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.