EPLAW Patent Blog

UK- GSK v Comptroller- General

Glaxosmithkline Biological SA v Comptroller-General of Patents Designs and Trade Marks, Patents Court, London, UK, 21 March 2013, Case No. [2013] EWHC 619 (Pat)

The UK Patents Court has made a further reference to the Court of Justice of the European Union, requesting that Article 1(b) of Regulation 469/2009/EC (the SPC Regulation) be clarified, and in particular the meaning of “active ingredient” and “combination of active ingredients”.

Glaxosmithkline Biological SA (“GSK”) filed two Supplementary Protection Certificate (“SPC”) applications, one for an adjuvant known as AS03, and one for a vaccine comprising an antigen and AS03.  In both applications, GSK relied upon a marketing authorisation for a influenza vaccine, sold under the trade mark, Prepandrix.  Acting on behalf of the Comptroller, the Deputy Director of the UK Intellectual Property Office, decided that neither application was allowable since AS03 was not an “active ingredient” of Prepandrix, within the meaning of the SPC Regulation.  GSK appealed this decision.

Both parties agreed that this issue should be referred to the CJEU for a preliminary ruling.  Mr Justice Arnold, hearing the case, agreed that this was necessary for three reasons: (1) the answer in this case was not acte clair; (2) there was a lack of consistent interpretation between different national authorities on this point; and (3) the present case raised a similar issue to the issue in a previous SPC related case, Bayer CropScience.

Accordingly, the following questions have been referred to the Court of Justice:

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 - GSK Biologicals v. Novartis

Glaxo Smith Kline Biologicals v. Novartis, appeal in descriptive seizure proceedings, Brussels Court of Appeal, Belgium, 4 December 2009, Docket No. 2009/KR/269 

Disclosure of confidential information in annexes of the report of a descriptive seizure harms the legitimate interest of GSK, since the information is irrelevant to establish infringement.

The risk of use of irrelevant information in the framework of proceedings other than the ones aiming at establishing the infringement, notably in the framework of amending the patent claims, was serious, and likely to harm the legitimate interests of GSK. Suppression of all annexes is therefore justified. 

Read the judgment (in French) here.