A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here

Saturday, 23 November 2013

Telmisartan/HCTZ combination: a French appeal

Here, thanks to our good friend and European patent attorney Edouard Kling ("en collaboration avec august & debouzy avocats"), is an English translation of Boehringer Ingelheim v Actavis, a limitation decision (which you can read or download) issued a couple of months ago by the French Court of Appeal which, though French readers are already aware of it, is ripe for spreading to the rest of the SPC Blog community. Edouard explains:
The decision actually relates to some of the previous posts of the Blog:

* first, because it deals with the basic patent and SPC application for the Telmisartan/HCTZ combination product and 
* secondly because it further illustrates the trend among the French jurisdictions to focus on the technical content of the specification and examples when assessing the subject matter disclosed in pharmaceutical patents.

In line with the previous decision of the High Court of Paris which revoked, for insufficiency of disclosure, the basic claim directed to the Irbesartan/Diuretic combinations in the absence of any related example, the Court of Appeal ruled that Boehringer should not be entitled to limit the subject matter of claim 8 to a combination product comprising both Telmisartan and HCTZ. The underlying reason for this was that, even though the specification explicitly teaches that the benzimidazoles of the invention could be administered in combination with a list of additional active ingredients (among which was HCTZ), such combinations should not be part of invention as the patent fails to study and exemplify the effects of these combination therapies. The Court considered that the teaching of the patent was merely speculative.

The readers will probably remember that a different section of the Court of Appeal of Paris decided last year (on June 8, 2012) to confirm the rejection of the SPC application to the combination product regardless of the pending request for limitation of claim 8. Notably the Court had, at the time, already raised concerns about the “hypothetical” combinations envisaged in the specification. The case is currently pending before the Supreme Court, but will most certainly be impacted by this decision.
The original French version of the decision can be read or downloaded.

1 comment:

Anonymous said...

2 new cases on curia, but questions are not available yet:

Merck Canada
Case C-555/13
Nationality of the parties
Tribunal Arbitral - Portugal
(in FR Curia: Objet
Demande de décision préjudicielle - Tribunal Arbitral - Interprétation de l’art. 13 du règlement (CE) nº 469/2009 du Parlement européen et du Conseil, du 6 mai 2009, concernant le certificat complémentaire de protection pour les médicaments (Version codifiée) (JO L 152, p. 1) - Durée du certificat - Période d’exclusivité pouvant dépasser un maximum de quinze années à compter de la date de la première autorisation de mise sur le marché du médicament en question dans l’Union )

Approximation of laws
Intellectual, industrial and commercial property

Actavis Group and Actavis
Case C-577/13
Procedural Analysis Information
Nationality of the parties
United Kingdom
Source of the question referred for a preliminary ruling
High Court of Justice (Chancery Division) - United Kingdom