Sandoz Uses Patent Dance to Limit Humira® Biosimilar Lawsuit to Two Patents For Now
Earlier this month, AbbVie filed suit against Sandoz’s proposed biosimilar to AbbVie’s HUMIRA® (adalimumab). Invoking the Biosimilar Price Competition and Innovation Act (“BPCIA”), AbbVie asserts two patents protecting Humira, a fraction of the 84 patents AbbVie wished to litigate. Taking full advantage of the pre-litigation “patent dance,” Sandoz limited the number of patents-in-suit to just two. As this case illustrates, following the patent dance affords biosimilar makers considerable control and power over the scope of biosimilar lawsuits.
AbbVie’s Humira is a blockbuster treatment for rheumatoid arthritis. AbbVie’s prior Humira biosimilar lawsuits against Samsung Bioepis, Amgen, and Mylan have settled, while its case against Boehringer Ingelheim is ongoing.
AbbVie’s suit against Sandoz in the District of New Jersey will involve only two patents for now: U.S. Patent Nos. 9,187,559 and 9,750,808. The narrow scope of the suit is a result of Sandoz’s approach to the BPCIA’s pre-litigation information exchange. See 42 U.S.C. § 262(l). Specifically, after AbbVie provided Sandoz with a list of 84 patents for which it believed a claim of patent infringement could be reasonably asserted and the parties exchanged contentions concerning these 84 patents as the statute requires, Sandoz declined to agree to litigate any of the patents. In this situation, the BPCIA calls for the applicant (here, Sandoz) to state the number of patents that it will agree to litigate. § 262(l)(5)(A). Here—in what AbbVie calls an act of “gamesmanship”—Sandoz stated that it would agree to litigate only one patent. At that point, the parties were required to simultaneously exchange lists of the patents they would like to litigate, but the product sponsor (here, AbbVie) was prohibited from listing more patents than the applicant lists. § 262(l)(5)(B)(i), (ii). AbbVie and Sandoz thus identified only one patent each. In this way, Sandoz choreographed the patent dance to limit the number of patents that AbbVie can assert in its biosimilar suit to just two.
Although AbbVie alleges that Sandoz’s strategy “put[s] off confronting the vast majority of AbbVie’s patents for another day,” Sandoz is unlikely to be providing a notice of commercial marketing any time soon. As the Supreme Court observed in Sandoz v. Amgen, 137 S. Ct. 1664 (2017), under the BPCIA, “[t]he applicant has substantial control over the timing and scope” of biosimilar patent disputes. AbbVie and Sandoz’s Humira patent dance provides a clear example.