Thursday, September 1, 2011

Parties in Myriad BRCA Patent Suit Ask Appeals Court for Rehearing


By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Plaintiffs and defendants in a suit seeking to overturn Myriad Genetics' BRCA patents have filed separate briefs with the US Court of Appeals for the Federal Circuit seeking a rehearing of the case.

The appeals court in early August overturned a lower court's decision and ruled that isolated gene sequences claimed in Myriad's patents are not products of nature and are therefore patentable. The court also determined, however, that several of the company's method claims that describe "comparing" and "analyzing" gene sequences were invalid.

In response, both plaintiffs and defendants in the case, Association for Molecular Pathology et al. v. US Patent and Trademark Office et al., have requested a rehearing by the three judges of the appeals court.

Last week, plaintiffs — including AMP, the American College of Medical Genetics, the American Society for Clinical Pathology, the College of American Pathologists, and other organizations and individuals — filed a petition for a panel rehearing on the grounds that the appeals court failed to consider whether the DNA fragments claimed in Myriad's patents are products of nature.

Specifically, the petition, filed by the plaintiffs' legal representatives at the American Civil Liberties Union and the Public Patent Foundation, claims that the appeals court "erred" in deciding that gene fragments described in Myriad's patents are "markedly different" from what exists in nature and therefore patentable because it failed to consider two points: "that the language of the patents defines the function, not the structure, of the patented genes and gene fragments;" and that "gene fragments with the altered chemical structure identified by the court exist in nature."

The brief argues that the composition claims in Myriad's patents are "not defined by chemical structure," but are instead "defined by function" — namely, they encode a particular protein or fragment of a protein. That function, the plaintiffs state, is "created by nature, not by Myriad."

Secondly, the petition notes that "DNA fragments identical to those claimed in the patents appear in the body," citing as examples the fact that DNA fragments are created "every time gametes are produced during the normal process of meiotic recombination as well as during the cellular process by which cells make copies of themselves." They also cite the fact that fragments of fetal genomes have been shown to be present in maternal plasma, and that DNA fragments, including fragments of BRCA genes, can be found in the blood of cancer patients.

The petition also charges that the court wrongly denied standing to two of the plaintiffs in the case — ACMG and Ellen Matloff, a genetic counselor at Yale.

Myriad's petition, filed on Aug. 29, also raises the issue of standing, but argues the opposite point — that none of the plaintiffs have standing to sue, including Harry Ostrer, the only plaintiff that the appeals court found to have standing in the case.

The defendants' argument is based on Ostrer's recent move from New York University to Montefiore Hospital and the Albert Einstein School of Medicine of Yeshiva University, which "eliminates his asserted controversy with Myriad" because Ostrer's new employer does not have a dispute with the company over the BRCA patents, the brief states.

While Myriad's lawyers claim that the appeal should be dismissed as "moot" due to the plaintiff's lack of standing, they request that the panel uphold its decision on the patentability of isolated DNA.

Myriad's petition does not address the appeals court's invalidation of its method claims.