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.

Portugal adjusts term to match CJEU order

From our friend João Jorge (RCF - Intellectual Property, Lisbon) comes the following information for which we gratefully thank him:

As a consequence of CJEU Decision C-555/13 (that's Merck Canada, noted on The SPC Blog here), the Portuguese PTMO has released on 17 April a Directive from the Board (2/2014), dated 10 April, informing that a verification is to be conducted to ensure that the term for all SPCs complies with the referred decision ensuring that "the 15 years exclusivity defined in that CJEU decision is not exceeded".

In practice this decision will affect about 30 SPCs currently in force, all corresponding to products in the market as SPCs normally do.

This Directive was not unexpected.

However, as PT patent attorneys we are used to seeing in this type of change, the PTMO has already corrected the term in the online database and has sent notifications informing the respective patent attorneys. The effect of the recalculation is that some of the SPCs will have a sudden death, some of them with a new end of validity date that is before the date of entry into force. The others will see a reduction in the duration but still remaining in force.

The Directive has a final note stating that a one month term shall be given to the owners of these affected SPCs that wish to file paediatric extensions but that, due to this recalculation, they would no longer be able to do it. We have to bear in mind that the duration of some of these SPCs was cut by more than two years.

Finally, publication in the Official Journal will be carried out for those SPCs that, with these changes, have already reached the end of their validity. For all the other affected SPCs, no publication is expected to occur.

Just a final note: this publication of end of validity will only happen in 21 April. So, until then what a wonderful grey area for lawyers!"

The SPC Blog also thanks its friends at the Lisbon practice of Baptista, Monteverde & Associados for sending us the link to the same information on the BMA Newsflash, here.

With all this news coming from Portugal, it almost feels as though that lovely country lies right at the heart of Europe and not at its distant Atlantic edge.

SPCs and medical devices: disappointment for Cerus

Via this post by Darren Smyth (EIP) on the IPKat weblog comes news of two SPC applications in the name of Cerus Corporation: SPC/GB/07/043 and SPC/GB/07/044.  The outcome of both applications was that authorisation to place a product on the market as a medical device under Directive 93/42 cannot be considered equivalent to authorisation under the medicinal products Directive, Directive 2001/83.  Accordingly, the two applications were held not to comply with Article 3(b) of the SPC Regulation, which requires "a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate".  Darren observes that this appears to be the majority view around Europe, though there are some conflicting cases in the Netherlands and Germany where the assessment processes were held to be equivalent and SPCs were allowed.  

The Cerus Corporation decision, dated 31 March, is summarised on the UK IPO website as follows:

EC Design Examination Certificate No. G7 02 05 16178 063 was filed in support of SPC application SPC/GB/07/043 for “Platelet preparation obtainable by addition, and subsequent photoactivation, of amotosalen or its salt, to a suspension of platelets in plasma”. EC Design Examination Certificate No. G7 06 09 60562 004 was filed in support of SPC application SPC/GB/07/044 for “Platelet preparation obtainable by addition to plasma, and photoactivation, of amotosalen or its salt”. These EC Design Examination Certificates relate to medical devices that meet the criteria of Article 1(4) of Directive 93/42/EEC because they relate to a device that incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product and which acts upon the body with action ancillary to that of the device. As a consequence, they fall within class III medical devices and the safety, quality and usefulness of the substance must be verified, taking account of the intended purpose of the device, by analogy with the appropriate methods specified in the medicinal products legislation (Directive 2001/83/EC). Class III devices have the highest risk potential in terms of the vulnerability of the human body (taking account of the potential risks associated with the technical design and manufacture of the device). Explicit prior authorization with regard to conformity is required for such devices to be placed on the market. As a consequence of the need to assess the substance as part of the assessment of the device overall, the applicant argued that these EC Design Examination Certificates can, as a consequence, be considered to meet the requirements of Art 3(b) of the SPC regulation, i.e. they represent a valid authorization to place, on the market as a medicinal product, the product for which an SPC has been applied for.

The hearing officer reviewed the SPC regulation and the relevant parts of the medical devices and medicinal products directives. He took account of the purpose of both codes, the means by which medicinal products and medical devices deliver their principle mode of action, and the actual performance that is being assessed under both codes. He concluded that the assessment carried out in relation to the substance, i.e. the safety, quality and usefulness of the substance, when considered in light of the means by which the medical device delivers its action and considering the process by which a device is approved, including the roles of notified bodies and competent bodies, means that the conformity assessment procedure for a class III medical device is not the same as or equivalent to the process carried out to authorise a medicinal product for human use.

As a consequence, the SPC applications were found not to meet the requirements of Article 3(b) and were rejected under Article 10(2) of the SPC Regulation. 

As ever, readers' comments are invited and appreciated.

Three SPC seminars coming up -- with discounts for SPC Blog readers

From our old friend Rechtsassessor Jean-Claude Alexandre Ho (IP conference manager at FORUM Institut für Management GmbH) comes news of three SPC-related seminars which he is organising. They are as follows:

1. 'Eli Lilly, Actavis, Georgetown II: Quo vadis, SPC?', the update seminar in which Dr Christopher Brückner, the author of the SPC commentary noted here (participants will receive the new second edition on top of course documentation), will speak on the CJEU's "Super Thursday" and on how to understand the decisions and which practical consequences we may expect for the future. Date: 17 June 2014; venue: Amsterdam. More information is available here. SPC Blog readers are entitled to a 10% discount against the registration fee (€ 880 down from € 980). 2. 'Supplementary Protection Certificates', the fifth edition of FORUM's advanced SPC seminar in English. This is a one and a half day course conducted by Dr Brückner (participants will also receive the new second edition of the SPC commentary on top of course documentation). Date: 25 and 26 September 2014; venue: Amsterdam. More information is available here. SPC Blog readers are entitled to a 10% discount against the registration fee (€ 1,200 instead of € 1,340). 

3. 'SPC for Beginners', the third edition of FORUM'S basic SPC seminar in English, once again with Dr Christopher Brückner and his updated SPC commentary as an add-on. Date: 24 September 2014; Venue: Amsterdam. More information is available here. SPC Blog readers are entitled to a 10% discount against the registration fee (€ 880 down from € 980).

To register and gain the benefit of your reduced fee, just forward this blogpost to Jean-Claude himself at jc.alexandreho@forum-institut.de, or call him, quoting "The SPC Blog" (+49 6211 500-675) and specifying which event(s) you would like to attend.