CAFC Reverses Massive Jury Verdict for Juno and Sloan Kettering

The U.S. Court of Appeals for the Federal Circuit (CAFC) today reversed a jury verdict for Juno Therapeutics and Sloan Kettering Institute for Cancer Research (Juno), wiping out a $1.2 billion judgment for the entities. The CAFC found that the jury’s verdict with respect to written description was not supported by substantial evidence.

The case relates to U.S. Patent No. 7,446,190, owned by Sloan Kettering, which is titled “Nucleic Acids Encoding Chimeric T Cell Receptors.” The patent generally covers cancer immunotherapy technology. Juno sued Kite Pharma, Inc. for infringement of the ‘190 patent through the sale of its YESCARTA product. Kite countersued, seeking declaratory judgments of noninfringement and invalidity. The jury ultimately found in Juno’s favor and, in post-trial briefs, Kite moved for judgment as a matter of law (JMOL) on several grounds, including that the claims were not supported by sufficient written description. The district court denied JMOL and Kite appealed.

Citing Ariad Pharms. V. Eli Lilly, the CAFC reiterated that “a specification adequately describes an invention when it ‘reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.’” The written description argument turned on one type of binding element included in the ‘190 patent, namely, single-chain antibody variable fragment (scFv). Kite argued that the asserted claims failed to satisfy the written description requirement because “the ’190 patent discloses neither representative species nor common structural features of the claimed scFv genus to identify which scFvs would function as claimed.” Kite further argued that the claims cover “an enormous number…of scFv candidates, only a fraction of which satisfy the functional binding limitation for any given target, and that the written description does not meet the written description requirement for this functional binding limitation.”

Juno countered that scFvs and how to make them were well-known, “that multiple scFvs for specific targets were well-known, that the ’190 patent describes two working scFv embodiments that are representative of all scFvs, and that scFvs had been incorporated in CARs well before the ’190 patent’s priority date.”

The CAFC agreed with Kite because the court found that the ‘190 patent’s specification did not contain enough detail about which scFvs can bind which target antigens. Claims 3 and 9, in particular, were too broad, and essentially cover “any scFv for binding any target,” said the court. Juno relied on its expert testimony to counter these arguments, but the CAFC said that testimony was “far too general.” While a patentee need not in every case disclose sequences with specificity to satisfy the written description requirement when such sequences are already known in the prior art, “the written description must lead a person of ordinary skill in the art to understand that the inventors possessed the entire scope of the claimed invention,” said the court. The opinion continued:

It is not fatal that the amino acid sequences of these two scFvs were not disclosed as long as the patent provided other means of identifying which scFvs would bind to which targets, such as common structural characteristics or shared traits. But this patent provides nothing to indicate that the inventors possessed the full scope of the genus that they chose to claim. Thus, the ’190 patent’s disclosure does not demonstrate the inventors possessed the entire class of possible scFvs that bind to various selected targets.

While Juno argued that scFvs were known, the court said that, even if they were, “the specification provides no means of distinguishing which scFvs will bind to which targets.” Thus, testimony that scFvs were generally known in the field does not help to satisfy the written description requirement for the relevant claims requiring scFvs that bind to a selected target.

The CAFC next found that the ‘190 patent also failed to disclose “structural features common to the members of the genus to support that the inventors possessed the claimed invention.” Juno said that scFvs are interchangeable, but the court said that argument is insufficient. The CAFC pointed out that even Juno’s expert acknowledged that “an scFv with the same general common structure but with a different amino acid sequence would recognize a different antigen.” Furthermore, the patent fails to disclose structural features common to scFvs capable of binding specific targets, as well as a way to distinguish scFvs that are capable of binding from scFvs incapable of binding those targets. The court added:

Simply put, the ’190 patent claims a “problem to be solved while claiming all solutions to it . . . cover[ing] any compound later actually invented and determined to fall within the claim’s functional boundaries,” Ariad, 598 F.3d at 1353, which fails to satisfy the written description requirement.

The court similarly found that claims 5 and 11, which are limited to scFvs that bind the specific target, CD19, lacked sufficient written description, explaining that the ‘190 patent “provides only an alphanumeric designation, SJ25C1, as the source for the CD19-specific scFv. Without more guidance, in a vast field of possible CD19-specific scFvs with so few of them known, no reasonable jury could find the inventors satisfied the written description requirement.”

Lastly, Juno argued that Ariad was irrelevant because “the claims at issue here do not involve method claims reciting a ‘newly-identified cellular function or mechanism of action,’” but instead were peripheral to the core invention. The court again rejected this argument, saying:

As we explained in Boston Scientific Corp. v. Johnson & Johnson, “[t]he test for written description is the same whether the claim is to a novel compound or a novel combination of known elements. The test is the same whether the claim element is essential or auxiliary to the invention.”

The opinion was authored by Chief Judge Moore and was one of four precedential patent opinions issued today.

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