Another week, another dose of irbesartan/HCTZ -- this time from France

Arc de Triomphe: who
will eventually triumph in
the Combination SPC War?

The SPC Blog's French friends Pierre Véron and Isabelle Romet (Véron et Associés, avocats, Paris) have kindly sent us copies of the original French text and English translation of a French judgment handed down earlier this month. The case --  Sanofi, Sanofi Pharma Bristol Myers Squibb and Sanofi Aventis France / Teva Santé, tribunal de grande instance de Paris, France, ordonnance de référé (preliminary injunction), No. 12/57056, 3 October 2012, -- fits within the framework of the European litigation concerning Sanofi’s combination SPC irbesartan/HCTZ. A further act of kindness is their provision of this helpful summary:

"On 3 October 2012 the presiding judge of the tribunal de grande instance de Paris issued a preliminary injunction against Teva Santé. This is a French development of the European litigation concerning Sanofi’s combination SPC irbesartan/HCTZ covering its flagship drug for the treatment of hypertension marketed under the brand CoAprovel which gave rise, inter alia, to the following decisions:

• UK - Actavis v Sanofi (ECJ referral)
• NL - Sanofi / Pharmachemie & Teva – Irbetasan & HCTZ (preliminary injunction against Pharmachemie and Teva)
• DE – Sanofi / Actavis Landgericht Düsseldorf 15 August 2012 (preliminary injunction against Actavis)

 The order handed down on 3 October 2012 by the presiding judge of the tribunal de grande instance de Paris enjoins Teva Santé from marketing in France a generic irbesartan/ hydrochlorothiazide (HCTZ). 

Sanofi’s French SPC No. 99 C0001 on the combination of the two active ingredients irbesartan, an angiotensin II receptor antagonist, and hydrochlorothiazide, a diuretic, is based on claim 20 of European patent No. 0 454 511 protecting the combination of irbesartan and “a diuretic”. Teva challenged the standing to sue of the plaintiffs (Sanofi itself, but also Sanofi Pharma Bristol Myers Squibb and Sanofi Aventis France which market in France CoAprovel): the judge dismissed this challenge. Teva also disputed the validity of the basic patent, European patent No. 0 454 511, for insufficiency and obviousness: having noted that it was somewhat surprising that such a challenge occurs only after the expiration of a successful patent, the judge examined these criticisms in greater details but held that she did not see any serious attack on this ground. 

The main attack was based on article 3(a) of Regulation 469/2009 and the Medeva holding that an SPC can only be granted for active ingredients which are “specified in the wording of the claims of the basic patent”. Teva argued that Medeva required that “hydrochlorothiazide” be mentioned in the claim as such, the mere mention of a “diuretic” being insufficient. Teva further argued that Sanofi’s SPC was invalid on the basis of articles 3(c) and 3(d) of Regulation 469/2009. 

The judge considered that none of the arguments put forward by Teva cast a serious doubt on its validity. 

About article (a) she considered that Medeva was not applicable because HCTZ was sufficiently identified in the wording of claim 20 by the word “diuretic”:

“HCTZ, which indisputably belongs to a therapeutic class of active ingredients, namely the diuretics family, could easily be identified at the time of the priority date of the patent, as was seen concerning the dispute relating to insufficiency; it is not obvious that the SPC is not valid.  

It cannot be inferred from Medeva, as the defendant does, that for a combination of active ingredients to be protected by an SPC, the basic claim must refer to all the active ingredients of the product.”

The judge further considered that the referral to the ECJ in parallel UK proceedings, concerning Actavis’ invalidity action of the UK corresponding SPC, by Arnold J on 20 September 2012, about articles 3(a) and 3(c) of Regulation 469/2009 did not preclude the grant of the requested preliminary injunction in France. 

She adopted a different view from that of earlier French decisions of 10 August 2012 which dismissed Sanofi’s request for a preliminary injunction against Mylan, Sandoz and Arrow Génériques because the validity of the SPC was “questionable”; in those previous cases, another French judge had considered that, with regard to article 3(a) and Medeva, the word “diuretic” in claim 20 of Sanofi’s patent No. 0 454 511 on the combination of irbesartan and a diuretic was not precise enough to cover HCTZ; appeals against these decisions are pending. 

The French decision of 3 October 2012 is in line with the decisions of the Landgericht Düsseldorf of 15 and 17 August 2012 which granted Sanofi preliminary injunction respectively against Actavis and Hexal, and the decision of the district court of The Hague of 14 September 2012 which granted similar relief against Teva.

Thanks, Pierre and Isabelle, both for providing all of the above and for letting us have the original German and English translation of the judgment handed down on 15 August 2012 by the Landgericht Düsseldorf which are referred to above.