Foreword

• Author: Kenneth L. Dorsney
• Pages: XXIII-XXIV

xxiii

Foreword

Well-deserved congratulations to the authors of this new edition on ANDA

litigation. While there are excellent materials available about patent law

generally, this book speaks specifically to the peculiar nature of ANDA

cases. As is mentioned in the preface that follows, the Hatch-Waxman Act,

which is the wellspring of ANDA litigation, represents an effort to balance

important societal interests in protecting the intellectual property rights

of pharmaceutical companies while making advanced drugs widely avail-

able. The particular mechanisms of the law make it unique and can shift

what judges and lawyers usually expect in a lawsuit.

For example, in most patent cases, as in other litigation, it is ordinarily

the plaintiff patentee who seeks an early trial date and as rapid a course

as possible through pretrial proceedings, while defendants often are happy

to see the case take a slower route to conclusion. In an ANDA case, by con-

trast, the plaintiff patentee may well be content for pretrial proceedings to

move more slowly, knowing that the defendant generic drug manufacturer

is laboring under an automatic stay of FDA approval for the generic drug,

a stay that kicks in when an ANDA suit is filed and may last until a judg-

ment is rendered against the patentee. A lawyer or judge might be sur-

prised when first encountering a leisurely plaintiff in an ANDA case, but

they will find in chapter 4 of this text a succinct explanation of the timing

motivations. This highlights an especially admirable quality of the book:

its balance. The authors have endeavored, with good success, to address

issues from the perspectives of both the name-brand drug patentees and

the generic drug manufacturers, thus enabling readers to understand the

conflicting strategies that frame specific disputes.

Each chapter ably addresses important topics, so that the book as a

whole is comprehensive and should prove valuable to judges and practi-

tioners. Among other things, readers will find a detailed description of the

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