Amgen Appeals Loss of Neulasta® and Neupogen® Litigation

On October 3, 2016, Amgen filed a Notice of Appeal in the U.S. District Court for the Southern District of Florida and thereby laid the groundwork for its next move in the ongoing Amgen v. Apotex dispute. (D.I. 272.)

The Notice of Appeal is the latest filing in a string of litigation between the two pharmaceutical companies. Amgen owns U.S. Patent No. 8,952,138, which covers a process of protein refolding. Amgen also owns and markets Neulasta® (pegfilgrastim) and Neupogen® (filgrastim), which are biologics used to treat neutropenia. In late 2014, Apotex filed two abbreviated Biologics License Applications ("aBLAs") seeking approval from the FDA to market biosimilar versions of Amgen's Neulasta® and Neupogen®. Pursuant to the Biologics Price Competition and Innovation Act ("BPCIA"), the parties then engaged in a series of information disclosures commonly referred to as the "patent dance." In August 2015, Amgen filed suit against Apotex under 35 U.S.C. § 271(e)(2)(C), alleging patent infringement of the '138 patent and U.S. patent No. 6,162,427 (later dismissed by stipulation), and seeking a declaratory judgment that (1) Apotex infringed the '138 Patent, and (2) Apotex's earlier notice of commercial marketing was ineffective because its biosimilars had not yet been approved by the FDA. Amgen also sought a preliminary injunction enjoining Apotex from commercially marketing its biosimilars until 180 days after FDA approval. (D.I. 1.) In December 2015, the District Court for the Southern District of Florida granted Amgen's Motion for Preliminary Injunction and enjoined Apotex from marketing its product until 180 days after FDA approval. (D.I. 70.) This decision was later upheld by the U.S. Court of Appeals for the Federal Circuit in July 2016. (D.I. 259.)

Following a bench trial in July 2016, the court granted Amgen's Motion for Judgment on Partial Findings and held that the asserted claims of the '138 patent were not invalid. Importantly, the court also allowed for post-trial briefing on the issue of infringement and reserved judgment on Apotex's enablement defense. (D.I. 245.)

On September 6, 2016, the U.S. District Court for the Southern District of Florida held that Amgen had not met its burden to prove by a preponderance of evidence that Apotex's process for refolding filgrastim and pegfilgrastim infringed the '138 Patent. (D.I. 267.) The court based its conclusion on its findings that: (1) Amgen failed to prove literal infringement of a protein concentration claim limitation found in the '138 Patent, and (2) Amgen failed to prove equivalent infringement of a redox buffer strength claim limitation. (Id. at 21, 24.) Because it ruled that Apotex's process did not infringe the '138 patent, the court declined to render an opinion as to whether the '138 Patent is invalid for lack of enablement. (Id. at 27.) The court also determined that this case was not an exceptional case sufficient to award attorneys' fees to Apotex. (Id. at 28.)

In the most recent chapter in this ongoing dispute, on October 3, Amgen filed a Notice of Appeal in the District Court for the Southern District of Florida. (D.I. 272.) The Notice disclosed that Amgen has appealed the District Court's Final Judgment entered on September 6 to the United States Court of Appeals for the Federal Circuit, and will challenge all "rulings, proceedings, orders, findings, and decisions" underlying that judgment. (Id.) Additionally, Amgen will challenge a Claim Construction Order entered on April 7, 2016. (Id.) Once the appeal is docketed with the Federal Circuit and preliminary matters are resolved, the parties will submit appellate briefs.

As discussed, Apotex also recently petitioned the U.S. Supreme Court for a writ of certiorari seeking review of the July 2016 Federal Circuit ruling that held that a biosimilar applicant must provide the reference product sponsor with a notice of commercial marketing 180 days before marketing its biosimilar following FDA approval, even when the parties engage in the "patent dance." That petition remains pending.

We will continue to monitor this litigation and provide updates.

Authors: Ethan Rubin, Jenny Shmuel, Tasha Francis