Geneva tells distributors to hold generic captopril pending resolution of Bristol hearing.

GENEVA INSTRUCTING DISTRIBUTORS TO HOLD GENERIC CAPTOPRIL pending the outcome of a hearing with Bristol-Myers Squibb over a temporary restraining order issued by a Newark federal court judge Nov. 11. The TRO came one day after the Ciba-Geigy subsidiary began shipping the generic version of Bristol's ACE inhibitor Capoten following the Nov. 9 approval of Geneva's ANDA ("The Pink Sheet" Nov. 13, T&G-1).

A hearing in the Newark federal court originally scheduled for Nov. 17 has been postponed to Nov. 21. Bristol is understood to have posted a $500,000 bond to secure Geneva for the six days between the TRO and the originally-scheduled hearing date.

Several other companies which hold tentative approvals for captopril also have amended their ANDAs to include paragraph IV certifications. Bristol has brought patent infringement suits against Mova, Mylan and Lemmon under Waxman/ Hatch procedures.

Royce continues to pursue approval for its generic captopril ANDA. Oral arguments were scheduled for Nov. 16 in Royce's suit in Atlanta federal court challenging FDA's decision not to approve the captopril ANDA following a favorable ruling by a Miami federal court. However, the federal government shutdown prevented Department of Justice lawyers from traveling to Atlanta, and oral arguments have been waived in the suit. The Miami court ruling was overturned by an appeals court ("The Pink Sheet" Nov. 6, T&G-1).

In a Nov. 15 letter to Geneva, Royce maintained that a favorable decision from the U.S. Supreme Court in its patent infringement suit would give Royce 180 days of exclusivity on generic captopril.

"Should Royce prevail in that case, Royce will claim a right to exercise exclusive commercial marketing and sale of generic captopril pursuant to 21 U.S.C. Sec. 355(j)(4)(B)(iv), because Royce's `paragraph IV' certification (dated June 26, 1995) predated Geneva's similar certification. Therefore, this letter is to advise you that in such event, it is Royce's position that any sales of Geneva's captopril prior to 180 days after such Supreme Court ruling may infringe on Royce's exclusivity rights," the letter states.

Royce may not be able to claim this exclusivity because Bristol's subsidiary Apothecon filed a perfunctory paragraph IV certification to gain full approval for its captopril ANDA. The Apothecon product has not yet been launched.

In a similar case in 1992, Schein's Danbury subsidiary was denied the 180-day ANDA exclusivity for generic atenolol/chlorthalidone following a successful patent challenge over Zeneca's Tenoretic. Schein's paragraph IV certification was pre-empted by a paragraph IV certification from Zeneca's IPR subsidiary. FDA's position is that the first company to file a complete ANDA and paragraph IV certification statement is the only one eligible for ANDA exclusivity.