Battling against an industry rival and the U.S. government, respectively, Bristol Myers Squibb and Pfizer have been quite busy in the courts. But now both of their efforts have ended in losses at the United States' top court.
Bristol Myers Squibb has come up short in its last-ditch effort to get the U.S. Supreme Court to review its decision from two months ago when it declined to hear its patent case against Gilead Sciences. Juno Therapeutics, Inc. versus Kite Pharma, Inc. was among (PDF) a laundry list of cases under the heading “rehearings denied,” that the Supreme Court released on Monday.
The case surrounds Gilead’s cell therapy Yescarta, which is on its way to blockbuster status after generating $317 million in sales in the third quarter of last year.
The intellectual property case dates to 2017 when BMS’s subsidiary Juno combined with Sloan Kettering Institute for Cancer Research to sue Gilead’s subsidiary Kite.
The plaintiffs argued that Kite copied research from Sloan Kettering in developing Yescarta, a CAR-T treatment for lymphoma. A federal jury in 2019 found Gilead at fault and ordered the company to pay $752 million to Juno and Sloan Kettering. Kite’s attempts to overturn the verdict were so unconvincing that in April 2020, a judge increased BMS’ award to $1.2 billion, ruling that Kite’s infringement was “willful.”
But in 2021, a federal appeals court overturned the massive verdict against Gilead. At the time, a three-judge panel ruled an earlier ruling favoring Juno was “not supported by substantial evidence.”
Since then, BMS has battled the result unsuccessfully. Two months ago, the Supreme Court declined to hear the case. Monday’s decision reinforces that decision.
As for Pfizer, the Supreme Court declined to take up the New York pharma giant's case against the United States Department of Health and Human Services. In that lawsuit, Pfizer asked the Supreme Court to review whether its prospective program to help Medicare patients pay out-of-pocket costs for its tafamidis drugs Vyndaqel and Vyndamax would run afoul of federal anti-kickback laws.
Vyndaqel/Vyndamax cost $225,000 a year before discounts, and, under Medicare’s formula, patients are responsible for a co-pay of about $13,000 per year. Pfizer’s proposed assistance program would lower the out-of-pocket cost to $35 per month, according to the company.
The Department of Health and Human Services (HHS) rejected Pfizer’s proposal in 2019, ruling that such an arrangement would violate a criminal ban on financial support to patients for a federally reimbursed healthcare product.
After Pfizer sued to overturn that verdict, it suffered two consecutive losses, which prompted the company to petition the Supreme Court in July. But now the court has said it isn't interested in taking up its case.
"(The company) believes that providing copay assistance represents an equitable way to lower out-of-pocket costs for eligible patients who receive their prescriptions through Medicare Part D," Pfizer said in a statement. "We believe the company’s proposed copay program would have provided a mechanism to reduce out-of-pocket costs for eligible patients for the medicine their doctors have already prescribed and is consistent with the statutory framework under the Anti-Kickback Statute. Copay assistance would help ensure that financially needy Medicare patients could afford access to Tafamidis, a life-extending medication that is the only FDA-approved treatment for ATTR-CM."