Baker Norton Pharmaceuticals, Inc. v. Food and Drug Administration

Under the Orphan Drug Act (ODA), 21 U.S.C. § 360cc(a), when the Food and Drug Administration (FDA) (defendant) approves a drug to treat a rare disease, the drug receives a seven-year period of exclusivity. For exclusivity purposes, the ODA defines two drugs as the same drug if they contain the same active moiety, unless the second drug is found to be clinically superior. Baker Norton (BN) (plaintiff) and Bristol-Myers Squibb (BMS) (defendant) each developed a drug with the same active ingredient to treat the same rare disease. BMS received FDA approval first to market its drug (Taxol), and four months later, the FDA informed BN that its drug (Paxene) was approvable but final approval would be delayed during Taxol’s period of exclusivity, unless BN could show that they were not the same drug. BN sued the FDA, alleging that the FDA arbitrarily and capriciously defined drug to include just the active ingredient—as opposed to the finished drug product—which it alleged is contrary to legislative intent and the term’s meaning in Section 355 of the act governing applications for approval of new drugs. Under a drug product definition, BN argued that the drugs were not the same because they were manufactured differently, contained different inactive ingredients, and different profiles of impurities, and they differently controlled the rate of degradation. BMS intervened as a defendant, and the parties cross moved for summary judgment.