New book -- a mega-title for SPCs

The SPC Blog is delighted to advise readers of a really helpful resource which will shortly be available.  It's a new book, Ergänzende Schutzzertifikate mit pädiatrischer Laufzeitverlängerung / Supplementary Protection Certificates with Paediatric Extension of Duration -- a commentary on the law relating to SPCs by Dr Christopher Brückner (Patentanwalt, Apotheker, Bardehle Pagenberg, Munich) and Peter von Czettritz (Rechtsanwalt, Preu Bohlig & Partner, Munich).  The vast scale of this work -- it's over 550 pages in length -- is accounted for by the fact that it is bilingual in German and English.

Dr Brückner has kindly given the blog some information about this commentary and what it seeks to achieve:

"Comments regarding the SPC Commentary

1. Users do not deal with this property right on a daily basis. But when they do, they are dealing with particularly valuable property rights and are confronted with particularly complex legal questions. This might be one of the reasons why no authors have taken this topic upon themselves up till now. 

2. The bilingual version allows for European-wide application and (hopefully) contributes to the harmonization of this property right in the community. 

3. Alongside the comparison of secondary sources it was at least just as important for the author to go directly to the wording of the Regulation and to consider what arose out of it. Naturally, this is particularly reflected in the passages for which hardly any secondary sources exist, for example Articles 4 and 5 (subject matter of protection and effects of the protection certificate). Further, by comparing the translations, it was possible to uncover several inconsistencies in the wording as between the English and German versions of the Regulations. 

4. As is explained by this author in his preface, he was initially interested in the abstract legal system, interested in what could result out of the wording of the Regulations, patent law, regulatory law and judicial practice. This is meant to ensure that the system is penetrated as completely as possible and that unpleasant surprises are avoided. Whether these points are relevant in practice was initially of secondary importance. This will arise out of further discussion. 

5. A newly introduced element is the “inner discussion”. This allows the author to introduce a problem, quickly summarize both points of view, compare possible pro and contra arguments, and to then reach his own conclusion. An illustrative example therefore is the discussion on protection certificates for combination products, in which the author, in clear contrast for example to the General Advocate in Medeva, takes a stand on the preference of the infringement theory. 

6. The external design was kept as user-friendly as possible: short paragraphs, so that the reader is able to navigate to the mentioned thoughts via the recitals, many short headings as well as a detailed structure, so that the reader can already see from the structure where everything is explained. 

7. The commentary is not satisfied with discussing merely existing issues and comparing opinions already presented, it also poses its own questions that have not already been discussed but which could quickly become very relevant in the near future such as, for example, the extension of an SPC term by means of foreign pediatric studies or the relationship of paediatric studies to the scope of protection of the basic patent, which is discussed in the special section paediatric extension of duration, written by von Czettritz and Brückner. Thus, the commentary takes over an active part in the development of the future of this property right".

Published by the Carl Heymanns Verlag imprint of Wolters Kluwer Deutschland GmbH, the book's ISBN is ISBN 978-3-452-27566-0.  Publication should take place within the next three-to-four weeks and its website is here.

Merci beaucoup

Following yesterday's post here on the French Cour d'appel de Paris decision in the Valsartan dispute, a number of correspondents emailed to ask whether, if the order of the court was available in English, it might not be available in the original French too.

Thanks once again to Tougane and Grégoire, you can now read the decision in French here.

Valsartan: now it's the turn of the Cour d'appel de Paris

From our French friends Tougane Loumeau and Grégoire Triet (Gide Loyrette Nouel A.A.R.P.I.) comes news of more developments concerning the much-litigated Valsartan. These relate to an order of the Cour d'appel de Paris dated 16 September 2011, kindly translated into English here for the benefit of this weblog's non-French-reading followers. The facts are these:

Novartis owns a patent on medicinal substance A which expired on 12 February 2011 and an SPC on product A which will expire in November. Novartis currently markets a blockbuster drug composed of A + B (another active ingredient). Actavis took steps to put on the market a generic version of product A + B after the expiration of the patent but before expiration of the SPC. Novartis sued Actavis to obtain an interim banning injunction based on its SPC on A.

On three occasions, French courts had ruled that an SPC confers exactly the same protection scope as a patent so that a product A+ B was considered as infringing an SPC on A.

Now for the first time, the Cour d'appel has had a chance to consider the issue. This is how it ruled:

A product, as defined by the EU Regulation, is not restricted to an active ingredient. An SPC, within the meaning of Article 4 of the Regulation, protects a product and not an active ingredient. In this case, the SPC only protects Valsartan as a product. 

It follows that, although the medicinal product Valsartan + HCTZ contains the active ingredient Valsartan, it is not the "product" Valsartan within the meaning of the Regulation but another "product" comprising a combination of active ingredients. 

Any other interpretation would be contrary to the rule of non-aggregation of sources of protection laid down in Article 3 of the Regulation according to which an SPC cannot protect another product and there can by only one SPC per product per patent holder. The active ingredient HCTZ cannot be considered a mere additional ingredient in the same way as we might view a vitamin. 

Accordingly, it does not appear likely that any marketing and sale of a medicinal product containing Valsartan as an active ingredient will constitute an infringement and thus violate the rights owned by Novartis in this active ingredient until 13 November 2011. 

Actavis' interpretation of the EU Regulation and its objections to the injunctive and other relief requested by Novartis are genuine and have merit and, contrary to what the lower court summary hearings judge held, remove all obviousness from the allegation of infringement.

Thanks so much, Tougane and Grégoire, we do appreciate your kindness.

Dawn of a new era? The AG's Opinion in Georgetown and Medeva

"Supplementary Protection Certificates: is a new era beckoning for combination drugs in the EU?" is the title of an article by Michael Pears and Mike Snodin (both of Potter Clarkson) which has recently been published in Scrip Regulatory Affairs. This article, which considers the effects of Advocate General Trstenjak's Opinion in Joined Cases C-422/10 Georgetown University and C-322/10 Medeva,  concludes with the following observations.

"Although the Advocate General seems to be ruling out an infringement test to establish whether a product is protected by a basic patent under Article 3(a), the precise test to be used remains unclear. At least some form of disclosure of each active ingredient of a product appears to be necessary, but how specific this must be is not known.

What is clear from the opinion, however, is the proposal for SPCs to be obtained for a patented part of authorised products containing a combination of active ingredients. In reaching this conclusion, the advocate general has obviously recognised the importance of providing SPC protection for active ingredients which are first authorised in combination with other active ingredients.

If the CJEU follows the opinion, the narrow interpretation of what is “protected” by a basic patent may mean that some granted SPCs are invalid. On the other hand, the more permissive interpretation of what represents a valid authorisation could provide new opportunities for obtaining useful (and very broad) SPC protection.

Overall, the above-mentioned aspects of the A-G’s opinion provide what seems to be a workable approach for obtaining SPC protection for combination products.

While the facts of the Medeva and Georgetown et al cases relate to combination vaccines, the issues apply equally to other areas of human and veterinary medicine and also in agriculture. Indeed, an increasing trend to authorise medicines and plant protection products in combination suggests that the Court’s decision may have far-reaching consequences. The final judgement will therefore be eagerly anticipated".

You can read this article in full here.

UK Patent Box cont...

Following on from our comments earlier in the year here, readers will be pleased to know that the second round of the UK Government's Patent Box proposal included SPCs as well as patent protection within its scope. The second round consultation has just ended (text here) and the next step is for draft legislation to be prepared.

Hopes rise for a bright future, if the court gets it right ...

"Hopes rise for a bright future for paediatric SPC extensions in the EU" is the title of an article by Mike Snodin (Potter Clarkson) which has recently been published in Scrip Regulatory Affairs. Mike's article, which considers the effects of Advocate General Bot's Opinion in Case C-125/10 Merck,  concludes with the following thoughts.

"The innovative pharmaceutical industry will welcome Mr Bot’s opinion as representing a pragmatic interpretation of the objectives of the legislation governing SPCs and their extension. A particularly important practical aspect of the opinion is that, if followed in the CJEU’s final ruling, there will no longer be a perverse incentive in some cases to delay marketing authorisation issuance in order to obtain a longer patent / SPC monopoly period.

However, the opinion will not allay the concerns of those who obtain marketing authorisation issuance 4 years and 6 months or less after patent filing. This is because this category of patent holder could still be obliged to conduct additional clinical trials in the paediatric population, but would not have the option of using an extended monopoly period to recoup the costs associated with the additional trials.

There may therefore be some in the innovative industry who will be hoping that the CJEU does not follow Mr Bot’s opinion, but instead agrees with the patent office of Greece. If this were to happen, patent holders might be able to obtain a full 6-month period of (extended) SPC monopoly beyond patent expiry, regardless of how short the time between patent filing and marketing authorisation issuance.

As discussed in the 2007 RAJ Pharma article, a uniform reward of a full (additional) 6 months of SPC exclusivity after expiry of a patent meeting the qualifying criteria of the SPC legislation could well be viewed as being consistent with the objectives of the Paediatric Regulation.

In particular, Recital (26) of the Paediatric Regulation indicates that, for those products where the marketing authorisation holder has satisfied the obligations of the Regulation:

“a reward should be granted in the form of a 6-month extension of the supplementary protection certificate created by Council Regulation (EEC) No 1768/92” (emphasis added).

It will be interesting to see what the CJEU make of this point, especially with regard to what “reward” will be granted to those who are able to obtain an SPC having a term of negative 6 months or less".

You can read Mike's article in full here.

That mystery reference: all is revealed

Further to our previous post on the mysterious reference to the Court of Justice in Novartis v Actavis, The SPC Blog thanks Laura Reynolds and Brian Cordery (both of Bristows) for forwarding copies of the approved judgment of Mr Justice Floyd and the order for a reference.

Plot spoiler: it's another valsartan thriller!

Novartis mystery case heads for ECJ: can anyone help?

According to the UK's IPO, Case C-442/11 Novartis AG v Actavis UK Limited is the latest SPC dispute to be referred to the Court of Justice for a preliminary ruling. According to the IPO, this case --  another reference from the High Court for England and Wales -- raises the following questions:

"Where a supplementary protection certificate has been granted for a product as defined by Regulation 469/2009 for an active ingredient, are the rights conferred by that certificate pursuant to Article 5 of the Regulation in respect of the subject matter as defined in Article 4 of the Regulation infringed:

i. by a medicinal product that contains that active ingredient (in this case valsartan) in combination with one or more other active ingredients (in this case hydrochlorothiazide); or

ii. only by a medicinal product that contains that active ingredient (in this case valsartan) as the sole active ingredient?"

This seems to be a bit of a mystery. Martijn de Lange (Netherlands Patent Office) has told The SPC Blog:

"I totally missed that reference and I can't find it on BAILII or with Google either. Maybe you could put it on the blog and possibly some reader may supply it". 

This blogger hasn't been able to find any reference to it on the Curia website either. Can anyone help?

nb If you were planning on submitting comments on this reference to the UK IPO so that the government can decide what, if any, position it wishes to take, the IPO's notice does not stipulate a deadline by which submissions must be made. Having said that, you would be well advised to email your comments here, if you have any, as soon as possible.

Note on recent ECJ memantine and galantamine rulings

Thanks are due to Herwig von Morze for drawing The SPC Blog's attention to a recent summary, "European Court of Justice holds SPCs for old medicinal products invalid", which was prepared by Ana-Laura Morales of Spanish law firm Grau & Angulo and published last week by International Law Office. The note deals with the ECJ's recent rulings in the memantine and galantamine cases (covered by this weblog here and here). .

Synthon ruling "raises inevitable concerns"

Placed online yesterday is a Current Intelligence note, "Court of Justice rules on material scope of supplementary protection certificate regime", which will be published in a forthcoming issue of the Journal of Intellectual Property Law and Practice (JIPLP).  This note, authored by Riccardo Sciaudone (Grimaldi e Associati), discusses the ruling of the Court of Justice just five weeks ago in Case C-195/09 Synthon BV v Merz Pharma GmbH & Co. KGaA, Court of Justice of the European Union (Second Chamber), 28 July 2011 (noted here on The SPC Blog).

After reviewing the facts of the ruling and the relevant law, the author comments:

"This much-awaited decision is welcomed for the clear and, in principle, correct answer given to an important point of law. It is crystal clear, from now on, that an SPC for a medicinal product will be valid only if the first marketing authorization in the EU is in line with Europe-wide regulatory rules. 

However, on a more practical level, the ECJ's decision raises inevitable concerns on a possibly significant number of similar cases that could be soon brought before national courts in order to verify the validity of any SPC in question. Furthermore, this situation could also affect additional research and investment for medicinal products that will soon be under scrutiny in respect of their SPC".

Merck: a case note

"Where do we stand on negative and zero term SPCs: analysis of the views of the AG Bot Merck v Deutsches Patent Case C-125/10" -- this is the title of a case comment that has just been published in volume 11, issue 6 of the bimonthly Bio-science Law Review, published by Lawtext Publishing (here).  The authors are Maria Isabel Manley (Partner and Head of Regulatory Practice, Bristows) and Muriel Riba (Associate, Regulatory Practice, at the same firm).  According to the abstract:

"Merck v Deutsches Patent is the first case at EU level to consider the possibility of granting a negative or zero term SPC. Advocate General Yves Bot recently gave his opinion on this issue of crucial commercial importance to the industry, which so far has been approached inconsistently by various Member States.

Although the SPC Regulation provides the tools to calculate the duration of an SPC, it does not address the situation where the period between the date on which the application for a basic patent was lodged and the date of grant of the first MA is less than five years, such that the SPC would have a negative or zero term. If the SPC was an independent right, this lacuna in the law would not have much importance. However, given that the option to apply for a paediatric extension depends on the prior existence of an SPC, the issue of negative or zero term SPCs is of major relevance.

This article assesses the impact of the Advocate General's opinion and an alternative interpretation that we consider to be more consistent with the objectives pursued by both the SPC and the Paediatric Regulations".