AbbVie Files Claim Construction Brief in BI Adalimumab Litigation


AbbVie filed its opening claim construction brief in its litigation with Boehringer Ingelheim (BI). AbbVie asserted eight patents against BI. The parties narrowed their dispute to two claim terms in three patents. U.S. Patent Nos. 9,018,361 (“’361 patent”) and 9,090,867 (“’867 patent”) are directed to methods of manufacture of adalimumab. U.S. Patent No. 9,272,041 (“’041 patent”) is directed to formulations of adalimumab.

The ’041 patent is related to four patents, U.S. Pat. Nos. 8,802,100; 8,916,157; 8,916,158; and 9,114,166, which were the subject of inter partes review challenges by Amgen Inc., Coherus BioSciences Inc., and Sandoz Inc. The PTAB denied institution of those IPRs.

AbbVie’s arguments are in key part as follows:

Term (patent) AbbVie proposed construction BI proposed construction AbbVie argument
“stable” (’041 patent) “a formulation in which the antibody therein essentially retains its physical stability, and/or chemical stability, and/or biological stability upon storage and use as a pharmaceutical formulation” “a formulation in which the antibody therein essentially retains its physical stability and/or chemical stability and/or biological activity upon storage” The court should adopt the construction used by the PTAB in its decision denying institution of the IPR challenges of related patents described above. BI’s construction omits the “clarifying clause that the PTAB adopted,” and will broaden the claims beyond the “broadest reasonable interpretation” provided by the PTAB in its construction.
“Protein A” (’361 patent, ’867 patent) “protein containing the five IgG binding domains of native protein A.” “a protein used in affinity chromatography to purify antibodies, particularly IgG1, IgG2, and IgG4 antibodies, based on its ability to bind to the Fc region of those antibodies” AbbVie’s proposed construction is “structural” and “based on the chemical structure of Protein A.” BI’s construction is “functional” and based on “what Protein A may be useful for, rather than what Protein A actually is.”

BI’s response is due December 19, 2018.

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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