Patenting Life Cycles & Life Sciences Products - Current Issues & Future Changes

Introduction

Pharmaceutical and biological technologies may develop rapidly, but one reality of the life sciences business remains central: the need for patent protection.

A commercially successful, patented technology corners the market - excluding competitors and guaranteeing that the rewards flow back to the innovator, allowing investment in more new products.

There is, however, more to a life sciences product than just a new molecule - this is typically the beginning of a longer life cycle that may include new dosage regimes, formulations, combinations, modifications, and adaptations.

Each of these may be entitled to a patent, extending exclusivity protection for many years.

All the while, generic competitors will be looking for opportunities to identify and challenge aging products with weaker patents, so that they can clear the way to enter the market.

The highly competitive nature of the market is also driving trend in pharmaceuticals and biotechnology to seek novelty in narrowing forms of application of known drugs - from new indications to use in treating sub-populations of existing patient groups.

But these are raising issues that are challenging the limits of the patent system.

There is a tension too between the commercial pressure to file patent applications as soon as possible and the public policy of demonstrating that the protected technology works.

This has been a particular issue for certain classes of drug, which by their nature are claimed broadly, such as monoclonal antibodies.

Even when patent protection has expired, supplementary protection certificates may allow further exclusivity for certain medicinal products, but how limited is it?

This new webinar will track the key features of the pharma and biologics product life cycle and the patenting issues that can arise, as have been played out in recent cases before the UK courts, and which we can expect to see more of in the future.

What You Will Learn

This webinar will cover the following:

• Typical product life cycles for small molecules and biologicals
• The applicant’s dilemma - when do I have enough to file (the Warner-Lambert pregabalin case)?
• Functional features - do they claim too much and what does the court in Kymab and FibroGen say?
• The problem of enforcing second medical use patents
• Untested issues with personalised/sub-population claims
• Staving off the end - secondary patents, divisional claims, and generic challenges.
• Life after death - what products can an SPC protect after the Santen case?

This webinar was recorded on 10th February 2022