Levocetirizine - USA

IPR decision: Jun. 09, 2020

AIA Review #	Filing Date	Institution Date	Petitioner	Patent	Respondent	Final Written Decision
IPR2019-00400	12/13/2018	07/15/2019	Apotex Inc.	8,633,194	UCB Biopharma Sprl	Claims 1–11 are patentable

US 8,633,194 (UCB Pharma; Exp: 10/16/2027):

1. A liquid pharmaceutical composition comprising (i) levocetirizine or a pharmaceutically acceptable salt of levocetirizine, and (ii) a preservative mixture consisting essentially of a mixture of methyl parahydroxybenzoate and propyl parahydroxybenzoate in a ratio of 9/1 expressed in weight, said mixture being present in an amount of more than 0 and up to 0.75 mg/ml of the composition, wherein said composition is substantially free of bacteria.

ORDER:

In consideration of the foregoing, it is hereby:

ORDERED that claims 1–11 of U.S. Patent No. 8,633,194 B2 are not determined to be unpatentable;

FURTHER ORDERED that Paper 44, Patent Owner’s Motion to Exclude Exhibits 1031–1038, 1040, 1041, and 1044 is denied;

FURTHER ORDERED that Paper 43, Petitioner’s Corrected Motion to Exclude Exhibits 2024, 2030, 2031, and 2034 is denied;

FURTHER ORDERED that Paper 18, Patent Owner’s First Motion to Seal is granted as to Exhibit 3005;

FURTHER ORDERED that Paper 28, Patent Owner’s Second Motion to Seal is granted as to Paper 27;

FURTHER ORDERED that Paper 35, the Parties’ Joint Motion to Seal is granted as to Exhibit 1039 only;

FURTHER ORDERED that Paper 35, the Parties’ Joint Motion to Seal is denied as to Exhibits 1042, 1043, and Paper 33 with leave to renew the request as set forth in section V(C)(2), above;

FURTHER ORDERED that, because this is a final written decision, parties to the proceeding seeking judicial review of the decision must comply with the notice and service requirements of 37 C.F.R. § 90.2.