Patent Hatch-Waxman

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. 

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. 

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. 

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... 

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. 

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

When a patent is delisted, the 30-month stay will not run and, hence, the FDA is free to approve the ANDA, if other regulatory requirements are met. However, two recent court decisions have held that there is no private right of action under Hatch-Waxman."... 

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 ... 

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. 

The Hatch-Waxman Act dramatically altered the nature and terms of generic competition after 1984. First, the Act established an Abbreviated New Drug Application (ANDA), which substantially reduced the cost of generic entry. Second, the Act allowed generic manufacturers to conduct their testing prior to patent expiration. This allowed generics to enter the market much more quickly after patent expiration than previously. 

Patent Challenges and the Strategic Use of the Hatch-Waxman Act by Brand Firms... 

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