As we reported yesterday, four cases being argued at the Federal Circuit in October attracted amicus briefs. One of these cases is REGENXBIO Inc. v. Sarepta Therapeutics, Inc. In this patent case, REGENXBIO Inc. and the Trustees of The University of Pennsylvania appeal a district court’s grant of summary judgment of ineligibility. This is our argument preview.
The appellants argue in their opening brief that, “[f]or claims directed to compositions that incorporate features based on natural products, the patent eligibility analysis focuses on whether the claimed composition is ‘markedly different’ from any natural product.” They further contend that, “[u]nder that standard, the undisputed facts demonstrate that the cultured host cells of the ’617 patent claims are markedly different from any natural product in both structure and function.” They argue that, “even though the facts were undisputed, the district court’s decision rests on unsupported and erroneous factual inferences that Sarepta invited the district court to draw in its favor.”
In its response brief, Sarepta Therapeutics argues the “Asserted Claims do not reflect the creation of a ‘new’ composition with ‘markedly different characteristics.’” It contends that “structural differences resulting from the isolation of the rh.10 sequences from the surrounding genetic material–such as the breaking of chemical bonds–are not sufficient for patent eligibility.”
In its reply brief, the appellants argue the district court’s finding of patent ineligibility “fails to follow cases from this Court and the Supreme Court, including Chakrabarty and Myriad.” Although the court “cited the ‘markedly different’ standard from Chakrabarty,” they continue, “it failed to properly apply it.” The reply brief further argues that “Sarepta’s failure to consider all claim limitations is fatal to its arguments that the claims recite an unpatentable natural product.”
Three amicus briefs have been filed in this case.
The American Intellectual Property Law Association filed an amicus brief in support of neither party and reversal. AIPLA argues the district court’s decision threatens to “upend patent law’s ‘delicate balance'” established by Supreme Court precedent and practice since 1980. The brief emphasizes that the district court’s holding “engrafts an entirely new requirement onto patent eligibility.” AIPLA further asserts that, if the district court’s decision is affirmed, it “will stifle innovation and put U.S. biotechnology innovators at a competitive disadvantage.”
The Parker Institute for Cancer Immunotherapy, the J. David Gladstone Institutes, and Dana-Farber Cancer Institute filed an amicus brief in support of appellants and reversal. The amici argue that the district court’s decision “injected significant uncertainty into well-settled law.” They argue that, here, the “human-made organism” or the “non-natural nucleic acid sequence” would have satisfied the “markedly different characteristics” test established by the Supreme Court. Thus, the amici argue, the claims fall “squarely within the heartland of patent-eligible subject matter.” If the district court’s decision is affirmed, they continue, it would “seriously hinder critical advances in biotechnology, including the lifesaving immuno-oncology work done by non-profit research organizations.”
Lastly, the Former Federal Circuit Judge Paul Michel filed an amicus brief in support of the appellants and reversal. He argues the district court’s decision is “plainly wrong under settled precedent” and misapplies the relevant statutory provisions and Supreme Court precedent. The brief asserts that the genetically engineered cells here are patent-eligible as “new” “composition of matter.” Furthermore, Michel argues, the district court’s decision “highlights the need for patent reform” to be passed by Congress.
Oral argument is scheduled to be heard on Tuesday, October 7 at 10:00 am. The argument is scheduled to take place at Northeastern University School of Law as part of the Federal Circuit’s sitting in and around Boston while concurrently holding its regular session in Washington, D.C., as we announced here.