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2021-08-27|

Gilead’s Kite Wins Legal Battle Against BMS, Gets Its $1.2B Fine Overturned

by Joy Lin
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On August 26th, the US Court of Appeals for the Federal Circuit threw out Gilead Sciences’ $1.2 billion fine, after judges unanimously agreed that the patent Gilead’s subsidiary Kite was accused of infringing, was invalid.

Bristol-Myers Squibb, the company that filed the lawsuit, has confirmed it would seek a review on the latest ruling.

Related Article: Addressing The Global Need for Biosimilars: Current Trends, Expectations, and Real-World Experiences

 

A Legal Struggle 4 Years Long and Counting

 

The legal battle between the two companies began in 2017 when BMS’s Juno Therapeutics unit sued Kite Therapeutics for infringing its US Patent No. 7,446,190. Juno’s patent is licensed by the Memorial Sloan Kettering Cancer Center (MSK). Juno has long alleged that Kite ripped off research done by MSK to develop its anticancer drug Yescarta.

Yescarta, Kite’s chimeric antigen receptor (CAR-T) drug was highly successful, making $338 million in the first half of 2021.

Kite had denied the accusations, arguing that the certificate of correction of the ‘190 patent was invalid for failing to “satisfy the written description”. However, a nine-member jury in 2019 agreed with Juno and determined that Kite owed Juno and MSK damages amounting to $778 million and 27% in royalties on ongoing sales.

In December 2020, a US District Judge increased the amount awarded to $1.2 billion in a second blow to Kite. The case eventually reached the US Court of Appeals. There, Chief US Circuit Judge Kimberly Moore found that key portions of Juno’s patent provided insufficient written descriptions.

The three-judge panel ultimately reversed the $1.2 fine against Gilead.

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