Trends in Human Gene Patent Litigation

Abstract

Previous studies have attempted to count the number of gene patents, or the number of human gene patents, or to gauge the effect of human gene patents on research or diagnostic testing. However, empirical research on the judicial enforcement of human gene patents has been lacking. To address this gap, I conducted a study to identify all instances in which a human gene patent was asserted in an infringement lawsuit and to track the results of these litigations. A total of 31 human gene patent litigations were identified, dating back to 1987. All 31 involved an alleged infringer engaged in substantial commercial activities focused specifically on the single gene that is the subject of the asserted patent, the antithesis of a patent thicket scenario. Sixteen of the litigations were brought in the context of therapeutic proteins, with the patents serving a function analogous to that of drug patents in the traditional pharmaceutical industry. Litigation outcome tends to vary depending on the nature of the alleged infringement. Six of the 16 therapeutic protein cases were litigated to a final, unappealable judicial decision (a seventh is currently on appeal), with the patentee prevailing in two cases and losing in the other four. In contrast, the litigations that did not involve a therapeutic protein all either settled or were dismissed before the case could be appealed to a higher court. The results of this study provide little empirical support for legislative part of the patenting of genes are DNA.

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