By Carmela DeLuca and Micheline Gravelle
No Longer Under the Sun
BRCA Gene Patents Held Not Patentable in the US
O
n Monday March 29th, 2010, in a highly anticipated decision, the U.S. District Court of the Southern District of New York ruled in favour of the plaintiffs in Association of Molecular Pathology et al v. U.S. Patent and Trademark Office et al., No. 09-CIV4515 (“BRCA”), granting partial summary judgment and finding the claims in several patents on BRCA1 and BRCA2 invalid for encompassing non-statutory subject matter. The plaintiffs included the American Civil Liberties Union (ACLU), various medical 34 BIOTECHNOLOGY FOCUS MAY 2010
organizations, the Public Patent Foundation (PUBPAT), breast cancer and women’s groups, and various doctors, researchers and individuals diagnosed with breast cancer. The defendants included the United States Patent and Trademark Office (USPTO) and Myriad and the University of Utah Research Foundation. Defendant Myriad owns or licenses the seven patents that were at issue. The subject patents included claims directed to 1) isolated DNA containing all or portions of the BRCA1 and BRCA2 gene sequence and 2) methods for “comparing”
Intellectual Property
or “analyzing” BRCA1 and BRCA2 gene sequences to identify the presence of mutations correlating with a predisposition to breast or ovarian cancer or screening for potential cancer therapeutics. Both types of claims were found invalid for including unpatentable subject matter. The Court rejected Myriad’s argument that purification of naturally occurring compounds that do not exist in nature in pure form renders such compounds patent eligible. According to the Court, purification of a product of nature, without more, cannot transform the product into patentable subject matter - the claimed invention must possess “markedly different characteristics.” The Court found that “in light of DNA’s unique qualities as a physical embodiment of information,” structural and functional differences cited by the defendants between native and the claimed isolated DNA do not render the claimed DNA “markedly different.” Isolated DNA “containing” naturally occurring sequences were found unpatentable. In addition to impacting patenting of isolated nucleic acids corresponding to naturally occurring gene sequences, this decision may be problematic for claims directed to primers and/or probes. The Court, in rejecting Myriad’s argument that isolated DNA is markedly different since it may be used as a probe or primer, indicated that the basis for this utility is primarily a function of the nucleotide sequence identity between native and isolated BRCA1/2 DNA (BRCA, page 131). It is unclear on the above reasoning if chimeric or optimized (e.g. codon optimized) nucleic acid molecules and/or labeled primers and probes whose utility is primarily a function of the nucleotide sequence identity between the native and modified sequence, will similarly be found unpatentable in the event that the decision is upheld. According to the Court, the decision is directed to naturally occurring DNA sequences and does not impact the patent eligibility of other isolated naturally occurring biomolecules. The Court explicitly stated that its decision did not extend to other molecules occurring naturally in the body and capable of conveying information, such as adrenaline (BRCA, page 124). Contested diagnostic method claims were found invalid under the “machine or transformation” test pronounced In re Bilski 545 F.3d 943 (Fed. Cir. 2008). The Court found that because “the claimed comparisons of the DNA sequence are abstract mental processes,
