In this article, Doug addresses a current patent subject of great interest and importance: whether isolated DNA segments are patentable. Doug tackles the question in the context of a current patent infringement lawsuit by a company holding patents “on two ‘isolated’ human breast and ovarian cancer susceptibility genes,” brought against companies engaged in clinical testing. Patent validity must be tested against both the Patent Clause of the Constitution (which prohibits patents that “remove existent knowledge from the public domain . . . or restrict free access to materials already available”) and 35 U.S.C. § 101, which sets out the statutory requirements for patentability. The patents at issue in this case were granted in the 1990's, and upheld as valid by the Federal Circuit in the case at issue. At the time of Doug’s writing, the plaintiffs had filed a petition for certiorari with the United State Supreme Court.

The article reviews the case law on patentable subject matter and concludes that the isolated DNA segments are not patentable. Doug explains that while the process of isolating DNA segments is a human invention and thus potentially patentable, the DNA segments themselves are for practical purposes the same as the analogous native segments and not patentable under previous Court decisions indicating manifestations of laws of nature cannot be patented. Doug also argues that the specific patents at issue are invalid because as written they purport to cover a physical phenomenon, like magnetism or electricity, another category the Court has labeled unpatentable. The article urges Supreme Court review and reversal of the Federal Circuit’s decision upholding the patents. After Doug’s article went to press, the Court decided a case involving a diagnostic blood test, in which the Court concluded that the federal circuit had improperly upheld a patent that, the Supreme Court concluded, was too close to a law of nature. The Court subsequently granted certiorari, vacated and remanded the case Doug discusses for reconsideration in light of the new precedent, and the remanded cases is currently sub judice in the Federal Circuit.

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