Oxycodone – USA

On Apr 04, 2019, Federal Circuit affirmed (Rule 36 judgment) PTAB’s finding that only claim of oxycodone composition patent is obvious.

Purdue appealed the decision of PTAB from IPR2016-01027 & IPR2016-01028 which found claim 1 of    US 9,060,976 unpatentable. Claim 1 reads:

1. An extended release abuse deterrent dosage form comprising: a. a core matrix comprising a blended mixture of: (a) PEO having a molecular weight of from about 300,000 daltons to about 5,000,000 daltons; (b) magnesium stearate; and (c) oxycodone or a pharmaceutically acceptable salt thereof; wherein the core matrix is heated to melt at least a portion of the PEO included in the core matrix during preparation of the dosage form; and b. PEG applied onto the core matrix; wherein the dosage form provides extended release of the drug.

Specifically, PTAB found claim 1 unpatentable under 35 U.S.C. § 103 as obvious over McGinity, Joshi, and Palermo in IPR2016-01027 & over the combinations of a) Palermo, the Handbook, and McGinity; and b) McGinity, Joshi, Bastin, and PDR in IPR2016-01028.

In summary, PTAB held that McGinity itself teaches or suggests all the components required for the claimed formulation, with the exception of the requirement of that PEG is “applied onto the core matrix” as a coating. Insofar as McGinity fails to disclose the use of a coating, Palermo provides the motivation to apply a PEG coating onto the core matrix taught by McGinity by teaching that opioid dosage forms “may optionally be coated with one or more materials suitable for the regulation of release or for the protection of the formulation.” Moreover, although McGinity does not teach that the controlled-release formulation taught therein is abuse deterrent, it construed “abuse deterrent” in the preamble of claim 1 as merely a statement of intended use that is not entitled to patentable weight. Regardless, Joshi confirms that the PEO within the molecular weight range taught by McGinity can serve as a gelling agent that confers abuse deterrence.

Therefore, skilled artisan would have consulted prior art’s teachings in arriving at the claimed formulation.