Endo Wins Block on Teva, Amneal Opana ER Copies

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By Dana A. Elfin

Oct. 11 — Endo Pharmaceuticals Inc. won a court ruling that prevents Amneal Pharmaceuticals LLC and Teva Pharmaceuticals USA Inc. from launching generics of its crush-resistant painkiller Opana ER ( Endo Pharm. Inc. v. Amneal Pharm., LLC , 2016 BL 336420, D. Del., Civil Action No. 14-1382-RGA, 10/7/16 )

The generic defendants failed to prove that a patent claiming Opana ER was invalid, said Judge Richard G. Andrews of the U.S. District Court for the District of Delaware in an Oct. 7 opinion. In addition, Andrews rejected Teva's claim that it had an implied license to the patent.

The decision likely is to keep the Teva and Amneal generics off the market until late 2029.

Opana ER is an extended-release opioid used to relieve moderate to severe pain. The Food and Drug Administration approved it in 2006. Opioid analgesics like Opana ER can be highly addictive, and there is growing public concern about the increasing incidence of opioid abuse in the U.S.

In 2012, Endo withdrew the original formula of Opana ER from sale after the FDA approved a new reformulated, crush-resistant version of Opana ER in 2011. The reformulated version, known as Opana ER CRF (crush-resistant formulation), was designed to be more difficult to abuse and misuse.

“We are very pleased with Judge Andrews' ruling for Endo recognizing and upholding the value of innovation and intellectual property,” Matthew J. Maletta, Endo's executive vice president and chief legal officer, told Bloomberg BNA Oct. 11. “As a result of the ruling, we believe Teva and Amneal must remain off the market until patent expiration in November 2029.”

Bloomberg BNA contacted Amneal and Teva Oct. 11 for comment on the ruling, but the companies didn't respond. Mallinckrodt, which licensed the patent to Endo also declined to comment.

Infringement Alleged

The patent at the center of the litigation is U.S. Patent No. 8,871,779. Mallinckrodt LLC, a coplaintiff in the litigation, owns the '779 patent which it licenses exclusively to Endo. In 2004, the Food and Drug Administration mandated opioid manufacturers to lower the levels of an organic compound known as ABUK (alpha, beta-unsaturated ketone) in their products. The '779 patent covers oxymorphone products with low ABUK.

In 2012, Amneal and Teva each filed separate abbreviated new drug applications (ANDAs) seeking to make generic copies of Endo's Opana ER CRF product.

Subsequently, Endo and Mallinckrodt sued both companies in federal court in Delaware for infringement of the '779 patent.

Both Amneal and Teva admitted that their proposed generic Opana ER products infringed the '779 patent but claimed that Endo's patent wasn't enforceable because it was obvious. In addition, Teva argued that it was protected from infringement liability because it had an implied license to the patent from Mallinckrodt.

After a two-day bench trial in July, Andrews ruled for Endo.

Generics' Arguments Rejected

“Defendants failed to prove by clear and convincing evidence that any of the asserted claims of the '779 patent are invalid,” Andrews wrote. In addition, he said that Teva failed to prove its affirmative defense of implied license by a preponderance of the evidence. Accordingly, because the judge rejected all of the patent infringement defenses raised by the generic defendants, their arguments that the patent wasn't enforceable failed.

Teva argued that a Letter of Authorization (LOA), a regulatory document it requested from Mallinckrodt, as well as Teva's two past purchases of low-ABUK oxymorphone active pharmaceutical ingredient (API) from Mallinckrodt supported its implied license argument.

But the judge wasn't convinced by either argument.

Mallinckrodt isn't suing Teva for its past uses of the previously supplied low-ABUK oxymorphone API, the judge wrote. Instead, he said, Mallinckrodt is suing Teva for its inclusion of the low-ABUK oxymorphone API in the generic product that is likely to be sold in the future.

“[T]o succeed in an implied license defense, Teva must show that Mallinckrodt consented to Teva's use of the patented invention in the product likely to be sold,” the judge said. “Under the facts here, there is no such license.”

First, the judge said the LOA, a regulatory document that grants an ANDA applicant permission to incorporate a supplier's API into its ANDA, doesn't create any binding commercial obligations or confer a patent license. Second, with regard to Teva's purchases of API from in 2010 and 2011, the judge said there wasn't any evidence to show that Mallinckrodt's two sales of the API to Teva amounted to Mallinckrodt's consent to Teva's commercial sale of products embodying the '779 patent.

“Teva has not pointed to any evidence demonstrating that Mallinckrodt granted Teva a license to include low-ABUK oxymorphone API in the CRF product it ultimately sells,” the judge said. “That is a fatal shortcoming.”

Antitrust Suits Pending

Meanwhile, Endo is facing antitrust suits over Opana ER.

Impax Laboratories Inc. makes the only other noncrush-resistant version of Opana ER currently on the market, an authorized generic version that it started marketing in January 2013. Authorized generics are generic drugs sold under a license from the patent holder.

Endo granted Impax a license to make the authorized generic as part of a patent litigation settlement. That settlement is the currently at the heart of both government and private payer antitrust lawsuits that allege the authorized generic deal violates antitrust laws (14 PLIR 469, 4/1/16).

The law firms of Dechert LLP in Philadelphia, Princeton, N.J. and Mountain View, Calif. and Morris, Nichols, Arsht & Tunnell LLP in Wilmington, Del., represented Endo Pharmaceuticals

The law firms of Kasowitz, Benson, Torres & Friedman LLP in Atlanta and Redwood Shores, Calif. and Morris, Nichols, Arsht & Tunnell LLP in Wilmington, Del., represented Mallinckrodt LLC.

The law firms of Robins Kaplan LLP, Minneapolis, and Morris James LLP, Wilmington, Del. represented Amneal.

The law firms of Goodwin Procter LLP in New York and Potter Anderson & Corroon LLP in Wilmington, Del. represented Teva.

Endo is based in Ireland, with its U.S. headquarters in Malvern, Pa. Mallinckrodt, with U.S. offices in St. Louis, is based in Ireland.

Teva is based in Israel with U.S. headquarters in North Wales, Pa. Amneal is based in Bridgewater, N.J.

To contact the reporter on this story: Dana A. Elfin in Washington at delfin@bna.com

To contact the editor responsible for this story: Brian Broderick at bbroderick@bna.com

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