Chugai settles cancer drug patent dispute with US firm

Parties to withdraw lawsuit over lung cancer drug | ANDA generic would have displaced sales of patented version in Delaware, said plaintiff.

Tokyo-headquartered Chugai Pharmaceutical has entered into a settlement agreement with healthcare firm Fresenius Kabi, ending litigation over a cancer drug.

Chugai said that the companies will now take steps to withdraw the lawsuit, but provided no further details of the settlement.

The parties submitted their consent order for dismissal without prejudice on Monday, August 8, the day the announcement was made.

Chugai—along with Roche and Genentech—had sued US-based Fresenius in March 2020, accusing the company of infringing four patents covering Alecensa (alectinib), which is used to treat lung cancer.

Roche had helped develop and obtain approval to market Alecensa from the US Food and Drug Administration (FDA) in 2017, while Genentech holds the exclusive right to sell, distribute, and market the drug in the US.

Chugai received notice in February 2020 that Fresenius had submitted an Abbreviated New Drug Application (ANDA) for a generic version of Alecensa to the FDA. As part of the submission, Fresenius alleged that the four patents were invalid, unenforceable and/or wouldn’t be infringed by the generic.

“On information and belief, defendants know and intend that, if approved, Fresenius’s ANDA product will be distributed and sold in Delaware and will thereby displace sales of Alecensa, causing injury to the plaintiffs,” said the suit.

Now, more than two years later, the parties have agreed to settle their dispute, with each party bearing its own costs and attorneys’ fees.

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