Gilead

Bristol Myers Squibb has failed to provide any legal argument in its cell treatment conflict with biopharma giant Gilead Science, despite years of judicial drama and conflict in the market.

The United States Supreme Court declined to hear BMS’ appeal to resuscitate a $1.2 billion victory in a five-year fight over a BMS CAR-T patent and Gilead’s cell treatment Yescarta on Monday.

The legal rebuke comes a little over a year after a federal appeals court reversed Gilead’s Kite Pharma’s huge penalties for allegedly duplicating and commercializing proprietary CAR-T technology. A three-judge panel found at the time that a previous judgment in favor of BMS subsidiary Juno Therapeutics was not an informed decision due to a lack of evidence.

According to a Gilead representative, they were satisfied with the Supreme Court’s verdict on the issue.

BMS, for its part, stated that it requested the review of the Supreme Court in order to “establish the correct balance to their innovation economy”. According to a BMS representative, the company will continue to address this imbalance and the flawed standard that the Federal Circuit has imposed. BMS had rather a different response to the judgment as they would have preferred a different verdict than what originally was given.

Yescarta from Gilead and Breyanzi from BMS are both licensed in the United States to treat specific individuals with large B-cell lymphoma.

In 2017, the intellectual property conflict began with Juno and the Sloan Kettering Institute for Cancer Research, who jointly sued Kite. The plaintiffs claimed Kite stole Sloan Kettering’s research to progress its CAR-T development and subsequently get clearance for the cancer cell treatment Yescarta. Juno obtained an exclusive license to a patent from Sloan Kettering and the Memorial Sloan Kettering Cancer Center in 2013. Kite was sued in federal court in Los Angeles by the partners. After a two-week trial in 2019, jurors ordered Gilead’s Kite to pay Juno and Sloan Kettering $752 million.

Pharmaceutical corporations such as Amgen Inc (AMGN.O) and GlaxoSmithKline (GSK.L) filed papers in favor of Juno, as did research organizations, such as St. Jude’s Children’s Research Hospital.

Kite’s attempts to reverse that decision fell on deaf ears the following year, while Juno described its rival’s claimed infringement as “egregious” and “willful” in its own post-trial application.

Judge Philip Gutierrez agreed in April 2020 that Kite’s “infringement was purposeful,” increasing BMS’ compensation to $1.2 billion.

Concerning the basis for the 2021 reversal of BMS’ victory, a trio of appeal judges later agreed with Kite that the key MSK patent granted to Juno was invalid due to a lack of textual description.

The intellectual property lawyer Ronal Cahill stated in an interview

“The Supreme Court’s refusal should not come as a surprise, considering the justices seldom hear patent matters on the petition”.

Nonetheless, the Supreme Court made a rare exception last week when it agreed to hear Amgen’s request to revive two patents on its cholesterol medication Repatha. In that lawsuit, Amgen has been battling Sanofi and Regeneron in court since 2014, alleging infringement by the partners’ competitor PCSK9 cholesterol medication Praluent.

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