The US Supreme Court is sending the most high-profile gene patenting case to date, focusing on Myriad Genetics' breast and ovarian cancer tests, back to a lower court for reconsideration in light of its decision last week to invalidate patents held by Prometheus Laboratories.
The decision to remand the case back to the US Court of Appeals for the Federal Circuit, which last year decided that patents Myriad has licensed and used related to the isolated gene sequences in the BRCA 1 and BRCA2 genes are valid, means that the Prometheus decision could influence or impact the case, though the effect of that case is unclear, as it centerd on different types of claims than the Myriad litigation.
The case against Myriad was brought by the Public Patent Foundation, American Civil Liberties Union, the Association for Molecular Pathology, and others who filed the suit in 2009 claiming that patents cannot cover natural phenomena and that Myriad's patents, and others like them, will hinder genetics research and keep some people from receiving the personalized medicine tests and second opinions.Myriad has held that its patents have not hindered science, that is has not impeded research, that the pricing of its BRACAnalysis tests are not prohibitive, and that most insurers cover them. Additionally, the company also says that there are other options for people seeking second opinions.
Those assertions may not mean much if the Supreme Court at some point decides that isolated DNA is not patentable, but the CAFC in its ruling in August 2011 decided that Myriad's patents covering isolated DNA are eligible under Section 101 of the US Patent Act.
That decision in part overturned an earlier ruling from the Federal District Court for the Southern District of New York, which decided that isolated DNA was not much different from gene sequences found in nature and therefore is not patentable.
"While, this case should not have any direct impact to Myriad and its operations because of our extensive patent estate, it has great importance to the medical, pharmaceutical, biotechnology and other commercial industries, as well as the hundreds of millions of people whose lives are bettered by the products these industries develop based on the promise of strong patent protection," Myriad Genetics President and CEO Peter Meldrum said today in a statement.
"Thus, we are prepared to vigorously defend the patent claims granted to Myriad by the U.S. Patent and Trademark Office and believe that we will be successful," he said.
The plaintiffs, led by ACLU and PUBPAT, have suggested that the Prometheus decision could impact the CAFC's second look at the Myriad case, and are holding to their core argument about the special status of genes in the natural world.
“In light of recent rulings from the court that mere laws of nature cannot be patented, we hope that the lower court will come to the correct conclusion this time around,” Chris Hansen, a staff attorney with the ACLU Speech, Privacy and Technology Project, said today in a statement. “It’s inconceivable that a company can own a patent on something as naturally occurring as DNA.”
“Nobody ‘invents’ genes, so no one should be able to claim ownership of them,” added Daniel Ravicher, executive director of PUBPAT and co-counsel in the lawsuit. “We are not talking about a new drug or a new tool to fight cancer. We are talking about a genetic marker that occurs naturally in the human body. That cannot, and should not, be patented.”
Paul Rivard, a shareholder at the intellectual property-focused law firm Banner and Witcoff, told GenomeWeb Daily News today that the Supreme Court decided to bounce the Myriad case back to the CAFC because of the Prometheus ruling.
That case involved patents related to the proper dosing of thiopurine drugs for autoimmune diseases by correlating dosage levels with the levels of certain metabolites in a patient's blood. In its unanimous decision, the Supreme Court said that these patents are invalid because they describe laws of nature and "add nothing specific to the laws of nature other than what is well-understood, routine, conventional activity."
"It is unclear exactly how the Prometheus ruling will guide the Federal Circuit on remand, particularly given that Myriad involves both composition-of-matter and process claims, whereas Prometheus involved only process [or method] claims," Rivard told GWDN in an e-mail. "Historically, composition-of-matter claims receive less scrutiny than do process claims with respect to subject matter eligibility."
Rivard said that despite the differences in the two cases, the CAFC will have to address the questions raised by the Prometheus decision.
"Given that [the Myriad case] involves a number of different types of claims (isolated DNA, cDNA, fragments, etc.), it is possible the Federal Circuit may reach different conclusions for different types of claims," Rivard said.
Goldman Sachs today said it is maintaining its 'neutral' rating of Myriad's shares in light of the Supreme Court's decision to send the case back to the lower court for review.
The investment bank said the case's "legal overhang is likely to persist for the foreseeable future and now includes the added twist of the Prometheus ruling as a factor to consider."
Myriad's shares rose 4 percent to $23.58 in late afternoon trading today on the Nasdaq.
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