Fordham Report 2014: SPCs

"They have confused more than they have clarified", declared moderator Gonzalo Ulloa (Gómez-Acebo & Pombo, Madrid), amid general rumblings of assent from the audience, when referring to the recent decisions of the Court of Justice of the European Union (CJEU) on Supplementary Protection Certificates. The occasion was a dedicated session at this year's Fordham IP Conference (programme here).

Brian Cordery (Bristows, London) spoke first: SPCs continue to be a hot topic in Europe, he explained. 2013 witnessed several further referrals to the CJEU and several more rulings have emerged. While it is possible to pick out a line of logic in the decisions, his theme was that much uncertainty remains and that the recent rulings have arguably confused as much as they have clarified. Brian offered a rapid, condensed review of the recent case-law, focusing closely on Eli Lilly v HGS (Tabalumab), a case that is coming back to Mr Justice Warren next week.

Rian Kalden (Court of Appeal of The Hague, The Hague) spoke next, addressing Actavis v Sanofi and whether you can obtain more than one SPC per patent. Georgetown indicated that it was possible to get two SPCs where the basic patent protected both combination products as well as the underlying product, making three in all.  Jürgen Dressel (Novartis Pharma AG, Basel) then offered an update on second medical use. He explained that legislators and courts in all developed countries have recognized both the value and the patentability of innovation stemming from clinical research. Jürgen's conclusion was that only now -- and very slowly -- have patent offices and courts began to learn how to deal with clinical inventions in a way that is fair to all stakeholders. Further stimulation of such important innovation business certainty and therefore a globally harmonized approach to patentability requirements and enforcement are thus of utmost importance.

In his presentation Jürgen led the audience through the process of research, development, through to market authorisation and commercialisation, observing that different types of claim, recognised in different jurisdictions, led to the protection of different concepts -- including second medical use.  He acknowledged that this was a matter of interest both to drug originators and to manufacturers of generic products and mentioned that this was a topic for the forthcoming AIPPI conference in Toronto. He also strongly recommended that conference participants read the well-reasoned judgment of Birss J in Hospira v Genentech (blogged for the IPKat by Darren Smyth here).

The panellists at this session were Laëtitia Bénard (Allen & Overy LLP, Paris), Joachim Feldges (Allen & Overy LLP, Munich) and Christine Kanz (Reimann Osterrieth Köhler Haft, Düsseldorf). Joachim raised the question of whether the function of the CJEU was to interpret EU law or to clarify it. He also added to the speculation regarding the treatment of patents with Markush formulae. Are some features of a claim "second class" because they only deal with the form and not the substance of a structure, he asked, and should any distinction be made once a patent has been granted? Sadly, we have to refer questions to the CJEU, he concluded, and the questions are a good deal clearer than the answers.

Christine observed that the CJEU was composed of legal generalists who struggled to appreciate what the SPC Regulation was about. The court appeared to be adopting an "inventive advance" approach without actually saying so, thereby importing patent law concepts into SPC law.

Inevitably, discussion took place on the meaning and significance of the term "necessarily and specifically" in the ruling of the CJEU in Eli Lilly v HGS that

Article 3(a) ... does not, in principle, preclude the grant of a supplementary protection certificate for that active ingredient, on condition that it is possible to reach the conclusion on the basis of those claims, interpreted inter alia in the light of the description of the invention, as required by Article 69 of the Convention on the Grant of European Patents and the Protocol on the interpretation of that provision, that the claims relate, implicitly but necessarily and specifically, to the active ingredient in question, which is a matter to be determined by the referring court".

This blogger was comforted by the fact that others seem to find it as difficult to appreciate the subtlety of this phraseology as he does.  He was however heartened by an intervention from the floor by respected academic Martin Adelman (George Washington Law School, Washington DC) to the effect that there was no threat of "evergreening" of a patented product since there is no jurisdiction in the world that provides for the possibility of evergreening a patent. "Anyone who uses the term 'evergreening'", remarked the professor, "is engaging in propaganda".

Mr Justice Arnold, speaking from the floor, observed that the CJEU has tended to formulate its rulings on SPCs in relation to the facts relating to the patent concerned in the reference before it, and not to the underlying legal issues [or to the terms of the marketing authorisation ...]. Further confusion has been caused by the CJEU's tendency to discuss policy issues without relating them explicitly to earlier case law which references from national courts invite them to reverse.

The full text of this session, once corrected, will be published in its entirety by Fordham University. It was simply not possible to provide an accurate summary of the speakers' presentations in real time, so The SPC Blog will let you know when the full, revised text has been made available.