Bio-Technology General Corp. v. Genentech, Inc.

80 F.3d 1553 (1996)

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Bio-Technology General Corp. v. Genentech, Inc.

United States Court of Appeals for the Federal Circuit
80 F.3d 1553 (1996)

Facts

Genentech, Inc. (defendant) held two patents related to recombinant human growth hormone (hGH): one patent was for producing a replicable cloning vehicle, not hGH, and the other was for a method for producing recombinant hGH. Bio-Technology General Corp. (BTG) (plaintiff), an Israeli company, also manufactured hGH by recombinant DNA techniques and sought to import its product for sale in the United States under the tradename Bio-Tropin and filed an investigational new drug application (IND) with the Food and Drug Administration (FDA) that was granted. Thereafter, BTG filed an action against Genentech seeking a declaratory judgment that Genentech’s patents were invalid, unenforceable, and not infringed by BTG. Genentech counterclaimed for infringement and moved for a preliminary injunction, arguing that if BTG imported its hGH into the United States, this would infringe Genentech’s patents. The district ruled for Genentech after finding that it had established a reasonable likelihood of success on the merits of its counterclaim because BTG’s processes for making a plasmid and its hGH was within the literal scope of Genentech’s patents. BTG appealed.

Rule of Law

Issue

Holding and Reasoning (Lourie, J.)

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