Patent Trial and Appeal Board Strikes Down Key Humira Patent, Again

Last week, the US Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) ruled to invalidate AbbVie’s patent on a method of treating rheumatoid arthritis (RA) using adalimumab (Humira). The PTAB deemed the claims in question unpattentable because of their obviousness.

Boehringer Ingelheim (BI) entered its petition to the PTAB in 2016, asking it to review claims 1 through 5 of AbbVie’s US Patent 8,889,135 (“the '135 patent”) for a method of treating rheumatoid arthritis (RA) by administering a dose of 40 mg of an anti-tumor necrosis factor (TNF) drug subcutaneously every 13 to 15 days for a period of time “sufficient to treat” RA. In its petition, BI relied on several studies that detailed the efficacy of anti-TNF treatments for RA to demonstrate the obviousness of the patent’s claims.

The PTAB decision brings BI one step closer to an eventual launch of its adalimumab biosimilar candidate, BI 695501. In January, the company announced that the product had been accepted for regulatory review at both the FDA and the European Medicines Agency (EMA), and in June, BI presented phase 3 results demonstrating that the biosimilar and reference adalimumab have equivalent clinical efficacy and similar safety and immunogenicity profiles. “If approved by regulatory authorities [BI 695501] will increase the treatment options for patients with autoimmune diseases, while contributing to the long-term sustainability of healthcare systems,” said Karsten Kissel, MD, head of global medical affairs for biosimilars at BI.

BI was not the first company to successfully challenge AbbVie’s patents on adalimumab. Coherus BioSciences, as it seeks to launch its own adalimumab biosimilar, CHS-1420, also prevailed against AbbVie in a May inter partes review proceeding for the same 5 claims of the ‘135 patent. This spring, Coherus announced that its adalimumab biosimilar had met the primary endpoints of its bioequivalence study. Meanwhile, in the European marketplace, the EMA’s Committee for Medicinal Products for Human Use delivered a positive opinion on Biogen’s adalimumab biosimilar (to be marketed as Imraldi) after a UK court struck down AbbVie’s European patents for adalimumab.

Global sales of adalimumab totaled $16.08 billion in 2016, an increase of 14.7% over its 2015 sales. Competition from biosimilar products, however, as well as from new, less expensive small-molecule anti-rheumatic drugs, is expected to erode AbbVie’s adalimumab profits in the years ahead.