Sanofi S.A. v. Pharmachemie B.V. and Teva Pharma B.V. and Sanofi S.A. v. Teva Nederland B.V., District Court of the Hague, 14 September 2012, Case No's 425814 / KG ZA 12-905 and 426135 / KG ZA 12-928
This judgment follows the earlier provisional ruling of the District Court of the Hague granting Sanofi a provisional injunction against Pharmachemie and Teva to stop the defendants from putting onto the market, reselling, delivering or otherwise trading or offering for any such purpose any high blood pressure medication comprising irbetasan and HCTZ for the entire duration of the preliminary injunction proceedings.
Sanofi holds a combination-SPC for irbesartan, in the form of a salt and/or a hydrate and hydrochlorothiazide (also known as HCTZ), which SPC is in force until 14 October 2013. The SPC is based on EP 0 454 511 for “Dérivés hétérocycliques N-substitués, leur préparation, les compositions pharmaceutiques en contenant” (hereinafter “EP 511”). An earlier SPC for just irbetasan, referred to in these proceedings as the ‘Mono-SPC’ was also based on this patent, but lapsed in August 2012.
Teva argued that the combination SPC is invalid because:
This judgment follows the earlier provisional ruling of the District Court of the Hague granting Sanofi a provisional injunction against Pharmachemie and Teva to stop the defendants from putting onto the market, reselling, delivering or otherwise trading or offering for any such purpose any high blood pressure medication comprising irbetasan and HCTZ for the entire duration of the preliminary injunction proceedings.
Sanofi holds a combination-SPC for irbesartan, in the form of a salt and/or a hydrate and hydrochlorothiazide (also known as HCTZ), which SPC is in force until 14 October 2013. The SPC is based on EP 0 454 511 for “Dérivés hétérocycliques N-substitués, leur préparation, les compositions pharmaceutiques en contenant” (hereinafter “EP 511”). An earlier SPC for just irbetasan, referred to in these proceedings as the ‘Mono-SPC’ was also based on this patent, but lapsed in August 2012.
Teva argued that the combination SPC is invalid because:
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i) it was granted in contravention of Article 3(a) of EC Regulation 1768/92 of 18 June 1992 (the SPC Regulation), because (a) the product does not fall under the scope of EP 511 and (b) the SPC was granted in contravention with the purpose of the SPC Regulation itself;
ii) it was granted in contravention of Article 3(c) of the SPC Regulation, because an SPC had already been granted for irbesartan, also with EP 511 as the basis; and
iii) EP 511 lacks an inventive step.
In its decision, the Court refers to the ECJ decisions C-322/10 (Medeva) and C-422/10 (Georgetown), where the ECJ ruled that:
Article 3(a) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate 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.
Adding, in the Georgetown decision:
Article 3(b) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that, provided the other requirements laid down in Article 3 are also met, that provision does not preclude the competent industrial property office of a Member State from granting a supplementary protection certificate for an active ingredient specified in the wording of the claims of the basic patent relied on, where the medicinal product for which the marketing authorisation is submitted in support of the supplementary protection certificate application contains not only that active ingredient but also other active ingredients.
Further referring to the judgement of the Court of Appeal of The Hague of 24 January 2012 in Lundbeck / Generics (read that decision here), the Court ruled that although the combination of irbetasan with HCTZ is not specified in EP 511, it followed the expert evidence and considered the product to be covered by claim 7 of EP 511for irebetasan in combination with “a diuretic”. The Court deemed it likely that the person skilled in the art would understand this to be a suitable diuretic, such as HCTZ.
The Court also disagreed with Teva’s argument that one can only get one SPC per patent (referring to the ECJ Medeva decision), finding no reason to divert from the rule of Biogen and Medeva that one can get an SPC for every product covered by a patent.
Teva’s final argument was that the combination SPC should not have been granted because it would go against the purpose of the SPC Regulation, namely to promote innovation. Teva’s position was that only the new and inventive ‘core of the invention’ could benefit from SPC protection. This argument, too, failed to convince the Court, since it would come down to an additional requirement for protection, one not found in the Regulation.
On the alleged lack of inventive step, the Court rejected Teva’s problem-solution approach as being the result of hindsight: irbetasan was not an obvious candidate, the lack of experimental evidence is not an obstacle under EPO case law and the fact that Ciba-Geigy also made the same discovery in the same period as Sanofi does not render the invention obvious.
The fact that Teva chose to start a launch-at-risk and refused to voluntarily desist from its launch, brings the Court to find that Sanofi has sufficient interest to obtain the injunction, also against Teva Pharma, the holder of the market authorisation.
The Court therefore grants the preliminary injunction, forbidding the defendants from putting onto the market, reselling, delivering or otherwise trading or offering for any such purpose any medicine comprising Irbetasan and HCTZ for the entire duration of the preliminary injunction proceedings. Court penalties were set EUR 100.000 per day or EUR 5.000 per product, presumably at Sanofi’s choice. A recall and rectification were also ordered.
Read the decision (in Dutch) here.
The earlier provisional judgment may be found here.
Head note: Maurits Westerik
i) it was granted in contravention of Article 3(a) of EC Regulation 1768/92 of 18 June 1992 (the SPC Regulation), because (a) the product does not fall under the scope of EP 511 and (b) the SPC was granted in contravention with the purpose of the SPC Regulation itself;
ii) it was granted in contravention of Article 3(c) of the SPC Regulation, because an SPC had already been granted for irbesartan, also with EP 511 as the basis; and
iii) EP 511 lacks an inventive step.
In its decision, the Court refers to the ECJ decisions C-322/10 (Medeva) and C-422/10 (Georgetown), where the ECJ ruled that:
Article 3(a) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate 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.
Adding, in the Georgetown decision:
Article 3(b) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that, provided the other requirements laid down in Article 3 are also met, that provision does not preclude the competent industrial property office of a Member State from granting a supplementary protection certificate for an active ingredient specified in the wording of the claims of the basic patent relied on, where the medicinal product for which the marketing authorisation is submitted in support of the supplementary protection certificate application contains not only that active ingredient but also other active ingredients.
Further referring to the judgement of the Court of Appeal of The Hague of 24 January 2012 in Lundbeck / Generics (read that decision here), the Court ruled that although the combination of irbetasan with HCTZ is not specified in EP 511, it followed the expert evidence and considered the product to be covered by claim 7 of EP 511for irebetasan in combination with “a diuretic”. The Court deemed it likely that the person skilled in the art would understand this to be a suitable diuretic, such as HCTZ.
The Court also disagreed with Teva’s argument that one can only get one SPC per patent (referring to the ECJ Medeva decision), finding no reason to divert from the rule of Biogen and Medeva that one can get an SPC for every product covered by a patent.
Teva’s final argument was that the combination SPC should not have been granted because it would go against the purpose of the SPC Regulation, namely to promote innovation. Teva’s position was that only the new and inventive ‘core of the invention’ could benefit from SPC protection. This argument, too, failed to convince the Court, since it would come down to an additional requirement for protection, one not found in the Regulation.
On the alleged lack of inventive step, the Court rejected Teva’s problem-solution approach as being the result of hindsight: irbetasan was not an obvious candidate, the lack of experimental evidence is not an obstacle under EPO case law and the fact that Ciba-Geigy also made the same discovery in the same period as Sanofi does not render the invention obvious.
The fact that Teva chose to start a launch-at-risk and refused to voluntarily desist from its launch, brings the Court to find that Sanofi has sufficient interest to obtain the injunction, also against Teva Pharma, the holder of the market authorisation.
The Court therefore grants the preliminary injunction, forbidding the defendants from putting onto the market, reselling, delivering or otherwise trading or offering for any such purpose any medicine comprising Irbetasan and HCTZ for the entire duration of the preliminary injunction proceedings. Court penalties were set EUR 100.000 per day or EUR 5.000 per product, presumably at Sanofi’s choice. A recall and rectification were also ordered.
Read the decision (in Dutch) here.
The earlier provisional judgment may be found here.
Head note: Maurits Westerik
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