive from relying on the absolute protection for the patented product accorded to it under the national legislation then applicable.

Key Take Away:-

In this context of patent infringement case, I would like to highlight two facts :-

Firstly, though the soy meal as stated by the court to be a “dead material” exported from Argentina is likely to be produced from soy plant, incorporating with the modified DNA encoding CP4-EPSPS, revealed by the tests could be a ardent fact of infringing, evidently, Monsanto’s protected process patent (though not product patent) in the European territory while trading the plant product into its (European) community where Monsanto holds still a valid patent.

Secondly, if Monsanto would have hold a Patent protection of RR soybean in Argentina, then Cefetra along with Vopak and Toepfer, certainly had to bear the cost for infringing Monsanto’s invention for the respective territory. Hence, the Infringement Suit would have been in Monsanto’s favor. This reminds our Indian corporates/Inventors and R&D Institutes to rethink their IP Portfolio strategy and to make sure that the patent has been protected globally.

CASE NO – C-428/08

About the Author:- Ms. Minusmita Ray, a Patent Specialist in IIPRD and can be reached at minusmita@iiprd.com

Long story in short, i4i filed a patent in 1994 and gets granted on 07/98 (US 5,787,449). ‘449 relates to a system and method for the separate manipulation of the architecture and content of a document, particularly for data representation and transformations. Interestingly, Microsoft, in its new product, described the new feature as “truly integrate your documents with business processes and business data,” and explained the role of XML Data Store in MS Office 2007 documents. Unfortunately, description of the MS Office document XML Data Store basically equates to the i4i patent’s description of the “raw content area.” Similarly, Microsoft description of the “relationship from the main document” to the data stored in the XML Data Store relates to the i4i patent’s metacode mapping.

I4i sued Microsoft for Patent infringement and in turn Microsoft requested and filed a Re-examination of the ‘449 Claims citing Prior arts ”DeRose” and “Cowan”. The Lower court said that the ‘449 Claims are valid and Microsoft decided to appeal to the Federal court. Even CAFC, affirmed the lower courts decision and ordered a heavy injunction on Microsoft. With a clear infringement, Microsoft has got less or no space in fighting for technicality or Novelty requirements of ‘449 Patent.

Knowing this, Microsoft has appealed to the apex court in an interesting manner. Microsoft is expected to attack the system of validating patents itself.  For sure, it will request the apex court to consider and lessen the burden of defendants to show prior arts for“clear and convincing evidence”. On the other hand i4i Chairman Loudon Owen warned about Microsoft’s argument that patent invalidity should be held to a lower standard. “The attack on patent holders and the adverse implications from the standard Microsoft is proposing is unprecedented and would deal a devastating blow to any U.S. patent holder, large or small,” Owen said. “Naturally, the proposed standard would be particularly destructive to the value of patents for inventors, technology pioneers and entrepreneurial companies that don’t have the resources of Microsoft and other giants.

We will come to know, whether the Supreme Court will nod for the change in Legal system, particularly the burden of Proof section, when the case to be heard in Spring 2011.

Author – Veera Raghavan Rajendran,

Senior Patent Consultant, IIPRD.

The Author of the Blog can be reached:  Raghavan@iiprd.com.

As an introduction, a third party requested ex parte reexamination of the patent. The U.S. Patent and Trademark Office (“PTO”) granted reexamination as to claims 5-8 and 10 of the ’503 patent. During reexamination, Glatt canceled claims 6, 7, and 9-11, limiting the reexamination to un-amended claim 5 and amended claim 8. The examiner rejected claim 5, but allowed amended claim 8. Glatt appealed the examiner’s rejection of claim 5 to the Board, which affirmed the examiner’s rejection.

The invention relates to a coating apparatus known as a “Wurster Coater” used to coat particles, e.g., pharmaceutical ingredients. Wurster coaters work by spraying the desired coating material onto particles circulating within the apparatus. The existing coating apparatus suffer from particle agglomeration, which increases the amount of time it takes to coat the particles. This agglomeration occurs because the circulating particles prematurely enter the stream of coating spray before the spray pattern has fully developed. This premature entry causes the particles to become overly wet and to stick together thereby causing blockages in the apparatus.

Glatt’s solution to this problem involves shielding the coating spray nozzle to prevent the particles from entering the spray prematurely. Glatt does this by creating a cylindrical partition that surrounds the coating spray nozzle and acts as a physical shield to prevent premature entry of the circulating particles. Col 5 Lines 3-12 of the Specification of Glatt’s patent additionally notes that “other shielding arrangements may be utilized. For example, shielding of the spray nozzle may be accomplished by formation of an air wall or stream that surrounds the nozzle and prevents particles from prematurely entering into the spray pattern.”

Following is the contested claim 5 of Glatt:

5. In a fluidized bed coater having a product container opening upwardly into an expansion chamber and downwardly into a lower plenum chamber through an air distribution plate/screen having openings formed therethrough for upward air flow from said lower plenum chamber into said product container, said product container including a substantially cylindrical partition spaced above said air distribution plate/screen for defining an inner upbed area and an outer downbed area, and an upwardly discharging spray nozzle mounted substantially centrally within said cylindrical partition,

the improvement comprising

shielding means positioned adjacent said spray nozzle for shielding the initial spray pattern developed by said nozzle against the entrance of particles moving upwardly through the upbed.

As can be seen, Claim 5 of the Glatt is written as a Jepson Claim, wherein the preamble is rendered as the prior art and the invention is the improvement. i.e., a shield used in the Wurster coater. Improvement portion of claim 5 also has a means-plus-function limitation—a “shielding means.”, wherein in a means-plus-function claim, scope of the claim is limited to the embodiments listed in the specification of the patent.

As the proposed novel part of the claim was considered as “shielding means positioned adjacent said spray nozzle”, during the re-examination procedure, the examiner identified DE 3323418 (“Naunapper”) and rendered Claim 5 (Jepson Claim) as obvious keeping in mind the embodiment put across in the specification of ‘503 Patent, which stated “shielding means” to include “formation of an air wall or stream that surrounds the nozzle and prevents particles from prematurely entering into the spray pattern”. The examiner contended that Naunapper discloses “an air wall, or air jacket, surrounding said spray nozzle” thereby rendering the Applicant’s invention obvious. After an appeal to the  board, the board of appeals too affirmed with the examiner and contended that the claimed subject matter was obvious as an air wall that surrounds the nozzle as disclosed by Naunapper would render all possible physical or air wall based shielding mechanisms of Glatt obvious.

When the matter was appealed to the US Court of Appeals, the Circuit Judges held that as Glatt does not contest that the preamble to claim 5 is admitted prior art, the inquiry is limited to whether Glatt’s invention as a whole would have been obvious to a person of ordinary skill in the art in view of the prior art Wurster coaters described in the claim and the Naunapper reference. It was understood that both Glatt’s invention and Naunapper’s coating apparatus contain coating spray nozzles and that both also include an air source located below the coating spray nozzle. Further, the air is used to circulate the particles in the apparatus into the spray of coating material.

However, additionally, Glatt’s invention includes an element that reduces particle agglomeration, described and claimed as “a shielding means that prevents the circulating particles from prematurely entering the initial spray pattern”. Naunapper, on the other hand, contains no such element and the PTO argues that the air source itself can be used to generate an air wall that shields the particles from the initial spray pattern. It was further held that the PTO indicates that Naunapper combats the particle agglomeration problem by temporarily increasing the airflow from the air source. The modulated “burst” of air/gas flow generated by this technique clears blockages by blowing through the agglomeration and dispersing the particles.

It was finally held that, that the proposed technique of Naunapper does not shield circulating particles from entering the initial spray pattern and rather merely teaches to remedy the blockage caused by particle agglomeration using bursts of air. In contrast, Glatt’s invention prevents the agglomeration from occurring in the first place. This led to the decision that the Board’s finding that Naunapper teaches shielding the nozzle to prevent particles from prematurely entering into the initial spray pattern is not supported by substantial evidence because Naunapper does not teach shielding but instead discloses the prevention technique of using airflow for combating and clearing of blockages by blowing through the agglomeration. Because Naunapper does not teach shielding, the federal circuit concluded that the Board has failed to make a proper prima facie case of obviousness.

Key Take Away’s:

1.      Determination of scope of protection of a means plus function claim should take into consideration all embodiments disclosed in the specification of the patent application and specifically the preferred embodiments as illustrated/described in the specification.

2.      Disclosing a potentially similar structure but a completely different purpose (an air wall of Naunapper vs.  formation of an air wall or stream of Glatt) does not objectively render the concerned application obvious. The intended purpose too plays a crucial role in determining the teaching or suggestion of the claimed subject matter by the prior art.

About the Author: Mr. Tarun Khurana, Partner and Patent Attorney in Institute of Intellectual Property Research & Development (IIPRD) and can be reached: Tarun@iiprd.com.

Story Behind the case:

A Lilly scientist invented a method to synthesize a genus of chemical compounds including gemcitabine and showed its antiviral activites in 1980s, for which the company got patent rights till May 15, 2010. Shortly after this, they also discovered anticancer activities of the same compound, and a second application was filed, but this one did not claim priority to the first application. All was smooth until the next decision taken by Lilly, of filing a CIP of the first application in order to add onto the definition of the disclosed genus of compounds. What must have been done in good faith, ended up in loss to Eli Lilly, as Sun put forward the disclosure of anticancer activity added to the first patent through the CIP application as the basis to invalidate the second patent on grounds of obviousness type double patenting.

The expansions of obviousness type double patenting:

A two-step process has been established by the Federal Circuit to analyze obviousness type double patenting. Step1- the court interprets the claims of original patent and those of the second patent. Step2- to determine if those differences make the claim’s patentably distinct.

Now, analysis for obviousness under section 103 becomes distinct from obviousness type double patenting in a way that in the later only the claims of the two patents are to be considered. (General Foods v. Studiengesellschaft Kohle, 1992). However, ten years later in 2002 Geneva v. GSK, Federal Circuit started using the description of the original patent to invalidate the second patent, thus marking the expansion of the doctrine of obviousness type double patenting.  The same was repeated yet again in 2007 in Pfizer v. Teva.

In the current Sun v. Lilly decision, the later went into trouble of obviousness type double patenting, due to its CIP filing for the original patent. The decision against Lilly has come opposite to the amended patent statute, 35 USC 103(c), which was brought about to encourage innovations and intra-company growth. The amendment stated that an invention by the company can not become a prior art to any of its own continued innovation made later on, thus giving protection to the company.

What should companies take note of in future:

The inventors should be clear on the repercussions of adding disclosure to a patent application, the details to be added in the disclosure, and the suitable time to invest in follow-on research. The best way would be to include only the minimum disclosure of methods to use the compounds so that it satisfies the utility requirement.

Author – Ms. Ritika Kishore,

Patent Consultant, IIPRD.

The Author of the Blog can be reached: iiprd@iiprd.com.

Technical Aspects of the Invention:

The present invention in question provides a closure plug that overcomes the problem of sealing gasket gripping and looping persisted in the available art.  Particularly, the Independent claim of the present invention is given below:

1. A closure plug formed with

i) a cylindrical side wall having an external helical screw thread,

ii) a circumferentially enlarged rim,

iii) an angular gasket seat immediately under the plug rim; and

iv) a continuous circumferential radially outwardly extending gasket retaining lip below the plug gasket seat,

characterized in that:

v) the gasket seat flares radially outwardly and upwardly directly from the root of the gasket retaining lip to meet the plug rim.

From the above claim, it is clearly seen that the subject matter as described and claimed involves a closure plug that has a cylindrical side wall, an enlarged plug rim, an angular gasket seat and a gasket retaining lip.

Opponent Contention:

The Opponent Technocraft cited six new prior arts to destroy the novelty and the inventive step of the claim in question. But during the oral proceedings, Opponent majorly used D5: US 3, 255, 916 Patent (‘916) as his powerful weapon.  The opponent contested that the subject matter present in the ‘916 patent reads the claim elements (feature i – iv) of ‘922.  Opponent further argued that gasket seat 19 from the figures 1 – 3 of ‘916 patent shows a gasket seat that flares radially outwardly and upwardly from the root of the gasket retaining lip to meet a plug rim.  Opponent finally argued that the word “directly” in the characterized portion is not clearly defined in the specification (patent in question) and further suggested the figures 1 – 3 of ‘916 patent shows like the arrangement as claimed in the patent that is in question.

Also, Opponent further cited two prior arts D3 (DE 44 40 852) and D8 (US 4, 768, 677) and merely stated that these prior arts destroy the novelty of the claim in question.

Opponent further cited D8 ‘677 Patent for destroying the Inventive step of the Invention.

Further, the Opponent cited the prior art combinations (D8 + D10) and (D8 + D9) and argued that even if the claim is novel in view of the prior art, it cannot be based on the Inventive step.

[D9: US 1, 964, 603 & D10: DE 810, 413]

Oral Hearing (Feb, 2010):

It is noteworthy to mention that the Proprietor consistently, during the opposition, said that none of the prior arts describe and disclose a gasket seat that flares radially outwardly and upwardly directly from the root of the gasket retaining lip to meet a plug rim. Further, Applicant argues, it is not obvious to a person skilled in the art to combine the prior arts as argued by the opponent.

As a last bomb, the Proprietor in the oral proceeding clearly argues that flaring is the solution to the problem of gripping mentioned in the description and that the seat directly flaring from the root of the lip provides an increased area of contact between gasket seat, as mentioned in the patent, aiding in the solution of the technical problem.

The Chairman who presided the Oral Hearing said that the Opposition division has decided to reject the opposition and to maintain the patent as granted

Take-a-ways from the Author:

The case that was related in this blog reminds us simple things but very clearly.  First of all, it is not the number of prior arts cited but the mapping of each claim elements along with its function is required.  It also reminds us that the innovative elements along with its function should be explicitly described and claimed in any patent application.  Further, in the mechanical invention, keeping the Prior art combinations to a minimum level and citing a prior art that maps the patent in question, by virtue of its function will be greatly rewarded.

REF: Europe Patent Office.

Author – Veera Raghavan Rajendran,

Patent Specialist, IIPRD.

The Author of the Blog can be reached: Raghavan@iiprd.com.

Do you need one? I am sure by this time you would have read or heard about the Bilski case somewhere. Well it’s not too late to know about it. Petitioner filed a patent application that claims a Business method @ USPTO. The claim included a subject matter that explains how commodities buyers and sellers in the energy market can protect or hedge against the risk of price changes. The Patent examiner rejected the application on the grounds that the invention is not implemented in any specific apparatus and merely solves a mathematical problem. Subsequently, the BPAI agreed to the examiner’s rejection and affirmed the case. At this time, Bilski moved to Federal circuit to fight for his case. The En Banc court decided and affirmed the case. But the reason in the Judgment presented by the court to reject the patent application has turned every Professional in this field to look back to this case.

Federal Circuit: The Bilski case goes famous

In order to patent a claimed Process, the invention should produce a “Useful, Concrete & Tangible” result and so far, this was the standard test that all the US courts including Fed. Circuit was relying upon. Contrastingly, Federal circuit when hearing this Bilski case rejected to apply the “Useful, Concrete & Tangible” test for the claimed Invention. Instead of the above test, the court was relying on “Machine or Transformation” test. “Machine or Transformation” test allows a claimed process to be patented if the claimed process is tied to a machine, state or thing or if the process transforms a particular article into a different state or thing.

When this “Machine or Transformation” test applied to Bilski case, the claims failed to meet the test requirements.

Claim 1 of Bilski consists of the following steps:

“(a) initiating a series of transactions between said commodity provider and consumers of said commodity wherein said consumers purchase said commodity at a fixed rate based upon historical averages, said fixed rate corresponding to a risk position of said consumers;

(b) identifying market participants for said commodity having a counter-risk position to said consumers; and

(c) initiating a series of transactions between said commodity provider and said market participants at a second fixed rate such that said series of market participant transactions balances the risk position of said series of consumer transactions.”

The judgment affirmed the case and summarized that the “Machine or Transformation” test is the sole test for determining whether a claimed process is an eligible patent subject matter. This created a big chaos for the people in this field questioning the rigidity of the Federal circuit when deciding the process claims of the patent applications. No wonder, Bilski tried the apex court to fight for his case.

Bilski in Supreme Court:

On June 28, 2010, Justice Kennedy, Justice Stevens, Justice Breyer & Justice Scalia gave their judgments together. In the judgment, they affirmed the case by saying the particular process of the Bilski case is not eligible to be a patentable subject matter. But the Judges pointed out the rigidity of the Federal circuit decision for this case.  In particular, Justice Breyer while conferring the Justice Kennedy’s judgment further added by saying “Although the courts can use “Machine or Transformation” test for determining whether a claimed process under section 101, but the Federal circuit erred in saying the test as “exclusive test”.

The War Continues…

Post Bilski, still it is not clear whether All Business method patents can be patentable or not by applying either one of the tests. What about method patents from other Industries. Definitely, they can be relieved and atleast they can protect their claims by relying on either of the tests…until new landmark case roots from Federal circuit…

Author – Veera Raghavan Rajendran,

Patent Specialist, IIPRD.

The Author of the Blog can be reached: Raghavan@iiprd.com.

Roche and Wockhardt – Roche got its first product patent in India in 2006 (and in return India got its first pharma product patent since its amended patent regime came into being) for Hepatitis Drug Pegasys. (Pegylated interferon alfa-2a). Its first and forthcoming patents all were being attacked by Indian Generics (not to forget various NGOs) whether through series of oppositions filed or counter attacking to Roche’s suits of infringement. Its struggle over its patents started in 2007, when India’s first post grant opposition was filed by Wockhardt and a Mumbai based NGO for “IN198952” on Pegasys attacking its validity claiming it to be non-inventive and not satisfying Section 3d (the section which has become the most controversial sections of Indian Patent Act since Novartis attacked its constitutionality in the famous Novartis Gleevec Case, an appeal is still pending in the Supreme Court).  That was the time (and the only time) when Roche could taste success with its patent by defending it successfully. Interestingly, Assistant Controller T.V. Madhusudan (in March 2009) ruled against the recommendation of Opposition Board to revoke the patent and held the patent to be valid. Roche successfully cleared the “enhanced efficacy” test in the Section 3d of the Indian Patent Act (including the novelty and obviousness tests). Section 3d allows a novel derivative of a known compound only when such derivative shows enhancement in known efficacy of a known compound. The efficacy is defined as therapeutic efficacy as per Madras High Court decision in Novartis Gleevec Case. Well, Interferon is known compound and known efficacy is its antiviral and anti proliferative activity and the experimental results in the patent showed that there is indeed enhancement of therapeutic efficacy which resulted in Roche’s victory. The complete decision could be read here:

Roche and Cipla - After Roche’s successful stint at winning Pegasys’ patent in the opposition proceeding, it faced the first blow to its Patent Rights for Tarceva, an anti-cancer drug. Roche sued Cipla before Delhi High Court claiming that Cipla’s generic product Erlocip violates former’s Indian Patent IN196774 claiming “Erlotinib Hydrocloride”. The trial Judge held against Roche on the ground of “public interest”, rejecting Roche’s appeal to grant interim injunction restraining Cipla from selling generic version of Tarcev as Cipla’s drug costs about 1/3rd of Roche’s patented drug. Roche’s subsequent appeal to Division Bench also failed miserably when not only did the bench uphold the findings of Trial Judge but also imposed costs on Roche for suppression of material patent information about Roche’s later filed application in India (IN/PCT/2002/00507/DEL) which was specifically on Polymorph B of Erlotinib Hydrocloride (‘507 application was rejected in 2008 following the opposition filed by Cipla primarily on Section 3d. Cipla argued that Tarceva corresponds to Polymorphic Form B of active ingredient Erlotinib Hydrocloride (claimed in ‘774 patent) and that it is Form B which is more stable and suitable for solid oral dosage form than the compound disclosed in ‘774 patent comprising a mixture of Forms A and B. The interesting part was that the claims were not even construed during the trial even once. Roche’s subsequent appeal before the Supreme Court (SC) challenging the order passed by the division bench got dismissed on August 29, 2009. Key reason for the dismissal was the ongoing trial at the Delhi High Court and SC ordered the ongoing trial be expedited.

Roche and Natco – While Roche’s fight for Tarceva over Cipla’s Erlocip was still continuing at the Delhi High Court, Roche brought another suit of infringement against Natco Pharma for infringing the same Tarceva Patent (‘774 patent). The issues pertaining to:

- drug pricing and public interest (the price of Natco’s drug “Erlonat” is equally low),

- interim injunction rejection (in Roche v Cipla) as a precedent,

- Natco’s filing of Compulsory license for the same patent (Natco earlier filed for the pre grant opposition for the same patent attacking its validity and later seeking to get compulsory license to produce generic version of the drug and export to Nepal),

- the selection patent application ‘507 later filed in India specifically pertaining to Polymorph B and suppression of material patent information.

All these are core issues (some of them were being discussed in Cipla too) which are being argued in the ongoing trial. Natco argued and proved by showing X-ray diffraction data that Tarceva is actually Polymorph B form of the compound claimed in suit patent ‘774, and that the Form B is claimed in ‘507 and not in the patent of question thus there could be no question of infringement. The Court will be hearing the Roche v Natco matter on a daily basis from July 27, 2010 onwards.

Roche and Ranbaxy plus others Roche got another blow meanwhile (in April 2010) when it lost patent rights (IN207232) over its anti-viral drug Valcyte (Valgancyclovir Hydrochloride), following the post grant opposition filed by Ranbaxy, Cipla and four other parties including Pharma companies and Indian NGOs. Valcyte is L-valine ester prodrug of known anti-viral drug “Gancyclvoir”. The patent was rejected primarily on grounds of lack of inventive step over US patent US 4957924 which claims L- valine ester prodrug of structurally similar nucleoside analogue and an anti-viral drug “Acyclovir” with improved oral bioavailability and is marketed as a hydrochloride (HCl) salt of said L-valine ester as Valacyclvoir Hydrochloride. It was argued that a person skilled in the art would be motivated to follow the same route to improve the oral bioavailability of Gancyclovir by forming its L-Valine ester prodrug and forming HCl salt of said ester with reasonable expectation of success. As regarding Section 3d here, it was held that increase in oral bioavailability is not an increase in therapeutic efficacy as both prodrug and the original drug are same classes of anti viral drugs and achieve the same therapeutically. The complete decision could be read here.

Key issues emerged

• Interpretation of the controversial Section 3d: The section 3d is under debate for quite some time now ever since the Novartis Gleevec case took off in India and its interpretation in the Madras High Court. The Court in the same case interpreted “efficacy” as “therapeutic efficacy” only and not in terms of enhancement in bioavailability or other pharmacological parameters. This ruling has been followed since then and the cases that follow and the cases we discussed above. The major issue revolving around is the lack of any quatifier for the term “efficacy” which makes the section open ended to be interpreted by courts at their own discretion.
• There should be a detailed analysis on the claim construction in such cases. The claims were not construed in the Cipla Tarceva case. The Indian Judges seem to lack technical know-how in pharmaceutical sciences and the various complexities involved. Having more resources and training could go a long way!
• Public Interest issue: In developing Countries like India, the issues like drug price and drug affordability make it unlikely that they will be able to resist pressure from their own citizens in favor of multinational drug companies like Roche. TRIPS intented to benefit both innovator and generic industries and both developed and developing nations , the balance seems to be little tilted towards the generic pharma world as pricing issue takes priority in most of the cases as discussed above
• Setback for innovation and R &D: The developed (innovator) industry should formulate some strategy for designing around drug prices in developing countries so that rewards for millions of dollars spent on research and innovation do not get diluted.

It is to be seen now when Roche’s wait for the verdict of the ongoing trials would be over and how it would affect its future business and patenting scenario in India.

About the Author: Ms. Meenakshi Khurana, a Patent Specialist in Institute of Intellectual Property Research & Development (IIPRD) and can be reached: meenakshi@iiprd.com.

A computer implemented invention was defined as any invention the performance of which involves the use of computer, computer network or other programmable apparatus, or an invention one or more features which are realized wholly or partially by means of a computer programme/ programmes. Computer programmes, on the other hand, were defined as a set of instructions for controlling a sequence of operations of a data processing system. It closely resembles a mathematical method. It may be expressed in various forms e.g., a series of verbal statements, a flowchart, an algorithm, or other coded form and maybe presented in a form suitable for direct entry into a particular computer, or may require transcription into a different format (computer language). It may merely be written on paper or recorded on some machine readable medium such as magnetic tape or disc or optically scanned record, or it maybe permanently recorded in a control store forming part of a computer.

The bar for examining such computer implemented inventions was set on the extent to which an invention demonstrates technical effect, which in turn being a hairy term, was further assessed based on whether the patent specification discloses to have a tangible output or a significant effect on the hardware/firmware. A hardware implementation performing a novel function therefore was not rendered patentable if the particular hardware system is known or is obvious irrespective of the function performed. In summary, “software per se” was differentiated from “software having technical effect” through its technical application in the industry. A claim directed to a technical process which process is carried out under the control of a programme (whether by means of hardware or software), cannot be regarded as relating to a computer programme as such. In such a case, a software specification relating to and claiming a method of predicting fluctuations in stock market, being purely based on a mental algorithm, would not be held patentable and a software for running an actuator on the other hand would be rendered patentable.

Finally to set the background for the actual status of 3(k) as a bar for examining patentability, Indian Patent office manual has been setting and/or quoting Patent Applications such as 558/DELNP/2005 which being a pure computer implemented software application, was denied a patent in India. The question being raised is whether 3(k) is being correctly applied in India in view of some recently granted Patents. We shall look at the same through some below mentioned case studies from across Hi-Tech domain:

Case Study 1: The Patent Application 8/CHENP/2005 is granted (Indian Patent No. 221272 filed by RGA Technology Partners). The granted patent relates to a method and system for evaluating insurability of an applicant for insurance based on an interactive questionnaire given a server by access of a database. The first Independent claim of the specification states:

A computerized method of evaluating insurability of an applicant for insurance from a carrier, said method comprising:

defining processing rules to determine which questions in a comprehensive set of application questions are to be presented to the applicant for collecting underwriting information from the applicant and to determine an order of presentation of the questions, said processing rules being based on underwriting rules associated with the carrier for rendering a decision on the insurability of the applicant from the underwriting information collected from the applicant;

assigning an engine variable to one or more of the questions in the comprehensive set of application questions for use in matching underwriting information previously obtained from the applicant to minimize redundant responses from the applicant;

presenting an interactive questionnaire via a browser operating on a client computer, said questionnaire including one or more base questions and one or more detail questions selected from the comprehensive set of questions according to the processing rules and the assigned engine variables, said detail questions each being related to at least one of the base questions for collecting further information related to the respective base question;
receiving at a server communications from the client computer including the responses to the questions presented to the applicant in the questionnaire, said server and said client computer being coupled to a data communication network; and

rendering a contemporaneous decision on the insurability of the applicant based on the questionnaire and the responses thereto from the applicant.

It is obvious from the very analysis of the specification, that the subject matter claims and pertains to a sequence of steps being implemented purely by a computer implemented software application. The specification does not claim any tangible output from the software and ultimately yields a suitability of application to get the insurance based on a set of questions from the server and answers given thereto by the Applicant.

It is furthermore important to note the view of the concerned subject matter by the EPO, which too, like India, applies the technical effect test for a computer implemented subject matter. According to the corresponding EPO Application No. EP 03 76 0294 having International Classification as G06F17/60, claims 1-40 pertain to a matter that is excluded from patentability under article 52(2) and (3) EPC and formulated to merely specify commonplace features related to a technological implementation of such matter to such an extent that a meaningful search is not possible. The search report also states that “Any problem which are addressed do not appear to require a technical but an administrative i.e. business solution.” The question therefore is if the Patent Office has loosened the bars for testing applications under 3(k) and granting application to reduce the backlogs or is it an indication of India slowly following the path of US Patent Law and approaching towards Bliski like contentions.

Case Study 2: The Patent Application No. 552/CHE/2004 is granted (Indian Patent No. 228947 filed by Samsung India Software Operations Pvt. Ltd). The granted patent relates to a method for anonymous instant messaging between an originating client and the recipient using an Instant Messaging (IM) server. The first Independent claim of the specification discloses:

A method for anonymous instant messaging between an originating client and the recipient using an Instant Messaging (IM) server, the method comprising the steps of:

a) receiving the request for hiding its actual user ID for anonymous message delivery from the originating client and confirming back to the message request;

b) creating or substituting a volatile ID for the actual ID of the originating client;

c) delivering the message to the recipient and obtaining the confirmation from the recipient;

d) receiving a subsequent reply from the recipient which makes use of the said volatile ID for communication and confirming back to the recipient client;

e) resolving the volatile ID with the actual user ID; and

f) delivering the reply from the said recipient to the originating client with the actual user ID and obtaining the confirmation from the originating client.

As can be observed, the invention pertains to three entities namely an originating client, a recipient, and a server all of which are operatively connected so as to enable sending of messages from the originating client to the recipient. The disclosure completely fails to discuss any subject matter pertaining to an impact on the hardware and/or firmware and also fails to demonstrate any technical effect on the hardware or produce a tangible output. The disclosure was restricted to a messaging mechanism which is well known in the art and purely an incremental improvement at the software level rather than at the network level. Therefore the concerned subject matter does not embody a technical process, which exists outside the computer.

The moot question therefore lies in:

1. The precise basis on which Section 3(k) is being implemented and justification that can be given for demonstrating technical effect in such pure computer enabled implementation.
2. Whether inclusion of a few hardware elements in the independent claim or merely enabling software objects to interact with hardware elements, the new test of bringing in substantiating arguments to make the subject matter patentable.
3. Whether system claims are no longer suggested and preferred over method claims when it comes down to computer implemented inventions.
4. Whether 3(k) is just for namesake!!!

References:

1. iPairs (Indian Patent Information Retrieval System)

2. Europe Patent office website

About the Author: Mr. Tarun Khurana, Partner and Patent Attorney in Institute of Intellectual Property Research & Development (IIPRD) and can be reached: Tarun@iiprd.com.

Sun Pharmaceuticals Ltd, a leading India-based global pharmaceutical company with interests in the cardiology, psychiatry, neurology, gastroenterology, diabetology and respiratory disease segments has been very active in building and enforcing an exhaustive patent portfolio. Sun has also been one of the early Indian players to take on with the Big Pharma on issues of ANDA Para IV and gaining exclusive marketing rights into US geographies.

Facts of the Case

As a part of its global business strategy Sun acquired US-based Caraco Pharmaceutical Laboratories in 1996. In March 2006, Caraco filed an Abbreviated New Drug Application (ANDA No. 78-219) with FDA seeking a generic approval for escitalopram oxalate in March 2006. Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is indicated for adults with major depressive disorder, generalized anxiety disorder, social anxiety disorder, or panic disorder and was developed by Danish pharmaceutical firm Lundbeck. Forest Laboratories, which also co-developed the molecule with Lundbeck, was assigned the exclusive license to manufacture and market the escitalopram oxalate based commercial brand, Lexapro.

Litigation

In reply to Caraco’s ANDA application, Lundbeck and Forest Labs jointly initiated a legal action against Caraco and on July 10, 2006 filed a patent infringement lawsuit at United States District Court Eastern District of Michigan alleging that Caraco’s ANDA products would infringe their patents covering escitalopram. The Orange Book lists three patents – US 6916941, US 7420069, and RE34712 – for escitalopram and Lundbeck’s and Forest’s assertion was that Caraco has to prove that its product would not infringe any of its 3 patents.

On February 20, 2007, Caraco filed a declaratory judgment action against Forest and Lundbeck seeking a declaration that Caraco’s ANDA Products will not infringe the ‘069 and the ‘941 patent.

Out-of-Court Settlement

Before the court could decide on the matter, the three companies reached a mutually agreed settlement in July 2009. The major provisions under this settlement were:

• Sun Pharma would give a global license to Lundbeck for the former’s patent applications related to escitalopram in return to a one-time upfront payment and if the Sun’s technology is used in any marketed product by Lundbeck, a royalty on sales would also be paid to Sun.
• Forest would provide licenses to Caraco for any patents related to Lexapro and with respect to the marketing of Caraco’s generic version of the product as of the date that any third party generic that has received final approval from the FDA enters the market other than an authorized generic or the first filer with Hatch-Waxman related exclusivity.
• Caraco would take over the commercialization and sales of several products from Forest’s Inwood business. Caraco would pay Forest an undisclosed advance against royalties and royalties on net sales of these products.
• Forest would reimburse Caraco for a portion of their costs related to this litigation.

Analysis

The terms and conditions for the settlement clearly indicate that the innovator companies could foresee the impact that the litigation could have on their revenues and goodwill. It also signifies the growing clout of mid level generic players who are now getting into a position to dictate their terms and conditions and getting an upper hand during such settlements. In the current case, Sun Pharma, through its US Subsidiary, Caraco Pharma Lab, was not only able to avoid a huge litigation cost but, through licensing and commercializing clauses, made the most out of the situation.

Conclusively, IP Litigation can not be taken to separate from other Business related Strategy. As is established from the current case, a sound strategy during following up an ANDA litigation can bring benefits for the Company that might not be exactly from the IP realm but goes much beyond it to cover Product and Brand Acquisition.

Latest Developments

• In October 2009, Caraco closed an asset purchase agreement with Forest Laboratories to acquire several products from Forest’s Inwood line of business.
• Sun Pharma received a one-time receipt of US $20mn from Forest Lab as a part of the Lexapro settlement.

About the Author: Mr. Abhishek Sahay, a Senior Patent Consultant in Institute of Intellectual Property Research & Development (IIPRD) and can be reached:  abhishek@iiprd.com.

This time Research In Motion (RIM) was “put in trouble” by Motorola for infringing the latter’s patent “Beletic”. Research In Motion’s BlackBerry Enterprise solution “BES” and BlackBerry Internet Solution “BIS” are alleged to infringe the Motorola’s patent. This time Research In Motion was well prepared and ready to revocate the patent as a matter of Counterclaim action.

Beletic Invention relates to an improved two-way paging and messaging system. Independent claim 1 relates to a method to operate messaging gateway system that is operable to receive message from a remote messaging system and to construct transmittable messages that includes portions of messages from the remote messaging system. The method further characterized by the messaging gateway system to receive a set of commands from a wireless subscriber device and to transmit the same into a protocol understood by the remote messaging system. The messaging gateway system then transmits the translated commands to the remote messaging system such that a user of the subscriber device can control the operation of the remote messaging system.

The Hon. Mr. Justice Arnold started the case by defining the person skilled in the art for the “Beletic” patent. Mr. Arnold then moved on to identify the portions of the claimed matter that are in Common General Knowledge. However there was strong dispute between the parties when it came to the question of whether the claimed element “application level command protocol translation” by gateways, was a part of Common General Knowledge. Research In Motion laid very strong platform for the case by citing strong evidences to prove the translation indeed a part of common knowledge. Research In Motion successfully established by strongly arguing on the evidences. By this time, Research In Motion almost won the case. Neverthless, Research In Motion wanted to destroy the novelty of the patent so as to thoroughly free. So, Research In Motion cited three prior arts claiming that “Beletic” is not Novel.

The Cited prior art 1 “Radiomail”, briefly relates to a gateway that permits wireless email to be sent to paging systems. The gateway clearly enables internetworking between the wired network on one side and the wireless networks on the other side.

The cited prior art 2 Motorola’s “MNI”, an architecture that has a software gateway to link the LAN with the wireless network.

The Cited prior art 3 “Pepe” relates to a PCI gateway that acts as an intermediary between various wired and wireless networks.

Motorola, as a defendant alleged that the prior art “MNI” does not disclose “Application level command protocol translation” Moreover, it argued that both the prior arts “MNI” and “Pepe”, failed to disclose the translation explicitly. Mr. Arnold carefully examining the cited prior arts held that the Motorola’s patent is novel over both “MNI” and “Pepe”.

Happy moments of Motorola does not cherish for long, as the case now moved onto the obviousness section, section that determines the lack of inventive step. In context to ‘Radiomail” prior art, Motorola accepted  that the concept of two way paging was known, but refused to accept that it would have been obvious to use the pager to control the remote messaging system as opposed to simply sending a short reply. To support this point, Motorola added that no-one had conceived the possibility of using a paging device to control a remote email server as claimed in its patent. Mr. Arnold pointed flaw in the Motorola’s submission by noting that the claim in issue is not limited to the case where the remote messaging system is an email server, but it can be a voicemail system. Mr. Arnold commented that it is obvious to use a two way pager to send commands such as save, delete or replay to the voicemail system. He said that if application level command protocol translation is a common general knowledge, then one obvious way to achieve this was to translate commands at the gateway e.g. by converting abbreviated commands into full ones. Mr. Arnold further added that the prior art “MNI” case is as same that of the “Radiomail”.

Mr. Arnold concluded by saying the Research In Motion’s BES and BIS was not infringing the Baletic patent and the patent is invalid as it is obvious in light of “Radiomail”, “MNI” and common general Knowledge.

Case No: HC08C02841

3 February 2010.

Author – Veera Raghavan Rajendran,

Senior Patent Consultant, IIPRD.

The Author of the Blog can be reached:  Raghavan@iiprd.com.

This time Asian Electronics Ltd., referred to as Asian hereinafter, owner of the Indian Patent Application No. 193488 titled “Conversion Kit to change the fluorescent lighting units inductive operation to electronic operation” claimed injunction and consequential reliefs including damages against the Defendant, also referred to as Havells hereinafter.

Mr. Shah, Chairman, Asian, developed an improved conversion kit to change the 4 feet long T8 or T12 from inductive operation to electronic operation without any re-wiring to avoid the problem of flicker while starting and discharge of invisible gas which cause inefficiency in the energy spent and claimed the following features in the first independent claim:

“Claim No. 1.

Conversion kit to change fluorescent lighting units from inductive operation to electronic operation, comprising a pair of sleeve like adaptors which are adapted to be mounted at the ends of a straight fluorescent lighting tube, and a wiring assembly for electrically connecting the adaptors, the structural components forming the electronic ballast being mounted in one or both of the adapters, or being mounted in the wiring assembly.”

Following claims and/or arguments were made by Asian in support of the intended novelty of the invention

ü      Patent being granted in 26 other countries

ü      Awards being awarded for innovation

ü      Publicity on the novelty of the invention giving the invention the due popularity

ü      Sales Figures

A claim mapping study by Asian revealed that one of Havells fluorescent lighting unit comprises of all the elements of the claimed subject matter. The learned counsel of Asian argued that the novel and unique features of the Asian products are the two adaptors based on 2 sides which assist in the process of conversion to electronic current from induction and thus minimize flickering which is normally associated with fluorescent lights. The plaintiff also argued that the Defendant had got enough opportunity to oppose the grant of the application.

Havells, on the other hand, contended that the Indian Patent of Asian is completely based on US Patent 4246629 and further claimed that the Plaintiff’s Patent lacked the necessary inventive step as being a mere workshop improvement and mere re-arrangement under S. 64 (1) (d) of the Indian Patent Act. Havells further argued that all indications in the suit are that Asian does not work its patent, and that therefore, the balance of convenience if at all, is against the grant of ad-interim injunction.

If analyzed carefully, claim 1 of ‘629 US patent states the following:

(c) two end caps and means retaining same at respective ends of said housing; and

Two end caps as claimed by the US Patent clearly anticipates the novelty as claimed and proposed by the learned counsel of Asian. Havells also made further arguments relating to working of the invention in India and that the plaintiff had no proven sales in India.

The court also more importantly stated that in Franz Xaver Humer v. New Yash Engineers, ILR (1996) 2 Del 791, a Division Bench ruling of this court, suggests that if the product is imported, or not sold widely in India (not “worked” in India) the court should be cautious in granting injunction. It was therefore held that the plaintiff has failed to establish that the balance of convenience is in favor of grant of an interim injunction. This was further substantiated by no filing of Form 27 by Asian to demonstrate use and/or significant commercialization of the invention in India.

Case No. IA No. 8205/2009 in CS (OS) 1168/2009

About the Author: Mr. Tarun Khurana, Partner and Patent Attorney in Institute of Intellectual Property Research & Development (IIPRD) and can be reached: Tarun@iiprd.com.

Does a combined reading of the Drug Control Act and the Patents Act lead to an inference that no marketing approvals can be granted to a third party for a drug/formulation for which a patent exists? This was a primary question before the Delhi High Court in a recent case involving, inter alia, Bayer & Cipla as the opposing parties.

There has been a long standing controversy on linking patent status with the drug regulatory/marketing approval process. As it happens, the drug regulatory/marketing body is separate from the patent granting body and there is naturally a grey area between the two over their functional overlap while allowing/disallowing a patented drug to get a marketing approval prior to the patent expiration. While countries like USA has a well defined ‘Patent Linkage’ system that allows a patent holder to link his patent rights with generic drug approval process (FDA mandates a patent expiration or patent validity challenge before giving any such market approvals), in countries like India, there has been no such policy bridging the regulatory and the patent approval systems gap.

The facts of the Bayer Vs Cipla case are as under:

Bayer was granted a patent in India for Sorafenib in March 2008. (vide Patent No.  215758). The patent is schedule to expire in 2020. Bayer manufactures and markets its Sorafenib product as Nexavar in India. The background for the current case started when Cipla filed an application with the Drug Controller General of India (DCGI) for a license to manufacture, sell and distribute a generic version of Sorafenib. Bayer opposed it in the court citing a potential patent infringement in case Cipla’s application for marketing approval is accepted.  Bayer particularly cited (a) its right to stop third parties to make, use, offer to sale, or import its patented product without its consent (Section 48 of the Patent Act) and (b) DCGI power not to approve the marketing right for a product that is ‘spurious’ (Section 2 of the Drugs & Cosmetic Act). Bayer’s contention was that an attempt by Cipla to manufacture Sorafenib will make Cipla’s drug a ‘spurious’ drug under the provisions of the Drugs & Cosmetic Act. Going further, Bayer demanded a Patent Linkage based system, wherein the DCGI does not approve the marketing rights for a drug for which a patent exists.

Cipla, along with the other respondents, the DCGI (represented by the Union of India), in its reply, relied on the logic that merely by granting a marketing approval the DCGI or Cipla, would not be infringing the patent rights accorded to Bayer in any manner as the act does not fall under the purview of making, using, offer to sale, or importing its patented product. Further, an act of infringement is established only by a court of law and not merely by a statement by the patentee. In the present case, the DCGI was not a competent authority to decide if the drug for which the marketing approval was sought was infringing any existent patent or not. The mandate of the DCGI is only to assess the safety and efficacy data related to the drug and either approve or disapprove the drug for marketing within in the Indian territory based on these assessments. Whether or not, the drug in question would be potentially infringing any patented product in India, is something which is beyond the scope of DCGI. Also, the Patents Act provides that a drug manufacturer can conduct experiments on a patented drug to meet the requirements of a drug controlling body (Section 107A). Cipla went a step further to claim that the Bayer’s patent is invalid and that Cipla is ready to challenge its validity.

On the ‘spurious’ drug issue, Cipla contends that Bayer’s counsel has failed to rightly interpret the word ‘spurious’ in the actual context that it is purported to be used. The addition of ‘spurious’ drug, Cipla maintains, was to prevent any substitute drug that could be passed off as the original one by use of deceptive marks or packaging. Cipla, on the other hand, is making a generic copy of the drug and not trying to pass off its product over Bayer’s product.

Cipla’s contention also extended to Bayer’s plan to introduce the system of ‘Patent Linkages’ in India. The former came down heavily upon the latter by accusing Bayer to trying to introduce a new system in India, which is only possible by bringing legislative amendments.

Counsel for DCGI maintained that vide Section 107A of the Patents Act, a provision is made to experiment on the patented products for the purpose of submitting data to a drug controlling body. Further, it argued that a patent right, which is a private right, cannot be enforced by a public entity (DCGI). Hence, the idea that the DCGI should also peep in the patent status and then grant the approvals is also not sustainable. DCGI role is restricted to disallow spurious, adulterated and mis-branded drugs and allowing other drugs for market distribution if its meets other experimental requirements.

Based on the arguments of both the parties, Justice Ravindra Bhat of the High Court of Delhi, concluded the following:

1. The Drugs & Cosmetic Act and the Patents Act are divergent in their objectives and serves very different purposes. While the former was framed to avoid any spurious or adulterated drugs to enter into the market, the latter was framed to allow an innovator company to stop third parties to commercialize their (innovator’s) product/process. The Officials enforcing the provisions of one Act is not technically competent to deal with the provisions of the other Act.
2. By accepting Bayer’s proposition to allow a Patent Linkage and stop Cipla/DCGI to approve the marketing rights for a drug, judiciary would be attempting to enter a legislative role, which it should not be doing.
3. Expecting DCGI to take patents into consideration while granting marketing approvals would not only be stretching too much of its normal reach but also an attempt to interpret the Drugs & Cosmetic Act beyond its intended boundaries.
4. The Patents Act has been amended many a times, latest being in 2005. Had there been any intention by the legislation to bring any changes relating to Patent Linkages, it would have found a place in the amended Act.
5. On the issue of spurious drug, Judge Bhat was in agreement with Cipla’s contention.

Justice Bhat concluded that the present case was an attempt by Bayer to ‘tweak’ public policies through court judgments. He came down heavily upon Bayer and dismissed the suit with costs.

CURRENT STATUS: Bayer filed an appeal before a division bench of the High Court. Later, the division bench ruled against Bayer, thus paving the way for the launch by Cipla. Bayer has now approached the Supreme Court.

REMARKS: The Judiciary at least seems to be very clear about the separate role and functioning of the Drugs & Cosmetics Act and the Patents Act. It sees a clear cut distinction between scope that one Act allows and the boundaries the other Act sets. The idea of introducing Patent Linkages was of interest to the Big Pharma Players and this decision, if in their favor, could have led to a formal introduction of the Patent Linkages concept in India. Undoubtedly, it would have added to the monopoly of these Big Players. The judgment, therefore, is timely and keeps in mind the larger interest of public. Moreover, it also acts as a warning signal for companies like Bayer and Novartis, which had repeatedly tried to tweak with Indian legislation via court rulings.

Case N0:  WP ( C ) No. 7833/2008

About the Author: Mr. Abhishek Sahay, a Senior Patent Consultant in Institute of Intellectual Property Research & Development (IIPRD) and can be reached:  abhishek@iiprd.com.

ACTAVIS UK vs NOVARTIS AG

The High Court, Court of Appeal has recently upheld a decision on Appeal from the High Court, Patents Court, that the Novartis’s European Patent (UK) 0948320, a sustained release formulation of Fluvastatin (a Cholesterol lowering drug), is invalid on the ground of obviousness.

Earlier in the Patents Court

Actavis claimed for the revocation of Novartis patent on grounds of obviousness and insufficiency in the Patents Court. There was also a counterclaim by Novartis for infringement of its patent. Novartis conceded that the claims as granted could not be granted and applied for their amendment.   The claim and counterclaim before Justice Warren is reported at Actavis UK Ltd v Novartis AG [2009] EWHC 41 (Ch) (16 January 2009) . The teaching of the patent was compared to the pleaded prior art and common general knowledge and the judge found that the patent was obvious. The claim on insufficiency however failed.  The Actavis’ preparation would have infringed the defendant’s patent had it been valid but in view of the finding of obviousness the counterclaim failed.

Advances In A Case And Analysis

Solubility: high and very high

Fluvastatin was a well-known statin available in an immediate release formulation in 1996 (priority date of the patent is October 1996). A dosage regime of a 40 mg capsule to be taken twice a day was well known by that date plus there was extensive knowledge of sustained release formulations generally. The patent suggests that there is a need for a sustained release formulation of Fluvastatin and in creating such a formulation, there is a problem of its high water solubility and that any of the conventional methods would not work.

Judge Lloyd says “the problem presented in the Patent was illusory”.

Patent is seeking to deal with a problem of high water solubility of Fluvastatin. However, there would be problem only at very high and very low solubility. The solubility of the drug is high and not very high and therefore Fluvastatin is not so highly soluble that the skilled person would expect it to be impossible or difficult to make a sustained release form.

Common General Knowledge and an Expectation of success

Although there was lurking in the Patents Court about some arguments about other claims namely 2, 3, 10 too, however, the only claim which really matters is claim 1, which is permitted to be amended by Justice Warren.

Claim 1 is as follows:

“A sustained release pharmaceutical composition comprising a water soluble salt of Fluvastatin as active ingredient and being selected from the group consisting of matrix formulations, diffusion-controlled membrane coated formulations and combination’s thereof, wherein the sustained release formulation releases the active ingredient over more than 3 hours.”

Actavis advanced a case that a sustained release form of Fluvastatin would be expected not only to be a more convenient formulation for patient compliance (the common perception in October 1996 was that a reduction from 2 doses daily to a single dose would result in improved patient compliance) but would be likely to have significant medical advantages, namely improved therapeutic effect and fewer side effects and hence there was a strong motive to create a sustained release form and a strong expectation that all three types of benefits would be obtained, the two medical and the convenience. The Judge rejected the “medical advantage” but accepted the “more convenient” advantage point.

The fact that an immediate release formulation was already available which could be taken at a dose of up to 40 mg once a day and up to 80 mg per day in two doses, was a part of the common general knowledge of the skilled team. As a result, the skilled team would have an expectation of being able to develop an 80 mg sustained release formulation with some clinical efficacy. It would however be uncertain about clinical efficacy, and there would be no strong expectation that it would be achieved. It would be unable to predict with anything approaching certainty that any reduction in the risk of side-effects would be achieved. The team might get better efficacy or fewer side effects, but it would certainly get better compliance.

The problem and solution gave the same answer and the Judge affirmed the invalidity of the Novartis Patent on the ground of obviousness. The problem was to produce a sustained release of fluvastain. And the solution was provided by any of the standard methods for such formulations, which was obvious. The problem is not to look for better medical effect as discussed above and thus the decision of the Patents Court was rightly upheld.

There was some dispute between the parties about the effect in the case of the decision of the in Conor Medsystems Incorporated v Angiotec Pharmaceuticals Incorporated.

In Conor, The patent claim in question was a taxol coated stent for treating restenosis and prior art claimed a use of stent coated with one of the drugs of the class of drugs to which taxol belonged to. The House of Courts held the patent to be not obvious as it was not obvious for taxon to show the same therapeutic effect.

However, this should always be kept in mind that the obviousness is a question of fact and is a multifactorial question. “The question of obviousness must be considered on the facts of each case. The court must consider the weight to be attached to any particular factor in the light of all the relevant circumstances. These may include such matters as the motive to find a solution to the problem the patent addresses, the number and extent of the possible avenues of research, the effort involved in pursuing them and the expectation of success.” Generics v Lundbeck[2007] RPC 32.

In Pozzoli terms the only difference between the prior art and the claim is the idea of making a sustained release formulation and for that there was a technical motivation. [Pozzoli v BDMO [2007] FSR 37)].  The “Problem and Solution approach” gave the same answer. The problem was to produce a sustained release form of Fluvastatin, which would be solved by any of the standard methods for such formulations. The problem was not to look for better medical effects and the Judge affirmed the invalidity of the Novartis Patent on basis on the ground of obviousness. Since this was one of the first cases after Conor, it is to be seen further whether the Conor would make any change in interpreting the issue of obviousness or not.

Case No: A3/2009/0675

About the Author: Ms. Meenakshi Khurana, a Senior Patent Consultant in Institute of Intellectual Property Research & Development (IIPRD) and can be reached: meenakshi@iiprd.com.

It all started when the licensing deal between Nokia and Ipcom broke in Germany. From then, it was a legal war between these two giants. While Ipcom along with its bunch of patents trying to target each and every mobile model of its rivalry, Nokia trying to revocate Ipcom’s each patent one by one. For now, Ipcom sued Nokia for they infringed its UK patents “540 808” (“808”) and “1 186 189” (“189”).

Validity of “808” Patent:

In “808” patent the principal claim relates to a synchronization method for mobile radio telephones in a cellular network comprising number of fixed stations and mobile telephones based on a GSM method, the synchronization includes an initial synchronization, a normal operation synchronization and lock-on synchronization. Testing obviousness using the principles (structured approach) in the court was not a dispute point for either of the parties. However, Nokia pointed out the claim 1 was divided into three compartments as initial, normal and lock-on synchronization, and hence in such a case it is legitimate to look into parts separately and to determine they were inventive individually. The judge agreed and Nokia presented a publication “GSM recommendations” for the obviousness attack. Nokia also relied on “Baier” patent publication and “D’ Avella”, an IEEE journal publication. The patent is anticipated by the prior art “GSM” except the data pre processing portion that happens in the normal synchronization. Also, based on the judge construction of claim and specification, “Baier” teaching of Pre-processing is very much obvious to one skilled in the art as “Baier” patent is related to a GSM scheme. Inspite of Ipcom’s argument on the technical point, Judge was of the opinion and concluded that the prior art “D’Avella” also discloses about preprocessing and hence finally concluded that the patent “808” is obvious in light of common general knowledge or in light of “Baier”, “D’Avella” and Common general knowledge taken together.

Infringement by Nokia 6300:

The judge noted that the Nokia 6300 which operates in EDGE mode, can use either GMSK or 8PSK modulation depending on the channel conditions. When 6300 uses GMSK, it follows a GSM method. The judge concluded that if the patent is valid, then the 6300 would infringe the Claims 1, 9 and 11.

Validity of “189” Patent:

In “189” patent the principal claim relates to a method for allocating access rights to atleast one subscriber station in the telecommunications network. The method further includes a check process whenever the subscriber station receives a receipt or an acknowledgment of an access authorization data. The method carries out the check process to determine whether the access authorization data that has threshold value (s) being compared to a Pseudorandom number (R).

It will be interesting to note that the judge refused to accept Nokia’s claim construction particularly in the check process. Nokia construction on check process as to whether the access threshold information is being transmitted and as such this is of no interest to the mobile station. According to judge claim construction, the check process is a check whether the mobile station is to use part of the access information to perform the access threshold function. Nokia relies on “GSM recommendation” prior art which includes a GPRS and it is an add-on to GSM. It was a piece of cake to destroy the novelty of Claim 1. The key feature “check process” to do an access threshold test is clearly disclosed in the prior art. Also, Judge issued the same opinion when Nokia pleaded to discuss the second prior art “Ericsson”. Finally, the judge concluded that there is no need to go into obviousness section over common general knowledge as it is not going to add significant value (most of them are covered in GPRS “GSM recommendation” part).

Infringement by Nokia N96:

The functioning of Nokia N96 is based on UMTS standard. Refusing to take the Nokia’s stand on infringement, Judge declares that the N96 performs both types of check as required by claim1. Therefore if “189”patent is valid, Nokia N96 would have infringed.

Although, Nokia won the battle, still the Legal War is on…as there are more cases to come…No doubt Ipcom, – $ 18 bn (approx) in the present battle, will evaluate the patent portfolio it has (including the acquired  patents!) and strongly comeback against Nokia next time…

Case Nos: HC 08C02525 and HC 08C03143

Author – Veera Raghavan Rajendran, Senior Patent Consultant

The author can be reached:  Raghavan@iiprd.com.

Although the claims do not include any indication about the dose and the complete composition of the medicine, it specifically discloses the treatment of ADHD by physicians. The independent claim states that  “A method of treating Attention-Deficit/ Hyperactivity disorder comprising administering to a patient in need of such treatment an effective amount of Tomoxetine”.

Plaintiff argues that each of the Defendants’ act of filing an ANDA constitutes infringement under 35 U.S.C. § 271(e)(2)(A) .Plaintiff further argues that the commercialization of generic atomoxetine before the expiration of the ’590 Patent would constitute further infringement under 35 U.S.C. §§ 271(a), (b), and/or (c).

Defendants assert that Lilly’s patent is for the treatment of patients by physicians and none of the Defendants are doctors, they never treat patients, and they do not prescribe medicines. Rather, they sell drugs to wholesalers or pharmacists, who in turn sell the drugs to patients possessing prescriptions from physicians. Defendants contend that Lilly cannot establish infringement under 35 U.S.C. § 271(e)(2) for the same reasons that Defendants argue infringement does not exist under 35 U.S.C. § 271(a) .

In a similar case Warner-Lambert Co. v. Apotex Corp the Federal Circuit concluded that there was no direct infringement because “there is no evidence in the record that Apotex has directly practiced or will ever practice any of the methods claimed. In reaching this conclusion, based on facts that are identical to the facts at issue in this case, the Federal Circuit explained that the activities of pharmaceutical manufacturers are fundamentally different than prescribing physicians and, therefore, pharmaceutical companies cannot directly infringe such method of treatment claims and defendants’ motion for partial summary judgment as to no direct infringement was granted. Lily lost the battle based on the evidence ground and for the same reasons, also lost the reconsideration request for the decision.

In the present case, the patent specifically teaches about treatment of patients by Physicians, which implies that a particular dose will be prescribed to the patient depending on the age of the patient and severity of the case. Hence, the method involves prescription of atomoxetine in a particular dosage to a patient as per the case. Although, the drug manufacturers neither prescribe nor administer the drug to the patients in any form, but availability of atomoxetine in the market by different manufacturers in different dosages will directly read upon the claimed method as the dosage prescription by the physician is a part and sole of the method involved in the patent. This will further have an impact on the method of treatment.

The above analysis leads to many questions like: Who will be responsible for influencing the treatment method of ADHD, physicians or the drug suppliers? As the drug manufacturers have managed to out themselves by saying they don’t treat patients and only manufacture drugs! It won’t be shocking if the manufacturers come out with a statement that they never forced patients to buy their drug as they just manufacture drugs and don’t treat patients.

Civil Action No. 07-cv-3770 (DMC).

Author:  Mr. Devpriya Kumar, Patent Consultant

The author can be reached devpriya@iiprd.com