Published: June 24, 2021
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.
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