Docket No. 2016-1378 (IPR2014-00652)
DYK, REYNA, STOLL
February 21, 2017
Brief Summary: Board conclusion of obviousness affirmed (prior art “suggests the desirability” of the claimed combination of PEO and HPMC).
Summary: Depomed appealed the Board’s final decision after IPR that claims 1, 3-5 and 10-13 of US 6,723,340 are unpatentable as obvious. The Board did not institute on two of the five combinations of prior art requested by Endo as redundant and declined to review claim 2. The challenged claims relate to “[u]nit dosage form tablets…formed of [a] pharmaceutical dispersed in a solid unitary matrix that is formed of a combination of poly(ethylene oxide) [2 to 10 million “viscosity average MW] and hydroxypropyl methylcellulose” (HPMC “viscosity of from about 4,000 centipose to about 200,000 centipose”). The ‘340 patent purports this combination improves on the prior art by combining PEO and HPMC” to avoid “[g]astric retention, where particles in a drug are retained in the stomach for a prolonged duration”. The FC panel opinion first addressed Depomed’s argument the Board failed “to account for the unexpected results of combining PEO and HPMC” (that it “yielded better controlled-release properties compared to HPMC or PEO alone”). The Board found this evidence “was entitled to ‘little weight’ and did not overcome” Endo’s showing of obviousness because, e.g., the prior art disclosed “a finite number of identified, predictable polymers that could be used individually or in combination, of which HPMC and PEO are ‘particulary preferred’, acknowledging the reference “does not explicitly disclose the combination of HPMC and PEO” (“[I]t suggests the desirability of such a combination by stating that ‘[c]ertain combinations will often provide a more controlled release of the drug than their components when used individually.”) The FC panel found no error with the Board’s conclusion, citing BMS (FC 2014 (must show an unexpected difference in results from the prior art)). The FC panel also disagreed with Depomed’s arguments that the Board reached its conclusion through hindsight (no explicit disclosure in prior art of HPMC and PEO but also no “limit [regarding] which polymers could be combined or” a suggestion “that certain polymers would not function properly in a combination”). The FC panel agreed with Depomed’s argument “that the Board incorrectly required evidence demonstrating a failure of others to establish a long-felt but unmet need”. It explained that while “long-felt but unmet need is closely related to the failure of others, [the two] are distinct considerations” (In re Cyclobenzaprine, FC 2012). However, the FC panel also pointed out that the Board, despite its “misstatement of the law”, did “accord some weight to Depomed’s…evidence” (“conclusory inventor testimony”) and that its assignment of little weight to the evidence was correct. The Board decision was therefore affirmed. Judge Reyna concurred with the conclusion but believes the Board took an improper “two-step approach in its obviousness analysis”, “first [making] initial conclusions of obviousness and only later consider[ing] Depomed’s objective indicia of nonobviousness” (addressed by the FC panel in FN2).