Are the First Significant Cracks Spreading in Humira’s Patent Shield?

On Monday, the Patent Court of England invalidated 2 contentious dosing and indication patents held by AbbVie for Humira®. This development all but ensures that biosimilar adalimumab will reach the European market in 2018.

The resolution of the litigation, brought by Samsung Bioepis in March 2016 and joined by Fujifilm and Biogen, likely means that SB5, which has already been approved by the European Medicines Agency, will be available for market upon the expiration of the composition of matter patent in October 2018 overseas (but not until 2022 in the US).

The lawsuit called into question the validity of AbbVie’s patents covering dosage regimens and indications for Humira® in the treatment of rheumatoid arthritis, psoriatic arthritis, and psoriasis. Likely sensing a negative outcome, AbbVie abandoned the 2 patients and offered to settle the litigation outside of the legal system, but Samsung Bioepis decided to press on with a final court decision. In its ruling, the patent court declared the 2 patents on Humira’s dosing regimens as not proprietary and in fact “obvious” at the time they were filed, and thereby invalid.

This is the first time AbbVie has suffered a Humira patent defeat in a major market. It may signal the beginning of an erosion to the dominance of Humira on the world market, although without faster US biosimilar introductions, this may take several years to play out. Amgen has 2 adalimumab biosimilars awaiting final approval by the European Medicines Agency, and Boehringer Ingelheim will likely have an EMA decision on their investigational product by the time of the October 2018 patent expiration.

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