Hydrocodone - USA

On Jun 13, 2017 CAFC affirmed the decision of PTAB in Interference proceedings & refused Purdue pharma’s patent applications for lack  written description support under 35 U.S.C. § 112.

Purdue Pharma L.P. (“Purdue”), the senior party in an interference proceeding, appeals from a judgment of the Patent Trial and Appeal Board (“Board”) refusing claims in Purdue’s Applications 13/833,263 (“’263 Application) and 14/094,968 (’968 Application) (collectively, the “Applications”). The Board granted junior party Recro Technology, LLC’s (“Recro”) motion for judgment that Purdue’s claims lack written description, concluding that claims 1, 6, 9, 10, 12–15, 23–26, 32, 39, 41–46, and 53–55 of the ’968 Application and claims 63–67 and 70–71 of the ’263 Application (collectively, the “involved claims”) are unpatentable for lack of written description support under 35 U.S.C. § 112. The Board found that the specifications do not describe “separate particles of inert beads coated with the each different formulation together in one dosage form.”

Purdue’s Applications are directed to controlled-release oral formulations of hydrocodone, a drug used to treat pain. Importantly for purposes of this appeal, each of the claimed dosage forms (capsules, for example) includes two types of multiparticulates: controlled release (“CR”) multiparticulates and immediate release (“IR”) multiparticulates. The CR and IR multiparticulates are each comprised of inert beads coated with hydrocodone. The claims also recite various in vitro dissolution rates and in vivo pharmacokinetic properties of the claimed dosage forms. The issue here is 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 Board found that the claimed formulation is not disclosed. CAFC concluded that substantial evidence supports the Board’s finding. Although the written description generally discloses that a single dosage form may include both IR and CR hydrocodone components, it does not disclose a formulation wherein the IR and CR components exist as separate multiparticulates each containing an inert bead core. The specifications explain, “[i]n certain embodiments of the present invention, an effective amount of opioid in immediate release form is included in the formulation.” The specifications provide several possible formulations combining CR and IR components. The disclosed embodiments include inert beads that are first coated with a CR layer and then additionally coated with an IR layer. The embodiments do not include inert beads coated directly with an IR layer. Purdue finally urges that the claimed formulations are supported by U.S. Patent No. 5,472,712, (“the ’712 Patent”), which was incorporated by reference into the Purdue applications. The Board was “not persuaded that the ’712 patent sufficiently describes the specific dosage forms Purdue claims. The descriptions do not recite the actual elements of Purdue’s claims, most notably inert beads coated with hydrocodone. Instead, the examples of . . . [the] ’712 patent describe formulations of [a] different drug[]: . . . hydromorphone . . . .”

Court said that we have considered Purdue’s remaining arguments and conclude that they are without merit. We affirm the Board’s determination that claims 1, 6, 9, 10, 12–15, 23–26, 32, 39, 41–46, and 53–55 of the ’968 Application and claims 63–67 and 70–71 of the ’263 Application are unpatentable for lack of written description support under 35 U.S.C. § 112.