“Everything Comes from Nature”: Federal Circuit Splits Hairs to let Myriad Split Genes
Thursday morning, the Court of Appeals for the Federal Circuit ruled that Myriad Genetics maintains patent rights in isolated genes that indicate a predisposition for breast and ovarian cancers, as well as the diagnostic test that identifies their presence. This ruling comes after the Supreme Court set aside the Court of Appeals’ earlier decision in Association of Molecular Pathology v. Myriad, which upheld Myriad’s patent rights on the two genes. The Supreme Court had remanded the case for further reconsideration after March’s Mayo Collaborative Services v. Prometheus, Inc., which denied patents for observations of “natural phenomenon.”
Even after its reconsideration, the Court of Appeals again affirmed Myriad’s patent rights to these genes, named BRCA1 and BRCA2. If a woman tests positive for these two genes, her likelihood of contracting breast and ovarian cancer throughout the course of her life is increased by 82% and 44% respectively. Myriad claimed that when isolated, the DNA’s chemical composition changed in such a way that rendered it recognizable to the BRCA testing technology. The court accepted Myriad’s arguments that its testing and recognition of the two BRCA genes was the result of human ingenuity, and reestablished its position on Myriad’s rights. Circuit Judge Alan Lourie’s majority opinion skirted the “natural phenomena” distinction of the Prometheus case with the reasoning that, “everything and everyone comes from nature, following its laws, but the compositions here are not natural products. They are the products of man, albeit following, as all materials do, laws of nature.” The Federal Circuit continued by urging courts (seemingly a subtle response to the Supreme Court’sPrometheus logic) not to confuse patentable subject matter with whether an invention does, indeed, warrant a patent.
The plaintiffs in the case, a combination of nonprofit and medical organizations, physicians, and individuals represented by the ACLU, expressed their disappointment at this hotly contested decision. Claiming that this decision creates a monopoly on the testing for these genes, ACLU attorney Chris Hansen went on to say that “human DNA is a natural entity like air or water. It does not belong to any one company.” Members of the medical community voiced their concern that this decision will prevent meaningful innovation in biotechnology and human health for fear that inventors will bump up (perhaps expensively) against another’s patents. On the other hand, giving the biotech industry assurances that genetic testing can be legally protected may increase investment in developing genetic testing that have the potential to improve health and medical treatments.
The plaintiffs, 20 in number, have the next 90 days to decide whether to petition the Supreme Court to settle this matter finally. Given the questionable unorthodox logic of the Supreme Court in Prometheus just 5 months ago, the sigh of relief echoing amongst biotech professionals Thursday may fall silent as Myriad develops.