EPLAW Patent Blog

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


BE - Indspec v. Sumitomo Bakelite Europe / wilful infringement

Indspec Chemical Corporation v. N.V. Sumitomo Bakelite Europe, Court of Antwerp, Belgium, 2 July 2010, Case No. A/09/08112

"On 16 July 2009, Indspec enforced a descriptive seizure upon Sumitomo Bakelite Europe, alleging infringement of its European Patents EP’741 and EP’792, which relate to rubber compounding resins (a cord-to-rubber adhesion promoter). Subsequent to the filing of the descriptive report, Sumitomo initiated proceedings on the merits, claiming a revocation of the asserted patents. Indspec filed a counterclaim for wilful patent infringement (on the basis of EP’741), unfair commercial practices and non-compliance with product regulations (classification, packaging and labelling)."

Continue reading the summary in English here.

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

BE - Ajinomoto v. Helm et al. - Process for producing L-Lysine by fermentation

Ajinomoto Co. Inc. v Helm AG et al., Antwerp Commercial Court, Belgium, 11 June 2010, Case nr. A/08/06919

The Antwerp commercial court finds the Belgian counterpart of Ajinomoto’s European patent nr. EP 0733710 B1 valid and infringed. EP ‘710 relates to a “process for producing L-lysine by fermentation”, particularly to a process applying a mutated Escheria bacterium which suppresses Lysine feedback inhibition.

The court discusses GAT/LuK and Roche/Primus and accepts international jurisdiction to adjudicate the issues of infringement raised against several foreign defendants based on Articles 5(3) and 6(1) of the Brussels-I-Regulation.

The defendants filed a counterclaim for revocation of the Belgian counterpart of EP ‘710 on the basis of insufficiency, added matter and lack of inventive step. On insufficiency, the court maintains that disclosure of a single embodiment or application of the invention is enough. The defendants’ arguments in respect to added matter were also dismissed. In that regard, the court concurred with the EPO that an obvious error regarding the exact positioning of the sequence mutations would be recognized as such by a person skilled in the art. Finally, the court accepts that the invention disclosed in EP ‘710 is inventive. Applying the problem-solution approach to EP ‘710, the court indicates that “it is possible to withhold two separate documents as closest prior art in case their respective disclosures do not contradict”.

BE – Iverness Medical / Ulti Med Products – infringement and five year time bar

Iverness Medical Switzerland v. Ulti Med Products, Commercial court of Ghent, 27 May 2010, Docket number A/08/2023

The Ghent commercial court finds that Ulti Med Products has infringed European patent 291 194 B2 for a specific analytical test device and an analytical method in which this test device is used.  Ulti Med did not deny having commercialized the contested product ('D Dimer Test', but said that Iverness’ rights were exhausted because the products had allegedly been placed on the market by Iverness or with its consent.

This defence was rejected by the court because there was not enough evidence of the alleged exhaustion. The court also rejected Ulti Med’s argument that no damages were due for some of the infringing sales as a result of the five year time bar for infringement claims under Belgian patent law. According to the court, the fact that Iverness carried out a 'saisie'  at Ulti Med, interrupted the statutory prescription term. An expert was appointed for the final calculation of the damages.

Read the judgment (in Dutch) here.

Head note: Philippe de Jong

BE - Teva v. Sepracor / invalidity

Teva v. Sepracor, Commercial court of Antwerp, 11 December 2009, Docket number A/08/5474

The Antwerp commercial court has annulled the Belgian tier of Sepracor’s European patent (EP 663 828) for “compositions for treating allergic disorders using (-) cetirizine”, as well as the ensuing SPC for “levocetirizin dihydrocholorid”. Applying (a hybrid version of) the problem-solution approach, the court found that the invention of EP ‘828 was obvious for the skilled person, who was held to be a team composed of persons with a medical, chemical and pharmacological background.

According to the court, the skilled person would have been able to solve the objective technical problem (circumscribed as “finding a substance which can be used for the treatment of allergic rhinitis and asthma and which is at least as effective and advantageous as ceterizine, yet having no or fewer side effects than racemic cetirizine”) with a reasonable expectation of success by combining a number of prior art documents. Referring to T 296/87, the court added that a skilled person who wants to preserve the pharmacological properties of a racemic mixture, but with less side effects, would routinely examine both enantiomers separately to see if he can achieve that goal.

Read the decision (in Dutch) here.

Head note: Philippe de Jong

NL - BVBA VR Construct v. Jurenco Equipment

BVBA VR Construct v. Jurenco Equipment B.V., District Court The Hague, The Netherlands, 26 May 2010, Case No. HA ZA 08-2766

Belgian and European patent on a brush and method for manufacturing such a brush. The District Court defers its decision as far as it concerns the question regarding infringement of the Belgian patent and the foreign parts of the European patent, since Jurenco alleges invalidity of those patents (with reference to GAT/LuK en Roche/Primus).

A decloratory judgment of non-infringement based on the argument that the patent is invalid due to lack of inventive step can also only be given for brushes sold in the Netherlands as the Court is not competent to rule on the validity of the foreign (part of the Eureopean) patent.

Serving a writ of summons based on a patent that is not yet granted is allowable (contrary to an earlier decision by the Judge in preliminary injunction proceedings). It suffices that the patent is granted at the moment the judgment is rendered. The patent was found to be invalid due to lack of inventive step.

Read the judgment (in Dutch) here.

BE – Du Pont et al. v. Mylan / Losartan SPC (Appeal)

Du Pont et al. / Mylan, Losartan SPC, decision in summary proceedings (appeal), Brussels Court of Appeal, 23 February 2010, Case No. A.R. nr. 2010/KR/53

According to the Brussels Court of Appeal, the scope of protection of the SPC for the active ingredient Losartan does not, at first sight (“prima facie”), extend to a generic version of the medicinal product Cozaar Plus® (containing the active ingredients Losartan and HCTZ) under Article 4 of the SPC-Regulation.  The main reason raised by the court is that, since the combination of Losartan and HCTZ was itself protected by an SPC, a medicinal product containing that combination could not infringe the SPC for Losartan alone.  According to the court, this would appear to run counter with Articles 3(c) and (d) of the SPC-Regulation.

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