Biologic and biosimilar drugs: strategies beyond patents

Biologic drugs and biosimilars – officially approved subsequent versions of innovator products – have been a topic of heated discussion in the recent past, and the debate continues. With the global biosimilars market expected to grow to US$10 billion by 2015, it is bound to garner attention. Usually, the generics are expected to bring low-priced versions of the innovator’s products and the same is expected with the biologics. But the game is different from small-molecule generic drugs. There are unique challenges on the innovator’s and the biosimilars’ sides.

New trends

While historically patents are considered to be one of the strongest intellectual property (IP) rights protection tools, we are experiencing new trends, especially in the biologic drugs/medicine area. In this article, we are looking at the case of trastuzumab, used for the treatment of metastatic breast cancer – more commonly known as Herceptina in India – to see how much protection a patent could provide to the innovator to protect its rights.

Genentech, a member of the Roche Group, was granted Indian Patent No. 205534 for trastuzumab in 2007, which is marketed in India under the brand names Herceptina, Herclon and Biceltisa.

The 20-year term was set to expire in 2019. With six years still remaining, in 2013 Roche decided not to maintain the patent, did not pay the annuity fee for the 15th year term, and the patent ceased on 3 May 2013.