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.
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