No High Court Review of Purdue OxyContin Patent Invalidity

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By Tony Dutra

Nov. 14 — Purdue Pharma L.P. lost its last chance Nov. 14 to use patent protection to stall certain generic versions of its best-selling painkiller, OxyContin.

The U.S. Supreme Court rejected two petitions for review of U.S. Court of Appeals for the Federal Circuit rulings. The appeals court held that three Purdue patents on a less toxic formulation known as low-ABUK oxycodone were invalid as obvious, and that Grünenthal GmbH’s patent on making OxyContin resistant to abuse was not novel. Purdue licenses Grünenthal’s patent.

Amneal Pharmaceuticals LLC, Epic Pharma LLC, Mylan Pharmaceuticals Inc. and Teva Pharmaceuticals USA Inc. have announced plans to introduce generic low-ABUK or abuse-resistant oxycodone.

Purdue’s U.S. Patent Nos. 7,674,799, 7,674,800 and 7,683,072 claim an improved formulation with reduced 14-hydroxycodeinone—an alpha, beta unsaturated ketone (ABUK) determined by the Food and Drug Administration to be toxic to human DNA. According to Purdue’s petition, scientists had tried but failed to achieve the reduction until Purdue and Rhodes Technologies discovered an agent that was reintroducing 14-hydroxycodeinone late in the manufacturing process.

The Federal Circuit ruled that an inventor can get a method patent based on being the first to recognize a problem and apply the remedy, but here Purdue claimed the end product. Purdue Pharma LP v. Epic Pharma, LLC, 811 F.3d 1345, 117 U.S.P.Q.2d 1733 (Fed. Cir. 2016).

Grünenthal’s U.S. Patent No. 8,114,383 claims “thermoforming” technology that makes the pills so hard it prevents crushing them and injecting the powder to get an opioid high.

The Federal Circuit said that the technology was previously described as a solution for “a broader group of analgesics.” The required hardness is an “inherited” quality when applying the solution to an opioid, the court said.

Gregory A. Castanias of Jones Day, Washington, represented Purdue. Charles E. Lipsey of Finnegan, Henderson, Farabow, Garrett & Dunner LLP, Reston, Va., represented Grünenthal. Fried, Frank, Harris, Shriver & Jacobson LLP, New York, filed an amicus brief urging review, on behalf of Professor Richard E. Kouri of North Carolina State University.

None of the generic drug makers filed a response in opposition. The high court’s docket identified Rakoczy Molino Mazzochi Siwik LLP, Chicago, as counsel of record for Mylan, and Carlson, Caspers, Vandenburgh, Lindquist & Schuman P.A., Minneapolis, as counsel for Teva.

Purdue Pharma L.P. v. Epic Pharma, LLC , U.S., No. 16-289, review denied 11/14/16 . Grunenthal GmbH v. Teva Pharms. USA, Inc. , U.S., No. 16-296, review denied 11/14/16 .

To contact the reporter on this story: Tony Dutra in Washington at adutra@bna.comTo contact the editor on this story: Mike Wilczek at mwilczek@bna.com

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