The SPC regime, which dates back to 1992, has the relatively straightforward and uncontroversial purpose of extending protection for pharmaceutical (and some other) products whose launch is delayed by the regulatory process.
However, its application in practice has been complex, with many cases generating questions over the definition, scope and term of SPCs, as well as their application in different EU member states.
Continuing uncertainty
Because the regime is based on an EU Regulation, national courts have had to refer many of these questions to the Court of Justice of the EU in the hope of getting a clear ruling. Unfortunately, that hope has not always been fulfilled, leading to continuing uncertainty for many in the industry.
Our webinar on June 23, which starts at 5pm London time, will feature Mike Gilbert and Angus Fairbairn of specialist IP firm Marks & Clerk and Dr Jocelyn Man of Gilead Sciences, and I will be moderating it.
The speakers will briefly set out the background to the SPC regime, before discussing the latest decisions from the CJEU and other open issues. These include questions such as: what does “protected by a basic patent” mean? And what is “active ingredient”? Jocelyn will also be able to provide a perspective from industry on the value of SPCs and the kinds of issues that pharma companies face.
In an industry where sales of blockbuster products can be counted in the millions of dollars per day, understanding the latest law on SPCs is vital for both originator and generic companies, so I’m sure this webinar will be of interest to all those in the industry around the world, as well as those who advise them in Europe and elsewhere.
Like all our webinars, you can easily view and listen from your desk (or anywhere with an internet connection) and there will be opportunities to ask questions of the speakers too. The webinar will last about one hour and if you can’t make next Tuesday, you can listen again at any convenient time. Registration is free, but must be done in advance.
