The district court in the Southern District of New York recently issued a decision in which patent claims directed to isolated DNA compositions and methods of isolation were determined to be invalid. The sole issue decided by the Court in Association for Molecular Pathology v U.S. Patent and Trademark Office, was whether the patent claims at issue met the threshold test for patentability, namely, whether these claims comprised patentable subject matter. In finding that the patent claims at issue did not meet this threshold, the ruling is a significant move away from current standards in the context of DNA and gene-related inventions. It may take years before the impact of this decision on the biotechnology industry is determined. Myriad Genetics, one of the defendants, has indicated it plans to appeal the decision to the Federal Circuit Court of Appeals, and depending on the Federal Circuit's decision and how the issue is framed or further developed in subsequent cases, the Supreme Court may take the opportunity to weigh in on the issue as well. It is doubtful that the USPTO will change its internal examination guidelines until all appeals of the current decision have been exhausted. Nevertheless, claim drafting strategies for biotechnology inventions may need to change to accommodate potential changes in the law.
Regarding the substance of the case itself, defendant Myriad Genetics and a group of academic researchers had sequenced Breast Cancer Susceptibility Genes 1 and 2 (BRCA1 and BRCA2), two human genes linked to breast cancer. The parties applied for and obtained patents covering the isolated and sequenced genes. Myriad Genetics developed and marketed genetic tests designed to identify mutated genes. The Association for Molecular Pathology and other organization brought the current suit seeking a declaration that the patents covering the BRCA1 and BRCA2 isolated and sequenced DNA and related methods were invalid as pertaining to unpatentable subject matter.
Central the District Court's decision regarding claims covering the BRCA1 and BRCA2 compositions was the idea that purification of a natural compound, without more, does not transform a product of nature into patentable subject matter. The Court reviewed a number of Supreme Court and accompanying lower court decisions and determined that patentable subject matter, in the context of purified products of nature, must possess "markedly different characteristics" in order to meet the threshold requirement for patentability. On this point, the Court found that the claimed isolated/purified DNA was not markedly different from native DNA as it exists in nature and is therefore not patentable subject matter. Patent claims covering methods for analyzing and comparing DNA sequences suffered a similar fate. The Court held that these claims lacked physical transformation of material and were therefore unpatentable as well.
While the immediate implications of this decision are clear, namely, the potential invalidity of a vast number of issued patents, competing interests on both sides of the issue have compelling arguments to make. DNA-related patents typically represent the fruits of the earliest stages of research. Without patent protection, and the ability to license patented technology, organizations are unlikely to be unable to raise the millions of dollars in capital necessary to advance the discovery of useful tests or treatments. Nevertheless, the research and development of large-scale genome projects may be hindered if each individual human gene is patented and subject must be licensed for such projects to move forward. The Association for Molecular Pathology v U.S. Patent and Trademark Office is likely the beginning of the story with competing concerns of all concerned parties likely to be accounted for in future caselaw, legislation and USPTO practice guidelines.
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Vol. 53, June 2010