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
Many countries both developed and developing made enforcement and monitoring of drug patents possible at drug regulatory level. Drug regulatory agencies in countries like
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.