On 12 December 2013, the Court of Justice of the European Union (the "ECJ") handed down three judgments in separate cases relating to supplementary protection certificates ("SPCs"). The judgments offer further clarification on which medicinal products and patents qualify for supplementary patent protection.
Under Regulation (EC) No 469/2009 of 6 May 2009 concerning the supplementary protection certificate for medicinal products (the "SPC Regulation"), SPCs are granted for medicinal products for which the period that elapses between the filing of an application for a patent for a new medicinal product and the authorisation to place the medicinal product on the market makes the period of effective protection under the patent insufficient to cover the investment put into the research of the product. Article 13 of the SPC Regulation allows for a single extension of the period of exclusivity granted by the patent by a maximum period of five years. However, the subject matter of the SPC is different to the subject matter of the patent. Whereas a patent is granted for any invention, an SPC is granted specifically for a medicinal product for which a marketing authorisation was obtained.
Under Article 3(a) of the SPC Regulation, an SPC can only be granted if the product (defined in Article 1 as the "active ingredient or combination of active ingredients of a medicinal product") for which the SPC is sought is protected by a "basic patent" in force. The "basic patent" is defined as: "a patent which protects a product as such, a process to obtain a product or an application of a product, and which is designated by its holder for the purpose of the procedure for grant of a certificate". In addition,the product must not already have been the subject of a certificate (Article 3 (c) of the SPC Regulation) and the marketing authorisation on which the SPC is based must be the "first authorisation to place the product on the market as a medicinal product" (Article 3 (d) of the SPC Regulation).
Eli Lilly v. Human Genome Sciences
In the first case, Case C-493/12, Eli Lilly had objected to an SPC application by Human Genome Sciences Inc. for a new protein, Neutrokine alpha (α). Eli Lilly argued that the patent claim relating to the relevant protein (active ingredient) was drafted too broadly and therefore the active ingredient was not "protected by a basic patent" as required under Article 3 (a) of the SPC Regulation as explained by the ECJ in the Medeva case (See, VBB on Belgian Business Law, Volume 2011, No. 12, p. 11, available at www.vbb.com).
In the basic patent, the protein was defined functionally, referring to the desired properties, but the protein was not identified by a structural definition in the basic patent. The referring court therefore sought to know whether a product could qualify for SPC protection if it was not identified by a structural definition in the basic patent.
The ECJ explained that for an active ingredient to be regarded as "protected by a basic patent in force", it is not necessary for the active ingredient to be identified in the claims of the patent by a structural formula, provided that the claims relate "implicitly, but necessarily and specifically" to the active ingredient. It is for the national court to apply this test to the case at hand.
However, the ECJ provided further guidance reminding the parties that the purpose of the SPC Regulation is to encourage research. Accordingly, the ECJ indicated that SPCs should not be granted if the holder of the patent failed to "identify the invention specifically, making it possible to ascertain clearly the active ingredient which may be commercially exploited", because he failed to take any steps to carry out more in-depth research. In such cases, the national court should refuse SPC protection.
Actavis v. Sanofi
The second case, Case C-443/12, pitted Actavis against Sanofi in relation to an SPC on CoAprovel, an antihypertensive product consisting of a combination of irbesartan and hydrochlorothyiazide. Sanofi's SPC for CoAprovel relied on its patent for a family of compounds, including the active ingredient irbesartan. The same patent also claimed the use of irbesartan in a pharmaceutical composition in association with a diuretic (but the choice of diuretic was not specified). It was not contested that hydrochlorothyiazide was a known diuretic (i.e., a product which promotes the excretion of urine) which was not claimed in the basic patent.
The basic patent had expired on 20 March 2011. On 8 February 1999, Sanofi obtained a first SPC for Aprovel, which had irbesartan as its single active ingredient. Later, on 21 December 1999, Sanofi obtained a second SPC, relating to CoAprovel, the product containing the irbesaratan - hydrochlorothyiazide combination. According to the assessment report of the European Medicines Agency, the combination of two active ingredients had an additive effect, reducing the blood pressure more than any of the active ingredients on its own. The SPC for CoAprovel expired on 14 October 2013.
Acatavis claimed that the SPC for CoAprovel was invalid for two reasons. First, it argued that the combination product was not protected by the basic patent within the meaning of Article 3(a) of the SPC Regulation. Actavis argued that the combination of active ingredients was not expressly specified or identified in the wording of any claims of the basic patent.
Second, Actavis contended that the SPC was invalid because the 'product' within the meaning of Article 3 (c) of the SPC Regulation had already been the subject of an initial SPC, namely the SPC for Aprovel.
The ECJ considered that in principle, it is possible to obtain several SPCs on the basis of a patent which protects several different products provided that each of those products is protected as such by the basic patent on which the SPC relies. However, the ECJ held that it cannot be accepted that the holder of a basic patent may obtain a new SPC each time he places a new product on the market containing the principle active ingredient protected by the basic patent with another active ingredient which is not protected as such by that patent.
In view of the answer to the second of Actavis' arguments, the ECJ saw no need to address the first argument.
Georgetown University v. Octrooicentrum Nederland
The third case, C-484/12, relates to Georgetown University's patent claiming a vaccine for the prevention of papillomavirus infection. The human papillomavirus ("HPV") has many genotypes. HPV types 16 and 18 are deemed to be responsible for precancerous lesions in the genital region and for cervical cancer. The patented vaccine contains the HPV L1 protein or a fragment thereof involving, among others, HPV-16, HPV-18 or a combination of HPV-16 and HPV-18. The patent was granted on 12 December 2007 and expired on 23 June 2013.
Georgetown filed eight SPC applications with the Dutch Patent Office (Octrooicentrum Nederland) relying on marketing authorisations for Gardasil® (Sanofi Pasteur) and Cervarix® (GSK). Two of the applications were granted, but on 19 May 2010, the application based on the marketing authorisation for Gardasil® was refused. This application referred to the recombinant L1 protein of the HOV type 16 as the 'product' within the meaning of the SPC Regulation.
Georgetown contested the decision before the court of 's Gravenhage arguing that Article 3 (c) of the SPC Regulation does not prevent it from obtaining several SPCs for several products which are all protected by the basic patent. Article 3 (c) of the SPC Regulation stipulates that an SPC is refused if the product has already been the subject of another SPC. The court of 's Gravenhage referred a number of questions to the ECJ for a preliminary ruling.
Similar to the second case, discussed above, the ECJ considered that if a patent protects several different 'products', it is possible to obtain several SPCs in relation to each of those products provided that each of those products is protected as such by that basic patent and that it is contained in a medicinal product with an MA. Accordingly, the ECJ explained that if a patent holder has already obtained an SPC for a combination of active ingredients, Article 3 (c) of the SPC Regulation does not preclude the patent holder from also obtaining an SPC for one of those active ingredients which, individually, is also protected as such by the basic patent.
The above cases offer some guidance for national courts to assess SPCs. It remains to be seen how national courts will apply the requirement of "implicitly, but necessarily and specifically" identifying a product in a basic patent. Moreover, a lot of questions remain unanswered. The intricate status of SPCs linking between patent rights and products, is likely to continue to require ECJ guidance.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
