On Friday, a complaint was filed in the Northern District of Illinois, Eastern Division against Alvotech HF by AbbVie Biotechnology Inc. The complaint represented the second patent infringement action that AbbVie has brought against Alvotech on the same issue, with the first one being brought in the same court on April 27 under the Biosimilar Price Competition and Innovation Act of 2009 (BPCIA).
The complaint relates to AbbVie’s product, Humira, which is designed for the treatment of inflammation, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, Crohn’s disease (adult and pediatric), ulcerative colitis (adult and pediatric), hidradenitis suppurativa (adult and pediatric), uveitis (adult and pediatric), and juvenile idiopathic arthritis.
While AbbVie has over 60 patents regarding Humira, the complaint explained, there are a total of 14 patents, which have been challenged via inter partes review with the Patent Trial and Appeal Board 20 times, including 5 petitions specifically challenging the patents that are allegedly being infringed by Alvotech.
Under the BPCIA, typically there are two rounds of litigation over biosimilar products that may infringe upon the original patent holder’s rights. The first round permits the infringing defendant to select a smaller set of patents to proceed against, which permits all parties and the court to focus on the strongest arguments regarding the validity of patents and the similarity of the drugs.
Once that round of litigation is completed, depending on the outcome, a second round may be initiated in order to deal with any remaining patent claims. This “domino” style of litigation expedites the process of biosimilars reaching the market without having to litigate all of the patents at once. However, it also requires that the infringing defendant make available to the patent holder manufacturing and process information to confirm which patents are at issue, which AbbVie alleged has not been completed in this instance.
AbbVie also claimed that Alvotech has been poaching AbbVie employees in order to obtain trade secrets and other protected information from AbbVie in order to expedite the infringement.
The complaint seeks 116 counts of patent infringement and preliminary and permanent injunctions regarding the infringement of the patents, monetary damages, attorney fees, and costs. The plaintiff is represented by Latham & Watkins.