On August 10, 2018, AbbVie, Inc. and AbbVie Biotechnology Ltd. (collectively “AbbVie”) sued Sandoz Inc., Sandoz GMBH, and Sandoz International GMBH (collectively “Sandoz”) in the district of New Jersey alleging infringement of two patents related to Humira®:  U.S. Patent 9,187,559 (“the ʼ559 patent”) and U.S. Patent No. 9,750,808 (“the ʼ808 patent”).

According to the complaint, the parties began exchanging information as required by the BPCIA in January of this year.  AbbVie alleges that although Sandoz made its application available to AbbVie, it did not provide other relevant information that describes the manufacturing process.  On March 18, 2018, AbbVie provided Sandoz with the list of patents for which it believed a claim for patent infringement could be asserted, and it twice supplemented that list.  On May 16, 2018, Sandoz contested its infringement and the validity of those patents, and provided additional information regarding its manufacturing process.  However, AbbVie asserts that the additional information is still not sufficient to confirm that Sandoz does not infringe the claims of each of the patents identified by AbbVie.

According to the complaint, on July 15, 2018, AbbVie responded to Sandoz’s non-infringement/invalidity contentions with a “detailed” statement alleging infringement of 84 patents.  AbbVie further alleges that during the negotiations, Sandoz informed AbbVie that it wished to litigate only a single patent.  Under the applicable provisions of the BPCIA, this means that the maximum number of patents that could be a part of this lawsuit is two.  However, AbbVie repeatedly asserts throughout its complain that when Sandoz provides its Notice of Commercial Marketing, AbbVie will have an additional opportunity to assert the remaining 82 patents.

The ʼ559 patent is entitled “Multiple-Variable Dose Regimen for Treating Idiopathic Inflammatory Bowel Disease,” and issued on November 17, 2015.  The ʼ559 patent issued with two independent claims, and 30 total claims.   AbbVie’s complaint alleges infringement of all 30 claims either literally or under the doctrine of equivalents.  The independent claims are directed to a method for treating idiopathic inflammatory bowel disease in a human comprising subcutaneously administering 160 mg of adalimumab within a day followed by a second dose of 80 mg adalimumab within a day, wherein the second dose is administered two weeks following the first dose.

The ʼ808 patent is entitled “Formulation of Human Antibodies for Treating TNF-α Associated Disorders,” and issued on September 5, 2017.   The ʼ808 patent issued with one independent claim, and 30 total claims.   AbbVie’s complaint alleges infringement of claims 1-10, 14-17, and 24-27 either literally or under the doctrine of equivalents.  Independent claim 1 is directed to a stable liquid aqueous pharmaceutical formulation comprising a human anti-TNF-α IgG1 antibody at a concentration of 45 to 105 mg/mL, and a buffer system wherein the formulation is isotonic, suitable for single-use subcutaneous injection, and has a pH of 4 to 8.   The claim also specifies that the antibody is D2E7, which was the initial name for adalimumab during development.

AbbVie’s complaint points out that Sandoz has previously challenged the validity of the ʼ559 patent in an IPR, but in that case the PTAB declined to institute review.  We reported that decision here.  The validity of the ʼ808 patent has not yet been challenged in an IPR.

We will continue to keep you apprised of future developments.