martes, 9 de diciembre de 2014

FDA Law Blog: Third Circuit Kicks OPANA ER Therapeutic Equivalence Rating Lanham Act Case Back to District Court

FDA Law Blog: Third Circuit Kicks OPANA ER Therapeutic Equivalence Rating Lanham Act Case Back to District Court

Posted: 08 Dec 2014 07:37 PM PST
By Kurt R. Karst –

'Tis the season to give back.  And that’s exactly what the U.S. Court of Appeals for the Third Circuit did late last week when itvacated and remanded for further proceedings a September 3, 2013 decision from the U.S. District Court for the District of New Jersey stemming from a 2012 Complaint Endo Pharmaceuticals, Inc. (“Endo”) filed against Actavis. Inc. and Actavis South Altantic LLC (collectively “Actavis”) alleging that Actavis violated the federal Lanham Act and the New Jersey Fair Trade and Consumer Fraud Acts by marketing its Oxymorphone HCl Extended-release Tablets drug products (approved under ANDA 079046) as “AB-rated” to Endo’s OPANA ER (oxymorphone HCl extended-release) Tablets drug products.

As we previously reported, OPANA ER is approved under two NDAs: (1) NDA 021610 covers an old formulation of OPANA ER that is no longer marketed and is listed in the “Discontinued Drug Product List” section of FDA’s Orange Book without a therapeutic equivalence rating; and (2) NDA 201655 covers Endo’s currently marketed crush-resistant version of OPANA ER, and for which no generic versions are approved.  NDA 021610 is the application referenced in Actavis’s approved ANDA 079046, which is listed in the Orange Book with an “AB” therapeutic equivalence rating with respect to other approved generic versions of OPANA ER (NDA 021610).

Endo alleged that “[d]espite the fact that its Generic Oxymorphone ER Tablets are not crush-resistant and were not approved based on the current Opana® ER [NDA], Actavis is falsely marketing its Generic Oxymorphone ER Tablets as ‘AB Rated to Opana® ER’,” and that “Actavis’s Generic Oxymorphone ER Tablets are not and never have been AB rated to the only Opana® ER tablets sold by Endo since May 2012, i.e., the crush-resistant tablets, and those Generic Oxymorphone ER Tablets are not designed to be crush-resistant like Opana®ER.”  Actavis subsequeently filed a Motion to Dismiss the case, arguing that the federal Lanham Act cannot be used as a tool to privately enforce the FDC Act.

In his September 2013 decision, District Court Judge Dennis M. Cavanaugh ruled for Actavis, granting the company’s Motion to Dismiss.  Applying the doctrine of primary jurisdiction, Judge Cavanaugh said that the issue of AB-rating is one for FDA to decide: “This Court defers to the FDA to determine whether the new formulation of Opana ER is no longer AB equivalent to the generic Actavis product. . . . [I]t would be improper for the Court to make a determination on this matter before the FDA has had an opportunity to do so.”

Importantly, while Endo’s Lanham Act case was moving through the New Jersey District Court (specifically, after briefing in this case had been completed), FDA ruled on a Citizen Petition and determined that the original formulation of OPANA ER approved under NDA 021610 and listed in the “Discontinued Drug Product List” section of the Orange Book was not withdrawn from sale for reasons of safety or effectiveness.  We previously posted on that decision here

Endo appealed Judge Cavanaugh’s decision to the Third Circuit where the parties sparred over, among other things, FDA’s Citizen Petition decision on the discontinuation of OPANA ER (NDA 021610) and the importance of that decision (or not) to the case.  According to Endo, the Third Circuit “should reverse the district court’s order granting Actavis’s motion to dismiss and remand to the district court to address the merits of Endo’s Lanham Act claims,” because “Lanham Act claims concerning pharmaceuticals may proceed provided they do not intrude upon the FDA’s expertise or exclusive authority to enforce its regulations,” which Endo contends is the case with OPANA ER.  The briefs in the case are available hereherehere, and here.

In its December 5th decision, the Third Circuit decided that the best course of action is to hand the case back to the New Jersey District Court.  “The District Court applied the doctrine of primary jurisdiction because it believed that the FDA had special competence to determine ‘whether Actavis’s generic is still AB equivalent to Opana® ER,’” wrote the three-judge panel of Circuit Judges Chagares, Hardiman, and Schwartz.  “Now that the FDA has issued its [Citizen Petition] determination, however, the District Court’s rationale for applying the primary jurisdiction doctrine is moot.  The logical course is to remand for the District Court to address the remaining arguments in the first instance.”

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