On May 11, 2021, Alvotech USA and Alvotech hf (jointly, Alvotech) filed a complaint seeking declaratory judgement against AbbVie Inc. and AbbVie Biotechnology Ltd (jointly, AbbVie) in the Eastern District of Virginia.  As readers of this blog may recall, in September 2020, Alvotech USA filed a BLA for AVT02, a biosimilar of AbbVie’s 100 mg/mL citrate-free Humira® formulation. In March of 2021, AbbVie filed a patent infringement lawsuit in the Northern District of Illinois (N.D. Ill.) under the BPCIA against Alvotech hf, alleging that Alvotech hf’s filing of a BLA infringed 62 of AbbVie’s patents.  Alvotech USA, based in Arlington, Virginia, is a wholly-owned subsidiary of Alvotech hf, based in Iceland.  AbbVie did not name Alvotech USA as a party in the infringement suit.

In Alvotech’s complaint, it alleges that AbbVie incorrectly sued Alvotech hf in the N.D. Ill. BPCIA litigation and that Alvotech USA, as the BLA applicant, should have been named as a defendant.   The complaint alleges that “AbbVie declined to sue Alvotech USA because AbbVie does not want to litigate this dispute in the Eastern District of Virginia” and that the failure to name the correct party, along with Abbvie’s actions during the required “patent dance,” is “misconduct [that] has necessitated this declaratory judgement suit.” The complaint alleges that “normally Plaintiffs would have filed as a counterclaim to AbbVie’s affirmative claim of patent infringement, had AbbVie brought its claims against the proper parties and in the proper jurisdiction.”  Below is a summary of the complaint’s claims.

Declaratory Judgement of Non-Infringement and Invalidity

The complaint alleges that only four of AbbVie’s patents are appropriate for litigation between the parties and that “invalidation of these four patents should pave the way for market entry of AVT02”: US 8,420,081; US 9,085,619; US 8,926,975; and US 8,961,973.  The ’081 and the ’619 patents are directed to various aqueous formulations of antibodies, including, specifically, adalimumab. The ’975 patent is directed to methods of treating active ankylosing spondylitis using certain doses of subcutaneously administered adalimumab. The ’973 patent is directed to methods of treating Crohn’s disease using certain doses of subcutaneously administered adalimumab. For each patent, the complaint asserts a claim for a declaratory judgment of non-infringement and invalidity.

Declaratory Judgement of Unenforceability for Inequitable Conduct

The complaint also alleges that the ’973 patent is unenforceable due to inequitable conduct. According to the complaint, during prosecution, “AbbVie argued to the [patent e]xaminer that a person of skill would be concerned about doses of adalimumab greater than 40mg/ml.” The complaint alleges that, contrary to AbbVie’s representations to the patent office, “AbbVie knew that [Abbott] had run prolonged safety studies that showed that adalimumab was safe in doses up to [5x] greater than the claimed induction doses.”

Declaratory Judgement of Unenforceability Due to Unclean Hands

The complaint further alleges that the asserted patents should be held unenforceable due to AbbVie’s “unclean hands.” According to the complaint, AbbVie has engaged in “misconduct designed to build and shield its ‘patent minefield’ from meaningful litigation, thus reducing the risk that those patents would undergo the legal scrutiny necessary to ensure that AbbVie’s ‘monopol[y is] kept within their legitimate scope.’” The complaint alleges that AbbVie’s assertion of 60+ “dubious patents” is unprecedented and that AbbVie’s refusal to pick a smaller subset of patents is a deliberate strategy designed to “‘reduce [its] risk that even the most frivolous patent will ever face judgement.”

The complaint also alleges that AbbVie “inflated” the Humira® patent portfolio by “patenting purported inventions that AbbVie does not use for Humira®; by seeking multiple patents on the same invention, both as part of the same and different patent families and without informing the PTO of the [related co-]pending applications in the other families; by seeking patents that cover prior art Humira®; by obtaining patents through inequitable conduct; and by obtaining patents on purported innovations that AbbVie itself did not invent.”

The complaint additionally alleges that AbbVie’s failure to launch the 100 mg/ml citrate-free formulation following the FDA’s approval in 2015 was a “strategic delay” designed to “maintain [AbbVie’s] monopoly even beyond 2023” when the 50 mg/ml biosimilars would launch.  According to the complaint, AbbVie was “banking that other potential biosimilar competitors had committed to developing biosimilars of the pre-existing, lower concentration formulation.”

Declaratory Judgement of Unenforceability Due to Patent Misuse

Finally, the complaint alleges that the patents in suit are unenforceable due to patent misuse. Per the complaint, “AbbVie’s scheme is to ‘engage the litigation process itself’—including the enormous expense and uncertainty of that process—to ‘deter others from competition,’ and to avoid legal scrutiny of its patents.” The complaint cites the size of AbbVie’s patent portfolio as the means by which it attempts to “intimidate both Alvotech and prior competitors” from engaging in legal scrutiny of the Humira® patent portfolio.

Stay tuned to Big Molecule Watch for updates as this case progresses.