What are SPCs?
The highest tribunal hearing disputes involving SPCs for EU member states is the Court of Justice of the European Union (CJEU). Historically there have been numerous referrals to the CJEU on points of law relating to SPCs and this is expected to continue. Some of the key decisions are discussed below.
The SPC regime was introduced as a mechanism to compensate patent holders for loss in effective patent term resulting from the time taken to receive marketing authorisation for such products2. However, regulatory delay is not of itself sufficient to justify the grant of SPCs.
In particular, the relevant regulation provides that an SPC can be granted only for an "active ingredient". This has been held to exclude substances that may enable or enhance the activity of a therapeutic ingredient, but which have no therapeutic effect of their own on the human or animal body. Despite the clinical testing (and consequent regulatory delay) involved in developing such auxiliary substances, the CJEU has on two occasions3 held that they do not qualify for an SPC. Similarly, it is not currently possible to obtain SPC protection for a medical device, irrespective of whether or not the marketing of such a device has been subject to regulatory delay.
Where are SPCs available?
SPCs are national rights: at present there is no such thing as a Europe-wide SPC. Accordingly, individual applications must be made to national patent offices in countries where SPC protection is desired.
SPC protection is available in all EU member states, namely:
Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden and the United Kingdom4.
SPCs in these countries are governed by EC Regulation 469/2009 ("the SPC Regulation" -- excerpts of which are included as Annex 1).
SPC protection is also available in the following non-EU States:
• Norway and Iceland: these States are members of the European Economic Area (EEA), but not of the EU, and the governing legislation is the EU SPC Regulation.
• Switzerland: Swiss SPCs are governed by legal provisions which are based on the EU SPC Regulation. An SPC issued in Switzerland will also automatically take effect in Liechtenstein5.
• Albania, Bosnia & Herzegovina, Macedonia, and Serbia: These are non-EU/EEA countries which may nonetheless be covered by a European patent application granted by the EPO. SPC protection is available in these countries under national legal provisions.
Similar provisions also exist in neighbouring jurisdictions including Russia and the Ukraine, and in other countries worldwide. Those interested in rights in these jurisdictions can contact J A Kemp for more information.
What scope of protection is provided by the SPC?
The scope of an SPC is limited to the product of the relevant marketing authorisation. It protects that product to the same extent as the patent on which the SPC is based ("the basic patent"). For example, if the basic patent covers the product per se, the SPC will also cover the product per se. If the basic patent only covers a method of manufacturing or using the product, then the SPC will be similarly restricted.
The product of the marketing authorisation has long been established to encompass therapeutically equivalent salts and esters of small molecule drugs6, provided of course that they are covered by the basic patent.
The situation is less clear for active ingredients which are biological molecules. A decision of the Norwegian Court of Appeal7 following an advisory opinion of the EFTA court8 recognised that it would be desirable for therapeutically equivalent variants of a biologic product to be covered by an SPC, but provided little guidance as to the extent of such coverage. It is to be expected that this question will be referred to the CJEU.
Subject to the scope of the basic patent, an SPC for a given active ingredient will cover any use of that active ingredient in a drug which is authorised before the SPC expires. Subsequent marketing authorisations made after grant of an SPC will therefore extend the scope of the SPC, even when the later marketing authorisation is obtained by an entity unconnected with the owner of the SPC.
Also, subject to the scope of the basic patent, an SPC will cover all subsequently authorised combinations of active ingredients containing the product at issue.9
What additional term is provided by the SPC?
An SPC takes effect at the end of the normal expiry term of the basic patent on which it is based, provided that the patent is maintained up to that point.
For EU/EEA member states, the SPC will expire at whichever is the earlier of:
• 15 years from the first Marketing Authorisation in the EU/EEA10
• 5 years from the expiry of the basic patent
The effective maximum term is therefore 5 years in addition to the term of the basic patent.
For non-EU/EEA member states, the term is determined by reference to the local marketing authorisation. For example, the term of a Swiss SPC is determined by reference to the date of the Swiss marketing authorisation. Since this can issue later than the EU/EEA authorisation, the Swiss SPC for a medicinal product may have a longer term than the corresponding SPCs in the EU/EEA countries.
It is possible to extend the term of an SPC by a further 6 months by providing clinical results obtained from an agreed paediatric investigation plan. The request for extension may be filed at any time up to 2 years before normal SPC expiry.
Further information is provided in J A Kemp's briefing note on the Paediatric Products Regulation, which is available upon request.
Who should apply for the SPC?
The Applicant for the SPC must own the basic patent, but need not hold the relevant marketing authorisation. Thus, it is possible to secure an SPC based on a marketing authorisation held by a third party11.
When should the SPC application be filed?
An application for an SPC must be filed with the national Patent Office of the country concerned within the later of:
• 6 months from the date on which the first authorisation to place the product on the market is granted in that country; or
• 6 months from the date of grant of the basic patent.
If the basic patent expires before marketing authorisation is achieved, it may not be possible to secure an SPC. Under such circumstances, it may be worthwhile filing an application for an SPC before expiry of the patent and following up with the marketing authorisation when it is available. However, the chances of persuading Patent Offices to grant an SPC under such circumstances would at best be uncertain12.
What are the substantive requirements for obtaining SPCs?
The requirements for grant of an SPC are set out in Article 3 of the SPC Regulation.
• Article 3(a) requires that the product be "protected" by a basic patent.
• Articles 3(b) and 3(d) require that the SPC be based on the first valid authorisation to place the product on the market as a medicinal product.
• Article 3(c) requires that the product has not already been the subject of an SPC.
Although these requirements may appear relatively simple, each has been subject to multiple referrals to the CJEU. More detailed discussion is provided below.
What is meant by "protected" by a basic patent?
Perhaps surprisingly, to fulfill this requirement it is not sufficient that the product would hypothetically infringe the claims of the basic patent. Unfortunately it is also not clear precisely what is sufficient. There have been several referrals to the CJEU on this point, and it is expected that more will follow.
The leading CJEU decisions are generally considered to be the "Medeva"13 and "Eli Lilly"14 decisions.
In Medeva, the CJEU held that for the SPC to be granted, the active ingredient must be "specified in the wording of the claims of the basic patent".
The decision in Medeva was made in the context of SPCs for a combination therapy. Specifically, the patent had a claim to A, which would prevent an unauthorised third party from manufacturing and selling a medicinal product containing A and another active ingredient, B. However, this was held not to support an SPC for the product A+B because B was not specified in any way in the wording of the claim.
This has generally been interpreted to mean that a patent which claims product A and does not mention combination therapies cannot support an SPC for combinations of active ingredients containing A, e.g., an SPC for A+B 15.
A subsequent CJEU decision16 has also confirmed that a patent which claims only a combination of A+B cannot be the basic patent for an SPC for A alone, despite the fact that sale of A may well, under some circumstances, infringe the patent under "contributory infringement" provisions. This remains true even where the marketing authorisation is for a medicine comprising A and includes an indication that A may or should be used together with B.
There has been much debate over the extent to which the reasoning in Medeva and other "combination" decisions should apply to single active ingredients. Clearly the requirement that the active ingredient is "specified" will be satisfied if the basic patent contains a claim which specifically mentions the product at issue. The situation is much less clear, though, when the claims of the basic patent embrace the product at without mentioning it specifically.
In Eli Lilly, the CJEU explored this question in the specific context of a functionally defined active ingredient ("…an antibody which binds to <target>…"). It was held that a functional definition can in principle support an SPC, provided that the claims when construed in the context of the description relate "implicitly but necessarily and specifically" to the active ingredient.
Although very little guidance was provided as to how to establish whether a claim meets this test, the referring UK Court17 interpreted the CJEU's intention to be that any general claim language which covers a single active agent, including a functional definition, will satisfy the requirements of Article 3(a) for an SPC directed to that active agent. This remains the case even if there is no "individualised description" of the active ingredient elsewhere in the patent. However, claims which embrace active ingredients only by virtue of open-ended language, such as "comprises", would not satisfy Article 3(a).
Perhaps reflecting general frustration with the lack of clarity on this issue, the UK Court has made a further referral to the CJEU18 posing a deliberately open question:
"What are the criteria for deciding whether 'the product is protected by a basic patent in force' in Article 3(a) of the SPC Regulation?"
The facts of that particular case again concern a combination product, but it is hoped that the CJEU will take the opportunity to provide guidance on Article 3(a) in general terms. Ideally the CJEU will also clarify other outstanding matters relating to Article 3(a), such as whether the claims of a basic patent can be amended after grant to cure a deficiency under Article 3(a). This question has also been put to the CJEU in a previous referral19 but they declined to answer.
What is meant by "a valid authorisation to place the product on the market as a medicinal product"?
The CJEU has confirmed that an SPC for a given product should be based on the first authorisation for a drug containing the product even if this is a combination therapy which includes the product. Thus, for example, an SPC for product A can be based on a patent claiming A and a marketing authorisation for a medicinal product containing A+B.20 This may be important for vaccine products, where marketing authorisations often relate to combinations of multiple active ingredients. An SPC granted under such circumstances will cover all products containing product A approved before the SPC expires.
How many SPCs may be granted for a given product or patent?
Although Article 3(c) of the SPC Regulation suggests that only one SPC can be granted for a given product, it has long been the case that if two basic patents are owned by different Patentees, each Patentee can secure an SPC. Under such circumstances, both SPCs can be based on the same marketing authorisation.
If two patents which cover a given product are held by a single Patentee, only one SPC is available. The Patentee must choose which patent to use to support the SPC. Considerations which may apply when determining which patent to choose will include the relative vulnerability of the patents to any validity challenge and the duration of the SPC available from each patent. If, however, the two patents are held by different entities, each patent can support a separate SPC.
In general, it is also possible to have multiple SPCs granted for multiple different products on the basis of the same basic patent, provided that each product is protected by the basic patent21.
An exception to this principle has however been set out by the CJEU in two cases22, both of which relate to a scenario in which an SPC has already been granted for a single active ingredient A, and a later application is filed for an SPC for a combination containing that active ingredient, A+B. The CJEU has held that the later SPC should not be granted in these circumstances.
However, the reasoning of the CJEU in both cases appears to have been influenced by a finding that the single active ingredient was the "sole" or "core" of the invention underlying the basic patent, and so they were reluctant to award a further SPC for the combination. It is unclear whether the exception would also apply if the combination represented a separate inventive advance disclosed within the same patent, or indeed if the combination had been presented in a separate patent.
Which Marketing Authorisation is the first Marketing Authorisation?
Article 3(d) of the SPC Regulation requires that an SPC be based on the first authorisation to place a drug on the market as a medicinal product (the earliest marketing authorisation). The proper identification of the earliest marketing authorisation may be an issue when a patent protecting a second or subsequent medical use of a particular drug is used as the basis for an SPC application.
Historically it had been thought that a patent to a new medical use of a drug could form the basis of an SPC, but that SPC had to be based on the earliest marketing authorisation for that drug, even if the earliest authorisation was for a different disease or condition from that specified in the patent.23 In practice, reference to the earliest marketing authorisation often meant that any resultant SPC would have a zero term, because of the maximum SPC term of 15 years from first marketing authorisation in the EU.
However, in the landmark "Neurim" decision24, the CJEU indicated that under certain circumstances it is possible to base an SPC application on an authorisation which is not the first marketing authorisation to place a particular drug on the market.
The facts in Neurim were that an earlier authorisation had been issued for a veterinary use. The CJEU held that this should not preclude grant of an SPC based on a later authorisation for a completely separate human use. However, the phrasing used by the CJEU was more general, stating that the "first" authorisation for the purposes of Article 3(d) is the "first" authorisation "which comes within the limits of the protection conferred by the basic patent". That is, an earlier authorisation which is outside the scope of the basic patent should not be taken into account.
There has been much debate over how broadly the principles outlined in Neurim should be applied, with the various national patent offices diverging to a significant extent. For example, some offices apply Neurim very narrowly, such that the SPC will only be granted if the earlier authorisation is veterinary and the later authorisation is for a different indication in humans. Many offices apply a broader interpretation, such that the SPC is granted provided the later authorisation is for any different indication. However, some offices apply Neurim very broadly, such that an SPC may be granted if the later authorisation differs from the earlier in any way, including e.g., the formulation of the active ingredient, the administration or dosage regime, or the specific patient population to be treated.
Perhaps unsurprisingly therefore, this point is the subject of yet another CJEU referral25. The UK Court has specifically requested clarification as to whether Neurim may apply if the later authorisation is for a new formulation of a previously authorised active ingredient.
In the meantime, however, it may be possible for Patentees to obtain SPCs on the basis of:
a) a patent to a downstream development of a known drug, for example a patent for a new medical use or a new formulation of a known active ingredient; and
b) a second or subsequent marketing authorisation for a medicinal product containing the active ingredient at issue.
Such SPCs may be granted if:
(i) the downstream patent does not cover the medicinal product specified in the original marketing authorisation; and
(ii) the second or subsequent marketing authorisation is the first authorisation for a medicinal product which is protected by the downstream patent.
Further information on SPCs based on patents for downstream developments of a known drug can be found in J A Kemp's briefing on the Neurim decision, which is available upon request.
Is it possible for a third party to challenge the grant of the SPC?
Even where there is no formal mechanism to do so, most national patent offices will consider observations filed by a third party against an application for an SPC. Such observations may draw the Examiner's attention to deficiencies in the application with respect to compliance with the substantive requirements of the SPC Regulation.
Such observations may slow (or even prevent) grant of the SPC application. After grant, the validity of an SPC may be challenged in the national courts on the same grounds.
The validity of the basic patent underlying an SPC may of course also be challenged separately via all normal routes (EPO opposition, national revocation action etc.). Should the patent be revoked, any SPC or SPC application based upon it is automatically invalidated.
1 SPCs are also available for active substances in plant protection products, but these are not the focus of this briefing.
2 The purpose is thus similar to Patent Term Extensions (PTE) available in, e.g., USA and Japan, but unlike those systems an SPC is not an extension of a patent, it is a separate right.
3 C-431/04 MIT (a bioerodible matrix) & C-210/13 Glaxosmithkline (an adjuvant in a vaccine).
4 The UK is expected to implement a corresponding national provision even in the event of a 'hard' Brexit, and thus SPCs should remain available in the UK.
5 Swiss marketing authorisations also automatically take effect in Liechtenstein, which unlike Switzerland is an EEA member. Thus, this must be taken into account when determining the first authorisation in the EU/EEA. See comments on additional term provided by an SPC below.
6 C-392/97 Farmitalia.
7 Pharmaq v Intervet 15-170539ASD-BORG/01.
8 Similar status to the CJEU for matters referred by the national courts of the EEA states: Norway, Iceland, Liechtenstein.
9 C-322/10 Medeva, C-422/10 Georgetown and C442/11 Novartis v. Actavis.
10 The CJEU confirmed in C-471/14 that the relevant date of an EU Marketing Authorisation is the date on which notification of the authorisation is made to the holder (typically a few days later than the Commission Decision granting the authorisation). This may result in extra days of SPC term, although some national patent offices have yet to correct the term of SPCs granted prior to the CJEU decision. A further referral (C-492/169) from the Hungarian Courts asks whether such correction is required. A hearing date has not yet been set.
11 C-181/95 Biogen V SKB explicitly endorsed this view.
12 A pending CJEU referral (C-567/16) asks the specific questions whether an "end of procedure" notice (indicates an MA is imminent) is sufficient to support an SPC and, if not, whether the absence of a full MA can be remedied later. A hearing date has not yet been set.
15  EWCA Civ 523 Medeva BV v Comptroller General of Patents.
16 C-518/10 Yeda.
17  EWHC 2404 (Pat) Eli Lilly.
18 C-121/17 Teva v Gilead – hearing date not yet set. Request for expedition was refused in April 2017.
19 C-577/13 Actavis v Boehringer.
20 C-322/10 Medeva and C-422/10 Georgetown.
21 C-484/12 Georgetown.
22 C-443/12 Actavis v Sanofi, C-577/13 Actavis v Boehringer.
23 C-202/05 Yissum.
24 C-130/11 Neurim.
25 C-tbc Abraxis Bioscience – hearing date not yet set.
Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 (selected provisions)
For the purposes of this Regulation, the following definitions shall apply:
(a) 'medicinal product' means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;
(b) 'product' means the active ingredient or combination of active ingredients of a medicinal product; […]
Any product protected by a patent in the territory of a Member State and subject, prior to being placed on the market as a medicinal product, to an administrative authorisation procedure as laid down in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use or Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products may, under the terms and conditions provided for in this Regulation, be the subject of a certificate.
Conditions for Obtaining a Certificate
A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application:
(a) the product is protected by a basic patent in force;
(b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate;
(c) the product has not already been the subject of a certificate;
(d) the authorisation referred to in point (b) is the first authorization to place the product on the market as a medicinal
Subject matter of protection
Within the limits of the protection conferred by the basic patent, the protection conferred by a certificate shall extend only to the product covered by the authorisation to place the corresponding medicinal product on the market and for any use of the product as a medicinal product that has been authorised before the expiry of the certificate.
Effects of the certificate
Subject to the provisions of Article 4, the certificate shall confer the same rights as conferred by the basic patent and shall be subject to the same limitations and the same obligations.
This article was reprinted with permission from J A Kemp.