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2022-06-17| Special

Bristol Myers Squibb Requests $1.2 Billion Patent Revival From Supreme Court

by Reed Slater
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In a back-and-forth court case, Bristol Myers Squibb’s (BMS) Juno Therapeutics unit asked the Supreme Court to revive its $1.2 billion drug patent. The case dates back to 2017, when Juno first sued Kite Pharma for allegedly copying its CAR-T cell-based technology to use in its large B-cell lymphoma targeting drug, Yescarta. 

 

Timeline of the Lengthy Court Case

 

A jury ruled in favor of Juno and Memorial Sloan Kettering Cancer Center (MSK), the organization that licenses the patent to Juno, in 2019. The ruling awarded Juno and MSK $585 million, plus 27.6% of Yescarta’s revenue through the court case, bringing the total to $778 million. 

In 2020, the U.S. District Judge presiding over the hearings, Phillip Gutierrez, increased the owed amount to $1.2 billion. Gilead Sciences, the corporation that owns Kite Pharma, immediately took action with requests to reverse the order claiming that the judgment was legally unsupportable. 

Lo and behold, one year later, the entire $1.2 billion ruling was thrown out, seemingly putting an end to the case, which had been going on for four years at this point. However, it was not the end. 

It took a year for BMS, Juno, and MSK to get their ducks in a row to gather enough basis for a revival request, but with enough evidence that they think supports their case, the companies formally submitted a request to reinstate the $1.2 billion ruling. 

 

Related Article: Alnylam Challenges Moderna and Pfizer with Patent Infringement

 

What This Case Means For Future Biology Patent Cases

 

The case is predicated on Kite’s Yescarta therapy, a CAR-T cell therapy targeting relapsed or refractory large B-cell lymphoma. Kite is accused of stealing the technology behind Yescarta from a patent derived from MSK. 

Juno and MSK explained in the most recent Supreme Court request that Dr. Michel Sadelain of MSK developed a CAR that not only targeted cancer cells but replicated in the body to destroy more cancer cells. 

The original jury in 2019 agreed that MSK clearly defined the technology warranting the patent, which led to BMS’s initial win, along with the jury’s decision that Kite willfully used the technology from a patent it did not own. 

The reversal of the $1.2 billion verdict contradicted the previous findings, though, stating that substantial evidence does not support the jury’s verdict in relation to the written description of the patent. The reversal states that MSK’s patent was not comprehensive enough to justify the jury’s original verdict.

In the most recent revival request, Juno and MSK outline the Federal Circuit’s desires for a patent as one that possesses the full scope of an invention, including all known and unknown variables of an invention. Juno and MSK call these stipulations “devastating for innovation” and that the guidelines set forth for future patents are “demanding the impossible.” 

Juno and MSK hope to regain the $1.2 billion ruling by arguing that the guidelines for defending a patent are too restrictive and that future technologies are at risk of devastating consequences if the current ruling is upheld. 

The proxy case fought between BMS’s and Gilead’s subsidiaries has gone on for five years now and does not appear to have an end in sight. Regardless of the outcome of BMS’s revival request, further action is likely to follow. Until then, the industry will have to wait for the next big update in one of the biggest ongoing biotechnology patent cases.

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