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73 J. Pat. & Trademark Off. Soc'y 24 (1991)
Biotechnology Process Patents: Judicial or Legislative Remedy

handle is hein.journals/jpatos73 and id is 50 raw text is: Biotechnology Process Patents: Judicial or Legislative Remedy Harold C. Wegner* I. OVERVIEW F ifteen years ago, the patent outlook for the then-emerging field of biotechnology had a wide range of uncertainties, including the fundamental question of the patentability of living inventions. One question that appeared to have been completely resolved was the patentability of claims to the method of expression of a protein through conventional brewing of an unobvious cell. See Wegner, Patent Protection for Novel Microorganisms Usefulf for the Preparation of Known Products, 5 Int'l Rev. Indus. Prop. & Copyright L. 285 (1974), discussing uncertainties in claiming living inventions and the pa- tentability of a conventional biotechnology method based on the unobvious microorganism culture in In re Mancy, 499 F.2d 1289, 182 USPQ 303 (CCPA 1974) (Process for the production of Dau- norubicin which comprises aerobically cultivating Streptomyces bi- furcus, strain DS 23,219 (NRRL 3539)... and separating daunorubicin The tables are turned. What fifteen years ago was completely unclear is now certain, as the door to patenting living inventions was opened wide in Diamond v. Chakrabarty, 447 U.S. 303, 309, 206 USPQ 193 (1980). What was clear from Mancy is today clouded by the limited interpretation given to that case by the United States Patent and Trademark Office (PTO), particularly its Board of Appeals and Interferences (Board). Starting with Ex Parte Kifer, 5 USPQ2d 1904 (1987), several cases have incorrectly interpreted In re Durden, 763 F.2d 1406, 226 USPQ 359 (Fed. Cir. 1985), in a broad fashion to preclude grant of method claims. Several noteworthy events took place in 1990. First, the need for process claims was underscored through Amgen's inability to enforce its erythropoietin host cell claims in Amgen Inc. v. U.S. Intern. Trade Com'n, 902 F.2d 1532, 14 USPQ2d 1734 (Fed. Cir. *Wegner, Cantor, Mueller & Player, Washington, D.C. 24

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