Preface

• Author: Kenneth Dorsney
• Pages: 21-23

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Preface

The Drug Price Competition and Patent Term Restoration Act, com-

monly known as the “Hatch-Waxman Act,” in reference to the Act’s two

congressional sponsors, Senator Orrin G. Hatch (R-Utah) and Henry A.

Waxman (D-CA), reflects a compromise in the pharmaceutical industry

in an effort to balance patent exclusivity against market competition.

The Act was passed into law in 1984. It introduced amendments to the

Federal Food, Drug and Cosmetic Act and the Patent Act of 1984. The

amendments included provisions for an abbreviated process for the Food

and Drug Administration’s (FDA) approval of generic versions of patented

pharmaceuticals by the filing of an Abbreviated New Drug Application

(ANDA) and a right to initiate patent litigation against an ANDA appli-

cant submitting an ANDA with the FDA having a Paragraph IV certifica-

tion. Paragraph IV ANDA (or “Hatch-Waxman”) patent litigation was thus

born. Branded and generic pharmaceutical companies have employed the

law ever since in a constant struggle to shape the landscape of the govern-

ing patent and regulatory regime and the marketplace for FDA approved

patented and generic drugs.

The resulting effect of the Hatch-Waxman Act on the law controlling

the pharmaceutical market and its participants remains unsettled. As a

hybrid of two already complex areas of law, U.S. patent and FDA regula-

tory, Hatch-Waxman patent litigation was complex from the start. The

Hatch-Waxman Act, as with any statutory text, is only the starting point.

Hatch-Waxman patent litigation has evolved substantially over the past

twenty-five years, and continues to evolve as the controlling statutes and

regulations are amended and interpreted further. During this period,

branded and generic pharmaceutical companies have struggled, and

continue to struggle, to strengthen their respective positions by shaping

the patent and regulatory law landscape governing the use and approval

of generic drugs. A constant in the struggle is the ultimate value and