Novartis ends eight-year cancer drug dispute for $182m
Case dismissed with settlement between Novartis and Daiichi Sankyo unit | Melanoma therapy at centre of feud after Novartis faced infringement claims over Tafinlar.
Novartis has agreed to end the long-running patent dispute with a Daiichi Sankyo subsidiary over its anti-cancer medicine Tafinlar, in a $182-million settlement.
Tokyo-based Daiichi Sankyo, which now owns Plexxikon, announced the news in a press release published yesterday, December 6.
Plexxikon first filed a complaint in the US in 2017, alleging that Novartis’ Tafinlar (dabrafenib) infringed its US patents 9,469,640 and 9,844,539.
These patents cover Plexxikon’s Zelboraf (vemurafenib) drug, which was approved in the US in 2011 as a late-stage treatment for melanoma.
Tafinlar was first developed by GSK but was acquired by Novartis in 2015 as part of a $16-billion asset swap between the two firms.
Both Tafinlar and Zelboraf are types of BRAF inhibitor, which are drugs that can shrink or slow the growth of metastatic melanoma in people whose tumours have a BRAF mutation. BRAFs are genes found on chromosome seven that encodes a protein, also called BRAF.
Rival drugs
When it filed its 2017 complaint, Plexxikon claimed that scientists from GSK had gathered just enough information to develop the rival drug Tafinlar after the two had been in talks about a partnership, which never materialised.
In 2021, the US District Court for the Northern District of California issued a jury verdict in favour of Plexxikon, finding that Novartis’ Tafinlar “wilfully” infringes Plexxikon’s patents.
The court subsequently ordered Novartis to pay $177.8 million in damages, pre- and post-judgment interest, plus a 9% royalty on US sales of Tafinlar until the patents expire.
Upon review, the district court upheld the decision, although it reversed the wilful infringement finding—a move which saved Novartis from facing up to triple the amount in damages.
Although Novartis lodged an appeal with the US Court of Appeals for the Federal Circuit in October 2022, this week’s settlement dismisses the case and Plexxikon will receive a lump sum payment from Novartis of approximately $182 million (¥26.4 billion).
Daiichi Sankyo acquired Plexxikon in 2011 for $935 million, but announced last year that it was closing down the business and reorganising its R&D structure.
The settlement comes just days after Daiichi Sankyo won its dispute with Seagen over antibody drug technology, in an arbitration hearing that awarded the Japanese firm $45.5 million.
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