BioDelivery Sciences Int'l, Inc. v. MonoSol RX, LLC, IPR2013-00315 (PTAB)
On November 13, 2013, the Patent Trial and Appeal Board issued a decision denying the petition for inter partes review filed by BioDelivery Sciences targeting MonoSol Rx's U.S. Patent 7,425,292. The '292 patent relates to thin films with non-self-aggregating uniform heterogeneity for use in drug delivery systems.
BioDelivery filed its petition for inter partes review on June 12, 2013, more than one year after MonoSol served BioDelivery with a complaint asserting infringement of the '292 patent, but less than one year after an ex parte reexamination proceeding terminated upon issuance of a reexamination certificate that confirmed or amended each of the original claims.
The Board denied BioDelivery's petition because it was untimely filed under 35 U.S.C. § 315(b). Specifically, the Board found that § 315(b) barred BioDelivery's petition even though the petition challenged claims that were amended by a reexamination certificate issued after service of the complaint. In adopting a broad interpretation of § 315(b), the Board emphasized that reexamination does not result in a new patent:
A reexamination certificate merely "incorporates in the patent any proposed amended or new claim determined to be patentable." 35 U.S.C. § 307(a). The reexamination certificate itself states: "The patent is hereby amended as indicated below." The identical reference in § 315(b), to the "date on which the petitioner . . . is served with a complaint alleging infringement of the patent" indicates that the timeliness analysis is to be made with reference to "the patent."
This decision comes as further development of the PTAB's broad interpretation of § 315(b). See, e.g., Accord Healthcare v. Eli Lilly and Co., IPR2013-00356 (a second complaint in the second of two prior lawsuits did not reset the time for filing a petition); St. Jude Medical, Cardiology Division, Inc. v. Volcano Corp., IPR2013-00258 (counterclaim is a "complaint alleging infringement of the patent" within the meaning of § 315(b).)