AbbVie sues BeiGene over brand-new Imbruvica patent as blood cancer rivalry heats up

AbbVie has opened a new front in its blood cancer drug rivalry against BeiGene.

In a new lawsuit, AbbVie’s Pharmacyclics unit contends BeiGene’s Brukinsa infringes a patent on its blood cancer drug Imbruvica. Both Imbruvica and Brukinsa are irreversible BTK inhibitors approved in chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

The patent in question, U.S. patent No. 11,672,803, was just issued on Tuesday. It covers the method of use for a BTK inhibitor developed under a certain chemical structure for treating CLL/SLL. 

BeiGene’s stocks in Hong Kong and the Chinese mainland both dipped more than 10% during Thursday’s trading.

In a statement Thursday, BeiGene said it will “vigorously defend” against the patent infringement allegations and that its work is original.

“It is an unfortunate but rather regular occurrence that companies make allegations that a competitive product potentially infringes their intellectual property rights, even more so in response to a clearly differentiated medicine for cancer patients as Brukinsa,” BeiGene said.

The BTK rivalry between BeiGene and AbbVie started years before this patent lawsuit but recently reached a new level after Brukinsa beat Imbruvica on both efficacy and some cardiovascular side effects in a head-to-head trial in CLL/SLL, the largest market for BTK inhibitors. BeiGene combined the trial win in previously treated patients with another phase 3 in newly diagnosed patients and won an FDA approval in January.

Because of Imbruvica’s toxicity, the National Comprehensive Cancer Network (NCCN) recently downgraded its guidance on Imbruvica, removing the AbbVie/J&J drug from a “preferred” regimen status. The NCCN guidelines committee has instead placed Brukinsa above Imbruvica in several areas.

In the first quarter, Brukinsa’s sales jumped about 20% over the last three months of 2022, reaching $211 million. SVB Securities analysts have put Brukinsa’s peak sales in the U.S. and EU at $3.1 billion in CLL/SLL alone.

Facing double pressure from Brukinsa and AstraZeneca’s Calquence, Imbruvica has been on fast decline. First-quarter sales of the first-generation BTK inhibitor dropped 25% year on year to $878 million for AbbVie.

For the current lawsuit, AbbVie is seeking a declaratory judgment that BeiGene infringes the ’803 patent plus damages.

Editor's note: The story has been updated to reflect that the patent in the complaint is about a method of use within a certain chemical structure, not the structure itself. 

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