IP Law Daily, PATENT—Fed Cir.: Obviousness findings affirmed in ophthalmic syringe dispute, (Sep 23, 2024)

By Kevin M. Finson

A PTAB decision finding claims related to syringes for injections into eyes was supported by substantial evidence because the board relied upon expert testimony.

A maker of ophthalmic syringes failed to show any error in a PTAB decision that held that all of its challenged claims were obvious, the U.S. Court of Appeals for the Federal Circuit has held. The PTAB had properly relied upon expert testimony which amounted to substantial evidence (Novartis Pharma AG v. Regeneron Pharmaceuticals, Inc., No. 23-1334 (Fed. Cir. Sept. 23, 2024)).

Novartis Pharma AG, Novartis Technology, LLC and Novartis Pharmaceuticals Corporation (collectively, Novartis) were the owners of U.S. Patent No. 9,220,631 (the ’631 patent), which claimed a small volume syringe suitable for ophthalmic injections. Regeneron Pharmaceuticals, Inc. (Regeneron) petitioned for inter partes review of all claims of the ’631 patent on the ground of obviousness. Novartis did not dispute that all limitations were disclosed in the prior art but argued that a skilled artisan would not have had a motivation to combine or a reasonable expectation of success. The Patent Trial and Appeal Board (PTAB) found all of the challenged claims unpatentable. Novartis appealed, raising what the court described as a “laundry list of fact intensive arguments.”

Motivation to combine and expectation of success. Novartis argued that the board erred in finding a motivation to combine two prior art references and that there was not a reasonable expectation of success because the prior art references taught away from combination. As to both issues the court found that the board properly relied upon expert testimony.

Sterility assurance. Novartis argued that the board erred in finding a prior art reference disclosed a limitation of “achieving a sterility assurance level of at least 10–6 using vaporized hydrogen peroxide.” The court found that the board properly credited expert testimony in finding that the prior art references to sterility references were referring to this same standard and that a person of ordinary skill in the art would know that this standard was required by regulation.

The court indicated that it did not find Novartis's remaining arguments persuasive and affirmed the decision of the board.

The Case is No. 23-1334.

Judge: Chen, R.

Attorneys: William M. Jay (Goodwin Procter LLP) for Novartis Pharma AG. Anish R. Desai (Weil, Gotshal & Manges LLP) for Regeneron Pharmaceuticals, Inc.

Companies: Novartis Pharma AG; Regeneron Pharmaceuticals, Inc.

Cases: Patent FedCirNews