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Recent Developments
DNA Patentability: What's In, What's Out.
Iván I. Hernández, J.D.


Abstract: In Ass'n for Molecular Pathology v. Myriad Genetics, 569 U.S. 12-398 (2013), the Supreme Court of the United States held that a “naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring.” 1 This holding has practical consequences in view of reports that breast cancer remains a leading cause of cancer among women. Presently, genetic testing is exceedingly expensive, particularly when one major player controls a significant share of the market. The present decision may have the effect of empowering competitors to offer alternative testing at a reduced cost. Traditionally, patent protection has been understood to create incentives for invention. But this notion seems to be turned on its face when the subject matter of the patent sought involves a human by-product. Critical to rendering this decision, the Court balanced two competing interests: the promotion of scientific innovation through patent protection and the flow of information that leads to such innovation. At the crux of this balance is the patient who can make better informed decisions regarding his healthcare choices or be muted by prohibitively expensive costs arising from monopolized testing of genetic conditions.

Keywords: Myriad, gene patents, genomic DNA, intellectual property

Published: January 30, 2014
Cite as:
Hernández I., DNA Patentability: What's In, What's Out. Bull Health L Policy. 2014; 2(2).

Introduction
Breast cancer is still on the rise, and continues to be the leading cause of cancer in women around the world.2 A riposte by science that is at least tantamount to the resiliency of the disease is a necessary, but perhaps, not a sufficient condition to combat it. At least in the eyes of the plaintiffs in the Association for Molecular Pathology v. Myriad Genetics3 case (“Myriad”), obstacles in the development of gene testing, as well as an impediment to receive the highest quality of breast cancer genetic testing, occurred as a result of defendant Myriad’s patents at issue in this case.4 Regarding the role of gene patents on the progress of science and medicine, plaintiffs asserted that “data sharing is the key to the future of genetic discoveries and bioinformatics.” 5 Of practical importance is the high cost of genetic testing, particularly when one market player has control over elements over which such testing can be done.6 But Myriad could just be the watershed moment where new competition on genetic testing for breast cancer begins to rise,7 leading to more affordable and ever expansive opportunities for patients to access healthcare options and make better informed decisions regarding their well-being.

Discussion
Unlike the first case heard by the Supreme Court of the United States on the patentability of genes—where bacteria was the source of those genes8 —the Myriad case dealt with human genes.9 As patentable genes were commodified, the biotechnology industry rapidly grew to capitalize on their new property value.10 Yet, whereas the patentability of nonhuman genes can be satisfactorily associated to a societal good—see., e.g., Diamond v. Chakrabarty, 447 U.S. 303, 308-318 (1980) (holding, “A live, human-made micro-organism [a genetically engineered bacterium capable of breaking down multiple components of crude oil] is patentable subject matter under [35 U.S.C.] § 101.”)—, it is much more difficult, and perhaps impossible, to justify the treatment of human by-products as patentable subject matter.

At the cusp of that debate is the present case in which the Supreme Court of the United States set to “resolve whether a naturally occurring segment of deoxyribonucleic acid (DNA) is patent eligible under 35 U.S.C. §101,” as well as to consider “the patent eligibility of synthetically created DNA known as complementary DNA (cDNA).” 11,12

In resolving this inquiry, the Court rendered a decision by balancing two important tenets of Patent Law—namely, that “Patent protection strikes a delicate balance between creating ‘incentives that lead to creation, invention, and discovery’ and ‘imped[ing] the flow of information that might permit, indeed spur, invention.’” 13 This balancing act brought forth a sui generis challenge as the constitutionally founded assertion that patents exist to “promote the progress of science,” is being turned on its face by the charge that “patents on human genes arguably do the opposite.” 14

Indeed, in this intense and at times emotionally charged dispute, patient advocates as well as other amici curiae have unequivocally accused the biotech company “Myriad of standing in the way of breast cancer diagnosis and treatment.” 15,16 Most worrisome to defenders of the non-patentability of genomic DNA (“naturally occurring” DNA) was the prospect that, if the biotech company was successful, “Myriad’s patents would, if valid, give it the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes.” 17 Eric S. Lander’s Brief is illustrative in this respect: “Such a patent can be used to exclude everyone from observing, characterizing or analyzing, by any means whatsoever, the product of Nature”, and notably, “[g]ranting a monopoly on possessing a molecule that is a product of Nature authorizes a patent holder to wall off an entire domain of Nature from observation.” 18 The sheer economic impact of fostering competition and efficient outcomes in biomedicine cannot be understated. For instance, great advances in biotechnology have made it possible to greatly reduce the cost of sequencing a human genome—the cost has gone from billions of dollars, to thousands, to predictably, hundreds of dollars. 19

It is against this backdrop that the U.S. Supreme Court overturned the Federal Circuit Appeals Court’s most controversial finding that isolated DNA (genomic or “naturally occurring” DNA) was patent eligible. 20 As an initial matter, the Court considered whether Respondent Myriad’s patent claims met the patent eligibility requirements under the applicable statute, which reads:

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. 21

In citing precedent, the Court noted that 35 U.S.C. §101 contains an “important implicit exception[:] Laws of nature, natural phenomena, and abstract ideas are not patentable.” 22 Further, the Court relied on Chakrabarti, 23 a 1980 case where a human-made microorganism was found to have “markedly different characteristics from those found in nature.” 24 The court noted in Chakrabarti that the microorganism was new “due to the additional plasmids and resultant ‘capacity for ‘degrading oil.’” 25 Contrasting Chakrabarti to the facts in Myriad, the Court concluded that “Myriad did not create anything.” 26

In the opinion delivered by Justice Thomas, the Court held in Myriad that “A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring.” 27

The Court took issue with Respondent Myriad’s argument that the relevant genes were patent eligible “simply because they have been isolated from the surrounding genetic material.” 28 During Oral Argument, the complexity of the biotech discourse was made apparent. Justice Sotomayor manufactured an analogy based on the basic elements of a chocolate chip cookie hoping to bridge a connection to “natural ingredients” for which she “could not imagine getting a patent.” 29 Even though counsel for Myriad qualified Justice Sotomayor’s analogy as being “really simplistic,” his did not fare much better. 30 Attorney for Respondents, Gregory Castanias argued that “A baseball bat doesn't exist until it's isolated from a tree. But that's still the product of human invention to decide where to begin the bat and where to end the bat.” 31 Opportunely, Chief Justice Roberts countered: “but we're not talking about process. Here, what's involved is snipping. You've got the thing there and you snip -snip off the top and you snip off the bottom and there you've got it[…]You don't have to invent the particular segment of the -- of the strand; you just have to cut it off.” 32 As succinctly put by former Science Advisor to the ACLU, Tania Simoncelli, “trees don’t have pre-carved baseball bats inside of them.” 33

Perhaps it is still a rare circumstance that courts have the support of law clerks with doctoral level degrees in life sciences, such as in the case of Judge Sweet of the Southern District Court of New York that first handled the present case, who availed his court of this important asset. 34 In a panel at the Petrie-Flom Center of Harvard Law School, trial attorney Claire LaPorte noted “[The Supreme Court of the United States] should probably be hiring some technically trained clerks to help them understand the science, because I really do think the chocolate chip analogies are not appropriate here.” 35 Just maybe, next time, Judge Alito will forgo the temptation of recurring to an imperfect analogy to help him understand better “some of this biochemistry,” 36 and perhaps also, Justice Scalia will join in the majority opinion, instead of absconding himself under the robes of his own (lack of) knowledge or his own belief. 37

Where the analogies during the oral arguments may have sounded imperfect at best, and at worst, puerile, scientific briefs, such as Dr. Lander’s Amicus Curiae Brief, may potentially have a profound effect in the Court’s ultimate legal findings. The Lander Brief parallels the two major findings in the Court’s holding—namely, that (1) isolated fragments of genomic DNA are “routinely found in the body, making them patent-ineligible…and (2) cDNAs are patent-eligible.” 38

With respect to genomic DNA, the rationale of the Court points to two major findings: (1) “The location and order of the nucleotides existed in nature before Myriad found them. Nor did Myriad create or alter the genetic structure of DNA,” 39 and, (2) “Myriad’s claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA. Instead, the claims understandably focus on the genetic information encoded in the BRCA1 and BRCA2 genes.” 40

Further, with respect to whether cDNA is patent-eligible, although Petitioners insisted that “[t]he nucleotide sequence of cDNA is dictated by nature,” the Court concluded that cDNA is patent-eligible, wherein “the lab technician unquestionably creates something new when cDNA is made.” 41

So far, the continuum of DNA patentability seems to adhere to the following relationship based on the Court’s reasoning:

(Definitely Patent-Ineligible)  → (Patent-Eligible)  → (Definitely Patent-Eligible)

Genomic DNA  → cDNA  → Recombinant DNA

Effectively, cDNA and recombinant DNA arguably account for the “vast majority of the medically and commercially important biotechnology products developed over the past quarter century [that] are protected by patents.” 42 Whereas a patent on the BRCA1 and BRCA2 genes would have ensured a windfall for Myriad—i.e., a virtual monopoly, charging inflated, exorbitant prices for diagnostic tests— 43 the outcome on its claim for cDNA places the company on equal footing with other biotech competitors. Although the Court made it clear that “extensive effort alone is insufficient to satisfy the demands of §101,” 44 there could be “method claims” and “new applications of knowledge about the BRCA1 and BRCA2 genes”—not implicated in this case—from which Myriad could still profit. 45

Competing Interests:
None reported.

Author(s)
Iván I. Hernández holds a J.D. from UC Berkeley School of Law and a B.A. in French and Spanish Literature from UC San Diego. He is currently a candidate in the M.A.S. program in Health Law & Policy at UC San Diego/California Western School of Law.

References (Bluebook)

1Ass'n for Molecular Pathology v. Myriad Genetics, 569 U.S. ___ (interim, 1) (2013) (No. 12-398).
2Helen Briggs, Breast cancer ‘rising in under 40-s’ across Europe, BBC News Health, Oct. 31, 2013,  http://www.bbc.co.uk/news/health-24746437.
3Myriad Genetics,  569 U.S. at 1.
4Ass'n for Molecular Pathology v. USPTO, 702 F. Supp. 2d 181, 205 (S.D.N.Y. 2010).
5Id. at 208.
6David B. Agus, The Outrageous Cost of a Gene Test, N. Y. Times, May 20, 2013, at A25, available at http://www.nytimes.com/2013/05/21/opinion/the-outrageous-cost-of-a-gene-test.html?emc=tnt&tntemail0=y&_r=0 .
7Julia Karow, Competition for Myriad Heats Up as US Testing Labs Launch BRCA Tests, Hereditary Cancer Panels, GENOMEWEB.COM, Jun. 26, 2013, available at http://www.genomeweb.com/sequencing/competition-myriad-heats-us-testing-labs-launch-brca-tests-hereditary-cancer-pan .
8Andrew Torrance, Nothing under the sun that is made of man, SCOTUSblog (Feb. 7, 2013, 12:24 PM), available at http://www.scotusblog.com/2013/02/nothing-under-the-sun-that-is-made-of-man/.
9Myriad Genetics, 569 U.S. at 1. 
10Torrance, supra note 8.
11Myriad Genetics, 569 U.S. at  4.
12Question Presented to the Supreme Court: Are human genes patentable?, available at
http://www.supremecourt.gov/qp/12-00398qp.pdf (last visited November 17, 2013).
13Myriad Genetics, 569 U.S. at  4. No. 12-398 (quoting Mayo Collaborative Servs. v. Prometheus Labs., 132 S.Ct. 1289, 1305 (2012) [“On the one hand, the promise of exclusive rights provides monetary incentives that lead to creation, invention, and discovery. On the other hand, that very exclusivity can impede the flow of information that might permit, indeed spur, invention, by, for example, raising the price of using the patented ideas  once created, requiring potential users to conduct costly and time-consuming searches of existing patents and pending patent applications, and requiring the negotiation of complex licensing arrangements.”]).
14Sharon Begley, In Surprise Ruling, Court Declares Two Gene Patents Invalid, available at http://www.sharonlbegley.com/in-surprise-ruling-court-declares-two-gene-patents-invalid (last visited Nov. 17, 2013).
15Greg Storh, Susan Decker; Biotech Industry at Stake in Human Gene Patent Decision. BLOOMBERG (Apr. 11, 2013), http://www.bloomberg.com/news/2013-04-12/biotech-industry-at-stake-in-human-gene-patent-decision.html.
16Brief for Eric S. Lander as Amicus Curiae Supporting Neither Party, 18-25, Ass'n for Molecular Pathology v. Myriad Genetics, 569 U.S. ___ (2013) (No. 12-398), available at http://www.americanbar.org/content/dam/aba/publications/supreme_court_preview/briefs-v2/12-398_neither_amcu_lander.authcheckdam.pdf (last visited November 17, 2013).
17Myriad Genetics, 569 U.S. at 9.
18Brief for Eric S. Lander as Amicus Curiae Supporting Neither Party, at 23-24,
19Id. at 28.
20USPTO, 689 F.3d at 1325(holdingthat“The isolated DNA molecules before us are not found in nature. They are obtained in the laboratory and are man-made, the product of human ingenuity”).
2135 U.S.C. §101 (West).
22Myriad Genetics, 569 U.S. at 11
23Diamond v. Chakrabarty, 447 U.S. 303 (1980).
24Ass'n for Molecular Pathology v. Myriad Genetics, 569 U.S. at12) (citing Chakrabarti).
25Id.
26Id.
27Id. at 1.
28Id. at 18.
29Oral Argument at 35, Ass'n for Molecular Pathology v. Myriad Genetics, 569 U.S. ___ (2013) (No. 12-398), available at http://www.supremecourt.gov/oral_arguments/argument_transcripts/12-398_h3dj.pdf
30Id. at 36.
31Id. at 37.
32Id. at 41.
33Video clip: Gene Patenting, the Supreme Court's Myriad Decision, and the Future of Biotechnology, The Petrie-Flom Center for Health Policy, Biotechnology, and Bioethics at Harvard Law School (Sep. 23, 2013), http://vimeo.com/75334202, min. 113.   
34Id. at 112.
35Id. at 102.
36Oral Argument at 48, Ass'n for Molecular Pathology v. Myriad Genetics, 569 U.S. ___ (2013) (No. 12-398), available at http://www.supremecourt.gov/oral_arguments/argument_transcripts/12-398_h3dj.pdf
37Concurring Opinion at (interim 1), Ass'n for Molecular Pathology v. Myriad Genetics, 569 U.S. ___ (2013) (No. 12-398).
38Brief for Eric S. Lander as Amicus Curiae Supporting Neither Party, 30, Ass'n for Molecular Pathology v. Myriad Genetics, 569 U.S. ___ (2013) (No. 12-398), available at http://www.americanbar.org/content/dam/aba/publications/supreme_court_preview/briefs-v2/12-398_neither_amcu_lander.authcheckdam.pdf.
39Myriad Genetics, 569 U.S.at15).
40Id. at 17-18.
41Id. at 20.
42Brief for Eric S. Lander as Amicus Curiae Supporting Neither Party, at 27.
43Steven Salzberg, Myriad Genetics CEO Claims He Owns Your Genes, FORBES, Apr. 13, 2013, available at http://www.forbes.com/sites/stevensalzberg/2013/04/13/myriad-genetics-ceo-owns-your-genes/.
44. Myriad Genetics, 569 U.S. at 16.
45Id. at 21.

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