Foreword

• Author: Kenneth Dorsney
• Pages: 19-20

xix

Foreword

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

litigation. While there are excellent materials available about patent law

in general, 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 well-spring 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 ANDA litigation 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 ordi-

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

course as possible through pre-trial proceedings, while defendants often

are happy to see the case take a slower route to conclusion. In an ANDA

case, by contrast, 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 judgment is rendered against the patentee. A lawyer or

judge might be surprised when first encountering a leisurely plaintiff in an

ANDA case, but they will find, in Chapter 4 of this text, a succinct expla-

nation 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-br and

drug patentees and the generic drug manufacturers, thus enabling read-

ers to understand the conflicting strategies which frame specific disputes.

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

whole, is comprehensive and should prove valuable to both judges and

practitioners. Among other things, readers will find a detailed descrip-

tion of the regulatory scheme behind the filing of an Abbreviated New