Judge Thwarts Biosimilar Competition For Amgen’s Enbrel

After an ongoing battle, the United States Court of Appeals for the Federal Circuit recently held in Amgen's favor on the validity of two patents that describe and claim Enbrel (etanercept) and methods for making it, according to an official court document.

The appellate court affirmed an August 9, 2019, decision by the United States District Court for the District of New Jersey that upheld the validity of two patents asserted against Sandoz Inc based on the company’s biosimilar of Enbrel.

The United States District Court for the District of New Jersey stated that Sandoz did not prove that the asserted claims of the patient-in-suit were invalid.

In February 2016, Immunex, and Roche, filed this patent infringement action against Sandoz under the Biologics Price Competition and Innovation Act (BPCIA).

According to Amgen, Novartis’ Sandoz division had acknowledged that Enbrel infringed seven claims in patents '182 and '522 before the trial even began.

US patents '182 and '522, which cover Enbrel's active ingredient and a process to make the drug, expire in November 2028 and April 2029, respectively, the document said.

Sandoz was the first company to receive FDA approval for a biosimilar of Endrel in 2016 based on a Phase 3 one-year study and its five-year open-label extension study to evaluate the safety and efficacy of its biosimilar in pediatric patients, aged 4 to 17, with chronic moderate-to-severe plaque psoriasis.

In addition to demonstrating significant efficacy, the adverse events were similar to those seen in previous studies in adults with moderate-to-severe plaque psoriasis.

Since the approval, Sandoz has not launched its biosimilar to Enbrel in the US market due to the patent suit brought by Amgen, Immunex, and Roche.

Roche is the owner and licensor of ‘182 and ‘522.

In 2004, Amgen, Immunex Corp., Roche, and non-party Wyeth, entered into an “Accord & Satisfaction” agreement concerning the same patent family.

“Under the terms of the agreement, Immunex has the first right to rectify any suspected infringement of the licensed patent family at its sole expense and under its sole control, by instituting suit or by sublicense,” the document said.

“Immunex may retain the entirety of any award of damages or lost profits resulting from such an infringement suit. Roche is obligated to cooperate in any such suit, including by participating as a party to the extent required by the court in order to bring suit.”

On August 9, 2019, after the February 2016 accusation against Sandoz, the United States District Court for the District of New Jersey stated that Sandoz did not prove that the asserted claims of the patient-in-suit were invalid.

Sandoz appealed, arguing that the patents-in-suit were invalid for three reasons, including obviousness-type double patenting, failure to meet the written description requirement, and obviousness.

The court rejected Sandoz’s argument.

On October 8, 2019, the New Jersey District Court entered final judgment and a permanent injunction prohibiting Sandoz from making, using, importing, selling or offering for sale Sandoz's Enbrel product.

"By stipulation of Amgen and Sandoz, the New Jersey District Court entered final judgment and a permanent injunction prohibiting Sandoz from making, using, importing, selling or offering for sale Sandoz's etanercept product,” the court document stated.