Ass’n for Molecular Pathology v. U.S. Patent and Trademark Office, No. 2010-1406, 2011 WL 3211513, (Fed. Cir. July 29, 2011).

On July 29, 2011 a three-judge panel of the U.S. Court of Appeals for the Federal Circuit ruled that “isolated” human genes are patentable subject matter but that methods that merely compare or analyze genetic sequences are not patentable. This ruling partially reverses an earlier decision by the U.S. District Court for the Southern District of New York.

Background

In 2009 the American Civil Liberties Union and the Public Patent Foundation filed suit against Myriad Genetics, Inc., the U.S. Patent Office, and the University of Utah Research Foundation challenging several patents assigned to Myriad. The patents relate to the human BRCA genes, mutations of which are correlated with increased risks for breast and ovarian cancer. The plaintiffs included several medical organizations and individual researchers, genetic counselors, and patients.

Myriad initially sought to have the District Court dismiss the case on the grounds that the plaintiffs lacked standing to sue. The District Court rejected that motion and eventually decided that fifteen of the challenged claims were invalid under 35 U.S.C. § 101 (the section of the Patent Statute that limits what is considered patentable subject matter). Myriad appealed the District Court’s decision.

The Federal Circuit Decision

The Federal Circuit first dealt with the standing issue and concluded that one of the plaintiffs met the necessary standing requirements to file the lawsuit, meaning that the District Court had the jurisdiction to hear the original case. The Federal Circuit then examined the fifteen challenged claims, which were organized into the following three categories: (i) composition claims directed to isolated DNA molecules; (ii) method claims directed to “comparing” or “analyzing” DNA sequences; and (iii) a method claim for screening potential cancer therapeutics. It determined that the claims in categories (i) and (iii) covered patentable subject matter (reversing the District Court) but those in category (ii) did not (affirming the District Court). Each of the three judges on the panel issued separate opinions providing different analyses and/or results regarding the patentability of isolated DNA.

Patentability of Isolated DNA Molecules

All three judges on the panel held that the claims directed to complementary DNA (“cDNA”) constitute patentable subject matter. cDNA is synthesized in the lab from messenger RNA (“mRNA”) and does not include segments of DNA known as introns that are present in the human body.

The patentability of isolated DNA proved more controversial, as both Judge Lourie and Judge Moore found it to be patentable (albeit, under different analyses), while Judge Bryson issued a vigorous dissent on this issue.

In holding that isolated DNA is patentable subject matter, Judge Lourie emphasized that the claimed DNA molecules do not exist in nature within a physical mixture to be purified. They are a distinct chemical entity that must be chemically cleaved from other genetic materials. The fact that their “information content” (i.e., their nucleotide sequences) may be similar to that in naturally occurring DNA is not a basis to deem them ineligible for a patent.

Judge Moore expanded on Judge Lourie’s analysis by noting that the shorter claimed isolated DNA molecules not only had a different structure than naturally occurring DNA, but also that this different structure imparts a new utility that “makes the molecules markedly different from nature.” For example, the shorter isolated DNA sequences can be used for primers in a diagnostic screening process.

Judge Bryson, dissenting-in-part with regard to the patentability of isolated DNA, criticized the majority’s use of the breaking of a covalent bond in cleaving as indicia that the resulting product is new.

Non-Patentability of “Comparing” and “Analyzing” Methods

All three judges affirmed the District Court’s holding that claims to methods of “comparing” or “analyzing” BRCA sequences are unpatentable subject matter under § 101. The court held that these claims are invalid because they are nothing more than “abstract mental processes.” In reaching this conclusion the court distinguished these unpatentable methods from the patentable methods of optimizing the dosage of thiopurine drugs described in Prometheus Labs., Inc. v. Mayo Collaborative Servs., 628 F.3d 1347 (Fed. Cir. 2010). In Prometheus, the steps of “administering” the drug and “determining” the drug’s metabolite levels in the subject were both deemed to be sufficiently transformative under the “machine-or-transformation” test and, therefore, patentable subject matter. In contrast, the Federal Circuit concluded that Myriad’s methods did not include the step of “determining” the sequence for BRCA genes.

Patentability of Methods of Screening Potential Cancer Therapeutics

All three judges held that the claim directed to a method for screening potential cancer therapeutics via changes in cell growth rates constitutes patentable subject matter. In reaching this conclusion, the Federal Circuit found that the step of “growing” transformed cells in the presence or absence of a potential cancer therapeutic is an “inherently transformative step involving the manipulation of the cells and their growth medium.” The Federal Circuit also noted that the step of the “determining” the cells’ growth rates “also necessarily involves physical manipulation of the cells.”

Next Steps

A request for en banc rehearing at the Federal Circuit or a petition for a writ of certiorari to the Supreme Court could be filed in this case. Any petition for an en banc rehearing must be filed within forty-five days after entry of judgment. Any petition for a writ of certiorari to the U.S. Supreme Court must be filed within ninety days after entry of judgment.

In the interim, the Federal Circuit’s decision demonstrates the value of presenting a variety of types of claims as well as claims of varying scope. As recognized in other technologies in the aftermath of the Bilski v. Kappos decision, 130 S. Ct. 3218 (2010), there is often value in presenting a set of claims that not necessarily distinguish the invention for novelty and obviousness analyses, but also includes claims that explicitly recite structure or transformations to satisfy the Bilski machine-or-transformation test for patentable subject matter.