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20 June 2023AmericasMuireann Bolger

AbbVie unit sues Chinese rival over blood cancer drug

Both drug treatments inhibit a protein called Bruton’s tyrosine kinase that can trigger cancer | Lawsuit comes in wake of patent grant for disputed drug | New study caused headaches for AbbVie’s subsidiary.

Pharmacyclics, a subsidiary of  AbbVie, has taken legal action against  BeiGene in a dispute concerning a patent covering the blockbuster blood cancer drug  Imbruvica (ibrutinib).

The lawsuit filed this month at the  US District Court for the District of Delaware alleges that the Beijing-based company’s new drug—marketed as  Brukinsa (zanubrutinib)—infringes US patent number 11,672,803.

Both drugs are used to treat chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL) by inhibiting a protein called  Bruton’s tyrosine kinase (BTK), which can act as a trigger for both diseases.

Groundbreaking invention

Pharmacyclics developed Imbruvica to irreversibly inhibit BTK’s enzymatic activity more than a decade ago, and went on to gain approval for its release from the  US Food and Drug Administration (FDA) in 2014.

In January 2023, BeiGene obtained FDA approval to market Brukinsa, which is in the same class of BTK inhibitors allegedly first invented by Pharmacyclics.

The  US Patent and Trademark Office issued a patent to BeiGene last week, prompting Pharmacyclcis to sue, seeking a declaratory judgment of infringement together with damages.

A vigorous defence

In a  statement posted on the company’s website, BeiGene insisted that its invention was “original”.

“We will vigorously defend against all allegations of patent infringement,” said the biotech firm. “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 Brukinska.”

BeiGene went on to say that Brukinsa’s “broad” programme includes more than 4,900 patients in 35 trials across 29 markets, and that the drug is now approved in more than 65 markets globally.

New study causes headaches for AbbVie

The statement pointed to results published in the  New England Journal of Medicine this year, showing that in a head-to-head comparison between Brukinsa and Imbruvica, the former demonstrated “superior” efficacy and safety.

The study also reported zero sudden cardiac death events for Brukinsa, compared with a 1.9% rate for Imbruvica, said BeiGene.

LSIPR has contacted Pharmacyclics for comment.

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