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Mutual Pharmaceutical Jumps the Gun By Sending Paragraph IV Notice Letter Before Acceptance of ANDA

By Aaron Barkoff

GlaxoSmithKline v. Mutual Pharm., No. 08-549 (E.D. Pa. 2008)

The U.S. District Court for the Eastern District of Pennsylvania recently granted a motion for judgment on the pleadings in a paragraph IV case because the ANDA filer sent its notice letter prematurely, before FDA had accepted the ANDA for filing.  The case concerns Mutual Pharmaceutical's generic version of GlaxoSmithKline's heart medication Coreg CR (carvedilol phosphate).

Mutual submitted its ANDA for carvedilol phosphate 80 mg capsules on November 19, 2007.  On December 21, Mutual filed an amendment to its ANDA, with a paragraph IV certification with respect to Glaxo's U.S. Patent No. 7,268,156.  At the same time, Mutual sent Glaxo a paragraph IV notice letter, but FDA had not yet accepted Mutual's ANDA at the time.

On February 4, 2008 (the 45th day after receiving Mutual's notice letter), Glaxo filed a complaint for declaratory judgment that, among other things, Mutual's paragraph IV notice letter was "improper, null, void, and without legal effect."  Mutual counterclaimed for a declaratory judgment that the '156 patent is invalid.  On March 17, following FDA's acceptance of Mutual's ANDA for filing, Mutual sent Glaxo a second notice letter.  The following day, Glaxo filed a motion for judgment on the pleadings.

In opposition to Glaxo's motion, Mutual argued that the relevant statute "says nothing that prohibits giving voluntary notice before the FDA has issued filing acceptance."  According to the court, Mutual "seems to suggest that an ANDA applicant may send a Paragraph IV notice letter and thus trigger patent litigation, at any time it chooses."

In a decision on April 28th, however, the court concluded that "under the statute and regulations, the sending of a notice of a Paragraph IV certification is expressly predicated upon the ANDA applicant receiving its own notice and acknowledgment from the FDA that the submitted ANDA has been received."  The court noted that the "Paragraph IV notice sequence ensures that the statutory litigation triggers do not result in unnecessary patent infringement litigation initiated by incomplete ANDAs."  The court cited legislative history and FDA's interpretation of the statute in support of its decision.

Furthermore, the court rejected Mutual's argument that even if the court dismissed Glaxo's patent infringement claim without prejudice, it retained subject matter jurisdiction over Mutual's counterclaim for a declaratory judgment of patent invalidity.  Here, the court contrasted the facts of the case with those of the Teva v. Novartis and Caraco v. Forest cases.  Additionally, the court reasoned that "due to the unfiled status of the ANDA, Defendants were not alleged infringers at the time this case was brought."

On April 30, Glaxo filed a second suit against Mutual, within the 45-day period from receipt of Mutual's second notice letter.  Interestingly, on May 27, Mutual filed a Notice of Appeal of the district court's decision on the first lawsuit.

Full post as published by Orange Book Blog: At the Intersection of Patent Law and FDA Law on July 01, 2008 (boomark / email).