PTAB 'Guiding Principles' Favor Supplementary Declaration In 'Close' Case

• Published date: 16 November 2022
• Subject Matter: Intellectual Property, Patent
• Law Firm: Jones Day
• Author: Ms Emily J. Tait and Jack Graves

A PTAB panel recently granted a Petitioner's motion to submit a second expert declaration that directly addressed deficiencies identified by the PTAB's Institution Decision. While a "close" case, the panel concluded that allowing the second declaration would "further our goals of efficiency and our mandate to 'secure the just, speedy, and inexpensive resolution' of this proceeding." Celltrion, Inc. v. Chugai Seiyaku Kabushiki Kaisa et al., IPR2022-00578, (PTAB 2022) (citing 37 C.F.R. ' 42.1(b)).

Celltrion (Petitioner) brought an inter partes review against Chugai Seiyaku Kabushiki Kaisa et al. (Patent Owner) challenging all claims of U.S. Patent No. 8,580,264 (the '264 patent), which relates to methods of treating rheumatoid arthritis (RA) by subcutaneously administering an anti-IL-6 receptor antibody at a fixed dosage. Following institution of the IPR, Petitioner sought to submit supplemental information in the form of a second declaration by Professor Maarten Boers.

Under 37 C.F.R. ' 42.123(a), a party may file a motion to submit supplemental information, provided that: (1) the request for authorization to file the motion is made within one month of the date the trial is instituted; and (2) the supplemental information is relevant to a claim for which trial has been instituted. However, the PTAB need not accept supplemental information just because it is timely and might be relevant. See Redline Detection, LLC v. Star Envirotech, Inc., 811 F.3d 435, 445 (Fed. Cir. 2015). Rather, keeping in mind what is necessary to "ensure efficient administration of the [Patent Office,]" the PTAB has the discretion to grant or deny these motions as it sees fit. Id.

In this instance, the supplemental declaration was intended to directly address a deficiency of Celltrion's Petition identified in the Institution Decision of the PTAB. Specifically, the panel found that Petitioner failed to sufficiently show that the Kremer reference ("Kremer") teaches or suggests a limitation of claim 12 "wherein structural joint damage at week 24 or week 48 is found to be inhibited." See IPR2022-00578, Paper 22. The second expert declaration sought to address this deficiency by explaining that a POSITA would have understood the data of Kremer cited in Celltrion's Petition to actually teach this limitation. Additionally, the supplemental declaration went a step further and included a claim construction argument explaining that a POSITA would not have understood claim 12 to require actual...