As Adalimumab Biosimilar Competition Heats Up, AbbVie Sues Sandoz

This month, AbbVie filed suit against biosimilar developer Sandoz over its proposed adalimumab (Humira) biosimilar. The suit was filed in the District of New Jersey and alleges infringement under the Biologics Price Competition and Innovation Act.

Sandoz has previously lost 6 inter partes review (IPR) proceedings at the Patent Trial and Appeal Board (PTAB) on patents related to Humira. “In each case, the PTAB held that Sandoz failed to establish a reasonable likelihood that any challenged claim would be held unpatentable. The PTAB’s decisions not to institute IPRs on these patents confirms and supports their validity,” read the complaint. The 9,187,559 patent, one of the patents at issue in this case, was the subject of 1 of the 6 IPRs that were previously denied institution by the PTAB.

Click here to learn more about AbbVie's Humira patents.

The complaint alleges that Sandoz notified AbbVie on January 12, 2018 that it had submitted an abbreviated Biologics License Application to the FDA for its potential adalimumab biosimilar, which was subsequently accepted. The 2 companies then engaged in the beginning stages of the so-called “patent dance,” or information exchange process. AbbVie alleges that although the parties began exchanging information in January 2018, Sandoz did not provide information regarding the processes used to manufacture its biosimilar in these meetings.

According to AbbVie, the Humira maker provided Sandoz with a list of potentially infringed patents in March 2018, which it continued to update in April and May to include subsequently issued patents. Sandoz then provided a response that the patents AbbVie specified will not be infringed or were invalid, and later notified AbbVie that Sandoz would agree to be sued under 1 patent infringement.

The suit is an interesting development in AbbVie’s latest attempt to protect reference product Humira from biosimilar competition, as it previously reached separate settlements with manufacturers Mylan, Amgen, and Samsung Bioepis as recently as last month. Under the terms of these agreements, the respective biosimilars will not be able to enter the United States marketplace prior to 2023. In addition to this case, AbbVie is in ongoing litigation with Boehringer Ingelheim regarding its adalimumab biosimilar, Cyltezo.

AbbVie’s Humira patents have also been a hot-button issue for other biosimilar stakeholders recently: a report released by the Initiative for Medicines, Access, and Knowledge (I-MAK) last week referred to AbbVie as the “worst patent offender” in the pharmaceutical sphere after having attempted 247 patents for Humira and raised prices by 144% since 2012.