The Supreme Court turned away a petition that sought to challenge two Amgen Inc. patents on the top-selling rheumatoid arthritis drug Enbrel, ensuring Novartis AG’s Sandoz unit won’t be able to sell a biosimilar of the drug in the U.S. until 2029.
The justices declined to hear arguments by Sandoz, which claims an appeals court erred in upholding the two Amgen patents that prevent it from entering the U.S. market. Sandoz got regulatory approval in 2016 to sell a copycat version that it calls Erelzi and the patents are the only thing standing in its way.
Enbrel, which is heavily promoted in ads featuring pro golfer Phil Mickelson, generated $5 billion in sales last year, 20% of Amgen’s revenue. Sold by Amgen’s Immunex unit, it’s been on the market since 1998 and the appeals court ruling gives Amgen a total of 31 years of exclusivity.
Biosimilars, which are copies of the living organisms used to create biotech drugs, have had a harder time getting traction in the U.S. than in Europe because of patents and regulatory delays. Basel, Switzerland-based Sandoz said that a biosimilar of Enbrel “could have saved” the U.S. health-care system $1 billion a year.
“Today’s decision means Erelzi, a more affordable biosimilar, will not be available to U.S. patients with autoimmune and inflammatory diseases until 2029,” Keren Haruvi, president of Sandoz US, said in a statement. “We remain committed to providing important treatment options for patients affected by these diseases.”
Amgen said it was pleased the Supreme Court denied Sandoz’s petition, “finally bringing this dispute to an end.”
“As the trial court and appeals court decisions make plain, upon both the facts and the law, these patents are valid and protect Enbrel until their expiration,” the Thousand Oaks, California-based company said.
Amgen was up 1.1% at 12:44 p.m. New York time, extending its its gain to almost 11% since Dec. 31.
The original patent on Enbrel expired in 2012, and the last of Immunex’s OWN Enbrel patents ended in 2019. In 2004, though, Immunex, then a standalone company, bought patent rights from Roche Holding AG since both companies were working in the same area.
Because Roche retained ownership of the patents, it enabled Immunex to avoid a legal theory known as “double patenting” that prevents inventors from later filing an application that’s essentially the same as an earlier patent just to extend their rights. It’s a stricter requirement than if two patents have different owners.
The U.S. Court of Appeals for the Federal Circuit, in a 2-1 decision, ruled that Roche still had substantial ownership rights in the patents so the newer ones were distinct from the earlier Immunex patent.
With that decision, the nation’s top patent court “has now allowed patent owners to buy themselves an exemption from that rule and to obtain a longer term of exclusivity,” Sandoz said. It called the ruling a “how-to guide for inventors trying to secure multiple patents — and thus multiple patent terms — for a single invention.”The patents in this case, which cover the drug’s active protein, etanercept, and a process to make the drug, expire in November 2028 and April 2029, respectively. Enbrel blocks the action of tumor necrosis factor, or TNF, a protein that regulates immune cells. When the body produces too much TNF, it can cause the immune system to attack healthy tissue and lead to inflammation.
Novartis had conceded infringement of the patents, a common legal tactic that allows the two sides to focus on the validity of the patents.
“Over years of litigation, a ten-day trial, and an unsuccessful appeal, Sandoz has thrown almost every defense known in patent law at the Roche patents, all without success,” Amgen said in response to Sandoz’ petition. “Under Sandoz’s double-patenting theory, a patent unquestionably valid in the hands of its original owner can spontaneously become invalid when licensed to someone else more than a decade after the invention was made.”
Enbrel, which is approved as a treatment for rheumatoid arthritis and plaque psoriasis, competes with branded drugs such as AbbVie Inc.’s Humira and Johnson & Johnson’s Remicade and Stelara, among others.
Erelzi is available in Europe, where it helped contribute to a 20% increase in revenue sales for the Sandoz unit last year, Novartis said in its annual report.
