Owning the Code: The U.S. Supreme Court's Decision in Myriad Genetics Distinguishes Between DNA and cDNA

Can someone, by patenting genes, exclude you from using your own genetic information? This question was at the heart of Association for Molecular Pathology v. Myriad Genetics, Inc.[1] Myriad concerned whether two of the most well-known “cancer genes”[2]—BRCA1 and BRCA2—could be patented. In the parlance of patent lawyers, the case concerned whether the genes were patent-eligible subject matter.[3] People with a faulty BRCA1 or BRCA2 gene face an increased risk of breast and ovarian cancer.[4] In the mid-1990s, the company Myriad Genetics obtained several patents[5] that claim the sequence of the genes.[6] Currently, Myriad sells BRCA gene testing kits. Many people, including Angelina Jolie, have undergone the BRCA gene tests.[7] Others have criticized Myriad for hindering the development of more affordable tests. Many people have no access to Myriad’s tests due to their high cost and the fact that insurance companies do not cover them.[8]

The Myriad case concerned not only the patentability of two genes but also the basic issue of how patent law should be used to promote scientific innovation.[9] Myriad and other biotech firms have long argued that patents are needed to justify the enormous cost of research and development. Without patent protection, this argument goes, investments on research and development of new diagnostic tests would decrease and therefore discourage innovation.[10] Others, including prominent scientists, have contended that patent protection is not necessary to create incentives for biotech innovations. For example, James Watson, the codiscoverer of the double helix structure of DNA and a Nobel laureate, has long argued that patents on human genes are “not necessary to encourage scientists to advance our knowledge and develop innovative new medicines or biotechnology inventions.”[11] One study showed that more than half of all laboratory directors say that they would not develop or would stop developing a new clinical test because of a gene patent.[12] Additionally, “publicly funded research still plays a dominant role in fostering the basic scientific and technological advances that drive biotechnology forward.”[13] About two-thirds of patents on gene sequences resulted from federally funded research.[14] In the case of Myriad’s patents, the National Institute of Health provided approximately a third of the funding for cloning the BRCA1 gene.[15]

Aside from policy considerations, the challenge against Myriad’s gene patents is based on the patent statute’s subject matter requirement under 35 USC Section 101, which has not always been a battleground for patent attorneys. More often, litigation has focused on novelty, nonobviousness, or the specification. This perception needs some adjustment, however, after recent decisions regarding Section 101.[16] In the last four terms, the U.S. Supreme Court has decided three Section 101 cases: Bilski v. Kappos,[17] Mayo Collaborative Services v. Prometheus Laboratories, Inc.,[18] and Myriad.[19] Myriad’s holding that isolated genes are not patent eligible has reversed a longstanding practice of the U.S. Patent and Trademark Office (PTO).[20] The Court did not set forth a clear test for Section 101 determinations nor did it provide much guidance on other issues,[21] but its analysis offers guidance for patent lawyers and clients for future cases.

Myriad

The question presented before the Court was whether human genes are patentable. Genes are made up of deoxyribonucleic acid.[22] Most DNA molecules are located in a cell’s nucleus in structures called chromosomes. Chromosomal DNA takes the form of double-stranded helixes with two chains of nucleotides. The two chains are chemically bound by nucleotide base pairing.[23] Some portions of the DNA sequence, known as exons, encode genetic information that is used to make proteins. Portions that do not encode genetic information are known as introns. Within a cell, proteins are made in a two-step process. First, the two strands of the DNA separate, and one strand is copied into a complementary ribonucleic acid (RNA) strand, known as pre-RNA. Pre-RNA is further processed by removing sequences corresponding to introns, resulting in an “exon only” RNA, which is known as messenger RNA (mRNA). Second, mRNA is translated into polypeptides, the sequence of which is determined by the sequence of the mRNA. After that, polypeptides undergo modifications to become mature proteins. Complementary DNA (cDNA) is single-stranded DNA that scientists create artificially by using mRNA as a template. Hence, cDNA is the informational version of the original DNA because it contains only the coding sequence—that is, exons. Using cDNA, scientists can manipulate and study genes and proteins, making cDNA an extremely useful tool for biomedical research.

In 2009, a group of plaintiffs brought a declaratory judgment suit in the Southern District of New York against Myriad, challenging the validity under Section 101 of several of Myriad’s composition and method claims relating to the BRCA1 and BRCA2 genes.[24] No method claims reached the Supreme Court. The Federal Circuit, relying on the Supreme Court’s decision in Bilski, found that method claims directed to screening were patentable but method claims directed to comparing or analyzing were not patentable.[25]

In March 2010, the district court adopted the plaintiffs’ view that DNA is informational and held that the claimed isolated DNA is not patent eligible because it is not “markedly different from native DNA as it exists in nature.”[26] Three months later, the Court decided Bilski, affirming that the claimed business method for “protecting against risk” was invalid under Section 101.[27] The Court, however, rejected the Federal Circuit’s “machine-or-transformation” test—in which a process is patent-eligible subject matter if “(1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing”[28]—as the sole test to determine patentability of method claims under Section 101.[29] Instead, the Court pointed to its precedents that held that “an abstract idea, law of nature, or mathematical formula” is not patent eligible, but “an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.”[30] The Court found that the business methods at issue claimed “an abstract idea” and thus were not patentable subject matter.[31]

After Bilski, the Federal Circuit reviewed and reversed the district court’s decision invalidating Myriad’s isolated DNA claims.[32] Judge Alan Lourie, writing for the majority, adopted Myriad’s position that DNA is a chemical composition rather than purely information content.[33] Under this view, when DNA is separated from chromosomes by severing the chemical bonds, it becomes a chemical entity distinct from the chromosomal DNA that exists in nature.[34] Thus, the court held, isolated DNA, including cDNA, is patent-eligible.[35] Judge Kimberly Moore concurred in the judgment but reached the conclusion based on the fact that an isolated DNA sequence “has different properties than the parent molecule from which it is derived.”[36] Judge William Bryson, viewing DNA as informational, dissented, arguing that “the isolated genes are not materially different from the native genes” because breaking chemical bonds does not lead to a new molecule, and the isolated genes carry the same genetic information as the native genes.[37]

In March 2012, the Court vacated the judgment and remanded the case to the Federal Circuit to reconsider in light of Mayo.[38] In that case, Prometheus’s patents covered a means for evaluating a drug’s effectiveness that was based on measurements of how the drug was metabolized.[39] The Court concluded that Prometheus had not invented the relationship between a drug’s effectiveness and its metabolization rate. Rather, the company had discovered a naturally occurring process and told doctors to apply it.[40] The Court unanimously held that this discovery was not patent eligible.[41] The Court then considered whether additional limitations would render the claims patent-eligible applications of natural laws. The Court found that the additional steps were “well-understood, routine, conventional activity” and thus insufficient “to transform an unpatentable law of nature into a patent-eligible application of such a law.”[42] Under Mayo, a process claim for a newly discovered law of nature is not patent eligible, and this type of claim may become patent-eligible only in combination with an “inventive concept.”[43]

On remand, the Federal Circuit issued a second opinion in Myriad that mostly followed its first opinion.[44] The plaintiffs filed a second petition for a writ of certiorari, and the Supreme Court granted it.[45] The only issue before the Court was whether human genes are patentable.[46] In June 2013, the Court issued its opinion, holding that naturally occurring DNA is not patent-eligible because it is a product of nature, but cDNA is patent-eligible because it does not occur in nature.[47]

The Myriad Court began by repeating the principles it set forth in Mayo that Section 101 defines patent eligibility broadly, with one judicially created exception: “[L]aws of nature, natural phenomena, and abstract ideas…are the basic tools for scientific and technological work” and are not patentable.[48] Without this exception, the Court reasoned, the use of these basic research tools would “inhibit future innovation premised upon them.”[49] The Court also acknowledged that the rule against patenting naturally occurring things “is not without limits.”[50] “[A]ll inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas.”[51] Overbroad interpretation of the exception “could eviscerate patent law.”[52]

Regarding the BRCA1 and BRCA2 gene sequences, the Court found that “Myriad did not create anything”[53] because “[t]he location and order of the nucleotides [of the BRCA genes] existed in nature before Myriad found them.”[54] Thus, Myriad’s gene claims are different from the modified, “nonnaturally occurring” bacterium that the Court had found to be patentable in Diamond v. Chakrabarty.[55] The Court also rejected several of Myriad’s arguments. First, discovery, no matter how groundbreaking or brilliant, “does not by itself satisfy the §101 inquiry.”[56] Nor does extensive research effort alone meet the demands of Section 101,[57] which requires the subject matter to be new and non-naturally occurring.[58] Simply discovering something that already exists in nature does not meet this requirement.[59] Second, the Court ruled that isolating DNA from the chromosome does not save Myriad’s claims because they “focus on genetic information encoded in the BRCA1 and BRCA2 genes” rather than the chemical composition.[60] Although the Court acknowledged that isolating DNA by severing chemical bonds does create a chemical composition, the Court also recognized that the key to gene patents is claiming the information that the genes carry.[61] Finally, the Court refused to defer to the longstanding PTO practice of granting gene patents because “Congress has not endorsed the views of the PTO.”[62] The Court also cited the government’s position that isolated DNA was not patentable subject matter and the PTO’s practice was not sufficient to hold otherwise.[63] The Court explained that concerns about reliance interests of patent holders should be addressed to Congress.[64]

Unlike isolated chromosomal DNA, however, cDNA does “not present the same obstacles to patentability as naturally occurring, isolated DNA segments.” As the Court pointed out, cDNA does not normally exist in nature but rather is created in a laboratory.[65] Although the cDNA sequence may be “dictated by nature,” as the petitioners argued, the Court found that with the removal of introns from DNA, cDNA becomes “something new.”[66] Thus, cDNA made from a gene that has introns is patentable.[67]

Patentability of DNA after Myriad

The Court expressly stated that its opinion was limited to the patentability of isolated DNA and cDNA.[68] Many practitioners and scholars have criticized the Court for refusing to provide clear guidance as to other issues relevant to biotechnology.[69] Nevertheless, it is helpful to analyze Myriad’s rationale in order to assess the patentability of DNA and other biologics.

Myriad holds that a DNA sequence may be patent eligible only if the sequence is not naturally occurring. Naturally occurring DNA is not patent-eligible because it is a product of nature, while “cDNA is patent-eligible because it is not naturally occurring.”[70] Several inferences can be drawn from this. First, the cDNA of an intronless gene is not patent-eligible because it is indistinguishable from naturally occurring DNA.[71] Many genes in animals and plants do not have introns.[72] Thus, cDNA sequences of intronless genes are the same as the naturally occurring chromosomal DNA. Intronless genes, according to the Court, can never be patented regardless of whether they were isolated from the genome or entirely created by researchers. Second, although the Court viewed DNA as information,[73] the fact that the intron-removed cDNA carries the same genetic information as the naturally occurring DNA does not render the cDNA unpatentable.[74] Third, partial DNA sequences, such as primers (strands of DNA used as starting points for DNA synthesis)[75] probably would be analyzed under the same test as the full-length DNA. If a partial DNA does not span at least one intron, it would have an identical sequence as the native DNA and therefore be patent ineligible. Fourth, there is an apparent tension between the Court’s decision in Mayo and its decision in Myriad.[76] In Myriad, the patentability of a DNA sequence depends on whether it exists in nature, not on whether the creation of the DNA molecules involves “inventive concepts” as required in Mayo. This apparent tension may be understood by distinguishing the composition claims in Myriad from the method claims in Mayo.[77] A composition is patent eligible only if it does not exist in nature, while a method is patent eligible only if the method involves something beyond routine and conventional activity. Finally, although the question presented to the Court concerned patentability of human genes,[78] the Court resolved the question without distinguishing between human and nonhuman DNA.[79]

Unresolved Questions

Myriad also does not resolve the question of whether cDNA will always be protected under patent law. For example, some scholars argue that patents claiming cDNA “are probably obvious once we assume knowledge of the naturally-occurring gene sequence.”[80] Even if cDNA is patentable subject matter under Section 101, it may be obvious and therefore unpatentable under Section 103, which concerns nonobvious subject matter. The genomes of many species, including humans, have been sequenced and published,[81] and there are many gene prediction programs that identify potential genes within DNA sequences. Thus, once a genome is known, most if not all cDNA sequences can be identified by programs and thus would be obvious to a person having ordinary skill in the art. Furthermore, to avoid infringing claims covering cDNA, a gene testing company can easily analyze a segment of genomic DNA that has at least one intron.[82] For these reasons, cDNA may not always be protected, even if it can be patent-eligible subject matter.

Myriad’s patent also claimed vectors and heterologously expressed genes. Gene sequences may be artificially integrated (or vectored) into existing DNA or cells, which in turn may produce (or express) new sequences or proteins.[83] The Court did not consider these patent claims.[84] Like the modified bacterium in Chakrabarty, vectors and heterologously expressed genes are not naturally occurring. In 1948, the Supreme Court found in Funk Brothers Seed Company v. Kalo Inoculant Company that combining several known nitrogen-fixing bacteria into a single inoculant did not satisfy the Section 101 subject matter requirement because the patentee “did not alter the bacteria in any way.”[85] Creating heterologously expressed genes, however, arguably does alter the gene and the original expressing system. Thus, Funk Brothers is distinguishable from Myriad. On the other hand, even though claims on heterologously expressed genes may pass muster under Section 101, they are probably obvious under Section 103. Vectors and altered life forms are now routine, conventional research tools. Myriad does not address these broader issues.

Another question left by the Myriad decision is, “Do mutants qualify as patentable subject matter?” A mutant is an “[o]rganism in which a mutation has occurred that makes it different from wild-type or from the ‘normal’ extent of variation in the population.”[86] Patents on mutants would allow a party to exclude others from studying the mutants or interpreting genetic testing results that indicate these mutants. Myriad’s patents claimed some naturally occurring BRCA mutants.[87] The Myriad Court expressly declined to “consider the patentability of DNA in which the order of the naturally occurring nucleotide has been altered.”[88] But under the Court’s “naturally occurring” test, mutants should not be patent-eligible because they exist in nature. It is more difficult to determine whether mutants that have been created in the laboratory are patentable. First, it is almost impossible to know whether laboratory-created mutants also exist in nature because mutations occur throughout an organism’s lifetime. Second, even if a mutant does not exist in nature,[89] that mutant may be considered “obvious” under Section 103 because the difference between the normal sequence and mutant may be obvious to a person having ordinary skill in the art.

Although the Myriad decision forecloses most gene patents,[90] the Court did suggest that an “innovative method of manipulating genes” or “new applications of knowledge about the BRCA1 and BRCA2 genes” may be patentable.[91] Through this suggestion, the Court offered some hope for patenting innovations in gene research. In fact, the Federal Circuit upheld Myriad’s method claims for screening potential cancer therapeutics.[92]

The patentability analysis of polypeptides or proteins under Section 101, however, may be different from that of the DNA sequences. Proteins are large biological molecules that perform many basic and critical functions in the body.[93] Purified proteins share the same amino acid sequence of the naturally occurring protein and therefore are not patent eligible. Proteins synthesized through heterologous expression, however, can differ from their naturally occurring counterparts structurally and functionally.[94] Consequently, it is unclear whether synthesized proteins and other biological molecules are patent eligible under Myriad.

Myriad has significantly limited the patent eligibility of DNA. Genomic DNA is naturally occurring and thus patent ineligible, and cDNA is probably obvious. Furthermore, a patent on cDNA may be circumvented. Under the Court’s “naturally occurring” test, any biomolecule is likely patent-ineligible subject matter if it exists in nature.

Practical Considerations

With Mayo and Myriad in mind, patentees and practitioners should consider reviewing portfolios and filing reissue applications to narrow claims that cover natural phenomena or products of nature. Attorneys and clients should also review and amend pending applications. When preparing for new patent applications, applicants should clearly describe the difference between the claimed subject matter and natural phenomena or products of nature to emphasize creation and avoid discovery. Finally, in addition to claiming compositions, practitioners should consider claiming “innovative” methods of making, using, or detecting the compositions. For example, to patent an invention for detecting a particular gene, one can claim the cDNA of that gene, any partial sequence (if at least some of it is noncoding) that may be used for detection, and methods for amplification or hybridization of the gene.

The Myriad decision has not stopped the fight over BRCA gene patents. After the decision, Myriad claimed that it still had 24 patents and 515 claims in the BRCA gene patent estate.[95] The Federal Circuit held that a few of Myriad’s method claims were valid, and most have not been challenged. In July, Myriad sued Ambry Genetics, one of the first companies to announce that it would offer BRCA genetic testing that was cheaper than Myriad’s. Myriad alleged patent infringement and is seeking a preliminary injunction. Ambry responded that Myriad’s patents are invalid under Sections 102, 103, and 112.[96] The validity of Myriad’s patents covering BRCA genes remains to be determined.

 

 

[1] Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. ____ (June 13, 2013).
[2] Kat Arney, Tracking down the BRCA genes (part 1), Science Update Blog (Feb. 28, 2012), http://scienceblog.cancerresearchuk.org/2012/02/28/high-impact-science
-tracking-down-the-brca-genes-part-1.
[3] See, e.g., Myriad, 569 U.S. ____, slip op. at 1.
[4] Id. at 4.
[5] See, e.g., U.S. Patent No. 5,747,282 (also known as the “‘282 patent”) for BRCA1 and U.S. Patent No. 5,837,492 for BRCA2.
[6] Association for Molecular Pathology v. U.S.P.T.O., 702 F. Supp. 2d 181, 185 (S.D. N.Y 2010).
[7] See Angelina Jolie, My Medical Choice, New York Times (May 14, 2013), http://www.nytimes.com/2013
/05/14/opinion/my-medical-choice.html?_r=0.
[8] See, e.g., Association for Molecular Pathology, 702 F. Supp. 2d at 203-04, 206.
[9] See U.S. Const. art. I, §8, cl. 8.
[10] See, e.g., Myriad, 569 U.S. ____, Brief for Respondents at 5.
[11] See, e.g., Myriad, 569 U.S. ____, Brief of James D. Watson at 3. See also Michael A. Heller & Rebecca S. Eisenberg, Can Patents Deter Innovation? The Anticommons in Biomedical Research, 280 Science 5364, 698 (1998).
[12] Myriad, 569 U.S. ____, Brief of James D. Watson at 3.
[13] John M. Golden, Biotechnology, Technology Policy, and Patentability: Natural Products and Invention in the American System, 50 Emory L.J. 101, 110 (2001).
[14] Association for Molecular Pathology, 702 F. Supp. 2d at 210.
[15] Id.
[16] See, e.g., Mayo v. Prometheus, 566 U.S. ____ (Mar. 20, 2012), Brief for the United States at 17.
[17] Bilski v. Kappos, 561 U.S. ____ (June 28, 2010).
[18] Mayo Collaborative Servs. v. Prometheus Labs., Inc., 628 F. 3d 1347 (2012).
[19] Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. ____ (June 13, 2013).
[20] Id. at 1, 16.
[21] See, e.g., Kevin E. Noonan, Association for Molecular Pathology v. Myriad Genetics, Inc. (2013), Patent Docs (Jun. 13, 2013), http://www.patentdocs.org/2013/06
/association-for-molecular-pathology-v-myriad-genetics
-inc-2013.html [hereinafter Noonan]; Dennis Crouch, Twenty Thoughts on the Importance of Myriad, Patently O (Jun. 14, 2013), http://www.patentlyo.com/patent
/2013/06/myriad.html [hereinafter Crouch].
[22] See Myriad, 569 U.S. ____, slip op. at 2-3, and Brief for Petitioners at 1; Association for Molecular Pathology, 702 F. Supp. 2d at 192-211.
[23] Myriad, 569 U.S. ____, slip op. at 2.
[24] Among the plaintiffs are several professional associations of research scientists, including the Association for Molecular Pathology, the ACLU, individual researchers, woman’s health advocacy groups, and patients with breast or ovarian cancer. Myriad moved to dismiss the complaint for lack of standing. The district court ruled against Myriad. Association for Molecular Pathology v. U.S.P.T.O., 669 F. Supp. 2d. 365, 392 (S.D. N.Y. 2009). The Federal Circuit found that at least one plaintiff has standing to challenge Myriad’s patents and thus affirmed the district court’s ruling. Association for Molecular Pathology v. U.S.P.T.O., 689 F. 3d 1303, 1309 (Fed. Cir. 2012). The Supreme Court, in a footnote, affirmed the Federal Circuit and put the standing issue to rest. Myriad, 569 U.S. ____, slip op. at 10 n.3.
[25] Myriad, 569 U.S. ____, slip op. at 20; Association for Molecular Pathology v. U.S.P.T.O., 653 F. 3d 1329, 1355 (Fed. Cir. 2011); Association for Molecular Pathology, 689 F. 3d at 1334-37.
[26] Association for Molecular Pathology v. U.S. Patent & Trademark Office, 702 F. Supp. 2d 181, 232 (S.D. N.Y. 2010).
[27] Bilski v. Kappos, 561 U. S. ____ (June 28, 2010), slip op. at 15-16.
[28] In re Bilski, 545 F. 3d 943, 954 (Fed. Cir. 2008) (en banc) (citing Gottschalk v. Benson, 409 U.S. 63, 70 (1972)).
[29] Bilski, 561 U. S. ____, slip op. at 7.
[30] Id. at 13-15 (internal citation omitted).
[31] Id. at 15.
[32] Association for Molecular Pathology v. U.S.P.T.O., 653 F. 3d 1329, 1358 (Fed. Cir. 2011).
[33] Id. at 1351.
[34] Id. at 1351-52.
[35] Id. at 1358.
[36] Id. at 1362.
[37] Id. at 1373, 1375-76.
[38] Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. ____ (June 13, 2013), slip op. at 7-8.
[39] Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U. S. ____ (Mar. 20, 2012), slip op. at 8.
[40] Id. at 3.
[41] Id.
[42] Id. at 10.
[43] Id. at 3. Scholars have argued that the Court’s “inventive concept” test overlaps with the nonobviousness requirement under 35 U.S.C. §103. See, e.g., Jacob S. Sherkow, And How: Mayo v. Prometheus and the Method of Invention, Yale L. J. Online, Apr. 1, 2013, http://www.yalelawjournal.org/the-yale-law-journal-pocket-part/intellectual-property/and-how:-mayo-v.-prometheus-and-the-method-of-invention.
[44] All three judges agreed that Mayo is a case about method claims and thus does not decide DNA patents, even though the analysis is instructive. Association for Molecular Pathology v. U.S.P.T.O., 689 F. 3d 1303, 1325 (Fed. Cir. 2012) (majority opinion), 1340 (Moore, J., concurring in part), 1354 (Bryson, J. concurring in part and dissenting in part). See also Crouch, supra note 21.
[45] Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. ____ (June 13, 2013), slip op. at 10.
[46] Id. at 1.
[47] Id.
[48] Id. at 11 (citing Mayo v. Prometheus, 566 U.S. ____ (Mar. 20 2012)).
[49] Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. ____ (June 13, 2013), slip op. at 10.
[50] Id.
[51] Id. at 11.
[52] Id.
[53] Id. at 15.
[54] Id. at 12.
[55] Id.; Diamond v. Chakrabarty, 447 U.S. 303 (1980).
[56] Myriad Genetics, 569 U.S. ____, slip op. at 12.
[57] Id. at 14.
[58] Id.
[59] Id. at 13.
[60]60 Id. at 14-15.
[61] Id.
[62] Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. ____ (June 13, 2013), slip op. at 15.
[63] Id. at 16.
[64] Id. at 16 n.7.
[65] Id. at 16.
[66] Id. at 17.
[67] Id.
[68] Id. at 17-18.
[69] See, e.g., Noonan, supra note 21; Crouch, supra note 21.
[70] Myriad Genetics, 569 U.S. ____, slip op. at 1.
[71] Id. at 17.
[72] See, e.g., Amel Louhichi et al., IGD: A Resource for Intronless Genes in the Human Genome, 488 Gene 35-40 (2011). For example, most olfactory receptor genes are intronless. See, e.g., Buck & Axel, A Novel Multigene Family May Encode Odorant Receptors: A Molecular Basis for Odor Recognition, 5 Cell 65, 175-87 (Apr. 1991).
[73] Myriad Genetics, 569 U.S. ____, slip op. at 14-15.
[74] The petitioners argued that cDNA and DNA “encode the same polypeptide/protein.” Id., Brief for Petitioners at 49. The Court did not address this argument directly.
[75] See Wikipedia, http://en.wikipedia.org/wiki/Primer_(molecular_biology).
[76] Jeffrey Lefstin, a respected patent scholar, has pointed out that the Court’s endorsement of cDNA relies on cDNA’s being new within the meaning of §101, not whether creation of cDNA involved anything beyond the “routine and conventional” activity described in Mayo. Crouch, supra note 21.
[77] Myriad Genetics, 569 U.S. ____ , slip op. at 17. The Court described Myriad’s method as “well understood, widely used, and fairly uniform insofar as any scientist engaged in the search for a gene would likely have utilized a similar approach.” Id. This suggests that the Court would rely on Mayo’s “inventive concept” test to determine the patentability of a method claim.
[78] Id., Brief for Petitioners at i.
[79] Id., slip op. at 1.
[80] Crouch, supra note 21.
[81] See, e.g., Jonathan Pevsner, Bioinformatics & Functional Genomics 525 (2d ed. 2009).
[82] E-mail message from Professor Mark Lemley to author (July 30, 2013) (on file with author). This approach, however, may be challenged under the doctrine of equivalents.
[83] See, e.g., U.S. Patent No. 5,747,282, claims 12 and 13.
[84] Myriad Genetics, 569 U.S. ____, slip op. at 1.
[85] Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948).
[86] Bruce Alberts, et al., Molecular Biology of the Cell, Glossary (4th ed. 2002) [Hereinafter Alberts].
[87] See, e.g., U.S. Patent No. 5,747,282, claim 7.
[88] Myriad Genetics, 569 U.S. ____, slip op. at 18.
[89] For example, inosine is a nucleotide that does not occur in genomic DNA or mRNA but can pair with adenine, cytosine, or thymine. Thus, replacing adenine, guanosine, or thymine with inosine would result an artificial DNA that has the same genetic information that was encoded in the original DNA.
[90] Myriad forecloses all naturally occurring genomic DNA; cDNA patents are easier to design around and may be rendered obvious once genomic DNA sequence is known.
[91] Myriad Genetics, 569 U.S. ____, slip op. at 17.
[92] Association for Molecular Pathology, 689 F. 3d 1303 (Fed. Cir. 2012).
[93] See, e.g., What Are Proteins and What Do They Do?, Genetics Home References, Handbook, http://ghr.nlm.nih.gov/handbook/howgeneswork/protein.
[94] Alberts, supra note 86.
[95] Myriad v. Ambry, No. 2:13-cv-00640-RJS (D. Utah 2013), Motion for Prelim. Injunctive Relief at 1.
[96] Myriad v. Ambry, No. 2:13-cv-00640-RJS (D. Utah 2013), Complaint; Ambry Genetic Corp.’s Answer to Plaintiffs’ Complaint; Affirmative Defenses; and Counterclaims for Antitrust Violations of the Sherman Act and Declaratory Relief of Invalidity and Noninfringement at 29-30. Ambry also asserted antitrust violation and patent misuse defenses. Id. at 32.