AbbVie’s Pharmacyclics division claims that BeiGene’s Bruki Nsa violates a patent on its blood cancer medication Imbruvica in a recent lawsuit. Imbruvica and Brukinsa are irreversible BTK inhibitors that have been authorized for the treatment of CLL or SLL, respectively.
The disputed patent, U.S. patent No. 11,672,803, was just recently granted on Tuesday. It addresses the application strategy for a BTK inhibitor created with a specific chemical structure for the treatment of CLL/SLL.
The price of BeiGene’s shares fell more than 10% on both the Chinese mainland and in Hong Kong on Thursday.
In a statement released on Thursday, BeiGene asserted that its work is original and that it will “vigorously defend” against the claims of patent infringement.
“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 battle between BioGen and AbbVie began years before this patent litigation, but it recently reached a new level after Brukinsa defeated Imbruvica in a head-to-head study in CLL/SLL, the biggest market for BTK inhibitors, on both effectiveness and certain cardiovascular adverse events. In order to receive an FDA approval, BeiGene coupled the trial victory in patients who had already received treatment with another Phase III in patients who had just been diagnosed.
Imbruvica was recently demoted by the National Comprehensive Cancer Network (NCCN) from a “preferred” regimen to “recommended” due to Imbruvica’s toxicity. Instead, the NCCN guidelines committee has ranked Brukinsa higher than Imbruvica in a number of categories.