drug by evaluating just the combination of active ingredients rather than each individual active ingredient. Whereas the FDA apparently evaluates combination drugs as a whole in determining their safety and efficacy, see 21 C.F.R. § 300.50, the Act permits patent term extension only with regard to “the active ingredient of [the] drug that receives FDA approval.” Hoechst-Roussel Pharmaceuticals, Inc. v. Lehman, 109 F.3d 756, 759 n. 3 (Fed.Cir.1997). The focus of the FDA approval process is the drug claimed by the patent as a whole, whereas the focus of § 156(a)(5)(A) is the “product,” defined as “the active ingredient” of that drug, whether “as a single entity or in combination with another active ingredient.” 35 U.S.C. § 156(f)(2); Fisons plc v. Quigg, 876 F.2d 99, 101 (Fed.Cir.1989) (<HOLDING>). The USPTO’s policy of extending the patent
holding that the race of the prosecutor is irrelevant holding that fda approval of the entire composition of a drug is irrelevant to the meaning of product in  156a5a holding that when a defendant is sentenced to a term that does not exceed the statutory maximum allowed for an indeterminate amount of the drug involved the jurys determination of drug quantity is practically irrelevant holding that the mere fact that the fda does not require a warning on a product label does not necessarily create a conflict holding that referring the issue to fda would be wasteful and duplicative in case where fda had filed seizure actions after rejecting premos attempt to file drug with agency