Kite wins appeal and reversal of jury verdict

The outcome

Kite Pharma, Inc. appeals a final judgment of the United States District Court for the Central District of California that (1) claims 3, 5, 9, and 11 of U.S. Patent No. 7,446,190 are not invalid for lack of written description or enablement, (2) the ’190 patent’s certificate of correction is not invalid, and (3) Juno Therapeutics, Inc., and Sloan Kettering Institute for Cancer Research (collectively, Juno) were entitled to $1,200,322,551.50 in damages. Juno Therapeutics, Inc. v. Kite Pharma, Inc., No. 2:17-cv-07639-PSGKS, (C.D. Cal. April 8, 2020), ECF 728. Because we conclude that the jury verdict regarding written description is not supported by substantial evidence, we reverse.

The technology involved

T cells are white blood cells that contribute to the body’s immune response. J.A. 32906–07. They have naturally occurring receptors on their surfaces that facilitate their attack on target cells (such as cancer cells) by recognizing and binding an antigen, i.e., a structure on a target cell’s surface. J.A. 32907–08. Chimeric antigen receptor (CAR) T-cell therapy involves isolating a patient’s T cells; reprogramming those T cells to produce a specific, targeted receptor (a CAR) on each T cell’s surface; and infusing the patient with the reprogrammed cells. J.A. 32913; ’190 patent at 2:31–36, 7:24–33.

The law on JMOL

We review denial of a motion for JMOL under regional circuit law. See Trs. of Boston Univ. v. Everlight Elecs. Co., 896 F.3d 1357, 1361 (Fed. Cir. 2018). The Ninth Circuit reviews a denial of JMOL de novo, and reversal is appropriate when “the evidence, construed in the light most favorable to the nonmoving party, permits only one reasonable conclusion, and that conclusion is contrary to that of the jury.” White v. Ford Motor Co., 312 F.3d 998, 1010 (9th Cir. 2002).

The CAFC sides with Kite

Kite argues that the asserted claims are invalid for failing 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 argues that the claims cover an enormous number (millions of billions) 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. It also argues that the scFv field is unpredictable since an scFv’s binding ability depends on a variety of factors. Juno responds that scFvs were well-known (as was how to make them), 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. It also argues that scFvs are interchangeable and have common structural features. 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. We hold that substantial evidence does not support the jury’s finding of adequate written description for any of the asserted claims.

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This is not to say, however, that a patentee must in all circumstances disclose the nucleotide or amino acid sequence of the claimed scFvs to satisfy the written description requirement when such sequences are already known in the prior art. See Capon, 418 F.3d at 1360–61 (holding it was error for the Board of Patent Appeals and Interferences to require “recitation in the specification of the nucleotide sequence of claimed DNA, when that sequence is already known in the field”). But 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. Ariad, 598 F.3d at 1353–54 (“[T]he purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification.” (internal quotation marks omitted)). Dr. Sadelain, one of the ’190 patent’s inventors, testified that, at the time he filed his patent application, he had used only the SJ25C1-derived scFv and J591-derived scFv. J.A. 32965–67.

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Even accepting that scFvs were known and that they were known to bind, the specification provides no means of distinguishing which scFvs will bind to which targets. See Eli Lilly, 119 F.3d at 1568 (“A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials.” (quoting Fiers, 984 F.2d at 1171)). Accordingly, testimony that scFvs were generally known in the field is insufficient to satisfy the written description