Two patents that AbbVie Inc (NYSE:ABBV) held on Humira, a treatment for arthritis, have been invalidated by an English court. The ruling was in favor of Samsung Bioepis, the biotechnology subsidiary of the biggest conglomerate in South Korea, Samsung Group. This now means that Bioepis can begin working on commercializing Humira’s biosimilar, SB5, in European markets. SB5 has already received approval from the continent’s drug regulator, the European Medicines Agency
“We welcome the court’s judgment. At Samsung Bioepis, we remain committed to driving positive change in the healthcare system through the development of affordable, high-quality biosimilars,” a senior Samsung Bioepis communications executive wrote via email.
In the ruling which was delivered over the weekend, the Patents Court of England ruled that AbbVie’s treatments for psoriatic arthritis, psoriasis and rheumatoid arthritis could not be patented. The case was initially filed in early 2016 and Samsung Bioepis’ intention was to have the dozens of patents AbbVie had filed for Humira nullified. Then Samsung had indicated that it intended to introduce its biosimilar in European markets as soon as the basic patent held on Humira had expired. The basic patent is set for an October 2018 expiry date.
Prior to the start of the trial, AbbVie had proposed that the dispute be settled through negotiations between the two parties and not through the court system. Samsung Bioepis, however, objected, preferring a definite court ruling instead.
Since it was approved in 2003, Humira has gone on to become the best-selling treatment of all time. In 2015, Humira generated sales of over $14 billion. Biosimilars would therefore have a very negative effect on AbbVie’s revenues and the chief executive of the company has vowed to exhaust all legal avenues in a bid to stop the biosimilars. The U.S. Food and Drug Administration has already approved a biosimilar of Humira that is manufactured by Amgen, Inc. (NASDAQ:AMGN) known as Amjevita and, as promised, AbbVie’s CEO is expected to head to court over the matter claiming infringement of patents.
In Friday’s trading session, shares of AbbVie Inc edged up by 0.14% to close the day at $63.34 a share.