Purdue Asks Sup. Ct. to Rescue Patents on OxyContin

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By Tony Dutra

Sept. 8 — OxyContin maker Purdue Pharma L.P. and another oxycodone patent holder filed separate petitions for U.S. Supreme Court review Sept. 1, hoping to overturn invalidity rulings in federal court.

Purdue is defending as nonobvious its three patents on a less toxic formulation known as low-ABUK oxycodone ( Purdue Pharma L.P. v. Epic Pharma, LLC, U.S., No. 16-289, review sought 9/1/16 ). Grünenthal GmbH contends that the U.S. Court of Appeals for the Federal Circuit misapplied standards for determining a lack of invention novelty when it invalidated its patent on making OxyContin resistant to abuse ( Grunenthal GmbH v. Teva Pharms. USA, Inc., U.S., No. 16-296, review sought 9/1/16 ). Purdue licenses Grünenthal's patent.

Source Material:

Case below: 811 F.3d 1345

U.S. Patent:No. 7,674,799 No. 7,674,800 No. 7,683,072 No. 8,114,383

The high court is Purdue's last hope to stall certain generic versions planned by Amneal Pharmaceuticals LLC, Epic Pharma LLC, Mylan Pharmaceuticals Inc. and Teva Pharmaceuticals USA Inc.

Purdue: Formulation Nonobvious Under Holistic Inquiry

The petitions challenge different portions of the same Federal Circuit decision. Purdue Pharma LP v. Epic Pharma, LLC, 811 F.3d 1345, 117 U.S.P.Q.2d 1733 (Fed. Cir. 2016) (21 PTD, 2/2/16).

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.

Since a Supreme Court decision in 1923, an invention merits a patent if the inventor discovers the source of a recognized problem and applies the remedy, Purdue said, citing Eibel Process Co. v. Minnesota & Ontario Paper Co., 261 U.S. 45 (1923). But the Federal Circuit ruled that Eibel Process doesn't apply when the patent claims the end product, rather than the method of solving the problem, Purdue claims.

The court applied “parochial limitations” and failed to conduct a “holistic inquiry into nonobviousness,” according to the petition.

Grünenthal: Big Stretch in Novelty Analysis

Grünenthal's U.S. Patent No. 8,114,383 covers abuse-resistant OxyContin, using “thermoforming” technology that makes the pills so hard it prevents crushing them and injecting the powder to get an opioid high. The Federal Circuit agreed with the district court that the patent was anticipated by an earlier “McGinity” patent.

According to the petition, McGinity's patent specification didn't describe at least two elements of the invention claimed in the '383 patent—use with opioids and a high breaking strength. The court said, though, that McGinity's references to “a broader group of analgesics” was directly related, and the required hardness is an inherited quality of thermoforming.

The Federal Circuit's ruling on the former is more closely related to obviousness analysis, Grünenthal said. And “inherent anticipation” can't apply when the prior art reference didn't even mention opioids, the products inheriting the quality, it said.

Gregory A. Castanias of Jones Day, Washington, filed Purdue's petition. Charles E. Lipsey of Finnegan, Henderson, Farabow, Garrett & Dunner LLP, Reston, Va., filed Grünenthal's petition. Responses are due Oct. 6 and 7, respectively.

Before the Federal Circuit, Akin, Gump, Strauss, Hauer & Feld LLP, Philadelphia, represented Amneal; Rakoczy Molino Mazzochi Siwik LLP, Chicago, represented Mylan; and Carlson, Caspers, Vandenburgh, Lindquist & Schuman P.A., Minneapolis, represented Teva.

To contact the reporter on this story: Tony Dutra in Washington at adutra@bna.com

To contact the editor responsible for this story: Mike Wilczek at mwilczek@bna.com

For More Information

Purdue petition available at http://src.bna.com/inE.

Grünenthal petition available at http://src.bna.com/inK.

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