Waxman-Hatch Amendment

Department of Health and Human Services, Food and Drug Administration (DHHS), and Center For Drug Evaluation and Research, Guidance for industry court decisions, ANDA approvals, and 180-day generic exclusivity under the Hatch-Waxman amendment to the Federal Food, Drug, and Cosmetic Act, DHHS, Washington, DC, March, 2000. 

This study examines whether the conduct that the FTC challenged represented isolated instances or is more typical, and whether the 180-day exelusivity and the 30-month stay provisions of the Hatch-Waxman Amendments are susceptible to strategies to... 

In April 2001, the Commission began an industry-wide study foeused on certain aspects of generic drug competition under the Hatch-Waxman Amendments. ... 

Appendix B contains the Hatch-Waxman Amendments, as codified at 21 U.S.C. 355 et seq. 

Id. at 355(j)(2)(B). Although the patent holder and the NDA filer are often the same person, this is not always the case. The Hatch-Waxman Amendments require that all patents that claim the drug described in an NDA must be fisted in the Orange Book. Occasionally, this requires an NDA filer to list a patent that it does not own. 

Chapter 2 Outcomes of Patent Infringement Lawsuits Under the Hatch-Waxman Amendments... 

FDA, Guidance for Industry, Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (Mar 2000). This guidance document also discusses the definition of a court to trigger the 180-day exclusivity, see Chapter 5. 

The analysis identified three broad categories of patents that raise questions about whether they fall within the class the Hatch-Waxman Amendments defines as listable in the Orange Book. These categories, which are more fully explained in Appendix H, are ... 

This chapter deseribes the 180-day provision in the Hatch-Waxman Amendments and details how FDA s rules governing 180-day exelusivity have evolved. The ehapter examines how the 180-day exelusivity has been triggered, and it also reviews the agreements that were obtained through the study that affeet the triggering of the 180-day exclusivity. 

Relevant Provisions of the Hatch-Waxman Amendments 21 USCA 355 (a), (b) and (j)... 

One district court explicitly has held that a brand-name company may not list a metabolite patent in the Orange Book, because the metabolite patent does not claim the drug, as required by the listing statute. " The court looked to the precedent, Hoechst-Roussel Pharms., Inc. v. Lehman, which interpreted the term claims in the Patent Term Restoration portion of the Hatch-Waxman Amendments at 35 U.S.C. 156(a) and concluded that a metabolite patent does not claim the approved dmg product. 

In addition, an applicant may submit a 505(b)(2) application for a change in a drug product that is eligible for consideration pursuant to a suitability petition under Section 505(j) (2) (C) of the Act. In the preamble to the implementing regulations for the Hatch-Waxman amendments to the Act, the Agency noted that an application submitted pursuant to section 505(b)(2) of the Act is appropriate even when it could also be submitted in accordance with a suitability petition as defined at section 505(j)(2)(C) of the Act (see 57 FR17950 April 28, 1992). 

The act served as a boon to the generic industry by paving the path to abbreviated and accelerated drug approvals. From a legal perspective, the Hatch-Waxman amendments modified Section 505 of the FD C Act to create two new abbreviated approval pathways (see Table 5) [14]. 

Most importantly, for biopharmaceuticals, however, and the eventual entry of generic products of biotechnological research into the marketplace (see discussion below) is the Restoration Act or Hatch-Waxman Amendments to the Drug Price Competition and Patent Term Restoration Act of 1984 [106]. This act creates an... 

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