Ass’n for Molecular Pathology v. Myriad Genetics, Inc.
By Alex Shank – Edited by David LeRay
Ass’n for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398 (U.S. Apr. 15, 2013)
Transcript of Oral Argument
On Monday, April 15, the Supreme Court heard oral arguments to determine the validity of a patent encompassing the use of the BRCA1 and BRCA2 genes. Mutations in these genes correlate strongly with the development of breast and ovarian cancers. As the patent owner, Myriad Genetics, Inc. (“Myriad”) possesses and exercises the exclusive right to sell diagnostic testing kits based on these genes.
The ACLU first challenged the constitutionality of the Myriad patent in the District Court of the Southern District of New York (“SDNY”), claiming that the patent violated the First Amendment. The SDNY invalidated the patent on other grounds, holding that the genes were “products of nature” and thus not patentable subject matter. On appeal, the Court of Appeals for the Federal Circuit (“CAFC”) affirmed that “comparing” gene sequences was unpatentable as an “abstract mental step” but reversed the SDNY by holding that Myriad’s “screening” claims were patentable. After deciding Mayo Collaborative Servs. v. Prometheus Labs., Inc., the Supreme Court vacated the CAFC’s earlier decision and remanded the case to be decided in light of Mayo. The CAFC reaffirmed that isolated genes were patentable as “markedly different” from genes in the human body and reaffirmed its earlier position on the various method patents. The ACLU appealed to the Supreme Court.
SCOTUSblog comments on the Supreme Court’s skepticism regarding the validity of the Myriad patents. The New York Times offers a summary of the oral argument and background on the case. Nature newsblog and Patently-O predict how the Supreme Court may narrow the scope of its holding to a particular class of genetic material. JOLT Digest previously commented on the implications of a ban on gene patents.
The Myriad patents in question contain claims covering both isolated gene molecules (“composition patents”), and methods for diagnosing breast cancer, in which the genetic material of a patient’s tumor is compared to the genetic material of the same patient’s healthy tissue.
The isolated gene molecules are known as complementary DNA, or cDNA which consist of isolated BRCA1/2 genes. Through a series of steps, scientists reverse engineer cDNA from other genetic material. The cDNA lacks “introns”—regions of DNA that do not encode genetic information—that exist in DNA in the body.
The method claims are divided into comparing/analyzing claims and screening claims; the Federal Circuit deemed the first category to be unpatentable subject matter in light of Prometheus and the latter patentable because it involves significant human intervention. Myriad currently sells diagnostic kits based on its patents to hospitals for around $3,000 each.
The oral argument focused on the composition claims covering cDNA. The Supreme Court attempted to determine whether Myriad’s patents claimed unpatentable “products of nature” or patent eligible human inventions. The justices and the litigants traded extensively in analogies.
Christopher Hansen, representing the ACLU, argued that although Myriad deserved recognition for having discovered the BRCA genes’ correlation to breast cancer, it did not deserve a patent over them. Transcript of Oral Argument at 3, Ass’n for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398 (U.S. Apr. 15, 2013). He compared the BRCA genes to gold. Id. at 4–5. According to Hansen, although one could get a patent on a new use of gold, such as earrings, one could not get a patent on gold itself as a “product of nature.” Likewise, the argument went, Myriad could get a patent on a new use of the BRCA genes, but not on the genes themselves.
In contrast, Gregory Castanias, representing Myriad, contested that the BRCA genes as used in the method claimed did not constitute products of nature. According to Castanias, isolated BRCA genes are not found in the human body. Scientists must cut the BRCA genes at specific locations from a much longer strand of DNA to perform the claimed method, and Myriad deserves a patent for its investment in finding where to make those cuts. Castanias likened it to awarding a patent over the first baseball bat, which was cut away from an unpatentable tree. Id. at 37.
The Supreme Court took issue with both metaphors. Justice Sotomayor compared the BRCA genes in a person to the “flour” used in baking “chocolate chip cookie[s],” and questioned “why gene sequences are not those basic products that you can’t patent.” Id. at 35. Chief Justice Roberts and Justice Kagan puzzled over why “snipping” a part of the body makes it patentable, speculating whether one could get a patent on piece of human liver by “snipping” it off. Id. at 54–55. Justice Alito pressed the parties to distinguish why a medicinal leaf plucked from a plant in the Amazon was unpatentable whereas a concentrated form of the compound in the leaf is patentable. He further asked where the BRCA gene plucked from human DNA fits in between the two. Id. at 7–8.
Amid the imagery, the justices and parties remained aware of broad doctrinal and policy implications of the Court’s eventual holding. Justice Breyer highlighted the “uneasy compromises” in patent law: “on the one hand, we do want people to invent; on the other hand, we’re very worried about them tying up . . . a thing that itself could be used for further advance.” Id. at 49. On the issue of what economic incentives would drive companies to invest in gene discovery if genes were deemed unpatentable, Justice Scalia criticized Hansen’s response that “curiosity,” “recognition,” and “taxpayers” would spur and fund innovation. Id. at 13–15. At the same time, Justice Kennedy cautioned that in “patent [law] . . . we have a uniform rule . . . that avoids giving special industries special subsidies.” Id. at 58. Castanias also suggested cabining or abolishing the “products of nature” doctrine, id. at 54–55, and requested that the court defer to the longstanding and expert decision by the USPTO that genes are patentable subject matter. Id. at 51.
Solicitor General Donald Verrilli, representing the United States as amicus but supporting neither party, offered a solution that would attempt to preserve “a necessary balance in the patent system between encouraging individual inventors and keeping the basic building blocks of innovation free for all to use.” Id. at 24. According to Verrilli, although “simply native DNA extracted from the body” would be patent ineligible, cDNA should be patent eligible as “an artificial creation in the laboratory.” Id. at 24–25. Verrilli supported the eligibility of the Myriad patent, but abstained from commenting on its obviousness. Id. at 26–28.
A decision is expected by the end of June.
Alex Shank is a 1L at Harvard Law School.