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".

Memantine: the Bundesgerichtshof speaks

From Cordula Tellmann (Freshfields Bruckhaus Deringer LLP, Düsseldorf) comes some helpful information concerning a judgment by the Bundesgerichtshof -- the German Federal Supreme Court -- regarding the supplementary protection certificate for memantine. The judgment was delivered in proceedings between Merz, as the owner of the SPC, against an entire bevy of companies which maintained that the SPC was invalid because the underlying patent was itself invalid: Neuraxpharm, Teva, Synthon, Pliva and Chemo Ibérica.

The Bundesgerichtshof held that the SPC was invalid, since the underlying basic patent was invalid for lack of novelty.

Cordula has kindly provided this weblog with a copy of the German original of the judgment. While the decision was issued following an oral hearing on 9 June 2011, it is only now that the written decision has been published only now.

According to Cordula, the Court held that the discovery that a certain active ingredient (here memantine) is effective against a pathological situation in a specific illness (in this case Alzheimer's disease) does not lead to a novel teaching if it was known in the state of the art that patients with this illness were treated with this active ingredient to alleviate such symptoms and if the patent does not teach a new way of dosage or a new group of patients which previously did not receive such treatment.

The decision must be read in the context of the decision of the Court of Justice of the European Union in Case C-195/09 Synthon on 28 July 2011 (noted by The SPC Blog here) regarding the validity of SPCs where there has been a pre-65/65 authorizations. In the German case, the Bundesgerichtshof did not have to address this question as the SPC was already invalid due to the invalidity of the basic patent.

Synthon ruling rejects pre-65/65 authorisations

This morning the Court of Justice of the European Union handed down its ruling in Case C‑195/09 Synthon BV v Merz Pharma GmbH & Co. KGaA, this being a reference for a preliminary ruling from the Patents Court, England and Wales.

To summarise, even before 1 September 1976 Merz was offering memantine for sale in Germany as a medicinal product for human use under the brand name Akatinol. That product, used in the treatment of Parkinson’s Disease and for other indications, was covered by an authorisation issued in accordance with German legislation from 1961 which did not requiere medicinal products to be tested for safety or efficacy. Under the German Law of 1976 memantine was granted a marketing authorisation in Germany without going through the procedures required under Directive 65/65, the first-ever European pharma Directive.

In June 1983 Merz applied to the competent Luxembourg authorities for a marketing authorisation for that medicinal product.  This was was issued in September 1983 under a Luxembourg Law of 1983. However, the Luxembourg authorities relied on the German marketing authorisation issued previously and did not test the safety and efficacy of memantine. In April 1989 Merz applied for a European patent for memantine hydrochloride which was granted even though memantine was already available commercially, on the ground that the patent was for a second medical use of memantine: for the preparation of a medicinal product to treat Alzheimer’s Disease. This patent expired on 13 April 2009.

Both the German and Luxembourg marketing authorisations were withdrawn when, in May 2002, a series of marketing authorisations valid within the European Community (‘the 2002 marketing authorisations’) were issued to Lundbeck as a licensee of Merz under Council Regulation 2309/93. This authorisation of 2002 was for the medicinal product Ebixa, the brand name adopted in order to market memantine's second medical use. Before this authorisation was issued, the safety and efficacy of Ebixa had been tested by the European Agency for the Evaluation of Medicinal Products, in accordance with Directive 65/65.

In November 2002 Merz applied to the United Kingdom Patent Office for an SPC for memantine. In its application, Merz referred to the basic patent valid in the UK and also to the 2002 marketing authorisation, but not to the prehistoric German or Luxembourg marketing authorisations. The SPC was granted in August 2003 for a term of five years.

Generics manufacturer Synthon then challenged the validity of Merz's SPC and maintained that, if valid, its term of protection should be fixed at zero. The Patents Court had some doubt both as to the scope of the SPC regulation, Regulation 1768/92, and the definition of ‘first authorisation to place … on the market in the Community’, within the meaning of Articles 13 and 19 of that regulation, it decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling:

‘(1) For the purposes of Articles 13 and 19 of [Regulation No 1768/92], is an authorisation a “first authorisation to place … on the market in the Community” if it is granted in pursuance of a national law which is compliant with [Directive 65/65], or is it necessary that it be established in addition that, in granting the authorisation in question, the national authority followed an assessment of data as required by the administrative procedure laid down in that directive? 

(2) For the purposes of Articles 13 and 19 of [Regulation No 1768/92], does the expression “first authorisation to place … on the market in the Community” include authorisations which had been permitted by national law to co-exist with an authorisation regime which complies with [Directive 65/65]? 

(3) Is a product which is authorised to be placed on the market for the first time in the EEC without going through the administrative procedure laid down in [Directive 65/65] within the scope of [Regulation No 1768/92] as defined by Article 2? 

(4) If not, is an SPC granted in respect of such a product invalid?’

Today's ruling runs as follows:

"1. Article 2 of Council Regulation ...1768/92 ... must be interpreted as meaning that a product, such as that at issue in the main proceedings, which was placed on the market in the European Community as a medicinal product for human use before obtaining a marketing authorisation in accordance with Council Directive 65/65 ... and, in particular, without undergoing safety and efficacy testing, is not within the scope of Regulation ...1768/92, as amended, and may not, therefore, be the subject of a supplementary protection certificate.

2. A supplementary protection certificate granted for a product outside the scope of Regulation No 1768/92, as amended, as that scope is defined in Article 2 of that regulation, is invalid".

The Court's ruling is, by ECJ standards, unusually short and to-the-point for an intellectual property ruling.  The SPC Blog's post on the Advocate General's Opinion, on which the Court's ruling was based, can be read here.

AG offers alternative solutions in Synthon reference

Case C‑195/09 Synthon BV v Merz Pharma GmbH & Co KG is the first of two Court of Justice Opinions published today on the Curia website on issues arising from Regulation 1768/92.  This reference for a preliminary ruling from the Patents Court, England and Wales, arose from an action in which Synthon claimed that a 2002 marketing authorisation for memantine was not its first marketing authorisation as a medicinal product since it had already been authorised, in 1983, in Luxembourg, as an ingredient of Akatinol, and that Merz’s SPC was therefore (i) invalid for failure to meet the requirements of Article 3 of the regulation or (ii) invalid or zero-term under Article 13 in that the first marketing authorisation in the Community predated the filing of the patent application (the SPC was invalid, said Synthon, because the first marketing authorisation in the Community was obtained before 1 January 1985 either in breach of Article 19(1) or because memantine was marketed as a medicinal product before authorisation was obtained in accordance with Directive 65/65, in breach of Articles 2 and 3). The court sought guidance on the following questions:

"(1) For the purposes of Articles 13 and 19 of Council Regulation (EC) No 1768/92, is an authorisation a ‘first authorisation to place ... on the market in the Community’, if it is granted in pursuance of a national law which is compliant with Council Directive 65/65/EEC, or is it necessary that it be established in addition that, in granting the authorisation in question, the national authority followed an assessment of data as required by the administrative procedure laid down in that directive?

(2) For the purposes of Articles 13 and 19 of Council Regulation (EC) No 1768/92, does the expression ‘first authorisation to place ... on the market in the Community’ include authorisations which had been permitted by national law to co-exist with an authorisation regime which complies with Council Directive 65/65/EEC?

(3) Is a product which is authorised to be placed on the market for the first time in the EEC without going through the administrative procedure laid down in Council Directive 65/65/EEC within the scope of Council Regulation (EC) 1768/92 as defined by Article 2?

(4) If not, is an SPC granted in respect of such a product invalid?".

This morning Advocate General Mengozzi gave the following somewhat bifurcated advice to the Court:

"95. Council Regulation ... 1768/92 ... 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 ...or with Council Directive 81/851 ... do not fall within the scope of the regulation.

Supplementary protection certificates granted for such products must be deemed to be invalid.’

96. Should the Court not adopt that solution, I propose that it should give the following answers to the first and second questions ...

‘A marketing authorisation granted by the authorities of a Member State in accordance with the national provisions transposing Directive 65/65 may constitute the first marketing authorisation in the Community for the purpose of Articles 13 and 19 of Regulation No 1768/92, even when the administrative procedure for which the directive provides has not been implemented or has not been properly implemented, particularly as regards the carrying out of the toxicological and pharmacological tests and the clinical trials required by the directive.

A marketing authorisation granted by the competent authorities of a Member State, under the transitional arrangements provided for by Article 24 of Directive 65/65, in conjunction with Article 39 of Second Council Directive 75/319 ...as amended ..., may also constitute the first marketing authorisation of the product in the Community, on the basis of a marketing authorisation granted before the transposition of Directive 65/65 into the legal order of that Member State.

For the purposes of the application of Articles 13 and 19 of Regulation No 1768/92, a marketing authorisation granted for a use of the product as a medicinal product different from the use or uses protected by the patent constituting the basic patent under Article 1(c) of that regulation may also be regarded as the first marketing authorisation in the Community".

This post is simply to alert readers to the availability of the Opinion. Further comment will follow.

Memantine -- now in English too!

Yesterday The SPC Blog posted this piece ("Memantine in Belgium") on the Belgian ruling in Merz/Synthon on the Memantine SPC. Steven Catoor (Hoyng Monegier, Brussels), who supplied us earlier with the original text, has now been able to let us have an unofficial but very helpful English translation, which you can read here. Thanks, Steven, from all of us!

Memantine in Belgium

From Steven Catoor (Hoyng Monegier, Brussels) comes news of the decision of the judgment of the Brussels Commercial Court of 11 January 2011 on the Belgian SPC for memantine (Synthon v Merz). The judgment is in Dutch but Steven hopes to provide us with an unofficial English translation shortly.  Says Steven:

"The Court essentially (and quite logically) decided to await the outcome of the pending referral to the CJEU by the Mr Justice Floyd in the corresponding UK action (previously reported on the SPC Blog here and here). As to the basic patent invalidity claim raised by Synthon at the very last minute, the Court refers this issue to the general docket and leaves it up to the parties to arrange for a timetable to exchange submissions on the subject.

Nevertheless, there are a few interesting passages in the judgment.

In particular, the Commercial Court refers to the decision of the Brussels Court of Appeal in Almirall (see the SPC Blog here), a decision which was invoked by Synthon to argue that the duration of the memantine SPC should be 0 years under Article 13 of the SPC Regulation. Not only does the Court identify a series of factual circumstances which distinguish the current case from Almirall, but it also questions whether the reasoning of the Court of Appeal is in line with the Hässle and Pharmacia Italia judgments of the ECJ.

In addition, the Court opines that the ECJ’s Novartis judgment is of very little relevance in the current case given that this case concerned the interpretation of the EEA Agreement rather than the SPC Regulation".

I hope this is useful to you.

More on Menantine - from the Netherlands and Germany

On 26 March 2009, the Netherlands Patent Office handed down its decision on Memantine. Here's a short English summary of the case:

Synthon requested that the Octrooicentrum revoke the certificate or revise the date of the certificate based on the earlier marketing authorisations that were not granted in accordance with directive 65/65. The Netherlands Patent Office denied this request. In their view it follows mainly from the recitals in the preamble that the relevant first marketing authorisation is an authorisation in accordance with directive 65/65, i.e. for a medicinal product which has been tested thoroughly for quality, safety and efficacy.

Thanks to Martijn de Lange from the Netherlands Patent Office for informing us about this decision.

Just in case you missed out on the German Patent Court decision on Memantine of 11 December 2007, you can get it here.