On June 15, the parties and several amicus curiae filed briefs with the Court of Appeals for the Federal Circuit in Ass’n for Molecular Pathology v. U.S. Patent and Trademark Office. The case is the first time that the Federal Circuit will apply the Supreme Court’s recently decision in Mayo Collaborative Services v. Prometheus Laboratories. Inc. and may thus shed light on how courts will handle future patent claims that implicate natural laws or products, particularly those in healthcare-related fields.
Ass’n for Molecular Pathology concerns whether patent claims covering isolated DNA and a method to screen cancer therapeutics through changes in cell growth rates are directed to patent eligible subject matter. Although the Federal Circuit initially found these patents to be valid, the Supreme Court vacated the decision in March and remanded the case for further consideration in light of its decision in Mayo. As reported in our previous release, in Mayo, the Supreme Court reversed a Federal Circuit decision which had held that patents claiming multistep processes for determining the right dosage of a drug were directed to patent eligible subject matter. The Supreme Court concluded that the claimed processes did not contain sufficient additional features such that “the patent in practice amount[ed] to significantly more than a patent upon the natural law itself.”1
Background. 35 U.S.C. § 101 provides that an individual may obtain a patent on “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, subject to the conditions and requirements of this title.” The Supreme Court has long held that “laws of nature, physical phenomena, and abstract ideas” are not patent eligible. The difference between a mere law of nature and patent eligible subject matter, however, is not always clear-cut.
The patents at issue in Ass’n for Molecular Pathology concern two genes: BRCA1 and BRCA2. Mutations in these genes correlate with a predisposition to breast and ovarian cancers. The United States Patent and Trademark Office (PTO) issued patents to Myriad Genetics and the University of Utah Research Foundation (“defendants”) for (1) isolated DNA containing all or portions of the BRCA1 and BRCA2 gene sequence, (2) methods for “comparing” or “analyzing” BRCA1 and BRCA2 gene sequences to identify the presence of mutations that correlate with a predisposition to breast or ovarian cancer, and (3) a method for screening potential cancer therapeutics via changes in cell growth rates. The Association for Molecular Pathology and others (“plaintiffs”) brought suit seeking, among other things, a declaration that these claims were not drawn to patent eligible subject matter.
Prior Proceedings. S.D.N.Y. The United States District Court for the Southern District of New York granted summary judgment for the plaintiffs on the patent-related causes of action.2 The court concluded that the defendants’ isolated DNA claims were invalid because they concerned a “product of nature” that is not “markedly different” from native DNA, i.e. DNA in the human body. The court also found that the defendants’ methods claims were invalid because they did not include sufficiently “transformative” acts under the “machine or transformation” test of patent eligible subject matter.
Federal Circuit. In July 2011, the Court of Appeals for the Federal Circuit reversed with respect to the isolated DNA claims and the method claim for screening potential cancer therapeutics via changes in cell growth rates.3 Writing for the majority, Judge Lourie reasoned that isolated DNA has a markedly different chemical structure than native DNA and is therefore patent eligible subject matter. The majority also found that the method for screening potential cancer therapeutics was patent eligible subject matter because it included “transformative steps” under the “machine or transformation” test, namely growing host cells in the presence or absence of a potential cancer therapeutic and determining the cells’ growth rates. Judge Bryson concurred in part and dissented in part, concluding that BRCA genes and gene fragments, as compared to cDNA (a different type of isolated DNA), are not patent eligible subject matter. He reasoned that BRCA genes only accumulate incidental changes when extracted and therefore are not “materially different” from native genes. Plaintiffs appealed.
Supreme Court. The Supreme Court vacated the decision and remanded the case for further consideration in light of its Mayo decision. The Federal Circuit requested supplemental briefing from the parties – and invited amicus briefing – on the applicability of Mayo to the two patent claims that that it found to be directed to patent eligible subject matter: the isolated DNA claims and the method claim for screening potential cancer therapeutics via changes in cell growth rates.
Merits Briefs. Plaintiffs argue that isolated DNA molecules are not sufficiently different from native DNA to be patent eligible. They contend that, under Mayo, the isolation of DNA is simply a “routine, conventional preparatory step” that discloses a natural law: the claimed correlation between disease and genetic mutations in BRCA gene. They further maintain that the Mayo Court minimized the importance of deferring to the PTO, and that it instead took into account the negative effect of the patents at issue on innovation and the quality of medical care. Plaintiffs argue that Prometheus’s isolated DNA patents similarly inhibit research on the BRCA genes, including the development of new and more effective treatment methods. With regard to the method claim, plaintiffs contend that it is functionally identical to the method claim in Mayo, in that it merely sets forth a law of nature – the effect of a drug – and related “well-understood, routine, conventional activity.”
Defendants argue that Mayo should have no effect on the Federal Circuit’s prior decision. They contend that Mayo is inapplicable to the isolated DNA claims because Mayo only addressed methods claims. Defendants also argue that even if Mayo applied to the isolated DNA claims, the Federal Circuit’s decision was correct, because isolated DNA molecules have 2 In a separate portion of the opinion, the district court also dismissed plaintiff’s constitutional claims. 3 In a separate portion of the opinion, the Federal Circuit also ruled that only the competitor who intended to resume clinical diagnostic testing of the DNA sequences in question had standing to sue. a “distinctive name, character, and use,” and are sufficiently different from what is found in nature to be patent eligible. Further, defendants urge deference to the PTO’s long-held view that DNA is patent eligible subject matter. With regard to the method claim, defendants contend that while it was not in the original petition for certiorari, on the merits, the claim involves significantly more than a “well-understood, routine, conventional activity” because it starts with a product of human ingenuity: a transformed cell containing an altered BRCA1 gene.
Amicus Curiae. Stakeholders filed nine amicus curiae briefs with the court. Several medical, health, and social justice organizations filed briefs in support of the plaintiffs. They argue that the patent claims at issue (a) do not pertain to subject matter that is markedly different from laws or products of nature that exist apart from the isolation and replication process, and (b) preempt the use of patents in the field of genetic testing and identification and are already impeding innovation and improvements in the quality and availability of medical treatment for breast and ovarian cancers, a major factor in the Mayo Court’s decision.
The New York Intellectual Property Law Association (NYIPLA) and the Protein Sciences Corporation each filed briefs in support of neither party. Protein Sciences argues that (a) Mayo is not relevant to the patent eligibility of isolated DNA (which is patent eligible subject matter because it is sufficiently different from native DNA), and (b) the method claim is directed to patent eligible subject matter because it utilizes cells that are not naturally occurring. The NYIPLA similarly argues that (a) Mayo did not alter existing law on this issue, (b) isolated DNA is patent eligible because it is a product of human invention, regardless of its resemblance to native DNA, (c) the method claim is likely patent eligible because it includes the use of transformed cells, and (d) the patent-eligibility of both claims is consistent with longstanding practices of the PTO, and it would be unwise to upset these expectations.
Among the other amici was a brief filed by a Eli Lilly and Company that argues for a bright line rule that rejects patent eligibility whenever one or more “mental steps” are set out in a multistep process claim, and a brief filed by law professor Christopher M. Holman of the University of Missouri-Kansas City that discusses why isolated DNA is different than native DNA based on its chemical and physical structure and how concerns about the patents preempting other work in gene sequencing are overblown.
Conclusion. Oral argument in the case is scheduled for July 20. Given the uncertainty in this area of patent law, and the variety of stakeholders who have indicated interest in the outcome of the case, the Federal Circuit’s decision in Ass’n for Molecular Pathology could have a significant impact on patent claims in healthcare-related industries.
