Novartis international AC,a Switzerland based multinational pharmaceutical company, filed a case against the Indian Patent Office in the Indian supreme court against the manufacturing of generic drug Glivec. Glivec or Gleevec (as known in US) is used for the treatment of Cancer.
In The court hearing held on 11th September the Supreme Court severely criticized The 2005 Patents Act which introduced amendments to the 1970 Act came. Meanwhile, Novartis filed a fresh affidavit, which claimed that they had distributed Glivec worth around Rs 7,500 crore between 2002 and 2011. It maintains that 85% of the patients in India were being provided the drug free of cost.
Novartis was prompted to file this affidavit after the court had expressed its shock over the high price (Glivec and can cost $70,000 a year) of the drug. Novartis also sought some more time to respond to the court’s suggestion that they should slash the price of Glivec instead of having an elaborate patient assistance programme.
Before going to the supreme court Novartis has filed same suit In 2006, at that time the Chennai patent board ruled that Novartis’s variation of Glivec was not novel enough to be patentable, and then again in 2007, the Chennai High Court dismissed Novartis’s challenge that Clause 3(d) did not fall in line with the TRIPS agreement.
However, in 2009, India’s Intellectual Property Appellate Board overturned the 2006 ruling and deemed the drug to be novel and inventive, but said that because the new version didn’t meet the criterion of enhanced efficacy required by 3(d), it still did not merit a patent.
Section 3(d) says that a new form of a known medicine can only be patented if it shows significantly improved therapeutic efficacy. This is intended to prevent companies from extending their patent monopolies by making routine modifications which is exactly what Novartis has done in terms of Glivec which is a amended version of its 11-year-old anticancer drug imatinib mesylate.
The result of this case holds the future of the Indian generic medicines and the lives of millions of poor people of developing countries especially Asian and African who cannot buy costly branded drugs. A victory for Novartis against the Indian Patent Office Not only will it challenge India’s position as the champion of generic drugs but health campaigners feel it will be akin to handing a death sentence to the poor and ill in third-world countries.