EPLAW Patent Blog

BE - Lundbeck v. Ratiopharm (Teva) and Tiefenbacher (escitalopram)

H. Lundbeck A/S v. Alfred e. & CO. Tiefenbacher GmbH, Ratiopharm GmbH, Ratiopharm Belgium N.V and Teva Pharma Belgium N.V., Court of Appeal Brussels, Belgium, 14 February 2012, Case No. 2011/AR/2821, with thanks to Steven Cattoor, Hoyng Monegier, for providing the case and a head note.

As reported earlier (see here), on 3 October 2011 the Brussels Commercial Court revoked Lundbeck’s Belgian escitalopram SPC and declared its decision immediately enforceable, notwithstanding appeal.

Lundbeck appealed this first instance decision and, by way of preliminary issue, requested that the ordered immediate enforceability be declared illegal. By judgment of 14 February, the Brussels Court of Appeal upheld Lundbeck’s appeal on this point and found that a first instance decision revoking a patent or SPC cannot legally be declared provisionally enforceable. According to the Court of Appeal, such immediate enforceability is contrary to Article 51§2 of the Belgian Patent Act (BPA), which, in view of Articles 18 and 19 SPC Regulation and in absence of any specific provision relating to SPC’s, is held to be applicable to SPC’s.

Deviating from the general rule under Belgian procedural law in this respect, Article 51§2 BPA stipulates that an application before the Supreme Court against a patent revocation decision rendered by an appellate court, has a suspensive effect. Allowing the immediate enforceability of a nullity decision in first instance is irreconcilable with the necessary suspensive effect of a cassation request under Article 51§2 BPA and would render the latter devoid of any meaning. A revoked patent/SPC cannot be declared valid again. The Court added that, given the erga omnes (and ex tunc) effect of a revocation decision, the legal guarantee under the Belgian Code of Civil Procedure providing that the party enforcing a judicial ruling does so at its own risk, cannot offer sufficient protection for the patentee.

This is the first time a Belgian court has ruled on the question of the (il)legality of the provisional enforceability of a nullity decision. The merits of the case will be heard shortly.

Read the decision (in Dutch) here.

UK - MedImmune v Novartis

MedImmune Limited v Novartis Pharmaceuticals (UK) Limited & another, High Court, 3 February 2012, Case No. HC11C01304, Neutral Citation Number: [2012] EWHC 181 (Pat)

On Friday 11 February 2012, Mr Justice Arnold handed down his second judgment in the ongoing litigation between MedImmune and Novartis.   

In his first judgment in July 2011 (which may be read here), Mr Justice Arnold held that MedImmune’s patents, relating to antibody phage display, were not infringed by Novartis’ dealings in ranibizumab (trade name Lucentis), a treatment for wet age-related macular degeneration, in the UK and were invalid.  That decision is under appeal.

This second judgment dealt with MedImmune’s UK SPC for ranibizumab and represented the UK Courts’ first consideration of the recent CJEU rulings in Medeva (C-322/10), Queensland (C-630-10) and the associated line of references.

In his judgment, Mr Justice Arnold found that the guidance provided by the CJEU in Medeva is not sufficiently clear.  The Judge expressed his disappointment that the CJEU did not actually answer Question 1 of the Medeva questions.  He held that the test laid down by the CJEU and its progeny is unclear save in its rejection of the infringement test in respect of combination cases.  Mr Justice Arnold went on to say that “regrettably”, further references will be required to clarify what is meant by “specified or identified in the wording of the claims”. 

Notwithstanding these views, in this case, the Judge did not make a further reference to the CJEU.  Instead, he decided that the Court of Appeal will be able to consider whether to make a reference at the appropriate time.  This judgment does not therefore take matters much further forward in the debate about the meaning of the CJEU decisions save that it has now been acknowledged by Mr Justice Arnold that there is still a great deal of uncertainty about the appropriate test to use to assess compliance with Article 3(a) of the SPC Regulation.

Read the decision (in English) here.

Head note:  Sarah Routledge

NL - Lundbeck v. Tiefenbacher / Escitalopram Appeal

Joined cases of H. Lundbeck A/S v. Alfred E. Tiefenbacher GmbH and H. Lundbeck A/S v. Centrafarm Services B.V. and H. Lundbeck A/S v. Ratiopharm GmbH, Court of Appeal The Hague, The Netherlands, 24 January 2012, Case Nos 312468 / HA ZA 08-1827, 314574/HA ZA 08-2142 and 314783/HA ZA 08-2172, with thanks to Marleen van den Horst en Jaap Bremer, BarentsKrans, for sending in the judgment and a summary in English

The Court of Appeal in the Hague has decided that Lundbeck’s patent for escitalopram, which patent had been invalidated in its entirety by the District Court in first instance, is partially invalid. The product claims for the active substance escitalopram were nullified for lack of inventive step, whilst the method claim describing a specific procedure for the synthesis of escitalopram and the claim relating to an intermediate product were considered valid. The SPC-specific nullity arguments were dismissed.

Read the entire summary in English here.

Read the judgment (in Dutch) here.  

FR - Novartis v. Sanofi / Valsartan (ex parte)

Novartis AG and Novartis Pharma v. Sanofi-Aventis France, Sanofi-Aventis Winthrop Industries and Zentiva K.S., the President of the Court of First Instance (ex parte preliminary injunction), Paris, France, 27 October 2011, Case No. 11/15302, with thanks to Pauline Debre, Bird & Bird, for providing a summary and comments in English

On 27 October 2011, the President of the Court of First Instance in Paris ordered ex parte preliminary injunctions against Sanofi-Aventis France, Sanofi-Aventis Winthrop Industries and Zentiva K.S. (hereinafter "Sanofi"), prohibiting the Valsartan generic Zentiva from being sold on the French market.

This ruling is important in two respects:

1. It is one of the first decisions in which an ex-parte preliminary injunction has been ordered in a patent case in France; and

2. It seems to conflict with a recent decision of the Court of Appeal in Paris on the extent of protection given by supplementary protection certificates.

Read the entire summary below the break:

 

AT - Lundbeck v. Ratiopharm / Escitalopram SPC

H.Lundbeck A/S, Lundbeck Austria GmbH v. Ratiopharm Arzneimittel Vertriebs GmbH, Escitalopram, SPC, Supreme Court, Austria, 7 March 2011, Case No. 17 Ob 5/11a

Another Escitalopram decision re the SPC for Escitalopram.

The Austrian Supreme Court considers the SPC valid. This is in line with other European courts such as the Bundespatentgericht in a decision of 30 March 2011 (the reasons have not yet been published).

Read the Austrian Supreme Court decision (in English) here.
Read the Austrian Supreme Court decision (in German) here.

Read the German Bundespatentgericht decision (in German) here.

EUCJ - Opinion A-G Mengozzi / SPC Memantine

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):

EUCJ - Opinion A-G Mengozzi / SPC Galantamine

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."

Read the Opinion (in English) here.  

DE - Novartis v. Actavis / SPC Valsartan

Novartis AG v. Actavis Deutschland GmbH and Actavis Ltd, Malta, Düsseldorf District Court, Germany, 8 March 2011, Case No. 4b O 280/10, with thanks to Frank-Erich Hufnagel and Cordula Tellmann, Freshfields, for sending in the case, including a translation and summary in English

"In preliminary proceedings initiated by Novartis AG against Actavis the Düsseldorf District Court held that Actavis' products containing the active ingredients valsartan and hydrochlorothiazide (HCTZ) would infringe Novartis' German SPC relating to valsartan (DE 196 75 036). In view of the pre-trial correspondence between the parties, there was no imminent threat as to an infringement of the underlying basic patent EP 0 443 983 B1. The decisions may be appealed. The key legal question was whether a combination product containing two active ingredients (e.g. valsartan and HCTZ) would fall under the scope of a SPC for one of these active ingredients, namely valsartan.

The Court explains:

"In view of the not very precisely phrased and thus not easy to understand wording of article 4 SPC-Regulation, the legislative purpose of the limitation of the protection only to "the product covered by the marketing authorisation" is of key importance for the interpretation of this article." 

UK - Neurim Pharmaceuticals (1991) Ltd v Comptroller General of Patents / Referral CJEU

Neurim Pharmaceuticals (1991) Ltd v Comptroller General of Patents, Court of Appeal, London, UK, 8 March 2011, Case no. [2011] EWCA Civ 228

Facts
This case concerns Neurim’s application for an SPC on “melatonin”. Further to the requirements of Council Regulation 1768/92/EEC  Article 3(b) and (d) (the “SPC Regulations”), the application cited a first marketing authorisation. In this case it was for “Circadin-melatonin”, relating to the use of melatonin and excipients as a monotherapy for the short-term treatment of primary insomnia in over 55 year olds.

However, an earlier authorisation to place melatonin on the market exists. This is for the veterinary product Regulin that comprises melatonin and excipients. Regulin is used to improve the reproductive importance of pure bred and cross bred lowland sheep that are to be mated before the usual peak of reproductive activity. Both the Regulin product and the Circadin product were protected by patents. However, Circadin did not fall within the protection of the Regulin patent and vice versa.

 

HU - Interpretation of transitional rules for granting SPC in Hungary

Interpretation of transitional rules for granting SPC in Hungary – Supreme Court refuses SPC based on transitional provisions if first marketing authorization in the Community was issued before January 1, 2000

The Supreme Court has recently handed down a ruling in which it interpreted Article 19a f) of Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products (SPC Regulation). The ruling declares that Article 19a f) of the Regulation, which provides transitional provisions concerning the availability of supplementary protection certificates after the accession of Hungary to the EU shall be understood in a way, that if the first marketing authorization for the concerned medicinal product was issued anywhere in the Community before January 1, 2000, no SPC shall be granted.

Read the entire summary here.

Read the judgment (in Hungarian) here.

Summary: Eszter Szakács