Mylan Loses Again on Generic NORVASC

July 9, 2007

On June 29, 2007, the U.S. District Court for the District of Columbia, in Mylan v. Leavitt, issued a memorandum opinion denying Mylan’s Emergency Motion for a Temporary Restraining Order that asked the court to order FDA to relist Pfizer’s U.S. Patent No. 4,879,303 covering NORVASC (amlodipine besylate) until the issue of Mylan’s claim to 180-day exclusivity is resolved.  FDA previously approved Mylan’s ANDA, but was prevented from approving subsequent generic applications due to various exclusivity issues. 

In an April 18, 2007 FDA Letter Decision, and pursuant to the district court’s April 30, 2007 opinion substantially agreeing with FDA, the Agency concluded (with respect to pending ANDAs for generic NORVASC) that “where an applicant has challenged a patent and has received a decision of invalidity or non-infringment, that applicant will not be subject to the NDA holder’s pediatric exclusivity once that decision becomes effective.” Accordingly, FDA approved Apotex’s ANDA once the Federal Circuit issued its mandate in Pfizer, Inc. v. Apotex, Inc.  FDA’s Letter Decision also states that “[i]f the remaining claims [of the ‘303 patent] do not provide a basis on which to list the patent, . . . the patent would no longer be eligible for listing in the Orange Book.  In such a case, the patent must be withdrawn by Pfizer and any pediatric exclusivity that attached to the patent will no longer serve as a barrier to ANDA approval.” FDA and the court also concluded that Mylan’s 180-day exclusivity period expired when the ‘303 patent expired (without pediatric exclusivity) on March 25, 2007.  Mylan sought reconsideration of this issue, which the court denied in a May 14, 2007 order.  Mylan then appealed the issue to the D.C. Circuit, where the case is being briefed.

On June 14, 2007, Pfizer notified FDA that the ‘303 patent no longer meets the Orange Book listing criteria with respect to NORVASC and requested that the Agency delist the patent from the Orange Book.  FDA delisted the patent on June 22, 2007 and notified ANDA applicants of this action on the same day.  FDA subsequently approved ANDAs submitted by Synthon and Teva on June 27 and June 28, 2007, respectively.  There are still several tentatively approved amlodipine besylate ANDAs awaiting final approval. 

On June 26, 2007, Mylan submitted an application for a preliminary injunction seeking to enjoin FDA “from taking any action to issue an approval of any [ANDA] for amlodipine besylate products in derogation of Mylan’s right to 180-day exclusivity until the issue is finally decided on appeal.”  In Mylan’s accompanying memorandum, the company states “[n]ow that the FDA has delisted the Pfizer patent, Mylan’s claim to 180-day exclusivity has moved to the forefront. . . .  Mylan is likely to prevail on its claim to 180-day exclusivity in the Court of Appeals, but its victory will be hollow unless the Court maintains the status quo until the appeal has been decided.”

FDA’s opposition memorandum states that “[u]nder the law of this Circuit, this Court has no jurisdiction to revisit [the 180-day exclusivity] issue at this time.  For this reason, Mylan’s application should be denied.  Even if the Court were to examine this issue, however, it has no merit and should be rejected.”  Teva’s opposition memorandum similarly states that “[b]eyond the fact that Mylan’s motion merely reiterates the same discredited arguments that this Court previously considered and rejected, its motion asks this Court to exercise jurisdiction it plainly does not possess.”  Mylan’s reply memorandum counters these arguments and states:

The FDA and Teva would prefer that this Court avoid the merits of Mylan’s motion for injunctive relief pending appeal by ruling that it does not have jurisdiction now that the Court’s denial of Mylan’s earlier motion for a preliminary injunction is on appeal. But both the Federal Rules of Civil Procedure and case law from this Circuit make clear that the Court may maintain the status quo while the case is on appeal. That is exactly what Mylan seeks here –no more and no less. On the merits, the FDA relies on cases holding that eligibility for 180-day exclusivity does not survive patent expiration, ignoring the fact that here Mylan’s 180-day exclusivity had vested before the ‘303 patent expired.

The district court, not persuaded by Mylan’s arguments, issued its memorandum opinion on June 29, 2007.  The court concluded that “[i]njunctive relief emanating from this court is wholly inappropriate.  [Mylan] has made no showing of irreparable harm.  The court maintains confidence in its substantive legal ruling regarding the 180-day exclusivity and its prior conclusion regarding the balance of harms to other parties and the public.  Moreover, its ruling is presently before the Circuit . . . .  Accordingly, the court denies the plaintiff’s request for a TRO and a stay pending appeal.”

The reasons for Pfizer’s decision to request that FDA delist the ‘303 patent are unclear, as the continued listing of the patent in the Orange Book could prevent additional generic competition until September 2007.  Unless the D.C. Circuit reverses the district court’s decision on the issue of Mylan’s claim to 180-day exclusivity, FDA may continue to grant final approval to tentatively approved amlodipine besylate ANDAs.

Categories: Hatch-Waxman