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Original Article 32 Biotechnology Law Report 1 Number 4, 2013 # Mary Ann Liebert, Inc. DOI: 10.1089/blr.2013.9912 The Supreme Court Takes On the Patent Eligibility of Human Genes: AMP v. Myriad By DALILA ARGAEZ WENDLANDT* and JOSEPH VAN TASSEL I n AMP v. Myriad, the Supreme Court will address the question of whether human genes are patentable. More specifically, the issue presented is whether isolated DNA molecules should be considered products of human invention and patent-eligible subject matter or should instead be considered products of nature and thus ineligible for patent protection. The answer to this question has far-reaching implications, not only for human DNA claims, but also for claims directed to plant and animal DNA. Importantly, the Court’s decision has the potential to invalidate thousands of issued patents claiming DNA molecules and to affect the balance of incentives and limitations imposed by the patent system on genetic research. Although we cannot be certain how the Supreme Court will rule on this issue, the questions posed at oral arguments offer some insight. In this article, we first examine the opinion of the Court of Appeals for the Federal Circuit, in which the majority held that claims to isolated DNA molecules are patent eligible. Next, we summarize the arguments made by the parties and by the United States in their briefs to the Supreme Court. Finally, we examine the questions asked by the Justices at oral argument, looking for hints on how the Court might ultimately rule. to assess more accurately their hereditary risk of developing these cancers and inform their decisions as to whether to undergo preventative measures, such as prophylactic surgery. Plaintiffs originally1 included several institutions, physicians, researchers, and patients that wanted to conduct (or undergo) clinical BRCA testing or conduct genetic research, but allegedly were stymied by Myriad’s patent protection. Plaintiffs brought suit against Myriad, seeking a declaration that its BRCA patents claims were invalid, arguing that they were drawn to ineligible subject matter under 35 U.S.C. x 101.2 To assist in understanding the challenged claims and the court’s reasoning, the Federal Circuit’s opinion included a short primer on genetics.3 It explained that humans have about 22,000 genes, which serve as the code for building the proteins that give us substance and life. This genetic code is formed by the particular sequence of four nucleotide base units—adenine, thymine, cytosine, and guanine—that make up a deoxyribonucleic acid (DNA) molecule. DNA typically exists, as it does in the naturally occurring chromosomes of a cell, as two complementary strands intertwined in a double helix. The genetic code contained in the ‘‘native’’ or ‘‘genomic’’ DNA is effectuated though a process in which a complementary messenger ribonucleic acid (mRNA) molecule is created and then translated into the encoded protein. RNA has a different sugar phosphate BACKGROUND Defendant Myriad Genetics, Inc. owns several patents containing ‘‘composition of matter’’ claims directed to two ‘‘isolated’’ human genes, BRCA1 and BRCA2, as well as mutations in these genes, which are associated with an increased risk of breast and ovarian cancers. Early detection of these mutations through diagnostic genetic testing may allow patients 1 The Federal Circuit concluded that only one physician plaintiff had standing to maintain this declaratory judgment action. See Ass’n for Molecular Pathology v. U.S. Patent & Trademark Office (‘‘Myriad’’), 689 F.3d 1303, 1323 (Fed. Cir. 2012). 2 35 U.S.C. x 101 provides: ‘‘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.’’ 3 See Myriad, 689 F.3d at 1310–4. *The authors are Intellectual Property Litigation Partner (DAW) and Intellectual Property Litigation Associate ( JVT), Ropes & Gray, LLP, Boston, MA. 1 2 Biotechnology Law Report Volume 32, Number 4 backbone than DNA and uses the nucleotide uracil in place of thymine. Genes carry sequences of nucleotides that do not code for a protein (introns) that are interspersed between segments of DNA that code for a particular protein (exons). Using well-established laboratory techniques, particular segments of naturally occurring DNA, such as a gene, can be extracted from the remaining chromosomal DNA to obtain an isolated DNA segment. This isolated segment of native DNA contains both exons and introns. Through a number of cellular processes, mRNA contains only exons, or only the portions of a gene sequence that code for a particular protein. Complementary DNA (cDNA) is a type of synthetic DNA molecule that is produced from an mRNA molecule template. Because cDNA is synthesized from mRNA, cDNA contains only the exons from a chromosomal gene sequence. Myriad’s claims encompassed both cDNA and isolated DNA molecules. Further, with respect to isolated native DNA molecules, the claims covered both relatively long nucleotide sequences (i.e., the entire gene) and truncated sequences, as short as 15 nucleotides, that represent only a portion of the gene. According to Judge Moore, who wrote a separate concurrence with the Federal Circuit majority, these shorter sequences have useful functions as primers (serving a starting point for DNA synthesis) or as probes (detecting the presence of a particular nucleotide sequence).4 The question presented in this case is whether an isolated DNA molecule, representing either an entire gene or a portion of a gene, or a cDNA molecule is eligible for patent protection. THE FEDERAL CIRCUIT OPINION The district court for the Southern District of New York held for the plaintiffs, concluding all of the challenged composition claims were drawn to ineligible subject matter and thus invalid under x 101.5 On the first appeal, the Federal Circuit reversed with respect to these claims, finding that Myriad’s composition claims to ‘‘isolated’’ DNA molecules were directed to patenteligible subject matter.6 Following this decision, the Supreme Court decided Mayo Collaborative Services v. Prometheus, Inc., 132 S.Ct. 1289 (2012),7 and it subsequently granted the plaintiffs’ petition for certiorari, vacated the decision below, and remanded Myriad to the Federal Circuit for reconsideration in light of Mayo.8 On remand, the same Federal Circuit panel, consisting of Circuit Judges Lourie, Moore, and Bryson, agreed that cDNA was patent eligible under x 101 but split over the question of whether isolated segments of native DNA could enjoy patent protection. The panel majority (Lourie and Moore) concluded that such isolated DNA molecules were patent eligible under x 101. First, the panel unanimously agreed that cDNA molecules were patent eligible compositions of matter. Writing for the majority, Judge Lourie noted that the claimed cDNAs were ‘‘especially distinctive, lacking the noncoding introns present in naturally occurring chromosomal DNA’’ and that they were ‘‘even more the result of human intervention into nature’’ than is regular isolated DNA.9 In her concurrence, Judge Moore explained that cDNA claims were the easiest to analyze because the claimed cDNA sequences do not exist in nature. Moreover, she reasoned, it has different (albeit complementary) nucleotide sequence than the mRNA template used to construct it and has a different chemical structure than the mRNA template.10 Likewise, Judge Bryson stated that ‘‘[t]he end product is a human-made invention with distinct structure because the introns that are found in the native gene are removed from the cDNA segment. Additionally, the cDNA has a utility not present in the naturally occurring BRCA DNA and mRNA.’’11 This unanimity dissolved, however, when it came to the question of whether isolated DNA molecules, extracted from native DNA, should be patent eligible. Concluding that these molecules were patentable under x 101, Judge Lourie focused on the fact that the isolated DNAs exist in a chemical form distinct 4 Id. at 1342 (Moore, J., concurring). Id. at 1308 (citing Ass’n for Molecular Pathology v. U.S. Patent & Trademark Office, 702 F. Supp. 2d 181 (S.D.N.Y. 2010)). 6 See Ass’n for Molecular Pathology v. U.S. Patent & Trademark Office (‘‘Myriad’’), 653 F.3d 1329, 1333–4 (Fed. Cir. 2011). The plaintiffs also challenged several of Myriad’s method claims directed toward the screening of cancer therapeutics via changes in cell growth rates and toward the comparison of DNA sequences. Id. 7 Mayo held that a diagnostic method was not patent eligible because it did not add ‘‘enough’’ additional elements to the claimed natural law—the correlation between metabolite concentrations in the blood and the toxicity/efficacy of the therapeutic. In Mayo, other than the claimed natural law, the elements were well understood, conventional, and routine steps engaged in by physicians prior to use of the claimed diagnostic method. Such well-understood, conventional, and routine steps, the Court held, were insufficient to make the claimed law of nature patent eligible. See Mayo Collaborative Services v. Prometheus, Inc., 132 S. Ct. 1289 (2012). 8 See Myriad, 689 F.3d at 1308 (citing 132 S. Ct. 1794 (2012)). As discussed supra, Mayo addressed the exception to patent eligibility of method claims that attempt to patent natural laws. Because plaintiffs had challenged both Myriad’s isolated DNA composition claims and its method claims, it was not clear to what extent the Federal Circuit should consider the challenges to the composition claims in light of Mayo. 9 Id. at 1329. 10 Id. at 1340 (Moore, J., concurring). 11 Id. at 1356 (Bryson, J., concurring in part dissenting in part). 5 Biotechnology Law Report Volume 32, Number 4 from that of DNA as it exists in the body. For example, Judge Lourie noted, the isolated DNA molecule is orders of magnitude smaller than the naturally occurring DNA molecule containing the gene.12 Isolated DNA is patent eligible, according to Judge Lourie, because it ‘‘results from human intervention to cleave or synthesize a discrete portion of a native chromosomal DNA, imparting on that isolated DNA a distinctive chemical identity as compared to native DNA.’’13 It has been ‘‘chemically cleaved’’ from its native chemical combination with other genetic materials and thus is not merely a purified form of a natural material, but rather a distinct chemical entity.14 Thus, the isolated molecule is shorter and has different ends than the naturally occurring molecule. Importantly, he adopted a chemical perspective in assessing whether the isolated DNA is ‘‘markedly different’’ from the naturally occurring DNA, holding that as a chemical matter, the isolated DNA was manipulated by human hands (that is, it was cleaved from its native environment) and thus was patent eligible.15 He declined to view the claimed isolated DNA from the perspective of its genetic informational content. From that genetic perspective, the informational content of the isolated DNA molecule is identical to the informational content of the DNA molecule in its native state.16 Judge Lourie’s reasoning on the issue of patent eligibility did not differ between isolated DNA segments that claimed the whole gene versus smaller nucleotide sequences. In both cases, Judge Lourie held, human intervention through cleaving was required. Judge Moore agreed that isolated DNA molecules were patent eligible, but her reasoning differed depending on whether the claimed isolated molecules were short nucleotide sequences or relatively longer ones, such as one encompassing an entire gene. For shorter sequences, she emphasized that ‘‘it is not the chemical change alone, but that change combined with the different and beneficial utility that leads me to conclude that small isolated DNA fragments are patentable subject matter.’’17 She reasoned that by defining what parts of the overall DNA molecule should be retained and what parts should be discarded, these smaller sequences are new products, having a function as a primer or a probe, that are entirely different from that of the full gene.18 For longer sequences, however, she noted that isolated DNA segments that code for an entire gene are too large to be suitable for primers or probes and thus do not have this additional, new utility.19 Nonetheless, she concluded that such longer sequences should remain patent eligible, asserting that it was for Congress, not the courts, to upset longstanding judicial and Patent and Trademark Office precedent allowing patents for isolated DNA molecules.20 She noted that the PTO had issued patents on these types of claims for more than 30 years, resulting in thousands of patents on isolated DNA.21 Recognizing that she might reach a different result if she had a ‘‘blank canvas’’ to address the patent eligibility of a 3 whole gene, she found the genes patentable in order not to disturb the long-standing PTO practice and the settled expectations resulting therefrom. Finally, Judge Bryson contended that isolated DNA segments that have the same sequence of nucleotides found in a naturally occurring DNA molecule are not materially different from the native molecule.22 Accordingly, he argued, isolated DNA should be ineligible patent subject matter. He asserted that there is no magic in the breaking of a chemical bond or in isolating a naturally occurring piece of a larger whole. He analogized a claim to an isolated DNA segment to a claim to a leaf snapped from a tree or a kidney removed from the human body. None of these items, he contended, becomes a patentable invention simply because it has been separated from its natural state.23 Instead, he argued that the court should have adopted a genetic perspective (which focuses on the identical nature of the sequence and the informational content of this sequence) rather than a chemical perspective (which focuses on the fact the molecule has been cleaved and has different terminal groups).24 BRIEFS OF THE PARTIES AND OF THE UNITED STATES TO THE SUPREME COURT In their brief, authored by attorneys from the Public Patent Foundation and the American Civil Liberties Union Foundation, the plaintiffs/petitioners argued that isolated DNA molecules are not patent eligible under x 101 because they are products of nature.25 The plaintiffs/petitioners acknowledged that genes are chemical compositions, but argued that they are unique because they ‘‘embody the information and the instructions the body uses to function.’’26 Petitioners argued that three ways to evaluate whether a patent impermissibly claims natural phenomena are discernible from Supreme Court 12 Id. at 1328. Id. 14 Id. at 1329. 15 Id. at 1330. 16 Id. 17 Id. at 1342 (Moore, J., concurring). 18 Id. (Moore, J., concurring). 19 Id. at 1343 (Moore, J., concurring). 20 Id. at 1343–7 (Moore, J., concurring). 21 Id. at 1344 (Moore, J., concurring). 22 Id. at 1350 (Bryson, J., dissenting). 23 Id. at 1352–3 (Bryson, J., dissenting). 24 Id. at 1352 (Bryson, J., dissenting). 25 Brief for Petitioners, Ass’n for Molecular Pathology v. U.S. Patent & Trademark Office (‘‘Myriad’’), 133 S.Ct. 694 (2013)(No. 12-398), 2013 WL 353961 at *23–4. 26 Id. at *5. 13 4 precedent. According to the petitioners to make this evaluation, the proper questions are: (1) whether the patented composition has ‘‘markedly different’’ characteristics from any found in nature;27 (2) whether the patent is based on an inventive concept;28 and (3) whether the patent preempts the use of the underlying product of nature and forecloses future innovation out of proportion to the patentee’s contribution.29 First, petitioners argued, isolated DNA does not have markedly different characteristics from naturally occurring DNA.30 When determining whether a claimed composition has markedly different characteristics from a natural product, petitioners claimed that one must examine both the structure and the function of the composition.31 They characterized the structural difference between native and isolated DNA as ‘‘minor chemical changes incidental to isolation’’ and asserted that the Court should not make the breaking of covalent bonds (that is, the cleaving process) the sole criterion for determining patent eligibility.32 More importantly, they argued, was that isolated DNA serves the same basic function as genomic DNA—to code for particular proteins and transmit information about a person’s heredity.33 Second, petitioners asserted that patents claiming isolated DNA molecules are not based on any inventive concept, but rather, claim products and laws of nature.34 Petitioners argued that ‘‘[t]he claimed composition is a discovery of nature’s handiwork’’—i.e., the fact that this DNA sequence codes the BRCA protein and is related to one’s hereditary risk of developing certain diseases.35 They declared that Myriad did not invent the isolated DNA molecule, the characteristics of the DNA that are incidental to its isolation, or the length, composition, or function of the BRCA genes; instead, these functions were determined by human biology.36 Thus, petitioners concluded, there was no inventive concept. Third, petitioners alleged that claims to ‘‘isolated DNA impermissibly preempt[s] scientific and medical work, far beyond what Myriad’s contribution can justify.’’37 They argued that genes and DNA molecules are fundamental ‘‘building blocks’’ upon which further innovations are built.38 They claimed that the Myriad BRCA patents have deterred scientific research as well as the discovery of new or refined treatments.39 For this reason and the two above, petitioners contended that isolated DNA molecules should not be patent eligible. Additionally, the petitioners argued that because the Myriad BRCA patents were not limited to cDNA molecules, the Court need not and should not reach the question of the patent-eligibility of cDNA.40 If the Court chooses to address this question, however, petitioners asserted that it should find cDNA ineligible for patent protection as well. They stressed that cDNA fails the same three criteria discussed above: (1) it is not markedly different from genomic DNA because Biotechnology Law Report Volume 32, Number 4 it serves the same basic function—encoding the same proteins—and it allegedly can occur in nature in the form of ‘‘pseudogenes’’; (2) nature dictates what portions of the gene are coding and which are not, so there is no inventive concept; and (3) patenting cDNA would preempt the use of a basic scientific tool that would serve as the basis for many additional genetic discoveries.41 Finally,42 petitioners argued that when deciding the issue of patent eligibility of isolated DNA, past or current PTO practice should be irrelevant.43 They noted that the Court had rejected a similar argument based on industry reliance on established practices in its recent decision in Mayo.44 In its brief, the United States split the difference. It argued that synthesized genetic materials, such as cDNA, are patent-eligible subject matter, whereas isolated but otherwise unmodified DNA is not patent eligible.45 The government also argued that the Court should not give weight to the PTO practice of granting patents on DNA-based claims or to the reliance interests in such patents.46 First, the United States asserted that cDNA should be patent eligible under x 101 ‘‘because it must be synthesized from other genetic materials, a process that involves significant manipulation and leaves the public free to exploit the underlying natural substances used to create cDNA.’’47 It noted that, with rare exceptions, cDNA molecules do not occur naturally and must be synthesized in a laboratory.48 Because of this fact, the government asserted, there is no risk 27 Id. at *23 (citing Diamond v. Chakrabarty, 447 U.S. 303, 310 (1980)). 28 Id. at *23–24 (citing Mayo, 132 S.Ct. at 1294). 29 Id. at *24 (citing Mayo, 132 S.Ct. at 1301–3). 30 Id. at *28–35. 31 Id. at *28. 32 Id. at *33–4. 33 Id. at *35. 34 Id. at*35–40. 35 Id. at *37. 36 Id. at *39. 37 Id. at *41. 38 Id. at *40–1. 39 Id. at *43–7. 40 Id. at *48. 41 Id. at *49–53. 42 Petitioners also included an argument that patent claims on isolated DNA violate the First Amendment because they grant exclusive control over a body of knowledge. Id. at *55–9. 43 Id. at *53–4. 44 Id. at *54 (citing Mayo, 132 S.Ct. at 1304–5). 45 See Brief for United States as Amicus Curiae, Ass’n for Molecular Pathology v. U.S. Patent & Trademark Office (‘‘Myriad’’), 133 S.Ct. 694 (2013)(No. 12-398), 2013 WL 390999 at *9. 46 Id. at *11. 47 Id. at *12. 48 Id. at *18. Biotechnology Law Report Volume 32, Number 4 that granting patent protection for cDNA molecules will ‘‘tie up’’ other uses of the natural raw materials involved in the creation of cDNA.49 In contrast, genomic DNA that has been isolated should not be patent eligible, argued the United States, because ‘‘it has merely been ‘isolated’—i.e., extracted from its cellular environment and separated from extraneous material—rather than significantly altered by human intervention.’’50 In other words, the differences between isolated DNA and genomic DNA are simple and necessary consequences of removing the DNA from its natural environment. This process is necessary, according to the government, to exploit and study DNA, and, accordingly, isolated DNA claims threaten to preempt the use of the underlying natural DNA.51,52 It contended that the structural differences between isolated DNA and native DNA (length and the terminal groups) were minor and do not render isolated DNA ‘‘markedly different.’’53 Moreover, it argued, the claimed additional utility of an isolated DNA molecule does not make this molecule ‘‘markedly different’’ because this utility is based on the inherent natural properties that it shares with native DNA.54 Finally, the United States argued that ‘‘neither the PTO’s practice of issuing patents for isolated DNA, nor Congress’s failure to overturn that practice, provides sufficient reason to hold that isolated DNA is patent-eligible.’’55 Claiming that there was no ‘‘highly visible’’ formal administrative action that thoroughly explained the PTO’s interpretation of the statute before the agency began issuing these DNA-based patents, the government asserted that there is little evidence that Congress had considered this precise question.56 Further, it argued, ‘‘no court had ever specifically upheld the patent-eligibility of isolated DNA until the court of appeals ruled in this case.’’57 The government also noted that although a ruling that isolated DNA is not eligible for patent protection might upset settled industry expectations, the Court has a duty to consider the public interest in ‘‘avoiding undue restrictions imposed by patents that effectively preempt natural laws and substances.’’58 Myriad responded in its brief by arguing first that the Court should dismiss the case for lack of subject matter jurisdiction.59 But if it did reach the merits, Myriad argued, the Court should affirm the decision below and rule that isolated DNA is patent eligible as a product of human invention.60 Myriad based this argument on the statutory text of x 101 and its assertion that the ‘‘implicit exception’’ to the scope of patent-eligible subject matter—excluding laws of nature, natural phenomena, and abstract ideas—only bars things that lack human invention. Moreover, Myriad argued, the Court should give weight to the established PTO practice of allowing such DNAbased claims and avoid disrupting the longstanding industry reliance on these patents. Finally, Myriad con- 5 tended that the approaches advocated by the United States and by the petitioners were misguided. First, Myriad noted that its claims to isolated DNA were statutorily patent eligible because each claim is directed to a ‘‘chemical ‘composition of matter,’ or a ‘new and useful improvement thereof.’’’61 Next, it argued that the claims did not fall under the ‘‘implicit exception’’ to patent eligibility that prevents patent claims on, among other things, natural phenomena.62 According to Myriad, the question that defines the boundary between eligible and ineligible subject matter is simply (and solely) whether the claimed composition is a product of human invention.63 In other words, the patent-eligibility question is ‘‘whether the claimed composition is a product of human ingenuity ‘having distinctive name, character, and use’ from naturally-occurring starting materials.’’64 But, Myriad asserted, x 101 should be interpreted broadly, and require only a small modicum of human invention or human ingenuity, because to require more would risk having the x 101 eligibility inquiry merge with the x 103 nonobviousness inquiry.65 Applying this standard, Myriad argued that its isolated DNA claims were patent eligible. It asserted that ‘‘[o]nly by human intervention have the claimed molecules come about.’’66 Additionally, Myriad claimed that the new, isolated molecules have ‘‘significant utility’’ not present in native DNA, such as probes and primers, that allow doctors and researchers to determine a patient’s hereditary predisposition to developing breast and ovarian cancers.67 Myriad claimed that this new utility is the result of human ingenuity 49 Id. at *18–9. Id. at *12. 51,52 Id. 53 Id. at *22. 54 Id. at *23–4. 55 Id. at *26. 56 Id. at *28. 57 Id. at *30 58 Id. at *33. 59 Brief for Respondents, Ass’n for Molecular Pathology v. U.S. Patent & Trademark Office (‘‘Myriad’’), 133 S.Ct. 694 (2013)(No. 12-398), 2013 WL 860315 at *17–22. Myriad argued that the Court lacks declaratory judgment jurisdiction over the one remaining petitioner (Dr. Ostrer) because Ostrer never had a ‘‘real and immediate’’ dispute with Myriad, and even if he did at one point, his case was mooted once Ostrer changed jobs and moved to a different institution. Id. 60 Id. at *15–7. 61 Id. at *23. 62 Id. 63 Id. at *23–8. 64 Id. at *23 (quoting Chakrabarty, 447 U.S. at 309–10)(some internal quotation marks omitted). 65 Id. at *26–7. 66 Id. at *34. 67 Id. at *35. 50 6 Biotechnology Law Report Volume 32, Number 4 and is ‘‘the quintessential mark of patent-eligible subject matter.’’68 Further, Myriad contended that the Supreme Court ‘‘has emphasized that a consistent and longstanding USPTO practice is entitled to substantial weight in interpreting and applying x 101.’’69 It asserted that the PTO has issued nearly 3,000 patents on isolated DNA molecules over the past 30 years and argued that Congress took no action to halt or modify this practice, despite numerous opportunities to do so.70 Myriad also responded to the arguments made by the United States and by the petitioners in their respective briefs. Myriad asserted that the U.S. position, distinguishing between the patent eligibility of cDNA and isolated DNA, was mistaken. Noting first that this position was at odds with the PTO, the agency with the relevant expertise in this area, Myriad also argued that this position finds no support in the law and would disrupt the enormous reliance interests in thousands of issued patents.71 Myriad similarly responded to the alleged flaws in the petitioners’ arguments. It asserted that the threepart test promoted by the petitioners was too cumbersome and represented a misreading of the Supreme Court’s precedent.72 Importantly, Myriad argued that the petitioners focus primarily on the similarities between the claimed isolated DNA and native DNA, whereas the proper inquiry focuses on the differences.73 Myriad noted that ‘‘modest changes introduced by man may confer ‘significant’ utilities that make a composition patent-eligible.’’74 Finally, Myriad also addressed several alleged mischaracterizations of its patent claims and of scientific facts, as well as arguing that the petitioners often conflated questions patent eligibility under x 101 with questions of patentability under other statutory sections such as xx 103 and 112. suggested by Justice Sotomayor and petitioner’s counsel, that the concern over incentives could be assuaged by the fact that the novel use of a natural composition could be patented even if the composition itself could not.76 According to Justice Sotomayor, ‘‘in isolation, [the natural product] has no value. It’s just sitting there.’’77 The United States also argued, in response to questions about the proper balance of incentives, that it was for the Court to apply the legal principles set by its precedents, not to optimize the incentives for a particular industry, stating that this balancing was Congress’s prerogative.78 Throughout the oral argument, the Justices also made use of several analogies when addressing this patentability issue. Justice Alito proposed an analogy to a plant growing in the Amazon, whose leaves are discovered to have powerful medicinal purposes when eaten. Several of the other Justices returned to this analogy, including Justice Kagan who returned to this analogy twice. She suggested that one might be able to get a patent for the use of this plant, but not for the leaves/composition itself, even if it took much effort and ingenuity to find the plant.79 Justice Breyer also used the medicinal plant analogy, assuming in his followup question that one could not get a patent on the composition itself.80 Justice Sotomayor proposed an analogy suggesting that isolated DNA segments might be like the basic ingredients (flour, sugar, etc.) that go into baking chocolate chip cookies, and that these basic, natural building blocks should not be eligible for patent protection.81 Similarly, Chief Justice Roberts posed questions based on an analogy to a wooden baseball bat. Although the bat is made from a material found in nature, Chief Justice Roberts posited that making it required more than mere isolation, something more than merely the ‘‘snipping’’ off the ends that is involved in isolating the DNA segments.82 He did not appear to give much weight to the answer given by Myriad’s counsel that the ORAL ARGUMENTS AT THE SUPREME COURT 68 The questions posed by the Justices at oral argument may offer some insight into how the Court might ultimately rule in this case. The Justices’ questions suggested skepticism as to whether claims directed to isolated DNA molecules should be eligible for patent protection, although this doubt seemed less pronounced with regard to the patent eligibility of cDNA. Most of the Justices’ questions centered on the eligibility of isolated segments of naturally occurring DNA. Justices Kagan and Scalia asked about the effect of not permitting patents on isolated genes on the incentives for companies to perform this kind of research—identifying and isolating genes.75 But most of the Justices appeared to accept the answer, Id. Id. at *30 (citing J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred Int’l, Inc., 534 U.S. 124, 145 (1996)). 70 Id. at *30–1. 71 Id. at *35–9. 72 Id. at *39–50. 73 Id. at *40. 74 Id. at *44. 75 Oral Argument Tr., Ass’n for Molecular Pathology v. U.S. Patent & Trademark Office (‘‘Myriad’’), 133 S.Ct. 694 (2013)(No. 12-398) at 10–5. 76 Id. at 16. 77 Id. 78 Id. at 32. 79 Id. at 32, 43. 80 Id. at 49. 81 Id. at 35–6. 82 Id. at 41. 69 Biotechnology Law Report Volume 32, Number 4 invention consisted of knowing where to snip the DNA strand, making the molecule itself patent eligible.83 Justice Kagan asked Myriad’s counsel whether the first person who isolated chromosomes could have gotten a patent on them.84 Her line of questioning appeared directed to the point that there may be no principled difference between an isolated segment of DNA and another, larger isolated part of the human body.85 Justice Sotomayor later jumped in and sought to know the difference for patent eligibility purposes between snipping off a piece of a DNA segment and snipping off a piece of a liver or kidney.86 None of the Justices’ questions seemed to suggest that they believed that the mere act of isolating a natural substance, such as a DNA segment, from a larger whole was sufficient to make the isolated substance itself patent eligible. The Justices also did not appear to give much weight to Myriad’s argument that the Court should respect the decision made by the PTO, reflected in its Utility Guidelines, to grant patents for isolated DNA molecules because the PTO is ‘‘the agency that sits at the intersection of law and science.’’87 Justice Ginsberg noted that the strength of this presumption of respect for the agency practice was diluted by the fact that the United States adopted an opposing position as amicus curiae.88 The questions raised by the Justices regarding cDNA, in contrast, suggest an outcome different than for the isolated gene claims. Justice Sotomayor emphasized in her questions to petitioners’ counsel that cDNA was created in a laboratory and is not a natural product but rather is a product of human invention.89 7 After Justice Breyer also noted that this molecule is different from any that occurs in nature, Justice Sotomayor responded to the argument made by petitioner’s counsel that it was not markedly different from natural DNA by asserting that the argument went to obviousness rather than to patent eligibility.90 Further, Justice Kennedy asked a series of questions that led to the concession that it was somewhat easier to work with cDNA than isolated DNA to make other humandesigned DNA molecules.91 In one instance, Chief Justice Roberts also had Myriad’s counsel quickly assume that cDNA would be patentable when seeking an answer to his question about the patent eligibility of isolated DNA.92 No questions suggested doubt as to the patent eligibility of cDNA, although concerns regarding whether such claims are obvious remain. CONCLUSION All in all, the tone and content of the questions posed by the Justices at oral argument suggest that the Court may be leaning toward agreement with the position advocated by the United States, ruling that cDNA molecules are patent eligible and isolated segments of native DNA are not. Although this outcome would disrupt the expectation of many current patent owners, it is not clear what effect, if any, such a ruling would have on the incentives and protection afforded to genetic research moving forward.93 83 Id. at 43. Id. at 52. (Justice Kagan noted that a chromosome is certainly a useful thing and would thus meet the other x 101 requirements). 85 Id. at 54. 86 Id. at 56. 87 Id. at 51. 88 Id. 51–2. 89 Id. at 17. 90 Id. at 18–9. 91 Id. at 20. 92 Id. at 42 (‘‘Okay. You’ve got the cDNA.’’). 93 Id. at 24 ( Justice Sotomayor wondered whether it really matters if only cDNA and not isolated DNA is patent eligible). 84