On August 16, 2012, the U.S. District Court for the Federal Circuit issued its decision on remand in Association for Molecular Pathology v. Myriad Genetics, Inc. (Myriad), which was returned as a petition for certiorari filed from the Federal Circuit's previous decision of July 29, 2011. The Supreme Court of the United States granted the petition, vacated the previous decision and remanded the case to the Federal Circuit for further consideration in light of its decision in Mayo Collaborative Services v. Prometheus, Inc., 566 U.S. ___, 132 S. Ct. 1289 (2012) (Prometheus). The Federal Circuit invited and received briefing from the parties and interested amici curiae (including an amicus brief filed by Vedder Price P.C. on behalf of Protein Sciences Corporation).
The Federal Circuit affirmed its previous decision. On the merits, the Federal Circuit reversed the district court’s decision that Myriad’s composition claims to "isolated" DNA molecules and Myriad’s method claim to screening potential cancer therapeutics were patent-ineligible. The Federal Circuit affirmed the district court's decision that Myriad’s method claims directed to "comparing" or "analyzing" DNA sequences were also patent-ineligible. The Federal Circuit further affirmed the district court's decision to exercise declaratory judgment jurisdiction, but on narrower grounds of finding the decision applicable to only one plaintiff with standing to maintain the action.
Prior to addressing the applicability of the Prometheus holding, the Federal Circuit stated what this appeal is not about, in particular whether (a) individuals suspected of having an increased risk of developing breast cancer are entitled to a second opinion, (b) the patentee/licensee acted improperly in its licensing or enforcement policies with respect to the patents, (c) it is desirable for one company to hold a patent or license covering a test that may save people's lives, or for other companies to be excluded from the market encompassed by such a patent or (d) the claims at issue are novel or nonobvious or too broad. The Federal Circuit also stated that disapproving of patents on medical methods and novel biological molecules is a policy question best left to Congress.
The Federal Circuit clarified that the remand was directed to patent eligibility, not patentability, and found that Prometheus does not control the question of patent eligibility of isolated DNA molecules. The Federal Circuit believes that § 101 of the U.S. Patent Act applies equally to all putative inventions, and isolated DNA is not and should not be considered a special case for purposes of patent eligibility under existing law. Their decision that isolated DNA molecules are patent-eligible also comports with the longstanding practice of the U.S. Patent and Trademark Office (USPTO) and the courts, as the USPTO has issued patents directed to isolated DNA molecules for almost 30 years.
The Federal Circuit also reaffirmed the prior holding that method claims directed to analyzing and comparing DNA sequences were patent-ineligible in view of Prometheus. According to the majority opinion, the claims therein recite nothing more than abstract mental steps necessary to compare two different nucleotide sequences and Myriad’s challenged method claims are indistinguishable from the claims the Supreme Court found invalid under § 101 in Prometheus.
The Federal Circuit also upheld the prior determination that method claims directed to growing transformed cells and determining growth rates were patent-eligible in view of Prometheus. According to the majority opinion, applying various known types of procedures to patent-eligible subject matter is not merely applying conventional steps to a law of nature. Rather, the transformed, man-made aspect of the underlying subject matter makes the claim patent-eligible. The claim also includes the steps of determining the cells' growth rates and comparing those growth rates, but that does not change the fact that the claim is based on a man-made, non-naturally occurring transformed cell.While the affirmance of the Myriad decision is a relief to patentees and licensees with isolated-DNA patent portfolios, the plaintiffs and their advocates are disappointed and have deemed the decision "devastating" for women's health care. This debate is far from being settled. Nevertheless, from a patent perspective, the Federal Circuit reaffirms preexisting case law and clarifies that any health care issues are not within the purview of patent courts—at least for now.