CGS-authored

Isolated and purified DNA lacking “markedly different characteristics” from native DNA is not a patentable composition under Section 101 of the Patent Act, the U.S. District Court for the Southern District of New York ruled March 29 (Association for Molecular Pathology v. U.S. Patent and Trademark Office, S.D.N.Y., No. 09 Civ. 4515, 3/29/10).

In a victory for civil libertarians, cancer patients, and medical researchers, the court found that patents relating to two human genes associated with breast and ovarian cancer are invalid. The patentee's claimed methods for detecting the presence of the genetic mutations by “analyzing” and “comparing” DNA, and for comparing the growth rate of cells, are also invalid, according to the court.

Issuing a 156-page opinion, Judge Robert W. Sweet did not address constitutional challenges to the patents held by the University of Utah Research Foundation and patent licensee Myriad Genetics. Instead, the court ruled that the patents should not have been issued by the Patent and Trademark Office.

Parties Involved in the Complaint.

A May 12 declaratory judgment complaint against the PTO and patent owners alleged...