Pharmaceuticals, Biotechnology and the Law 4th ed

Written by a leading patent and regulatory lawyer, this text comprehensively covers the wide variety of legal and regulatory issues in the life sciences industry sector. This new edition has been fully revised, expanded and restructured to facilitate easy navigation, and has been updated to cover all the latest recent developments in legislation and case law, including preliminary material as to the likely effect of Brexit on the life sciences sector in both the UK and the EU27.

What's new

Regulatory

• CJEU case law as to what constitutes genetic modification
• Expanded and updated treatment of clinical trials, in particular the new clinical trials Regulation 536/2014/EC, the transparency of clinical trial data, and General Court and CJEU case law as to the latter.
• Expanded and updated treatment of medicinal products regulation, in particular advanced therapy medicinal products, pharmacovigilance, and the new veterinary medicinal products Regulation (EU) 2019/6 and recent CJEU case law on the medicinal products Directives
• Expanded and updated treatment of medical devices regulation, in particular new Regulations 2017/745 on medical devices and 2017/746 on in vitro diagnostic medical devices and the current status of their implementation, and recent CJEU case law on issues under the Directives which these Regulations replace

Patents SPCs and Non-Patent Exclusivities

• Separate chapter on validity issues encountered with medical use patents including recent EPO national case law on plausibility as a threshold test after which sufficiency and inventive step analyses can be applied
• Developments in the patenting of stem cells and of the products of essentially biological processes, and the ongoing controversy as to the latter involving the EU, the Administrative Council of the EPO, and the Boards of Appeal of the EPO
• Separate chapter on infringement and enforcement issues other than in the context of generic entry, including the developing law on the effective scope of protection, proportionate injunctions and recent German case law on compulsory licences, and recent case law on “skinny labelling” and the protective scope of claims to medical uses when applied to products having such labels
• Latest CJEU and National SPC case law and the new Regulation amending the medicinal products SPC Regulation to provide for a manufacturing waiver
• Recent national and CJEU case law on data exclusivity, and the revision to the data exclusivity regime for veterinary effected by veterinary medicinal products Regulation (EU) 2019/6
• Separate chapter on orphan medicinal products covering latest CJEU case law and the effect of amending Regulation (EU) 2018/781

Competition law

• Recent Commission, General Court and CJEU case law on competition law issues associated with generic entry
• New treatment of post generic entry competition law issues that are not associated with IPRs and the approach to these adopted by the competition law authorities at a national level