Teva has nine months to resolve questions surrounding its first-to-file rights for generic pravastatin before the expiration of Bristol-Myers Squibb's exclusivity for Pravachol in April 2006.

Teva is considering its legal and administrative options in response to FDA's decision that the 180-day exclusivity period for generic pravastatin was triggered by an earlier court order and has already expired.

FDA has determined that any exclusivity period for pravastatin was triggered on Aug. 22, 2004, the date of a final court order dismissing a case filed by Apotex against Bristol over three Pravachol patents.

The agency's decision means that the 180-day exclusivity period on generic pravastatin 10 mg, 20 mg, 40 mg and 80 mg expired in February 2005.

As a result, Teva, which believes it holds first-to-file rights on generic pravastatin 10 mg, 20 mg and 40 mg, will not receive a six-month exclusivity period, the company said in a July 6 press release. The first-to-file holder of 80 mg would be similarly affected.

As many as six generic companies - including Teva and Apotex - could be in a position to launch pravastatin generics when Pravachol loses exclusivity on April 20, 2006. Teva, Apotex, Ranbaxy, Sandoz, Ivax and Lek hold tentative approvals for various doses of pravastatin.

In a letter to Teva explaining its decision, FDA said that any exclusivity period from patent nos. 5,030,447, 5,180,589, and 5,622,985 began on Aug. 22, 2004, the date an order dismissing a declaratory judgment action filed by Apotex against Bristol became final.

A fourth patent listed in FDA's "Orange Book" (no. 4,346,227) is the Pravachol composition-of-matter patent, which expires on April 20, 2006, following a six-month pediatric extension period.

Teva said it "strongly disagrees" with FDA's interpretation of the case law and believes there are "significant distinctions between the facts surrounding the pravastatin dismissal and the prior case law."

FDA appears to be using a 1999 lawsuit involving Roche's Ticlid (ticlopidine) to support its decision.

In that case, Apotex and Teva took views opposite to the Pravachol case: Apotex held first-to-file rights to generic ticlopidine and Teva took legal action in an attempt to open up the market to additional generics.

In the Ticlid case, Teva filed for a declaratory judgment in June 1998 that its ticlopidine generic did not infringe Roche's Ticlid patent. The suit was dismissed in August of that year for lack of subject matter jurisdiction based on a statement from Roche verifying non-infringement.

Teva argued that the dismissal triggered the clock on Apotex' 180-day exclusivity period for generic ticlopidine. FDA disagreed, and approved Apotex' generic in July 1999 with 180 days of exclusivity.

A D.C. federal court upheld FDA's decision, but the case was overturned on appeal, with the D.C. federal appeals court ruling that Apotex' 180-day exclusivity period was triggered by the dismissal of Teva's declaratory judgment action against Roche (¹ Also see "Dismissal Of Teva Suit Triggered Ticlopidine 180-Days, Appeals Court Rules" - Pink Sheet, 26 July, 1999., p. 32).

Teva believes FDA's interpretation of the prior case law is incorrect.

Teva argues that in the Ticlid case, the court made a ruling on non-infringement, which started the clock on Apotex' six-month exclusivity. The Pravachol decision, however, did not determine whether Teva infringed, and therefore is not an appropriate trigger, the company maintained.

"Teva will immediately pursue legal action to obtain reversal of the decision," the company said.

FDA's decision comes as a surprise to Teva: as recently as May 3, the firm said it expected 180 days of exclusivity on the three lowest pravastatin doses.

Bristol also appears to have anticipated a 180-day exclusivity period for generic pravastatin. In a discussion of the Apotex suit in a 10-Q filing with the Securities & Exchange Commission in August 2004, Bristol said the "initial generic ANDA filers...are expected to have 180 days of semi-exclusivity after April 2006."

Bristol is pursuing an over-the-counter switch of Pravachol 20 mg.

Teva Loses Exclusivity On Generic Pravachol; Earlier Court Case Was Trigger

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