Similarly to the patent term extension available in the United States under 35 USC § 156, European legislation provides a system to apply for patent term extension, termed a Supplementary Protection Certificate (“SPC”), in order to compensate patent holders for the delays caused by seeking marketing authorization for medicinal and plant protection products.

The SPC protects the so-called “product” (i.e. active ingredient or combination of active ingredients) in a medicinal/veterinary product (EU Regulation 1768/92) or a plant protection product (EU 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. Further, there is no pan-European SPC rather individual applications must be made before each national patent office where the SPC is required.

Qualification

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.

Deadline for applying for an SPC

The deadline for applying for an SPC is the later of:

• 6 months from the date of grant of the basic national patent, or
• 6 months from grant of the first marketing authorisation in the country concerned, whichever is the later.

Duration of an SPC

SPCs extend the patent term for a period that is equal to the time that elapsed between the filing date of the patent application and the date of the first marketing authorisation in the European Union, minus five years. The overall term of an SPC may not exceed five years in most circumstances.

Crucially, when calculating the duration of an SPC, the first marketing authorisation in the European Community (ie, the European Union plus the EEA states) is important, which can differ from the first marketing authorisation in the country in which the SPC application is being filed.

The term of an SPC can be further extended by six months if the marketing authorisation preparations included all of the studies required in compliance with an agreed paediatric investigation plan (“PIP”). The intention of the legislator was to provide further incentives for the pharmaceutical industry to include clinical trials specifically addressing paediatric uses of a drug.

The ECJ recently clarified in Merck (C- 125/10) that an SPC can also be granted with a zero or negative term. The grant of such an SPC can be desirable, as the paediatric extension is possible only if an SPC is in place. For example, a six-month extension of a negative- term SPC, provided that the negative term is less than six months, can result in patent term extension for the proprietor.

Opposition

There is a mechanism for third parties to seek to invalidate a granted SPC.

Data Exclusivity

For marketing authorisation applications made from November 2005 onwards, the period of data exclusivity has been harmonised as 8 years from the date of first authorisation in Europe. For marketing authorisation applications made before November 2005, the period of data exclusivity varies from EU member state to EU member state, and is either 6 years or 10 years.

Further, marketing authorisation applications made from November 2005 onwards, there is an additional period of 2 years of "market exclusivity". This is the period of time during which a generic company may not market an equivalent generic version of the originator's pharmaceutical product.

As noted above, the rules determining exclusivity changed in 2005. The new system follows an "8 + 2 + 1" year approach:

• During the first 8 years from the grant of the innovator company's marketing authorisation, data exclusivity applies.
• After the 8 years have expired a generic company can make use of the pre-clinical and clinical trial data of the originator in their regulatory applications, but still cannot market their product.
• After a period of 10 years from the grant of the innovator company's marketing authorisation, the generic company can also market their product, unless the innovator product qualifies for a further one year of exclusivity. 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. 

http://www.aipla.org/committees/committee_pages/Biotechnology/international/Shared%20Documents/International_Buzz_201312e.pdf