In principle, a compulsory licence for a patent makes the patent holder an unwilling licensor. Innovators consider that the compulsory licence provision undermines the research efforts behind the patent in question. This and other developments in Indian patent law, including the Novartis decision, may give the impression to innovators that patenting and patent enforcement may not be the ideal solution to the issues being raised in the pharmaceuticals sector.
Previously, rather than limiting itself to a simple infringement action to prevent alleged infringers, Bayer attempted to prevent the sale of a generic through a different route – the patent linkage system. This effort was unsuccessful, with the Delhi High Court rejecting Bayer's petition and the Supreme Court dismissing an appeal against this order. Subsequently, during the negotiations over the India-EU free trade agreement, efforts were made to incorporate data exclusivity provisions into Indian law, but to no avail. However, these efforts reinforced the idea that there could be other ways to handle strategically issues raised in the pharmaceuticals patent sector.
A recent development in this line of thought is Roche v DCGI. This case related to the drug Herceptin®, in relation to which Roche had abandoned its patent rights. The patent had been subject to a compulsory licence by the Indian government since 2012 and brought in global revenue of nearly $6.3 billion to Roche, with the revenue from sales in India being only $21 million. Although Roche was taking steps to use Emcure Pharmaceuticals in India "to produce its innovative biologics in India" and to reduce the price for cancer drugs trastuzumab (Herceptin) and rituximab (MabThera), in a surprising but strategic move, Roche chose not to renew its patent for the drug in India. This effectively ended any threat of compulsory licensing.
As a follow-up action, Roche filed a suit in the Delhi High Court to restrain the marketing of biosimilars by Mylan and Biocon and successfully obtained an interim injunction against such marketing. The injunction was issued on the basis of a common law passing-off action. The biosimilars in question were marketed as "biosimilar trastuzumab" and "biosimilar version of Herceptin®", with the tag that the products were similar in efficacy and safety to Roche's drug. Roche's case was that the product in question had not been approved as a biosimilar by the drug regulator. The Delhi High Court agreed prima facie with Roche at this interim stage and restrained the defendants from relying on or otherwise referring to Roche's drugs or any data relating to thereto, or claiming any similarity thereto.
While wider questions were raised as to whether the defendants' products were actually licensed appropriately under law, the court noted this to be a factual question that needed to be clarified by the defendants by producing the necessary approvals. Nonetheless, Roche's suit highlighted an alarming question. The product in question is a biologic and the guidelines on the assessment of the safety and efficacy of similar biologics were issued only in 2012. Roche's case was that ,as per publicly available information, the clinical trials and testing for the biosimilars at issue were conducted by the defendants even before the guidelines were issued in 2012. Therefore, on what basis were approvals granted until that time? What is the position of biosimilars that have been under R&D in India even before the guidelines were issued?
Similar to the patent linkage issue that Bayer litigated and lost, this case represents an interesting triangle between regulatory, patent and trademark law. Further developments are awaited in order to appreciate fully the impact of these issues on the larger question of access to biosimilars.
Adarsh Ramanujan, KS Ramanujan
This article first appeared in IAM magazine. For further information please visit www.iam-magazine.com.