Saturday, July 3, 2021

Takeda’s Baxalta settles with Bayer over $173M hemophilia patent infringement verdict

Takeda subsidiary Baxalta has spent more than two years pushing back against the $173 million in damages it was ordered to pay as a result of Bayer’s hemophilia patent infringement lawsuit. But after an appeals win for Bayer in March, the companies are putting the case to rest.

The two drugmakers, along with Nektar Therapeutics, have entered into a settlement agreement over the patent infringement case, a court filing shows. Bayer will not seek claims for the many millions in damages it was owed under a 2019 verdict and a subsequent appeals ruling.

Under the latest settlement, each drugmaker will cover their own legal expenses and Baxalta will give up its right to appeal the 2019 verdict any further. The filings didn’t provide other details on the terms of the settlement.

Bayer said in a statement the drugmakers “have settled their disputes and both sides will be able to continue to market their respective hemophilia products.” Takeda did not immediately respond to a request for comment.

Bayer’s lawsuit, filed in 2016, argued Baxalta’s Adynovate infringed on its patent on recombinant Factor VIII technology for hemophilia. Bayer said at the time that the infringement came out of a licensing deal between Baxalta and Nektar Therapeutics, which had partnered with both Bayer and Baxalta on hemophilia research in the 2000s. 

Nektar “knew or should have known” about Bayer’s patent despite licensing technology to Baxalta, Bayer contended.

RELATED: Takeda ordered to pay Bayer $155M for hemophilia patent infringement

A jury sided with Bayer in 2019 and settled on $155 million in damages, but that penalty grew by an additional $18 million in supplemental damages. Baxalta was a unit of Shire at the time, but the company was later acquired by Japanese drugmaker Takeda, which was then stuck with the bill. 

Despite efforts to appeal the decision, a unanimous Federal Circuit U.S. Court of Appeals panel sided with Bayer in March of this year, rejecting Baxalta’s argument that the patent wasn’t infringed and was invalid for “lack of enablement,” Reuters reports

In a slight blow to Bayer, the court also sided with the previous judge’s ruling that Baxalta did not have “specific intent to infringe” on Bayer’s hemophilia intellectual property. 

The FDA first approved Baxalta’s Adynovate in late 2015 for the treatment of hemophilia A in people aged 12 and older. The rare disease drug reeled in $545 million for the fiscal year ended March 31, 2020, out of Takeda’s roughly $30 billion in total revenues. 


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