New judgment by the CJEU concerning SPCs for combinations of pharmaceutical products

The Court of Justice of the European Union has issued new judgment interpreting Articles 1, 3, and 13 of Regulation (EC) No. 469/2009 concerning the supplementary protection certificate (SCP) for medicinal products.

The judgment (Case C-577/13) was issued in the context of a dispute between the Actavis and Boehringer Ingelheim pharmaceutical companies. The question referred to the CJEU for a preliminary ruling basically comes down to whether an SPC may be sought for a combination of two products included in the claims after the initial grant of the basic patent, subsequent to amendment of the said patent. The combination was composed of: (i) an active ingredient claimed as the sole subject matter of the invention, for which the holder had already obtained a first SPC (telmisartan) and (ii) a second substance (hydrochlorothiazide) within the public domain.

In response to the questions from the referring court, the CJEU made the following preliminary observations:

- First, the expression "as such" as used in Article 1(c) and Article 3(a) of the EU Regulation is to be interpreted autonomously in light of the objectives pursued by that Regulation and the "subject matter of the invention" covered by the basic patent.

- Second, where a patent claims several products, it may be possible to obtain several SPCs for the different products, provided that each of the said products "as such" is protected by the basic patent and constitutes the "subject matter of the invention" covered by the patent.

On that basis, the CJEU ruled that a second SPC may not be obtained for a product comprising a combined product composed of an active ingredient that is the sole "subject matter of the invention" for which an SPC has already been obtained in combination with another substance. In the CJEU's view, in the case that concerns us here the combination of the active ingredients telmisartan and hydrochlorothiazide, the latter being in the public domain, is not the true "subject matter of the invention" covered by the basic patent.

The CJEU based its decision in this case on the requirement to balance the interests of the pharmaceutical industry and those of public health, since unlimited entitlement to multiple SPCs for subsequent marketing of an active ingredient by combining it with another ingredient or substance that is not the subject matter of the invention as originally protected would tip the balance in favour of the former.

The CJEU thereby upheld previous case law set forth in earlier judgments concerning SPCs for combinations of products (see cases Actavis vs Sanofi – C-443/12 – and Georgetown University II – C-484/12). The judgment leaves undecided the question as to whether a patent may be amended after grant so as to insert claims for a combination of products that could comply with the requirements for obtaining an SPC. However, while this question was not expressly addressed, the CJEU appears to be implicitly opposed to that possibility.

Authors: Enrique Armijo Chávarri -- María Cadarso

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CJEU rules on importation of patented pharmaceutical goods from new EU Member States

On 12 February 2015 the CJEU issued its ruling (in Case C-539/13) on interpretation of the Specific Mechanism provided for in Chapter 2 of Annex IV to the Act concerning the conditions of accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia, and the Slovak Republic and the adjustments to the Treaties on which the European Union is founded ("the 2003 Act Accession").

The provision prescribes a mechanism enabling the holder of a patent or supplementary protection certificate (SPC) for a pharmaceutical product to oppose importation of the said product from the new Member States in which protection of the product could not be obtained at the time the patent or SPC was filed. That is, the mechanism lays down an exception to the principle of exhaustion of a patent right. The exception consists of the requirement for whoever is going to import or market a pharmaceutical product from the new Member States into or in a Member State where the product is protected by a patent or SPC to give the holder or beneficiary of the said patent or SPC one month's prior notification of intent to do so.

The ruling ensues from a dispute over parallel import of a pharmaceutical product named Singulair from Poland into the United Kingdom. Merck Canada, Inc. ("Merck Canada") are the holders of a patent and an SPC for the active ingredient used in Singulair. Merck Sharp and Dohme ("MSD") are the exclusive licensees for the said patent and SPC. Pharma XL Ltd (a company associated with Sigma) notified MSD of their intention to import Singulair from Poland into the United Kingdom. Three months after first giving notice, Sigma began to import Singulair from Poland. Merck did not manifest their opposition to importation until several months later, whereupon Sigma ceased importing Singulair from Poland. Even so, Merck Canada and MSD commenced infringement proceedings against Sigma for the sales of Singulair Sigma had made to that time. The matter reached the Court of Appeal (England and Wales), which stayed the proceedings to refer a question concerning interpretation of the said Specific Mechanism provided for in Chapter 2 of Annex IV to the 2003 Act of Accession to the CJEU. Several questions were referred, the main one being, in summary: does the holder or beneficiary of a patent or SPC who wishes to prevent the importation in question have to demonstrate its intention previously and, if so, what form should the opposition take?

The wording of the applicable provision is ambiguous and thus susceptible to contradictory interpretations. This was the situation in the main proceedings, in which the positions put forward by the parties can be summarized as follows:

- Sigma contended that the legal provision dealing with the importer's obligation to furnish the holder of the patent or SPC with one month's prior notification of its intention to import the protected product meant that where the holder or beneficiary of protection did not invoke its rights within one month from the time notification was furnished, the importer was entitled to import and market the said product in the Member State concerned after it had obtained authorization from the competent authorities. It consequently maintained that the time period set by the provision implied for the holder or beneficiary of the patent a requirement to exercise its rights in good faith and to give notification of its intention to exercise its rights within the said term, because otherwise the importer would be left in a state of legal uncertainty detrimental to its legitimate interests and expectations.

- Merck, in turn, contended that the said Special Mechanism did not impose any requirement on the holder or beneficiary of the patent or SPC to furnish prior notification of its intention to prohibit parallel imports and that if any such requirement existed, both the requirement as such and the means of discharging it would have been expressly laid down.

The CJEU's ruling held that: (i) the holder or beneficiary of a patent who intends to prohibit parallel imports of a pharmaceutical product is not required to demonstrate its opposition to importation within one month under the aforesaid Specific Mechanism to be able to enforce its rights over the said product; however, (ii) where the holder or beneficiary does not indicate its opposition to importation within the one-month time limit, the parallel importer may commence importation and marketing after first obtaining authorization from the competent authorities; consequently, (iii) the holder or beneficiary of a patent of SPC may not rely on its rights with regard to any importation and marketing of the pharmaceutical product in question carried out before it intention has been expressly indicated.

Thus, this ruling helps define the meaning and scope of the Specific Mechanism provided for in the 2003 Act of Accession as it relates to parallel imports of patented pharmaceutical products, striking a balance between the rights conferred by patents and SPCs and the principle of the free movement of goods in the European Union.

Authors: Enrique Armijo Chávarri -- María Cadarso

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New ruling of the CJEU on the interpretation of articles 1 and 3 of Regulation (EC) 469/2009 concerning the supplementary protection certificate for medicinal products

On 15 January 2015 the Eighth Chamber of the Court of Justice gave a judgment in response to a request for a preliminary ruling relating to the interpretation of articles 1 (b) and 3 (a) and (b) of Regulation (EC) 469/2009 concerning the supplementary protection certificate (SPC) for medicinal products (Case C-631/13).

The request was put to the Court of Justice within the following factual framework:

- A dispute arose between the Austrian Patent Office and the owner of a European patent relating to Protein D.

- Protein D is present in a pneumococcal vaccine for paediatric use called Synflorix, for which the necessary marketing authorization (MA) had been obtained.

- Protein D is not contained as such in Synflorix, but is covalently bonded to other active ingredients.

- Aside from being part of that covalent bond, Protein D  has a therapeutic effect of its own as a vaccine against the Haemophilus influenzae bacterium. However, the Synflorix MA describes Protein D only as a carrier and makes no specific reference to that therapeutic effect.

In response to the questions raised by the Austrian referring court, the Court of Justice states:

- First, the Community Regulation does not preclude the possibility that an active ingredient can give rise to the grant of an SPC where the active ingredient is covalently bound to other active ingredients which are part of a medicinal product.

- Second, the Regulation does, on the other hand, preclude the grant of an SPC for an active ingredient whose effect does not fall within the therapeutic indications covered by the wording of the MA. The CJEU reasons that, since no trial or data concerning the therapeutic effects of Protein D against Haemophilus influenzae was integrated into the marketing authorisation procedure, that procedure could not have delayed the commercial use of the basic patent. In such circumstances, the grant of an SPC would have been contrary to the aim pursued by the Regulation, which is to offset, at least in part, the delay to the commercial use of a patented invention on account of the time needed for the first MA in the European Union to be granted.

- Third, the Regulation must be interpreted as meaning that a carrier protein conjugated with a polysaccharide antigen by means of a covalent binding may be categorised as an active ingredient only if it is established that it produces a pharmacological, immunological or metabolic action of its own which is covered by the therapeutic indications of the MA. That is a matter for the referring court to determine in the light of all the circumstances of the case.

In the second and third replies the CJEU rejects the contentions of the applicant for the SPC with respect to Protein D and upholds the views taken by the European Commission.

Author: Enrique Armijo Chávarri

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