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Gepubliceerd op woensdag 17 januari 2007
IEF 7723
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Conor vs. Angiotech: Spiro/Flamco, research exception, Bolar, moratorium

The Hague District Court , 17 January 2007, HA ZA 06-261. Conor Medsystems Inc. versus Angtiotech Pharmaceuticals Inc, the University of British Columbia and Boston Scientific Corporation.

Patent law. Partial decision on the validity of and infringement upon the patent by Angiotech and the University of British Columbia (the ‘Hunter-patent”). The patent concerns so-called Drug Eluting Stents (DES). Problem-solution method, partial nullification (Spiro/Flamco), research exception, Bolar-stipulations, moratorium.

In this 33 page judgement the court for a second time renders its opinion on the validity of the Hunter patent. In an order by the court dated 3 May 2006 in the matter Angiotech/Sahajanand the court had ruled that conclusion 6 and 12 of the patent are valid and that Sahajanand had infringed on the patent with its Infinnium-stent. The court did not render a decision with regard to the other patent conclusions.

In this case Conor claims nullification of the patent for the Netherlands. Angiotech c.s. counterclaim a ban on infringement with ancillary claims, among other a moratorium of three years concerning the in the Netherlands unlawfully gained research data for the purpose of a request for CE-authorisation.

Validity

According to the court conclusion 1 of the patent is in its present form non-inventive. According to the court, the invention, in short, sees to the application of, specifically, taxol (paclitaxel) as a drug for a in itself familiar Drug Eluting Stent. The use of taxol should solve the problem of recurring ingrowth of body material. It concerns first and foremost the problem or recurring ingrowth of tumours/cancer tissue and secondly the problem of restenosis. Taxol does however not provide an inventive solution for the problems of ingrowth of tumours/cancer tissue. See consideration sub 4.8 of the judgement.

The court does consider the invention inventive in as far as the taxol-stent offers a solution for the problem of restenosis. The specific application for restenosis is only found again in conclusion 12 of the patent. The court extensively addresses the inventiveness of this conclusion (with application of the problem-solution method) and concludes that this conclusion is also valid. The court refers the case to the docket for further written brief concerning the possible partial upholding of the patent taking into consideration the criteria of the Spiro/Flamco-judgment (NJ 1998/2).

Infringement

The court considers that the CoStar-stent and the Medstent by Conor fall under the scope of protection of the patent and there is sufficient serious threat of infringement. Conors appeal to the research exception fails. The trials sponsored by Conor which have taken place in the Netherlands according to the court do not have a pure scientific aim. The court considers it adequately proven that the Conor used the research results in order to obtain the CE-marking, while Conor was unable to make it sufficiently plausible that the trials were directed exclusively towards research for an improved stent. Conors appeal to the Bolar-stipulations also fails, merely because the trials were executed at a time that the implementation term of Directive 2004/27/EC had not yet lapsed. Apart from a ban on infringement, the court sees no room for a 3-year moratorium as claimed by Angiotech.

Read the entire judgment here.

 

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