The U.S. Court of Appeals for the Federal Circuit (CAFC) earlier today affirmed a district court ruling that Biogen International’s patent for a method of treating multiple sclerosis (MS) was invalid for lack of written description. Judge O’Malley dissented, arguing that the district court clearly erred in its finding that Biogen was judicially estopped from drawing a distinction between clinical and therapeutic effect, and that the entire analysis “might well change” if the case was remanded “for reconsideration of the record with the understanding that the patent is not about clinical efficacy” but therapeutic effect.
On November 5, the U.S. Court of Appeals for the Federal Circuit (CAFC) issued a precedential decision in Celgene Corp. v. Mylan Pharmaceuticals Inc. affirming a ruling of the District of Delaware, which dismissed a Hatch-Waxman lawsuit against related Mylan entities for either improper venue or failure to state a claim upon which relief could be granted. In issuing the decision, the Federal Circuit found that Mylan’s submission of a notice letter to Celgene regarding Mylan’s paragraph IV certification to the U.S. Food and Drug Administration (FDA) stating that Mylan’s generic version of the multiple myeloma treatment Pomalyst would not infringe Celgene’s patents was not itself an act of infringement for purposes of the patent venue statute.
The Federal Circuit issued an Order staying further proceedings at the PTAB relating to the RESTASIS patents now owned by the Saint Regis Mohawk Tribe. The stay will remain in place until at least one day after the oral argument scheduled for June 2018. The Court will consider whether the stay shall remain in effect or be lifted based on the merits of the case.
Tribal sovereignty is not a “sham” or a “contrivance,” even when it produces results Petitioners do not like. There is no dispute that the St. Regis Mohawk Tribe is what the Supreme Court has termed a “domestic dependent nation[]” entitled to tribal sovereign immunity and that its agreement with Allergan is a legitimate contract… Moreover, Petitioners’ objections are being raised in the wrong forum. Congress – rather than the Board, the Article II executive, or even the Article III courts – controls the availability of tribal sovereign immunity.
American drugmakers Bristol Myers Squibb Co. (NYSE:BMY) and Pfizer, Inc. (NYSE:PFE) fired off a series of nine lawsuits to prevent generic versions of Eliquis, a treatment that helps reduce the risk of stroke in patients with atrial fibrillation. The lawsuits stem from abbreviated new drug applications (ANDAs) filed with the U.S. Food and Drug Administration (FDA) to market generic versions of apixaban, the anticoagulant agent used in Eliquis. The suits have all been filed in the U.S. District Court for the District of Delaware (D. Del.).