Alvotech takes AbbVie to court over alleged patent 'minefield' surrounding megablockbuster Humira
AbbVie has so far been successful in shooing away competition to its megablockbuster Humira, deploying a number of patents and settlements to keep biosimilars off the US market until 2023. But one Icelandic drugmaker doesn’t want to wait — and on Tuesday, it filed a lawsuit challenging what it called a patent “minefield.”
Alvotech has accused AbbVie of trying to “overwhelm” and “intimidate” it with “an outrageous number of patents of dubious validity,” according to court documents. The company is currently seeking approval for its Humira copycat AVT02, which AbbVie says would infringe upon 62 patents.
“Every company that has even hinted at challenging AbbVie’s portfolio in court has been threatened with at least 60 patents from AbbVie’s ‘minefield,’ and each has settled without the merits of any single patent being addressed in court, with AbbVie securing years of additional time for its monopoly,” the complaint states.
If approved, Alvotech says AVT02 would be the only biosimilar to match the strength of AbbVie’s latest Humira formulation (100mg/ml as opposed to an earlier 50 mg/ml version), which the pharma markets as less painful. The drugmaker is requesting a declaratory judgement that would render the patents-in-suit invalid and unenforceable.
AbbVie did not respond to a request for comment.
The two companies’ lawyers are already well-acquainted. Back in March, AbbVie filed suit against Alvotec, accusing the Icelandic drugmaker of stealing manufacturing secrets to create its copycat.
The alleged scheme revolves around the hiring of Rongzan Ho, a former AbbVie team leader of Humira’s upstream manufacturing, who AbbVie accused of emailing “trade secret information” to his personal email account before leaving the company for Alvotech. At the time, Alvotech said it “strongly disputes” the allegations, adding it’s been three years since the “purported date of the alleged wrongdoing,” and the employee in question no longer works for Alvotech.
In the new complaint, Alvotech called AbbVie’s lawsuit “improper,” and said it started developing its manufacturing process years before Ho even started at the company.
AbbVie has been called out by a host of critics, including US lawmakers, for its patent-aggressive strategy to protect Humira. When AbbVie’s main patent for Humira ran out in 2016, the company applied for a raft of new patents — a move that was further strengthened by agreements with Amgen, Samsung Bioepis, and Novartis’ Sandoz to keep biosimilars off the US market until 2023.
The drug raked in more than $16 billion in US sales in 2020 alone.