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CLIENT ALERT: Association for Molecular Pathology, et al., vs. United States Patent and Trademark Office et. al. (USDC SDNY 09 Civ. 4515, 2010)

On March 29, 2010, The University of Utah and Myriad Genetics Inc. lost a U.S. court ruling over some of its patents for detecting inherited breast cancer related to the genes BRCA1 and BRCA2.  The 152-page decision, which addresses questions about whether human genes should be subject to patent protection, could have major ramifications for gene-related patents.

The lawsuit, initially filed in May 2009 against the University of Utah, Myriad Genetics and the United States Patent Office by the American Civil Liberties Union, the Public Patent Foundation, health groups, individual breast cancer patients, and scientific associations, challenged the legality and constitutionality of four categories of claims in seven US patents.  In its decision, the Court granted summary judgment of invalidity on the composition of matter claims, based on Supreme Court precedent and old "product of nature" cases from several district courts and regional Circuit Courts of Appeal.  The method claims were found invalid under the Federal Circuit's "machine or transformation" test from In re Bilski. 

The United States Supreme Court has recognized three categories of subject matter that fall outside the scope of 35 U.S.C. § 101i: the laws of nature, physical phenomena and abstract ideas.  The reasoning of the Court in its decision to hold the University of Utah and Myriad Genetics, Inc. patents invalid was based largely on these statutory requirements and case law precedence in defining the scope of the statute. 

In reviewing the composition of matter claims under 35 U.S.C. § 101, the Court relied heavily on case law which set forth both the scope of the statute and the definition of the patentable subject matter.  The Court opined that even though "Congress plainly contemplated that the patent laws would be given wide scope" Diamond v. Chakrabarty, 447 U.S. 303, 308 (1980), that the broad reading of § 101 and eligibility of patentable subject matter was not without its limits.  The Court also emphasized that novelty of an invention was distinct from whether an invention fell into statutory subject matter.  Under the analysis of the scope of § 101, the Court concluded that an invention must be "markedly different" from a product of nature.  The court did not find the claims, directed to isolated BRCA1 and BRCA2 nucleic acid sequences, "markedly different" from the native BRCA1 and BRCA2 DNA.  Furthermore, the Court emphasized that "purification of a product of nature, without more, cannot transform it into patentable subject matter" since the isolation or "purification of native DNA" did not alter the "essential characteristic- its nucleotide sequence..."  Based on this reasoning, the Court held the composition of matter claims of the BRCA1 and BRCA2 patents did not meet the statutory requirements of 35 U.S.C. § 101 and were thus invalid.

As it stands at this precise moment, any patents directed to isolation of genetic material and their expressed products, without anything more, could be rendered invalid should a decision by the Federal Circuit or the Supreme Court affirm the above holding.  This decision would apply to both the issued patents as well as patent applications and would be binding on all patent holders and applicants, as well as the USPTO.

i Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.