EPLAW Patent Blog

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

BE - Supreme court upholds traditional Belgian prima facie validity test in PI proceedings

Novartis v. Mylan, Supreme Court (“Hof van Cassatie/Court de Cassation”), Belgium, 5 January 2012, Docket number C.11.0101.N,

The Belgian Supreme Court has confirmed an earlier decision of the Brussels court of appeal whereby Novartis saw its claim for a preliminary injunction against Mylan’s intended commercialisation of a generic sustained release formulation of fluvastatin granted. In doing so, the Supreme Court upheld the established approach applied by the Belgian courts that a granted (European) patent is presumed to be valid for the purpose of obtaining an interim injunction. This prima facie validity is not affected by a decision of the Opposition Division of the EPO against which an appeal has been lodged before the EPO Technical Board of Appeal, even if the patent concerned was revoked in its entirety by the Opposition Division. According to the Court, this directly ensues from the suspensive effect of such an appeal pursuant to Article 106(1) EPC.

Read the judgment (in Dutch) here.

Head note: Philippe de Jong

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:

 

NO - Novartis v. Actavis / Valsartan

Novartis v. Actavis, Valsartan, District Court Oslo, Norway, 10 February 2011, Case No. 10-062600TVI-OTIR/04

On 10th of February 2011 the Oslo District Court rendered its decision in a case between Novartis AG/Novartis Norge AS (hereafter Novartis) and Actavis Group PTC hf/Actavis Norway AS (hereafter Actavis) regarding Novartis’ patent NO 304023. Novartis had initiated the proceedings, requiring preliminary measures to stop Actavis’ infringement of patent NO 304 023 by producing and selling products containing the pharmaceutical ingredient valsartan.

The patent in question is a process patent and the question before the court was whether the process used by Actavis to fabricate valsartan – QSSA Route C – constituted an infringement of patent NO 304 023.The District Court assessed the question using the doctrine of equivalence.

 

BE - Novartis v. GSK Biologicals / Confidentiality Measures Upheld

Novartis v. GlaxoSmithKline Biologicals & B.J., Belgian Supreme Court, 24 March 2011, Case No. C.10.0130.F/1, with thanks to Steven Cattoor, Hoyng Monegier LLP, for providing the case and a summary in English

Belgian Supreme Court upholds confidentiality measures

"On Thursday 24 March 2011, the Supreme Court pronounced its judgment in the GSK Bio/Novartis case, a case dealing with the disclosure of confidential information by an expert appointed in the framework of ex parte “descriptive seizure” or saisie contrefaçon proceedings. In the case in point, the expert had given a description of GSK Bio’s activities as relevant in view of the invoked patent, but also annexed to his report substantially all confidential documents received during the saisie operations.

As reported earlier (see here), the Brussels Court of Appeal had by judgment of 4 December 2009 ordered the removal of all annexes and prohibited Novartis to make any use of any information not included in the body of the report, subject to a penalty of 1 million Euro per breach.

The Supreme Court now dismisses Novartis’ request to have that appeal judgment annulled.

Novartis invoked two grounds, in essence arguing as follows:

FR - Institut Pasteur v. Chiron Healthcare & Novartis / Cour de cassation

Institut Pasteur v. Chiron Healthcare & Novartis Vaccines & Diagnostics, French Cour de cassation, 23 November 2010, Case No. 1194 F-D, with thanks to Pierre Véron, Véron & Associés, for sending in the judgment, summary and translation in English

The French Cour de cassation gives here its first decision in a case for infringement of a molecular biology patent (European patent No. 178 978 relating to “cloned DNA sequences, hybridizable with genomic RNA of the LAV” covering a method for detecting HIV).

It rejects the appeal on points of law lodged by claimant Institut Pasteur against a judgment of the Cour d’appel of Paris, 4 March 2009 available here which dismissed the case.

The judgment confirms how Article 69 EPC should be applied to determine the scope of a patent (in the present case, the court does not admit that, after having narrowed the scope of its claims during the opposition procedure to circumvent prior art, the claimant tries and recapture the initial scope during the infringement proceedings).

It also contains a discussion on infringement by equivalence, according to the French theory whereby “infringement by equivalence presupposes that the patented mean does fulfil a new function” the court decides that the patented mean at issue did not fulfil any new function.

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

Read the previous post 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." 

BE - No faultless liability for ‘saisie’ after patent limitation

Brussels Commercial Court, 3 November 2010, GSK Biologicals / Novartis Vaccines and Diagnostics and Novartis AG, joined cases AR/1188/09 and AR/7427/09

The Brussels Court of Commerce has decided that the Belgian legal provisions governing the “saisie description” cannot be interpreted in the sense that a patentee can be held objectively liable for having carried out such a “saisie” on the basis of a patent which was subsequently limited at the EPO level to the extent that it no longer covered the allegedly infringing product. Novartis had carried out a ‘saisie’ at the Belgian offices of GSK against a number of GSK’s vaccines which allegedly infringed Novartis’ EP 1401489 for “solubilization of capsulated polysaccharides”. The EPO Technical Board of Appeal later limited EP ‘489 so as to no longer cover GSK’s vaccines. GSK then claimed compensation from Novartis arguing that it was objectively liable for the alleged prejudice GSK had suffered. Its claim was based on Article 1369bis/3, §2 of the Belgian Judicial Code, which transposes Article 7(4) of the Enforcement Directive into Belgian law. The Brussels court rejected this claim, finding that a “saisie” cannot be considered unlawful merely because the invoked patent is subsequently limited or revoked. The court furthermore held that Novartis had not committed any fault by carrying out the “saisie” and rejected GSK’s allegations of misuse by Novarits of the “saisie” information.

Read the decision (in French) here.

Headnote and summary: Philippe de Jong

BE - Novartis v. Mylan / Fluvastatin

Novartis v. Mylan, Brussels court of appeal, Belgium, 26 October 2010, Docket number A.R. 2010/KR/175, with thanks to Philippe de Jong, Altius, for sending in the case and translation

The Brussels court of appeal has reversed a decision from the Brussels commercial court which had rejected Novartis’ claim for a preliminary injunction against Mylan’s intended commercialisation of a generic sustained release formulation of fluvastatin. In doing so, the Brussels court of appeal upheld the established approach applied by the Belgian courts that a granted (European) patent is presumed to be valid for the purpose of obtaining an interim injunction. According to the court, upon a proprer application of Article 106(1) EPC, it is irrelevant that the EPO Opposition Division revoked the patent, even in its entirety, since the appeal against that decision before the EPO Technical Board of Appeal has suspensive effect.

Read the decision (in Dutch) here.

Read the decision (in English) here.

Head note: Philippe de Jong


FR - Novartis v. Johnson & Johnson

Johnson & Johnson Medical Limited, Johnson & Johnson Vision Care Inc and Ethicon v. Novartis AG, Cour d'Appel of Paris, France, 27 October 2010, Case no. 09/08135

Various decisions were handed down earlier in the worldwide litigation brought by Novartis against Johnson & Johnson about a patent for contact lenses. In a decision of Wednesday 27 October, the Cour d’Appel of Paris affirmed the 25 March 2009 judgment of the Tribunal de Grande Instance (which can be read here). In a nutshell, the Cour d’Appel rejects all Johnson & Johnson arguments of insufficiency and lack of novelty, thereby taking an opposite view to the English Court of Appeal and German Bundespatentgericht.

The patent was granted in 2001, revoked in opposition in 2003 and maintained in its original form by the Technical Board of Appeal 3.4.02 in its decision T 246/04 dated July 12, 2007. In the Netherlands, an injunction was granted against Drogisterij.net (which can be read here). In France, the Tribunal de Grande Instance in Paris gave a verdict on March 25, 2009, finding validity and infringement and ordering an injunction against J&J (read that decision here). The UK High Court held the patent to be new and inventive, the J&J lenses to be infringing, but the patent invalid on grounds of insufficiency. The Court of Jacksonville in Florida, USA, found the patent valid and J&J's lenses to be infringing. The German Bundespatentgericht judged the patent to be invalid in light of anticipation on December 14, 2009. An English Court of Appeal judgment from 29 September 2010 affirmed the High Court and revoked the patent for insufficiency (read that decision here).  

Read the decision (in French) here.

Read the English translation of the French decision here. (with thanks to Véron & Associés)