ELECTRONIC NEWSLETTER

Abelman, Frayne, &Schwab

Summary

The Court of Appeals for the Federal Circuit holds that claims to isolated DNA molecules are patentable, but claims to methods of screening which involve only "comparing" and "determining" steps do not satisfy 35 U.S.C. § 101.

On July 29, 2011, the Court of Appeals for the Federal Circuit issued its long awaited opinion in Association for Molecular Pathology v. Myriad Genetics, (2010-1460).

The case arose out of a decision by Judge Sweet of the Southern District of New York, which held that numerous claims in Myriad Genetics: patents to isolated BRCA1 and BRCA2 genes and their use, were unpatentable as failing to satisfy the utility requirement of 35 U.S.C. §101.

The Court of Appeals for the Federal Circuit reversed the lower court decision in part. The three-judge panel held, unanimously, that claims to molecules such as cDNA, which do not appear in nature, did satisfy 35 U.S.C. § 101 and were patentable.

The panel split, 2-1, in holding that claims which included isolated genomic DNA within their scope were patentable, with Judges Lourie and Moore reaching the same result, but for different reasons. Judge Bryson, in dissent, reasoned that, while isolating genes involves substantial, potentially patentable efforts, the resulting DNA is simply a purified form of what occurs in nature, and is not patentable.

A unanimous court held that claims that were drawn to screening methods, such as a method for determining if a sample contained a mutated gene which only involved "comparing" or "determining" sequences, were unpatentable under the Supreme Court's recent In re Bilski decision. Such claims, according to the Federal Circuit involve only abstract mental processes, and are not patentable under 35 U.S.C. § 101.

While not presenting any specific guidelines as to what is necessary for a "screening" claim to satisfy 35 U.S.C. § 101, the Court appeared to indicate that the "machine or transformation" test employed in other cases could be satisfied by adding steps such as extracting DNA from a sample, or by actually sequencing the molecules.

Either party may request a rehearing "en banc," i.e., by all judges on the Court, and we expect that at least one party to the case will eventually seek review by the Supreme Court. We will continue to monitor the case and would be pleased to offer suggestions on whether pending and/or proposed "method of screening" claims are likely to satisfy the dictates of this new decision.

Abelman, Frayne & Schwab

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