Request for a preliminary ruling from the Cour d’appel de Paris (France) lodged on 9 December 2014 — Genentech Inc. v Hoechst GmbH, formerly Hoechst AG, Sanofi-Aventis Deutschland GmbH, (Case C-567/14)
‘Must the provisions of Article 81 of the Treaty (now Article 101 TFEU) be interpreted as precluding effect being given, where patents are revoked, to a licence agreement which requires the licencee to pay royalties for the sole use of the rights attached to the licensed patent?’
Read a previous post on the case, by Pierre Véron and Amandine Métier, Véron & Associés entitled 'A 100 Million Euro question referred to the CJEU' here.
Spain and Italy v Council, CJEU 16 April 2013, Case Numbers C-274/11 and C-295/11
In their actions seeking annulment of the Council’s decision of 10 March 2011 authorising enhanced cooperation in the area of the creation of unitary patent protection, Italy and Spain mainly submitted that Article 118 TFEU was not a proper legal basis for the Council’s decision. Following the Attorney General’s proposal (see post dated 11 December 2012), the CJEU dismisses the actions.
In particular, the CJEU concludes that the Council’s decision was taken within the competence provided by Article 118 TFEU and that it was taken as a last resort considering the fruitless stages before the contested decision. The Court rejects the plaintiffs’ argument that creating uniform protection in one part only of the Union would undermine the internal market and states that it is inherent in the concept of enhanced cooperation that acts adopted in its framework bind only participating Member States. Rather, the Court follows the Council’s position that the fragmentation of the market is to be found, not in the contested decision, but in the present situation, in which the protection offered by European patents is national.
The decision does not finally bring legal certainty for the unitary patent since Spain filed actions against the results of the enhanced cooperation, i.e. the Regulations (EU) No 1527/2012 and No 1260/2012 on the creation of unitary patent protection and on the translation arrangements (Cases C-146/13 and C-147/13). The statements of grounds of these actions are not yet available.
Read the press release of the ECJ No 47/13 (in English) here.
Provisional Cross-Border Jurisdiction in Patent Cases according to the CJEU in Solvay, by Richard Ebbink, Brinkhof
Introduction The Court of Justice of the European Union last year delivered a decision on the impact of the GAT/LuK decision on jurisdiction in preliminary infringement proceedings (Solvay/Honeywell).
As the case below is continuing its way through the Dutch courts, the frequency of publications trying to make sense of the 2012 CJEU decision come down significantly. The majority of the commentators so far seem to conclude that the CJEU in Solvay gave the green light to cross-border jurisdiction in preliminary infringement proceedings.
This is a fresh attempt at establishing the impact of the Solvay decision on the interpretation of the relevant articles of the Brussels Regulation (EU Regulation 2001/44).
AstraZeneca AB v. Comptroller General of Patents, High Court of Justice, Chancery Division, Patents Court, London, UK, 19 October 2012, Case No.  EWHC 2840 (Pat)
AstraZeneca applied for a supplementary protection certificate (SPC) on 11 December 2009 for the product gefitinib. This is the active ingredient in a medicinal product marketed by AstraZeneca as Iressa. Iressa is used to treat non-small-cell lung cancer. The basis for the SPC is EP (UK) 0 832 900 (“the Patent”), which will expire on 22 April 2016. The SPC was granted with an expiry date of 1 March 2019, being calculated by reference to a marketing authorisation granted by the Swiss regulatory authority on 2 March 2004 (“the Swiss MA”). AstraZeneca appealed this, contending that the correct expiry date is 22 April 2021 because the duration of the SPC should be calculated by reference to a marketing authorisation granted by the European Medicines Agency (“EMA”) on 24 June 2009 (“the European MA”).
Stating that the resolution of the appeal depends on two issues of interpretation of Regulation 469/2009/EC of 6 May 2009 (“the SPC Regulation”) Arnold J has referred the following questions to the Court of Justice of the European Union:
1. Is a Swiss marketing authorisation not granted pursuant to the administrative authorisation procedure laid down in Directive 2001/83/EC, but automatically recognised by Liechtenstein, capable of constituting the ‘first authorisation to place the product on the market’ for the purposes of Article 13(1) of Regulation 469/2009/EC?
2. Does it make a difference to the answer to the first question if:
(a) the set of clinical data upon which the Swiss authority granted the marketing authorisation was considered by the European Medicines Agency as not satisfying the conditions for the grant of a marketing authorisation pursuant to Regulation 726/2004/EC; and/or
(b) the Swiss marketing authorisation was suspended after grant and was only reinstated following the submission of additional data?
3. If Article 13(1) of Regulation 469/2009 refers solely to marketing authorisations granted pursuant to the administrative authorisation procedure laid down in Directive 2001/83/EC, does the fact that a medicinal product was first placed on the market within the EEA pursuant to a Swiss marketing authorisation automatically recognised in Liechtenstein which was not granted pursuant to Directive 2001/83/EC render that product ineligible for the grant of a supplementary protection certificate pursuant to Article 2 of Regulation 469/2009?
European Court of Justice, 9 February 2012, Novartis AG v. Actavis UK Ltd., case number C-442/11
Within about 6 months after referral, the CJEU has already answered the questions referred to it by the English High Court concerning the interpretation of Articles 4 and 5 of the SPC-Regulation in the context of a dispute between Novartis and Actavis. Novartis was the proprietor of an SPC for the product valsartan. This basic patent for this SPC was also, inter alia, directed to valsartan. Actavis’ generic drug contained not just valsartan, but also another active ingredient, HCTZ.
The CJEU now confirms that this amounts to an infringing use of valsartan. According to the court, it follows from Article 5 of the SPC-Regulation that an SPC confers the same rights as the basic patent it ensues from. Since the basic patent gave Novartis the absolute right to stop unauthorised use of any product containing valsartan, the CJEU held that the same necessarily applies to the ensuing SPC, albeit within the limits of Article 4 of the SPC-Regulation: “if, during the period in which the patent was valid, the patent holder could oppose, on the basis of his patent, all use or certain uses of his product in the form of a medicinal product consisting of such a product or containing it, the SPC granted in relation to that product would confer on the holder the same rights for all uses of the product, as a medicinal product, which were authorised before the expiry of the certificate” (decision, § 20).
Synthon B.V. v. Merz Pharma GmbH & Co KG, Opinion of A-G Mengozzi, 31 March 2011, Case C-195/09
"On the basis of all of the foregoing considerations, I propose that the Court should give the following answers to the questions submitted by the High Court of Justice (Chancery Division):
'Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products, must be interpreted, pursuant to Article 2 thereof, as meaning that products placed on the market as medicinal products in Community territory before obtaining a marketing authorisation in accordance with Council Directive 65/65/EEC on the approximation of the provisions laid down by law, regulation or administrative action relating to proprietary medicinal products or with Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products do not fall within the scope of the regulation.
Supplementary protection certificates granted for such products must be deemed to be invalid.’
Should the Court not adopt that solution, I propose that it should give the following answers to the first and second questions submitted by the High Court of Justice (Chancery Division):
Generics (UK) Ltd v Synaptech Inc, Opinion of Advocate General Mengozzi, 31 March 2011, Case C-427/09
"In the light of all of the foregoing considerations and, without prejudice to the observations at points 33 to 35 above, I propose that the following reply be given to the questions referred by the Court of Appeal for a preliminary ruling:
(1) A marketing authorisation for a medicinal product granted by the competent authorities of a Member State pursuant to the transitional arrangements introduced by Article 24 of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products – in conjunction with Article 39 of Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products, and as amended by Article 37 of that directive – on the basis of a marketing authorisation granted prior to the transposition of Directive 65/65 into the legal order of that Member State, may constitute the first marketing authorisation for the purposes of Article 13 of Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products.
For the purposes of the application of Article 13 of Regulation No 1768/92, an authorisation granted for use of a product, as a medicinal product, other than that or those protected by the patent which is the basic patent within the meaning of Article 1(c) of the regulation, may also constitute the first authorisation to place the product on the market in the Community.
(2) A marketing authorisation for a medicinal product granted by the competent Austrian authorities in accordance with the national legislation, and maintained in force following the accession of Austria to the European Economic Area, initially, and to the Community, subsequently, must be treated as an authorisation granted in accordance with Directive 65/65 for the purposes of applying Article 13 of Regulation No 1768/92."
Little Hope for an EU Patent Court after the CJ Opinion, by Jochen Pagenberg
"After the Opinion of the Advocates General of July 2, 2010 in the case 1/09 which had come to the conclusion that the Proposal for an Agreement on a combined court system for EPC and EU patents is incompatible with the EU Treaties , now the European Court of Justice (CJ) has spoken. The Opinion comes to the conclusion that
The envisaged agreement creating a unified patent litigation system (currently called ‘European and Community Patents Court’) is not compatible with the provisions of the EU Treaty and the FEU Treaty.
In its reasoning the Court challenges some of the corner stones on which the Draft Agreement of 23 March 2009 was built. The Opinion seems to request a court which would have little in common with the court envisaged in the Draft Agreement. It is therefore doubtful whether such drastic modifications as they would be required would still be attractive for the users."
EUCJ - Opinion 01/09 - Analysis and Consequences, by Winfried Tilmann
"I. The Opinion
1. In 2009 the Council, at the request of the Commission, submitted a draft Agreement for the creation of a European and Community Patents Court (PC) to the Court of Justice of the European Union (EUCJ) for an opinion on the compatibility of this draft Agreement with EU law.
2. The EUCJ, in its Opinion 01/09 of March 8, 2011, came to the conclusion (Nr. 89) that conferring an exclusive jurisdiction to hear a significant number of actions in the field of the Community patent and interpreting and applying European Union law in that field
on an international court which is outside the institutional and judicial framework of the European Union
would deprive Member States courts and the EUCJ of their powers and obligations to cooperate in interpreting and applying Union law."
Brüstle v. Greenpeace, CJEU, Opinion of the Advocate General, 10 March 2011, Case C-34/10
According to Advocate General M. Yves Bot, totipotent cells carrying within them the capacity to evolve into a complete human being must be legally classified as human embryos and must therefore be excluded from patentability.
Nor can a procedure using other embryonic stem cells, known as pluripotent cells, be patented where it first requires the destruction or modification of the embryo.
Read the opinion (available in various languages) here.
Solvay S.A. v. Honeywell Fluorine Products Europe B.V. et al, District Court The Hague, the Netherlands, 22 December 2010, Case No. 09-2275, with thanks to Willem Hoyng, Howrey, for sending in the decision
The present case is a follow up of the interlocutory judgment of the District Court of The Hague d.d 15 September 2010 (read the previous post here), in which the court decided to refer questions on the correct interpretation of 'irreconcilable decisions' in the context of Article 6 (1) EEX and the correct interpretation of Article 22 (4) EEX to the Court of Justice EU.
DHL Express (France) SAS v.Chronopost SA, Opinion Advocate-General P. Cruz Villalón, 7 October 2010, Case C-235/09, with thanks to Pierre Véron, Véron & Associés, for sending in the case and the informal English translation
Referral to CJEU by the French Cour de cassation about the territorial scope of the injunction granted by a community trademark court, a question which may have some impact on cross border patent litigation.
The Opinion of Advocate General Pedro Cruz Villalón is not yet available in English, but an informal translation in English follows hereafter (for other languages, see the bottom of the post):
1. Must Article 98 of Council Regulation (EC) No 40/94 of 20 December 1993 on the Community trade mark be interpreted as meaning that the prohibition issued by a Community trade mark court has effect as a matter of law throughout the entire area of the Community?
Article 98 of Council Regulation (EC) No 40/94 of 20 December 1993 on the Community trade mark must be interpreted as meaning that the prohibition issued by a Community trade mark court has effect as a matter of law throughout the entire area of the Community, except otherwise specifically provided.
Request of the Council of the European Union for an Opinion on the compatibility of the proposed European Patent Court System with European Treaty Law, Court of Justice of the European Union, Opinion of the A-G, No. 1/09, 2 July 2010, with thanks to Pierre Véron, Véron & Associés for sending in the translation
* Now including the translation in English*
Conclusion: not compatible
"En son état actuel, l'accord envisagé créan un système unifié de règlement des litiges en matière de brevets est incompatible avec les traités."
Read the opinion of the A-G (in French) here. Read the opinion of the A-G (in English) here.