District Court Rules That Genes and Genetic Tests Are Not Patentable

On March 29, 2010, the U.S. District Court for the Southern District of New York issued its decision in Association for Molecular Pathology v. U.S. Patent & Trademark Office, No. 09-Civ-4515. The District Court's decision on cross-motions for summary judgment invalidated all raised claims in Myriad's seven patents at issue. If the District Court's judgment is sustained on appeal, this decision will have a profound effect on the intellectual property assets and strategies used by a wide range of biotechnology and pharmaceutical companies.

In this case, a coalition of plaintiffs, led by the ACLU, sought a precedential court decision that claims in patents assigned to Myriad Genetics are invalid. The plaintiffs include women who cannot afford Myriad's tests, researchers who want to perform the patented tests in their laboratories, and associations representing professionals who perform and interpret these tests. Plaintiffs advanced two theories in support of its motion. First, plaintiffs argued that the patents are invalid because they claim subject matter that is not patentable under 35 U.S.C. § 101. Second, plaintiffs argued that the Patent & Trademark Office ("PTO") had exceeded its constitutional authority in granting the patents.

Defendant Myriad is the owner or exclusive licensee of a series of patents claiming isolated genes and methods for testing for the presence of mutations in the BRCA1 and BRCA2 genes. Mutations in these genes are linked to increased likelihood of breast and ovarian cancers. Myriad offers several different tests for the presence of these mutations and has asserted the patents to preclude competitors.

The claims in Myriad's patents can be divided into two categories: (1) claims to compositions of matter consisting of isolated DNA encoding all or part of the BRCA1 or BRCA2 genes (which are associated with breast cancer), and (2) claims to methods of using the isolated genes to detect the mutations in BRCA1 and BRCA2 by analysis of the gene sequences or by comparison of the sequence of the patient's gene with the sequence of a normally occurring gene. The District Court found that both categories of claims are invalid because they are directed to non-statutory subject matter.

Claims Directed to Isolated Genes

The District Court determined that the claims to the isolated genes are not patentable because the claims encompass products of nature, which are not patentable under 35 U.S.C. § 101. Claim 1 of U.S. Pat. No. 5,747,282 is representative of this category of claims:

An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2. In the course of determining that composition of matter claims to isolated DNA are invalid, the District Court had to resolve several questions: (1) Whether the Court could appropriately address the issues presented in the case; (2) How to interpret the statutory language in 35 U.S.C. § 101 that defines patentable subject matter; and (3) Whether the claims directed to isolated genes fall within this definition of patentable subject...