EPLAW Patent Blog

UK- GSK v Comptroller- General

Glaxosmithkline Biological SA v Comptroller-General of Patents Designs and Trade Marks, Patents Court, London, UK, 21 March 2013, Case No. [2013] EWHC 619 (Pat)

The UK Patents Court has made a further reference to the Court of Justice of the European Union, requesting that Article 1(b) of Regulation 469/2009/EC (the SPC Regulation) be clarified, and in particular the meaning of “active ingredient” and “combination of active ingredients”.

Glaxosmithkline Biological SA (“GSK”) filed two Supplementary Protection Certificate (“SPC”) applications, one for an adjuvant known as AS03, and one for a vaccine comprising an antigen and AS03.  In both applications, GSK relied upon a marketing authorisation for a influenza vaccine, sold under the trade mark, Prepandrix.  Acting on behalf of the Comptroller, the Deputy Director of the UK Intellectual Property Office, decided that neither application was allowable since AS03 was not an “active ingredient” of Prepandrix, within the meaning of the SPC Regulation.  GSK appealed this decision.

Both parties agreed that this issue should be referred to the CJEU for a preliminary ruling.  Mr Justice Arnold, hearing the case, agreed that this was necessary for three reasons: (1) the answer in this case was not acte clair; (2) there was a lack of consistent interpretation between different national authorities on this point; and (3) the present case raised a similar issue to the issue in a previous SPC related case, Bayer CropScience.

Accordingly, the following questions have been referred to the Court of Justice:

FR - Novartis v. Actavis - Cour de cassation

Novartis v. Actavis, French Cour de cassation, Paris, France, 15 January 2013, Case number  A 11-26.632, with thanks to Pierre Véron and Nicolas Bouche, Véron & Associés, for providing the judgment, a translation in English and a summary

The French Cour de cassation follows the Court of Justice of the European Union’s ruling of 9 February 2012 in the parallel UK case and decides that the proprietor of an SPC for product A may prevent third parties from marketing a drug combining A + B.

Novartis was the proprietor of a basic patent (expired on 12 February 2011) covering valsartan and of an SPC for the product valsartan, a drug against hypertension.

Actavis marketed in France a drug containing valsartan and another active ingredient, HCTZ, a diuretic.

Novartis sought a preliminary injunction against Actavis, which was granted by the tribunal de grande instance on 28 January 2011, but the cour d’appel de Paris reversed it on 16 September 2011 on the grounds 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”.

Novartis brought the case before the Cour de cassation, the highest French court for civil matters.

The legal question (the interpretation of Articles 4 and 5 of Regulation (EC) No 469/2009 of 6 May 2009 concerning the supplementary protection certificate for medicinal products) was whether the SPC covering the product valsartan was infringed.

In other words, whether the owner of an SPC for product A can prevent the marketing of an A + B product where B is also an active ingredient.

UK - Dr Reddy’s Laboratories v Warner-Lambert

Dr Reddy’s Laboratories (UK) Ltd and Dr Reddy’s Laboratories Ltd v Warner-Lambert Company LLC, 20 December 2012, Patents Court, UK, Case No. HC 11C03027

This is a UK decision clarifying certain provisions of Regulation (EC) 1901/2006 (the “Paediatric Regulation”) which applies in relation to the grant of a six month extension to Supplementary Protection Certificates (SPCs), and of Regulation (EC) 469/2009 (the “SPC Regulation”).  The Court held that deferrals under the Paediatric Regulation can be requested on the ground where the safety of the product was a concern, or the paediatric study would have caused the delay in the authorisation for adults.  Further, Article 45(3) of the Paediatric Regulation is transitional in nature and has no application in cases where all the studies included in a paediatric investigation plan were initiated after the regulation came into force on 26 January 2007. 

The Court also clarified that Article 16 of the SPC Regulation grants discretion to national bodies whether or not to revoke an extension if the conditions of Article 36 of the Paediatric Regulation are not met.

NL - Georgetown University v. Dutch Patent Office

Georgetown University, Washington, DC, USA v. Octrooicentrum Nederland (Dutch Patent Office), Administrative Law division of the District Court The Hague, the Netherlands, referral judgement of 12 October 2012, case no. AWB 10/4769

*** Now including a translation in English with thanks to Hoyng Monegier ***

Georgetown University (“GU”) held the EP0647140 patent for ‘Papillomavirus vaccines’ and filed an application for an SPC on 14 December 2007 (application no. 300321) for recombinant L1 protein of human papillomavirus (HPV) type 16, which application was denied by the Dutch Patent Office (“DPO”) by decision of 19 May 2010. GU filed objections against this refusal on 30 June 2010. Parties agreed to directly appeal to the District Court of The Hague and they have filed their views regarding the decisions of the ECJ of 24 and 25 November 2011 in C-322/10 (Medeva), C-422/10 (Georgetown University) and C-630-10 (Queensland).

UK - AstraZeneca v. Comptroller General / SPC referral to CJEU

AstraZeneca AB v. Comptroller General of Patents, High Court of Justice, Chancery Division, Patents Court, London, UK, 19 October 2012, Case No. [2012] 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?

 
Read the decision (in English) here.

Head note: Paul England

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

Lundbeck H. A/S v. GmbH Tiefenbacher, Ratiopharm GmbH, Ratiopharm Belgium N.V., Teva Pharma Belgium N.V., Eurogenerics NV, Court of Appeal, Brussels, Belgium, 17 september 2012, Case No. 2011/AR/2821, with thanks to Steven Cattoor, Hoyng Monegier, for sending in the case and an extended summary in English

** Now including a translation in English **

"Less than a year after the first instance judgment of the Brussels Commercial Court (see here), the Brussels Court of Appeal has rendered its final decision in the escitalopram case. The first instance decision of 3 October 2011, under which Lundbeck’s Belgian escitalopram SPC had been revoked, is completely overturned, and the Court of Appeal confirms the validity of the SPC and the underlying basic patent.

"In particular, the Court finds that both the product claims as well as the process claim of the patent are new and inventive, and that the requirements of Articles 3(c) and 3(d) SPC Regulation are met. Consequently, any generic product containing escitalopram as active ingredient is held to be infringing and the requested injunction is granted.

"The (128 page) judgment is well-motivated and analyzes in detail the nullity arguments raised by the generics, dismissing them one by one.

"When dealing with the issues of patent validity, the Court repeatedly refers to the EPO case law and Guidelines:

Read the entire summary in English here.

Read the decision (in Dutch) here.
Read the decision (in English) here.

FR - Sanofi v. Teva

Sanofi, Sanofi Bristol Myers Squibb and Sanofi Aventis France v. Teva Santé, Tribunal de Grande Instance, Paris, France, 3 October 2012, Case No. 12/57056, with thanks to Pierre Véron and Isabelle Romet, Véron & Associés, for sending in the decision, including a translation and summary in English

On 3 October 2012 the presiding judge of the tribunal de grande instance de Paris issued a preliminary injunction against Teva Santé.

This is a French development of the European litigation concerning Sanofi’s combination SPC irbesartan/HCTZ covering its flagship drug for the treatment of hypertension marketed under the brand CoAprovel which gave rise, inter alia, to the following decisions:

UK - Actavis v. Sanofi, (CJEU referral, which may be read here)

NL - Sanofi / Pharmachemie & Teva – Irbetasan & HCTZ  (preliminary injunction against Pharmachemie and Teva, which may be read here)

DE – Sanofi / Actavis Landgericht Düsseldorf 15 August 2012 (preliminary injunction against Actavis, which may be read here)

The order handed down on 3 October 2012 by the presiding judge of the tribunal de grande instance de Paris enjoins Teva Santé from marketing in France a generic irbesartan/hydrochlorothiazide (HCTZ).

Sanofi’s French SPC No. 99 C0001 on the combination of the two active ingredients irbesartan, an angiotensin II receptor antagonist, and hydrochlorothiazide, a diuretic, is based on claim 20 of European patent No. 0 454 511 protecting the combination of irbesartan and “a diuretic”.

DE - Sanofi v. Actavis

Sanofi SA v. Actavis Deutschland GmbH & Co, Düsseldorf Regional Court, Düsseldorf, Germany, 15 August 2012, Case No. 4a 0 109/12, with thanks to Pierre Véron and Isabelle Romet,  Véron & Associés, for sending in the judgment and the translation in English

A preliminary injuction against Actavis was awarded. Read more here.

Read the decision (in German) here.
Read the decision (in English) here.

UK - Actavis v. Sanofi

Actavis Group PTC EHF and Actavis UK Limited v. Sanofi, High Court of Justice, Chancery Division, Patents Court, London, UK, 20 September 2012, [2012] EWHC 2545 (Pat)

The Patents Court referred two questions of interpretation on the Supplementary Protection Certificate (SPC) Regulation to the CJEU for a preliminary ruling.

Sanofi was the proprietor of European Patent (UK) No. 0454 511 which covered the anti-hypertensive drug, irbesartan (marketed under the name Aprovel). The patent had expired on 20 March 2011 but Sanofi had obtained two SPCs based on the patent. The first, SPC GB98/07 (the Irbesartan SPC), had expired on 14 August 2012 and the second, SPC GB99/008 (the Combination SPC) was due to expire on 14 October 2013. The Combination SPC covered a fixed dose of irbesartan and hydrochlorothiazide and was marked by Sanofi under the trade name, CoAprovel.

Actavis intended to market generic versions of Aprovel and CoAprovel and applied to revoke the Combination SPC.

Mr Justice Arnold decided to refer two questions to the CJEU regarding the SPC Regulation. The first related to the criteria for deciding whether ‘the product is protected by a basic patent in force’ in Article 3(a) of the Regulation. The second related to the meaning of Article 3(c) of the Regulation regarding the number of SPCs which can be granted in respect of a single basic patent. Mr Justice Arnold has requested the parties to provide submissions regarding the precise wording of the questions to be referred to the CJEU.

Read the judgment in English here.

Head note: Rob Fitt

NL - Sanofi / Pharmachemie & Teva – Irbetasan & HCTZ

Sanofi S.A. v. Pharmachemie B.V. and Teva Pharma B.V. and Sanofi S.A. v. Teva Nederland B.V., District Court of the Hague, 14 September 2012, Case No's 425814 / KG ZA 12-905 and 426135 / KG ZA 12-928

This judgment follows the earlier provisional ruling of the District Court of the Hague granting Sanofi a provisional injunction against Pharmachemie and Teva to stop the defendants from putting onto the market, reselling, delivering or otherwise trading or offering for any such purpose any high blood pressure medication comprising irbetasan and HCTZ for the entire duration of the preliminary injunction proceedings.

Sanofi holds a combination-SPC for irbesartan, in the form of a salt and/or a hydrate and hydrochlorothiazide (also known as HCTZ), which SPC is in force until 14 October 2013. The SPC is based on EP 0 454 511 for “Dérivés hétérocycliques N-substitués, leur préparation, les compositions pharmaceutiques en contenant” (hereinafter “EP 511”). An earlier SPC for just irbetasan, referred to in these proceedings as the ‘Mono-SPC’ was also based on this patent, but lapsed in August 2012.

Teva argued that the combination SPC is invalid because: