AbbVie Files Complaint Against BI in New BPCIA Litigation Over Humira

AbbVie is engaged in new litigation over its blockbuster adalimumab (Humira). This week, the drug maker filed suit against Boehringer Ingelheim (BI) in a Delaware federal court, saying that BI will infringe on 74 of its patents for adalimumab in its development of a biosimilar product, BI 695501.

AbbVie earned $16.08 billion on sales of Humira in 2016, and seeks to defend its sales against biosimilars in development by asserting its numerous patents for the drug. The patents at issue in this case vastly outnumber those litigated in a previous suit against Amgen over its own biosimilar; in that case, AbbVie asserted only 10.

“While AbbVie has spent vast resources over decades developing Humira, Boehringer seeks to copy AbbVie’s work and ignore AbbVie’s patents,” the drug maker said in its complaint. “But while the Biosimilar Price Competition and Innovation Act (BPCIA) gives Boehringer an abbreviated regulatory pathway for its biosimilar version of Humira, it does not give Boehringer license to infringe AbbVie’s patents.”

The complaint indicates that AbbVie will assert 8 of those 74 patents in its initial wave of litigation, and will undertake a second wave when BI provides 180-day notice of commercial marketing, as BI did not consent to AbbVie’s proposal of a single stage of litigation for all 74 patents.

The patents that AbbVie has chosen to assert in this litigation include composition, methods of treatment, methods of administration, use of anti-tumor necrosis factor antibodies, and methods of production, among others. Among the patents on AbbVie’s list is the so-called “‘135 patent” for a method of treating rheumatoid arthritis. Five claims of that patent were struck down by the US Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) after a challenge from BI. The same claims were also invalidated by the PTAB in a previous inter partes review proceeding concerning Coherus BioScience’s CHS-1420.

Last week, BI announced that it had enrolled its first patient in a study to demonstrate interchangeability of its BI 695501 molecule with Humira. The results of the study—which will compare pharmacokinetics and clinical outcomes in 240 patients with moderate to severe chronic plaque psoriasis, and include safety, efficacy, and immunogenicity data—are expected in the second half of 2019.