Docket No. 2016-22260
DYK, BRYSON, CHEN
June 13, 2017
Brief Summary: Board’s decision of lack of written description affirmed (“a description that merely renders the invention obvious does not satisfy the [WD] requirement”).
Summary: Purdue appealed PTAB refusal of claims in US 13/833,263 and 14/094,968 directed to controlled-release formulations of hydrocodone, and grant of junior party Recro’s motion for judgment that the claims lack written description (WD). During the interference proceeding, each party filed motions alleging the others’ claims were invalid. The Board agreed and terminated the proceedings. It found that Purdue claims lack written description because the “specifications do not describe ‘separate particles of inert beads coated with each different formulation together in one dosage form’”. The FC panel explained that “[w]hether patent claims satisfy the [WD] requirement of 35 U.S.C. § 112 is a question of fact” (Ariad, FC 2010) and that “the Board’s factual findings” are reviewed “for substantial evidence” (Inphi, FC 2015). It also explained that the test for WD “is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art had possession of the claimed subject matter as of the filing date” (Ariad, FC 2010 (description does not need to be “in haec verba” but “a description that merely renders the invention obvious does not satisfy the requirement” (Ariad; Novozymes, FC 2013)). It summarized “[t]he issue here” as being “whether the specifications adequately disclose the claimed separate populations of IR and CR multiparticulates, which each comprise inert beads coated with hydrocodone, combined in a single dosage form.” The FC panel agreed with the Board that the specifications did not include such a description, finding the recitations such as “an effective amount of opioid in immediate release form is included in the formulation” to be insufficient (“the written description…does not disclose a formulation wherein the IR and CR components exist as separate multiparticulates containing an inert bead core…the Board correctly determined that these disclosures ‘describe overcoating the different release formulations on top of each other [and] not combining two populations of beads.”) Purdue argued the specification “discloses an IR layer directly onto an inert bead” and that an “intermediate product ‘may’ be overcoated with the CR material”, meaning the CR coating is optional (“therefore the method teaches preparation of both IR and CR beads”). However, the FC agreed with the Board’s conclusion that “[e]ven if the method is read to disclose both IR and CR beads, the disclosure does not suggest that the IR and CR beads would both be combined in a single dosage form.” Purdue also unsuccessfully argued the incorporation-by-reference of US 5,472,712 provided that description, the FC concluding the Board correctly found that disclosure was directed to hydromorphone. The FC panel concluded Purdue’s argument “that a person…would isolate and combine aspects from various embodiments…to obtain the claimed invention” was the wrong test since, as mentioned above, “a description that merely renders the invention obvious does not satisfy the [WD] requirement”. Thus, the Board’s decision was affirmed.