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Patenting Biotechnology Process Inventions

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Abstract

A new law should make biotechnology process patents easier to obtain—and defend

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References

  1. Public Law No. 104-41.

  2. 763 F.2d 1406, 226 U.S.P.Q. 359 (Fed. Cir. 1985).

  3. 35 U.S.C. §§ 101-103.

  4. 35 U.S.C. § 100(b).

  5. 35 U.S.C. § 271(g), which provides patent protection for products made by patented processes.

  6. 763 F.2d 1406, 226 U.S.P.Q. 359 (Fed. Cir. 1985).

  7. 763 F.2d at 1408, 226 U.S.P.Q. at 360 (emphasis in original).

  8. Id. at 1409, 226 U.S.P.Q. at 361.

  9. H. Wegner, Durden after Dillon, 9 Biotech. Law Reporter 272, 278 (1990); see also R. Seide and A. Weiss, The Biotechnology Patent Protection Act of 1991: The Battle Lines Have been Drawn, 4 J. Proprietary Rts. 6, 8 (March, 1992).

  10. 902 F.2d 1532, 14 U.S.P.Q.2d 1734 (Fed. Cir. 1990).

  11. 902 F.2d at 1534 n.l, 14 U.S.P.Q.2d at 1736 n.l.

  12. 902 F.2d at 1537-40, 14 U.S.P.Q.2d at 1739-41. Amgen was subsequently able to enforce its patent claims to their DNA coding for EPO against Genetics Institute (GI) to prevent GI from making rEPO in the U.S. See Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200,18 U.S.P.Q.2d 1016 (Fed. Cir.), cert, denied, 502 U.S. 856 (1991). However, Chugai was free to make rEPO abroad and import it into the U.S. without infringing Amgen's patent on the DNA. After much delay, Amgen has recently been issued its patent covering the method for making EPO using the rDNA of its earlier patent. See U.S. Patent No. 5,441,868.

  13. 910 F.2d 823, 15 U.S.P.Q.2d 1738 (Fed. Cir. 1990).

  14. This distinction is most easily understood through specific illustrations. For example, a biotechnology “method-of-making” claim might read, “A process of making protein X comprising culturing a microorganism transformed with a DNA encoding protein X under conditions such that the DNA is expressed and protein X is produced, and recovering protein X. Whereas as “method-of-using” claim might read, “A method of using a microorganism transformed with DNA encoding protein X for production of protein X.”

  15. 919 F.2d 688, 16 U.S.P.Q.2d 1897 (Fed. Cir. 1990), cert, denied, 500 U.S. 904(1991).

  16. 919 F.2d at 695, 16 U.S.P.Q.2d at 1903.

  17. 919 F.2d at 695, 16 U.S.P.Q.2d at 1903. See also in re Ochiai, No. 92-1446 (Fed. Cir., Dec. 11, 1991)

  18. Appeal No. 94-0979 (April 3, 1995).

  19. Id. at p. 4.

  20. Public Law No. 104-41 (1995). See generally 51 Patent, Trademark & Copyright Journal (BNA) 45 (1995).

  21. 35 U.S.C. § 103.

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Authors and Affiliations

  1. partner, Brumbaugh, Graves, Donohue & Raymond, 30 Rockefeller Plaza, New York, NY 10112

    Louis S. Sorell

  2. attorney, Brumbaugh, Graves, Donohue & Raymond, 30 Rockefeller Plaza, New York, NY 10112

    Rochelle K. Seide

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  1. Louis S. Sorell
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  2. Rochelle K. Seide
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Sorell, L., Seide, R. Patenting Biotechnology Process Inventions. Nat Biotechnol 14, 158–159 (1996). https://doi.org/10.1038/nbt0296-158

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