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The Product of Nature Doctrine in the Myriad Saga
Published online by Cambridge University Press: 20 January 2017
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References
1 See U.S. Supreme Court Order 11-725, 26 March 2012, available on the Internet at <http://www.supremecourt.gov/orders/courtorders/032612zor.pdf= (last accessed on 30 April 2012).
2 U.S. Supreme Court March 20, 2012, Mayo Collaborative Services, Mayo Medical Laboratories, et al. v. Prometheus Laboratories, Inc., 566 U.S. (2012), available on the Internet at <http://www.supremecourt.gov/opinions/11pdf/10-1150.pdf= (last accessed on 30 April 2012).
3 See Mariachiara Tallacchini, Gene Patenting in Europe (forthcoming): “In Europe, after two patents on BRCA1 (Patents EP0699754 and EP0705902) were granted by the EPO in January and November 2001, Switzerland’s Social Democratic Party, Greenpeace Germany, the French Institute Curie, Assistance Publique-Hôpitaux de Paris, the Belgian Society of Human Genetics, the Netherlands, the Austrian Federal Ministry of Social Security et al. filed an opposition with the support of the European Parliament. Opponents argued that both inventions lacked novelty, inventive step and industrial application and posed ethical and policy co cerns. One of the patents was revoked and the other was amended. After Myriad’s appeal and opposition they were restored, but in an amended form”.
4 Guido De Wert, Ruud Ter Meulen, Rorberto Mordacci and Mariachiara Tallacchini, Ethics and Genetics. A Workbook for Practitioners and Students (Oxford-New York: Berghahn Books 2003). On the discovery of BRCA1 and 2 genes see also Shobita Parthasarathy, Building Genetic Medicine. Breast Cancer, Technology, and the Comparative Politics of Health Care (Cambridge MA: The MIT Press 2007), pp. 3–7.
5 (1) The Association of Molecular Pathology (AMP); (2) The American College of Medical Genetics (ACMG); (3) The American Society for Clinical Pathology (ASCP); (4) The College of American Pathologists (CAP).
6 The “product category” includes: (a) Claims that cover the isolated BRCA genes (claim 1 of the ’282 patent, claim 1 of the ’473 patent, and claims 1 and 6 of the ’492 patent); (b) Claims that cover only the BRCA cDNA (claims 2 and 7 of the ’282 patent and claim 7 of the ’492 patent); Claims that cover portions of the BRCA genes and cDNA as small as 15 nucleotides long (claims 5 and 6 of the ’282 patent).
7 The “method category” encompasses method claims directed at comparing or analyzing a patient’s altered BRCA sequence with the normal one or wild-type one to identify the presence of cancerpredisposing mutations (e.g. claim 1 of the ’999 and ’001 patents).
8 See 35 U.S.C. § 101 Inventions patentable, available on the Internet at <http://www.wipo.int/clea/docs_new/pdf/en/us/us007en.pdf= (last accessed on 30 April 2012).
9 Plaintiffs point out claims 1, 2, 5 and 6 of “patent 282”; claim 1 of “patent 492”. See Association for Molecular Pathology et al. v. United States Patent and Trademark Office et al., Complaint, at pp. 20–21.
10 Scientists often use the term “wild-type” to refer to the normal gene sequence, i.e. the sequence of a gene without any variation, against which individuals’ gene sequences are compared. Association for Molecular Pathology et al. v. United States Patent and Trademark Office et al., Case 1:09-cv 04515-RWS, at p. 31. However Senior Judge Sweet points out that “there is an increasing recognition that the notion of a single ‘normal’ gene sequence may not be entirely accurate in light of the high frequency of variations in a gene sequence between individuals”. See note 8, Association for Molecular Pathology et al. v. United States Patent and Trademark Office et al., Case 1:09-cv-04515-RWS, at p. 31.
11 U.S. Supreme Court June 16, 1980, Diamond v. Chakrabarty (447 U.S. 303), the “Chakrabarty case”.
12 On the First Amendment of U.S. Constitution see Angela Roddey Holder and John Thomas Roddey Holder, The Meaning of the Constitution (Hauppauge, NY: Barron’s 1997), at p. 57.
13 Art. I, section 8, clause 8 states: “The Congress shall have the Power 7#x2026; To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries”. See Angela Roddey Holder and John Thomas Roddey Holder, The Meaning of the Constitution (Hauppauge, NY: Barron’s 1997), at p. 28.
14 U.S. Court of Appeals for the Federal Circuit, July 29, 2011, Association for Molecular Pathology et al. v. United States Patent and Trademark Office et al., at p. 8.
15 U.S. Court of Appeals for the Federal Circuit, July 29, 2011, Association for Molecular Pathology et al. v. United States Patent and Trademark Office et al., at p. 41.
16 U.S. Court of Appeals for the Federal Circuit, July 29, 2011, Association for Molecular Pathology et al. v. United States Patent and Trademark Office et al., at pp. 43–44.
17 U.S. Patent No. 6,355,623 (’623 patent) and U.S. Patent No. 6,680,302 (’302 patent).
18 U.S. Supreme Court, March 20, 2012, Mayo Collaborative Services v. Prometheus Laboratories, Inc., at p. 3.
19 The District Court held that Mayo’s test infringed the two patents, but granted to Mayo summary judgment, regarding the processes claimed in the patents non patentable under the product of nature exception. The Federal Circuit reversed, considering the processes patent eligible under the “machine or transformation test”.
20 U.S. Supreme Court, March 20, 2012, Mayo Collaborative Services v. Prometheus Laboratories, Inc., at p. 16.
21 See O’Reilly v. Morse, 56 U.S. 15 How. 62 (1853).
22 U.S. Supreme Court, March 20, 2012, Mayo Collaborative Services v. Prometheus Laboratories, Inc., at p. 23.
23 See Hank Greely, “The Supreme Court Decides Mayo v. Prometheus, Strikes down Patents”, 20 March 2012, available on the Internet at <http://blogs.law.stanford.edu/lawandbiosciences/2012/03/20/the-supreme-court-decides-mayo-v-prometheusstrikes-down-patents/= (last accessed on 30 April 2012). On March 26, 2012, Myriad Genetics, Inc. stock declined 2.4 percent to $22.78 in aftermarket session when the company announced that the Supreme Court of the United States remanded the case to the Federal Circuit Court of Appeals. See Satya Nagendra Padala, “Post-Market NASDAQ Losers”, 27 March 2012, available on the Internet at <http://www.ibtimes.com/articles/319974/20120327/neurocrine-biosciences-nektar-therapeutics-apollo-group-valuevision.htm= (last accessed on 30 April 2012).
24 Some legal scholars have purported that the “product of nature” argument is redundant and vague. See e.g. William Lesser, “Nature or Nurture: Is There a Case Basis for a Judicially Created ‘Product of Nature’ Exclusion? Are Genes Somehow Different?”, 11 The John Marshall Review of Intellectual Property Law (2011), at p. 320.
25 See Sheila Jasanoff, “Taking Life: Private Rights in Public Nature”, in Kaushik Sunder Rajan (ed.), Lively Capital – Biotechnologies, Ethics, and Governance in Global Markets (Experimental Futures)(Durham, NC: Duke University Press, 2012), pp. 155–183.
26 In the European Union the criteria of isolation and purification were introduced (art. 5.2) with the approval of the European Parliament and Council Directive 98/44/EC on the Legal Protection of Biotechnological Inventions, available on the Internet at <http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:1998:213:0013:0021:EN:PDF= (last accessed on 30 April 2012).
27 After the controversial granting in the ’90s of some patents on the so called ESTs (expressed sequence tags), in 2001 the USPTO had to enact new Utility Examination Guidelines to stem the “far-west patent rush” to DNA sequences (see Michael A. Heller and RebeccaS. Eisenberg, “Can Patents Deter Innovation? The Anticommons in Biomedical Research”, Science, 1 May 1998, Vol. 280, at p. 699). In the Guidelines were set forth the concepts of isolation and purification to discriminate non patentable DNA sequences from patentable ones: “An isolated and purified DNA molecule that has the same sequence as a naturally occurring gene is eligible for a patent because (1) an excised gene is eligible for a patent as a composition of matter or as an article of manufacture because that DNA molecule does not occur in that isolated form in nature, or (2) synthetic DNA preparations are eligible for patents because their purified state is different from the naturally occurring compound” (USPTO, January 5, 2001, Utility Examination Guidelines, 66 Fed. Reg., at p. 1092).
28 The origin of the “product of nature” doctrine can be traced back to the XIX century, at least in 1889 when Ex parte Latimer [Commn. Dec. 123(1889)] was decided by the Commissioner of patents.See John Wilson, “Patenting Organisms. Intellectual Property Law Meets Biology”, in David Magnus, Arthur Caplan and Glenn Mc-Gee (eds.) Who Owns Life? (Amherst, NY: Prometheus Books, 2002) at pp. 47–48. For a critical historical reconstruction of the “product of nature” doctrine, see Linda J. Demaine and Aaron X. Fellmeth, “Reinventing the Double Helix: A Novel and Nonobvious Reconceptualization of the Biotechnology Patent”, in 55 Stanford Law Review (2002), pp. 303–462.
29 U.S. District Court Southern District of New York March 29, 2010, Association for Molecular Pathology et al. v. United States Patent and Trademark Office et al., at p. 7. Eisenberg explained why the chemical analogy was applied to genes in such a successful way. Rebecca S. Eisenberg, “Why Gene Patenting Controversy Persists”, 77 Academic Medicine (2002), at p. 1381; Rebecca S. Eisenberg, “Patenting Genome Research Tools and the Law”, 326 Comptes Rendus Biologies (2003), at p. 1116.
30 See Lily E. Kay, Who Wrote the Book of Life? A History of the Genetic Code (Stanford, CA: Stanford University Press, 2000).
31 U.S. District Court Southern District of New York March 29, 2010, Association for Molecular Pathology et al. v. United States Patent and Trademark Office et al., at pp. 7–8.
32 The main substantive argument advanced by the plaintiffs and agreed on by Judge Sweet is based on the “product of nature doctrine”. See U.S. District Court Southern District of New York, Association for Molecular Pathology et al. v. United States Patent and Trademark Office et al., Complaint, at p. 18.
33 See U.S. District Court Southern District of New York March 29, 2010, Association for Molecular Pathology et al. v. United States Patent and Trademark Office et al., at p. 8.
34 Rebecca S. Eisenberg, “Re-Examining the Role of Patents in Appropriating the Value of DNA Sequences”, 49 Emory Law Journal (2000), at pp. 786–787.
35 See Steven Seidenberg, “US Perspectives. US Supreme Court Edges Toward Reviewing Extent of GMO Patents”, 13 April 2012, available on the Internet at <http://www.ip-watch.org/2012/04/13/ussupreme-court-edges-toward-reviewing-extent-of-gmo-patents/= (last accessed on 30 April 2012). In 2002 Vernon Bowman, an Indiana farmer, purchased soybeans (Monsanto’s Roundup Ready® soybean seeds) from Pioneer Hi-Bred, which is one of Monsanto’s licensed seed producers. Roundup Ready® soybean seeds are genetically modified to exhibit resistance to glyphosate-based herbicides, such as Monsanto’s Roundup®. Bowman planted the beans and, after the first crop, he saved some of the plants’ seeds and planted them for subsequent crops. In 2007 Monsanto sued and accused him of patent infringement for using the second and later generations of seeds. Bowman claimed that their use was legal, as Monsanto’s patent rights were exhausted upon the first sale of the seeds. Monsanto acknowledged that patent rights in goods are exhausted by a lawful sale, but it argued that the exhaustion covered only those seeds sold by Monsanto-the first generation of seeds. In 2011, the U.S. Court of Appeals for the Federal Circuit held that by growing new seeds, Bowman created “newly infringing article[s]” not covered by patent exhaustion.