Five of the world's biggest drugmakers failed to comply with mandatory disclosure laws for their patented medicines in India, which means they are vulnerable not only to fines, but also competition in the form of compulsory licenses that could be issued to generic drugmakers, which would then have the right to sell lower-cost versions of the patented drugs.
The breach was uncovered by Shamnad Basheer, a professor of intellectual property law at the National University of Juridicial Sciences in New Delhi, India, and a contributor to the Spicy IP patent blog. He led a group of lawyers who collected information on patent disclosures made by foreign drugmakers to regulators under what is known as a Right to Information, or RTI, request.
At issue is a requirement that drugmakers share information in order to ensure patents granted in India are used in ways to benefit patients. For instance, drugmakers must provide info about how much product is sold, whether the meds are made domestically and if the needs of the domestic market are adequately met. The requirement is fulfilled by filing what is called Form 27. If the Indian patent office is not convinced that consumer interests are served, a compulsory licence can be issued.
The lawyers filed RTI requests for two kidney cancer treatments - Bayer's Nexavar and Pfizer's Stutent; two hepatitis C meds - Roche's Pegasus and Merck's Viraferonpeg; a pair of drugs sold by Bristol-Myers Squibb - Dastinib, which treats chronic myeloid cancer, and the Entecavir hepatitis B med; and Tarceva, which is sold by Roche to treat non-small cell lung cancer. The patents were granted between 2006 and 2008.
"None of the firms that we studied complied fully with the disclosure norms under Form 27 and section 146," Basheer writes (read here). "In some cases, firms such as Roche, (Pfizer) and BMS did not file Form 27 at all for some years. In others, such as Pfizer’s Sutent & Schering’s Viraferonpeg, the information provided was woefully inadequate. This indicates that firms are not taking this disclosure requirement seriously."
All these drugs are subject to patent challenges in local courts and patent offices. Consequently, the drugmakers have prevented rival generic drugmakers from launching cheaper versions by getting court injunctions even when their patents were not used in the country, which is a violation of local laws, according to Basheer. He expects to release the full results of his investigation, which he calls a "transparency mission," shortly.
A few of the drugmakers denied breaching the required law, although some did not respond to requests for comment from the local media. You can read more in The Times of India, The Economic Times and LiveMint.