HATCH-WAXMAN'S RENEGADES

被引:0
|
作者
Thomas, John R. [1 ]
机构
[1] Georgetown Univ, Washington, DC 20057 USA
来源
关键词
ACT; LAW;
D O I
暂无
中图分类号
D9 [法律]; DF [法律];
学科分类号
0301 ;
摘要
No intellectual property rights impact society more forcefully than pa-tents on pharmaceuticals. But as a practical matter, only a handful of jurists resolve disputes involving them. Two neighboring federal districts, Dela-ware and New Jersey, adjudicate the vast majority of patent contests be-tween brand-name drug companies and generic manufacturers. And in con-trast to Eastern Texas, which has been persistently derided as a renegade jurisdiction, the authority of the mid-Atlantic courts has seldom been ques-tioned. The complex workings of the Hatch-Waxman Act, the compromise legislation that governs pharmaceutical patent litigation, go a long way to explaining such distinct shareholder reactions to highly similar judicial be-haviors.Yet the dominance of Delaware and New Jersey in pharmaceutical patent litigation may have come to an end. A recent decision of the U.S. Court of Appeals for the Federal Circuit, Valeant v. Mylan, has narrowed the rules for venue in Hatch-Waxman cases. We are now poised to see mul-tiple, parallel trials involving the same patented pharmaceutical proceed-ing in courts across the country.The new order of pharmaceutical patent litigation affords an oppor-tunity to reconsider an intellectual property environment that aims to pro-mote pharmaceutical innovation but also increase public access to medica-tions. Venue determinations are puzzling in pharmaceutical patent cases due to a concept originating within the Hatch-Waxman Act, the tort of "ar-tificial" infringement. Artificial infringement occurs when a manufacturer petitions the federal government to obtain permission to market a generic drug. But the federal government both issues patents, and awards regula-tory approval to sell a drug, with effect across the entire nation. Congress gave no thought towards situating artificial infringement at a certain place, and judicial efforts to do so have amounted to a facile and strained exercise.Venue is not artificial infringement's only problem. Artificial infringe-ment also creates disconnects with personal jurisdiction principles, incor-porates obsolete remedial provisions, and fails to comply with the international commitments of the United States. Courts should instead rec-ognize their authority to accept declaratory judgment actions to resolve pharmaceutical patent infringement cases, with legislative abolition of ar-tificial infringement presenting another, preferred possibility.
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页码:831 / 879
页数:49
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