By Kurt R. Karst -
In an unpublished, and subsequently sealed, decision handed down earlier this week by Chief Judge Garrett Brown, Jr. of the U.S. District Court for the District of New Jersey, the court dismissed without prejudice an Amended Complaint filed by Paddock Laboratories, Inc. ("Paddock") seeking a declaratory judgment of noninfringement and invalidity of Orange Book-listed U.S. Patent No. 7,101,574 ("the ‘574 patent") covering ANTARA (fenofibrate) Capsules, which is approved under NDA No. 21-695, and granted a Motion to Dismiss filed by defendants Ethypharm S.A., Lupin Limited, and Lupin Pharmaceuticals, Inc. (collectively "Ethypharm/Lupin") arguing that the court lacks subject matter jurisdiction over the action. The decision is the first that we are aware of in which a court has exercised its discretion to decline jurisdiction under the Declaratory Judgment Act based on FDA’s requirement that an ANDA sponsor make a Paragraph IV recertification.
Paddock, which is reportedly not a first applicant eligible for 180-day exclusivity, submitted ANDA No. 91-362 to FDA in February 2009 seeking approval to market generic fenofibrate capsules, 43 mg and 130 mg. Paddock’s ANDA contained a Paragraph IV certification to the ‘574 patent. After FDA received the ANDA, Paddock reportedly provided timely notice if its Paragraph IV certification to Ethypharm/Lupin, but was not sued for patent infringement within the statutory 45-day period (or thereafter), which would have triggered a 30-month stay of approval of ANDA No. 91-362. As such, in July 2009, and consistent with the FDC Act’s declaratory judgment provisions at § 505(j)(5)(C) as added by the December 2003 Medicare Modernization Act, Paddock filed a complaint seeking a declaratory judgment that the company’s proposed fenofibrate capsules drug product does not infringe the ‘574 patent.
Just one month after Paddock filed its initial Complaint (later amended), FDA apparently informed the company that the Agency’s review of ANDA No. 91-362 was suspended because the proposed drug product did not meet the definition of a "capsule," and recommended that the company reformulate its drug product. Paddock has described its initial proposed drug product as having the active ingredient coated on the outside of the capsule. (Interestingly, in August 2010, FDA denied without comment a Lupin citizen petition (Docket No. FDA-2010-P-0092) requesting that FDA refuse to approve Paddock’s ANDA because it is "not in capsule dosage form and, therefore, is not in the same dosage form as Antara capsules.") Paddock apparently followed FDA’s recommendation and submitted an amendment to the company’s pending application, making the drug product a capsule by placing the previous formulation inside a larger, enveloping capsule, but the company reportedly did not submit a new Paragraph IV certification (i.e., a recertification to the ‘574 patent). We understand that FDA subsequently contacted Paddock and conveyed the news that a new certification to the ‘574 patent is required, and Paddock presumably complied. Last fall, Lupin filed a second citizen petition (Docket No. FDA-2010-P-0561) to FDA requesting, among other things, that FDA enforce the FDC Act’s patent certification requirements against Paddock.
In October 2010, Ethypharm/Lupin filed a Motion to Dismiss the case arguing that as a result of FDA’s requirement that Paddock recertify to the ‘574 patent, the court no longer has subject matter jurisdiction. The court agreed in its January 18, 2011 decision, granting Ethypharm’s/Lupin’s Motion to Dismiss, and therefore giving the companies another chance to sue for infringement in response to a new Paragraph IV certification.
Patent recertification issues seem to be a hot topic these days. As we previously reported, in October 2010, FDA granted a citizen petition requesting a second, superseding 30-month stay for one sponsor’s ANDA for a generic version of HECTOROL (doxercalciferol) Injection after the ANDA sponsor reformulated and recertified to certain Orange Book-listed patents. Although the case involving generic ANTARA does not involve a second, superseding 30-month stay (as Ethypharm/Lupin did not sue for infringement in response to Paddock’s initial Paragraph IV certification triggering an initial 30-month stay), it seems likely that, consistent with FDA’s HECTOROL decision, Ethypharm/Lupin will argue for a stay if there is a timely filed patent infringement lawsuit.