A Brief Comment on Patents and Particularly Pharmacogenomics and Personalized Medicine

To begin this discussion of patents in pharmaceutical policy, let me first set out two basic points that I think are central to pharmaceutical policy. First, I believe that strong patent protection, at least in developed countries, is an essential component of pharmaceutical policy. Second, I believe that the rapid development and implementation of pharmacogenomics and personalized medicine are absolutely critical for pharmaceutical policy. However, I do not necessarily believe that the development and implementation of pharmacogenomics and personalized medicine require the same breadth of patent protection afforded to the development of new drugs. Patent protection, and with it the rewards of the exclusive rights to make, use, or sell the patented invention, has been a feature of the legal landscape in every country in which significant numbers of new drugs have been developed since the modern pharmaceutical industry began. There have been proposals to do away with patents.  Prizes seem to be a recurrent suggested alternative to patents.1  However, I think it is clear that prizes are not a viable alternative reward for the occasional success in a risky and expensive enterprise. No one suggests prizes on the scale of the profits that are earned through patent protection when that risky and expensive enterprise succeeds.  It is simply not logical that the amounts of capital required to drive pharmaceutical innovation and drug development would be invested under a prize system, or any other system which significantly reduces the rewards obtainable with strong patent protection. However, that is not to say the details of the current system get the balance right. A number of years ago I suggested that much broader patents should be awarded for the significant innovation that is accomplished by the discovery and validation of a new target for drug development.2While the Court of Appeals for the Federal Circuit (the principal forum for patent law in the U.S. other than the Supreme Court) has moved further in the other direction (over the vigorous dissent of Judge Rader),3I still believe in the core of that argument and will expand on that problem in a future post. For now, it is sufficient to say that the validation of new biological targets for pharmaceutical therapy are the biggest (and riskiest) innovations in the drug development enterprise. Ideally the patent system would provide financial rewards that are proportional to the degree of innovation. That is not the system we have, but it is a reasonable and reasonably obtainable goal.

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