Mr. Arne Forsgren v. Spanish Patents and Trademarks Office, High Court of Justice (Contentious-Administrative Chamber - 2nd Section) of Madrid, Spain, 9 July 2014, Docket No. 945/2012.
The wave of resolutions from the European Court of Justice (ECJ) concerning SPCs and the related interpretation of the provisions from the Regulation (EC) No. 469/2009 (hereinafter, “the Regulation”) recently brought the ECJ Judgment of 15 January 2015, in case C 631/13 (Arne Forsgren v. Österreichisches Patentamt), in reply to the request for a preliminary ruling submitted by the Austrian Supreme Patent and Trade Mark Adjudication Tribunal (Oberster Patent- und Markensenat) which concerned the request for grant of a SPC for Protein D present in the ‘Synflorix’ pneumococcal vaccine.
Before the rendering of the Judgment above, the High Court of Justice of Madrid had to decide upon the appeal filed by Arne Forsgren against the decision by the Spanish Patent Office (“SPTO”) not to grant an SPC for Protein D on the basis of the marketing authorization for ‘Synflorix’. It did so by means of a Decision dated 9 July 2014, where, accepting the patentee’s arguments, it revoked the previous rejecting resolution, and hence ordered to grant the requested SPC.
H.Lundbeck A/S, Lundbeck España, S.A. & Almirall, S.A. v. Synthon Hispania, S.L., Cantabria Pharma, S.L., Mylan Pharmaceuticals, S.L. et al., Court of Appeals (15th Section) of Barcelona, Spain, 22 October 2014, Docket No. 371/2013
TRIPS Agreement and patentability of pharmaceuticals in Spain: another turn of the screw.
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In a Decision rendered on 22 October 2014, the Court of Appeals of Barcelona confirmed the earlier Decision of Commercial Court no. 4 dismissing Lundbeck’s and Almirall’s (former’s licensee) actions for patent infringement against a large number of generics companies marketing in Spain Escitalopram generic drugs.
Merck Sharp & Dohme Animal Health, S.L & Intervet International, B.V. v. Bayer Hispania, S.L., Commercial Court No. 1 of Barcelona, Spain, 29 July 2014, Docket No. 727/2014.
MSD companies Merck Sharp & Dohme Animal Health, S.L. (“MSD AH”) and Intervet International, B.V. (“Intervet”) have been awarded in Spain urgent and ex parte preliminary relief against the Spanish branch of the group Bayer, Bayer Hispania, S.L. (“Bayer”), in a patent infringement and unfair competition litigation which brings cause of Bayer’s off label promotion in the Spanish market of its dog collar ‘Seresto’ as suitable for controlling canine leishmaniasis. Commercial Court No. 1 of Barcelona granted such urgent relief in hardly 24 hours, by means of a Decision rendered on 29 July 2014, in light of serious indications that Intervet’s patent rights were indeed being infringed, which justified injunctive measures being urgently ordered on Bayer.
Laboratorios Cinfa, S.A. & Actavis Group PTC EHF v. Boehringer Ingelheim Pharma GmbH & Co. KG, Court of Appeals (3rd Section) of Navarra, Spain, 20 May 2014, Docket No. 278/2012.
In a Decision rendered on 20 May 2014, the Court of Appeals of Navarra confirmed the invalidity of Boehringer’s SPC for the combination product Telmisartan + Hidrochlorotiazide (“HCTZ”) (MICARDIS PLUS), which ratified the previous first instance decision in the same sense issued on 20 June 2012. In a clear example of the Spanish Courts’ embracing of the European Court of Justice’s (“ECJ”) current stance with regards to combination SPCs, these proceedings were substantially decided upon on the basis of the doctrine stemming from Medeva (C-322/10; 24 November 2011) and Actavis (C-443/12; 12 December 2013).
Astellas Pharma Inc. et al. v Synthon Hispania et al., Barcelona Commercial Court no. 10, 30 June 2014, ordinary declarative action 725/2011 – 2, judgment no. 118/2014
Patent infringed despite restrictive functional interpretation of product features
Astellas Pharma Inc. (and others) sued Synthon Hispania (and others) for infringement of the Spanish part of European patent 0 661 045. The patent protects a sustained-release hydrogel preparation containing tamsulosin hydrochloride. Synthon Hispania was accused of manufacturing and selling generic tablets which fall within the scope of claims 1 and 6 of the patent.
On 30 June 2014, the Barcelona Commercial Court rendered its judgment in proceedings on the merits. The Court found the patent to be infringed. The judgment is remarkable, as the decision hinges on the functional interpretation of product features which, in the end, lead to a scope which falls short of the literal wording.
ROS Roca S.A. v. Envac Centralsug Aktiebolag, Supreme Court, Barcelona, Spain, 17 October 2012, Case No. 431/2012, with thanks to Luis Fernández-Novoa and Álvaro Velázquez, Hoyng Monegier, for sending in the judgment and a summary in English
"The Spanish Supreme Court decided on a much debated point of Patent Law in Spain which had been subject to controversial decisions in the past and which the Supreme Court has now finally settled, which is the date on which European Patents shall be considered as effective in Spain.
"In the first instance decision by Commercial Court No. 3, which had granted the complaint for infringement of a waste management process patent filed by ENVAC against ROS ROCA and dismissed the counterclaim for invalidity filed by the latter, the Court had stated that the date from which damages (to be compensated according to the hypothetical royalties fee – which resulted in one of the biggest compensations ever granted by Patent Courts in Spain) should be starting to accrue is the date of the filing of the translation into Spanish of the European Patent before the Spanish Patent Office, in accordance with the provisions set by the Spanish Royal Decree implementing article 65 of the EPC (filing of a translation within 3 months after publication of the grant by the European Bulletin).
Goedecke Aktiengesellschaft & Pfizer, S.A. v. Laboratorios Rubió, S.A., Supreme Court, Spain, 14 June 2010, Docket No. 1801/2006.
The Supreme Court, by means of a decision dated 14 June 2010, declared the existence of infringement of the patent ES 2063219, owned by Goedecke Aktiengesellschaft (Goedecke) and licensed in Spain to Pfizer, S.A. (Pfizer) in relation to the gabapentin generic drugs intended to be marketed in Spain by Laboratorios Rubió, thus confirming the previous judgment handed down by the Court of Appeals of Barcelona on 17 May 2006.
Goedecke and Pfizer had brought legal actions against Laboratorios Rubió with occasion of the request for and obtaining by this company of an authorization to market in Spain several gabapentin generic drugs. Indeed, the plaintiffs understood that the obtaining of such authorization infringed their rights derived from the aforementioned patent, protecting a method for the stabilization of pharmaceutical compositions comprising cyclic amino acids, one of them being gabapentin. Goedecke and Pfizer had therefore claimed for the patent infringement to be declared, the cease and desist of any exploitation activities over gabapentin compositions having being obtained by implementing the patented process, as well as a compensation for damages suffered.
Laboratorios Cinfa, S.A. v. Pfizer Ltd., Pfizer Corporation & Pfizer, S.A., Supreme Court, Spain, 30 June 2010, Docket No. 1785/2006.
On 30 June 2010, the Supreme Court rendered a decision putting an end to the long-lasting proceedings in which Pfizer and Laboratiorios Cinfa (Cinfa) have been confronted for 8 years in relation to the marketing in Spain of generic drugs of amlodipine besylate. Contrary to what both the First Instance Court and the Court of Appeals had previously declared, the Supreme Court understood that Cinfa could not take advantage of the experimental use exception to patent rights -as drafted subsequent to the insertion of the “Bolar Provision” in the Spanish Patents Act- to elude the infringement of Pfizer’s patents ES 2012803 (EP 244944) and ES 520389 with respect to the activities carried out aimed at obtaining the corresponding marketing authorization from the Spanish Medicines Agency, thus declaring the Supreme Court the infringement of Pfizer’s patents.
Eisai Co. Ltd. & Pfizer S.A. v. Mylan Pharmaceuticals S.L., Commercial Court No. 5 of Barcelona, Spain, 29 December 2009, Docket No. 581/2009
Commercial Court No. 5 of Barcelona has confirmed its previous decision of 29 July 2009 pursuant to which it granted interim injunction inaudita parte against Mylan Pharmaceuticals (Mylan), which had been ordered to temporarily refrain from commercializing in Spain generic drugs with the active compound donepezil for the treatment of mild to moderate dementia caused by Alzheimer's disease.
Comment on Envac Centralsug AB v. Ros Roca, S.A., Court of Appeal (15th Section), Barcelona, Spain, 23 October 2008, with thanks to Álvaro Velázquez and Luis Fernández-Novoa Howrey Martinez Lage
"Recent decisions of the Commercial Courts of Barcelona specialized in Patent cases, like that of Court No. 3 of 30 March 2009, are relying on the findings of a late 2008 decision of the Court of Appeals of Barcelona to delay the effectiveness of granted European Patents (EP), even dismissing actions brought for infringements taking place before the publication of the Spanish translation by the SPTO.
"This case comment analyzes the different key aspects which the cited Decision of the Court of Appeals of Barcelona, which is one of the best IP Courts in Spain, overlooked in interpreting the exact date triggering the effectiveness of European Patents in Spain, applying a limiting interpretation of the EPC. Unless they are finally reversed by the Supreme Court, the findings of this decision shall undoubtedly affect future patent enforcement in Spain."
Read the entire comment (in English) here. Read the judgment (in Spanish) here.
Section 28 of the Court of Appeal of Madrid has recently confirmed the first instance decision ordering Teva Genéricos Española (Teva) to temporarily refrain from commercializing in Spain generic drugs with the active compound galantamine for the treatment of Alzheimer and related diseases.
Janssen had brought legal actions against Teva for the infringement of the SPC no. C 20010009, which, expiring on 15 January 2012, had been granted over the basic patent EP 236684, validated in Spain as ES 2000428. Said patent (and accordingly its SPC) protects the use of the compound galantamine, or a pharmaceutically acceptable acid addition salt thereof -which is the active compound of Janssen's Reminyl® product- to prepare a medicinal product for the treatment of Alzheimer and related diseases.