The antiquated legal standard that natural laws and products are not eligible for patent protection is ill-suited for gene and diagnostics patents. Here, I propose a new, technology-agnostic framework for determining patent eligibility that is tailored to the meet the US Constitutional objective of promoting innovation.
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References
No. 09 Civ. 4515 (RWS), 2010 U.S. Dist. LEXIS 35418, at *2 (S.D.N.Y. Mar. 29, 2010, revised Apr. 2, 2010).
U.S. CONST. art. I, § 8, cl. 8.
Diamond v. Diehr, 450 U.S. 175 (1981).
See Association for Molecular Pathology, supra note 2.
See Prometheus Laboratories, Inc. v. Mayo Collaborative Services, 581 F.3d 1336 (Fed. Cir. 2009).
Transcript of Oral Argument at 20, Bilski v Kappos, 130 S. Ct. 3218 (2010) (No. 08–964).
Bilski v. Kappos, 130 S. Ct. 3218 (2010).
Ibid.
Brief For The United States as Amicus Curiae in AMP v. USPTO (No. 2010–1406) at 20. (emphasis in original)
Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948).
Parker v. Flook, 437 U.S. 584 (1978).
“Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.” 35 U.S.C. §101.
Supra note 15 at 12.
Motion by Plaintiffs-Appellees for Recusal of Chief Judge Randall R. Rader, AMP v. USPTO, No. 09-CV-4515 (Fed. Cir. June 29, 2010).
See Association for Molecular Pathology, supra note 2 at 114.
Prometheus Labs, Inc v. Mayo Collaborative Services, 581 F.3d 1336, 1346 (Fed. Cir. 2009)
Diamond v. Chakrabarty, 447 U.S. 303 (1980).
35 U.S.C. §102(a) (2010).
Dan, L. Burk & Mark A. Lemley, Inherency, 47. William Mary Law Rev., 371 (2005).
O'Reilly v. Morse, 56 U.S. 62, 117–18 (1853).
Brief of Amici Curiae Christopher M. Holman and Robert Cook-Deegan in Support of Neither Party in AMP v. USPTO (No. 2010–1406) at 24.
“...the reason for exclusion [of laws and products of nature] is that sometimes too much patent protection can impede rather than 'promote the Progress of Science and useful Arts,' the constitutional objective of patent... protection.” Laboratory Corp. of America Holdings v. Metabolite Labs., Inc., cert. dismissed as improvidently granted, 548 U.S. 124, 126–27 (2006) (Breyer, J., dissenting).
Chakrabarty, supra note 17.
Diamond v. Diehr, supra note 3.
Ibid.
Laboratory Corp. supra note 22.
Chakrabarty, supra note 17 at 309.
Carbone, J. et al. Nat. Biotechnol. 28, 784–791 (2010).
Fore, J. Jr. et al. J. Biomed. Discov. Collab. 1, 7 (2006).
Ibid.
Cook-Deegan, R. et al. Genet. Med. 12 Suppl, S15–S38 (2010).
35 U.S.C. §§200–12 (2010).
35 U.S.C. §287(c) (2010).
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The author is grateful to J. Mixco for his contribution and assistance. The views expressed are solely those of the author.
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Chahine, K. Anchoring gene patent eligibility to its constitutional mooring. Nat Biotechnol 28, 1251–1255 (2010). https://doi.org/10.1038/nbt.1728
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DOI: https://doi.org/10.1038/nbt.1728
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