EPLAW Patent Blog

DE - Bundesgerichtshof rules that patents on embryonic stem cells are partially valid

In a fundamental decision on 27 November 2012 (BGH Decision of 27 November 2012, case no.: X ZR 58/07) the Bundesgerichtshof ruled that a patent (DE 197 56 864) registered in favour of the German stem cell researcher, Oliver Brüstle, is invalid in part.

The subject of the patent, which was applied for in 1997, is the protection of neural precursor cells and the procedure to cultivate these cells and use them in therapy of neural defects. Using the invention by Mr Brüstle upon which the patent is based, transplantation of neural precursor cells in the nervous system can play an important role in treating Parkinson's disease and multiple sclerosis in the future. Such neural precursor cells are usually obtained from embryonic stem cells and can then be used as transplant material.

The European Patent Office deemed that such neural precursor cells, the method for producing them and their use in therapy of neural defects were patentable, and in 1999 granted the patent which Oliver Brüstle applied for, and registered it in the patent register.

Greenpeace e.V. filed an action for annulment of this patent before the Federal Patent Court. According to Greenpeace the subject of this patent violated public policy and accepted principles of morality insofar as it concerned precursor cells which were developed from human embryonic stem cells. Use of such cells is also being discussed because the state of the art at the time destroyed the embryo when the neural precursor cells were produced.

NO - Actavis v. Novartic / Valsartan

Actavis Group PTC hf and Actavis  Norway AS v. Novartis Norge AS and Novartis AG, Borgarting Court of Appeal, Norway, 23 October 2012, Case no. 11-062214ASD-BORG-02, with thanks to Inga Kaasen and Thomas Hagen, Advokatfirmaet Grette, for sending in the judgment and a head note

On 23 October 2012 the Borgarting Court of Appeal rendered its judgment in the case between Actavis Group PTC hf and Actavis Norway AS, hereafter Actavis, and Novartis Norge AS and  Novartis AG, hereafter Novartis, regarding Novartis’ patent NO 304023. The patent protects an analogical process for the production of valsartan. Valsartan is an active ingredient in medicinal products used for the treatment of cardiovascular diseases. Novartis’ patent NO 304023 expired in February 2011, but SPC/NO 1998024 prolonged the protection until 13 May 2011.

The Court of Appeal had to evaluate whether or not QSSA’s “Route C”, used by Actavis, was an obvious modification of Novartis’ patent protected process. All the features of the patent could not be found in Actavis’ process. However, the Borgarting Court of Appeal’s majority found that Actavis’ process constituted a patent infringement based on the doctrine of equivalence, as it considered the process as a nearby modification of the patent protected process. The minority found that Actavis’ QSSA process was a different process than the patented process.

The Court of Appeal concluded that Actavis had committed patent infringement. When considering Novartis’ claim for damages, the court adjusted the claim reasonably from NOK 17,000,000 to NOK 11,400,000 [approximately EUR 1,553,063; editor]. In accordance to this, Actavis had to pay NOK 11,400,000 in damages to Novartis. Legal fees were not awarded.

Read the judgment (in Norwegian) here.

EU - New draft on Unitary Patent Protection

New Article 5a of the Regulation on Unitary Patent Protection

Uniform Protection

(1) The European patent with unitary effect shall confer on its proprietor the right to prevent any third party from committing acts against which the patent provides  protection throughout the territories of the participating Member States in which the patent has unitary effect, subject to applicable limitations.

(2) The scope of this right and its limitations shall be uniform in all participating Member States in which the patent has unitary effect.

(3) The acts against which the patent provides protection referred to in paragraph 1 and the applicable limitations shall be those defined by the law applied to European patents with unitary effect in the participating Member State whose national law is applicable to the European patent with unitary effect as an object of property in accordance with Article 10.

(4) In the report referred to in Article 20(1) the Commission shall evaluate the functioning of the applicable limitations and, where necessary, shall make appropriate proposals.

New Recitals 9 and 10 of the Regulation on unitary patent protection

Read the entire set of proposed changes (in English) on the Dutch IP website www.ie-forum.nl here.  

EU - Draft agreement on a Unified Patent Court and draft Statute - Consolidated text

"Delegations will find in the Annex a revised version of the consolidated text of the above mentioned draft agreement, which takes into account delegations’ comments. Changes in relation to the previous version (14750/12) are underlined."

Read the draft agreement (in English) here.

UK - Hollister v Medik Ostomy

Hollister Incorporated and Dansac A/S v Medik Ostomy Supplies Limited, 9 November 2012, Court of Appeal, Case No. A3/2012/0331 and 0334

In an important decision for the assessment of compensation for infringement of intellectual property rights, the Court of Appeal in London has held that when calculating an “account of profits” it is not permissible for a defendant simply to allocate a proportion of general overheads to an infringing activity, in order to reduce the level of profits payable to the rights holder.  On the contrary, the defendant must show that the relevant overheads are properly attributable to the infringing activity.

The effect of this decision is that we are likely to see an increase in patentees and holders of other intellectual property rights electing to receive an account of profits, instead of general damages, following successful infringement actions in the UK.

Background

Medik was a parallel importer of the claimants’ ostomy products. Medik had admitted trade mark infringement and, after reviewing Medik’s disclosure, the claimants made an election for an account of profits. At the subsequent inquiry, Judge Birss ordered Medik to pay half of its net profits assessed on the normal basis under English law. Both sides appealed. A number of issues fell to be determined by the Court of Appeal, including the correct approach to assessing net profits.

EPO - Extended access to Administrative Council documents

EPO improves transparency of legislative process - database still small

Legislative history is an important tool for interpreting the law. The travaux préparatoires for the EPC 1973 and for the EPC 2000 have been available for some time on the EPO’s website and contribute to a better understanding of the European patent system. By contrast, no comparable documentation existed for the ongoing legislative activity of the Administrative Council (AC) which is in particular competent to amend the Implementing Regulations and the Rules relating to Fees. Whereas the Boards of Appeal quite often cite documents like legislative proposals of the Office or minutes of the Patent Law Committee as background for the interpretation of law, the access to such documents was locked for the users of the EPO. The secretariat of the AC did not even respond to queries for copies of such documents.

As a rule, decisions of the AC are published by the EPO without explanation which can make it difficult to understand in which respect the legal situation has changed. An illustrative example is the recent decision of the Council of 25 October 2012 reducing the fee for the supplementary European search in certain cases (CA/D 14/12) which was published on the EPO’s website on 31 October 2012. Without knowing that the previous decision of the Council is temporary and will cease to apply it is difficult to recognize what is new. To get the context, the reader has to study the new decision, to find the previous one, and to understand its transitional provision in order to find out that nothing has changed in substance. Since November 12, 2012 the new access to the AC documents has been open and it contains not only doc. CA/D 14/12 but also the proposal of the EPO CA/90/12 on which the decision is based and which explains the background.

The new means of information is still limited. So far it contains only 6 documents, all dated 2012 and none of the previous decisions of the AC in this year. It is to be hoped that the database will be quickly expanded. International legislation should not be less transparent than national legislation.

URL to the database:
www.epo.org → About us → European Patent Organisation → Documentation → Administrative Council Documents
 
Reported by Rudolf Teschemacher

UK - Mölnlycke Health Care v BSN Medical

Mölnlycke Health Care AB and Mölnlycke Health Care Limited v BSN Medical Limited and BSN Medical GMBH, 9 November 2012, Case No. HC09C03755, Neutral Citation Number: [2012] EWHC 3157

Mölnlycke Health Care alleged that BSN Medical’s “Cutimed Siltec” range of layered wound dressings infringed its European Patent (UK) No 0855921, which claimed a wound dressing comprising a layer of “holey” form coated with a layer of skin-adhering hydrophobic gel (e.g. silicone gel) wherein the walls of the holes in the foam were coated with gel at the ends which were proximal to the wearer’s skin.  BSN claimed that the patent was invalid for want of novelty, inventive step and sufficiency.

Mr Justice Floyd held that the patent was valid, but not infringed by the BSN products.

In construing the patent, Mr Justice Floyd confirmed that in the context of a product claim, the court was concerned with the end result and not with the means by which that result was achieved. Thus the requirement in claim 1 that the foam be “coated” with hydrophobic gel would be understood by the skilled person to mean that the foam and gel must be in intimate contact with one another; investigation into how that contact was achieved was irrelevant for the purposes of the claim.

The assessment of infringement turned on: (i) whether the silicone layer of the BSN products constituted a “gel”; and (ii) whether the silicone in the BSN product coated the walls of the holes in the foam.

EPLAW - Congress and General Assembly

The EPLAW Congress and General Assembly will take place on 7 December 2012 at the usual venue in Brussels (Le Méridien, close to the Central station).

You may read the programme here.

Please register by 28 November 2012.

NL - Medinol v. Abbott

Medinol Limited v. Abbott B.V., Abbott Vascular Devices B.V. and Abbott Logistics B.V., Court of Appeal The Hague, The Netherlands, 30 October 2012, Case/case list number : 329760 / HA ZA 09-418, with thanks to Simon Dack and Peter van Schijndel, Hoyng Monegier, for providing the judgment and a translation in English

The District Court of The Hague had ruled that the Medinol patent related to stents was not infringed by Abbott since the term 'meander pattern' in the claims had to be construed based on a definition in the description of a meander pattern as 'a periodic pattern about a center line'. This implied, according to the Court that the patterns had to be symmetrical. The attacked stents did not have this feature.

Also the Court of Appeal concludes that there is no infringement, but on different grounds. The Court of Appeal ruled that the Medinol patent was in fact limited to stents that showed longitudal shortening upon expansion. The patent resolved the shortening problem by providing a compensation mechanism between the first and the second meander patterns. The attacked stents were stents in which no shortening occurs upon expansion, so that no compensation is needed. Thus there was no infringement and the question regarding symmetry could be left undiscussed.

Costs of EUR 508,196.55 were awarded despite Medinol's objections. Abbott argued that the case is substantial and demanded a great deal of investigation, in part as a result of the way in which the case was presented; the Court of Appeal deems this plausible.

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

NL - Georgetown University v. Dutch Patent Office

Georgetown University, Washington, DC, USA v. Octrooicentrum Nederland (Dutch Patent Office), Administrative Law division of the District Court The Hague, the Netherlands, referral judgement of 12 October 2012, case no. AWB 10/4769

*** Now including a translation in English with thanks to Hoyng Monegier ***

Georgetown University (“GU”) held the EP0647140 patent for ‘Papillomavirus vaccines’ and filed an application for an SPC on 14 December 2007 (application no. 300321) for recombinant L1 protein of human papillomavirus (HPV) type 16, which application was denied by the Dutch Patent Office (“DPO”) by decision of 19 May 2010. GU filed objections against this refusal on 30 June 2010. Parties agreed to directly appeal to the District Court of The Hague and they have filed their views regarding the decisions of the ECJ of 24 and 25 November 2011 in C-322/10 (Medeva), C-422/10 (Georgetown University) and C-630-10 (Queensland).