HUMIRA® Subject to Additional IPRs

Guest Post by Tia Fenton & Jeff McIntyre

As discussed previously, biosimilar applicants can gain significant strategic advantage by availing themselves of Patent Trial & Appeal Board (PTAB) patent challenge mechanisms. Last week, the Board agreed to consider two additional patentability disputes over AbbVie’s HUMIRA® drug (IPR2016-00188 and IPR2016-00189).
In the new ‘188 and ‘189 IPRs, Coherus challenged the patentability of AbbVie’s U.S. Patent Nos. 9,017,680 (“the ‘680 patent) and 9,073,987 (“the ‘987 patent”), respectively.  The ‘680 and ‘987 patents are two of a series of patents covering various aspects of AbbVie’s HUMIRA® drug.  HUMIRA®, one of the top selling drugs in the world, is used to treat numerous autoimmune diseases including rheumatoid arthritis. Coherus announced its plans to file an application to market a biosimilar version of HUMIRA® in the second half of 2016 and filing IPRs against HUMIRA® patents is part of Coherus’s strategy for entering the market.

The ‘680 patent is a continuation of U.S. Patent No. 8,889,135 (“the ‘135 patent).  As discussed previously, Coherus filed IPR2016-00172 against the ‘135 patent, and the ‘172 IPR was instituted last month.  

In the ‘188 IPR, pending claims 1-4 (directed to methods of treating rheumatoid arthritis) were challenged as obvious over prior publications.  In the ‘189 IPR, pending claims 1-2 (also directed to methods of treating rheumatoid arthritis) were challenged as obvious over the same prior publications. The obviousness challenges were both supported by the declarations of two scientists.  AbbVie filed preliminary patent owner responses, but before the current rule change that would have allowed a responsive submission of new, expert evidence.  In its responses, AbbVie argued that Coherus’s position was flawed and that the claims were entitled to secondary considerations of non-obviousness.

At this preliminary stage, the PTAB agreed with Coherus, determining there is a reasonable likelihood that Coherus will show that the challenged claims are unpatentable.  The PTAB noted that, based on currently available evidence, HUMIRA®’s commercial success is not commensurate with the scope of the claimed invention.  Of course, this determination will likely be revisited once AbbVie is able to present evidence.  Trial will proceed and the PTAB will make a final determination on the patentability of the claims of the ‘680 and ‘987 patents within the next 12 months.

Coherus has lodged one additional IPR petition at the PTAB directed against another patent in AbbVie’s HUMIRA® portfolio, IPR2016-01018.  A decision on instituting trial in IPR2016-01018 will be issued in late fall.