This book sets out governing statutes and rules at the beginning of each chapter and includes sample litigation documents where possible. The casebook begins with discussions of who to sue, where to sue, pleading requirements, discovery, and trial strategy. It then moves into substantive legal issues. The Third Edition includes new material on pharmaceutical litigation under the Hatch-Waxman Act and the most developments in the law of invalidity and infringement. The book next addresses issues surrounding remedies, including injunctive relief (with a discussion of the Supreme Court's eBay decision), contempt proceedings, and damages. Also included are post-trial matters including jury instructions, special verdict forms, the preclusive effect of final judgments, judgment as a matter of law, and new trial motions. Finally, the book covers the appeal process and reexamination and reissue proceedings.

Examining the intersection between the statutory and regulatory scheme governing approval of generic pharmaceuticals and U.S. patent law in the context of Paragraph IV ANDA litigation, this comprehensive guide focuses on current and developing law as well as litigation strategies and tactics. This ready roadmap begins with an explanation of the Hatch-Waxman Act, its implementation, and litigation. Other topics include preparing and trying the case, post-trial issues and appeals, remedies, settlement, antitrust implications, and litigation of pharmaceuticals outside the U.S.

At head of title : European Commission Research Project on Judicial Cooperation in Matters of Intellectual Property and Information Technology.

Pharmaceutical and Biotech Patent Law provides you with the legal, scientific, and technical information you need to help clients obtain, defend, and challenge patents in these important business areas. This practical guide shows you how to craft problem-free patent applications, including how to partner with the government to bring patented inventions quickly to the marketplace - invalidate competitors' patents by proving that they fail to meet key requirements - protect against various forms of patent infringement - and successfully rebut charges of infringement. It includes detailed checklists that help you resolve thorny patent problems in the complex pharmaceutical and biotech fields, and is regularly updated to reflect Federal Circuit rulings and other significant court decisions.

In recent years, business leaders, policymakers, and inventors have complained to the media and to Congress that today's patent system stifles innovation instead of fostering it. But like the infamous patent on the peanut butter and jelly sandwich, much of the cited evidence about the patent system is pure anecdote--making realistic policy formation difficult. Is the patent system fundamentally broken, or can it be fixed with a few modest reforms? Moving beyond rhetoric, Patent Failure provides the first authoritative and comprehensive look at the economic performance of patents in forty years. James Bessen and Michael Meurer ask whether patents work well as property rights, and, if not, what institutional and legal reforms are necessary to make the patent system more effective. Patent Failure presents a wide range of empirical evidence from history, law, and economics. The book's findings are stark and conclusive. While patents do provide incentives to invest in research, development, and commercialization, for most businesses today, patents fail to provide predictable property rights. Instead, they produce costly disputes and excessive litigation that outweigh positive incentives. Only in some sectors, such as the pharmaceutical industry, do patents act as advertised, with their benefits outweighing the related costs. By showing how the patent system has fallen short in providing predictable legal boundaries, Patent Failure serves as a call for change in institutions and laws. There are no simple solutions, but Bessen and Meurer's reform proposals need to be heard. The health and competitiveness of the nation's economy depend on it.

This two volume looseleaf treatise offers procedural guidance to the Patent Act, the U.S. Patent and Trademark Office Rules, and the Manual of Patent Examining Procedure. The work provides substantive analysis of the Semiconductor Chip Protection Act, new patent interference rules, and the differences between U.S. and foreign patent law.

Scientific and technological innovations are forcing the inadequacies of patent law into the spotlight. Robin Feldman explains why patents are causing so much trouble. She urges lawmakers to focus on crafting rules that anticipate future bargaining, not on the impossible task of assigning precise boundaries to rights when an invention is new.

"The text will outline the history and rationale behind patent law, outline major areas of patent examination, and complexities, provide economic analysis, Maori and patent issues, international trade issues, and specialist patent court and tribunal issues"--Publisher information.

The authors feel that students considering patent law for the first time should look forward to learning legal tenets as venerable as the Constitution itself yet as current as the latest development from the laboratory bench. This casebook is comparative and constantly refers to aspects of foreign patent systems. This is with the understanding that patent practitioners without an understanding of the international patent system place their clients at a significant disadvantage.