India’s draft rules on patenting drugs draw mixed response

Mumbai: India’s latest draft rules on patenting drugs that say modifications of existing medicines can be patented only if they show increased therapeutic value has drawn sharp reaction from international pharma companies.

In 2006, the Madras high court had ruled that the term efficacy in Section 3(d) of India’s patent law meant therapeutic efficacy, while rejecting a Novartis AG petition. The Swiss firm had claimed patent for its cancer drug Glivec, which was a modified version of a previously known anti-cancer molecule called imatinib mesylate.

Novartis lost the appeal in the Supreme Court as well, after which the patent office in August issued guidelines enshrining therapeutic efficacy as a patent criterion for such claims.

The guidelines do not provide guidance on scope and application of Section 3(d), as it merely reiterates existing Indian case law, according to the International Federation of Pharmaceutical Manufacturers Association (IFPMA), a global lobby of firms that relies on drugs research.

“Therapeutic efficacy profiles are rarely available at the time of invention because these are determined once the clinical trials are conducted,” IFPMA said in its response to the guidelines. “Therefore, such an obligation is difficult to meet at the time of patent application.”

“The fact that ‘efficacy’ is to be construed only as ‘therapeutic efficacy’ is still problematic because it incorporates further limitations into Section 3(d) that may be more difficult to establish,” Pharmaceutical Research and Manufacturers of America commented.

However, Access Campaign, an initiative of non-profit Medecins Sans Frontieres that provides medical humanitarian services, has welcomed the new criterion of efficacy but objects to the way proposed to check for previous patents.

Before any patent is granted, the examiner must search and establish that the claimed invention is unknown and no patents existed for this prior to 1995. To eliminate patent applications for pre-1995 molecules, the new guidelines direct the patent examiner to rely on the drug’s so-called international non-proprietary name (INN), which is the generic name of a drug given by the World Health Organization (WHO) to identify the unique nature of the drug’s ingredients as the key words for online search.

“We welcome the development that revised draft guidelines on the examination of patent applications clearly recognizes that prior art searches by examiners on compounds should also be based on the INN of the medicine. However, the burden seems to be on the examiner and not on the applicant,” the global non-profit organization said in its response to the latest rules. “The burden of providing INNs to which a particular patent application relates should be shifted to those who are in the best possible position to provide this information—the patent applicants.”

A worldwide online search for prior data on patent claims is important before deciding on the patentability of drugs in India as the country doesn’t allow patent grants for drugs known or patented before 1995. INNs also help in identification, safe prescription and dispensing of medicines to patients, and for exchange of information among health professionals and scientists.

The comments reviewed by Mint also show conflicts on some other aspects, including generalization of certain criteria on pharma patents with those of other sectors where research priorities are different and the restrictive approach on patenting drug compounds.

The patent office received feedback from around 35 stakeholders in the sector, including industry lobbies, health care and patent access groups, intellectual property law firms and drug firms across the world.

The last date for submitting reactions and suggestions was 5 September. The patent office may modify its final norms after taking these suggestions before finalizing it in a month, said an official of the commerce ministry’s department of industrial policies and promotion, which frames policies for implementing intellectual property law in the country. He declined to be named.