In principle, patents confer protection for a maximum of 20 years. In Europe, however, the patent terms for pharmaceutical products that meet the conditions necessary for supplementary protection certificates (“SPC”) can be extended for up to five years.
Why an extra five years might be necessary
Once a patent has been filed, a corresponding pharmaceutical product often has to undergo time consuming regulatory approval before it can be marketed. Sometimes there are only a few years left on the patent by the time the product is first launched. As a result, the net sales time under the exclusivity conferred by the patent is often not long enough to ensure sufficient research incentives and the possibility of compensation. In the EU, Regulation (EC) No 469/2009 (“SPC Regulation”) addresses this issue by providing the possibility to obtain SPCs for an authorized medicinal product, granting essentially the same rights as the original patent (the “basic patent”) for an additional maximum term of five years. Yet another six months can be added if the requirements of the Regulation (EC) No 1901/2006 and Regulation (EC) No 1902/2006 (“Pediatric Extension Regulation”) are met.
Patent originators and generic manufacturers’ conflicting interests
Every single day of these extra five years of market exclusivity is extremely valuable to originators because exclusivity is the only way to enable originators to continue to collect the high revenues necessary to recover development costs. Generic manufacturers, on the other hand, strive to compete on that very product as quickly as possible to generate their own profits. As a result, while SPCs help to promote research for the benefit of patients, extended exclusivity arguably may also delay effective treatments from becoming available at affordable prices.
The different interests involved spur originators to enforce their SPCs in courts all across Europe and encourage generic manufacturers to take actions against the granted SPCs. In this article, we summarize the decisions of the Court of Justice of the European Union (“CJEU”) of the past 20 years clarifying key questions of the SPC Regulations that emerged in litigations in the various Member States of the EU.
Quick introduction to the SPC Regulation
An SPC is not simply an extension of the patent term. The protection an SPC affords is strictly confined to the product that the applicant obtained authorization to place on the market as a medicinal product, provided that: (1) the product is a medicinal product; (2) the product is protected by a basic patent in force; (3) the medicinal product has been granted a valid first marketing authorization; (4) the product has not already been the subject of an earlier certificate; and (5) the first application for an SPC is lodged with the competent industrial property office of the Member State that granted the basic patent within six months of the date the first marketing authorization was granted for the respective country, or within six months of the basic patent being granted.
Case Law of the CJEU
The cases that were in front of the CJEU essentially concerned the following five questions:
- When is a product a medicinal product?
- When is a product protected by the basic patent?
- What is the “first marketing authorization”?
- When has a product not already been the subject of a certificate?
- What are the time limits of SPC applications and their duration of protection?
1. Medicinal Product
According to Art. 1 (a) and (b) of the SPC Regulation, a “medicinal product” is any active ingredient or any combination of active ingredients presented for treating or preventing disease in human beings or animals. The following cases of the CJEU have further detailed the requirements for “medicinal products”:
Pursuant to these cases, a medicinal product within the meaning of Art. 1 (a) and (b) of the SPC Regulation:
- is a product that achieves its principal intended action in the human body by pharmacological, immunological or metabolic means (C-631/13);
The C-631/13 decision concerned whether a carrier protein used in a medicinal product without having its own immunogenic effect covered by the marketing authorization can be considered as an “active ingredient” if it exerts such an effect once conjugated to a polysaccharide antibody by means of a covalent bond. The CJEU ruled: In order to be classified as an active ingredient, the carrier protein must have a proven pharmacological, immunological, or metabolic effect of its own that is covered by the therapeutic indications of the authorization. Therefore, an SPC is not granted for an active ingredient whose effect does not fall within the therapeutic indications covered by the wording of the marketing authorization (C-631/13).
On the other hand, a substance that has no therapeutic effect of its own and that is used to render a specific pharmaceutical form of the medicinal product is not covered by the term “active ingredient.” Consequently, such a substance cannot give rise to the grant of an SPC (C-431/04 and C-631/13).
- is the active pharmaceutical ingredient itself or a combination of active ingredients, irrespective of any indication, used in human or animal therapy, formulation, or the presence of a prodrug form;
The C-202/05 decision stated that, when a basic patent protects a second medical use of an active ingredient, that use does not form an integral part of the definition of the product. Since an earlier marketing authorization was granted in this case for the same active ingredient only in a different formulation and different use, and since the use of the active ingredient does not classify and define a product itself, a subsequent SPC was not possible.
- does not include medical devices incorporating an ancillary drug substance;
The CJEU denied an SPC for medical devices incorporating an ancillary active ingredient (C-527/17). According to the CJEU, a substance that:(a) forms an integral part of a medical device within the meaning of Art. 1 (4) of the Medical Devices Directive (93/42/EEC), and (b) performs on the body an action ancillary to that of the device in which it is incorporated cannot be classified, in respect of the use, as a medicinal product within the meaning of the Directive 2001/83, even if it could be classified as such if it were used separately. Such a substance thus cannot fall within the scope of the SPC Regulation. In other words: The substance contained in a medicinal device may only be granted an SPC if it has been separately authorized as an active ingredient in a medicinal product. If the substance is used alone in a drug-medical product combination for which the marketing authorization procedure under pharmaceutical law is not available, an SPC cannot be granted.
- does not cover adjuvants due to lack of active function;
An adjuvant does not fall within the definition of “active ingredient” (Art. 1 (b) of the SPC regulation). As a result, a combination of two substances, namely an active ingredient having therapeutic effects on its own and an adjuvant that, while enhancing those therapeutic effects, has no therapeutic effect on its own, does not fall within the definition of “combination of active ingredients” within the meaning of Art. 1 (b) of the SPC regulation (C-210/13).
- concerns not just a single combination of active ingredients but a sum of individual active ingredients, or combinations of active ingredients if a medicinal product contains several active ingredients or a combination of active ingredients that serve different therapeutic purposes (C-322/10 and C-484/12). Several SPCs may be granted for these if they are distinguishable (medicinal) products (C-577/13).
2. Scope of the Basic Patent
The following cases of the CJEU have set first limits and framework for the determination of what is meant by “the product is protected by a basic patent in force” within the meaning of Art. 3 (a) of the SPC Regulation:
According to these cases, a product is protected by a basic patent within the meaning of the SPC Regulation if:
- the product that is the subject of the SPC is explicitly mentioned in the claims;
This was the holding in C-322/10 and C-630/10. As a result, no SPC can be granted for active ingredients that are not specified in the wording of the claims of the basic patent relied on to support the application for such a certificate (C-322/10).
The SPC is a “mirror image” of the basic patent. If the basic patent claims an active ingredient that forms a composition with another active ingredient but the latter is not the subject of an independent claim, an SPC for the isolated active ingredient cannot be granted (C-518/10).
This means: In case of a basic patent for the active ingredient combination A+B and a drug approval for the combination A+B+C, no SPC can be granted for A+B+C, neither for A nor B, but for A+B (C-322/10). In line with this, in case C-443/12, the Court of Justice regards the combination A+B covered by a subclaim as protected by the basic patent for A and thus the principle admissible object of a certificate. However, in principle, this means that one and the same basic patent can protect both an active ingredient and a combination of active ingredients, but can only affect one medicinal product (cf. Art. 1 (b) of the SPC Regulation).
- the active ingredient can be identified in the claims of the patent by a functional formula; a structural formula is not necessary;
In case C-493/12, the patent claim in question was broadly worded and concerned several antibodies. The claim did not define the antibody structurally but functionally. The claim comprised an indefinite number of unspecific antibodies as a result. Also, the patent specification did not include an example of created or tested antibodies or a structural description of possible antibodies for the purpose of a therapeutic antibody. The court decided that such a functional formula might be sufficient and thus allowed the interpretation of the patent claims pursuant to the respective national patent laws of the European Member States.
- the product is composed of several active ingredients with a combined effect and the claims of the basic patent in force relate necessarily and specifically to that combination even if the combination of active ingredients composing that product is not expressly mentioned in the basic patent’s claims (C-121/17);
For that purpose from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent, (a) the combination of those active ingredients must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by that patent, and (b) each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent (C-493/12 and C-121/17).
- the active ingredient with all its derivatives is protected by the basic patent (C-392/97);
In case C-392/97, the marketing authorization concerned a particular salt, but the patent holder applied for an SPC that related to the active ingredient (called idarubicin) and salts thereof. According to the CJEU’s ruling, the SPC is capable of covering the active ingredient and its various derived forms such as salts and esters as medicinal products, to the extent that they are covered by the protection of the basic patent.
- the product is designated as a process product in the claims;
Process patents can only form the basis of an SPC application if the products are mentioned as process products in the claims. Process products covered by the scope of protection of the process patent, but not mentioned as direct procedural products, cannot be subject of an SPC (C-630/10).
The CJEU has not yet conclusively decided on the scope of protection of the basic patents. Instead, the CJEU leaves that decision with the national courts. Also the question of the applicability of the equivalence doctrine is left to the national courts, but future preliminary judgements of the CJEU might clarify this question and give some guidelines for the application of the equivalence doctrine.
c. Valid and first marketing authorization
The SPC shall be granted if a valid authorization to place the product in the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate (Art. 3 (b) of the SPC Regulation). This marketing authorization must be the first one (Art. 3 (d) of the SPC Regulation).
The following cases of the CJEU have shaped the prerequisites of the marketing authorization within the meaning of Art. 3 (b) and (d) of the SPC Regulation:
Pursuant to Art. 3 (b) and (d) of the SPC Regulation, a valid marketing authorization requires:
- that a marketing authorization has been granted, i.e., that an act has been completed;
An end of procedure notice is only an “intermediate step in the decentralized procedure” and does not allow the medicinal product to be placed on the market. Thus, such a notice issued by the reference Member State in accordance with Art. 28 (4) of Directive 2001/83/EC before the end of the expiry of the patent may not be treated as equivalent to a marketing authorization within the meaning of Art. 3 (b) of the SPC Regulation, and an SPC may not be obtained on the basis of such a notice (C-567/16).
- an administrative procedure as provided under Art. 3 (b) of the SPC Regulation and the Directive 2001/83;
According to the C-527/17 ruling, substances authorized under Art. 1 (4) of the Medical Devices Directive (93/42/EEC) do not undergo an administrative procedure equivalent or comparable to a marketing authorization, as provided under Art. 3 (b) of the SPC Regulation and the Directive 2001/83.
- that the valid authorization is the first authorization to place the product in the market as a medicinal product;
An administrative authorization issued for a medicinal product by the Swiss Institute for Medicinal Products (SwissMedic), which is automatically recognized in Liechtenstein, must be regarded as the first authorization to place that medicinal product on the market within the meaning of that provision in the European Economic Area where that authorization predates marketing authorizations issued for the same medicinal product, either by the European Medicines Agency (EMA) or by the competent authorities of European Union Member States in accordance with the requirements laid down in Directive 2001/83/EC and the authorities of the Republic of Iceland and the Kingdom of Norway (C-617/12).
d. SPC not previously issued – no multiple certification
In accordance with Art. 3 (c) of the SPC Regulation, a certificate shall be granted for a product that has not already been the subject of a certificate. The following cases of the CJEU have shaped the criteria to prevent multiple certifications within the meaning of Art. 3 (c) of the SPC Regulation:
Pursuant to these cases, a product has already been the subject of an earlier certificate if:
- minor changes or developments have been made to the subsequent medicinal product, such as a new dose, the use of a different salt or ester, or a different pharmaceutical form, formulation, or use;
Such minor changes are not entitled to an SPC because an excipient does not form part of the “product” which is understood to mean an “active substance” or “active ingredient” in the strict sense (C-431/04).
- the active ingredient or combination of two active ingredients does not qualify as a new product;
In C-443/12, the patent holder had applied for a second SPC comprising a combination of the active ingredient irbesartan – which was already the subject of the first SPC – and another active ingredient without providing a new therapeutic effect to the combination of these two active ingredients. The CJEU denied the patent holder a second SPC since it would in fact be connected, wholly or in part, with the same product.
The same rule applied in case C-577/13, where an SPC was issued for the active ingredient telmisartan (“T”). After the SPC was granted to the patent owner, he added a claim to the basic patent for the combination of the active ingredient T and a second active ingredient. The patent owner applied for a second SPC covering the combination. The CJEU denied the second SPC because according to the CJEU, the basic patent was distinguished solely by T, and T was already granted an SPC.
NB: On the other hand, if a combination consisting of an innovative active ingredient for which an SPC has already been granted and another active ingredient that is not protected as such by the patent in question, is the subject of a new basic patent within the meaning of Art. 1 (c) of the SPC Regulation, the new patent could, so far as it covered a totally separate innovation, confer entitlement to an SPC for that new combination that is subsequently placed on the market (C-443/12).
In case C-484/12, the basic patent protected the combination of four active ingredients as well one of the four active ingredients individually. According to the CJEU’s opinion, Art. 3 (c) of the SPC Regulation does not, in principle, preclude the patent holder being granted, on the same patent, the marketing authorization for an SPC both for the combination of active ingredients and any one of the active ingredients individually.
e. Time limitations regarding the application and duration of SPCs
The first application for an SPC must be lodged with the competent industrial property office of the same Member State that granted the basic patent within six months of the date of the first marketing authorization for the respective country. If the basic patent is not granted until after the marketing authorization is issued, the first application must be lodged within six months after the basic patent was granted (Art. 7 (1) and (2) of the SPC Regulation).
The date of first authorization to place the product on the market within the meaning of Art. 7 and 13 (1) of the SPC Regulation is the date on which notification of the decision granting marketing authorization was given to the addressee of the decision, not the date of approval (C-471/14).
The maximum term of an SPC is five years (Art. 13 (2) of the SPC Regulation). As the SPC extends the patent term for the elapsed time period between the filing of the patent application and the first marketing authorization, this time period must be reduced by five years in order to determine the exact SPC term. The maximum term of five years will be granted if the first marketing authorization is granted more than ten years after the application date of the patent. Otherwise, if less than ten years have elapsed, the SPC term will be less than five years. In case of five or less years between these two points in time, no SPC extension will be granted at all.
In case of a calculation error, the expiration date of an SPC can be corrected. The holder of an SPC may, under Art. 18 of the SPC Regulation, bring an appeal for rectification of the duration stated in the certificate, provided that that certificate has not expired (C-492/16).
Conclusion and Outlook
The described line of cases of the CJEU provides good guidance through the complex legal requirements set out by the SPC Regulation. Yet, many aspects remain unclear and it will be exciting to see how case law will further develop. Also, the European lawmaker is currently considering certain amendments to the SPC Regulation. Most importantly, in an attempt to strengthen the competitiveness of EU-based manufacturers of generics and biosimilars, the introduction of a so-called “manufacturing waiver” to the SPC Regulation is being discussed. This is an exemption to the protection offered by SPCs that would allow the manufacture of medicinal products in the EU during the period of protection if these products are solely intended to be sold in third countries – that is outside the EU. In any case, we will keep you informed on any new developments in this area of the law.