“Residual Issues in Patentability Criteria in India & Overseas”

1. “Residual Issues in Patentability Criteria in India & Overseas” Dr. Gopakumar G. Nair Gopakumar Nair Associates (gopanair@gnaipr.net) on 11th July 2008 at Hotel Taj Krishna, Hyderabad GNAs

2. Patent Policy CONVERGENCE Indian & US Patent Laws are converging On substantive aspects of patentability criteria. GNAs

3. Patentability Criteria Novelty - Prior art based Indian Patent Offices – rely on prior art USPTO now insists on Prior Art Disclosure as compulsory – McKesson Information Solutn Inc v. Bridge Medical, Inc When related prior art material disclosures are not made in the patent application and are not continuously intimated to the patent office thereafter, such a conduct is considered inequitable and the patent application is to be declared invalid and unenforceable. Incase of prior art materials, disclosures should be made in the patent application and as such should be communicated to the patent office as and when available to the patent applicant GNAs

4. Patentability Criteria Non-obviousness / inventive step India liberal on obviousness US was liberal on obviousness Now tightening up after – KSR vs. Teleflex (SC 04-1350 decided April 30, 2007) Pfizer vs. Apotex (USCAFC 2006-1261 – May 21, 2007) GNAs

5. Patentability USA “Anything under the sun involving manual intervention”. INDIA “INVENTIONS not PATENTABLE” 3(a) TO 3(p) GNAs

6. Non-patentability 3(d) New Forms without enhanced efficacy. (Chennai High Court on Gleevec) 3(p) Traditional Knowledge. GNAs

7. Non-patentability Compulsory for microorganisms and life forms including plants –  Disclosure of Origin (Budapest Treaty)  Benefit Sharing  Biodiversity Act (The Biological Diversity Act, 2002) GNAs

8. Plant Patentability US – Plant Patents India – Plant Varieties Protection Act (The Protection of Plant Varieties and Farmers Rights Act, 2001) (http://agricoop.nic.in) GNAs

9. Patentability Criteria Anticipation – India – rigid on single Prior art-based anticipation Insists “mosaic” of Prior arts are not “anticipation” PCT/US – Often cites close prior arts as affecting Patentability GNAs

10. Unity of Invention India – more liberal on group of inventions USPTO – very restrictive Insists on electing one invention / Filing Divisionals Even Process / Composition / use as separate inventions GNAs

11. Timelines India – Rigid on extensions Normally extensions not granted US – very liberal protracted prosecution Court order based fast tracking GNAs

12. Publication / Public Domain Information India – Bibliography US/EU – Full Patent US – Total Transparency – “Public Pair” EU – Legal Status Patent Family GNAs

13. Patent Office Procedures India – Post dating (allows) Complete to Provisional Cognates Addition Patents US – Liberal procedures (allows) C.I.Ps Amendments/RCE GNAs

14. US vs. INDIA US grants • Patent Term extensions/adjustments • Data Exclusivity • Orange Book Listings • 180 Day Exclusivity INDIA does not grant any of above GNAs

15. Indian Patent/Regulatory Unlike USA/Europe, the Patent Regulatory link has not been formalised. Generic launch friendly Indian policy GNAs

16. Oppositions USA – Opportunity to protest “Amicus Curie” in litigation India (Recent Gleevec Case) – Pre-grant Opposition Post-grant Opposition Counterclaim for Revocation Government use option GNAs

17. Research Exemptions USA – Used to be rigid Under Bolar exemption (Hatch - Waxman) Became liberal after US Supreme Court Judgement on Merck vs. Integra Contrast with Madey vs. Duke India – Research & Educational Exemptions More liberal & broad Sec. 47A – Educational Sec. 107A – Research for ANDA GNAs

18. Compulsory Licence USA – 28 USC 1498 India – Sec. 63 to 94 & 92A Govt. use – Sec. 99 to 103 (Recent Natco Case) GNAs

19. Patent Challenges USA – Para IV Challenge Recent Developments Caraco vs. Forest MedImmune vs. Genentech India – Infringement based litigation Roche vs. Cipla on Tarceva GNAs

20. Injunctions / summary suits India – Frequency increasing Recent Case – Garware Wall Ropes Ltd. V. M/s. TECHFAB India (A "Synthetic" Judgment) Facts of the CaseThe present case involves two manufacturers of synthetic ropes, twines, yarns and various rope products such as gabions. The first of them are the appellants/patentee Garware Wall Ropes Ltd. and the other, the respondents M/S Techfab India who have been accused of infringing the appellants' patent on a certain “Synthetic Rope Gabion” (referred to as SRG in short). The judgment doesn’t explain what exactly are the features of SRG but for a vague mention that it is a gabion which uses synthetic rope, as opposed to a metal wire, as the meshing element that forms the outer body of the gabion (neither is the specification of the patent available on any of the patent websites). Accordingly, the appellants claim that the use of synthetic rope imparts greater flexibility to the gabion, which helps overcome the disadvantages associated with a rigid metal frame. … Contd GNAs

21. Injunctions / summary suits(contd….) According to the appellants, an agent of theirs in Gujarat informed them of the infringement of their patent by the respondents early in October 2005 and on the 17th of the same month, an infringement suit along with a prayer for ad-interim relief was filed in the District Court, Surat, which was granted ex-parte the next day. Following this, the respondents filed for an appeal in the Gujarat High Court against the injunction, exactly a week after the grant of the injunction. The following day, the injunction was vacated by a Single Judge, with the observation that “in case the respondents feel that the impugned gabions are different than (from) the patented SRG invention of the appellant, the respondents were free to manufacture and sell the impugned gabions”. The respondents were then directed to maintain accounts of such manufacture and sale.Consequent to the filing of a counterclaim by the respondents for revocation of the patent, the suit was transferred to the High Court (under proviso to s.104) along with an application by the appellants to quash the Single Judge’s order. GNAs

22. THANK YOU !