The US Patent and Trademark Office has agreed to consider a challenge filed by Coherus BioSciences against a patent protecting AbbVie's Humira (adalimumab), Coherus announced Tuesday. The patent office agreed to hear the petition after concluding that Coherus has demonstrated a "reasonable likelihood" that it will win the challenge. Shares in AbbVie dipped as much as 6 percent on the news, with shares in Coherus surging by as much as 23 percent.
The patent under challenge, which was issued in 2014, covers a bi-weekly dosing formulation of Humira for the treatment of rheumatoid arthritis. In its challenge, Coherus argued that the patent should be invalidated because it covers a "routine optimisation of the therapy" that was known by researchers. The drugmaker has also filed separate but similar challenges to two other patents protecting Humira.
Conversely, AbbVie argued that the challenge "merely rehashes the same arguments thoroughly considered by the examiner" during the application process and uses hindsight to ignore "critical efficacy and safety issues." The patent office determined that AbbVie's arguments are "best resolved during trial." Meanwhile, AbbVie indicated that it was "confident in the validity of our patents and will vigorously defend them."
Commenting on the news, Barclays analyst Geoff Meacham stated the patent "constitutes one of the cornerstones of the Humira [intellectual property] estate, so the decision represents an important toehold for biosimilar developers to get around AbbVie’s patent defences." The analyst explained that the ruling increases the likelihood the patent office will hear similar challenges filed by Boehringer Ingelheim on the same patent. Meacham predicted that a Humira biosimilar could reach the market by 2019 or 2020. Meanwhile, Evercore ISI analyst Mark Schoenebaum suggested that challenges will likely be filed on other patents protecting Humira, such as that covering the drug's use in the treatment of Crohn's disease.
AbbVie recorded sales of just over $14 billion for Humira last year, representing 61 percent of its total income. CEO Richard Gonzalez has said that AbbVie was prepared to pursue litigation to prevent the launch of biosimilar versions of the drug in the US until at least 2022.
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