Can Large Companies Own Human Genes? The Supreme Court Says No…Yes…Well Maybe…It Depends.

By Tyler P. Hite

This summer the Supreme Court handed down a unanimous 9-0 decision invalidating Myriad Genetics’ patent of the human genes BRCA1 and BRCA2 found in deoxyribonucleic acid (DNA), but validating Myriad’s genetic patents of synthetically created composite deoxyribonucleic acid (cDNA).[1]  The Court’s reasoning hinged upon the fact that human genes found in DNA are “naturally occurring” and thus not eligible for patent, even though isolating human genes from DNA severs naturally occurring chemical bonds, thus altering but not re-creating anything new.[2]  cDNA, which the Court deemed to be synthetically created from DNA by lab technicians, is created from naturally occurring DNA through a process which splits the DNA double helix and allows lab technicians to isolate specific genes for study, manipulation, and use.[3]  The Supreme Court’s decision allows for the patent of human genes that are deemed “not naturally occurring,” even though “the nucleotide sequence of cDNA is dictated by nature, not by the lab technician.”[4]

Myriad Genetics discovered the precise location and sequences of BRCA1 and BRCA2, two genes which if mutated, can drastically increase an individual’s risk of developing breast cancer (50-80% risk) and ovarian cancer (20-50% risk).[5]  Asserting their genetic discovery was patent eligible, Myriad invoked §101 of the Patent Act, which provides: “[w]hoever invents or discovers any new and useful . . . composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.”[6]  By applying for and retaining patents of the BRCA1 and BRCA2 genes, Myriad was granted the exclusive right to isolate these genes within individual’s DNA, giving Myriad the sole right to test individuals for BRCA1 or BRCA2 mutations.[7]  On review, the Supreme Court was guided by language derived from Mayo Collaborative Services v. Prometheus Laboratories, Inc., which affirmed the Court’s interpretation of §101 of the Patent Act whereby the “laws of nature, natural phenomena, and abstract ideas are not patentable.”[8]  As such, Justice Thomas reasoned that extensive effort alone was insufficient to satisfy §101 of the Patent Act, as Myriad did not create or alter the genetic information encoded in the BRCA1 and BRCA2 genes.[9]

It would seem at first glance that Myriad Genetics’ effort to discover the BRCA1 and BRCA2 genes, while beneficial for society in its pursuit of genetic knowledge, was not necessarily a lucrative enterprise.  Myriad was able to charge $3,400 for each BRCA DNA test, but following the Myriad ruling, other companies lunged at the opportunity to offer similar tests, with a spokeswoman from Quest Diagnostics stating, “[b]ased on our initial review of the court’s decision, we expect it will open opportunities for Quest Diagnostics to develop new testing services, including in the area of hereditary breast cancer.”[10]  Considering Myriad Genetics recovered nearly $353 million, or 88% of their total revenue for the 2011 fiscal year directly from the BRCA gene testing, the ability of other companies to conduct similar BRCA testing will likely have a significant impact upon Myriad’s revenue in the foreseeable future.[11]  Following the Supreme Court’s ruling in Myriad, the question is whether companies will be deterred from investing in further genetic research if they are unable to patent their discoveries.

While it is far too early to resolutely determine how Myriad will alter the genetic research market, it is clear that Myriad Genetics is not implementing a wait-and-see method for that answer.  Just 3 months after the Supreme Court’s ruling, Myriad Genetics commenced an action in the U.S. District Court for the District of Utah, Central Division for injunctive relief based upon patent infringement regarding Myriad’s remaining 24 patents and 515 patent claims, all of which concern BRCA1 and BRCA2 genes.[12]  Even though Myriad Genetics is not challenging the Supreme Court’s decision from this summer, it seems the Supreme Court’s ruling is not as expansive and determinative as initially portrayed by various media outlet headlines.[13]  Myriad’s argument, outlined in their Motion for Preliminary Injunctive Relief and Memorandum in Support, argue that the defendant, Ambry Genetics Corporation, infringed upon Myriad’s patent rights by offering BRCA1 and BRCA2 testing even though “such testing requires use of methods and synthetic DNA over which Plaintiffs [Myriad Genetics] have exclusive patent rights.”[14]

The allegations filed circumvent the barrier established by the Supreme Court’s ruling in Myriad, since Myriad Genetics, if successful, will retain the process by which the BRCA1 and BRCA2 genes are isolated.  While the issue of patenting “naturally occurring” genes within DNA was resolved in Myriad, the Court’s narrow ruling provides no guidance as to whether the process by which certain genes are isolated is patent eligible. A recent Supreme Court decision, Bilski v. Kappos, may provide some guidance for Myriad’s claims.[15]  Bilski concerned the patent of “a procedure for instructing buyers and sellers how to protect against the risk of price fluctuations in a discrete section of the economy.”[16]  The Court reasoned that that the machine-or-transformation test, which states “a claimed process is surely patent-eligible under §101 if: (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing,”(Id. at 3224) is not the exclusive test for determining a process’s patent eligibility, but is a “useful and important clue, an investigative tool, for determining whether some claimed inventions are processes under §101.”[17]

Since it was an uncontested fact in Myriad that Myriad Genetics was the first to discover the BRCA1 and BRCA2 genes, it would seem to follow that the process by which they achieved their discovery, by isolating segments of DNA, is the type of process which “transforms a particular article into a different state or thing.”[18]  If this is the case, it would seem that Myriad is only a temporary impediment to a genetic researcher’s ability to control the fruits of their labor, as cutting-edge techniques and innovations for discovering and manipulating segments or stands of DNA could still be patent eligible.  Perhaps these companies cannot own the exclusive right to a particular gene, but current law seems to indicate that companies can sidestep this obstacle by simply patenting the process by which specific genes are isolated.  It follows that under §101 of the Patent Act, entities which develop a particular process for isolating various genes may secure the exclusive right to that process. Thus, companies would be rewarded for their expensive research and development of innovative processes.

Myriad Genetics’ pending litigation may provide an additional opportunity for the judiciary to reinforce a fundamental principle of patent law, which as reaffirmed in Myriad states that “[p]atent protection strikes a delicate balance between creating ‘incentives that lead to creation, invention, and discovery’ and ‘impeding the flow of information that might permit, indeed spur, invention.’”[19]  While the Supreme Court invalidated the patent of human genes, it did not completely diminish the lucrative aspect of developing cutting age genetic methods and procedures.  If anything, the Court might have reinvigorated a competitive spirit among biotechnological and pharmaceutical companies to develop the most precise and efficiency methods that lead to genetic discoveries.[20]

 


[1] Association for Molecular Pathology et al. v. Myriad Genetics, Inc., et al., 133 S.Ct. 2107, 2111 (2013).

[2] Id. at 2110.

[3] Id. at 2112.

[4] Id. at 2116; Myriad, 133 S.Ct. 2107 at 2119 (citing Brief for Petitioners 49).

[5] Id. at 2112; See also Susan G. Komen, Testing for BRCA1 & BRCA2 Mutations, http://ww5.komen.org/Content.aspx?id=5332&terms=Testing%20for%20BRCA1%20%26%20BRCA2%20Mutations (last visited Sep. 10, 2013); National Cancer Institute, BRCA1 and BRCA2: Cancer Risk and Genetic Testing, http://www.cancer.gov/cancertopics/factsheet/Risk/BRCA (last visited Sep. 10, 2013).

[6] 35 U.S.C. §101 (2012).

[7] Myriad, 133 S.Ct. 2107 at 2113.

[8] Mayo Collaborative Services v. Prometheus Laboratories, Inc.,132 S.Ct. 1289, 1293 (2011).

[9] Myriad, 133 S.Ct. 2107 at 2118.

[10] Reuters, U.S. Top Court Bars Patents on Human Genes Unless Synthetic, (Jun. 13, 2013), http://www.reuters.com/article/2013/06/13/us-usa-court-genes-idUSBRE95C0PW20130613 (last visited Sep. 10, 2013).

[11] N.Y. Times, Despite Gene Patent Victory, Myriad Genetics Faces Challenges, (Aug. 24, 2011), http://www.nytimes.com/2011/08/25/business/despite-gene-patent-victory-myriad-genetics-faces-challenges.html (last visited Sep. 10, 2013).

[12] Tech Dirt; Myriad Mocks Supreme Court’s Ruling on Gene Patents; Sues New Competitors Doing Breast Cancer Tests (Plaintiff’s Brief available in PDF format).

[13] See Reuters, U.S. Top Court Bars Patents on Human Genes Unless Synthetic, (Jun. 13, 2013), http://www.reuters.com/article/2013/06/13/us-usa-court-genes-idUSBRE95C0PW20130613 (last visited Sep. 10, 2013); Huffington Post, The Supreme Court’s Gene Patenting Decision Was Personal, (June 20, 2013), http://www.huffingtonpost.com/rep-debbie-wasserman-schultz/supreme-court-gene-patenting-decision_b_3474586.html (last visited Sep 10, 2013); CNN, Court: Human Genes Cannot Be Patented, (June 13, 2013), http://www.cnn.com/2013/06/13/politics/scotus-genes/index.html (last visited Sep. 10, 2013).

[14] Motion for Preliminary Injunctive Relief and Memorandum in Support, U.S. District Court for the District of Utah, Central Division, Case No. 2:13-cv-00640-RJS. http://www.patentlyo.com/myriadmotionforpreliminaryrelief.pdf (last visted Sep. 10, 2013).

[15] Bilski v. Kappos, 130 S.Ct. 3218 (2009).

[16] Id. at 3223.

[17] Id. at 3227.

[18] Myriad, 133 S.Ct. 2107 at 2117; Bilski, 130 S.Ct. 3218 at 3227.

[19] Myriad, 133 S.Ct. 2107 at 2116.

[20] See Reuters, U.S. Top Court Bars Patents on Human Genes Unless Synthetic.