FDAnews Drug Daily Bulletin
Pharmaceuticals / Commercial Operations

PTAB Invalidates AbbVie’s Humira Dosing Patent — Again

July 11, 2017

The PTO’s Patent Trial and Appeal Board once again ruled that a patent for AbbVie’s Humira was invalid and unpatentable, responding to additional challenges by Boehringer Ingelheim.

In May, the PTAB ruled the patent — which covers dosing methods for anti-tumor necrosis factor alpha antibodies, such as Humira (adalimumab), for the treatment of rheumatoid arthritis — was considered obvious based on materials submitted by Coherus Biosciences. The patent includes a subcutaneous dosing regimen of 40 mg once every two weeks.

Humira brought in over $16 billion in 2016, making up 63 percent of AbbVie’s international net sales, with $10.4 billion raised in the U.S.

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