On March 26, 2012 the US Supreme Court granted the petition for writ of certiorari in Ass’n for Molecular Pathology et al., v. Myriad Genetics et al., vacated the Federal Circuit judgment and remanded the case for further consideration in light of the Court’s recent decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc.
The initial decision in the Myriad Genetics case was issued on March 29, 2010 by Judge Robert W. Sweet of the United States District Court for the Southern District of New York. Judge Sweet issued a summary judgment opinion invalidating (i) composition of matter claims directed to the BRCA1 and BRCA2 human genes implicated in breast and ovarian cancer and (ii) methods of detecting mutations in those genes that are linked to incidence of cancer. Ass'n for Molecular Pathology v. U.S.P.T.O., S.D.N.Y. No. 09-CV-4514, Docket No. 255. The central question on summary judgment was whether "isolated human genes and the comparison of their sequences [are] patentable.” (Slip op., p. 2).
One composition claim that the court considered to be representative was:
An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2. (Slip op., p. 80).
The court held that such composition claims "directed to ‘isolated DNA’ containing sequences found in nature are unsustainable as a matter of law and are deemed unpatentable subject matter under 35 U.S.C. § 101.” (Slip op., p. 4).
One method claim that the court considered to be representative was:
A method for detecting a germline alteration in a BRCA1 gene [selected from a referenced list] in a human which comprises analyzing a sequence of a BRCA1 gene or BRCA1 RNA from a human sample or analyzing a sequence of BRCA1 cDNA made from mRNA from said human sample . . . . (Slip op., p. 83).
In rejecting the method claims, the court held that "because the claimed comparisons of DNA sequences are abstract mental processes, they also constitute unpatentable subject matter under § 101.” (Slip op., p. 4).
On June 16, 2010, Myriad Genetics filed a notice of appeal to the United States Court of Appeals for the Federal Circuit (Case No. 2010-1406). On July 29, 2011, the Federal Circuit reversed-in-part the summary judgment of the Southern District of New York. The Federal Circuit held in a 2-1 panel decision that Myriad’s composition claims to isolated DNA constituted patentable subject matter under 35 U.S.C. § 101. Further, the Federal Circuit held that Myriad’s claim directed to a method of using cells to screen for cancer therapeutics constituted patentable subject matter, but that other method claims directed to "analyzing” and "comparing” DNA sequences did not. Judge Lourie wrote the opinion for the Court, with a concurring opinion by Judge Moore, and an opinion concurring-in-part and dissenting-in-part by Judge Bryson.
The Federal Circuit first addressed the issue of standing. Ass'n for Molecular Pathology v. U.S.P.T.O., 2010-1406 (July 29, 2011). Basing its decision on the Supreme Court case MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118 (2007), the Federal Circuit held that at least one of the medical researcher plaintiffs, Dr. Ostrer, had standing to sue for declaratory judgment because he had an actual and imminent plan to engage in potentially infringing activities that Myriad had asserted were barred by its patents. Ass'n for Molecular Pathology, slip op., at 24-35.
The Court then addressed whether Myriad’s claims to isolated DNA, methods for "comparing” or "analyzing” DNA sequences, and methods for screening for cancer therapeutics were directed to patentable subject matter. Relying on Supreme Court decisions Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948) and Diamond v. Chakrabarty, 447 U.S. 303 (1980), the Federal Circuit found that Myriad’s claims to cDNA and isolated DNA were indeed patentable subject matter. The Court reasoned that "a portion of a native DNA molecule—an isolated DNA—has a markedly different chemical nature from the native DNA” and that "[i]t is, therefore, patentable subject matter.” (Slip op., p. 46). The Court also looked to the U.S. Patent and Trademark Office’s longstanding practice of issuing patents directed to DNA molecules, finding that "[i]f the law is to be changed, and DNA inventions excluded from the broad scope of § 101 contrary to the settled expectation of the inventing community, the decision must come not from the courts, but from Congress.” (Slip op., p. 48).
The Court held that Myriad’s method claims directed to "comparing” or "analyzing” DNA sequences were not patentable because they describe abstract mental processes. (Slip op., pp. 49-50). Applying the machine-or-transformation test from Bilski v. Kappos, 130 S. Ct. 3218, 3225 (2010), the Court reasoned that these method claims recite "nothing more than the abstract mental steps necessary to compare two different nucleotide sequences…” (Slip op., p. 50). The Court distinguished Myriad’s claims from those held to be patentable in Prometheus Labs., Inc. v. Mayo Collaborative Servs., 628 F.3d 1347 (Fed. Cir. 2010). In distinguishing the claims, the Federal Circuit held that Myriad’s claims failed to include a transformative step such as the step of "determining” the sequence of BRCA genes by, e.g., isolating the genes from a sample and sequencing them. (Slip op., p. 52).
Lastly, the Court held that Myriad’s claim directed to methods for screening potential cancer therapeutics based on changes in cell growth rates constituted patentable subject matter. (Slip op., p. 53). The Court found that this method claim satisfied the machine-or-transformation test set forth in Bilski, because the claimed steps of "growing” cells and "determining” the cells’ growth rate were transformative steps. (Slip op., pp. 53-54). Relying on Research Corp. Techs., Inc. v. Microsoft Corp., 627 F.3d 859, 869 (Fed. Cir. 2010), the Court further held that this method claim was not so "‘manifestly abstract’ as to claim only a scientific principle, not a patent-eligible process.” (Slip op., p. 54).
Judge Bryson concurred with the decision regarding standing and the patentability of cDNA claims and the method claims. However, he disagreed that the BRCA gene claims and claims directed to gene fragments were patentable subject matter. Judge Bryson reasoned that these claims should be unpatentable because the only change made to the isolated genes related to their extraction from the natural environment, such that they were not materially different from the native genes. He did not believe the PTO’s longstanding practice of issuing gene patents was entitled to any particular deference.
The plaintiffs filed a petition for writ of certiorari in the US Supreme Court on December 7, 2011. On March 26, 2012 the Court granted the petition, vacated the Federal Circuit judgment and remanded the case for further consideration in light of the Court’s recent decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc.
Federal Circuit Opinion
Parties' Federal Circuit Briefs
Federal Circuit Amicus Briefs in Support of Defendants-Appellants, Supporting Reversal
Federal Circuit Amicus Briefs in Support of Plaintiffs-Appellees, Supporting Affirmance
Federal Circuit Amicus Briefs in Support of Neither Party
District Court Opinions
Parties’ District Court Briefs
District Court Amicus Briefs in Support of Plaintiffs
District Court Amicus Briefs in Support of Defendants
Patents In Suit
- US 5,747,282
- US 5,837,492
- US 5,693,473
- US 5,709,999
- US 5,710,001
- US 5,753,441
- US 6,033,857