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Published online by Cambridge University Press: 20 January 2017
In June 2013, the U.S. Supreme Court decided Association for Molecular Pathology et al. v. Myriad Genetics, Inc., et al., holding that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring”.
This case note gives an overview of the U.S. Supreme Court's decision, which is focused on the product of nature doctrine, and discusses its implications for the implementation of the criterion of isolation to DNA sequences and the United States Patent and Trademark Office's long-standing practice of granting patents on isolated DNA sequences (author's headnote).
1 See Supreme Court of the United States, Association for Molecular Pathology et al. v. Myriad Genetics, Inc., et al., 13 June 2013, 569 U.S. 12-398 (2013), available on the Internet at <http://www.supremecourt.gov/opinions/12pdf/12-398_1b7d.pdf> (last accessed on 14 August 2013).
2 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 concerns. One of the patents was revoked and the other was amended.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”.
3 De Wert, G., Ter Meulen, R., Mordacci, R. and Tallacchini, M., Ethics and Genetics. A Workbook for Practitioners and Students (Oxford-New York: Berghahn Books, 2003)Google Scholar. On the discovery of BRCA1 and 2 genes see also Parthasarathy, S., Building Genetic Medicine. Breast Cancer, Technology, and the Comparative Politics of Health Care (Cambridge MA: The MIT Press, 2007), at pp. 3–7 Google Scholar.
4 (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).
5 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); (c) Claims that cover portions of the BRCA genes and cDNA as small as 15 nucleotides long (claims 5 and 6 of the ’282 patent).
6 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 cancer-predisposing mutations (e.g. claim 1 of the ’999 and ’001 patents).
7 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 14 August 2013).
8 Plaintiffs point out claims 1, 2, 5 and 6 of “patent ’282”; claim 1 of “patent ’492”. SeeAssociation for Molecular Pathology et al. v. United States Patent and Trademark Office et al., Complaint, 12 May 2009, available on the Internet at <http://docs.justia.com/cases/federal/district-courts/new-york/nysdce/1:2009cv04515/345544/1/0.pdf?ts=1243609964> (last accessed on 14 August 2013), at pp. 20–21.
9 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, 29 March 2010, available on the Internet <http://graphics8.ny-times.com/packages/pdf/national/20100329_patent_opinion.pdf?scp=3&sq=Myriad%20Genetics&st=cse> (last accessed on 14 August 2013), 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., 29 March 2010, at p. 31.
10 U.S. Supreme Court, Diamond v. Chakrabarty (447 U.S. 303), 16 June 1980, the “Chakrabarty case”.
11 On the First Amendment of the U.S. Constitution see Roddey Holder, A. and Roddey Holder, J.T., The Meaning of the Constitution (NY Hauppauge: Barron’s, 1997), at p. 57 Google Scholar.
12 Art. I, section 8, clause 8 states: “The Congress shall have the Power … 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 A. Roddey Holder and J.T. Roddey Holder, The Meaning of the Constitution, supra note 11, at p. 28.
13 cDNA or complementary DNA is “a man-made copy of the coding sequences of a gene; cDNA is produced in a test tube – it is not a natural product. In a living cell, the protein-coding sequences of DNA are transcribed as mRNA. Molecular biologists use reverse transcriptase, an enzyme that makes DNA copies from RNA, to make copies of the mRNA. The resulting cDNA – a copy of a copy, so to speak – may then be analyzed by various methods”. See Kevles, Daniel J. and Hood, Leroy (eds.), The Code of Codes: Scientific and Social Issues in the Human Genome Project (Cambridge MA: Harvard University Press, 2000), at p. 376 Google Scholar.
14 U.S. Court of Appeals for the Federal Circuit, Association for Molecular Pathology et al. v. United States Patent and Trademark Office et al., 29 July 2011, available on the Internet at <http://www.aclu.org/files/assets/10-1406.pdf> (last accessed on 14 August 2013), at p. 8.
15 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 14 August 2013).
16 U.S. Supreme Court, Mayo Collaborative Services, Mayo Medical Laboratories, et al. v. Prometheus Laboratories, Inc., 20 March 2012, 566 U.S. (2012), available on the Internet at <http://www.supremecourt.gov/opinions/11pdf/10-1150.pdf> (last accessed on 15 July 2013).
17 U.S. Court of Appeals for the Federal Circuit, Association for Molecular Pathology et al. v. United States Patent and Trademark Office et al., 16 August 2012, available on the Internet at <http://www.cafc.uscourts.gov/images/stories/opinions-orders/10-1406.pdf> (last accessed on 14 August 2013), at p. 7.
18 U.S. Court of Appeals for the Federal Circuit, Association for Molecular Pathology et al. v. United States Patent and Trademark Office et al., 16 August 2012, supra note 17, at pp. 7-8.
19 U.S. Court of Appeals for the Federal Circuit, Association for Molecular Pathology et al. v. United States Patent and Trademark Office et al., 16 August 2012, supra note 17, at p. 8.
20 See In the Supreme Court of the United States, Association for Molecular Pathology et al. v. Myriad Genetics, Inc., et al., on Petition for a Writ of Certiorari to the United States Court of Appeals for the Federal Circuit, Petition for a Writ of Certiorari, 25 September 2012, available on the Internet at <http://sblog.s3.amazonaws.com/wp-content/uploads/2012/11/12-398-Petition.pdf> (last accessed on 14 August 2013), at p. i.
21 See In the Supreme Court of the United States, Association for Molecular Pathology et al. v. Myriad Genetics, Inc., et al., on Petition for a Writ of Certiorari to the United States Court of Appeals for the Federal Circuit, Petition for a Writ of Certiorari, supra note 20, at p. i: “2. Did the Court of Appeals err in upholding a method claim by Myriad that is irreconcilable with this Court's ruling in Mayo Collaborative Servs. v.Prometheus Labs., Inc., 132 S. Ct. 1289 (2012) 3. Did the Court of Appeals err in adopting a new and inflexible rule, contrary to normal standing rules and this Court's decision in MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118 (2007), that petitioners who have been indisputably deterred by Myriad's “active enforcement” of its patent rights nonetheless lack standing to challenge those patents absent evidence that they have been personally threatened with an infringement action?”
22 Mayo Collaborative Services, Mayo Medical Laboratories, et al. v. Prometheus Laboratories, Inc., 20 March 2012, supra note 16, at p. 3, citing Benson, 409 U. S.
23 U.S. Supreme Court, Diamond v. Chakrabarty, 16 June 1980, supra note 10.
24 See Supreme Court of the United States, Association for Molecular Pathology et al. v. Myriad Genetics, Inc., et al., 13 June 2013, supra note 1, at p. 12.
25 See Supreme Court of the United States, Association for Molecular Pathology et al. v. Myriad Genetics, Inc., et al., 13 June 2013, supra note 1, at p. 12.
26 See Supreme Court of the United States, Association for Molecular Pathology et al. v. Myriad Genetics, Inc., et al., 13 June 2013, supra note 1, at pp. 14-15.
27 Supreme Court of the United States, Association for Molecular Pathology et al. v. Myriad Genetics, Inc., et al., 13 June 2013, supra note 1, at p. 18.
28 U.S. Court of Appeals for the Federal Circuit, Association for Molecular Pathology et al. v. United States Patent and Trademark Office et al., 16 August 2012, supra note 17, at pp. 16-17.
29 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/Lex-UriServ.do?uri=OJ:L:1998:213:0013:0021:EN:PDF> (last accessed on 30 July 2013).
30 As the U.S. Department of Justice explained in its brief for the United States as amicus curiae in support of neither party, in 2001 the USPTO issued its first written explanation of its practice of granting patents for isolated DNA molecules. In response to comments concerning proposed revisions to its Utility Examination Guidelines (66 Fed. Reg. 1092, January 5, 2001), the PTO held that an isolated DNA molecule is not a product of nature “because that DNA molecule does not occur in that isolated form in nature”. See In the Supreme Court of the United States, Association for Molecular Pathology et al. v. Myriad Genetics, Inc., et al., Brief of the United States as amicus curiae in support of neither party, 31 January 2013, available on the Internet at <http://www.americanbar.org/content/dam/aba/publications/supreme_court_preview/briefs-v2/12-398_neither_amcu_us.authcheckdam.pdf> (last accessed on 14 August 2013), at pp. 27-28.
31 In 2001 the USPTO published a revised version of the Utility Examination Guidelines to be used by office personnel in their review of patent applications for compliance with the ‘utility’ requirement of 35 U.S.C. § 101, that became effective on January 5, 2001. See USPTO, <http://www.uspto.gov/web/offices/com/sol/og/2001/week05/patutil.htm> (last accessed on 14 August 2013).
32 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 M.A. Heller and R.S. 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).
33 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 Wilson, J., “Patenting Organisms. Intellectual Property Law Meets Biology”, in Magnus, D., Caplan, A., McGee, G. (eds.) Who Owns Life? (Amherst NY: Prometheus Books, 2002) at pp. 47–48 Google Scholar. For a critical historical reconstruction of the “product of nature” doctrine, see Demaine, L.J. and Fellmeth, A.X., “Reinventing the Double Helix: A Novel and Nonobvious Reconceptualization of the Biotechnology Patent”, in 55 Stanford Law Review (2002), at pp. 303–462 CrossRefGoogle ScholarPubMed.
34 See Kay, L.E., Who Wrote the Book of Life? A History of the Genetic Code (Stanford CA: Stanford University Press, 2000)Google Scholar.
35 U.S. District Court for the Southern District of New York, Association for Molecular Pathology et al. v. United States Patent and Trademark Office et al., 29 March 2010, available on the Internet at <http://graphics8.nytimes.com/packages/pdf/national/20100329_patent_opinion.pdf?scp=3&sq=Myriad%20Genetics&st=cse> (last accessed on 14 August 2013), at pp. 7-8.
36 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 for the Southern District of New York, Association for Molecular Pathology et al. v. United States Patent and Trademark Office et al., Complaint, supra note 8, at p. 18.
37 See U.S. District Court for the Southern District of New York, Association for Molecular Pathology et al. v. United States Patent and Trademark Office et al., 29 March 2010, supra note 35, at p. 8.
38 U.S. Court of Appeals for the Federal Circuit, Association for Molecular Pathology et al. v. United States Patent and Trademark Office et al., 16 August 2012, supra note 17, at p. 45.
39 U.S. Court of Appeals for the Federal Circuit, Association for Molecular Pathology et al. v. United States Patent and Trademark Office et al., 16 August 2012, supra note 17, at p. 48.
40 In the Supreme Court of the United States, Association for Molecular Pathology et al. v. Myriad Genetics, Inc., et al., Brief of the United States as amicus curiae in support of neither party, 31 January 2013, supra note 30, at p. 22.
41 In the Supreme Court of the United States, Association for Molecular Pathology et al. v. Myriad Genetics, Inc., et al., Brief of the United States as amicus curiae in support of neither party, 31 January 2013, supra note 30, at p. 23.
42 Supreme Court of the United States, Association for Molecular Pathology et al. v. Myriad Genetics, Inc., et al., 13 June 2013, supra note 1, at p. 8.
43 U.S. District Court for the Southern District of New York, Association for Molecular Pathology et al. v. United States Patent and Trademark Office et al., 29 March 2010, supra note 35, at p. 7. Eisenberg explained why the chemical analogy was applied to genes in such a successful way. Eisenberg, R.S., “Why Gene Patenting Controversy Persists”, 77 Academic Medicine (2002), at p. 1381 CrossRefGoogle ScholarPubMed; Eisenberg, R.S., “Patenting Genome Research Tools and the Law”, 326 Comptes Rendus Biologies (2003), at p. 1116 CrossRefGoogle ScholarPubMed.
44 In the Supreme Court of the United States, Association for Molecular Pathology et al. v. Myriad Genetics, Inc., et al., Brief of the United States as amicus curiae in support of neither party, supra note 30, at p. 28.
45 See, for example, Genomic Science and Technology Innovation Act of 2002 (H.R. 3966, 107th Cong., 2d Sess., 2002); Genomic Research and Diagnostic Accessibility Act of 2002 (H.R. 3967, 107th Cong., 2d Sess., 2002); Life Patenting Moratorium Act of 1993 (S. 387, 103d Cong., 1st Sess., 1993); Consolidated Appropriations Act of 2004 (Pub. L. No. 108-199, § 634, 118 Stat. 101).
46 In the Supreme Court of the United States, Association for Molecular Pathology et al. v. Myriad Genetics, Inc., et al., Brief of the United States as amicus curiae in support of neither party, 31 January 2013, supra note 30, at p. 28.
47 Supreme Court of the United States, Association for Molecular Pathology et al. v. Myriad Genetics, Inc., et al., 13 June 2013, supra note 1, at p. 11.
48 In the Supreme Court of the United States, Association for Molecular Pathology et al. v. Myriad Genetics, Inc., et al., Brief of the United States as amicus curiae in support of neither party, 31 January 2013, supra note 30, at p. 33.
49 See Johanna Bennett, “About Face on Myriad Genetics, Stock Falls 5.6%”, available on the Internet at <http://blogs.barrons.com/stockstowatchtoday/2013/06/13/about-face-on-myriad-genetics-stock-falls-5-6/> (last accessed on 30 July 2013).
50 In the United States District Court for the District of Utah, Central Division, University of Utah Research Foundation, et al., v. Gene by Gene LTD, Complaint Demand for Jury Trial, 10 July 2013, available on the Internet at <http://files.priorsmart.com.s3.amazonaws.com/utdce/89792/Complaint.pdf?Signature=7Cgxhnu5Qlu%2FgM7jCmSRghLXeZI%3D&Expires=1375782713&AWSAccessKeyId=AKIAJWOP3U6XRH5BBMOA> (last accessed on 31 July 2013).
51 In the United States District Court for the District of Utah, Central Division, University of Utah Research Foundation, et al., v. Ambry Genetics Corporation, Motion for Preliminary Injunctive Relief and Memorandum in Support, 9 July 2013, available on the Internet at <http://www.patentlyo.com/myriad-motionforpreliminaryrelief.pdf> (last accessed on 31 July 2013), at p. 4.
52 See In the United States District Court for the District of Utah, Central Division, University of Utah Research Foundation, et al., v. Ambry Genetics Corporation, Motion for Preliminary Injunctive Relief and Memorandum in Support, 9 July 2013, supra note 51, at p. 4.
53 See In the United States District Court for the District of Utah, Central Division, University of Utah Research Foundation, et al., v. Ambry Genetics Corporation, Motion for Preliminary Injunctive Relief and Memorandum in Support, 9 July 2013, supra note 51, at p. 4.
54 Myriad alleged that Gene by Gene was infringing the following patents, owned or exclusively licensed to Myriad: U.S. patent No. 5,709,999 (the “’999 Patent”); U.S. patent No. 5,747,282 (the “’282 Patent”); U.S. patent No. 5,753,441 (the “’441 Patent”); U.S. patent No. 5,837,492 (the “’492 Patent”); U.S. patent No. 6,033,857 (the “’857 Patent”); U.S. patent No. 5,654,155 (the “’155 Patent”); U.S. patent No. 5,750,400 (the “’400 Patent”); U.S. patent No. 6,951,721 (the “’721 Patent”); U.S. patent No. 7,250,497 (the “’497 Patent).
55 In the United States District Court for the District of Utah, Central Division, University of Utah Research Foundation, et al., v. Gene by Gene LTD, Complaint Demand for Jury Trial, 10 July 2013, supra note 50, at p. 4.
56 Myriad alleged that Ambry Genetics is infringing: claims 16 and 17 of patent ’282, claims 29 and 30 of patent ’492, claims 8 and 7 of patent ’441, claim 4 of patent ’857, claim 5 of patent ’721, claims 2 and 4 of patent ’155. See In the United States District Court for the District of Utah, Central Division, University of Utah Research Foundation, et al., v. Ambry Genetics Corporation, Motion for Preliminary Injunctive Relief and Memorandum in Support, 9 July 2013, supra note 51, at p. 15.
57 In the United States District Court for the District of Utah, Central Division, University of Utah Research Foundation, et al., v. Ambry Genetics Corporation, supra note 51, at p. 30.
58 In the United States District Court for the District of Utah, Central Division, University of Utah Research Foundation, et al., v. Ambry Genetics Corporation, supra note 51, at p. 3.
59 For example, U.S. patent No. 5,747,282 (the “’282 Patent”), which is owned by the University of Utah, along with the Public Health Service, through the National Institutes of Health and is exclusively licensed to Myriad; U.S. patent No. 5,753,441 (the “’441 Patent”), which is owned by the University of Utah and Public Health Service and exclusively licensed to Myriad. See In the United States District Court for the District of Utah, Central Division, University of Utah Research Foundation, et al., v. Gene by Gene LTD, Complaint Demand for Jury Trial, 10 July 2013, supra note 50, at pp. 6-7.
60 The Bayh-Dole Act was passed in December 1980 (Act of December 12, 1980, Pub. L. No. 96-516, § 6(a), 94 Stat. 3015, 3019-3028, 1980, codified as amended at 35 U.S.C. §§ 200-212, 1994). Its main purpose is “to use the patent system to promote the utilization of inventions arising from federally funded research or development …”. See 35 U.S.C. § 200.
61 The Stevenson-Wydler Technology Innovation Act was passed in 1980 (Pub. L. No. 96-480, § 2, 94 Stat. 2311-2320, 1980, codified as amended at 15 U.S.C. §§ 3701-3714, 2000).
62 See Senator Patrick Leahy's Letter addressed to Doctor Francis S. Collins, Director of the National Institutes of Health, available on the Internet at <http://www.leahy.senate.gov/download/07-12-13-pjl-to-nih-re_-myriad-march-in> (last accessed on 14 August 2013), at p. 1.
63 See 35 U.S.C. § 203 March-in rights, available on the Internet at <http://www.gpo.gov/fdsys/pkg/USCODE-2011-title35/pdf/USCODE-2011-title35-partII-chap18-sec203.pdf> (last accessed on 14 August 2013).
64 Rai, Arti K. and Eisenberg, Rebecca S., “Bayh-Dole Reform and the Progress of Biomedicine”, in Boyle, James (ed.), Law and Contemporary Problems, Vol. 66: 2003, Nos. 1 & 2, at pp. 289–314 Google Scholar.
65 Arti K. Rai and Rebecca S. Eisenberg, “Bayh-Dole Reform and the Progress of Biomedicine”, supra note 64, at pp. 289.
66 See Arti K. Rai and Rebecca S. Eisenberg, “Bayh-Dole Reform and the Progress of Biomedicine”, supra note 64, at pp. 290-291.
67 See Arti K. Rai and Rebecca S. Eisenberg, “Bayh-Dole Reform and the Progress of Biomedicine”, supra note 64, at p. 294.