India Releases New Draft Pharmaceutical Patent Guidelines

In order to reduce the risk of future patent litigations, the Indian Patent Office (IPO) announced draft guidelines for drug patents on March 7, 2014. A two week period was given for public comment. This draft guideline revision comes in the wake of Novartis’ 7 year case against the Indian government for rejecting Novartis’ Glivec patent application.

The draft guidelines clarify that “enhanced therapeutic efficacy” is the only criteria that should be used in determining whether to give a new patent to a modified form of a known drug substance. This replaces the previous phrase, “enhanced efficacy.” The change in phrasing follows the court rulings in the Novartis case.

While these guidelines are not law, the guidelines are used as procedural norms to help patent officials uniformly enforce patent standards when examining patent applications. The relevant regulations (Patent Act, Section 3(d)) are not as restrictive as the newly released draft guidelines. However, the Supreme Court’s ruling regarding “enhanced therapeutic efficacy” will likely strengthen the regulatory requirements to the level provided in the new guidelines, in practice.

This means that receiving patents for incremental innovation products in India will probably be more difficult going forward. The draft guidelines, if approved, will also likely result in increased consistency in the application of Indian patent procedures and rules for pharmaceutical products.