Pharmabiz
 

INCREMENTAL INNOVATION

P A FrancisWednesday, April 25, 2007, 08:00 Hrs  [IST]

Definition of patentability of drugs in the Indian context is getting murkier with the increasing number of patent challenges on one side and the government's determination to redefine this most controversial aspect of the new patent law on the other. More than 20 cases pertaining to grant of patent are lying in various courts of the country after the Patent Act was notified in January 2005. The most well known among them is the one filed by Novartis over the rejection of its patent application for Glivec by the Patent Controller over pre grant opposition. The case was being heard by Madras High Court until last month. Another case is that of Wockhardt seeking patent for a new version of nadifloxacin. The company challenged the rejection of its application for patent for nadifloxacin by the Patent Controller. The case is admitted in the Bombay High Court. These and other patent related cases will now be heard only by the Intellectual Property Appellate Board set up on April 2. It may probably take a few months for commencing hearing by the Appellate Board. Now, the Mashelkar Committee appointed by the government to look into various patent related issues including patentability of drugs has not come up with any concrete recommendations. But he has made an observation that Indian pharmaceutical industry is capable of incremental innovations only and therefore India should not limit patenting to new chemical entity or new medical entity. As government is not happy with the report, a rewriting of the same is being contemplated. Once the government accepts the modified report of the Mashelkar Committee, that could have a bearing on decisions on Novartis and Wockhardt cases by the Board. Both the cases are of incremental innovation and the petitioner companies are seeking patents claiming inventiveness and efficacy of the compounds. Although Dr Mashelkar found nothing wrong in granting patents to incremental modifications to known chemical substances he has not made any specific recommendation in this regard. Yet, the report was strongly objected to by the Indian sector pharma companies particularly Indian Pharmaceutical Alliance. Until now, the Novartis' case was the one pertaining to granting of patent to incremental innovation. With the filing of Wockhart's case seeking patent for a version of nadifloxacin, what should be the stand of IPA on granting patents for incremental innovation, is something to be seen. IPA has been strongly opposing grant of patents to trivial modifications of existing molecules thereby allowing ever greening of patents. Doha declaration on TRIPS agreement and public health had confirmed the flexibilities allowed to WTO members to define patentability in the national laws. India can thus use this flexibility to protect public health and its generic industry as per the section 3(d). OPPI has been pressing for extension of patent protection for incremental innovations for long.

 
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