- A federal appeals court upheld patents protecting one of Amgen’s best-selling drugs from generic competition for five years.
- The case concerns Otezla, a psoriasis and arthritis treatment that Amgen agreed to buy from Celgene for $13.4 billion before Celgene’s takeover by Bristol Myers Squibb in 2019. After acquiring the medicine, Amgen also took over a raft of lawsuits Celgene started in 2018 to protect Otezla from generic competition. Most of the cases have since been settled, but Sandoz and Zydus Pharmaceuticals persisted, taking their bid to trial.
- Now, the U.S. Court of Appeals for the Federal Circuit has agreed with a lower federal court that two patents prevent Sandoz and Zydus from entering the market until February 2028, Amgen announced Wednesday. The appeals court ruled against Amgen on a third patent that would have expired years later and focused on a dosing schedule for the drug.
The court victory offers breathing room as Amgen faces several sources of competition for Otezla. The medicine was the biotech giant’s third-best selling drug last year, with worldwide revenue of $2.3 billion.
Amgen was able to secure Otezla from Celgene because federal antitrust regulators were concerned about the overlap with a new kind of experimental drug under development by Bristol Myers. That medicine, Sotyktu, won Food and Drug Administration approval in September and now poses the most immediate new competitive threat to Otezla.
Meanwhile, drugmakers are racing to bring treatments similar to Sotyktu to market. Last month, Japanese drugmaker Takeda unveiled hotly anticipated data suggesting its experimental option can compete with the standard set by Sotyktu and may even have an advantage.
Amgen executives say they are confident that Otezla will continue to do well in a sizable market for psoriasis. It’s approved for a broad range of psoriasis patients and can be used as the first option that dermatologists prescribe.
“These are busy dermatologists,” Murdo Gordon, Amgen’s executive vice president for global commercial operations, said on a recent call with analysts and investors. “They want something that’s easy . . . And they want to be able to provide an ability for patients to start quickly on their therapy. Only Otezla offers that in the psoriasis market.”