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15 June 2017Americas

Federal Circuit affirms PTAB decision on Purdue painkiller patents

The US Court of Appeals for the Federal Circuit has affirmed a decision by the Patent Trial and Appeal Board (PTAB) which found that two patent applications by Purdue Pharma were unpatentable.

In a  decision handed down on Tuesday, June 13, the court backed the PTAB’s finding that the applications lacked written description, and were unpatentable under 35 USC, section 112.

Purdue’s applications, US numbers 13/833,263 and 14/094,968, are directed to controlled-release oral formulations of hydrocodone, a drug used to treat pain.

The PTAB had granted Delaware-based Recro Technology’s motion for judgment that Purdue’s claims lacked written description.

In addition to challenging Purdue’s applications, Recro Technology itself filed an application including claims directed to oral formulations of hydrocodone. But after a challenge from Purdue, the PTAB also found this application to be lacking written description.

According to the board, the specifications in Purdue’s applications do not describe “separate particles of inert beads coated with the each different formulation together in one dosage form”.

Purdue’s specifications explain that, generally, “controlled (slow) release formulations ... provide a longer period of pharmacological action after administration than is ordinarily obtained after administration of immediate-release dosage forms”.

Each of the claimed dosage forms included two types of multiparticulates: controlled release (CR) and immediate release (IR).

The CR and IR multiparticulates each comprise inert beads coated with hydrocodone.

“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,” said  Circuit Judge Timothy Dyk, on behalf of the court.

Both parties had submitted expert testimony on this issue, and the board found that the claimed formulation wasn’t disclosed.

“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,” said Dyk.

The Federal Circuit affirmed the PTAB’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 under section 112.

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