Twenty-one years of SPCs – a cause for celebration?
Supplementary Protection Certificates (SPCs) for medicinal products were created in Europe 21 years ago this year, with the enactment of Council Regulation No. 1768/92. The aim was to improve the protection of innovation in the pharmaceutical sector. Although patents represented the best tool for protecting innovation in general, it was recognised by the European Commission that additional measures were required to support the research and development of new medicines.
Long safety and toxicity studies meant that on average new drugs did not get to the market until 12 years following the filing of the application for the patent protecting the active ingredient of the drug. This meant that only eight years remained of the 20-year patent term for the innovator company to recover the investment put into developing the drug.
SPCs offer a solution to this problem by giving the holder of a basic patent protecting the active ingredient(s) of the new drug protection supplementary to that given by the patent. The protection was to be strictly limited to the active ingredient(s) of the drug which was authorised for sale, the maximum expiry date of the certificate was to be 5 years from the normal expiry date of the patent and the duration of the patent and certificate combined was to be fifteen years from the first marketing authorisation in the European Community.
When the SPC Regulation came into force, on January 2, 1993 there were just 12 members of the European Community – now there are 27. The territorial scope of the regulation also extends to the members states of the European Economic Area (EEA), that is Norway, Iceland and Liechtenstein. Although Switzerland is not a member of the EU or the EEA, it does have its own related SPC legislation.
On the other hand, because of the close legislative ties between Lichtenstein and Switzerland, an earlier marketing authorisation in Switzerland can determine the duration of an SPC in the EC. This was the subject of two, combined, references to the European Court of Justice (ECJ) in 2002, C-207/03 Novartis and C-252/03 Millennium, and a very recent reference to the court (now the Court of Justice of the European Union, CJEU) in C-617/12 (Astra Zeneca AB).
The SPC Regulation was amended to take account of EU enlargement, setting out transitional provisions for the new member states that had only recently adopted an SPC regime. This in turn led to a reference to ECJ in C-66/09 (Kirin-Amgen) about the interpretation of the transitional measures.
Following the coming into force of the Paediatric Regulation, 1901/2006, in 2007, it has been possible to get a six-month extension to the term of the SPC if the patent proprietor carries out clinical trials in a paediatric population in accordance with an agreed Paediatric Investigation Plan (PIP). Following a reference, C-125/10 (Merck Sharp & Dohme), the ECJ clarified that it was possible to be granted an SPC with a negative term of up to six months, which would permit the filing of a subsequent paediatric extension, when a PIP had been completed.
The amendments necessitated by enlargement of the EU and by the Paediatric Regulation, the SPC Regulation were consolidated in 2009 and reissued as Regulation 429/2009, which is the current version.
Some four years after the SPC Regulation for medicinal products came into force, it was joined by a parallel SPC Regulation, 1610/96, for plant protection products. This followed very closely the wording of the SPC Regulation, but also included extra provisions which filled in gaps in the earlier legislation.
One of these gaps resulted in a reference to the ECJ, C-181/95 (Biogen v Smithkline Beecham Biologicals), which clarified that where an active ingredient is covered by several basic patents, the regulation did not preclude the grant of an SPC to each holder of a basic patent. Following this ruling it is not unusual for a single active ingredient to be protected by several SPCs – for example, adalimumab, the active ingredient of Humira® has been the subject of at least three SPCs held by different proprietors.
“Drugs containing more than one active ingredient require a new marketing authorisation even if the individual active ingredients have been authorised for sale.”
The Biogen case highlighted a potential shortcoming of the SPC Regulation – that it was based on the concept of a vertically integrated pharmaceutical industry, in which one undertaking was responsible for the entire drug development process. This is rarely the model nowadays, with early stage research and later stage development often being carried out by different entities and the resulting patents being held by different holders.
But that is not the only short coming of the regulation. Drugs containing more than one active ingredient require a new marketing authorisation even if the individual active ingredients have been authorised for sale. According to the SPC Regulation, such combination drugs can be the basis of an SPC. But combination drugs vary tremendously in their innovation. Often the components are well known and the combination is merely a way of improving patient compliance.
On other occasions, such as a vaccine, none of the ingredients would be sold individually, as the therapeutic demand is for a multivalent drug that treats several aspects of a disease in one shot. And on yet other occasions, one active ingredient dramatically improves the effect of another – such as Kaletra®, where ritonavir ‘boosts’ the activity of lopinavir, by inhibiting its metabolism.
Regulatory law does not distinguish between these situations. However, in patents, it may be that the innovation lies in a single active ingredient rather than the combination. What are the conditions for grant of an SPC for combination products? The SPC Regulation requires that the active ingredient or combination of active ingredients is protected by the relevant patent.
But this raises the issue of what is meant by ‘protected’. This issue first came before the national courts in the early 2000s, most notably in a UK case involving Takeda. However, it was only in 2010 that the issue was referred to the ECJ for a preliminary ruling in a rush of cases, which included C-322/10 (Medeva) and C-422/10 (Georgetown University).
One interpretation of the meaning of ‘protected’ is to argue that it is sufficient that the combination of active ingredients infringes the relevant patent. If there are three active ingredients, A, B and C in the drug, then a patent claiming A or B or C protects the drug and so qualifies for an SPC. The CJEU (the successor of the ECJ) rejected this approach. Instead, they took the view the Regulation required that the active ingredients were ‘specified in the wording of the claims’.
So a patent claiming only A does not protect a drug with the combination of active ingredients A, B and C. Rather what is needed is a patent claiming the combination as such. However, the CJEU took a helpful interpretation of what was meant by a marketing authorisation for the drug in question – another key criteria for the grant of an SPC. Previously, most patent attorneys had thought that there must be an exact correspondence between the active ingredient(s) protected by the SPC and the active ingredient(s) of the authorised drug.
But the CJEU decided that it was enough that the SPC related to at least one of the active ingredients – so it was possible to get on SPC for A based on a patent claiming only A, even though the drug had active ingredients A, B and C. This meant that an SPC for A could be used to prevent the unauthorised sales of drugs having A or A and B, or A, B and D, as well as A, B and C – much broader protection than some had thought possible.
The CJEU rulings in Medeva and Georgetown raised new questions about what was meant by ‘specified in the wording of the claims’ and new references have been made to the court by the English courts, in C-443/12 (Actavis v Sanofi) and C-493/12 (Lilly). Further questions have also been referred from the Dutch courts, C-484/12 (Georgetown University) relating to whether or not it is permissible for one patent to be the subject of more than one SPC.
To qualify for an SPC, the relevant patent must be a substance patent, a process patent or a use patent. The questions of whether patents for new uses or new formulations could give rise to SPCs were referred to the ECJ in C-31/03 (Pharmacia Italia) and C-431/04, (Massachusetts Institute of Technology).
In the Pharmacia case, the ECJ ruled use could not be a distinguishing feature of an active ingredient, so that a previous veterinary use of an active ingredient prevented the grant of an SPC for a subsequent human use of the same active ingredient. In the Massachusetts case, the ECJ ruled that excipients could not be regarded as active ingredients, so that it was not possible to get an SPC for a new formulation, on the grounds that it was a new combination of active ingredients.
The scope of these two rulings was thrown into confusion when in C-130/11 (Neurim Pharmaceuticals) the CJEU appeared to open up possibilities of SPC for new uses of old products. The dust hasn’t settled yet on the implications of this ruling, which suggests that the grant of SPCs for certain new uses and perhaps even new formulations is permissible.
The SPC Regulation for medicinal products had a fairly uneventful childhood, but in recent years has shown an astonishing talent to entertain and surprise. Even if there are many issues that remain unclear about the applicability of the regulation, it works well for the majority of active ingredients, delivering the extra protection so needed by the pharmaceutical industry to encourage research into new medicines.
That alone is a cause for celebration. But the issues of interpretation brought about by a regulation designed for a model of pharmaceutical research that is largely superseded and a concept of drug (‘medicinal product’) that is far from ideal pose enormous challenges for the practitioner – and that too is a cause for celebration.
Gordon Wright is a partner at Elkington Fife LLP. He can be contacted at gordon.wright@elkfife.com
