Recent court decisions effectively call for researchers and companies to reduce their biotechnology and pharmaceutical inventions to practice before they can apply for patent protection.
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References
Enzo Biochem, Inc. v. Gen-Probe Inc., 296 F.3d 1316, 63 USPQ2d (BNA) 1609 (Fed. Cir. 2002).
35 USC § 112, ¶1.
Enzo Biochem, Inc. v. Gen-Probe Inc., 285 F.3d 1013, 62 USPQ2d (BNA) 1289 (Fed. Cir. 2002), vacated by 296 F.3d 1316 (Fed. Cir. 2002).
Regents of Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 43 USPQ2d (BNA) 1398 (Fed. Cir. 1997), cert. denied, 523 US 1089 (1998).
Enzo, 296 F.3d at 1325 (emphasis added).
Enzo, 296 F.3d at 1326. Interestingly, this view represents an about-face for the Enzo panel from their earlier ruling: “This is not a case in which the inventors could not have provided a description of the nucleotide sequences.” 285 F.3d at 1022. “Even if Enzo's expert, Dr. Wetmur, were correct that one of skill in the art could routinely sequence the deposited material and so obtain a description of those deposits, that description is not in the patent.” Id.
Amgen, Inc. v. Chugai Pharmaceutical Co., Ltd., 927 F.2d 1200, 18 USPQ2d (BNA) 1016 (Fed. Cir. 1991). See also In re Lundak, 773 F.2d 1216, 227 USPQ (BNA) 90 (Fed. Cir. 1985).
Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 19 USPQ2d (BNA) 1111 (Fed. Cir. 1991).
Enzo, 285 F.3d at 1021.
35 USC §112, ¶2.
35 USC §132.
Fiers v. Revel, 984 F.2d 1164, 25 USPQ2d (BNA) 1601 (Fed. Cir. 1993).
Enzo, 285 F.3d at 1018; Fiers, 984 F.2d at 1171; Amgen, 927 F.2d at 1206.
Pfaff v. Wells Elecs., Inc., 525 US 55, 67-68 (1998) (holding that readiness for patenting may be satisfied “by proof that prior to the critical date the inventor had prepared drawings or other descriptions of the invention that were sufficiently specific to enable a person skilled in the art to practice the invention”). Accord Space Sys./Loral, Inc. v. Lockheed Martin Corp., 271 F.3d 1076, 1080, 60 USPQ2d (BNA) 1861 (Fed. Cir. 2001).
Mycogen Plant Science, Inc. v. Monsanto Co., 243 F.3d 1316, 1330, 58 USPQ2d (BNA) 1030 (Fed. Cir. 2001) (“The doctrine of simultaneous conception and reduction to practice is somewhat rare, but certainly not unknown, especially in the unpredictable arts such as chemistry and biology. ...Although Burroughs Wellcome specifically notes that the doctrine does not state that an inventor can never conceive of an invention in the unpredictable arts until a reduction to practice has occurred, the doctrine still may apply to cases in such arts.”) (citations omitted).
Enzo Biochem. Inc. v. Gen-Probe Inc., 42 Fed. Appx. 439, 451 63 USPQ2d (BNA) 1618 (Fed. Cir. 2002) (unpublished) (Rader, J., dissenting).
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Blaug, S., Shuster, M. & Su, H. Enzo Biochem v. Gen-Probe: Complying with the written description requirement under US patent law. Nat Biotechnol 21, 97–99 (2003). https://doi.org/10.1038/nbt0103-97
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DOI: https://doi.org/10.1038/nbt0103-97
