Life Sciences and Intellectual Property: Law and Practice is a new title providing sought after guidance on intellectual property law and rights protection within the life sciences.
Written by a leading team of experts at Bird & Bird LLP, it draws together all the relevant aspects of intellectual property law that you are likely to encounter in this uniquely complex field. It takes a particularly detailed look at patents and specific obtaining, validity, and infringement issues as well as other rights such as trade marks, copyright, designs, and database rights.
The following is an extract from the Foreword, written by Lord Neuberger:
“The law relating to life sciences is not only very important: it is very complex, having many different aspects… Patrick Kelleher has done an excellent job in drawing the multifarious strands together and producing a book which will be of enormous value to anyone seeking out the law in this very interesting and very challenging field.”
For anyone working in the intersecting disciplines of life sciences and intellectual property, this is a must-have text that will provide you with clear answers and authoritative advice in a single, accessible volume.
- Draws together all the relevant aspects of intellectual property law to clarify the protection of such rights in the life sciences.
- Provides targeted advice addressing industry-specific issues.
Comprehensive coverage of relevant intellectual property rights within the life sciences: patents, designs, copyright, database rights, confidential information, and trade secrets.
- Looks at different types of patent claims such as second medical use, biosimilars, product by process, numerical limits, and “reach-through” claims.
- Explains how to obtain a patent nationally and internationally and how to enforce them.
- Takes a detailed look at infringement, including the scope of claim, experimental use, and the ‘Bolar’ exemption.
- Analyses pharmaceutical conflicts between innovators and generics.
- Addresses key validity issues: industrial application, novelty, obviousness, insufficiency, plausibility, and the impact of equivalents.
- Dedicated commentary on Supplementary Protection Certificates and their regulation including recent disputes and the latest domestic and CJEU guidance.
- Examines pharmaceutical trade marks (national and European Union) and related registration, validity, and infringement issues such as counterfeit products and parallel trade.
- An overview of the European regulatory regime and its role in clinical trials, research and development, and data and market exclusivity.
- Discusses the role of competition law in the pharmaceuticals sector, including generic entry, abuse of dominant position, and “pay for delay” agreements.
- Explores intellectual property law in the emerging technologies of genomics, stem cell technology, artificial intelligence, and 3D printing.