Getting Lost in the Thicket: AbbVie Wields Its Expansive Humira® Patent Portfolio Against Alvotech’s Adalimumab Biosimilar

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In the most recent of a series of litigations by AbbVie against manufacturers seeking to market biosimilar versions of Humira®, the world’s most profitable drug, AbbVie initiated an action against Alvotech in the district court for the Northern District of Illinois on April 27, 2021, after Alvotech requested approval of its biosimilar, AVT02, a biosimilar to the high-concentration 100 mg/ml formulation of adalimumab (Humira®). Alvotech stated that it believes AVT02 will be the first biosimilar to the citrate-free, 100 mg/ml formulation of Humira® approved in the United States. AbbVie initially stated in its “3C” statement (under 42 U.S.C. § 262(l)(3)(c)) that it reasonably believed that Alvotech would infringe 63 patents out of purportedly more than 100 total patents covering Humira®, although it subsequently removed one from that list. The 62 patents allegedly infringed by Alvotech are listed in the table below.

Alvotech responded that only four of the 62 patents should be the subject of the action pursuant to 42 U.S.C. § 262(l)(6), specifically U.S. Patent Nos. 8,420,081; 8,926,975; 8,961,973; and 9,085,619. The ’081 and ’619 patents are directed to self-buffering formulations, for example, for the 100 mg/ml formulation of Humira®.  The ’975 and ’973 patents are directed to methods of treating ankylosing spondylitis and Crohn’s disease using adalimumab, respectively. Although AbbVie asserted that litigating only the four patents selected by Alvotech would not resolve all of the infringement issues, Alvotech disagreed, stating that “invalidation of these four patents should pave the way for market entry of AVT02.” Consequently, on April 27, 2021, AbbVie asserted the four patents selected by Alvotech (NDIL-1-21-cv-02258). Alvotech has moved to dismiss that action for failure to join a necessary party (Alvotech USA) for which venue is improper in Illinois.

On May 11, 2021, Alvotech filed a Declaratory Judgment Action in the Eastern District of Virginia (EDVA-1-21-cv-00589; EDVA-2-21-cv-00265) asserting non-infringement, invalidity, and unenforceability due to inequitable conduct and unclean hands.  Notably, Alvotech asserted that AbbVie sought to “systematically and artificially inflate the size of the Humira® portfolio,” including patenting purported inventions that AbbVie does not use for Humira®, by seeking multiple patents on the same invention without informing the USPTO of pending applications in other patent families, seeking patents for prior art Humira®, by obtaining patents through inequitable conduct, and seeking patents on inventions that AbbVie did not invent. Alvotech alleged that the foregoing actions were taken to create what Alvotech described as a “minefield of IP,” which AbbVie’s CEO stated in a 2013 earnings call would be the very obstacle that would face biosimilar manufacturers.  Alvotech asserted that as a result of these activities, AbbVie has been able to garner $10 billion to $20 billion in revenue per year despite the fact that patents covering the Humira® product expired in 2016.

Subsequently on May 28, 2021, AbbVie filed a second complaint in the Northern District of Illinois (NDIL-1-21-cv-02899) asserting the other 58 patents that AbbVie alleged to be infringed by Alvotech. Alvotech has noted in its declaratory judgment action that there has never been a case in U.S. history where 60 or more patents were litigated to final judgement. Yet, AbbVie contends that all 62 must be litigated to resolve the dispute.

In the most recent example of aggressive patent litigation tactics, AbbVie continues to bury its competition in infringement claims while continuing to enjoy monopoly profits on the world’s most lucrative drug for nearly two decades.

We previously reported on AbbVie’s patent portfolio around Humira® (here). AbbVie is not the first and only company to create what has been termed a “patent thicket” around its products. For example, Amgen/Immunex’s Enbrel® (etanercept) and Roche’s Rituxan ® (rituximab) are also protected by large portfolios. However, the expansiveness of AbbVie’s Humira® portfolio, and AbbVie’s apparent willingness to wield their IP against would-be competitors, has heightened the focus on AbbVie’s practices as reported here. As discussed in our earlier post, this prompted an unprecedented antitrust suit against AbbVie in which the district court judge ultimately sided with AbbVie, but which is currently on appeal in the 7th Circuit.

As noted in the table below, challenges to AbbVie’s patents have not garnered much success to-date. As a result, the sheer size and scope of the portfolio continues to present a daunting barrier to market entry for biosimilars to AbbVie’s Humira®. As discussed here, while biosimilar versions of Humira® have launched in numerous countries around the world, AbbVie® continues to thwart biosimilar competition in the United States, where it secured over $16 billion of Humira® sales revenues in 2020.

We will continue to monitor the progress of the battles between AbbVie and Alvotech, as well as new challenges to the patents AbbVie asserted against Alvotech.

Previously challenged patents are noted as follows:

* Pending; ¥ Settled/voluntarily dismissed; # Institution denied

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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