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­­The U.S. Government’s View on Gene Patentability Likely Changed
By Harry Zhou — Edited by Matt Gelfand

Brief for the United States as Amicus Curiae Supporting Neither Party, Association for Molecular Pathology v. USPTO, No. 10-1406 (Fed. Cir.)
Brief hosted by the New York Times

On October 29, the U.S. Department of Justice (“DOJ”) filed an amicus curiae brief in the U.S. District Court for the Federal Circuit in Association for Molecular Pathology v. USPTO, No. 10-1406. In its brief, the DOJ advocates for a change in policy for the patentability of genomic DNA.

The DOJ brief draws a distinction between “human-engineered DNA molecules” and “isolated but otherwise unmodified genomic DNA.” While recognizing engineered DNA molecules as patentable “human invention,” the DOJ nonetheless argues that genomic DNA isolated from human cells without further manipulation or alternation should not constitute patentable subject matter. This bifurcated position of the DOJ is in conflict with the Patent and Trademark Office’s longstanding practice of granting patents for isolated genomic DNA.

JOLT Digest previously reported on the district court’s opinion and examined the decision’s possible implications. Summaries of the DOJ brief are available from Patently-O and The Patent Prospector. The New York Times provides coverage of the patent law community’s reaction to the brief.

On March 29, 2010, the U.S. District Court for the Southern District of New York invalidated two patents issued to Myriad Genetics, Inc. for different versions of isolated human DNA molecules. Association for Molecular Pathology v. USPTO, 702 F. Supp. 2d 181 (S.D.N.Y. 2010). The district court held that, because isolated human genes contain unmodified DNA sequences that are naturally occurring, they are “product[s] of nature” ineligible for patent protection under 35 U.S.C. § 101. Myriad appealed, and the DOJ filed an amicus curiae brief in support of neither party.

The DOJ agrees with the district court that genomic DNA merely isolated from human cells is not patentable absent artificial alteration or modification, reasoning that a naturally occurring DNA sequence and its capacity to produce proteins are not “human-made inventions.” By way of analogy to separating cotton fibers from cottonseeds or extracting coal from coalmines, the DOJ argues that the process of isolation does not render genomic DNA more human-made. The DOJ further contends that the causal link between a natural mutation in a DNA sequence and elevated risk for certain diseases is a “law of nature,” and is therefore equally incapable of serving as a pathway to patentability.

The DOJ nonetheless claims that the district court “erroneously cast doubt” on the patentability of a host of “man-made compositions of matter” derived from natural DNA. The DOJ explained that products such as genetically engineered crops and vaccines are “in every meaningful sense the fruits of human ingenuity,” and are therefore patentable.

In conclusion, the DOJ has adopted the position that, in determining gene patentability, “crossing the threshold of section 101 . . . requires something more than identifying and isolating what has always existed in nature, no matter how difficult or useful that discovery may be.” This brief signals a possible change in the government’s attitude towards the issue of gene patentability. This new position, if accepted by courts, could have a far-reaching impact on the future development of the biotechnology industry.

Harry Zhou is a 2L at the Harvard Law School.

Posted On Nov - 12 - 2010 Comments Off

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