The U.S. Court of Appeals for the Federal Circuit (CAFC) is expected Monday to hear oral arguments by Myriad Genetics and a rival seeking to market its own breast cancer gene test, more than a year after a mixed ruling by the U.S. Supreme Court invalidated seven of Myriad’s 24 patents related to its BRCA diagnostic.

Myriad is appealing a U.S. district court decision in March denying the company’s preliminary injunction seeking to stop Ambry Genetics from selling its own BRCA diagnostic temporarily, pending a trial on Myriad’s contention that Ambry infringed 10 BRCA-test patents it co-owns and were not part of the Supreme Court case (In re BRCA1- and BRCA2-Based Hereditary Cancer Test Patent Litigation, Case Nos. 14-1361, -1366).

Judge Robert J. Shelby of the U.S. District Court for the District of Utah, Central Division, also ruled that Ambry had raised a substantial question about the validity of Myriad’s primer and method claims under 35 U.S.C. § 101, which exempts products of nature and abstract ideas from patent eligibility.

Myriad asserts that Ambry is infringing on patents covering synthetic primers, probes, and arrays plus testing methods related to BRCA1 and BRCA2. Myriad owns five of the 10 patents and licenses the rest from co-appellants University of Utah Research Foundation, University of Pennsylvania, an entity of Toronto’s Hospital for Sick Children, and Canadian company Endorecherche.

In its opening brief, Myriad noted that while the Supreme Court ruled the isolated BRCA genes themselves were not patentable, it also stated Myriad could patent applications of those genes, such as BRCA composite DNA (cDNA) and other synthetic genetic material not meeting the “product of nature” exemption.

“It is thus manifestly not the case—as the district court found—that Myriad’s methods of diagnosis employing BRCA-related probes and primers are ‘conventional’ or unlawfully preempt use of the gene,” Myriad contended. “It is manifestly not the case that pairs of short, single-stranded BRCA-related DNA primers created in the lab to initiate the polymerase chain reaction ('PCR') in order to replicate portions of the BRCA genes are unpatentable 'products of nature' under the Supreme Court’s precedent.” 

Myriad also argued that the primer and method claims were valid, and that the district court erred by examining the physical steps separate from the gene sequences, rather than reviewing and analyzing the claims as a whole, as the Supreme Court did in Prometheus Laboratories v. Mayo Collaborative Services.

The district court “probably went a little too far in reinterpreting what the Supreme Court said,” Gerald J. Flattmann Jr., a partner in the Intellectual Property practice of Paul Hastings, told GEN. “As diligent as the district court judge was in terms of looking into the science and digging in, being very careful about the factual findings, this is likely reversible. Otherwise, we’re down a slippery slope on what is patentable in the biotech space.”

“One has to wonder what would still be considered patentable subject matter if this decision is upheld,” Flattmann added. “In life sciences, anything that you claim is going to be, at least at some level, part of a product of nature or a law of nature. But those are the only building blocks we have.”

In a response brief, Ambry challenged the district court’s finding that Myriad would likely be irreparably harmed absent an injunction based in part on loss of patent exclusivity. While Myriad initially said its patents “begin to expire” August 12, 2014, Ambry noted the correct date was January 20, 2015. Myriad countered in a reply brief that the error was harmless and did not “fatally infect” the irreparable-harm finding, which also cited price erosion and lost market share.

Ambry won support from the American Civil Liberties Union and other allies in the original Supreme Court case. In an amici curiae filing, they accused Myriad of seeking to monopolize examination of genetic data: “Myriad can continue to offer BRCA testing services to patients in the manner it selects. What it cannot be permitted to do, however, is stop all others from analyzing people’s genetic information, the blueprint for our cells, organs, and bodies, which contains significant medical clues about our susceptibility to diseases and responsiveness to treatments.”

Joining the ACLU were AMP, Breast Cancer Action, the Public Patent Foundation, and AARP. They urged the CAFC to assess patent claims based on whether they are “based on an inventive concept, and whether the patent ties up the use of underlying natural phenomena”—factors cited by a unanimous Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories Inc. (132 S.Ct. 1289 [2012]).

“We are focused on providing the highest quality molecular diagnostic products and services in the healthcare industry. [Monday]’s hearing, while important, will not change that commitment,” Myriad spokesman Ron Rogers told GEN.

An Ambry spokesman at deadline had not responded to a GEN query seeking comment.

Ambry launched its BRCA test June 13, 2013, the day the U.S. Supreme Court unanimously overturned seven Myriad patents related to its discovery of the precise location and sequence of breast cancer susceptibility genes BRCA1 and 2 (Association for Molecular Pathology (AMP) v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2120 [2013]).

The high court’s mixed ruling prompted several Myriad competitors to launch BRCA tests, only to be challenged by Myriad with patent infringement suits. In addition to Ambry, Myriad has also sued Gene by Gene, GeneDx, Invitae, LabCorp, and Quest Diagnostics.

Gene by Gene has settled its suit, agreeing in February to stop offering tests in North America that include analysis of the BRCA1 and/or BRCA2 genes—alone or with gene panels—until either February 12, 2016, or when the last valid patent claim of any of the BRCA patents involved in the case expires, whichever comes first. Gene by Gene can, however, continue offering such tests elsewhere in the world.

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