Experimental use and the orphan drug act: A biotechnology conundrum

1. Holme Roberts and Owen LLC. The opinions expressed are those of the author and not necessarily those of Holme Roberts and Owen LLC or its clients.
2. For a history of the enactment of this section, see Neesemann, C.E. and Hough, J.E. 1995. The Infringement Exemption. Bio/Technology 13: 1065−66. | ISI |
3. 25 USPQ2d 1196(Fed.Cir.1992).
4. 21 U.S.C. §§ 360aa−360ee.
5. See Pub. L No. 97-414, § 2(a), 96 Stat. 2049, 2050. (1983).
6. Genentech, Inc. V. Otis R. Bowen, 676 F. Supp. 301 (D.D.C. 1987).
7. There is legislative history that indicates Congress intended that such a conflict shouldn't arise; see H.R. Rep. 153, 99th Cong., 1st Sess., reprinted in 1985 U.S. Code Cong. & Admin. News 301.
8. Amgen Inc. v. Chugui Pharmaceutical Co., Ltd. 18 USPQ2d 1016 (Fed.Cir 1991) cert. denied 116 LE.d 2d 132,112 S.Ct. 169 (US 1991).
9. Article 1,§ 8.
10. Chartex International PLC v. M.D. Personal Products Corporation August 12, US App. LEXIS 20560 (Fed. Cir. 1993).
11. Abtox, Inc. v. Exitron Corporation 35 USPQ2d 1508 (D.Mass. 1995).
12. Infinitech, Inc. v. Vitrophage, Inc. 30 USPQ2d 1201 (N.D. III. 1994).
13. Farmaceutisk Laboratorium Ferring v. Solvay Pharmaceutical, Inc., 25 USPQ2d 1344 (N.D. Georgia 1992).

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