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The Infringement Exemption

Questions remain about how this decade-old law will affect biotechnology

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  1. The legislative history of Section 271 (e)(1) is reprinted at 1984 U.S.C.C.A.N. 2647. The section was amended in 1988, but the amendments do not affect the subject of this article.

  2. 733 F.2d 858 (Fed. Cir. 1984).

  3. Id. at 863.

  4. The legislative history of Section 271 (e)(1) is reprinted at 1984 U.S.C.C.A.N. 2647. The section was amended in 1988, but the amendments do not affect the subject of this article.

  5. 31 U.S.P.Q.2d 1423 (D.N.J. 1994).

  6. NeoRx Corp. v. Immunomedics, Inc., 31 U.S.P.Q.2d 1423 (D.N.J. 1994).

  7. 31 U.S.P.Q.2d at 1428.

  8. Id.

  9. 666 F. Supp. 1379 (N.D. Cal. 1987).

  10. Intermedics, Inc. v. Ventritex, Inc.,775 F. Supp. 1269 (N.D.Cal. 1991); Elan Transdermal Ltd. v. Cygnus Therapeutic Systems, 24 U.S.P.Q.2d 1926, 1931-1932 (N.D. Cal. 1992).

  11. 982 F.2d 1520, 1525, and n.5 (Fed. Cir. 1992) (citing with approval the analysis in Intermedics, Inc. v. Ventritex, Inc., 775 F. Supp. 1269 (N.D.Cal. 1991). A contrary view was taken by the district court in Scripps Clinic & Research Foundation v. Genentech, Inc., 666 F. Supp. 1379 (N.D. Cal. 1987).

  12. Congress was also interested in correcting the distorting effect that the lengthy FDA approval process (at that time averaging 7-10 years) had on the patent term. See generally Eli Lilly and Co. v. Medtronic, Inc., 496 U.S. 661,669-672, (1990); Telectronics Pacing Systems, Inc. v. Ventritex, Inc., 982 F.2d 1520, 1524 (Fed. Cir. 1992).

  13. Intermedics Inc. v. Ventritex, Inc., 775 F. Supp. 1258, 1276-78. (N.D. Cal. 1991).

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Neesemann, C., Hough, J. The Infringement Exemption. Nat Biotechnol 13, 1065–1066 (1995). https://doi.org/10.1038/nbt1095-1065

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