Evercore ISI Analyst Breaks Down Amgen's IPR Against AbbVie's Humira Formulation Patent

Last Friday, Amgen, Inc. AMGN filed an intellectual property rights (IPR) suit against AbbVie Inc ABBV’s 8,916,157 patent, which claims an innovative formulation for Humira.

According to IPR timelines, AbbVie should file a response to Amgen’s petition in three months (by the end of September). Once filed, the Patent Trial and Appeal Board (PTAB) will decide if it accepts to review the IPR again in another three months – by the end of December.

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In an email sent to investors on Monday, Evercore ISI’s fundamental research analyst Mark Schoenebaum shared some key points from his reading of the IPR and the '157 patent:

• AbbVie’s formulation patent 8,916,157 was filed in August 2014 and issued in November 2014. The patented formulation seems to be a "more stable" version of Humira (“the injection volume and protein concentration are the same as the already marketed product,” the analyst explains). However, it is not possible to know the exact formulation and how it compares to what is currently being reviewed by the FDA, Schoenebaum adds.
• The patent in question “does not specify that the formulation is stable for any specific time and under specific conditions (e.g. at room temperature or for how long), thus it's still unclear at this stage about the specific benefits of this new formulation, although they appear incremental,” the expert expounds.
• In the IPR, Amgen states that AbbVie’s patent “is obvious in light of earlier patents that claim antibody formulations identical to those claimed in ABBV's new formulation, and that it would have been obvious to a person skilled in the art to use adalimumab in the formulations claimed by the prior art.”
• AbbVie’s formulation patent was issued in approximately 4 months, “after it was filed without any prosecution by the PTO in view of prior art.”