First, pioneer drugs, those with NCEs new to the market, receive a five-year exclusivity period, during which time no ANDA may be submitted.
84) The American regulatory system is not designed for this new environment--the regime protects brand-name manufacturers with long exclusivity periods to shield their flagship pioneer drugs.
95) In 1992, the Commission introduced the Supplementary Protection Certificate ("SPC") to extend the monopoly period of pioneer medications by an additional five years from their time of marketing, thereby allowing up to a fifteen-year effective monopoly period for pioneer drugs.
The FDA's Orange Book restriction conflicts with both of the stated purposes of the Hatch-Waxman Act, and would confer substantial additional rights on pioneer drug patent owners that Congress quite clearly did not intend to confer.
BMS is the earliest case addressing the FDA's authority to approve ANDAs even though the label of the generic drug would not include an indication that appears on the label of the pioneer drug.
So long as the generic drug label does not render the drug less safe or effective than the pioneer drug, the generic should satisfy Hatch-Waxman's (and consequently the FDA's) labeling requirements.
section] 355(j) (2) (A) (v) permits the agency to approve an ANDA for a new generic drug even though the label of the generic product will not include one or more indications that appear on the label of the pioneer drug upon which the ANDA is based.
170) See Mahn, supra note 1, at 10-11 ("Because patents to nonapproved conditions were not to be listed in the Orange Book, FDA appeared willing to accept the rationale that generics could omit language from pioneer drug labels protected by claims of patents that were not eligible for listing, and, hence, not subject to the generic certification requirement.
T]he purpose of Title I of the Bill is to make available more low cost generic drugs by establishing a generic drug approval procedure for pioneer drugs.