Hatch-Waxman

The Hatch-Waxman Act Balancing Innovative and Initiative Competition.536... 

The following sections of this paper examine the economic characteristics of the R D process in pharmaceuticals that make patents so crihcal. Sections 30.2 to 30.4 discuss the costs of innovation in pharmaceuhcals and the effects on innovative and imitative competition of the 1984 Hatch-Waxman Act. Section 30.5 considers whether the biotech industry is different from the pharmaceuhcal industry in terms of R D costs. Section 30.6 considers the distribution of returns on R D in these industries. The final section presents conclusions and policy considerations. 

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... 

The study focuses solely on the procedures used to facilitate generic drug market entry prior to expiration of the patent(s) that protect the brand-name drug product. The study does not address other procedures for generic entry, and it does not address the patent restoration features of Hatch-Waxman. 

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

The study was prompted, in part, by the Commission s enforcement actions against alleged anticompetitive agreements that relied on certain Hatch-Waxman provisions." The study was designed to... 

The study did not examine how generic competition has developed under the other methods the Amendments established. Nor did the study examine whether Hatch-Waxman provisions have achieved another purpose of the Amendments to compensate brand-name companies for lost patent life due to the time needed for FDA s safety and efficacy review process. 

Appendix A contains a glossary of frequently used terms and their meanings under Hatch-Waxman. 

Before deseribing the seope of the study, it is important to understand the historical context in whieh Hateh-Waxman arose. Moreover, the generie approval process Hatch-Waxman implemented demands an understanding of the interaction of the patent system and the regulatory structure governing the approval of brand-name drugs. 

Thus, Hatch-Waxman balanced an expedited FDA approval process to speed generic entry with patent term restoration to... 

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

When an applicant makes a paragraph IV certification, two additional provisions of Hatch-Waxman are implicated. These two provisions are at the heart of the FTC s study. 

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. 

According to the FDA, from the time Hatch-Waxman became effective in 1984 through December 31, 2000, 8,019 ANDAs were filed wifh the FDA." Of these applications, 7,536 (94 percent) raised no patent issues (i.e., the ANDAs did not contain a paragraph IV certification). A substantial portion of the total number of ANDAs, however, relate to the same brand-name product or NDA. Thus, the total number of ANDAs does not represent 8,019 unique brand-name drug products, and it is unclear as to how many unique brand-name drug products the total 8,019 ANDAs related. 

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