Posts Tagged: "mylan pharmaceuticals"

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.).

Last week the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office (USPTO) instituted six separate inter partes reviews (IPRs) against patents owned by Allergan plc, which cover RESTASIS®. Each of the patents is listed in FDA’s Orange Book and are set to expire on August 27, 2024. Each of these patents, with the exception of the ‘191 patent, were previously challenged by Apotex Corporation in IPRs filed on June 4, 2015. The Apotex IPRs were settled on December 16, 2015, prior to any decision on institution.

Nome, Alaska and San Juan, Puerto Rico are both home to a federal courthouse where, ostensibly, under the recent Acorda Therapeutics holding and subsequent court decisions, a generic pharmaceutical company will be subject to personal jurisdiction if they file an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration (FDA). In Acorda Therapeutics, Inc. v. Mylan Pharmaceuticals, Inc., 817 F.3d 755 (Fed. Cir. 2016), the Federal Circuit held that an ANDA filer opens themselves up to nationwide personal jurisdiction merely by virtue of filing an ANDA application. This is a broad holding that, in effect, subjects a generic company to personal jurisdiction in any forum that has a district court.

The Federal Circuit held that Mylan Pharmaceuticals, Inc. (“Mylan”), a generic drug manufacturer, was subject to specific personal jurisdiction in Delaware because Mylan had filed an abbreviated new drug application (“ANDA”) and “contemplate[d] plans to engage in marketing of the proposed generic drugs” in the state.[1] The ruling affirmed two different decisions by judges in the United States District Court for the District of Delaware that Mylan was subject to specific jurisdiction in Delaware.[2] However, as noted below, it looks like Mylan intends to seek panel or en banc rehearing and possibly pursue a petition for certiorari if the Federal Circuit does not grant the rehearing or re-hears the case and continues to find personal jurisdiction.