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In re Huai-Hung Kao

United States Court of Appeals for the Federal Circuit

May 13, 2011, Decided

2010-1307, 2010-1308, 2010-1309

Opinion

 [***1802]  [*1061]   Linn,  [**2] Circuit Judge.

Endo Pharmaceuticals, Inc. ("Endo") is the assignee of three patent applications related to controlled-release tablets containing the opioid narcotic oxymorphone. The Board of Patent Appeals and Interferences ("the Board"), in separate appeals, affirmed the rejection of the claims of each application as obvious, and Endo has separately appealed each decision to this court.

The Board affirmed the rejection of all pending claims of United States Patent Application No. 11/680,432 ("the '432 Application"), United States Patent Application No. 12/167,859 ("the '859 Application"), and United States Patent Application No. 11/766,740 ("the '740 Application") principally over a prior art international patent application that is involved in each appeal. Endo timely appealed each decision of the Board, and this court has jurisdiction under 28 U.S.C. § 1295(a)(4)(A).

Because the Board based its conclusion of obviousness regarding the '432 Application on factual findings lacking in substantial evidence, this court vacates and remands. Because the Board's conclusions regarding the obviousness of the '859 and '740 Applications were supported by substantial evidence, this court affirms  [**3] the Board's decisions regarding those two applications.

Background

I. The '432 Application

The claimed invention of the '432 Application relates to drug formulations containing opioids, a type of narcotic frequently used to manage chronic pain. To provide consistent pain relief, a minimum level of the opioid must be maintained in the blood. Opioids, however, are typically available in immediate release formulations that quickly release the entire dose of the opioid into the body. Moreover, some opioids are rapidly metabolized by the liver (a phenomenon known as the "first-pass effect") resulting in the drug having a low "bioavailability." When a drug has low bioavailability this means that only a small amount of the drug is systemically available throughout the body. Because of these drawbacks, immediate release opioid formulations must be administered frequently (e.g., every 4-6 hours) to maintain continuous pain relief. But frequent administration of opioids can result in a variety of side effects, ranging from disturbed sleep to altered mental states.

To overcome the difficulties associated with immediate release formulations, the '432 Application discloses controlled release formulations  [**4] containing the opioid oxymorphone, and capable of relieving pain for between twelve and twenty-four hours.

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639 F.3d 1057 *; 2011 U.S. App. LEXIS 9729 **; 98 U.S.P.Q.2D (BNA) 1799 ***

IN RE HUAI-HUNG KAO, ANAND R. BAICHWAL, TROY MCCALL, AND DAVID LEE;IN RE HUAI-HUNG KAO, ANAND R. BAICHWAL, TROY MCCALL, AND DAVID LEE;IN RE HARRY AHDIEH

Subsequent History: Rehearing denied by, Rehearing, en banc, denied by In re Huai-Hung Kao, 2011 U.S. App. LEXIS 21125 (Fed. Cir., Sept. 14, 2011)

Prior History:  [**1] Appeal from the United States Patent and Trademark Office, Board of Patent Appeals and Interferences in application Serial No. 11/680,432. Appeal from the United States Patent and Trademark Office, Board of Patent Appeals and Interferences in application Serial No. 12/167,859. Appeal from the United States Patent and Trademark Office, Board of Patent Appeals and Interferences in application Serial No. 11/766,740.

Disposition: VACATED AND REMANDED AS TO THE '432 APPLICATION. AFFIRMED AS TO THE '859 AND '740 APPLICATIONS.

CORE TERMS

oxymorphone, dissolution, patentability, prior art, secondary, correlation, invention, opioid, unexpected, formulations, embodiment, dosage, administering, discloses, informing, Pharmaceuticals, hydrophobic, comprising, oxycodone, teaches, argues, profile, skill, commensurate, effective, food, bioavailability, patient, substantial evidence, prima facie case

Patent Law, Jurisdiction & Review, Standards of Review, De Novo Review, Substantial Evidence, Nonobviousness, Elements & Tests, Ordinary Skill Standard, Prior Art, General Overview, US Patent & Trademark Office Proceedings, Appeals, Examinations, Office Actions, Graham Test, Secondary Considerations