Pravachol Exclusivity Ruling Adds Uncertainty For ANDA Filers, Counsel Says

A court decision reinstating Teva's generic exclusivity rights for Pravachol will make it more difficult for ANDA filers to predict when a dismissed declaratory judgment action could trigger 180-day exclusivity, FDA Associate Chief Counsel Elizabeth Dickinson said Oct. 26.

In an Oct. 21 ruling, D.C. federal Judge John Bates overturned FDA's determination that Teva's exclusivity on pravastatin was triggered by the dismissal of Apotex' declaratory judgment action against Bristol-Myers Squibb.

The court's ruling "will make it increasingly difficult for industry to try and posture itself, position itself, in a way that it will know the outcome of a particular dismissal," Dickinson said at the Generic Pharmaceutical Association's technical conference.

In June, FDA determined that Teva's exclusivity on three dosage strengths of Bristol's statin was triggered on Aug. 22, 2004, the date of a final court order dismissing Apotex' declaratory judgment action over three Pravachol patents (¹ (Also see "Teva Loses Exclusivity On Generic Pravachol; Earlier Court Case Was Trigger" - Pink Sheet, 11 Jul, 2005.), p 28).

Pursuant to FDA's decision, Teva's exclusivity rights to the 10 mg, 20 mg and 40 mg doses of pravastatin would have expired in February 2005. Teva filed suit on July 26 challenging FDA's decision.

In the underlying dispute, Bristol wrote Apotex multiple letters stating that it had no intention of suing Apotex for infringement of the three patents.

Nevertheless, Apotex filed a declaratory judgment action. Bristol subsequently moved to have the action dismissed for lack of case or controversy.

Apotex and Bristol reached a "voluntary, consensual stipulation" to dismiss the action, Judge Bates' opinion notes.

However, FDA determined that the dismissal of the action constituted a "decision of the court," thereby triggering exclusivity. The agency based its reasoning on an earlier case involving a dispute between Teva and Apotex over exclusivity for Roche's Ticlid (ticlodipine) (² (Also see "Dismissal Of Teva Suit Triggered Ticlopidine 180-Days, Appeals Court Rules" - Pink Sheet, 26 Jul, 1999.), p. 32).

Judge Bates concluded that "under both Second Circuit and D.C. Circuit law, the BMS-Apotex dismissal is not a 'decision of a court'" under Waxman/Hatch. Consequently, "the 180-day exclusivity period for Teva as the first ANDA applicant was not triggered by the filing or court approval of that dismissal."

"This dismissal was wholly voluntary and entirely uncontested," and did not even require the court's signature, Judge Bates said. "The district court weighed no evidence and made no judgments."

Apotex has appealed Judge Bates' ruling.

Dickinson told the GPhA audience that the Pravachol decision "has another level of complexity as you all and we are trying to determine when exclusivity for a particular drug product has been triggered as a result of the DJ action."

The ruling could set a standard for an inquiry into "the extent of the fact finding" in the underlying DJ case, as well as "consideration of jurisdiction in which the dismissal occurred," the FDA attorney said.

Declaratory judgments remain a troublesome issue for the generic drug industry.

In January, the Federal Circuit Court of Appeals ruled that the Medicare Modernization Act's generic drug reforms did not relax the requirement that an ANDA filer establish a "reasonable apprehension" of being sued in order to bring a declaratory judgment action (³ (Also see "Declaratory Judgment Ruling Will Add Uncertainty To Generic Launches" - Pink Sheet, 31 Jan, 2005.), p. 33).

Pravachol is slated to lose exclusivity in April. Generic marketing rights for another statin scheduled to go off-patent in 2006 - Merck's Zocor (simvastatin) - are also the subject of litigation (see ⁴ (Also see "Zocor Exclusivity: Ranbaxy Needs Quick Win In Suit Seeking Patent Re-Listing" - Pink Sheet, 31 Oct, 2005.) ).

The growing number of generic drug legal disputes has forced a change in FDA's nomenclature for the court cases, Dickinson noted.

"We're going to have to start numbering these cases," the FDA attorney said. "I think we're up to Teva IV or V, and Apotex IV or V.... Now we describe them in our own internal documents by the name of the drugs that ...are in dispute because it has gotten so complicated."