Pharma forum is back, and the morning sessions of our upcoming event will be dedicated to exploring the significant intellectual property issues impacting the pharmaceutical and biologics industries in the UK and Europe. Here our experts have identified three of the key areas set to dominate the patent landscape – all of which will be explored in greater detail during our in-person event on Thursday 22 September.
Compulsory licensing in Europe after COVID-19
In the maelstrom of the COVID-19 pandemic, several pharmaceutical companies rushed to find vaccines and treatments to tackle the new virus, some with considerable success. In the face of unprecedented public need, some companies said they would not enforce their patent rights on their drugs.
Many governments may not have to wait for companies to waive their patent rights. In emergency situations, to ensure that sufficient supplies are available to meet the urgent need of the public, governments may be able to rely on compulsory licensing powers instead. Recently, the European Commission has initiated a consultation on 'how to build a more efficient and coordinated compulsory licensing scheme in the EU, reduce current fragmentation and improve Europe's resilience in managing crises such as the COVID-19 pandemic'.
The possible changes to compulsory licensing post-pandemic will be explored by our international experts - Julius Zacharias, David Mulder and Michael Washbrook – as they kick off the first presentation of the day.
What are limitations of exclusivity protection for rare disease drugs?
The power of new technology is accelerating issues that are already stretching the application of patent case law. For example, as artificial intelligence (AI) makes it easier to find new uses for old drugs, particularly those affecting smaller populations. But unresolved questions will surface about the novelty of such claims and how they can be enforced with traditional injunctions.
The supplementary protection certificate (SPC) regime further illustrates the challenges that existing rights face. As a model that just about worked for the medicines sector when the original SPC legislation was introduced in 1993, it was not designed to adapt.
Rare disease or personalised drug treatments also provide an example of how sui generis rights might be added to the statute book to deal with some challenges. In this case, personalised drug treatments can, in the right circumstances, receive structural support and encouragement from regulators in orphan drug legislation.
Our rare diseases panel, chaired by Hannah Kuchler, Global pharmaceuticals correspondent for the FT, with guest speaker Elizabeth Crooks (Patent attorney, Kilburn & Strode) and Taylor Wessing partner Matthew Royle, will discuss the likelihood of whether this form of protection will eventually replace patents.
The Unified Patent Court and Unitary Patent are coming!
For the very first time, after almost 50 years of negotiations and many stops and starts along the way, rights holders in Europe will soon get the option to add Unitary Patents (UPs) to their patent portfolios, as well as the addition of a single patent litigation system covering the major part of the European market – the Unified Patent Court (UPC).
The protection of the UP and the decisions of the UPC will have effect in the whole territory of the participating countries, be it injunctions and damages due to infringement of patents, or patent revocations. In total, the UPC covers a market of approximately 350 million people, comparable to the US. In addition to UPs it will also be possible, subject to their opt-out from the new court, to litigate European patents in the UPC.
What are the strategic and practical challenges of this new system for those willing to use it? Our panel of patent litigation specialists - Amanda Ebbutt, Dr Jan Phillip Rektorschek and Patricia Cappuyns - will address the big questions for pharmaceutical companies considering their UPC strategies.
