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Should genes be patented in the United States?(08/27/10)
The Court of Appeals for the Federal Circuit will consider this question in a case of considerable interest to the biotech industry and its critics: Association for Molecular Pathology v. United States Patent and Trademark Office. On March 29, 2010 (amended on April 5, 2010), the U.S. District Court for the Southern District of New York granted summary judgment in favor of twenty challengers. The plaintiffs included associations of scientists or pathologists and various individuals, including cancer patients who stated that they cannot afford the expensive genetic tests covered by the patents held by two of the defendants, Myriad Genetics and the University of Utah Research Foundation. District court judge Robert Sweet decided that claims of seven patents directed to breast cancer susceptibility genes isolated from a human body and methods of analyzing or comparing such genes for mutations correlating with a tendency to breast or ovarian cancer were invalid because they were not directed to patent-eligible subject matter under 35 U.S.C. § 101. The patent holders appealed this decision to the Federal Circuit on April 16, 2010. Thirty-four organizations or individuals filed “friend of the court” or amici curiae briefs supporting or opposing the summary judgment motion in the district court, including the American Medical Association (against the gene patents) and Biotechnology Industry Organization (in favor of the gene patents). It is expected that even more amici briefs will be filed in the appeal.
In an opinion having 152 pages, the district court determined that the claims for genes isolated from the body, such as “[a]n isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO. 2,” were not directed to patent-eligible subject matter because the claimed genes were a product of nature. A “product of nature” cannot be patented unless it has been transformed by giving it “markedly different characteristics” compared to the original. The court held that the “isolation” of the gene from a person’s body, which involves purification of the gene in the sense of separating it from the many other molecules found in the human body, does not make it anything other than a “product of nature,” because it contains the same nucleotide sequence as that of the “native” DNA found in the body. The battle on appeal will be fought on whether the identification and isolation of the gene made it patent-eligible subject matter.
The district court determined that the claims to methods of analysis or comparison claims also were invalid. The court held that these claims did not comprise patent eligible subject matter because they were directed to abstract mental processes. The court issued its summary judgment before the Supreme Court’s decision in Bilski v. Kappos. It therefore relied on the “machine or transformation” test established by the Federal Circuit as the exclusive test to determine whether method claims were directed to patent-eligible subject matter. The Supreme Court in Bilski v. Kappos accepted the “machine or transformation” test as being useful but did not agree that it was the only test. The parties to the appeal in Association for Molecular Pathology will no doubt dispute whether the method claims are directed to one of the three exceptions to patent-eligible subject matter recognized by the Supreme Court, namely, abstract ideas.
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