India denies patent protection to Bayer, BI blockbusters
- Citing failure to meet inventiveness requirements, India has stuck down patents for Bayer's Nexavar and Boehringer Ingelheim's Spiriva, RAPS' Alec Gaffney reports.
- India is on the U.S. Trade Representative's Priority Watch List because of concerns about insufficient IP protection and enforcement.
- India's Patent Act is controversial, especially section 3(d), which prevents pharmaceutical companies from "evergreening" their products.
India's policies and behavior around patent protection continues to generate controversy, as one multinational biopharma company after another seeks to protect its patents and loses in court. For example, Novartis was unable to protect its patent for Gleevec, just as Gilead was unable to protect its patent for Sovaldi. The upshot of losing these cases is that generics manufacturers are able to step in and copycat the drugs for India's domestic market.
On the other side of the dispute with Bayer over the Nexavar patent was Natco Pharma and Fresenius Kabi Oncology. BMS faced off with Cipla over Spiriva. This issue of "inventiveness" seems to favor companies that oppose the original manufacturer's patent in that the interpretation of "inventiveness" is very narrow.
However, although the U.S. opposes India's Patent Law, groups such as Medicines Without Borders endorses it, because, according to this humanitarian group, this law ultimately makes drugs more affordable in developing countries. Most likely, patent-related tension will continue to mount until India reforms its laws, assuming that ever happens.
- RAPS Regulatory Focus Bayer, Boehringer Latest to be Hit by Indian Patent Office Decisions