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87 Tex. L. Rev. 503 (2008-2009)
Unpatentable Drugs and the Standards of Patentability

handle is hein.journals/tlr87 and id is 511 raw text is: Texas Law Review Volume 87, Number 3, February 2009 Articles Unpatentable Drugs and the Standards of Patentability Benjamin N. Roin The role of the patent system in promoting pharmaceutical innovation is widely seen as a tremendous success story. This view overlooks a serious short- coming in the drug patent system: the standards by which drugs are deemed unpatentable under the novelty and nonobviousness requirements bear little re- lationship to the social value of those drugs or the need for a patent to motivate their development. If the idea for a drug is not novel or is obvious-perhaps because it was disclosed in an earlier publication or made to look obvious by recent scientific advances-then it cannot be patented. Yet, the mere idea for a drug alone is generally of little value to the public. Without clinical trials prov- ing the drug's safety and efficacy, which is a prerequisite for approval by the Food and Drug Administration (FDA) and acceptance by the medical community, that drug is unlikely to benefit the public. Given the immense investment needed to fund clinical trials on drugs and the ability of generic manufacturers to rely on those tests to secure regulatory approval for their own products, pharmaceutical companies are rarely willing to develop drugs without patent protection. The novelty and nonobviousness requirements make no con- cession for the development costs of inventions and thus cause patents to be withheld from drugs that are unlikely to reach the public without that protection. This gap in the patent system for drugs has created a pervasive problem in the pharmaceutical industry, causing firms to regularly screen their drugs during the research-and-development process and discard ones with weak patent protection. The harm to the public from the loss of these drugs is potentially quite significant. Congress can easily avoid this problem by ensuring that the successful completion of the FDA's rigorous clinical-trial process is rewarded with a lengthy exclusivity period enforced by the FDA.

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