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This Article examines the possible inequity of the treatment of licensees' rights in tort litigation in comparison to patent rights in patent litigation. In particular, this Article presents the presumptions afforded from issued patents as a valid model for the proper treatment of FDA approval in litigation. Presently, most academic discussion proposes either preclusion of tort claims or leaving the system more or less as it stands. This Article, on the other hand, proposes a middle ground.

This Article begins by examining the differences between the USPTO and the FDA. In particular, the quantity and quality of the review provided by each agency is explored along with the purposes of that review. The Article then turns to a more complete examination of how a patent or FDA approval is treated in litigation, both in principle and in practice. The advantages to the patent-holder include evidentiary presumptions as well as instructions from the judge regarding those presumptions.

With the factual scenario and the differences in treatment established, this Article next looks to why the treatments of the agency determinations in question differ in these contexts. Presently, the patent holder is positioned to benefit from USPTO mistakes (i.e., an erroneous grant of a patent) more than the manufacturer of an FDA-approved medicine will benefit from an FDA mistake (i.e., approval of an unsafe or ineffective drug). In other words, in a comparably close case, a patent holder will win while a holder of an FDA approval will lose.

A determination of whether this difference in advantages is appropriate can be made only through examination of the interests at issue. As an initial matter, this Article examines government interests including ensuring that determinations made by the USPTO or FDA are accurate and implemented appropriately. Also examined are the individual and societal interests furthered by patent litigation and product liability litigation. In patent litigation, courts seek to protect proper patent monopolies while preventing improper ones (i.e., those based on invalid or unenforceable patents). In the pharmaceutical context, courts seek to protect citizens from unsafe drugs while avoiding imposing unwarranted liability on drug producers. Whether these interests are, or are not, furthered through a variety of procedural mechanisms is a critical matter when determining if those mechanisms are appropriate.

After exploring the USPTO and FDA in comparison to each other, this Article lays out the present posture of the debate on how to treat FDA approval in litigation. The bulk of discussion can be categorized into two areas: one urging preclusion of tort liability if the defendant complied with relevant regulatory requirements and another opposing such preclusion and leaving the system as it stands, with some incremental institutional changes.

Concluding remarks demonstrate that a juxtaposition of the USPTO and FDA processes indicates that FDA approval should receive at minimum the deference in litigation that an issued patent receives. Therefore, this Article proposes a presumption of safety and efficacy for FDA-approved drugs. With the outlines of the proposed presumption established, the Article further considers the presumption in the context of the concerns raised by the various commentators in the regulatory compliance defense debate. Finally, the Article concludes that a presumption from FDA licensing addresses these concerns better than the proposals made by commentators to date.

Recommended Citation

5 Minn. Intell. Prop. Rev. 155 (2004)