IPR2016-01111 (U.S. Pat. No. 8,603,514 B2)
Decision Denying Institution of IPR
December 5, 2016
Brief Summary: IPR petition denied because Dr. Reddy’s did not show obviousness by a preponderance of the evidence; no collateral estoppel since issues in two cases were not identical.
Summary: Dr. Reddy’s petitioned for IPR of Monosol’s US 8,603,514 relating to “rapidly dissolving films for delivering orally administered active ingredients” and providing “equally sized individual unit doses which do not vary by more than 10% of said desired amont of said at least one active” (“illustrative” claim 1). Dr. Reddy’s alleged obviousness in view of two combinations of two out of three cited prior art references (Bess US patent, Chen WO publication, and Cremer CA patent), and also submitted an expert declaration. The Board first agreed with Monosol that the term “‘without the loss of substantial uniformity’ should be given its plain meaning” under the broadest reasonable construction standard applicable to IPRs (Cuozzo, US 2016). Regarding the combination of Bess and Chen, the Board concluded “Petitioner has not identified, nor do we see, any disclosure in Bess that teaches or suggests any specific degree of uniformity regarding the film product at all, and notably not subsequent to casting and drying”, shown that “Bess recognizes a potential loss of uniformity with respect to the amount of active ingredient in individual unit doses after casting and drying”, or “explained persuasively how [Bess’ disclosure of the thickness and weight of the film after drying] establish that the desired amount of the active ingredient in the individual unit doses does not vary by more than 10%.” And the expert’s declaration was found not to address “the importance of selecting a proper viscosity, and making adjustments to the” same and whether Chen addresses that point, and did not fully explain his data analysis regarding the 10% variance limitation. Dr. Reddy’s reliance on the FDA’s requirement that doses must not vary by more than 15% was not persuasive because “Petitioner has not shown how  the cited prior art or other knowledge in the art at the time of the invention would have informed an artisan how to reach that goal” (“recognition of a need does not render obvious the achievement that meets that need” (Cardiac Parameters, FC 2004; Abbott Labs., FC 2008). Dr. Reddy’s routine experimentation arguments were also not persuasive since neither it nor the expert discussed the “facts allegedly supporting those assertions.” The Board also disagreed that the determination that Chen teaches the 10% limitation was already decided in another proceeding (Appeal 2014-000547 regarding US 7,824,588B2) because it was not actually resolved there (no collateral estoppel since “the issue presented in the ‘588 patent is not identical to the issue presented here” (In re Freeman, FC 1994)). Thus, the Board determined Dr. Reddy’s did not show obviousness in view of Bess and Chen by a preponderance of the evidence. The combination of Chen and Cremer was also unpersuasive as no further explanation regarding Chen was provided. Thus, the Petition was denied.