Navigating IP Rights in Medical Inventions - Key Opportunities & Recent Developments

Introduction

New medicines often enjoy a valuable period of exclusivity before generic competition begins and the way this exclusivity is secured can have a major impact on commercial success.

To maximise this period, pharmaceutical companies typically deploy layered intellectual property strategies combining multiple patent filings, regulatory data exclusivity, market exclusivity and in some cases patent term extensions such as Supplementary Protection Certificates. Together, these rights can create robust, multi-layered protection that may delay generic entry for many years.

However, the legal and regulatory landscape is highly dynamic. Many pharmaceutical innovations, particularly those developed later in the R&D process, sit close to the boundaries of patentability and are frequently challenged by generic manufacturers seeking early market entry. At the same time, courts and legislators must balance incentives for innovation with the public interest in timely access to affordable medicines, a tension reflected in ongoing reforms to EU pharmaceutical law.

Understanding how these rights interact and how they are being shaped by recent legal and regulatory developments is increasingly critical for anyone operating in the pharmaceutical sector. This includes navigating evolving standards of patentability at the EPO, responding to significant case law from the EPO, UPC and UK courts and anticipating changes to regulatory exclusivity frameworks across Europe.

This new virtual classroom seminar provides a clear and practical overview of the current state of pharmaceutical intellectual property rights in Europe. It will cover key opportunities for patent protection during R&D, with a focus on EPO patentability requirements, and examine recent legal and regulatory developments affecting pharmaceutical IP, including emerging case law and forthcoming changes to European exclusivity regimes.

What You Will Learn

This live and interactive course will cover the following:

• Pharmaceutical inventions and when they arise
• Second medical uses - requirements for novelty and inventive step at the EPO and challenges for infringement
• Patenting clinical research
• Plausibility in the UK and Europe following G2/21
• Early pharmaceutical decisions from the UPC
• SPCs - subject matter eligibility in view of recent court decisions
• The EU Pharma package and incoming changes to regulatory exclusivities

Recording of live sessions: Soon after the Learn Live session has taken place you will be able to go back and access the recording - should you wish to revisit the material discussed.