On July 22, 2021 Plexxikon, a member of the Daiichi Sankyo Group and a leader in structure-guided discovery and development of novel small molecule pharmaceuticals, reported that it has won its patent infringement lawsuit against Novartis (Press release, Plexxikon, JUL 22, 2021, View Source [SID1234585110]). In a jury trial at the U.S. District Court for the Northern District of California, Novartis conceded infringement and sought to invalidate Plexxikon’s patents covering Tafinlar on the grounds of anticipation, written description and enablement. The jury rejected Novartis’s arguments, upheld the validity of Plexxikon’s patents, and found Novartis’s infringement was willful. Plexxikon was awarded damages of $178 million for past infringement of its patents and will receive additional royalty payments for future sales of Tafinlar in the United States through the life of the patents.
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"We are delighted with the jury’s verdict which validates Plexxikon’s pioneering role in the field of BRAF inhibitors and enables proper credit for our proprietary discovery efforts," said Chao Zhang, PhD, chief executive officer. "Genus patents — like those in the lawsuit — are routinely used to prevent competitors from knocking off our scientific innovations with slight molecular changes. We are gratified that the jury upheld their validity, protecting our investment so that we can continue discovering and developing innovative new drugs for patients in need."
Tafinlar was developed by GSK and acquired by Novartis for $2.4B. Tafinlar is a BRAF inhibitor that is approved for the treatment of metastatic melanoma, adjuvant melanoma, non-small cell lung cancer and anaplastic thyroid cancer. Tafinlar also competes with Zelboraf, another BRAF inhibitor that was discovered by Plexxikon and licensed to Roche.
In the suit, Plexxikon alleged that Novartis owed the company substantial royalties on its drug Tafinlar, which infringes two Plexxikon patents (U.S. Patent Nos. 9,469,640; and 9,844,539).