Mylan & Apotex Submit Motions For Reconsideration of District Court Decision; Mylan Petitions FDA to Prevent the Delisting of NORVASC Patent

May 3, 2007

It has been a hectic week for those of us following the various twists and turns involving generic versions of Pfizer’s high blood pressure drug NORVASC (amlodipine besylate) Tablets and the availability and applicability of both 180-day generic drug exclusivity and pediatric exclusivity with respect to U.S. patent No. 4,879,303 (“the ‘303 patent”) covering NORVASC. 

On Monday, the U.S. District Court for the District of Columbia issued its opinion in Mylan Labs. et al. v. Leavitt et al., No. 07-579 (D.D.C. 2007) denying: (1) Mylan’s application for a preliminary injunction; (2) Apotex’s motion for a preliminary injunction; and (3) Teva’s application for injunctive relief.  The court essentially agreed with FDA’s April 18, 2007 letter decision, in which the Agency concluded that:

  • All of the unapproved ANDAs are currently blocked by Pfizer’s pediatric exclusivity.
  • If and when the mandate effectuating the panel’s March 22 decision issues in the Apotex case, Apotex’s ANDA will not be blocked by Pfizer’s pediatric exclusivity.
  • FDA cannot determine on the current record whether other ANDAs will continue to be blocked by pediatric exclusivity at this time.
  • Mylan’s 180-day marketing exclusivity terminated when the patent expired.

Orange Book Blog provides an excellent overview of the court’s decision.

Today we learned that Apotex filed an Emergency Motion for Reconsideration of Denial of its Motion for Preliminary Injunction, and that Mylan filed a Motion for Reconsideration of the Opinion and Order Denying Mylan’s Motion for Preliminary Injunction.

Apotex requests that the court reconsider its April 30, 2007 decision, because:

in view of the fact that, in addition to being reversed by the Federal Circuit in Pfizer v. Apotex, the district court’s judgment against Apotex was vacated by the district court in an Order dated March 29, 2007 . . . .  Under this Court’s ruling in the present case, a district court’s decision is considered binding on FDA unless it is stayed or mandate issues overturning the judgment . . . .  Because the district court injunction in Apotex’s case has been vacated, Apotex is entitled to the same benefit that Mylan has already received . . . .  In other words, if a stay of the district court’s injunction counts for Mylan, it must count for Apotex too under the logic of FDA’s and this Court’s decisions.  As such, Apotex is entitled to an injunction to compel immediate final approval and entry to market, just like Mylan.

Mylan requests that the court reconsider its April 30, 2007 decision with respect to the applicability of Pfizer’s pediatric exclusivity to Apotex’s ANDA, and argues that:

Apotex’s ANDA must be treated as a paragraph II certification for all purposes.  As a matter of fact, the FDA converted Apotex’s paragraph IV certification to a paragraph II certification when the ‘303 patent expired on March 25.  The mistaken assumption that Apotex retained its paragraph IV certification led the Court to apply § 355a(c)(2)(B) of the [Best Pharmaceuticals for Children Act], which governs paragraph IV certifications.  The Court should have applied § 355a(c)(2)(A), which governs paragraph II applications and unambiguously provides that such applications shall not be approved for six months after patent expiration.

Mylan has not yet indicated whether the company will challenge FDA’s and the district court’s decisions that Mylan’s eligibility for 180-day exclusivity does not extend beyond expiration of the ‘303 patent covering NORVASC.  However, three days before the district court’s decision, Mylan submitted a citizen petition to FDA requesting that the Agency not delist the ‘303 patent from the Orange Book during any 180-day exclusivity period to which Mylan is entitled. 

Mylan argues that the company’s “hard-earned exclusivity is in jeopardy if Pfizer requests the Agency to delist the ‘303 patent and the Agency complies with that request,” and that the “policy underlying [180-day exclusivity] would be frustrated if an NDA holder such as Pfizer could extinguish a first-filer’s market exclusivity by delisting its patent.”  Mylan cites the FDC Act, FDA’s regulations, and precedents involving mirtazapine and brimonidine tartrate to support the company’s position. 

Mylan’s petition acknowledges, however, that FDA’s regulations “would allow delisting after patent expiration,” but notes that the company is challenging FDA’s position that 180-day exclusivity ends when the patent subject to a paragraph IV certification expires.  Given the fact that Mylan’s petition preceded the district court’s April 30th decision, the company’s petition would appear to be moot, unless Mylan challenges the court’s decision on this issue.

Categories: Hatch-Waxman