September 28, 2012

Supreme Court Asked to Review Gene Patent Challenge (Again)

The plaintiffs have filed a petition for certiorari with the Supreme Court in the ongoing gene patent challenge, Association for Molecular Pathology v. U.S. Patent and Trademark Office et al. (AMP v. USPTO). The litigation centers on whether genes and methods for their use qualify as patentable subject matter. The doctrine of patentable subject matter asks whether a patent fits into the kinds of inventions that are eligible for patenting or whether it goes too far and extends into the impermissible categories of "abstract ideas, natural phenomena and laws of nature;" more background here. The Supreme Court had previously been asked to hear the case, but then remanded the case back to the Federal Circuit in view of the Mayo v. Prometheus (a patent to a method of drug treatment) decision that they had just handed down. In their decision this summer, the Federal Circuit upheld the patent claims to genes, rejecting arguments that such patents covered products or laws of nature. In the opinion authored by Judge Lourie, the court relied on the chemical differences between native and isolated DNA to find enough structural differences to confer patent eligibility. In her concurrence, Judge Moore also cited the reliance interests held by existing patentees and the biotechnology industry as a reason for not undoing decades of patenting. The new petition argues that Supreme Court precedent supports their view that the function of a molecule is paramount in the analysis comparing native to isolated; they argue that the isolated gene maintains the functions of native DNA and therefore cannot not be patentable. The petition also advances a First Amendment basis for not patenting genes (the patent interfering with a right to use information) and revives another source of dispute in this case, which is over which parties in this complex coalition of plaintiffs have the standing to sue. We could get a decision on whether the Supreme Court will take the case in the next few months. The Court has not heard a patentable subject matter case that involves molecular genetics since Diamond v. Chakrabarty in 1980. However, that case involved a genetically engineered organism (a bacterium), while this case centers on isolated genetic molecules - the genes.

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