The April 2, 2002, Federal Circuit opinion in Enzo Biochem, Inc. v. Gen-Probe Inc., may have the greatest potential impact on a multidimensional basis of any decision from that court in recent years. Far more important than whatever disruption takes place domestically—which may be fixed through Congressional or further judicial action—one must look to the foreign impact of the Enzo opinion. This decision threatens to undermine the patent basis for American protection of biotechnology inventions abroad, once the case is understood and embodied in the several foreign patent laws. Problems with Enzo are not limited to biotechnology. What’s good for the biotechnology goose is good for the e-commerce gander. Fundamentally, we must address whether the pro-patent philosophy of Chakrabarty is to be maintained, with all the ramifications for not only existing patent rights but also for what will happen to the rights of Americans and others in foreign systems and what will happen for the new technologies of the future.
Harold C. Wegner, An Enzo White Paper: A New Judicial Standard for a Biotechnology "Written Description" Under 35 U.S.C. § 112, ¶ 1, 1 J. Marshall Rev. Intell. Prop. L. 254 (2002)