EPLAW Patent Blog

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 The first instance decision of 3 October 2011, under which Lundbeck’s Belgian escitalopram SPC had been revoked, is completely overturned, and the Court of Appeal confirms the validity of the SPC and the underlying basic patent.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.

BE - Escitalopram / PI based on EP annulled at first instance

Brussels court of appeal, 27 June 2012, Lundbeck / Eurogenerics, case number 2012/KR/129 and 2012/KR/137 (PI proceedings)

In an earlier decision from the Belgian supreme court (reported here on the EPLAW Patent Blog), the Belgian tier of a European patent was declared prima facie valid despite having been revoked by the EPO Opposition Division.  It was held that, in view of the suspensive effect of the appeal that was lodged before the EPO Board of Appeal against that decision (Article 106(1) EPC), the revocation could not prevent a PI being granted on the basis of that patent.

The Brussels court of appeal has now declared this reasoning applicable to invalidity decisions issued by Belgian first instance courts. Lundbeck’s SPC for escitalopram was declared invalid by the Brussels commercial court in October 2011 in proceedings against the generic manufacturers Teva and Tiefenbacher.  Lundbeck has in the meantime appealed this decision and has already obtained a partial reversal of the first instance decision.  It now sought to enforce the same SPC against another generic manufacturer of escitalopram, Eurogenerics.  Eurogenerics argued that the patent was not prima facie valid because it had been annulled at first instance. The Brussels court of appeal did not accept this defence and stated that, by analogy to the supreme court decision on Article 106(1) EPC, the SPC should be considered prima facie valid for the purpose of PI proceedings, given the pending appeal against the first instance nullity decision.

Read the decision (in French) here.

Head note: Philippe de Jong

 

BE - Claim for “guiding surface” is not limited to shape depicted in drawing

Germeau Carrière v. Core Distribution and Urban Sporting Goods, expedited proceedings on the merits, Liège court of appeal, Belgium, 21 February 2012, case number 2010/RG/1369  

The respondents (Core Distribution and Urban Sporting Goods) are the co-proprietors of a European patent for an “extending ladder and associated manufacturing methods” (EP 1 448 865).  One of the features of the patented ladder is that in contains columns to which rings are coupled with an interior guiding surface for contacting the exterior surfance of another column. The appellant, who was found to infringe the patent at first instance, argued that the claim should be construed to mean that the said guiding surface was flat and that, since its own guiding surface allegedly had a different shape, there could therefore be no infringement.

The appellant found support for its argument in the description (§ 42) and the drawings (figure 7) of the patent specification, which described the embodiment of figure 7 as “[columns] with … shapes including flat surfaces … so as to preclude relative rotation between the columns”. The court of appeal rejected this argument and held that, on proper construction of the claims, figure 7 only depicted one possible embodiment of the invention and that no such limitation could be read into claim 1 or any other claim of the patent. What was claimed was a guiding surface, not a flat guiding surface. The court thereby confirmed the first instance decision.

However, the court reversed the first instance decision to the extent that it held that a court adjudicating a patent claim in expedited proceedings on the merits could not order to the restitution of the costs of the saisie carried out prior to the start of the proceedings. The reason for this being that no damages can be awarded in expedited proceedings. According to the court of appeal, however, these costs do not amount to damages, but to procedural costs, and could therefore be reimbursed to the respondents in expedited proceedings, without needing to start separate genuine proceedings on the merits.

Read the decision (in French) here.

Head note: Philippe de Jong

BE - Belgian supreme court broadens literal infringement test (for claims with numerical features)

Nouvag v. Malak, Supreme Court, Brussels, Belgium, 3 February 2012, Case number C.10.462.F/1

The Belgian supreme court has upheld a 2009 decision of the Brussels court of appeal in which the Swiss company Nouvag was held to infringe a European patent (EP 971 754) for a liposuction apparatus registered in name of a Belgian doctor, Mr Malak.  The main claim of the patent was directed to a liposuction device comprising inter alia a cannula that moved in a specific way (nutation), whereby the movement had a vibration component and a translation component. According to the claim, this translation component had an amplitude between 2mm and 1cm. The amplitude of Nouvag’s cannula was 1,98 mm. 

According to the supreme court, this difference in amplitude, despite the numerical values in the claim, does not stand in the way of a finding of literal infringement.  The supreme court explains that, for there to be an infringement, it is not required that there is an identical reproduction of the invention. It is sufficient that the essential characteristics are reproduced. Secondary or superficial differences do not prevent infringement. According to the court, for a court to conclude that a difference is secondary or superficial under a literal infringement plea, it is not required to examine whether the allegedly infringing product presenting such a difference has an equivalent effect. The court declares that this also applies to the assessment of the infringement of patent claims with numerical features, as in the present case.

Read the decision (in French) here.

Head note: Philippe de Jong 

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.

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

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

Brussels Commercial Court, 3 October 2011, Ratiopharm (Teva) and Tiefenbacher v. Lundbeck, joined cases A.R. 7.271/08 and A.R. 8.245/08

Brussels court holds escitalopram to be the same product as citalopram under Articles 3(c)-(d) of the SPC-Regulation.

Lundbeck commercialises two antidepressants called Cipramil® and Sipralexa®.  Both drugs inhibit the re-uptake of serotonine by the brain. The first MA for Cipramil® in Belgium dates back to May 1990, whereas the first MA for Sipralexa® was issued in July 2002. The active ingredient of Cipramil® is citalopram, whereas that of Sipralexa® is escitalopram. Escitalopram is the S-enantiomer of the racemate citalopram. Lundbeck is the proprietor of an SPC for citalopram, granted in September 1994, and one for escitalopram, applied for in December 2002 and granted in June 2003. The basic patents (one Belgian and one European) from which these SPCs ensued, have expired. Ratiopharm (later on Teva) and Tiefenbacher wished to launch a generic escitalopram product on the Belgian market and sought the invalidation of both the patent and SPC for escitalopram, which extended the protection until 1 June 2014.

 

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:

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