Exclusivity Rights in Life Sciences - An Introductory Guide

Introduction

The diversification of the life sciences into previously unthought of areas certainly poses challenges for the patent system, which has been the mainstay of exclusivity protection for medical innovations for many decades.

Patents will nonetheless remain central to intellectual property protection in the life sciences.

The life sciences are, of course, intrinsically technical and it is products and processes of this nature that patents are designed to protect. A commercially successful, patented technology can corner the market - excluding competition for the same technology.

And, although patents cannot guarantee that an innovation will be commercially successful, they do ensure, if properly managed, that the rewards of a successful invention flow to the patent owner.

There are also supplementary protection certificates, which are rights designed specifically to extend the exclusivity afforded to particular medicinal products and plant protection products, based on an underlying patent, to make up for delay in obtaining approval.

But how can investment in the collecting of the clinical data that goes into approving a medicinal product itself be protected? The answer is to use various forms of data exclusivity and market exclusivity rights.

This new virtual classroom seminar will introduce the key exclusivity rights available to protect life sciences products, focusing on the substantive requirements to obtain and protect patents, supplementary protection certificates and other regulatory exclusivity rights, including orphan drug protection.

What You Will Learn

This live and interactive session will cover the following:

• Patent rights and their requirements:
• Basic concepts I: territory, term, prosecution
• Basic concepts II: prior art, common general knowledge and the skilled person
• Identifying subject matter that is or is not patentable
• Plausibility and sufficiency: how much information must the patent give about the invention?
• Novelty/anticipation: is the subject matter new over the prior art?
• Invention: is the subject matter obvious?
• Infringement: the breadth of patent protection and what it protects against
• Supplementary protection certificates (SPCs):
• Calculating how long an SPC lasts
• What are the requirements to obtain an SPC?
• The products that SPCs protect and their limitations
• Developments in the EU
• Regulatory data protection:
• How regulatory data protection arises
• What is protected and for how long
• Proposed changes in the EU.
• Orphan drugs:
• The products that orphan drug protection protects
• Length and nature of protection
• Proposed changes in the EU.

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.