FDA Decision on Pfizer's Norvasc Exclusivity Upheld

In an April 18 decision, the FDA determined that Pfizer (PFE) is entitled to six months of pediatric exclusivity on Norvasc (amlodipine besylate). It also stated that Mylan (MYL) may continue to sell its generic version of Norvasc, and that the FDA will approve Apotex's generic Norvasc ANDA if, and when, the Federal Circuit issues a mandate from its March 22 decision. No other Norvasc generics will be approved unless Pfizer's Norvasc patent is removed from the Orange Book.

Last week, Mylan, Apotex, and Teva (TEVA) filed motions in the U.S. District Court for the District of Columbia challenging various aspects of the FDA's decision. Monday morning, in a 22-page Opinion (pdf file) and Order, (pdf file) Judge Ricardo M. Urbina denied all three motions.

Judge Urbina noted at the outset that the FDA's decision is subject to the "arbitrary and capricious" standard of review, under which the court "must consider whether the agency's decision was based on a consideration of the relevant factors and whether there has been a clear error of judgment."

According to the Supreme Court, "The scope of review under the arbitrary and capricious standard is narrow and a court is not to substitute its judgment for that of the agency."

With this in mind, Judge Urbina addressed each of the FDA's decisions:

The FDA's Decision that the Effective Date of the Federal Circuit's Ruling is the Date it Issues its Mandate

Judge Urbina agreed with FDA's decision that Pfizer is entitled to pediatric exclusivity, though he used different reasoning to get there. He reasoned that because 21 USC 355a(c)(2)(B) is silent "as to the particular court which may determine the patent dispute," the January 24, 2006 Northern District of Illinois Order (pdf file) in Pfizer v. Apotex triggered Pfizer's pediatric exclusivity. And, moreover, that decision "is effective and remains so during the pendency of the appeal unless the district court's judgment is stayed or until the Federal Circuit issues its mandate."

I expect Apotex will file a motion for stay very shortly.

The FDA's Decision that Apotex Will Cease to Be Subject to Pfizer's Exclusivity if the Mandate Issues Before September 25, 2007

If FDA had followed its "longstanding practice to deem paragraph IV certifications as paragraph II certifications upon patent expiration,"
Pfizer's pediatric exclusivity period (which began upon the patent's expiration on March 25, 2007) would block final approval for Apotex's ANDA. However, Judge Urbina deferred to the FDA's reasoning that Section 355a "manifests a clear Congressional intent that pediatric exclusivity not block the approval of an ANDA where the ANDA applicant has prevailed in the paragraph IV litigation."

He concluded that the "FDA's decision to exempt Apotex in light of its status as a prevailing party in challenging Pfizer's patent is reasonable and is not contrary to the language in Hatch-Waxman."

The FDA's Decision that Apotex is the Sole Statutory Beneficiary of the Federal Circuit's Apotex Ruling

Here, the FDA ruled that because the Federal Circuit invalidated only three of the claims against Pfizer's Norvasc patent and left several claims untouched, Pfizer's patent remains valid as to the remaining claims and is presumed to be properly listed in the Orange Book. Judge Urbina agreed, concluding that: "Until Teva succeeds in its own patent litigation with Pfizer or until administrative or legal action completely de-lists Pfizer's patent from the Orange Book, the FDA's decision to withhold market approval for Teva's generic drug remains in effect."

The FDA's Decision that Mylan's Eligibility for 180-Day Exclusivity Does Not Extend Beyond Patent Expiration

This one is interesting. It sounds like Mylan meant to hold its challenge to this decision in reserve, but mistakenly filed a brief on it now. The court decided to proceed anyway.

Mylan argued that "nothing in the text or legislative history of the Hatch-Waxman Act indicates that generic exclusivity is forfeited upon patent expiration."

Judge Urbina quickly dispensed with this argument, observing that "[u]nder Hatch-Waxman, paragraph IV certifications are no longer valid upon patent expiration" and must be changed to paragraph II certifications. At that time, the ANDA becomes eligible for immediate final approval.

Because there's so much money at stake, I would be surprised if one or more of the generic companies didn't appeal to the D.C. Circuit.

RELATED READING:

Mylan press release

Bloomberg article