India looks to tighten rules for filing pharma patents

The requirement would make it easier for patent examiners, generic drugmakers and patient advocates to block what some call ‘frivolous’ incremental patents from being granted and also make it more difficult for brand-name drugmakers to receive patents for incremental innovations, which some argue do not demonstrate any increased effectiveness for an existing medicine, the paper writes.

“We are currently consulting key stakeholders on the feasibility of mandating disclosure of WHO-assigned INN (international non-proprietary names) in the pharma patent applications, wherever applicable," an official at the Indian Patent Office told the Economic Times. "A final decision, however, has not yet been taken on the matter."

The proposal comes as India is already under fire for its handling of patents. In particular, the pharmaceutical industry has been critical of a decision last spring by the Indian Supreme Court, which rejected a patent sought by Novartis for its Gleevec cancer medication. A previous government ruling denied its request after deciding a new form of the drug did not meet a standard for enhanced efficacy.

Patient advocates argued a Novartis (NVS) victory would have amounted to evergreening, a reference to patent extensions based on minor changes, and inhibit access to Gleevec since generic drugmakers would be prevented from making copycats. Novartis countered that the decision will inhibit incentives to pursue innovation (back story).

India has also sustained ongoing criticism for issuing compulsory licenses for some drugs used to treat cancer or HIV (look here, here and here). The government has maintained it has the right to do so under the Trade Related Aspects of Intellectual Property Rights, or TRIPS, since the cost of the medicines is out of reach of many of its citizens and other countries, such as Brazil and South Africa, are considering the same step (see this and this).

But attorneys who represent the pharmaceutical industry tell the paper that the latest patent proposal is not feasible and would violate obligations under the TRIPS agreement. But patent experts and patient advocates argue the move will help sort frivolous incremental innovations from valid innovations.

This is an “important step,” Carlos Correa, a global patent expert and professor at the University of Buenos Aires, tells the paper. "Patent applicants seem to deliberately conceal the known INN to discourage oppositions (before and after a patent is granted) and challenges to the patent's validity. The absence of this information also complicates procurement of drugs and local production since it is difficult to know when a patent can be infringed."

And Leena Menghaney, who works with Doctors Without Borders, tells the Times, multiple patent applications are filed for the same drug, but do not cite the common INN. And this makes it difficult to identify which patent claims relate to which medicines out of the many applications that are filed.

Attorneys, however, discount the maneuver. “There are only three criteria for patentability - novelty, utility and non-obviousness. INN cannot be included as a fourth requirement," Archana Shanker, senior partner at Anand and Anand tells the paper. She adds that any administrative guideline that requires such a disclosure would violate both Indian law and TRIPS obligations.

And Ashwin Julka, managing partner at Remfry & Sagar, says: "Generally, INN is not available at the time of filing a patent application and the same are assigned later. Therefore, in case disclosure of INNs is made mandatory, the applicant would have to keep track of the assignment of an INN to each and every compound mentioned in the patent application or patent, which in itself is a cumbersome process and may not be feasible for the applicant."

But patient advocates say that, while this may be true of new drugs, most patents filed are secondary and the disclosure can be required for cases where INN has already been assigned.

Source: Pharmalot