EPLAW Patent Blog

SE - Ferring v. Medac

Ferring International Center S.A v. Medac Gesellschaft für klinische Spezialpräparate G.m.b.H, Gebro Pharma G.m.b.H. v. Ferring International Center S.A, Medac Gesellschaft für klinische Spezialpräparate G.m.b.H v. Ferring International Center S.A, District Court of Stockholm, 31 March 2011, Docket No. T T 26687-06, T 1370-07 and T 15455-07 (joint cases)

Ferring International Center S.A was the holder of a Swedish patent granted in October 2006 for a pharmaceutical in tablet form (with desmopressin as active substance) and lodged a patent infringement claim against Medac Gesellschaft für klinische Spezialpräparate G.m.b.H for its marketing of the pharmaceutical Nocutil (manufactured by Gebro Pharma G.m.b.H.) in November 2006. In defence to the patent infringement claim, each of Medac Gesellschaft für klinische Spezialpräparate G.m.b.H and Gebro Pharma G.m.b.H. intitiated separate proceedings claiming that the patent was invalid in the first half of 2007. The District Court of Stockholm decided to hear the cases jointly.

The patent was declared invalid due to lack of inventive step. Also lack of novelty had been invoked, referring to tablets having been made publically available before the patent's priority date by delivery from Ferring to Sandoz. However, the Court concluded that Sandoz had undertaken not to transfer the information and that the existence of such confidentiality undertaking meant that the tablets could not be considered to have been made publically available. For the Court's assessment of inventive step, it concluded that the objective problem could be solved by further development of Ferring's previous products based on the common general knowledge in the art (i.e. the Handbook of Pharmaceutical Excipients, 3d ed., 2000 by Kibbe).

Furthermore, the Court declared in the infringement case (T 26687-06), in an intermediate judgment, that the disputed patent had been infringed by Medac (a defence of prior use was rejected). The assessment of whether the disputed patent had been infringed was done in an objective manner only, based on the hypothetical assumption that the patent was valid (either as granted or as amended). The remainder of the proceedings, including the trial of claims damages, were stayed awaiting a final judgment with regard to the validity of the patent.

Read the judgment (in Swedish) here.

Head note: Erik Ficks

SE - Välinge v. Pergo

Välinge Innovation AB v. Pergo (Europe) Aktiebolag, District Court of Stockholm, 24 January 2012, Docket No. T 19793-09

The Swedish developer of flooring technology, Välinge Innovation AB, raised an invalidity claim against a Swedish patent granted in 2005 for a locking system for floor panels held by Pergo (Europe) Aktiebolag. The invalidity claim was based on lack of both novelty and inventive step. Pergo denied the invalidity claim and held that the patent at least should be upheld in respect of the first patent claim as amended.

The District Court concluded that the invention was new, but declared it invalid due to lack of inventive step (also as amended). Compared to the matter cited in the state of the art, the alleged invention was considered merely a product of routine work by the person skilled in the art. Noticeable is the Court's several references to case law from the EPO and the EPO's Guidelines in its assessment of the disputed patent. This is another confirmation of the clear trend of Swedish Courts closely adhering to the practice of the EPO in its decision-making.

Read the judgment (in Swedish) here.

Head note: Erik Ficks

NL - Lundbeck v. Tiefenbacher / Escitalopram Appeal

Joined cases of H. Lundbeck A/S v. Alfred E. Tiefenbacher GmbH and H. Lundbeck A/S v. Centrafarm Services B.V. and H. Lundbeck A/S v. Ratiopharm GmbH, Court of Appeal The Hague, The Netherlands, 24 January 2012, Case Nos 312468 / HA ZA 08-1827, 314574/HA ZA 08-2142 and 314783/HA ZA 08-2172, with thanks to Marleen van den Horst en Jaap Bremer, BarentsKrans, for sending in the judgment and a summary in English

The Court of Appeal in the Hague has decided that Lundbeck’s patent for escitalopram, which patent had been invalidated in its entirety by the District Court in first instance, is partially invalid. The product claims for the active substance escitalopram were nullified for lack of inventive step, whilst the method claim describing a specific procedure for the synthesis of escitalopram and the claim relating to an intermediate product were considered valid. The SPC-specific nullity arguments were dismissed.

Read the entire summary in English here.

Read the judgment (in Dutch) here.  

NL - Lübbers v. Relco and annular gap injectors

Lübbers Anlagen und Umwelttechnick GmbH v. Relco Wet & Dry B.V., accelerated patent proceedings before the District Court of The Hague, the Netherlands, 25 January 2012, Case No. 387236 / HA ZA 11-451 
 


On 25 January 2012, the District Court of The Hague ruled in the case brought by Lübbers against Relco. Lübbers acted as the exclusive licensee for EP 1 105 202 (relating to an annular ring injector aimed at cleaning air purification chambers), which patent is owned by Dutch patent holder and licensor Korporam B.V. Lübbers sought an injunction against Relco for patent infringement, but saw the invoked patent partially invalidated instead. Relco attacked the patent on grounds of lack of clarity / insufficiency, lack of novelty and lack of inventive step.

The Court ruled that although lack of clarity arguments under Article 84 EPC are not as such admissible in national proceedings, but that such arguments can indeed lead to invalidation on grounds of insufficiency (Article 83 EPC). Claim 4 is invalidated for that reason.

FR - Sandoz v. Eli Lilly

SAS Sandoz v. Eli Lilly and Company, Court of Appeal of Paris, France, 13 January 2012, Case No. 10/17727, with thanks to Dominique Menard and Stanislas Roux-Vaillard, Hogan Lovells, for providing the judgment and an extended summary in English

On 13 January 2012, the Court of appeal of Paris confirmed the judgment which found that the French part of Eli Lilly's patent No. EP 0 577 303 regarding a process for stereoselective glycosylation shows inventive activity, is sufficiently disclosed and consequently valid. The failing generics company is ordered to pay half a million Euros in attorney's fees.

Read the entire summary (in English) here.

Read the judgment (in French) here.

DE - Walzgerüst II (Rolling Stand II)

Walzgerüst II (Rolling Stand II), nullity proceedings, German Federal Supreme Court, 7 September 2010, Docket No. X ZR 173/07

In case of a complex embodiment whose components or modules can just be moved in limited directions, an invention related to the movement of one component is not lacking an inventive step, if the specific way of movement requires a material redesign of the components.

Read the decision (in German) here.

Head note: Tilman Müller-Stoy

UK - Mölnlycke v. Brightwake

Mölnlycke Health Care AB v. Brightwake Limited (trading as Advancis Medical), High Court of Justice, Chancery Division, Patents Court, London, UK, 25 February 2011, [2011] EWHC 376 (Pat)

The Patents Court held that the product claims of Molnlycke’s patent EP (UK) 0 633 757 relating to wound dressings were invalid and not infringed.

Mölnlycke commenced infringement proceedings in respect of Brightwake’s Episil and Episil Absorbent products. Brightwake counterclaimed that the product claims of the patent were invalid for lack of novelty and for lack of inventive step.

His Honour Judge Birss QC, sitting as a judge of the Patents Court, held that the Episil and Episil Absorbent products did not infringe the patent.

HHJ Birss QC held that claim 6 of the patent was novel in respect of the Brassington prior art but that the product claims were obvious over Brassington. The Judge found that claim 6 was not obvious over the Fabo prior art.

Read the judgment (in English) here.

Head note: Robert Fitt

NL - Global Factories v. Ziuz

Global Factories B.V. v. Ziuz B.V. and Ziuz Medical B.V., District Court The Hague, The Netherlands, 3 December 2010, Case No. KG ZA 10-1216

Global Factories owns European Patent EP 1 656 630 (EP 630) regarding a method and a device for inspecting a series of medicaments. The claimed device relates to a device for inspecting a patient specific string of interconnected drug packs, comprising of several characteristics, among which the characteristic that patient data are provided on each pack and the presence of a camera for scanning the drugs, an input for patient/drug data, a comparison device for comparing the patient/drug data with the camera scans and storage means for storing the patient data scans and drug scans for providing proof of the state of each pack at the time of inspection. Ziuz c.s. develops technology in the field of digital image processing and is also active in the pharmaceutical sector. Ziuz c.s. developed a device, called the Forsee Inspector, that checks the contents of large numbers of drug packets.
Global Factories sought a preliminary injunction prohibiting Ziuz c.s. to infringe EP 630. 

NL - Sandoz cs v. Merck

Sandoz B.V. and Hexal AG v. Merck Sharp & Dohme Corp., District Court The Hague, The Netherlands, 27 October 2010, Case No. HA ZA 09-4241

The District Court of The Hague has invalidated the Dutch part of MSD's European Patent relating to an ophthalmic drug for treatment of glaucoma. The patent claims describe a medicinal product consisting of a combination of dorzolamide, a carbonic anhydrase inhibitor, and timolol, a β-blocker. In earlier preliminary injunction proceedings, it had already been decided that there was a serious, non-negligible chance that the patent would be invalidated (read that decision here). The District Court has now confirmed in proceedings on the merits that the patent lacked inventive step over the Nardin abstract, a document which disclosed the concomitant administration (one after the other, but not together) of timolol and dorzolamine, in combination with common general knowledge. The Nardin abstract was found to be prior art, inter alia since it had been received by the British Library and made available for public use at the priority date.
 
The Court took Nardin as the closest prior art, found that the skilled person would know that concomitant administration lead to therapy adherence problems and, applying the problem and solution approach, ruled that the objective technical problem to be solved was how to enhance the ease of administration and the therapy adherence of the combination thereapy disclosed in Nardin. The obvious answer was: by creating a topical co-formulation, combining timolol and dorzolamine. MSD had argued that the skilled person would be dissuaded from trying to create a co-formulation, since timolol had a less than optimal bioavailability at a pH value lower than 7.0, whereas dorzolamine should be formulated at a somewhat acidic pH, to maintain the stability and solubility. However, the Court disagreed and ruled that the skilled person would know to try to come to a compromise. He would know from prior art that dorzolamine was clinically effective at a pH of 6.0 and he would routinely try whether a co-formulation with a pH value of 6.0 would also be clinically effective. The fact that he knew that the bioavailability of timolol was less than optimal at a pH of 6.0, is irrelevant; what is relevant, is whether there is clinically sufficient bioavailability. The skilled man would know to add a viscosity enhancer, to increase the contact time of the drug with the cornea. In light of this, the Court found there is no prejudice against attempting to create a topical co-formulation of timolol and dorzolamine.

Read the judgment (in Dutch) here.

Head note: Jaap Bremer

EPO - Technical Board of Appeal 3.3.08 renders decision on automatic genotype determination in the field of bioinformatics. Features pertaining to a general manner of analysing data are found to be ignored in assessing inventive step

Beckman Coulter Inc. (patentee) v. Roche Diagnostics GmbH (opponent), Technical Board of Appeal 3.3.08, 23 June 2010, Case No. T 0784/06-3.3.08, with thanks to Stefan Steinbrener, Bardehle Pagenberg, for sending in the case, summary and head note

This appears to be the first decision of an EPO board of appeal explicitly dealing with aspects of bioinformatics. Board 3.3.08 expressed its clear intention to apply the established case law on computer-implemented inventions mainly developed by boards in electricity and physics also in the field of molecular biology, not least because it considers this case law to have now been confirmed by the Enlarged Board.

Hence, the Board was guided by the principle that non-technical features, such as the mental activities found in steps B to E of claim 1, were not to be ignored in assessing inventive step if they interacted with the technical activity of step A  of claim 1 for solving a technical problem and thereby contributed to the technical character of the claimed subject-matter. In the Board's view, such interaction was required by case law to lead to a "tangible technical result". Since the patent claimed and disclosed steps B to E too generally so that a skilled reader lacked the information how to proceed from step A to step E, no such interaction leading to a "tangible technical result" could be established, with the consequence that the features of steps B to E did not count for inventive step and the patent was revoked.

Read the decision (in English) here.

Read a summary in English provided by Bardehle Pagenberg, here.

Head note: Stefan Steinbrener