BeOne Medicines and AbbVie’s Pharmacyclics have decided to voluntarily dismiss the patent lawsuit the Big Pharma firm brought against its competitor over their BTK inhibitors.
BeOne announced the decision in a securities filing (PDF) to the Hong Kong stock exchange. The move comes after the U.S. Patent and Trademark Office (USPTO) recently invalidated all claims of AbbVie’s patent, No. 11,672,803, which underpinned the Illinois pharma’s patent infringement lawsuit filed in 2023.
The patent covers a method of use for a BTK inhibitor developed under a certain chemical structure for treating chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), the most important indication of the drug class.
Filing of the lawsuit was not a good look on AbbVie because it was initiated right after the ’803 patent was issued, nearly 10 years after the FDA approval for the company’s Johnson & Johnson-partnered Imbruvica in CLL/SLL. And it came shortly after BeOne’s Brukinsa beat Imbruvica in a head-to-head phase 3 trial in second-line CLL/SLL.
Specifically, the patent describes orally administering a BTK inhibitor with a certain structure daily until CLL/SLL disease progression or unacceptable toxicity, wherein lymphocytosis is not considered progression. AbbVie argued that BeOne—formerly BeiGene—stepped on its patent because Brukinsa describes the same method of use.
In response, BeOne challenged the ’803 patent with the USPTO. April 29, the U.S. agency invalidated all claims of the patent, siding with BeOne that the patent was overly broad. AbbVie filed a request for a director review, hoping to overthrow the earlier verdict, but was denied by the USPTO on July 17, according to a recent BeOne securities filing.
Sept. 30, the two companies filed a joint stipulation to voluntarily dismiss the related lawsuit, and the matter is considered “fully resolved,” BeOne said in its Oct. 2 filing.
Brukinsa has become a major growth engine for BeOne. In the second quarter, the drug hauled in $950 million in sales, ahead of AstraZeneca’s second-generation BTK inhibitor Calquence, which generated $872 million during the period.
By comparison, AbbVie reported Imburvica global revenues of $754 million in the second quarter, down by 9.5% year over year. The AbbVie number included profit sharing for Imbruvica internal revenues with J&J.
BeOne is also working on a next-generation BCL2 inhibitor for combination with Brukinsa in CLL/SLL. The drug, called sonrotoclax, just turned in a positive pivotal readout in mantle cell lymphoma.
Similar to Brukinsa’s proposition as a more efficacious and more tolerable BTK than Imbruvica, BeOne is angling sonrotoclax as a better BCL2 than AbbVie and Roche’s Venclexta. Analysts have predicted that the Brukinsa-sonrotoclax duo has potential to further transform CLL/SLL treatment.