Fed Circ probes validity of cancer treatment patent from $1.2 bln win

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The United States Court of Appeals for the Federal Circuit in Washington, D.C. REUTERS/Andrew Kelly

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  • Kite Pharma's Yescarta found to infringe Sloan Kettering, Juno Therapeutics patent
  • Federal Circuit questions whether patent sufficiently described invention

(Reuters) - A panel of judges at the U.S. Court of Appeals for the Federal Circuit on Tuesday grilled an attorney for the Sloan Kettering Institute for Cancer Research and Bristol Myers Squibb subsidiary Juno Therapeutics Inc on the validity of a cancer treatment patent that netted them nearly $1.2 billion from Gilead Sciences subsidiary Kite Pharma Inc for infringement.

The panel — comprised of Chief U.S. Circuit Judge Kimberly Moore and Circuit Judges Sharon Prost and Kathleen O'Malley — questioned if the relevant parts of the patent described the invention specifically enough to merit patent protection.

The oral argument was one of the first in-person arguments at the Federal Circuit since the beginning of the COVID-19 pandemic.

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Juno sued Kite in Los Angeles federal court in 2017, alleging Kite's Yescarta immunotherapy treatment infringed a Sloan Kettering patent that it licensed to Juno. A jury found that Kite willfully infringed and awarded Juno and Sloan Kettering $778 million in 2019, which U.S. District Judge Philip Gutierrez increased to nearly $1.2 billion in 2020.

Juno alleged in its 2017 complaint that a Kite collaborator copied Yescarta's structure from the patent's inventor, and O'Malley told Kite attorney Josh Rosenkranz of Orrick Herrington & Sutcliffe on Tuesday that Juno has "such a great story here about your client being the bad guys and tricking the inventor into disclosing his information."

"I mean, it's a really good jury trial story," O'Malley said.

Kite argued on appeal that, among other things, the relevant parts of the patent — which relates to the use of single-chain antibody variable fragments (scFv) to bind to tumor antigens and kill cancer cells — were invalid because they didn't provide a sufficient written description of the invention.

Kite said in its opening brief that Juno's patent provided "no guidance whatsoever" on how to determine which scFvs will work. Rosenkranz told the court Tuesday that the patent describes a "genus of millions of billions of potential candidates" whose binding capabilities were "highly unpredictable".

Moore echoed Rosenkranz's argument while questioning Juno attorney Morgan Chu of Irell & Manella.

"You haven't defined or given any sort of roadmap for how you would identify which scFv might work with which antigen – there are many, many of each," Moore said.

Chu said the patent's written description was sufficient to meet the Patent Act's requirement of informing an artisan how to make the invention because it provided a "clear roadmap," the inventors "quickly isolated" 60 relevant scFvs, and all scFvs had a common structure.

"But that's not the same as saying you disclosed enough for people to identify which one" works, Moore said.

"What if I go to a car dealership, and I tell my children to pick up the car," and "I say, 'ah, well mine is the car with four wheels,'" Moore said. "Every car has a common structure, it has four wheels – I haven't helped my children identify which car to drive off the lot."

The case is Juno Therapeutics Inc v. Kite Pharma Inc, U.S. Court of Appeals for the Federal Circuit, No. 20-1758.

For Juno: Morgan Chu of Irell & Manella; and Greg Castanias of Jones Day

For Kite: Josh Rosenkranz of Orrick Herrington & Sutcliffe; Jeffrey Weinberger of Munger, Tolles & Olson; and Geoffrey Biegler of Fish & Richardson

Read more:

Bristol-Myers' win in U.S. patent case against Gilead boosted to $1.2 billion

Federal Circuit will restart in-person arguments in August

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Blake Brittain reports on intellectual property law, including patents, trademarks, copyrights and trade secrets. Reach him at blake.brittain@thomsonreuters.com