From the Desk of Patent Circle: Is Patent-Drug Regulatory Linkage a Necessity? Part I

Some time back we ran couple of thought provoking posts touching issues pertinent to the Delhi HC Dasatinib order. In our first post we particularly analyzed that both Bristol-Myer Squibb (BMS) and the Delhi High Court acted within the periphery of the law and the Delhi HC order nowhere created any sort of “patent-drug regulatory” linkage, an argument unnecessarily sensationalized and propagandized by newspaper media. In second post we tried to clear distorted arguments that the Delhi HC Dasatinib order contravenes Bolar-provision aka section 107A (1) but at the same time emphasized that exemption under sec. 107A (1) is not a statutory go-ahead for willful infringement. Now continuing from our earlier two posts, we will analyze two important aspects – (1) Enforcement of drug patents, and (2) Patent-drug regulatory linkage.

Enforcement is the heart of drug patents and in absence of proper enforcement policies a patent is not even worth a penny. Proper enforcement is not possible without regulated monitoring mechanism particularly in a country such as India which has vastly fragmented drug industry. Often it is not easy for a company located in some part of India to track and monitor what drugs are been sold in market in other parts of country, for example, any company located in Gujarat or Maharashtra will not be in position to track and monitor what drugs are been marketed in extreme north-eastern states or deep southern cities of India. And, if a company needs to keep account of drugs marketed in all parts of India then obviously need to spend enough time and resources in preparing expert teams or hiring investigation agencies to track such information which will undoubtedly bring undue burden on companies. Even we have witnessed cases where drugs are widely sold to patients loosely (without any packaging/packaging details) by doctors and dispensaries. Such practices make patent enforcement almost improbable as it is not possible to track and monitor such loosed drugs even in metropolitan city like Mumbai then what to say about whole India.

Many countries both developed and developing made enforcement and monitoring of drug patents possible at drug regulatory level. Drug regulatory agencies in countries like Singapore, Thailand, Malaysia, Russia and CIS countries, and European contracting states opt to reject generic dossier outrightly if there is an Innovator patent for the drug compound/product and generic manufacturer is seeking marketing approval before the expiration of patent. The only option for generic manufacturers to submit generic dossier for market approval is to first challenge the validity of patent and get it invalid/non-infringing. Quite understandable any law abiding country will never create a chaotic situation where a legal right granted by the government/sovereign is diluted by its own government body. India too need to frame proper policy for monitoring patent enforcement and that can only be possible at drug regulatory level. The policy should permit the DCGI to reject application for generic dossier of a patented drug before the expiration/validity of patent.

However, there is a strong section of people arguing that a mere marketing approval to a generic manufacturer (for the generic version of a patented drug) by the DCGI is not a violation of patent right under sec. 48 of the Patents Act, 1970 – the infringement is only possible when the generic manufacturer launches its product in market. Though we do have difference of opinion on this but still let us assume that in India the DCGI is not allowed to reject application for generic dossier of patented drug before the expiration of patent and generic manufacturers can obtain marketing approval for generic versions of patented drugs. In other words, obtaining marketing approval for generic version of patented drug is not an infringement of patent right which mean that a patentee has no legal stand for filing patent infringement suit based on presumption that the marketing approval will lead to product launch until and unless the generic manufacturer(s) launches its generic product in market. Now let’s put this situation into hypothetical case studies.