India, China Revoke Drug Patents for Western Manufacturers

In August 2013, India’s patent appeal board revoked patents on three drugs produced by Western firms, including Allergan’s glaucoma treatment Ganfort and GlaxoSmithKline’s breast cancer drug Tykerb. The drugs failed to meet the board’s “improved efficacy” test, which is being used with increasing frequency by Indian companies to challenge Western drug patents.

The Allergan case was brought by Ajanta Pharma, an Indian pharmaceutical firm that sells generic versions of Allergan’s glaucoma drugs in India. The GSK case was brought by the Indian subsidiary of Germany’s Fresenius Kabi, which makes generic versions of intravenous oncology products.

Some foreign pharmaceutical firms have accused India of circumventing intellectual property standards in order to support Indian generics manufacturers. But Indian regulators have charged Western firms with “evergreening.” This is the practice of citing “incremental improvements” in patent applications in order to extend the shelf life of a branded drug.

In China, the State Intellectual Property Office (SIPO) is also ruling against pharmaceutical patents that are not considered “novel” enough for the Chinese market. In August, SIPO revoked Gilead’s patent on its HIV/AIDS and hepatitis B drug Viread (tenofovir). Most observers saw the ruling as a way for China to expand patient access, by getting cheaper generic drugs onto the Chinese market.