[JURIST] US Supreme Court [official website] on Friday granted certiorari [order list, PDF] in Association for Molecular Pathology v. Myriad Genetics, Inc. [cert. petition PDF; JURIST report], which deals with the issue of whether human genes are patentable. Myriad Genetics [corporate website] patented two genes, BRCA1 and BRCA2 [NCI backgrounder], which are isolated genes—different from native genes because the process of extracting them changes their molecular structure but not their genetic code. The Association for Molecular Pathology [advocacy website] and other plaintiffs argue that human genes cannot be patentable simply because they have been isolated from DNA. They also contend that Myriad’s use of its patent to limit research and clinical testing on these genes has inhibited other laboratories from offering new testing procedures and made it impossible for patients to obtain second opinions that could offer more information about their cancer risks. The US Court of Appeals for the Federal Circuit [official website] ruled [JURIST report] in August that Myriad had a right to patent the isolated cells because they were “transformed” and Myriad’s method of isolation included steps that were not naturally occurring. When asked to reconsider the case in light of Mayo Collaborative Services v. Prometheus Laboratories, Inc. [opinion, PDF], a case in which the Supreme Court ruled earlier this year to deny medical tests relying on correlations between drug dosages and treatment cannot be patented, the judges were split on how it applied and each stuck to his or her original decision on the outcome.
The second case the court agreed to hear is Mutual Pharmaceutical Co. v. Bartlett [cert. petition, PDF], which presents the issue of whether federal law preempts state law design-defect claims against pharmaceutical companies. In this case, the plaintiff sustained permanent injuries from ingestion of a generic drug made by Mutual Pharmaceuticals. The main argument from the plaintiff in his petition to the Supreme Court is that the US Court of Appeals for the First Circuit [official website] contradicted Supreme Court precedent in ruling [opinion] that federal law did not preempt the plaintiff’s design-defect claim. In 2011, the Supreme Court decided in PLIVA, Inc. v. Mensing [opinion, PDF; JURIST report] that federal regulations on warning labels preempt state law on warning labels. The First Circuit differentiated these cases in ruling that the Supreme Court has not addressed the specific issue of design-defect claims.