Patenting Nature and Seattle Biotech

April 29, 2010 (Seattle, WA) - Andrew T. Serafini, Ph.D., partner in the Life Sciences Group at Fenwick & West LLP, was recently featured on the National Public Radio KUOW segment "Patenting Nature and Seattle Biotech."

On March 29, 2010, the U.S. District Court for the Southern District of New York issued a decision in Association for Molecular Pathology v. U.S. Patent & Trademark Office, No. 09-Civ-4515 (S.D.N.Y. 2010), holding that several claims in patents drawn to isolated DNA sequences encoding the BRACA1 and BRCA2 genes, and methods of using those sequences to detect or screen for cancer, are invalid because the claims were not drawn to statutory subject matter under 35 U.S.C. §101.

The American Civil Liberties Union (ACLU) initiated, organized and led the effort to invalidate the patents. Plaintiffs argued that the patents are invalid because they claim subject matter that is not patentable under 35 U.S.C. §101 of the Patent Act, as well as that the U.S. Patent and Trademark Office had exceeded its constitutional authority in granting the patents at issue.

"The ACLU was very candid in saying they wanted to use this suite as a test case to basically invalidate all DNA patents. Their arguments were so sweeping that this decision, if affirmed by the Court of Appeals for the Federal Circuit after appeal by Myriad Genetics, might also apply to patents in the plant, bacterial, viral and other medicinal fields. All biotech platforms will be affected by this ruling," Dr. Serafini said.

While supporters of this ruling say it diminishes the legal roadblocks in the way of potentially life-saving technology, opponents argue that it marginalizes any market incentive to invest in biotechnology.