Preface

• Author: Kenneth L. Dorsney
• Pages: XXV-XXVII

xxv

Preface

The Drug Price Competition and Patent Term Restoration Act, commonly

known as the Hatch-Waxman Act in reference to the Act’s two congres-

sional 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 Food and Drug Admin-

istration (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 applicant submitting an

ANDA with the FDA having a paragraph IV certification. 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 governing 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 law, 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

25 years, and continues to evolve as the controlling statutes and regula-

tions 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 throughout the struggle is the ultimate value and

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