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Thursday, 21 June 2012

Telmisartan combination: the Cour d'appel de Paris rules

SPC Blog reader Edouard Kling and his colleague François Pochart (august & debouzy avocats , Paris) have let us have sight of another "sartan" ruling, this one being particularly significant in that it is the first post-Medeva decision in France to decide on SPC for combination products. They write:
"In its ruling dated Friday 8 June, the Court of Appeal of Paris confirmed the rejection of the SPC application 02C0028 directed to the combination product Telmisartan + HCTZ. The basic European patent EP 502 314 did not claim the combination product but the specification disclosed a list of additional compounds to be used in combination with Telmisartan.

Of note, Boehringer had applied for a limitation of the French part of the basic patent to enter HCTZ into the claims and comply with Medeva. However, the limitation was rejected only a few days before the hearings. As a matter of procedural law, the court disregarded the request for the stay of the proceedings, pending the appeal proceedings against the limitation and ruled:
“It is common ground, as the Director of the INPI (French National Intellectual Property Institute) points out, that the Court, ruling on the appeal, is required to evaluate the facts on the date the decision is handed down, so that proceedings that are brought subsequently to the issuance of the disputed decision have no impact on the dispute for which the court was seized.

Moreover, the outcome of the late patent limitation request will not influence the resolution of the dispute, in so far as Boehringer requests, as the Director of the INPI points out, that the Court “attributes to claim 9 (as granted) the appropriate scope, namely that in light of the description of the basic patent, the term medicament indeed protects a combination of active ingredients Telmisartan – Hydrochlorothiazide” (paragraphs 56 et seq. of its submissions); 
No ground derived from the proper administration of justice requires, consequently, that the examination of this appeal be postponed further;”
This issue of limitation may be related to a previous decision dated 7 September 2011 where the court considered that a combination product was concerned with a different subject matter than the mono product and could not be construed as a mere limitation. The decision is attached.

Therefore, the Court turned to the claims as granted and logically rejected the SPC. Nevertheless, the judge did provide some elements that may be used in view of Medeva and remaining issues of clarity.
“Whereas, however, it is in vain that the claimant supports that the terms of claim 9 of the basic patent prevail;

Indeed, said patent is concerned with Benzomidazoles, being the subject matter of claims 1 to 7 referred to in claim 9: that, contrary to Hydrochlorothiazide, only Telmisartan is protected by the patent claims, the Director of the INPI specifying, without being challenged, that Benzomidazoles works on the contraction of blood vessels whereas Hydrochlorothiazide has diuretic effects; even if claim 9 mentions the use of a compound for the preparation of a medicament, it does not refer in any way to a combination with an active ingredient such as Hydrochlorothiazide;

Moreover, the interpretation that it contemplates for the condition laid out in paragraph a) for it to be ruled that the scope of the basic patent must be determined by taking into account not only the actual claims but also the description of the patent could not be based on Article 69 paragraph 1 of the European Patent Convention which only attributes to the description of the patent the function of interpreting the claims; …

If the description of the patent considers, in hypothetical terms, a combination with active ingredients such as Hydrochlorothiazide, the protection of the combination of those two ingredients which is not the subject matter of a claim, would not allow the reasonable degree of legal certainty to be provided to third parties, within the meaning of this text;

Lastly, despite the positions that were adopted by the authors or despite previous decisions, the Court of Justice of the European Union, which intends to harmonize Member States’ rights and refers to different European texts that corroborate this approach (point 27), ruled, in a decision issued on 24 November 2011 (Medeva BV v Controller General of Patents, Designs and Trade Marks):

-that “it should be recalled that Article 5 of Regulation No 469/2009 provides that any SPC confers the same rights as conferred by the basic patent and is subject to the same limitations and the same obligations. It follows that Article 3(a) of the regulation precludes the grant of a SPC relating to active ingredients which are not specified in the wording of the claims of the basic patent” (point 25),
-and, in response to the preliminary ruling that were put forward to the Court, “Article 3(a) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the SPC for medicinal products must be interpreted as precluding the competent industrial property office of a Member State from granting a supplementary protection certificate relating to active ingredients which are not specified in the wording of the claims of the basic patent relied on in support of the application for such a certificate”. 
Whereas, regarding the difference in treatment also mentioned by Boehringer, the content of the preliminary ruling put to the CJEU in the previously mentioned decision by the High Court of Justice (England & Wales), Chancery Division (Patent Court) (point 17) as well as the grounds for this decision (point 20 et seq.), all noting that there are dissenting positions in the States and a will towards harmonization, contradict the claimant assertions according to which the INPI would have rendered a decision which is contrary to the unanimity of the European Offices and that INPI could not rely upon different conditions of Examination according to the Offices; 
It follows that none of the arguments invoked by Boehringer to support the appeal are valid and that therefore such claim should be dismissed”.
The text of the judgment has been kindly provided and can be read here. Edouard and François hope to be able to provide us with a full translation in due course.

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