The Drug Price Competition and Patent Term Restoration Act (Publ. No. 98-417, 98 Stat. 1585 (1984)), commonly known as the Hatch–Waxman Act (the Act) provides the statutory framework by which most generic drugs are approved for marketing in the USA. Most provisions in the Act concern the standards and procedures the US Food and Drug Administration (FDA) must follow to approve generic drugs. A relatively small number of the provisions, however, create a framework for resolving patent disputes between the brand and generic pharmaceutical companies. These provisions have been the subject of much recent activity, in the US Courts, in Congress, in the FDA itself and in the White House. Much of the activity revolves around a publication by FDA entitled Approved Drug Products with Therapeutic Equivalence Evaluations, known colloquially as the Orange Book.Under present FDA practice, the mere listing of a patent in the Orange Book corresponding to a brand pharmaceutical product invokes a number of statutory provisions that confer valuable exclusivity rights on the brand company, and also possibly on one or more generic companies. This situation creates a strong incentive for patentees and brand pharmaceutical companies to list patents in the Orange Book. A number of recent court cases have addressed the remedies and damages available when the listing is found to be improper. Thus far, the most successful means to challenge or prevent improper listings has been through private and governmental enforcement of the antitrust laws.
Do Regulatory Bioequivalence Requirements Adequately Reflect the Therapeutic Equivalence of Modified-Release Drug Products?