The 180-day exclusivity for first generics cannot extend beyond the expiration of the patent challenged in the ANDA's paragraph IV certification, FDA said in granting exclusivity to American Pharmaceutical Partners for generic cisplatin even though it was not the first company to submit an ANDA for the drug.

Pharmachemie was originally eligible for exclusivity for generic cisplatin (Bristol-Myers Squibb's Platinol AQ) because its ANDA, referencing patent 4,310,515, was the first submitted.

However, "that eligibility was only with respect to the '515 patent," which expired Jan. 12, FDA said. "Because exclusivity cannot extend beyond the expiration of a patent, Pharmachemie lost eligibility for exclusivity when the '515 patent expired" before exclusivity was triggered.

APP submitted its ANDA after Pharmachemie's, but was the first applicant to amend its paragraph IV certification to challenge Bristol's patent 5,562,925, which Bristol licensed from Research Corporation Technologies after it was granted to RCT in 1996. Pharmachemie and other applicants have since amended their certification to address the '925 patent.

FDA approved APP's ANDA for generic cisplatin July 16 with 180 days of market exclusivity. APP and generic cisplatin applicants Benvenue Labs, Gensia Sicor and Pharmachemie are currently awaiting a ruling from Trenton, N.J. federal court Judge Garett Brown, who heard arguments from the defendants on the claim of "obviousness type double patenting" for Bristol's '925 patent on July 28. APP does not plan to market the drug until the judge issues a decision.

In a June 9 petition to FDA, Pharmachemie maintained that generic exclusivity should be granted to the first paragraph IV ANDA holder to file, regardless of subsequent changes to the application's certification or to the patent challenged (¹ Also see "Pharmachemie Cisplatin ANDA Should Get 180-Day Exclusivity As First To File" - Pink Sheet, 28 June, 1999.).

FDA's proposed regs on 180-day exclusivity note that if the first ANDA applicant files with paragraph IV certification for a patent that subsequently expired, the applicant would become ineligible for the 180 days (² Also see "ANDA 30-Month Stay Of Approval Does Not Apply If Patent Case Is Settled" - Pink Sheet, 16 August, 1999.).

Generic Exclusivity Does Not Apply After Challenged Patent Expires - FDA

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