Supplementary protection certificates for medicinal products
A supplementary protection certificate (SPC) is an IP right which can give up to five extra years of exclusivity after a patent has expired. SPCs are available in many European countries for active ingredients of human and veterinary medicinal products that require marketing authorisation. They were introduced to compensate patent holders whose effective patent term was eroded by delays in receiving marketing authorisation. An SPC is in some ways similar to a patent term extension, which is available for US patents.
SPCs are national rights – as yet there is no such thing as a European-wide SPC. Rights holders must apply individually to the national patent office of each country in order to secure protection. To qualify for SPC protection, an active ingredient of the medicinal product must be protected by a patent in force in the country of interest. In addition, there must be a valid marketing authorisation to market the product in that country.
Although separate rights, SPCs remain linked to the patent on which they are based. If the patent is revoked or surrendered, the SPC also lapses.
The highest tribunal hearing disputes involving SPCs is the European Court of Justice (ECJ). Recently there have been a number of key ECJ decisions which could affect the availability of SPCs. Some of the case law suggests that it may be advisable to optimise a patent estate for SPC purposes in certain cases well before a medicinal product is authorised. These issues are considered further below.
SPC protection in the European Union is governed by EU Regulation 469/2009 (the SPC Regulation), which applies in all 28 EU member states, as well as in the European Economic Area (EEA) territories of Norway and Iceland. SPCs are also available under national law in the non-EU/EEA countries Switzerland (and Liechtenstein), Albania, Bosnia, Macedonia and Serbia.
SPCs are granted for an active ingredient or a combination of active ingredients of an authorised medicinal product for human or veterinary use. The applicant must own a basic patent for the active ingredient(s) at issue, but need not hold the relevant marketing authorisation (Article 6 of the SPC Regulation). Thus, it is in principle possible to secure an SPC based on a marketing authorisation held by a third party.
An SPC confers the same rights as the patent on which it is based (Article 5 of the SPC Regulation), insofar as the patent relates to the specific product which is the subject of the relevant marketing authorisation (Article 4 of the SPC Regulation). For example, if the basic patent covers the product per se, the SPC will also cover the product per se. If the basic patent covers only a method of manufacturing or using the product, then the SPC will be similarly restricted.
Although Article 2 of the SPC Regulation indicates that the subject of the SPC must be the ‘product’ approved on the marketing authorisation, it has long been established that an SPC may extend to derivatives of the active product, in particular salts and esters (provided that they are covered by the basic patent). However, when the active ingredient is a biologic, it is less clear to what extent an SPC can cover variants of it (eg, similar proteins with different glycosylation patterns).
As regards the field of use, an SPC for a given drug will cover any use of that drug which is authorised before the SPC expires (subject to the scope of the basic patent). Subsequent marketing authorisations made after an SPC has been granted will extend the scope of the SPC, even when later marketing authorisations are obtained by entities unconnected with the SPC’s owner. The ECJ has also confirmed that an SPC for a product will, subject to the scope of the basic patent, cover all subsequently authorised combinations of active ingredients containing the product at issue (C-322/10, Novartis v Actavis, C-422/10, Medeva and C442/11, Georgetown).
An SPC takes effect at the end of the normal expiry term of the patent on which it is based. The term of protection for an SPC granted under the SPC Regulation is established by the date of the earliest marketing authorisation in any EU/EEA country, the term being equal to the period of time between the filing date of the basic patent and the date of first EU/EEA marketing authorisation, minus five years, up to a maximum term of five years (Article 13 of the SPC Regulation). Given a patent term of 20 years from the filing date of the basic patent, any SPC will therefore expire 15 years from the first EU/EEA marketing authorisation or five years from expiry of the basic patent – whichever is earlier.
Since 2007 it has been possible to extend the term of an SPC by six months by providing clinical results obtained from an agreed paediatric investigation plan.
Time limits for applying for an SPC
An SPC application must be filed with the national patent office of the country concerned within six months of the later of the date on which the first authorisation to place the product on the market is granted in that country or the date on which the basic patent is granted (Article 7 of the SPC Regulation).
If the basic patent expires before the 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 the patent expires and following up with the marketing authorisation when it is available. However, the chances of persuading a patent office to grant an SPC under such circumstances are uncertain at best.
Substantive requirements for obtaining an SPC
The requirements for obtaining 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 the product not to have already been the subject of an SPC.
All of these criteria have been subject to comment from the ECJ and are discussed in more detail below.
What is meant by ‘protected by a basic patent’?
Perhaps surprisingly, in order to fulfil the requirement that the product be ‘protected by a basic patent’, it is insufficient that the claims of the basic patent merely embrace the product at issue. Regrettably, however, it is not entirely clear what is required.
In 2010 the ECJ held that an SPC may not be granted for active ingredients which are not “specified in the wording of the claims of the basic patent” (C-322/10, Medeva and C-422/10, Georgetown). This arose in the context of a patent claim to active ingredient A, which would prevent an unauthorised third party from manufacturing and selling a medicinal product containing A and another active ingredient B. However, this would not support an SPC for the product A+B because B was not specified in the wording of the claims.
There has been much debate about whether, and if so how, the ECJ’s requirement should be applied to single active ingredients and what, if any, degree of specificity is required. Clearly, this criterion will be satisfied if the basic patent contains a claim which specifies the product at issue. However, the situation is less clear when the claims of the basic patent embrace the product at issue without mentioning it specifically.
That said, there is further judicial guidance. A patent which claims product A and does not mention combination therapies cannot support an SPC for combinations of active ingredients containing A – for example, an SPC for A+B (Medeva BV v Comptroller General of Patents  EWCA Civ 523 – note, however, that this is a ruling of the Court of Appeal of England and Wales, and it is not impossible that courts in other EU member states may take a different view).
A patent which claims a combination of A+B cannot be the basic patent for an SPC for A alone, despite the fact that the sale of A may well, under some circumstances, infringe the patent under the contributory infringement provisions. This remains true even where the marketing authorisation is for a medicine comprising A and including an indication that A may or should be used together with B (C-518/10, Yeda).
The granting of an SPC can – in principle – be supported by a generic disclosure, such as a functional definition in the claims of the basic patent which embraces a marketed product. However, the ECJ has held that in order for an SPC to be granted in those circumstances, the claims when construed in the context of the description must relate “implicitly but necessarily and specifically to the active ingredient in question” (C-493/12, Eli Lilly). Regrettably, it is far from clear what this means and no further guidance is yet available from the ECJ in this regard.
What is meant by ‘a valid authorisation to place the product on the market as a medicinal product’?
The ECJ has confirmed that an SPC for a given product can be based on any marketing authorisation for 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 (C-322/10, Medeva and C-422/10, Georgetown). 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 each patent to any validity challenge and the duration of the SPC available from each. However, if the two patents are held by different entities, each patent can support a separate SPC.
The ECJ has confirmed that, in principle, it is possible to have multiple SPCs granted for multiple different products based on different marketing authorisations on the basis of the same basic patent, provided that each product is protected by the basic patent (C484/12, Georgetown). However, in an exception to this general position, the ECJ has held that where an SPC had been granted for an active ingredient (irbesartan), a subsequent SPC – in that case having a later expiry date – could not be granted on the basis of the same patent for a combination containing that active ingredient (irbesartan and hydrochlorothiazide) (C443/12, Actavis v Sanofi).
Which marketing authorisation is the first one?
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). However, identifying 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.
Previously, it was thought that a patent for a new medical use of a drug could form the basis of an SPC, but that the 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 (C-202/05, Yissum). 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 European Union.
However, more recent guidance from the ECJ suggests that in certain circumstances it may be possible to base an SPC application on an authorisation which is not the first marketing authorisation to place a particular drug on the market (C-130/11, Neurim). Thus, it may be possible for patentees to obtain SPCs on the basis of both a patent for a downstream development of a known drug (eg, a patent for a new medical use or a new formulation of a known active ingredient) and a second or subsequent marketing authorisation for a medicinal product containing the active ingredient at issue.
Optimising a patent estate to facilitate SPC applications
In view of the complex legal position, it may be necessary to optimise a patent estate before any product is approved in order to ensure maximum SPC protection. Some specific points to consider are set out below:
- It is important to secure claims focusing on specific clinical candidates to the fullest extent possible. This might mean that it is appropriate to file patents for selection inventions with claims to specific subject matter embraced by, but not disclosed in, earlier patent applications.
- Particular care needs to be taken with combination products: consider including claims to combinations of novel and inventive drugs with further specific actives. It may also be appropriate to divide out such combination claims during prosecution if it is likely that separate marketing authorisations will be secured for a monotherapy and for a combination product. Such division may assist in avoiding situations such as Actavis v Sanofi (C-443/12), where the same basic patent could not support SPCs to a monotherapy and a corresponding combination product.
- Where claims of a granted patent appear unsuitable for use in obtaining SPCs, consider post-grant amendment of the patent before the European Patent Office or national offices before SPCs are applied for. (A referral on this point is pending before the ECJ (C-577/13, Actavis) which may affect the ability to amend the claim scope for SPC purposes.)
- Given the difficulties of obtaining multiple SPCs for the same product based on multiple patents, in situations where there are two interested commercial parties (eg, a patentee and licensee), consider splitting the patent estate between the two parties so that both can obtain separate SPCs.
- In situations where a patent application is held which covers a new use of a known product, to benefit from the ECJ’s decision in Neurim it may be necessary to fine-tune the scope of the claims before the patent is granted to ensure that it does not cover an earlier marketing authorisation (but does cover a later one).
J A Kemp
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Alastair Newman is an associate at J A Kemp. He gained a master’s degree in natural sciences (chemistry) from Cambridge University, focusing on synthetic organic and medicinal chemistry, before qualifying as a chartered patent attorney and a European patent attorney.
Mr Newman joined J A Kemp in 2006 and currently handles patent work in all aspects of chemistry, including pharmaceuticals, nutraceuticals (particularly lipids), industrial minerals and electroluminescent polymers. He also has experience filing and prosecuting SPCs and advises on related regulatory issues. Mr Newman was recently involved in referrals in this area to the European Court of Justice.
Ravi Srinivasan is a partner at J A Kemp. He specialises mainly in pharmaceutical work and has many years’ experience of devising and implementing patent strategies for pharmaceutical companies around the world. Mr Srinivasan is known for his practical and commercial approach. He is experienced in oppositions and appeals before the European Patent Office and has acted in some high-profile conflicts, including the dispute between Spanish company Almirall SA and Boehringer Ingelheim in the chronic obstructive pulmonary disease field.
Mr Srinivasan has advised on many SPC cases and spoke recently at the Nordic IP rights conference on Extending Exclusivity: Supplementary Protection Certificates.
IAM Patent 1000: The World’s Leading Patent Practitionersidentifies Mr Srinivasan as a recommended individual for his expertise in pharmaceuticals.