GENE PATENTS
A US district court decision threatens the future of so-called ‘gene patents’ in the US. Lee Crews and Vicki Norton look at the current position and assess the possible futures for the case.
On October 22, 2010, Myriad Genetics, Inc filed a brief on appeal to the US Court of Appeals for the Federal Circuit in its widely watched ‘gene patenting’ case. While many patent attorneys speculated that the ruling would not stand on appeal, recent developments, including the US Department of Justice’s (DOJ) filing of an amicus brief taking the position that isolated genes are not patentable, and Judge Dyk’s dissenting opinion in Intervet Inc. v. Merial Limited and Merial SAS, are providing room for doubt. An affirmation would have a tremendous impact on the biotechnology community because the decision turns on whether isolated DNA and methods that require assessing its sequence are eligible for patent protection. Te US Patent and Trademark Office (USPTO) has taken the position that this subject matter is patent- eligible, and thousands of US patents include such claims.
Myriad’s position is that the US District Court of the Southern District of New York improperly held invalid patent claims related to the BRCA1 and BRCA2 genes and to methods of using nucleotide sequences within those genes to assess susceptibility to cancer. Te district court held that the isolated DNA was a product of nature and the methods constituted nothing more than a mental process, neither of which are eligible for patent protection.
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To analyse Myriad’s DNA claims, the district court asked whether the isolated DNA possessed markedly different characteristics to the same DNA in vivo. Despite the fact that the DNA must be isolated in order to be used, and despite Myriad’s arguments that the inventors were the first to discover that the genes could be used to assess risk for breast and ovarian cancers, the court found that “the purification of native DNA does not alter its essential characteristic—its nucleotide sequence—that is defined by nature and central to both its biological function within the cell and its utility as a research tool in the lab”. Accordingly, the court concluded that the isolated DNA claimed was not markedly different from native DNA as it exists in nature and, therefore, constituted unpatentable subject matter under 35 USC § 101.
On appeal, Myriad argues that “markedly different” is not the appropriate legal standard. Te district court relied heavily on two Supreme Court cases: Diamond v. Chakrabarty, which held that a genetically modified bacterium was patent-eligible, and the earlier case of Funk Bros Seed Co v. Kalo Inoculant Co, which held that a mixture of different types of bacterial cells was not (even though the mixture was agriculturally beneficial). Myriad asserts that the district court “erroneously divined” a legal standard from Chakrabarty; that the court was not setting “markedly different” as the legal standard for patent-eligible subject matter but was, instead,
simply contrasting Chakrabarty’s genetically modified bacterium with the mixtures of bacteria in Funk Bros. According to Myriad, the phrase “markedly different” appears nowhere else in Supreme Court precedent and is wholly unexplained in Chakrabarty. Tis would invite subjective decisions and “surely was not meant as a legal standard to govern all future cases decided under the statute”. Instead, Myriad argues that the proper legal standard set out in Chakrabarty is “a non-naturally occurring manufacture or composition of matter—a product of human ingenuity ‘having a distinctive name, character and use’”. Myriad further argues that this standard would be met by their claims as “[i]solated DNA molecules are ‘products of human ingenuity’”. In this portion of its brief, Myriad concludes that the “inventors’ work yielded a new composition of matter with substantial societal benefit, which added to the body of human knowledge” and that this “is enough to demonstrate that these compositions of matter are patent-eligible”.
Myriad also specifically addresses Judge Dyk’s dissent in Intervet. Judge Dyk wrote that it is “far from clear” that an “isolated DNA sequence is qualitatively different from the product occurring in nature” and further, that “[i]t would be difficult to argue, for instance, that one could patent the leaves of a plant merely because the leaves do not occur in nature in their isolated form”. According to Myriad, both the analogy to
World Intellectual Property Review November/December 2010 31
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