Global Patent Protection and Enforcement of In Vitro Diagnostic Inventions

Global Patent Protection and Enforcement of In Vitro Diagnostic Inventions describes the patentability requirements and enforcement challenges faced by in vitro diagnostic inventions in nine major worldwide markets, providing practical tips on how to overcome these challenges and build a globally enforceable patent portfolio for such inventions. Patent protection for the makers of these diagnostics is vital since obtaining regulatory approval is a time-consuming and expensive process. Like all inventors, developers of in vitro medical diagnostic tests depend on patent protection that is enforceable against alleged infringers and ensure royalties and other payments. Due to recent United States (US) court decisions that have made the patentability of such tests untenable in the US, there is an expectation that patent applications for in vitro diagnostic inventions will increase in commercially important countries that provide broader protection.

What’s in this book:
For each of the nine jurisdictions – Australia, Canada, China, the European Union, India, Japan, Russia, South Africa and the US – an author knowledgeable in the patent law of his or her country examines elements as the following:

• subject matter eligibility;
• specific patentability hurdles;
• recent and relevant cases;
• specific issues relating to enforcement; and
• exceptions to infringement.

Specific examples of types of claims (both immunohistochemistry and molecular in vitro diagnostics) are provided, along with tips for drafting and prosecuting applications and best practices for forestalling rejections based on subject matter eligibility and prior art.

How this will help you:
This book is the first to provide a comprehensive global examination of the patentability of in vitro diagnostic tests. The editor, a patent attorney, globally known for her work with the pharmaceutical industry, has assembled a compendium of international expertise that will prove indispensable to patent practitioners (prosecution as well as litigation), corporate research teams, pharmaceutical and other companies and academics throughout the world. This book will be a single resource and reference guide for practitioners to understand the requirements for patenting in vitro diagnostics in each of the nine jurisdictions.