- Gilead does not owe Bristol Myers Squibb $1.2 billion in damages related to a key cancer drug patent, a federal appeals court ruled Thursday, overturning a prior judgment that would have forced the California biotech to pay sizable royalties to its New York rival.
- A three-judge panel for the U.S. Court of Appeals for the Federal Circuit determined that the claims contained in Bristol Myers' patent were not specific enough for Gilead to infringe upon with its cancer cell therapy Yescarta. In reaching their ruling, the judges threw out a district court verdict in favor of Bristol Myers, which Gilead had appealed.
- Bristol Myers "disagrees" with the appeals court's ruling, a company spokesperson said in an emailed statement, and intends to "seek review" of the decision. In an emailed statement, Gilead said it was pleased with the court's decision.
The appeals court ruling is a significant one for the field of cancer cell therapy and for the two pharmaceutical companies, both of which inherited the patent dispute after absorbing pioneering biotech developers of the complex medicines.
Bristol Myers' involvement in the case comes from its 2019 acquisition of Celgene, which one year earlier had bought the Seattle-based biotech company Juno Therapeutics and its cancer drug research for $9 billion.
Juno, which licensed the patent in question from Memorial Sloan Kettering Cancer Center, had previously sued Kite Pharma for alleged infringement on Oct. 18, 2017, the day the Food and Drug Administration approved Kite's lymphoma treatment Yescarta.
Six weeks before Juno filed the lawsuit, Gilead agreed to buy Kite in a $12 billion deal that accelerated a technological arms' race between large cancer drugmakers.
At issue were blueprints for how to construct a cancer therapy by reengineering a patient's own immune cells. The Juno patent, known in shorthand as the '190 patent, describes three components that together make up what's known as a chimeric antigen receptor, or CAR. Researchers can reprogram immune cells to express these CARs on their surface, guiding them to proteins commonly found on certain cancer cells, particularly those in lymphoma and in leukemia.
Juno alleged Yescarta used the same blueprint and that Kite was therefore violating its patent, a claim upheld in a two-week jury trial in federal court in California. Juno was initially awarded $585 million in damages, an amount that was later upgraded to $1.2 billion.
Gilead can now escape paying that sizable sum with the appeals court reversal. The judges' ruling centered on a legal test for patent claims known as "written description," a full written accounting of the claimed invention.
Gilead's lawyers argued Juno's patent did not contain enough information for a skilled practitioner to actually construct a CAR that could bind to the right cancer cells.
The appeals court judges largely agreed, finding the patent provided "scant details" about which CAR components would bind to which cancer targets.
"We agree with Kite that no reasonable jury could find the '190 patent's written description sufficiently demonstrates that the inventors possessed the full scope of the claimed invention," the judges wrote.
In addition to striking the $1.2 penalty, the ruling also reverses the previous judgment that Gilead would owe Bristol Myers Squibb and Memorial Sloan Kettering royalties on sales of Yescarta, which totaled $338 million in the first six months of 2021.
Bristol Myers now also sells a rival CAR-T cell therapy originally developed by Juno, called Breyanzi and also for lymphoma.
Gilead shares were little changed in Thursday trading, while Bristol Myers stock fell by nearly 1%.
In the emailed statement, the Bristol Myers spokesperson added the appeals court's decision "does not have any impact on the development" of the company's CAR-T therapies.
Note: This story has been updated to include comment from Gilead.