Super Thursday for SPCs No.1: Actavis v Sanofi

The text that appears below is an amended version of the text posted earlier.

The ruling in Case C‑443/12, Actavis Group PTC EHF, Actavis UK Ltd v Sanofi, Sanofi Pharma Bristol-Myers Squibb SNC intervening, a reference for a preliminary ruling from the Court of Justice of the European Union (CJEU), was handed down this morning.

In short, Sanofi owned European Patent No 0454511 which covered to a family of compounds that included the antihypertensive active ingredient irbesartan. The invention's description also referred to pharmaceutical compositions containing a combination of active ingredients, one of which was a compound in accordance with the invention, whereas the other ingredient or ingredients might be a beta-blocking compound, a calcium antagonist, a diuretic, a non-steroidal anti-inflammatory or a tranquiliser. Claims 1 to 7 of the basic patent were based just on irbesartan, or on one of its salts. Claim 20 of the patent related to a pharmaceutical composition containing irbesartan in association with a diuretic -- but no specific diuretic was named either in claim 20 or in the description of the basic patent.  That patent, granted on 17 June 1998, expired on 20 March 2011.

On the basis of that basic patent and marketing authorisations (MAs) granted on 27 August 1997 for the medicinal product Aprovel, which had irbesartan as its single active ingredient and was used principally to treat primary hypertension, Sanofi obtained its first SPC for that active ingredient on 8 February 1999. That certificate expired on 14 August 2012.  Also, on the basis of its basic patent but with MAs granted on 15 October 1998 for the medicinal product CoAprovel, comprising a combination of irbesartan and a diuretic (hydrochlorothyiazide, used to treat primary hypertension), Sanofi obtained a second SPC relating to the irbesartan–hydrochlorothiazide combination: this was granted on 21 December 1999 and expired on 14 October 2013.

According to the summary of the European Public Assessment Report of the European Medicines Agency, the combination of the two active ingredients had an additive effect, reducing the blood pressure more than either medicine alone.  Accordingly curative properties of that combination of active ingredients corresponded to the total therapeutic effect that would otherwise be obtained by separate administration of Aprovel and hydrochlorothiazide. In that regard, the studies of Aprovel used with hydrochlorothiazide as separate tablets were used to support the use of CoAprovel, so that that combination  had no new therapeutic effect when compared with the effects obtained as a result of those two active ingredients being used separately.

Actavis wanted to market generic versions of Aprovel and CoAprovel. However, as a generic medicinal product corresponding to CoAprovel would infringe Sanofi's second SPC, for the irbesartan-hydrochlorothiazide combination, Actavis brought proceedings before the Patents Court, England and Wales, challenging its validity. Said Actavis, Sanofi's second SPC for the combination of irbesartan and hydrochlorothiazide was invalid: that combination was not protected by the basic patent within the meaning of Article 3(a) of Regulation 469/2009 since that combination of active ingredients was not expressly specified or identified in the wording of any of the claims of that patent. No, said Sanofi, that combination was specified or identified in claim 20, which stated that the patent related to a combination of irbesartan and a diuretic -- after all, hydrochlorothiazide was nothing other than a diuretic.  Actavis also relied on Article 3(c) of the same Regulation since that the ‘product’ within the meaning of that provision had already been the subject of an initial SPC. No, said Sanofi: the first SPC and the MAs granted for Aprovel were obtained for the single active ingredient irbesartan, while the second SPC and the MAs for CoAprovel were obtained for a different product --the combination of irbesartan and hydrochlorothiazide.

The Patents Court noted the growing number CJEU rulings on SPCs but considered that it was impossible to resolve the dispute in the main proceedings on the basis of those ruling alone.  This being so, the Court decided to stay proceedings and refer two questions to the Court for a preliminary ruling:

‘(1) What are the criteria for deciding whether “the product is protected by a basic patent in force” in Article 3(a) of … Regulation No 469/2009?

(2) In a situation in which multiple products are protected by a basic patent in force, does Regulation [No 469/2009], and in particular Article 3(c), preclude the proprietor of the patent being issued a certificate for each of the products protected?’

The CJEU ruled as follows:

"In circumstances such as those in the main proceedings, where, on the basis of a patent protecting an innovative active ingredient and a marketing authorisation for a medicinal product containing that ingredient as the single active ingredient, the holder of that patent has already obtained a supplementary protection certificate for that active ingredient entitling him to oppose the use of that active ingredient, either alone or in combination with other active ingredients, Article 3(c) ... must be interpreted as precluding that patent holder from obtaining – on the basis of that same patent but a subsequent marketing authorisation for a different medicinal product containing that active ingredient in conjunction with another active ingredient which is not protected as such by the patent – a second supplementary protection certificate relating to that combination of active ingredients".

On this basis, said that CJEU at [44]

"In view of the answer given to Question 2, to the effect that a second SPC, such as that at issue in the main proceedings, may not be granted to Sanofi for the irbesartan-hydrochlorothiazide combination, irrespective of whether that combination was protected as such by the basic patent within the meaning of Article 3(a) ..., there is no need to answer Question 1".

In its review of Question 2 the CJEU said, at [31] to 934]:

"31 The SPC is designed simply to re-establish a sufficient period of effective protection of the basic patent by permitting the holder to enjoy an additional period of exclusivity on the expiry of his patent, which is intended to compensate, at least in part, for the delay to the commercial exploitation of his invention by reason of the time which has elapsed between the date on which the application for the patent was filed and the date on which the first MA in the European Union was granted ...

32 In the main proceedings, Sanofi’s patent, which protects the active ingredient irbesartan as such within the meaning of Article 3(a)  ..., has already enabled its holder to obtain an SPC relating to that active ingredient. Moreover, it is common ground that hydrochlorothiazide, an active ingredient that is a member of a class of diuretics, is not protected as such by that patent or indeed by any other patent.

33 In accordance with Article 5 ..., an SPC granted in connection with a product confers, upon the expiry of the basic patent, the same rights as were conferred by that patent in relation to the product, within the limits of the protection conferred by the basic patent, as provided for in Article 4 ... Accordingly, if, during the period in which the patent was valid, the patent holder could oppose, on the basis of his patent, the use or certain uses of his product in the form of a medicinal product consisting of such a product or containing it, the SPC granted in relation to that product would confer on the holder the same rights for all uses of the product, as a medicinal product, which were authorised before the expiry of that certificate ...

34 Thus, in the main proceedings, since it is common ground that, during the period in which the first SPC was valid, Sanofi was entitled to oppose, on the basis of its basic patent, the use or certain uses of irbesartan in the form of a medicinal product consisting of such a product or containing it, the SPC (now expired) granted for that product also conferred on Sanofi the same rights for all uses of the product, as a medicinal product, which were authorised before the expiry of that certificate".