France - ezetimibe and simvastatin combination SPC - Paris Court of Appeal refuses request for preliminary injuction

Gérard Dossmann and Marianne Gabriel (Cassalonga) have kindly provided the SPC Blog with a copy of the original French text of a recent decision of the Paris Court of Appeal refusing a request for a preliminary injunction based on the SPC of the combination of ezetimibe and simvastatin.  In addition, they have kindly sent us a summary of the case, below.

By decision dated June 26, 2018, and on the basis of Articles 3 (c) and 3 (d) of Regulation (EC) No 469/2009, the Paris Court of Appeal upheld the interim order issued on April 5, 2018 by the Paris Court of First Instance (here), dismissing the requests for preliminary injunction against Biogaran based on SPC n° 05C0040 protecting a combination product of ezetimibe and simvastatin. 

The basic patent and the SPC
In this case, the basic patent EP 0 720 599 (hereinafter EP 599), filed on September 14, 1994, and now expired, concerned "hydroxy-substituted azetidinone compounds effective as hypocholesterolemic agents", and referred in particular to ezetimibe in claim 8 and to the combination of ezetimibe with simvastatin in claim 17. 

This EP 599 patent is the basic patent of a first SPC No. 03C0028 (hereinafter SPC 028) relating to ezetimibe (corresponding to a marketing authorization for the Ezetrol®) which expired on April 17, 2018 and of a second SPC no. 05C0040 (hereinafter SPC 040) relating to the "ezetimibe optionally in the form of its pharmaceutically acceptable salts in combination with simvastatin" expiring on April 2, 2019 (corresponding to a marketing authorization for Inegy®). 

These two SPCs had been issued before the decisions of the CJEU in Medeva & Co. 

The proceedings
In December 2017, Biogaran filed an action on the merits before the Paris Court of First Instance for the invalidation of SPC 0040. 

Biogaran was subsequently summoned in interlocutory proceedings on February 15, 2018 by the owner of the SPC 040, accusing it of an imminent infringement of its rights and seeking interim measures against it. 

The interim order of 5 April 2018
By an interim order issued on April 5, 2018, the Paris Court of First Instance dismissed the holder of its application for preliminary injunction, considering : 

- if "claim 17 meets the condition laid down by the CJEU since it specifically targets simvastatin in combination with ezetimibe (...) however, to obtain a second SPC from the same basic patent, the combination must not only be specified as such in a claim, it must still be in itself the center of the invention", 

- and that in this case, "only the compounds of the substituted azetidinone family among which ezetimibe are the heart of the invention, simvastatin being already known", and "if this association corresponds to the novelty criterion as far as the validity of SPC 05C0040 is concerned, it does not correspond to the additional criterion defined by the CJEU which imposes that the claim relating to the combination discloses the center of the invention. However, this association is only the juxtaposition of two characteristics or active ingredients, one that can exist without the other and does not require the implementation of the other to come true, what companies also admit [the claimants]. The patent does not teach any advantage in taking ezetimibe and simvastatin in the same tablet compared to taking a drug containing ezetimibe alone and another medicine containing simvastatin alone”, "thus, this proposed combination does not correspond to the center of the invention","therefore, failing to fulfill the second condition defined in Georgetown namely that the claimed combination is also the center of the invention, SPC 05C0040 is not valid and will be declared invalid". 

Confirmation by the Court of Appeal: the decision of June 26, 2018
Ruling in summary proceedings, the Paris Court of Appeal has just confirmed the order in all its provisions, ruling not only in the light of Article 3 (c) but also of Article 3 (d) of Regulation (EC) No 469/2009. 

After referring to the Case Law of the Court of Justice, the Paris Court of Appeal ruled: 

Implementation of Article 3 (c) of Regulation (EC) No 469/2009:
"It is not disputed in the present case that simvastatin, an active ingredient in the category of statins or "HMG CoA reductase inhibitors", is not protected as such by this patent or, elsewhere, by another patent;

It follows that Article 3 (c) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of May 6, 2009, as interpreted by that judgment, precluded that SPC 040 be granted;

Whereas, however, in order to oppose the foregoing, the companies[respondent] claim, as stated above, that EP 599 would cover two inventions, one relating to a new class of compounds, of which ezetimibe and the other on the use of ezetimibe in combination with statins for the reduction of cholesterol level in the blood and within the meaning of Articles 1 and 3 (a) of the SPC Regulation, the combination of active ingredients ezetimibe and simvastatin would constitute a "product" protected by the basic patent;

But whereas it follows from the foregoing reasons that only ezetimibe is the novel active ingredient protected by EP 599, while simvastatin, a known medicinal product, is not protected by that patent, the claim regarding the inventive nature of their combination is inoperative in the light of the foregoing reasons in the aforementioned judgment C-443-12; (...)” 

Implementation of Article 3 (d) of Regulation (EC) No 469/2009:
“Considering finally, even assuming, what is denied above, that EP 599 protects, within the meaning of Articles 1 and 3 (a) of the SPC Regulation, as such two distinct products, on the one hand ezetimibe, on the other hand, the combination of ezetimibe with simvastatin, it is rightly that in case of appeal the company Biogaran opposes that the marketing authorization of July 28, 2005 covering this second combination product under the trademark Ezetrol® would not have been the first within the meaning of Article 3 (d) of the Regulation; 

It is apparent from the summary of the characteristics of the product Ezetrol® that gave rise to the marketing authorization of June 11, 2003 that this medicinal product, proposed in the form of a 10 mg tablet of ezetimibe, is the subject of a therapeutic indication in association with a statin for the treatment of hypercholesterolemia, for the prevention of cardiovascular events and homozygous familial hypercholesterolemia; that its dosage, when prescribed with a statin, is the subject of particular developments; that its administration in association with a statin is contraindicated in certain cases, especially in case of pregnancy; more generally, the 17 pages of this document all refer to the administration of the drug Ezetrol® either alone or in combination with a statin; that more specifically, developments are devoted on pages 10, 11, 12, 13, 14 and 15 to the administration of Ezetrol with simvastatin; 

It follows from the foregoing analysis that the combination product of ezetimibe with simvastatin has already been the subject of a first marketing authorization on June 11, 2003, and that the second authorization obtained on July 28, 2005 did not allow the grant of a supplementary protection certificate under Article 3 (d) of the Regulation; 

Since the imminent infringement of a private right is not characterized, there is no need for summary proceedings and the order will be confirmed to that effect". 

The case is currently pending on the merits before the Paris Court of First Instance.

 Cassalonga acted for Biogaran.

Tenofovir - High Court Decision in France

Those following the tenofovir SPC litigation in Europe will be pleased to hear that the High Court of Paris has recently handed down a decision in relation to Gilead's SPC based on EP0915894.  Denis Schertenleib, who acted for Mylan in these proceedings, has kindly provided a short summary of the case, along with a copy of the decision and an English translation.

"Recently, the High Court of Paris had to opine on the validity of the Gilead SPC on Truvada covering tenofovir and emtricitabine. The SPC was based on the basic patent for tenofovir.  One of its claims covered a combination of tenofovir with another optional therapeutic ingredient.  

In the context of preliminary injunction proceedings, the Presiding judge of the Paris High Court had to decide whether this SPC was likely to be held invalid on the merits. The Court held in a ruling dated 5 September 2017, that the SPC was likely to be invalid.

The reasoning of the Court was based on the finding that the reference to another “therapeutic ingredient” could not be deemed to constitute a functional definition of any compound under the Eli Lilly v HGS doctrine of CJEU case C-493/12. In addition, the Court held that nothing in the description or the prior art could be held to point to Emtricitabine as being this optional therapeutic ingredient. Finally, the Court noted that the combination of tenofovir and emtricitabine could not constitute the core invention of the basic patent under the Actavis v Sanofi doctrine of CJEU case C-443/12. The Court thus held that the SPC was likely to be invalid and that no preliminary injunction could be granted.

The Judgment in French and translated in English can be downloaded here.

The ruling can be appealed and a case on the merits is ongoing.”

Many thanks to Denis for this!

Novartis v Actavis: preliminary injunction for Valsartan confirmed

The SPC Blog is grateful to David Por (Allen & Overy, Paris) for submitting the following note:

"Novartis v Actavis: French Court renders a preliminary injunction confirming the scope and effects of an SPC (Valsartan)

After the preliminary injunction rendered on 12 February 2010 enjoining Mylan and Qualimed from marketing a generic drug comprising Losartan and HCTZ on the basis of Du Pont's SPC granted for Losartan, the President of the Paris First Instance Court confirmed on 28 January 2011 that an SPC covering a compound (Valsartan in the present case) obviously prohibits the marketing of pharmaceutical products containing Valsartan alone or in combination with another active ingredient.

The French Judge carried out a combined reading of Article 4 (subject-matter) and Article 5 (effects) in light of the definitions given in Article 1 of the SPC Regulation: 

“Within the limits of the protection conferred by the basic patent (EP No. 0 443 983), the protection conferred by an SPC (SPC No. 97C0050) shall extend only to the active ingredient that is to say valsartan covered by the corresponding MA, for any use of the product as a medicinal product that has been authorised before the expiry of the certificate”,

and added that

"while Article 4 of the Regulation provides some limits to the effects of an SPC, once these are defined, the SPC grants the same rights as those conferred by the basic patent".

Having held that SPC No. 97C0050 has for its subject-matter the sole active ingredient valsartan, the Judge ruled as follows:

"[O]nce this SPC No. 97C0050 is defined, the rights conferred to Novartis are the same as the rights conferred by the basic patent, such that Novartis can oppose to any use of this active ingredient for the treatment of hypertension, alone or in combination with another active ingredient.


Any marketing of a medicinal product containing valsartan as an active ingredient therefore obviously constitutes an infringement, since it infringes the rights that the claimants hold on this active ingredient until 13 November 2011.


The obviousness of the infringement that would result from the arrival of the pharmaceutical products “valsartan hydrochlorothiazide Actavis 80mg/12.5mg” and “valsartan hydrochlorothiazide Actavis 160mg/25mg” before 13 November 2011 is therefore demonstrated".

This decision can be appealed".

You can read the French decision here and the English translation here.