Isolated DNA Compositions Are Not Patent Eligible: Association for Molecular Pathology v. Myriad Genetics

Vol. 6 No. 2

By

Marylee Jenkins is a partner at  Arent Fox LLP in New York, where she heads the office’s intellectual property group. She counsels international companies on intellectual property disputes and strategies and portfolio enforcement and management. She can be reached at marylee.jenkins@arentfox.com. Kristi Nicholes Burton, an intellectual property attorney in the same office, counsels clients in connection with patent preparation and prosecution and transactional matters. She can be reached at kristi.nicholes-burton@arentfox.com. The views expressed herein are their own and do not necessarily represent the views of, and should not be attributed to, their firm.

For over 30 years, the United States has been grant- ing patents relating to DNA molecules for many useful applications, such as diagnosis and treatment of disease.1 While there is much debate about whether patents relating to DNA molecules have advanced innovation and progress in the field of medicine or, alternatively, created a substantial barrier to research and adequate health care, it is readily apparent that the biotechnology industry and its corresponding patent filings have grown tremendously over the past three decades.

Since patents were first granted on DNA molecules, there has been extensive controversy over their patentability due to the nature of the technology, particularly as it relates to human DNA molecules. It is, therefore, not surprising that a challenge to the patent eligibility of DNA molecules eventually appeared before the courts.

In Association for Molecular Pathology v. USPTO (Myriad I), the U.S. District Court for the Southern District of New York ruled that patent claims for isolated DNA and cDNA compositions and methods of analyzing gene sequences were categorically ineligible.2 The U.S. Court of Appeals for the Federal Circuit reversed the district court’s decision and found that the claims directed to both isolated DNA and cDNA were patent eligible.3

The U.S. Supreme Court ultimately decided the controversy, and in Association for Molecular Pathology v. Myriad Genetics, Inc. (Myriad IV), reversed the Federal Circuit in part, holding that the composition claims directed to isolated DNA were not patent eligible under 35 U.S.C. § 101, but affirmed the Federal Circuit’s holding that cDNA was patent eligible.4

Background and Procedural History

The Association for Molecular Pathology (AMP) and others brought a declaratory judgment action against Myriad Genetics Inc. (Myriad) that challenged the validity of 15 claims from seven of Myriad’s patents relating to breast cancer susceptibility genes 1 and 2, known as “BRCA1” and “BRCA2.”5 The claims at issue were directed to inter alia “isolated DNA” compositions that code for the BRCA1 or BRCA2 polypeptide. Through extensive research, the inventors discovered the precise location and sequences of the BRCA1/2 genes and identified the mutations in these genes that correlate with a significantly increased risk of developing breast and ovarian cancer. Myriad proceeded to secure patent protection over the use of diagnostic tests for breast and ovarian cancer based on the BRCA genes.

The BRCA genes are among more than 20,000 genes in a human genome, which is a complete set of a person’s deoxyribonucleic acid (DNA). DNA is a molecule that encodes instructions required by living cells to create proteins necessary for cellular function and structure. A gene is a short section of a DNA molecule that, through its nucleotide sequence, codes for a specific protein. Only sections of a gene’s nucleotide sequence, called “exons,” code for the protein expressed by the gene. The gene also contains noncoding sequences called “introns.”

Human DNA is packaged together with proteins in complex structures known as “chromosomes.” Every living cell contains chromosomes made from long DNA molecules—each chromosome consists of thousands of genes. Thus, in its natural environment, each BRCA gene is a small part of a long strand of DNA existing in one of 46 chromosomes.6 Many laboratory techniques can be used to extract DNA from its cellular environment and excise a gene from the DNA. Excising a gene from its DNA includes breaking the covalent chemical bonds that attach the gene to the DNA. This process results in “isolated DNA,” which is then in a form for further study and use. The isolated DNA claimed in the Myriad patents is a short strand of DNA that codes for either the BRCA1 or BRCA2 polypeptide.

In addition to isolated DNA, the Myriad patents also claim complementary DNA, or “cDNA,” compositions. A cDNA molecule includes only the exons of the naturally occurring gene from which it is derived. cDNA molecules are created from messenger ribonucleic acid molecules, or “mRNA.” First, however, the isolated DNA must form ribonucleic acid (RNA) through transcription and synthesis during which a temporary copy of a DNA sequence is created in the form of an RNA molecule. This newly formed RNA molecule contains both exons and introns. Through a process called “splicing,” the introns are removed from the RNA molecule and the remaining RNA segments are rejoined. The resulting molecule is known as mRNA. cDNA is so named because it is “complementary” to the mRNA from which it is produced. More specifically, each nucleotide base in the cDNA molecule can bind with the corresponding base in the mRNA molecule from which it is derived.

A critical issue before the district court was whether an isolated DNA compound qualifies as subject matter eligible for patenting under 35 U.S.C. § 101.7 The court held that it does not, noting that subject matter is patent eligible if it is “markedly different” from a product of nature.8 Indeed, the court stated that isolated DNA was not “sufficiently distinct in its fundamental characteristics” from the corresponding DNA sequence found in nature.9 The district court thus found that all of the composition claims at issue were invalid because they recited unpatentable products of nature.10

In its first decision dated July 29, 2011, a divided panel of the Federal Circuit reversed the district court’s holdings and found that all 15 claims of Myriad’s patents were patent eligible under 35 U.S.C. § 101.11 On March 26, 2012, AMP petitioned for a writ of certiorari to the Supreme Court. While that petition was pending, the Supreme Court rendered its decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc.12 Following Mayo, the Supreme Court granted the petition but proceeded to vacate and remand the case to the Federal Circuit for rehearing in light of Mayo. On remand, the same Federal Circuit panel reaffirmed its prior decision largely for the same reasons given previously.13

Specifically, the Federal Circuit held in an opinion written by Judge Lourie “that the challenged claims to isolated DNAs, whether limited to cDNAs or not, are directed to patent-eligible subject matter under § 101.”14 Notably, while the three panel members of the Federal Circuit agreed that cDNA is patentable subject matter, they were divided as to the patentability of isolated DNA. Judge Lourie found that isolated DNA compositions are patent eligible because they “are markedly different—have a distinctive chemical structure and identity—from those found in nature.”15 In Judge Lourie’s view, “[i]solated DNA has been cleaved (i.e., had covalent bonds in its backbone chemically severed) or synthesized to consist of just a fraction of a naturally occurring DNA molecule,” and therefore the isolated DNA molecules differ from DNA that exists in the body.16

Judge Moore did not join with Judge Lourie in the majority opinion in regard to isolated DNA. Instead, Judge Moore issued a concurring opinion that provided a detailed explanation of important chemical considerations of isolated DNA. She stated, “If I were deciding this case on a blank canvas, I might conclude that an isolated DNA sequence that includes most or all of a gene is not patentable . . . .”17 However, Judge Moore reasoned that isolated DNA could be patentable if it had greater utility than native DNA.18 She further weighed the chemical considerations against the historical practice of the USPTO in granting patents on isolated DNA molecules and the belief that the judiciary should be cautious in expanding the judicial exception to patentable subject matter.19 Ultimately, Judge Moore decided the scales tip in favor of patentability.20

Judge Bryson dissented and found that the material of the claimed BRCA genes is the same both structurally and functionally, in both the natural gene and its isolated form, and therefore is a product of nature.21

On April 15, 2013, the Supreme Court heard oral arguments.22 At issue was the validity of nine composition claims from three of Myriad’s patents.23 Notably, none of the method claims were before the Supreme Court.24 The questions before the Supreme Court were whether a naturally occurring segment of DNA is patent eligible under 35 U.S.C. § 101 by virtue of its isolation from the rest of the human genome, and whether cDNA, which omits noncoding portions of DNA, is patent eligible under 35 U.S.C. § 101.

The U.S. Supreme Court Decision

In a unanimous decision drafted by Justice Clarence Thomas, the Supreme Court held that Myriad’s claims directed to isolated DNA compositions were not patent eligible under 35 U.S.C. § 101 because: (1) Myriad did not create a new composition, but merely discovered the location and genetic sequences of the BRCA1/2 genes; (2) the claims were drafted to cover genetic information encoded in the BRCA1/2 genes and were not drafted in terms of chemical composition or chemical changes resulting from isolated DNA sequences; and (3) the USPTO’s historical practice of granting gene patents was not entitled to deference because Congress has not endorsed the USPTO’s view concerning isolated DNA, and indeed even the U.S. solicitor general argued that isolated DNA is not patent-eligible subject matter.25 However, the Court affirmed the Federal Circuit holding that cDNA is patent-eligible subject matter because it is not a product of nature but rather is created in a laboratory.

In arriving at its decision, the Court noted that § 101 defines the subject matter eligible for patenting under the Patent Act: “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 therefor, subject to the conditions and requirements of this title.”26 Section 101 thus specifies four independent categories of inventions or discoveries that are eligible for patent protection: processes, machines, manufactures, and compositions of matter. “In choosing such expansive terms . . . modified by the comprehensive ‘any,’ Congress plainly contemplated that the patent laws would be given wide scope.”27 Congress took this permissive approach to patent eligibility to ensure that “ingenuity should receive a liberal encouragement.”28

Citing to its recent decision in Mayo, the Supreme Court identified the three, long-held, implicit exceptions to § 101’s broad patent eligibility principles: laws of nature, physical phenomena, and abstract ideas.29 The Court recognized the dangers of tying up the “basic tools of scientific and technological work”30 because this would conflict with the purpose of patents to promote creation.31 Indeed, the Court noted that “[p]roducts of nature are not created, and ‘manifestations . . . of nature [are] free to all men and reserved exclusively to none.’”32 The Court further relied on its decisions in two important cases: Funk Bros. Seed Co. v. Kalo Inoculant Co.33 and Diamond v. Chakrabarty.34

In Funk Bros., the Supreme Court held that a claim directed to a plurality of naturally occurring bacterial strains that did not inhibit each other was invalid.35 The Court found that the aggregation of naturally occurring strains, which did not exhibit characteristics different from the individual strains themselves, “was not the product of invention.”36 As characterized by Justice Thomas in Myriad IV, “the composition was not patent eligible because the patent holder did not alter the bacteria in any way,” and thus the claims fell within the law of nature exception.37 Justice Thomas reasoned that Myriad’s claims similarly fell within the law of nature exception because it merely discovered the location of the BRCA1/2 genes, which alone did not render the BRCA genes patent eligible.38

The Supreme Court appropriately noted that its decision in Chakrabarty was fundamental to the issue in Myriad IV. In Chakrabarty, the Court distinguished its earlier decision in Funk Bros. by observing that, unlike the mixture of natural microbial cultures claimed in Funk Bros., Chakrabarty’s genetically engineered microorganism had “markedly different characteristics from any found in nature and [was] one having the potential for significant utility.”39 Thus, the Court found that a live, human-made microorganism constituted patent-eligible subject matter because it had “markedly different” characteristics from what appeared in nature.40 The Court “explained that the patent claim was ‘not to a hitherto unknown natural phenomenon, but to a nonnaturally occurring . . . composition of matter—a product of human ingenuity having a distinctive name, character [and] use.’”41

The Court unequivocally stated that “Myriad did not create anything,” and separating an important and useful gene from its natural genetic material is not invention.42 Indeed, in isolating the BRCA1/2 genes, Myriad did not create or alter any of the genetic information encoded in these genes. The location and order of the nucleotides existed in nature—Myriad only discovered the location and genetic sequence of the genes.

The Court also was not persuaded by the fact that isolating DNA involves severing covalent bonds to create a nonnaturally occurring molecule.43 Justice Thomas stated that Myriad’s claims were directed to “the information contained in the genetic sequence, not . . . the specific chemical composition of a particular molecule.”44 He reasoned that Myriad obviously did not claim the unique molecule (i.e., the BRCA1 or BRCA2 sequence) because such infringement could be avoided “by isolating a DNA sequence that included both the BRCA1 or BRCA2 gene and one additional nucleotide pair.”45

Finally, the Court did not give any weight or deference to the USPTO’s historical practice of granting patents relating to DNA molecules. First, the Court noted that Congress has not endorsed the USPTO’s practice in subsequent legislation.46 Second, the Court cited to the United States’ amicus brief, which stated that isolated DNA is not patent-eligible subject matter under 35 U.S.C. § 101, and the USPTO’s historical practice is insufficient to hold otherwise.47

With respect to cDNA, the Supreme Court held that it is not a “product of nature.” The Court reasoned that through the process of creating cDNA, a lab technician creates a new composition that is different from any naturally occurring molecule. In other words, although the sequence of cDNA is dictated by nature, scientists create something new when making cDNA. Thus, the Court found that cDNA was not a “product of nature” and is patent eligible under 35 U.S.C. § 101. The Court noted an exception in that certain naturally occurring DNA segments may not contain introns, in which case a short strand of cDNA may be indistinguishable from natural DNA.48

The Impact of Myriad

The USPTO’s Response and Practice Implications

Upon issuance of the Supreme Court’s decision in Myriad IV, the USPTO sent a memorandum to its Patent Examining Corps regarding the decision.49 The memorandum acknowledged that the USPTO’s examination policy concerning nucleic acid–related technology had significantly changed in light of Myriad IV. The memorandum stated that “naturally occurring nucleic acids are not patent eligible merely because they have been isolated. Examiners should now reject product claims drawn solely to naturally occurring nucleic acids or fragments thereof, whether isolated or not, as being ineligible subject matter under 35 U.S.C. § 101.”50 Conversely, the USPTO indicated that claims directed to “non-naturally-occurring nucleic acids, such as a cDNA or a nucleic acid in which the order of the naturally-occurring nucleotides has been altered (e.g., a man-made variant sequence), remain eligible.”51

The memorandum stated that the USPTO will provide more comprehensive guidance after further reviewing the Myriad IV decision. In the meantime, it may be possible to rely on other sources to provide insight as to how claims will be examined in view of Myriad IV. For example, the USPTO sent a memorandum to its Patent Examining Corps for examining process claims involving laws of nature in light of Mayo.52 The USPTO recognized that in view of Mayo, “any . . . claim in which a law of nature, a natural phenomenon, or naturally occurring relation or correlation is a limitation, should be examined under this procedure.”53 The USPTO may take this expansive view with respect to Myriad IV as well. Therefore, the Supreme Court’s rationale that a naturally occurring DNA molecule is not patent eligible merely by virtue of its isolation could arguably be extended to other molecules, such as proteins, antibiotics, or pigments.

The USPTO defined these types of limitations collectively as a “natural principle,” which it explained is “the handiwork of nature and occurs without the hand of man.”54 As an example, the USPTO stated that the “relationship between blood glucose levels and diabetes is a natural principle.”55 Furthermore, a naturally occurring correlation resulting from the interaction of a man-made drug with blood is also considered a natural principle.56 The USPTO reasoned that “while it takes human action to trigger a manifestation of the correlation, the correlation exists in principle apart from any human action.”57 A claim is directed to a natural principle if it is a limiting element or step of the claim.58

In Mayo, the analysis rests on whether a claim recites enough elements/steps to achieve a practical application.59 As an example, a claim for “diagnosing an infection that recites the step of correlating the presence of a . . . bacterium in . . . blood with a . . . type of bacterial infection with the additional step of recording the diagnosis on a chart would not be eligible because the step of recording . . . is extra-solution activity . . . unrelated to the correlation and does not integrate the correlation into the invention.”60 Moreover, “[e]lements . . . that are well-understood, purely conventional, and routinely taken by others in order to apply the natural principle, or that only limit the use to a particular . . . field-of-use[], would not be sufficiently specific.”61 Clearly in light of both Mayo and Myriad IV, a claim directed to an isolated DNA molecule will require “something more” to overcome a rejection under § 101. Indeed, the issue is how much modification in an isolated DNA molecule (or any other composition determined to be a “natural principle” or “law of nature”) is needed in order to render a composition patent eligible.

The USPTO also provides numerous practice points useful in analyzing claims under Mayo that also may be applicable to analyzing claims under Myriad IV. For example, adding elements provided “at a high level of generality, to a natural principle does not make the claim patent-eligible.”62 In addition, elements that “are well-understood, routine, conventional activity, previously engaged in by those in the field add nothing specific to the natural principle that would render it patent-eligible.”63

Myriad’s Current Activity: Filing New Patent Lawsuits

Immediately after the issuance of the Myriad IV decision, Ambry Genetics Corporation (Ambry) announced it would begin offering analysis of BRCA1 and BRCA2 as part of its cancer testing options.64 Similarly, Gene by Gene Ltd. also allegedly began offering BRCA1/2 analyses.65 Less than a month later, Myriad and various patent owners filed infringement suits against Ambry and Gene by Gene.66

The complaints allege patent infringement of 10 patents, including many of the patents challenged in the Myriad lawsuit.67 The asserted patents are U.S. Patent Nos. 5,654,155; 5,709,999; 5,747,282; 5,750,400; 5,753,441; 5,837,492; 6,033,857; 6,051,379; 6,951,721; and 7,250,497. Myriad also filed a motion for preliminary injunction against Ambry in which Myriad clarified which claims were being asserted:

Plaintiffs collectively [have] 24 patents containing 520 claims concerning two genes (BRCA1 and BRCA2), and methods of use and synthetic compositions of matter related thereto. [T]he Supreme Court . . . ruled that five patent claims covering isolated naturally occurring DNA were not patent-eligible, thereby reducing the overall patent estate to 24 patents and 515 patent claims. This case involves none of those five rejected claims.68

In Myriad’s view, the Supreme Court’s ruling only impacted “a small number of claims” and simultaneously “affirmed . . . patent eligibility of synthetic DNA and underscored the importance and applicability of method-of-use patents for gene-based diagnostic tests.”69

The complaints allege that Myriad invested more than $500 million to create diagnostic tests for breast and ovarian cancers related to the BRCA1 and BRCA2 genes.70 Myriad claims these “efforts have revolutionized patient care and provided medical diagnosis and treatment options never thought possible.”71 According to the complaints, Ambry and Gene by Gene’s rival tests will reduce Myriad’s revenues and decrease royalty payments for the patent owners.72 Myriad maintains that, since Ambry and Gene by Gene introduced their rival tests, the company “has suffered and will continue to suffer substantial damage to its business.”73

These new lawsuits instituted by Myriad suggest that, even without composition claims covering naturally occurring isolated DNA, companies can still obtain patent coverage for their diagnostic products and services and use such patent coverage in their patent enforcement efforts.

Recent Congressional Response

In response to Myriad IV, Senator Patrick Leahy (D-Vt.) sent a letter to the National Institutes of Health (NIH) urging it to use its “march-in rights under the Bayh-Dole Act to ensure greater access to genetic testing for breast and ovarian cancer.”74 Senator Leahy stated that because Myriad’s BRCA1/2 diagnostic tests were developed using federally funded research, they are subject to the Bayh-Dole Act and the government can require a patent holder to grant a license to a patent on reasonable terms.75 In addition, under limited circumstances, the government can directly license the patent if “‘necessary to alleviate health or safety needs which are not reasonably satisfied’ by the patentee.”76 In Senator Leahy’s view, the health needs of potentially millions of women are not being satisfied because many women are unable to afford the cost ($3,000–$4,000) of the BRCA1 and BRCA2 diagnostic tests.

As an aside, the NIH has funded part of almost “every major US biomedical research project at some stage.”77 In 2009, it drafted guidelines concerning when grant recipients should file a patent application for a genomic invention and the manner in which those recipients should grant licenses to their patents.78 The guidelines state that “[w]henever possible, non-exclusive licensing should be pursued as a best practice.”79 The NIH also has sponsored numerous studies to investigate “the scope and impact of university gene patents.”80 It will be worthwhile watching to see if the NIH takes any action or initiative based on Senator Leahy’s letter or with regard to the Supreme Court’s decision in general.

The Biotechnology Industry after Myriad

Patent protection and enforcement in the biotechnology industry continue to develop and evolve. The USPTO’s patent examination policy concerning nucleic acid–related technology has significantly changed in view of Myriad. The question remains how broadly will the USPTO interpret Myriad when examining claims involving compositions other than isolated DNA molecules? We will look to the USPTO for its updates on its office examination policy regarding nucleic acid–related technology while also keeping in mind how such updates may affect other related technologies. At the same time, we must be mindful of how the Myriad decision impacts pending court cases as well as new litigation, and how Congress may act to address ongoing public concerns over this technology.

Endnotes

1. See Brief for the United States as Amicus Curiae in Support of Neither Party at 4, Ass’n for Molecular Pathology v. USPTO (Myriad III), 689 F.3d 1303 (Fed. Cir. 2012) (No. 2010-1406).

2. 702 F. Supp. 2d 181, 230 (S.D.N.Y. 2010).

3. Myriad III, 689 F.3d 1303; see Ass’n for Molecular Pathology v. USPTO (Myriad II), 653 F.3d 1329 (Fed. Cir. 2011).

4. No. 12-398, slip op. at 1, 12, 16–17 (U.S. Jun. 13, 2013) (the USPTO was granted its motion for judgment on the pleadings by the Federal Circuit and therefore was no longer a defendant in the case); see Brief for the United States as Amicus Curiae in Support of Neither Party, supra note 1, at 17–36.

5. Myriad I, 702 F. Supp. 2d at 211–12 (claims 1, 2, 5, 6, 7, and 20 of U.S. Patent No. 5,747,282; claims 1, 6, and 7 of U.S. Patent No. 5,837,492; claim 1 of U.S. Patent No. 5,693,473; claim 1 of U.S. Patent No. 5,709,999; claim 1 of U.S. Patent No. 5,710,001; claim 1 of U.S. Patent No. 5,753,441; and claims 1 and 2 of U.S. Patent No. 6,033,857).

6. BRCA1 exists on chromosome 17, and BRCA2 exists on chromosome 13.

7. Myriad I, 702 F. Supp. 2d at 181.

8. Id. at 227–32.

9. Id. at 229.

10. Id. at 220–32.

11. Myriad II, 653 F.3d 1329 (Fed. Cir. 2011).

12. 132 S. Ct. 1289 (2012).

13. Myriad III, 689 F.3d 1303 (Fed. Cir. 2012).

14. Id. at 1326–33; see Myriad II, 653 F.3d at 1350–55.

15. Myriad III, 689 F.3d at 1328.

16. Id.

17. Id. at 1343 (Moore, J., concurring in part).

18. Id. at 1338–43.

19. Id.

20. Id.

21. Id. at 1348–58 (Bryson, J., concurring in part and dissenting in part).

22. Transcript of Oral Argument, Myriad IV, No. 12-398 (U.S. Apr. 15, 2013).

23. Claims 1, 2, and 5–7 of U.S. Patent No. 5,747,282; claim 1 of U.S. Patent No. 5,693,473; and claims 1, 6, and 7 of U.S. Patent No. 5,837,492.

24. Myriad IV, No. 12-398, slip op. at 17–18 (U.S. Jun. 13, 2013).

25. Id. at 1, 12, 16–17; see Brief for the United States as Amicus Curiae in Support of Neither Party, supra note 1, at 17–36.

26. 35 U.S.C. § 101.

27. Diamond v. Chakrabarty, 447 U.S. 303, 308 (1980).

28. Id. at 308–09 (quoting 5 Writings of Thomas Jefferson 75–76 (H. Washington ed. 1871)) (internal quotation marks omitted).

29. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012); Chakrabarty, 447 U.S. at 309.

30. Myriad IV, No. 12-398, slip op. at 11 (quoting Mayo, 132 S. Ct. at 1293) (internal quotation marks omitted).

31. Chakrabarty, 447 U.S. at 309.

32. Myriad IV, No. 12-398, slip op. at 11 (quoting Chakrabarty, 447 U.S. at 309).

33. 333 U.S. 127 (1948).

34. 447 U.S. 303.

35. 333 U.S. at 131–32.

36. Id. at 132.

37. Myriad IV, No. 12-398, slip op. at 13.

38. Id.

39. Chakrabarty, 447 U.S. at 310.

40. Id.

41. Myriad IV, No. 12-398, slip op. at 12.

42. Id.

43. Id. at 14.

44. Id. at 15.

45. Id.

46. Id.

47. Id. (citing Brief for the United States as Amicus Curiae in Support of Neither Party at 20–33, 26, Myriad IV, No. 12-398 (U.S. Jan. 31, 2013)).

48. Id. at 16–17.

49. Memorandum from Andrew H. Hirshfeld, Deputy Comm’r for Patent Examination Policy, to the Patent Examining Corps, Supreme Court Decision in Association for Molecular Pathology v. Myriad Genetics, Inc. (June 13, 2013), available at www.uspto.gov/patents/law/exam/myriad_20130613.pdf.

50. Id.

51. Id.

52. Memorandum from Andrew H. Hirshfeld, Deputy Comm’r for Patent Examination Policy, to the Patent Examining Corps, 2012 Interim Procedure for Subject Matter Eligibility Analysis of Process Claims Involving Laws of Nature (July 3, 2012), available at www.uspto.gov/patents/law/exam/2012_interim_guidance.pdf.

53. Id. at i.

54. Id. at 3.

55. Id.

56. Id.

57. Id.

58. Id.

59. Id. (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1297 (2012)).

60. Id. at 4.

61. Id. (citing Mayo, 132 S. Ct. at 1297).

62. Id. at 5.

63. Id.

64. Press Release, Ambry Genetics Corp., Ambry Genetics Launches BRCA 1 & 2: Single Genes and NGS Panel Offerings (Jun. 13, 2013), www.ambrygen.com/press-releases/ambry- genetics-launches-brca-1-2-single-genes-and-ngs-panel- offerings; see Complaint at 4, Univ. of Utah Research Found. v. Ambry Genetics Corp., No. 2:13-cv-00640-RJS (D. Utah July 9, 2013) [hereinafter Ambry Complaint].

65. Complaint at 4, Univ. of Utah Research Found. v. Gene by Gene Ltd., No. 2:13-cv-00643-EJF (D. Utah July 10, 2013) [hereinafter Gene Complaint].

66. Ambry Complaint, supra note 64; Gene Complaint, supra note 65.

67. Ambry Complaint, supra note 64, at 2–3; Gene Complaint, supra note 65, at 2–3.

68. Motion for Preliminary Injunctive Relief & Memorandum in Support at 4, Ambry, No. 2:13-cv-00640-RJS (D. Utah Jul. 9, 2013).

69. Id.

70. Ambry Complaint, supra note 64, at 4.

71. Id.

72. Id.; Gene Complaint, supra note 65, at 5.

73. Ambry Complaint, supra note 64, at 4; Gene Complaint, supra note 65, at 5.

74. Letter from Patrick Leahy, Chairman, U.S. Senate, to Dr. Francis S. Collins, Dir., Nat’l Insts. of Health 1 (Jul. 12, 2013), available at www.leahy.senate.gov/download/07-12-13-pjl-to-nih- re_-myriad-march-in.

75. Id. at 1–2.

76. Id. at 2 (citing 35 U.S.C. § 203).

77. E. Richard Gold & Julia Carbone, Myriad Genetics: In the Eye of the Policy Storm, 12 Genetics in Med. S39, S48 (2010), available at www.nature.com/gim/journal/v12/n1s/pdf/gim2010142a.pdf.

78. Id. (citing David Malakoff, Intellectual Property: NIH Roils Academe with Advice on Licensing DNA Patents, 303 Sci. 1757, 1757–58 (2004); Best Practices for the Licensing of Genomic Inventions, 70 Fed. Reg. 18,413 (2005), available at www.ott.od.nih.gov/policy/lic_gen.html).

79. Best Practices for the Licensing of Genomic Inventions, 70 Fed. Reg. at 18,415.

80. Gold & Carbone, supra note 77, at 20.

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