Previous Paragraph IV Certification Does Not Foreclose Institution of IPR

A recent decision by the PTAB highlights two unsuccessful arguments by a patent owner attempting to prevent institution of an IPR. Petitioner, Johnson Matthey Inc. and two others, filed an IPR petition against U.S. Pat. No. 8,129,431 (“the ‘431 patent”). The patent relates to an aqueous liquid preparation named Prolensa, consisting of essentially two components: (1) bromfenac (or its salts and hydrates); and (2) tyloxapol. Patent Owner Bausch & Lomb filed a response and raised two threshold issues that it alleged bar the Petitioner from pursuing an IPR. The PTAB rejected the Patent Owner’s contentions and instituted the IPR. (IPR2014-01041 Paper 19)

The Petitioner had filed a Paragraph IV certification alleging the invalidity of the ‘431 patent prior to filing the petition for IPR. The Patent Owner asserted that the filing of the Paragraph IV certification was the functional equivalent of filing a declaratory judgment action and should foreclose Petitioner’s access to an IPR. The PTAB disagreed, holding that while the filing of a Paragraph IV certification may represent an out-of-court challenge to patent validity, it does not constitute a civil action challenging the validity of the patent as required under the statute. (Note that there several Paragraph IV litigations regarding the ‘431 patent have been filed).

The Patent Pwner also argued that filing date should be vacated because the Petitioners failed to name all of the real parties in interest. The PTAB, acknowledging the gravity of the argument, requested additional briefing on the issue. The Patent Owner argued that Coastal Pharmaceuticals, Inc. (“Coastal”), was an unidentified real party-in-interest because Coastal was identified in the Paragraph IV Notice Letter, and Petitioner had previously made statements in federal court that Coastal and Petitioner were in privity. Petitioner argued that Coastal was no more than a “business name” such as a “doing business as – d/b/a” name, and therefore was not a separate legal entity separate from the underlying corporate entity. The PTAB accepted Petitioner’s argument, determined that the fictional name is not a separate legal entity, and declined to vacate the filing date of the IPR petition.

The PTAB decision makes clear that an earlier filing of a Paragraph IV certification challenging the validity of a patent will not bar institution of an IPR on that patent. The PTAB decision also emphasizes the importance of correctly identifying all of the real parties-in-interest in IPR petitions.