![]() ![]() In doing so, the Justice nailed the cDNA synthesis process perfectly, even up to saying the words “introns” and “exons,” perhaps a Supreme Court first. Out of this mire, Justice Sotomayor jumped in, and cut straight to the heart of the matter, asking why cDNA, as a synthetic molecule, should not be patentable. Hansen then tried to flip the issue on its head, suggesting that DNA patents in fact hindered the commercialization of other, similar recombinant DNA, but it was unclear whether the Justices agreed with that either. Hansen attempted to suggest that scientific curiosity would normally play a role, but it appeared that the Justices rejected this position. Hansen to respond to the incentive issue–whether anyone in Myriad’s position would have invested in such research were it not for the possibility of patent protection. § 288.) Seeming to lead this conversation away from a morass of confusion, Justice Kagan then asked Mr. (The answer is Yes, as explicitly stated in 35 U.S.C. This then led to some brief confusion among the judges as to whether invalidated claims were divisible from the remainder of the patent. Hansen to respond that if the product were identical to that found in nature, a product-by-process patent would be unobtainable as well. This led to some strange confusion among the Justices about the difference between product and product-by-process patents, which in turn led Mr. ![]() Hansen began, and lead his argument with the proposition that Myriad didn’t actually invent anything it unlocked the secrets of two genes but that those were not, themselves, patentable inventions. Castanias, of Jones Day, argued for Myriad. Hansen, of the ACLU, argued in favor of AMP the government, who requested an appearance in this case, was represented by Solicitor General Donald J. Interestingly, the Court limited its acceptance of the case to the first and, consequently, broadest question–not its typical practice.īased on the Court’s acceptance of this loaded question–and based on Justice Breyer’s recent foray into patent law–good money going into the argument was on the Court striking down Myriad’s gene claims. The lead petition presented three questions: (1) Are human genes patentable? (2) Did the court of appeals err in upholding a method claim that is irreconcilable with Mayo? and (3) a question related to the extent of declaratory judgment jurisdiction after MedImmune. On remand, the Federal Circuit issued an almost identical decision, which the parties again appealed, and the Supreme Court again took up. The parties petitioned the Supreme Court for certiorari in 2011, which, in 2012, the Supreme Court granted, vacated, and remanded in light of Mayo v. The district court had concluded that almost all of Myriad’s patents’ claims were invalid, but, on appeal, the Federal Circuit mostly reversed, affirming only the district court’s invalidation of one type of method claim. Out of concern, a consortium of BRCA researchers, labeled the Association of Molecular Pathology, in conjunction with the ACLU, filed suit against the PTO and Myriad Genetics to invalidate the patents. The researchers then exclusively licensed their patents to Myriad Genetics. In reality, the claims directed toward the genes were of a variety of types: the genes isolated from chromosome 17, the so called “isolated DNA” claims the same genes as in the isolated DNA but missing their non-coding portions, or the cDNA (cloned DNA) claims and primers, or short DNA sequences, 15 nucleotides in length, used to clone BRCA1 and 2. They patented various aspects this discovery, such as methods for using the sequence of these mutations to test for breast cancer, a kit to perform that test, and–now at issue before the Supreme Court–the “genes” themselves. To briefly recap the facts: In 1994, researchers at the University of Utah discovered that several mutations in the genes BRCA1 and 2 corresponded to a significantly elevated risk of breast and ovarian cancer. Whether that jeopardy will translate into five or more votes, however, remains to be seen. Nonetheless, Myriad’s composition claims–that is, gene patent–claims seem in jeopardy. ![]() Almost all of the Justices seemed struggled with basic principles of laboratory genetics, and several seemed hung up on various points of basic patent law. Myriad Genetics were wide-ranging–and often-times confusing. Today’s oral arguments in Association for Molecular Pathology v.
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