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Putting your best mode forward

Nature Biotechnology volume 18, pages 1113–1114 (2000)Cite this article

Unique to US Patent Law, the best mode requirement presents a delicate balancing act for biotech inventors.

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References

  1. Eli Lilly & Co. v. Barr Laboratories, 55 USPQ 2d 1609 (Fed. Circ. 2000). In suit were US Patents Nos. 4,314,081 and 4,626,549.

  2. Eli Lilly & Co. 1999 Annual Report.

  3. The appeals court agreed with Barr's second argument, that Lilly had double-patented an active ingredient of Prozac. The term “double-patenting” refers to obtaining two patents at different times to claim the same invention, thus effectively extending the term of protection. It is on this issue that Lilly lost the case.

  4. Chemcast Corp. v. Arco Industries Corp., 16 USPQ2d 1033 (Fed. Circ. 1990).

  5. Glaxo Inc.v. Novopharm Ltd., 29 USPQ2d 1126, 1134 (E.D.N.C. 1993).

  6. Glaxo Inc.v. Novopharm Ltd., 34 USPQ2d 1565, 1569 (Fed. Cir. 1995).

  7. Transco Prods. Inc. v. Performance Contracting Inc., 32 USPQ2d 1077, 1082 (Fed. Cir. 1995).

  8. Lilly v. Barr, supra, at 1614.

  9. Interestingly, the compound p-trifluoromethylphenol itself was not novel but was essential for practicing the inventors' best mode of the claimed fluoxetine hydrochloride.

  10. The court's invocation of these doctrines may be superfluous as disclosure of Lilly's novel synthetic method and its recrystallization conditions were unequivocally not required under the court's own formula.

  11. Glaxo v. Novopharm, (Fed. Cir. 1995), supra, at 1570.

  12. The appellate court did not reach this issue and only commented that “there may be a question whether the azeotroping process is indeed the best mode of carrying out the claimed invention.” Glaxo v. Novopharm, supra, n.7.

  13. Amgen v. Chugai, 18 USPQ2d 1016, at 1026.

  14. Amgen v. Chugai, supra, at 1024.

  15. Despite this point of law, many patent practitioners use language such as “preferred embodiment” to identify the best mode. On the other hand, it is impermissible to bury the best mode with a great number of other modes. (Randomex, Inc. v. Scopus Corp. 7 USPQ2d 1050 (Fed. Cir. 1988)).

  16. Hybritech Inc. v. Monoclonal Antibodies, Inc. 231 USPQ 81 (Fed. Cir. 1986).

  17. In re Wands, 8 USPQ2d 1400, 1403 (Fed. Cir. 1988).

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Authors and Affiliations

  1. Y. Rocky Tsao is a principal and Ramon K. Tabtiang is a technology specialist at Fish & Richardson PC, 225 Franklin Street, Boston, 02110, MA

    Y. Rocky Tsao & Ramon K. Tabtiang

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  1. Y. Rocky Tsao
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  2. Ramon K. Tabtiang
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Tsao, Y., Tabtiang, R. Putting your best mode forward. Nat Biotechnol 18, 1113–1114 (2000). https://doi.org/10.1038/80327

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