AbbVie's Imbruvica-Brukinsa patent suit may have merit, and BeiGene will likely settle: expert

AbbVie recently filed a patent infringement lawsuit against BeiGene over their blockbuster BTK franchises. Although the litigation was launched right after a patent’s issuance, AbbVie may actually have a case here, according to one expert.

AbbVie could win the lawsuit and take home potential damages, a patent attorney opinion leader said during an SVB Securities call, according to a Tuesday note.

The two companies will likely settle the case in the form of royalty payments from BeiGene to AbbVie, the expert said. SVB’s analysts projected a 12% royalty based on Brukinsa’s U.S. sales, with the total payment eventually reaching about $2.5 billion.

In response to SVB, BeiGene said it views the AbbVie patent in question as overly broad, and that SVB’s settlement number is too much, the analysts wrote in the note. The biotech has previously said that it will “vigorously defend” itself against the allegations.

AbbVie’s Pharmacyclis filed the lawsuit two weeks ago on the heels of receiving U.S. patent No. 11,672,803. It covers the method of use for a BTK inhibitor developed under a specific chemical structure for treating chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in a fixed-dose, once-daily oral regimen given until progression or unacceptable toxicity. AbbVie argues that BeiGene’s fast-growing BTK rival Brukinsa infringes on that patent.

The patent expert views the patent as narrow enough to be deemed valid, according to SVB. Brukinsa, which got its CLL/SLL approval from the FDA in January, appears to share some of the structural features described in the patent, as well as the CLL/SLL dosing method.

BeiGene could try to invalidate the patent, but it would be a difficult strategy to pursue, the expert noted.

BeiGene could use a “prior art” argument by pointing to potential evidence that was overlooked by the patent office to indicate that the AbbVie invention was in fact not new. But AbbVie has included an extensive, 24-page list of prior-art citations, the expert noted, suggesting that it would be hard to find a missing element.

BeiGene could also argue that some parts of the patent were too vague or inadequately defined, the expert said.

BeiGene now has until July 7 to respond to the complaint, with the possibility of an extension. It wouldn’t be uncommon for a trial to be scheduled as late as three years from now, the expert noted.

If AbbVie prevails, the Illinois pharma could theoretically ask to remove Brukinsa from the market, the expert said. But that will likely cause a backlash from physicians and patients. Alternatively, the lawyer views a settlement to avoid a protracted legal battle as the likely outcome, where BeiGene pays some sales-based royalties to remain on the market.

CLL/SLL is the most important battleground for BTK inhibitors. For Brukinsa, SVB’s analysts have previously put the BeiGene drug’s peak sales in CLL/SLL at $3.1 billion in the U.S. and EU.