- Samsung Bioepis bested rival AbbVie in a U.K. patent court on Friday, clearing a huge hurdle to European markets for the South Korean company's biosimilar.
- The drug, dubbed SB5, is a copycat to AbbVie's Humira (adalimumab) — an anti-inflammatory that had the highest revenues of any pharmaceutical in 2016, raking in more than $16 billion. The basic patent protecting Humira from competition is set to expire in 2018, but AbbVie has also locked down dosing and indication patents to extend exclusivity of its blockbuster.
- Judge Henry Carr of the England and Wales High Court, however, invalidated those patents in a March 3 ruling, and took AbbVie to task for attempting to shield its patents from scrutiny by abandoning before the end of legal proceedings.
Fujifilm Kyowa Kirin Biologics and Biogen joined Samsung Bioepis as claimants in the case. While Carr's ruling is an individual win for the companies, it also underscores how rapidly AbbVie's is losing ground protecting its biggest medication. Pfizer, Amgen, Merck and a host of other pharmaceutical developers have Humira biosimilars in the works as well.
Samsung Bioepis' sought declarations that three of AbbVie's patents, two of which pertained to Humira's rheumatoid arthritis indication and one for psoriasis and psoriatic arthritis, were not valid. There was also some controversy over the dosing of Humira and regulatory requirements surrounding that.
"I consider that, on the most unusual facts of this case, there are special reasons which support the grant of the declarations," Carr wrote in the ruling. "These include AbbVie’s conduct of threatening infringement whilst abandoning proceedings at the last moment (in order to shield its patent portfolio from scrutiny); the amount of money at stake for the Claimants in terms of investment in clinical trials and potential damages if they launch at risk; and the need for commercial certainty, having regard to AbbVie’s threats to sue for infringement throughout the world."
Carr also questioned the motives behind some of AbbVie's moves, namely that it wouldn't submit to judgment and offered alternative resolutions rather than agree to Samsung Bioepis' declarations.
"In my judgment, AbbVie would not have invested the considerable resources that this trial has required unless there was a good commercial reason to resist the declarations,' he wrote. "In the absence of any alternative explanation in evidence, I believe that the declarations will be more damaging to AbbVie’s strategy in relation to its Humira patent portfolio than the complex set of undertakings and abandonment of UK patent protection that it has chosen to provide."