UK High Court rules against AbbVie’s Humira patents

The UK High Court has ruled that two of AbbVie patents, related to dosing regimens for rheumatoid arthritis, psoriasis and psoriatic, were invalid. The case was brought by claimants Samsung Bioepis, Biogen and Fujifilm Kyowa Kirin Biologics, represented by Gowling WLG, as each tries to bring their own Humira biosimilar to the European market.

AbbVie had initially tried to settle the case without taking it to court but the claimants persisted and brought an official decision from the court. The original case was filed in March 2016, with Samsung Bioepis aiming for entry into the market with biosimilar in 2018. However, the patents filed by AbbVie could have blocked entry until 2022 and 2023, if they were not found invalid. The UK High Court declared that "the dosing regimens were obvious and are therefore not eligible for patent protection."

The decision to overturn the patents could see Samsung Boepis’ SB5 passage to market smoothed. It is currently being reviewed for marketing approval by the European Medicines Agency and the South Korean Ministry of Food and Drug Safety. However, AbbVie has amassed patent protection of more 70 different patents that will continue to cause delays as companies try to bring their biosimilars to market.

Amgen has already secured the FDA’s approval of Amjevita, a Humira-referencing biosimilars, but the company is holding off on bringing the drug to market as AbbVie has already filed a lawsuit claiming patent infringement.

Humira is the best-selling drug in the world, having accrued sales worth $14 billion since its approval in 2003. AbbVie is certain to attempt to protect this profit to the last.