BioPharma, Legal

Sandoz loses challenge to patent on Amgen’s $5.2B autoimmune drug, may appeal to Supreme Court

A federal appeals court upheld two key patents covering Amgen’s Enbrel, thus further preventing Novartis’ generics unit from launching its biosimilar. However, an analyst wrote that the probability of Sandoz overturning the decision is low.

A large biotech company will maintain patent protection on one of its key products for the next several years following a federal court’s ruling that a biosimilar challenger infringed on its patents.

Thousand Oaks, California-based Amgen said Wednesday that the U.S. Court of Appeals for the Federal Circuit ruled in its favor regarding the validity of two patents covering Enbrel (etanercept), a drug used to treat autoimmune diseases. The ‘182 and ‘522 patents respectively cover composition of matter and manufacturing methods through 2028 and 2029, respectively. The company challenging the patents, Swiss drugmaker Novartis’ generics division, Sandoz, had appealed an Aug. 9, 2019 decision by the U.S. District Court for the District of New Jersey that upheld the validity of the patents. The generics company had received Food and Drug Administration for its biosimilar, Erelzi (etanercept-szzs), in August 2016, though patent litigation prevents it from launching the product.

Sandoz said it is reviewing options, which could include an appeal to the Supreme Court, noting that the appeals court’s ruling continues to prevent Erelzi’s launch.

Shares of Amgen rose 6.4% on the Nasdaq Wednesday following the ruling, from $233.65 to $248.56 per share, and were trading at $259.84 per share Thursday morning. Shares of Novartis did not appear to be affected. Enbrel had global sales of $5.2 billion in 2019, according to Amgen.

“Sandoz will continue its efforts to make Erelzi available to U.S. patients with autoimmune and inflammatory diseases,” Sandoz U.S. President Carol Lynch said in a statement. “Our company respects valid intellectual property, however Sandoz continues to believe the patents asserted by Amgen are not valid, and that it should not be able to use them to extend the drug’s exclusivity.”

In a note to investors, however, RBC Capital Markets analyst Kennen MacKay wrote that the likelihood of Sandoz overturning the court’s decision is low, while it also removes an overhang on Amgen’s stock. The investment bank forecasts that sales of Enbrel could reach $4.9 billion this fiscal year and $3.2 billion in 2027, followed by a decline to $1.6 billion in 2030.

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