Patenting in the pharmaceutical industry: supplementary protection certificates

In certain fields, such as pharmaceuticals and plant protection products, the requirement for marketing authorisation before a product can be launched means that commercial exploitation of an invention is simply not possible for several years after the invention has been made and patent applications filed. An unfortunate consequence of this is that the effective period during which a patent can be exploited is reduced, which is disadvantageous to those working in such industries, particularly when the extremely high costs of product development are taken into account. Accordingly, a mechanism has been devised in Europe whereby in appropriate cases, the term of a patent can be extended after its normal expiry date to compensate for time which is unavoidably lost in placing a product onto the market. This mechanism is termed a “supplementary protection certificate” (SPC), and has the effect of extending the protection conferred by a patent on a particular medicinal or plant protection product that has been approved for marketing in Europe. Similar rights are available in some other countries, for example, the USA and in Japan.

There is no unitary European SPC. SPCs are national rights, available in member states of the European Union by separately applying to each of the various national patent offices in which an SPC is desired. The SPC must be based on a national patent, although this may either have been obtained directly from a national patent office or from the European Patent Office. Like patents, SPCs are subject to the payment of national renewal fees. If the basic patent is revoked, the SPC also falls. Furthermore, an SPC can also be revoked in its own right e.g. after the patent has expired.

The SPC protects the so-called “product” (i.e. active ingredient or combination of active ingredients) in a medicinal/veterinary product (Regulation 1768/92) or a plant protection product (Regulation 1610/96).

It is important to recognize that an SPC is not a general patent term extension, but extends the 20-year term of the patent only in respect of the particular product and therapeutic indication (including any further therapeutic indications subsequently authorised) which is approved in the marketing authorisation and thus for which the SPC is granted.

The term of an SPC is calculated by the interval between the patent application date and the date of first marketing authorisation anywhere in the European Community or EEA, reduced by five years, and capped at a maximum of five years. Assuming that it takes between five and ten years to obtain the first marketing authorisation, the aim of the SPC is thus to restore up to 15 years of effective patent life between the grant of the first marketing authorisation for the product and the ultimate expiry of the SPC. Accordingly, where there is less than five years between the patent application date and the date of first marketing authorisation, no SPC term will be available.

For some medicines, the term of an SPC may be further extended by six months by a paediatric extension, and this possibility is discussed further below.

In order to qualify for SPC protection, the product must be protected by a basic patent that is in force at the time that the SPC application is made. A valid authorisation to place the product on the market as a medicinal or plant protection product must have been obtained in that country. Furthermore, the specified marketing authorisation must be the first for that product in the country concerned.

The national patent on which the SPC is to be based must “protect” the product, that is to say, it must either protect the product itself, a process to obtain the product, or an application of the product. If there is more than one relevant patent, the patentee may choose which of its patents to designate as the basic patent for the SPC.

The deadline for filing an SPC application is either i) within six months of the grant of the basic national patent; or ii) within six months of grant of the first marketing authorisation in the country concerned, whichever is the later.

As with patents, the various territories of the Community differ in the degrees and manner in which SPC applications are examined. Most national patent offices undergo at least a formalities examination, although certain territories additionally conduct a detailed substantive examination for allowability. Broadly speaking, SPC practice is harmonised across Europe, although there are points of practice where differences exist in the ways in which the primary EU Regulations are applied under national law.

Paediatric extensions

Children are subject to many of the same diseases as adults, and by necessity, are often treated with the same drugs. However, only a small fraction of all drugs marketed has been studied in paediatric patients, and a majority of marketed drugs are not labelled, or are insufficiently labelled, for use in paediatric patients. The absence of paediatric testing and labelling poses significant risks for children.

In 1997, the US Congress enacted a new law that provides marketing incentives to manufacturers who conduct studies of drugs in children. In exchange for clinical studies in children patentees receive a six-month exclusivity term added on at the end of their intellectual property rights, i.e. patent term, patent extension for regulatory delay and data exclusivity periods (this protects the clinical data package used for applying for regulatory approval). The six-month period is added to each one of these intellectual property rights listed in the Orange Book at the time the paediatric exclusivity is awarded, although usually it will only be the term which expires last for which the paediatric extension will be significant, and during the six-months of paediatric exclusivity the FDA will not approve any aNDA.

On 26 January 2007, a new EU legislation [Regulation (EC) No 1901/2006 as amended by 1902/2006] came into force introducing a requirement to conduct paediatric studies in paediatric indications and possible rewards for completing such studies. One of the rewards is a six-month extension to the term of an SPC, another is the ‘+1’ year of exclusivity of the data exclusivity period1. If a product is not covered by an SPC or patent qualifying for an SPC, for example where all such property has expired, then the product can benefit form the full data exclusivity (under the 8+2+1 rules ) under a separate Paediatric Use Marketing Authorisation (PUMA) for a new indication exclusively developed for use in children.

Under the Regulation any company submitting a new marketing authorisation application will have to provide the results of paediatric clinical trials based on a paediatric investigation plan (PIP) to be agreed with the European Medicines Agency's (EMEA) new paediatric committee. If a product is not suitable for use in children companies can request a waiver from this requirement (for example medicines for Alzheimer's disease) or if complying with the requirement would delay authorisation of the product in adults the company can request a deferral for completing the PIP.

The European Medicines Agency’s Paediatric Committee (PDCO) had its first meeting on 4 July 2007 and the provisions of the Regulation come into play in stages:

(i) as from 26 July 2007 companies were able to begin agreeing PIPs with the paediatric committee;
(ii) from 26 July 2008 the PIP (or waiver or deferral) became compulsory for all marketing authorisations for new substances not approved in the EU when the Regulation came into force; and
(iii) from 26 January 2009 it also applied to new indications, new pharmaceutical forms and new routes of administration of already authorised products.

There are a number of restrictions to the availability of the SPC paediatric extension:

(i) In contrast to the US, the SPC extension will only be available if the patentee has an SPC, it is not available to extend the term of the basic patent;
(ii) The extension will only be available if the product is authorised in all member states.
(iii) Orphan drugs will benefit from an additional two years of market exclusivity added to the existing ten years granted under EU orphan legislation provided the orphan drug is authorized in all member states. The SPC paediatric extension is then not available.
(iv) The extension must be applied for either with the SPC application itself or whilst the SPC application is pending. If the SPC has already granted the application must be made not later than two years before expiry of the SPC.

However, until 26 January 2012 if the SPC has already granted it will be possible to apply up to six months before expiry of the SPC.

There are penalties if companies do not abide by the Regulation. The Members States will be responsible for determining the penalties to be applied if companies infringe the provisions of the Regulation and are obligated to inform the Commission immediately of any litigation instigated for infringement of the Regulation. The Commission will make public the names of anyone infringing the provisions of the Regulation and the amounts and reasons for any financial penalties imposed. There is also a provision which allows the Commission to impose financial penalties directly.

Once a paediatric SPC extension has been granted the holder of the extension will have the same rights as under the SPC and therefore would be able to sue a party for infringement if they launched a product, without permission from the holder of the extension, prior to expiry of the extended SPC.

The paediatric regulation should provide substantial benefit to paediatric patients but will impose additional costs on innovator companies bringing drugs to the market. However, this should be offset by the rewards, such as the six months SPC extension, available to the innovator companies. Since the Regulation has only recently come into force there are likely to be additional developments as applications are made and the Regulation is better understood.

Further information and guidance with respect to requirements under the Paediatric Regulation can be found on the European Medicines Agency (EMEA) website.

Footnote:
1. The 8+2+1 rules give 8 years of data exclusivity and 2 years of marketing exclusivity for a clinical trial package. During the last 2 years of which a generic can perform clinical trials to show bioequivalence, i.e. 8+2 = 10. There is the possibility of a further 1 year (‘+1’) marketing exclusivity if clinical trials are performed on a significant new medical indication distinct from the medical indication on which 8+2 year data exclusivity is based before the end of the 8 years.