ECJ rules on SPCs – and French courts react

From 2011 to 2013, the European Court of Justice (ECJ) handed down several important decisions concerning the interpretation of the EU Regulation on Supplementary Protection Certificates (SPCs) for Medicinal Products (469/2009). One such decision, Novartis v Actavis, clearly replied to questions referred to the ECJ for preliminary ruling. In contrast, the Medeva decision and the orders that adopted the grounds for that decision (in particular, University of Queensland and Daiichi Sankyo) have been considered by interested parties to be imprecise. Rather than clarifying the SPC system, these decisions have had the opposite effect. The recent Eli Lilly decision (C-493/12) tries to mitigate this, but still leaves some room for clarification.

Furthermore, during the same period the ECJ handed down the Neurim decision, which modified or even contradicted the position which appeared to have been clearly established by earlier ECJ decisions.

All of these decisions have led to upheaval in the legal landscape with regard to SPCs. This chapter considers the implications for the French courts and legislation.

Medeva judgment and University of Queensland and Daiichi Sankyo orders

Medeva

The Medeva decision is now well known to all practitioners of SPC law. Medeva obtained a patent for a method of manufacturing a vaccine comprising two antigens as active ingredients. Medeva filed several SPC applications at the UK IP Office (UKIPO), some of which were rejected since they were directed to a greater number of constituents than appeared in the claims of the basic patent. The UKIPO considered that the claims of the basic patent did not enable those combinations of products to be protected under Article 3(a) of the regulation, according to which “[a] certificate shall be granted if… (a) the product is protected by a basic patent in force”.

In its judgment, the ECJ decided that this provision “must be interpreted as precluding the competent industrial property office of a Member State from granting a SPC relating to active ingredients which are not specified in the wording of the claims of the basic patent relied on in support of the SPC application”.

On February 3 2012 the High Court of Justice of England and Wales ruled on an SPC granted for ranibizumab (Novartis v MedImmune). This active ingredient did not feature explicitly in the claims of the basic patent. The English judge referred to Medeva, expressing a degree of disapproval for the decision. Indeed, he indicated that this decision did not reply to the questions for preliminary ruling put to the court, and that the directives it gave were insufficiently clear to enable future disputes to be settled. Nevertheless, he had to rule taking into account the Medeva decision. Thus, after having found that ranibizumab was not described in the patent, he considered that the product was not protected by the basic patent under Article 3(a) of the regulation.

In Eli Lilly the ECJ decided that Article 3(a) does not mean that it is necessary to identify the active ingredient with a structural formula in the patent claims. The ECJ added that when the active ingredient is covered by a functional formula in the claims, the SPC is in agreement with Article 3(a) if, in light of the description of the invention, the claims relate, implicitly but necessarily and specifically, to the active ingredient. But for the ECJ, this is a matter to be determined by the national courts.

What is meant by “implicitly but necessarily and specifically” should give rise to interesting decisions from national courts.

Post-Medeva decisions in France

The Irbesartan decision, issued by the French courts, reveals the uncertainties which the Medeva decision has created. Sanofi was the owner of a patent of which Claim 1 protected a family of compounds, one of which was irbesartan. This compound was more specifically protected by Claim 7. Claim 20 of the patent protected a composition containing a compound according to one of Claims 1 to 7, in association with a diuretic.

Sanofi had obtained a Community SPC in France for an association between irbesartan and a specific diuretic: hydrochlorothiazide (HCTZ). HCTZ was not specifically referred to in the basic patent.

In July 2012 Sanofi petitioned for a preliminary injunction against several generic manufacturers, including Mylan. In summary proceedings the judge dismissed the petitions for preliminary injunction on the grounds that the validity of the SPC was open to challenge, since HCTZ appeared only in the claims of the basic patent under the “imprecise term of ‘diuretic’”.

A few months later, Sanofi petitioned for a preliminary injunction against another generic manufacturer, Teva, on the basis of the same SPC, but before another section of the Paris Court of First Instance. This time, the court ordered the preliminary injunction because it considered that the SPC was valid as it is well known that HCTZ is a diuretic (Sanofi v Teva, October 3 2012).

According to the court, the fact that the basic patent did not specifically identify HCTZ did not prevent the product forming the subject matter of the SPC from being properly identified in the patent claims, in accordance with the requirements of the Medeva decision.

The judge (a different judge from that who handed down the July 2012 orders rejecting a preliminary injunction) justified the conflict between the decisions by noting that “it is incumbent upon each generic manufacturer to assess which course of action to take”. In other words, the judge handed down his decision according to the arguments presented to him.

Teva was enjoined from commercialising its generic specialties based on irbesartan and HCTZ, subject to a penalty for failure to comply.

In other European countries, Sanofi was also able to obtain preliminary injunctions on the basis of its SPCs – in particular, in Germany, the Netherlands and Belgium.

In a judgment on the merits rendered on February 28 2013, the Paris Court of First Instance found that the SPC for a combination of active ingredients can be valid only if those active ingredients are “stated as such in the wording of the claims of the basic patent”. As the court found that HCTZ did not appear in the claims of the patent, it revoked the SPC.

That was not the final decision. On May 23 2013 the Paris Court of Appeal revoked the October 3 2012 summary proceedings order for an injunction against Teva, this time finding that the basic patent was invalid – but without taking a position as to the validity of the SPC in relation to Medeva.

These decisions highlight the difficulties faced by the French courts in interpreting the Medeva decision.

Patent limitations

The French IP Office (INPI), which is charged with examining and granting SPCs, generally takes a more relaxed approach than that ultimately adopted by the courts in the Irbesartan case. Nevertheless, when the claims of a patent protect only one active ingredient, the INPI, based on the Medeva decision, has refused to grant SPCs for an association between that active ingredient and another active ingredient which does not appear in the claims of the patent.

For this reason, certain applicants have attempted to limit the claims of the basic patent, such that its claims specify the association of products. It is possible to limit a patent in France, whether a French national patent or the French part of a European patent. In the context of limitation proceedings, it is incumbent on the French examiner to determine whether the amendments made to the claims actually constitute a limitation relative to the earlier claims of the patent, and whether they are clear and are based on the description.

However, the INPI has taken a rigorous stance on certain limitations. The INPI considers that a claim relating to a composition comprising active ingredient A cannot be validly amended by introducing compound B into that claim, for which the claim ultimately covers a composition comprising A and B. According to the INPI, such an amendment does not constitute a limitation.

On this basis Syngenta, the holder of a patent for a fungicidal composition comprising azoxystrobine as an active ingredient, was refused a limitation to its claims consisting of adding to the active ingredient another biologically active compound (folpel), chosen from a high number of compounds. Syngenta appealed that decision to the Paris Court of Appeal, which in a September 5 2011 decision ruled that the amendment made by Syngenta did not constitute a limitation, but on the contrary, “gave a very broad range of possible new combinations”.

In a March 19 2013 decision the Supreme Court overturned the ruling of the Paris Court of Appeal. Although this decision was welcomed by the pharmaceutical industry, its grounds could have been clearer. In fact, the Supreme Court overturned the appeal court’s decision since it had not “sought to determine whether the subject matter of the amended claim was disclosed directly and unambiguously in the description of the patent as granted”.

Yet in this case, it would seem that it was not so much a question of whether the appeal court should have looked for support for the limitation in the description, as whether the addition of one or more active ingredients to a claim directed to a composition would actually constitute a limitation.

This lack of clarity was perhaps why, in a recent decision (Boehringher Ingelheim v INPI, September 11 2013), the Paris Court of Appeal believed that it could maintain the position that it had taken in Syngenta, despite the Supreme Court decision.

In that case, Boehringher attempted to obtain an SPC for an association between the anti-hypertensive compound telmusartan and the diuretic HCTZ. The INPI had rejected the SPC application because the claim asserted by Boehringher protected only a composition comprising telmusartan, and not an association between it and another active ingredient.

Thus, Boehringher applied to the INPI for a limitation on its patent to claim an association between telmusartan and several diuretics, including HCTZ. For the same reasons that led to the refusal of Syngenta’s limitation, the INPI refused the limitation proposed by Boehringher. Boehringher appealed the INPI decision, but again the appeal court upheld the INPI’s position by rejecting the limitation. This decision appears surprising in view of the position taken by the Supreme Court.

However, since the Supreme Court rendered its decision in Boehringher, new episodes in Syngenta have taken place.

Further to the Supreme Court decision of March 19 2013, the case was reheard by the appeal court, which handed down its decision on October 25 2013. This time, the appeal court changed its opinion by considering that a patent relating to a composition comprising an active ingredient also covers any association using that active ingredient with any other substance described in the patent.

Thus, it considered that the amendment to the claim, adding a second active ingredient, did constitute an acceptable limitation.

This was not the end of the story. As the limitation was eventually accepted, Syngenta requested that its SPC for the product “azoxystrobine + folpel”, which was now protected by the patent as limited, be granted by the INPI. However, the INPI refused to grant it as, when the SPC application was initially refused, it was because at that time the combination of the two active substances was not protected by the patent claims.

The case was sent to the Paris Court of Appeal, which in its decision of May 30 2014 confirmed the INPI’s position on the grounds that appeal court rulings on INPI decisions have no devolutive effect. Thus, Syngenta has not obtained its SPC in spite of all its efforts.

Novartis v Actavis order

In a February 9 2012 order, handed down in Novartis v Actavis UK, the ECJ held that an SPC for an active ingredient should be able to prevent the commercialisation of a medicinal product containing that active ingredient in combination with one or more other active ingredients.

Novartis v Actavis UK had also been the subject of a Paris Court of Appeal decision (September 16 2011) which found that, on the contrary, an SPC for an active ingredient could protect only that active ingredient, and not an association thereof with another active ingredient.

However, the Supreme Court took into account the ECJ’s order of February 9 2012, and on January 15 2013 overturned the decision of the Paris Court of Appeal.

Therefore, at present in France there can be no doubt that an SPC protecting an active ingredient also protects that active ingredient when combined with other active ingredients.

Neurim pharmaceutical judgment

The Neurim judgment was rendered by the ECJ on July 19 2012. Neurim had filed an SPC application based on its marketing authorisation for the product Circadin, a formulation of melatonin, issued on June 28 2007. The UKIPO refused the SPC because it identified a 2001 marketing authorisation for melatonin for use in sheep. Consequently, the UKIPO considered that the requirements of Article 3(d) of the regulation were not met. This article provides that: “A certificate shall be granted if… (d) the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product.”

The ECJ eventually found that “the mere existence of an earlier marketing authorisation obtained for a veterinary medicinal product does not preclude the grant of a supplementary protection certificate for a different application of the same product for which a marketing authorisation has been granted, provided that the application is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the supplementary protection certificate”.

The decision was not expected since the ECJ had previously rendered two opposing decisions.This ECJ decision was quickly applied in France, in particular in Merck and Co. On November 16 2006 Merck filed an SPC application in France for a pharmaceutical specialty with the varicella-zoster virus as the active ingredient. The INPI rejected that SPC application, considering that the product had already been the subject of an earlier marketing authorisation. The case was brought before the Paris Court of Appeal, which agreed to stay proceedings until the ECJ had issued its decision in Neurim. Thus, in a February 15 2013 decision, the Paris Court of Appeal overturned the INPI’s decision rejecting the SPC.

Comment

The French courts are always ready to follow decisions of the ECJ, even when they reverse its own previous position. Nevertheless, it is necessary for such decisions to be handed down in a sufficiently clear manner to avoid differences of interpretation from one member state to another.

It is regrettable that Medeva did not lead to a clearer decision and it was expected that some further ECJ decisions, in particular Eli Lilly v HGS (Case C-493/12), would clarify it. However, it appears that ultimately, Eli Lilly did not provide much more guidance to the courts, patent offices and users.

 

Santarelli

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Thierry Caen

Partner

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Thierry Caen is a partner at Santarelli and is a qualified French and European patent attorney. He heads the firm’s chemistry, pharmacy and biotechnology group. He assists his clients in both establishing their patent portfolios and defending their rights, in particular in litigation and opposition cases. He also has particular expertise in the field of supplementary protection certificates. Mr Caen is a member of the French Association for the Protection of Industrial Property, the Association des Praticiens Européens des Brevets, the Licensing Executives Society and the International Association for the Protection of Intellectual Property.