by Jake Meyer

On March 29th, 2010, Judge Sweet of the United States District Court in the Southern District of New York declared that the challenged patent claims, owned by Myriad genetics, that cover the BRCA1 and BRCA2 breast cancer genes are invalid.  The full opinion is available here.  I had previously blogged about the plaintiffs in the case here, and I previously blogged about Judge Sweet’s denial of the defendant’s motion to dismiss here.  This was the first case to raise the argument that gene sequences and correlations between gene mutations and disease are unpatentable subject matter under 35 U.S.C. section 101.

There were two types of claims at issue in the case:  1) claims to “isolated” DNA containing the BRCA1 or BRCA2 sequence or certain segments of those sequences, and 2) claims to methods of comparing two BRCA1 or BRCA2 sequences to determine whether a mutation that predisposes a subject to cancer is present.  Judge Sweet found that both of these types of claims were invalid subject matter.

U.S. patent law does not allow for the patenting of products of nature.  As Judge Sweet recognizes this in his opinion there is a “judicially created ‘products of nature’ exception to patentable subject matter, i.e. ‘laws of nature, natural phenomenon, and abstract ideas.'”  Judge Sweet applied analysis from the 1980 Supreme Court case Diamond v. Chakrabarty to determine whether the product claims directed to “isolated” DNA were patentable.  The Supreme Court in Chakrabarty held that a genetically engineered bacterium was patentable because the “patentee had produced a new bacterium with markedly different characteristics from any found in nature.”  Sweet found that the requirement that an invention have “markedly different characteristics” from a product of nature to be patentable had been stated (although using different language) in earlier cases as well, such as in the Supreme Court case American Fruit Growers and in the Court of Customs and Patent Appeals case In re Merz.

Judge Sweet held that the “isolated” DNA was not “markedly different” than DNA inside the human body.  The analysis focused on the DNA’s unique role as both a physical molecule and as information.  While the “isolated” DNA was removed from the body, the information embodied by the DNA was not changed:

In light of DNA’s unique qualities as a physical embodiment of information, none of the structural and functional differences cited by Myriad between native BRCA1/2 DNA and isolated BRCA1/2 DNA claimed in the patents-in-suit render the claimed DNA “markedly different.”  This conclusion is driven by the overriding importance of DNA’s nucleotide sequence to both its natural biological function as well as the utility associated with DNA in its isolated form.  The preservation of this defining characteristic of DNA in its native and isolated forms mandates the conclusion that the challenged composition claims are directed to unpatentable products of nature.

The second types of claims to methods of comparing two BRCA1 or BRCA2 sequences to determine whether a mutation that predisposes a subject to cancer is present were found invalid because they involved a law of nature and did not satisfy the Federal Circuit’s machine-or-transformation.  When a method claim makes use of a law of nature, the claimed method must either use a specific machine or apply a transformation to be patentable.  Judge Sweet found that the method did not include a transformation and since the claims did not include the use of a specific machine the method claims were directed to an unpatentable law of nature.