Patent fights in pharmaceutical sector


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Patent fights in pharmaceutical sector

  2. 2.  for an invention by the government to the inventor in exchange for full disclosure of the invention
  3. 3.  Novelty Inventive step Industrially applicable
  4. 4. a) Frivolous inventionb) Use for commercial exploitationc) Mere discoveryd) New form of known substance which does not resultin the enhancement of the efficacye) Mere admixturef) Mere arrangement or rearrangementg) Agricultrure or horticultureh) Medicinal,surgical,curative,prophylactic,diagnostic,therapeutic or other treatments for human beings andanimals
  5. 5. i) Production and propagation of plants and animalsj) Mathmatical or business process or a computerprogrammek) A literary,dramatic,musical or artistic workl) Mere scheme or rulem) Presentation of informationn) Topographyo) Traditional knowledge
  6. 6.  Patent evergreening Cost Compulsory liscence Patent linkage
  7. 7.  Pregrant opposition-Application of patent has been published but a patenthas not been granted. Postgrant opposition-Anytime after the grant of patent but before the expiryof a period of one year from the date of publication
  8. 8.  Novartis applied for patent in India on July 17,1998. Indian patent office rejected the application on January25,2006 based on 3(d) of the IndianPatent(amendment)Act 2005. Pregrant opposition by Cancer Patient Aid Associationand domestic drug maker like Cipla and Natco. Glivec cost Rs.1,20,000 per patient per month &generic cost Rs.8000 per patient per month.
  9. 9. On 17,may 2006 Novartis filed two cases in ChennaiPatent Office- First against the pregrant opposition. Second to challenge the constitutionality of section3(d) of Indian Patent Act,2005. Court rejected patent application of Novartis on„Glivec‟ as it is not able to prove therapeutic efficacyon 1 april 2013. Court also rejected the argument of petitioner that sec3(d) is not compliant to TRIPS agreement.
  10. 10.  Bayer obtained a patent in India in 2008 for Nexavar. The Controller of Patents, Mumbai, granted the first-ever compulsory licence to Natco in march 2012 tomake „sorofenib tosylate‟. Bayer has filed an appeal against an Indian PatentsOffices order, with the Intellectual Property AppellateBoard. Natco argued on high price and limited availability.
  11. 11.  On 14 september 2012 IPAB rejected a petition byBayer. In a separate case, Bayer has accused Cipla ofinfringing its patent on Nexavar in march 15, 2010 atthe Delhi High Court. The Delhi High Court on dismissed an appeal by Bayerthat sought to stop Cipla from obtaining a marketingapproval.
  12. 12.  February 23, 2007 patent granted to Roche. 2008, Cipla launch generic version erlocip. Roche had sued Cipla in 2008. Case filed by Cipla on basis of section 3(d) and section8 of Indian Patent Act. Cipla Ltd won in the Delhi high court on 7 sptember2012.
  13. 13.  Also Cipla was selling the erlocip at 1/3rd of the priceof Roche therefore “public interest”demanded that noinjunction be granted. Natco then arguing variously as follows- That Roche had suppressed material facts. That the Indian patent specification made no mentionthat the patent cured Non-Small Cell Lung Cancer. That the Division Bench had specifically asked Rocheto disclose X-ray diffraction data.
  14. 14.  Sugen was granted a patent for Sutent in 2007 andlicensed to Pfizer for marketing it globally. Cipla filed a post-grant opposition in 2008, arguingbased on section 3(d) and section 8 of Indian PatentAct. The Patent Controller had revoked the patent onSutent, 4 october 2012.
  15. 15.  Roche was granted patent no. 198952 by Indian PatentOffice on 21stFebruary, 2006. This patent was immediately challenged by localgeneric drug maker Wockhardt and SankalpRehabilitation Trust. The technology of combining interferon and otherbiologically active proteins with PEG has been knownfor many years.
  16. 16.  In 2009 the IPO rejected their challenge and upheldRoches patent. Sankalp subsequently appealed to IPAB, whichannounced its decision in favour of the groupschallenge on November 2, 2012.
  17. 17.  In 2004, Merk in India claiming a product patent onan aerosol suspension formulation containing twoactive drugs mometasone furoate and formoterolfumarate. The grant of the patent was published in the PatentOffice Journal on 4th March 2011. Cipla,that produces COPD/asthma medicinesparticularly inhalers, filed a post grant opposition.
  18. 18.  The patent has been revoked on 12 december 2012. The decision also states that there is no inventive stepin the selection of non-CFCs for the preparation of theaerosol suspension formulation. There is no inventive concept on selecting HFA 227and/or HFA 134a from known non-CFCs.
  19. 19.  On 30,November 2011 Lipitor patent expired. Ranbaxy, has been fighting the anti-cholesterol Lipitorbattle with Pfizer in about 17 countries since 2002. Patent office rejected all 14 claims of re issueapplication. Pfizer and Ranbaxy settled their Lipitor ANDAlitigation in 2008, agreeing that Ranbaxy would notmarket its generic version of Lipitor until November30, 2011.
  20. 20.  Cost Proper healthcare Drug export Growth of Indian generic companies Avoid patent evergreening
  21. 21.  Effect on economy Harmful for innovation MNC‟s moved away from R&D investment MNC‟S threatened India
  22. 22.  Patent wars in India between the foreign innovatorcompanies and the Indian generics seem to bespreading over life management disease segment. Court‟s decision against the patent linkage andcompulsory licence will encourage the genericcompanies and it is in the favour of public healthcare.
  23. 23.  -v/s- Glenmark-case-revives-patent-linkage-issue/articleshow/19484055