Regulator freed from the shackles of ‘patent linkage’

The idea of a link between the drug regulator and the patent office has been the subject of controversy in Indian pharmaceutical circles ever since the Drug Controller General of India (DCGI) withdrew its initial proposal to create such a link in September 2008. The implication of a link between the drug regulator and the patent office, commonly referred to as “patent linkage”, is that the drug regulator does not grant marketing approval to generic versions of drugs for which a valid patent exists in that jurisdiction. This prevents the entry of generic versions into the market during the life of the patented drug, and helps “innovator” companies deter possible infringement.

The DCGI announcement was followed by two interim orders of Delhi High Court in the matters of Bristol-Myers Squibb v Hetero Drugs Ltd in December 2008 and Bayer Corporation and Ors v Union of India and Ors early in 2009, both in favour of a DCGI-patent linkage system. However, the Bayer matter saw a reversal of the interim order in September, when the court refused to entertain Bayer’s plea to prevent a generic version of its patented drug sorafenib tosylate, which it markets as Nexavar, used for the treatment of primary kidney cancer and advanced primary liver cancer, being produced and marketed by Cipla under the name Soranib. Sorafenib tosylate is protected under patent number 215758, granted by the Indian Patent Office on 3 March 2008.

Bayer contended that Cipla’s product Soranib is a “spurious drug” as defined in Section 17-B of the Drugs and Cosmetics Act, 1940. Bayer also held that a grant of marketing approval for Soranib would lead to violation of its patent rights under Section 48 of the Patents Act, 1970, and that a combined reading of the provisions of the Drugs Act and the Patents Act supports the conclusion that India has an inbuilt mechanism for patent linkage.

The legislative and regulatory update is compiled by Nishith Desai Associates, a Mumbai-based law firm. The authors can be contacted at nishith@nishithdesai.com. Readers should not act on the basis of this information without seeking professional legal advice.