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Gene Patents Survive Yet Again

August 17, 2012
Intellectual Property Alert
On August 16, 2012, the Federal Circuit found, once again, that isolated genes are patent-eligible subject matter. Association for Molecular Pathology v. United States Patent and Trademark Office, (Fed. Cir. 2012). Claims to methods of analyzing and comparing DNA sequences, however, are not eligible under 35 U.S.C. § 101, because they essentially claim natural laws, which are not patentable subject matter. Conversely, the claim in question which relates to a method of screening a therapeutic agent was found to be patentable subject matter, due to the element of “growing transformed cells and determining those growth rates.” Id. at 55.

The Federal Circuit first decided the case, commonly referred to as “Myriad,” on July 29, 2011. However, in acting on a petition for certiorari, the Supreme Court granted the petition, vacated the earlier decision and remanded the case to the Federal Circuit for further consideration in light of the recent Supreme Court decision in Mayo Collaborative Services v. Prometheus, Inc., 566 U.S. __, (2012). In Mayo, the Court found claims to a diagnostic method unpatentable under § 101, because the claims merely observed a correlation that was the result of a law of nature.

The Myriad patents in question relate to the BRCA1 and BRCA2 genes, in which mutations are strongly implicated in breast and ovarian cancer. The patents include claims to “isolated” DNA, as well as methods for analyzing and comparing DNA sequences. The company uses their invention in tests commonly used for assessing the genetic risks for breast and ovarian cancer. Opponents argue that Myriad’s enforcement of its patents to restrict the use of the genes by others has led to an increased price of the test and lack of alternate screening options.

The Myriad case was initially brought by the American Civil Liberties Union, joining individual patients and medical organizations as plaintiffs, in the Southern District of New York. The United States Patent and Trademark Office (USPTO) and the University of Utah were also named as defendants in the suit. On March 29, 2010, the District Court judge penned an opinion finding the patents in the suit to be invalid. With respect to claims to isolated DNA, the District Court found that the subject matter falls under the category of laws of nature, and thus are not patent-eligible subject matter.

The practice of claiming “isolated” DNA is a time-honored strategy used by patent practitioners and specifically endorsed by the USPTO. One theory behind this practice is that DNA does not exist in nature in an isolated form and, as previously stated by Congress and reiterated by the Supreme Court, patentable subject matter includes “anything under the sun that is made by man.” In its opinion, the Federal Circuit noted that Congress has not indicated that the USPTO’s position on isolated DNA is inconsistent with § 101, and if the law is to be changed, that decision must come from Congress and not from the Court.

Myriad’s claims to methods involving comparing the BRCA gene sequence from a tumor sample to that of a non-tumor sample were found to be nonpatentable under § 101, because they claim only abstract mental processes and fail to meet the “machine-or-transformation test” that is the standard for subject matter eligibility. The opinion states that the claims “do not apply the step of comparing two nucleotide sequences in a process. Rather, the step of comparing two nucleotide sequences is the entire process that is claimed.” Myriad at 57. As a result, the claims are indistinguishable from the diagnostic claims in Mayo. The Mayo claims involve methods for optimizing the dosage of thiopurine drugs; including “administering” a drug to a subject and “determining” the metabolite levels in the subject. The Supreme Court held that the Mayo claims are invalid, because “administering” and “determining,” combined with a correlation to a natural law, are not sufficiently transformative to satisfy the requirements for patent eligible subject matter.

The Federal Circuit has now spoken twice on the question of subject matter eligibility of Myriad’s patents, with little change in its position despite the remand by the Supreme Court. Nonetheless, the latest opinion might not be the last word. The possibility remains that the Federal Circuit will rehear the case en banc, or the case might still go to the Supreme Court by way of another petition for certiorari. Honigman will continue to monitor this issue and keep you apprised of any developments.