GLAXO’s CEFTIN TWO-YEAR PATENT EXTENSION UPHELD

GLAXO's CEFTIN TWO-YEAR PATENT EXTENSION UPHELD in a Jan. 24 decision by a federal court of appeals. The appellate court affirmed a Feb. 17 ruling by the Alexandria, Virginia federal court that Ceftin (cefuroxime axetil) is a different product than cefuroxime (Lilly's Kefurox) and is entitled to a two-year patent extension, to May 2000, under the 1984 ANDA/patent term restoration law. The appeals court's decision represents the first federal circuit ruling in favor of a drug manufacturer seeking patent term restoration after an initial denial by the Patent and Trademark Office. The circuit court upheld the district court's reversal of PTO's judgment that the Ceftin patent was ineligible for extension. PTO had reasoned that the Ceftin contained the same active ingredient as the previously approved Kefurox because the active moiety of the two products was the same ("The Pink Sheet" Feb. 27, p. 8). In its opinion, the circuit court said "it is undisputed that cefuroxime axetil is the active ingredient of Ceftin tablets." The 1984 act allows patent extension for "the first permitted commercial marketing or use of the product," and the law defines "product" as "the active ingredient of a new drug...including any salt or ester." The circuit court said the act provides "precise statutory definitions" of active ingredient, salt, ester and acid. "The plain meaning of the statutory language must stand as Congress' intent and be honored by both the courts and the" PTO. The ruling adds further substance to industry objections against FDA's use of "active moiety," instead of "active ingredient," in proposed regs implementing the ANDA portion of the Waxman/Hatch law. The Pharmaceutical Manufacturers Association objected to the proposed terminology in Jan. 9 comments to the agency, citing the lower court ruling in the Ceftin case as well as comments made by the court in Abbott's Depakote exclusivity case ("The Pink Sheet" Jan. 22, p. 16).