Friday, May 13, 2011

Pharmaceutical Innovation: A Few Un-original Prelim Thoughts

A few evenings ago I had an impromptu discussion which turned into a debate, with me realizing at the end of it that I really knew very little about the inner workings of the pharma industry or the motivations which propel the pharma industry. 

The person I was discussing with is someone who‘s become a dear friend in a very short time and for whom I have the deepest of regards as a professional.

During the course of the discussion, I realized that certain arguments which those with academic proclivities are often tempted to employ, may not really cut ice in the real world. And this could be because in the real world, the dynamics of innovation are far removed from the romantic view that some of us are prone to taking.

One such romantic argument is “innovation must and inevitably happens for innovation’s sake”. Apparently, this isn’t the case, at least not now; this made me want to read up more on the issue. One article that I, as a greenhorn, found helpful in understanding the issue from both analytical and prescriptive points of view is “Pharmaceutical Patent Life-Cycle Management After KSR v. Teleflex”published in the Food and Drug Law Journal in 2008.

The author of the article, Dr.Michael Enzo Furrow, starts off with a sub-issue which I had briefly averred to in a post I had written way back in 2008, namely the innovator-generic balance. The author states that government intervention in the pharmaceutical market was primarily reactionary in nature i.e. the State was forced to step into the picture to prevent exploitation of customers on account of information asymmetry, and to ensure that safety of patients was not sacrificed at the altar of profits.

However, the elaborate framework that was subsequently put in place to ensure consumer safety resulted in increased costs for innovator companies, besides the fact that the commercial entry of the drug into the market too was delayed. 

Further, even if a drug of an innovator is protected by a patent, the elaborate procedure employed for validation of the drug by the drug regulatory authorities means that a good number of years in the term of the patent would not be available for commercial exploitation.

Given the various pulls and pushes that the pharma debate is subjected to owing to multiple interests acting on stakeholders with diverse, and at times antithetical motivations, it is but natural that pharma innovation jurisprudence has evolved into a complex, probably tortuous and sui generic animal which demands and deserves to be treated as a separate branch of study worthy of specialized and dedicated attention.

In the next few posts, I will discuss the literature and pepper it with my own thoughts wherever and whenever they are worth sharing.

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