Supplementary protection certificate

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In European Union member countries, a supplementary protection certificate (SPC) is a sui generis, extension of a patent under a specific, different, set of right. This type of right is available for medicinal products, such as drugs, and plant protection products, such as insecticides, and herbicides. Supplementary protection certificates were introduced to compensate for the long time needed to obtain regulatory approval of these products (i.e. authorization to put these products on the market).^[1]

A supplementary protection certificate comes into force only after the corresponding general patent expires. It normally has a maximum life time of 5 years. The duration of the SPC can, however, be extended to 5.5 years when the SPC relates to a human medicinal product for which data from clinical trials conducted in accordance with an agreed Paediatric Investigation Plan (PIP) have been submitted (as set out in Article 36 of Regulation (EC) No 1901/2006^[2]).

The total combined duration of market exclusivity of a general patent and SPC cannot normally exceed 15 years. However, the reward of a 6-month SPC extension for the submission of data from an agreed PIP can extend this combined duration to at least 15.5 years (it is yet to be judicially clarified whether more than 15.5 years can be obtained in some circumstances). It extends the life time of a patent, but under somewhat different rights.

Supplementary protection certificates in the European Union are based primarily upon two regulations. Although all countries in the EU are required to provide supplementary protection certificates, no unified cross-recognition exist. Applications must be filed and approved on a country-by-country basis.

Contents 1 Determination of term 1.1 Paediatric extension 2 Scope 3 Legal basis 4 Statistics 5 See also 6 References 7 External links 7.1 Search

[edit] Determination of term

The term of an SPC depends on the date of issuance of the first Marketing Authorisation (MA) within the EEA and can be determined by the equation:

 Term = ([date of 1st MA in the EEA] - [date of filing of corresponding patent]) - 5 years

Under normal circumstances, this means the following.

• No SPC term is available if less than 5 years have elapsed between the date of filing of the corresponding patent and the date of issuance of the first MA in the EEA.
• If the first MA is issued more than five years but less than ten years after the filing date of the corresponding patent, an SPC is granted for a term corresponding to the period elapsed between the five-year point and the MA issuance date.
• If the first MA is issued more than ten years after the filing date of the corresponding patent, an SPC is granted for a five-year term.

A MA in Switzerland was also considered as being a first MA for the calculation of the SPC duration, even though Switzerland is not part of the European Economic Area (EEA). This is because such a MA was automatically effective in Liechtenstein, which is a member of the EEA (since May 1, 1995). This was decided by the European Court of Justice (ECJ) in joined cases Novartis et al. v. Comptroller-General and Ministère de l'Economie v. Millennium Pharmaceuticals. ^[3][4] However, as answer to the decision of the ECJ the contract between Switzerland and Liechtenstein was amended. Since July 1 2005 the automatic effect of a Swiss MA in Liechtenstein is abolished. The recognition is now delayed by a time period, which is normally 12 months.

[edit] Paediatric extension

This section relies largely upon a single source, a 2007 paper by Snodin and Miles (Snodin and Miles RAJ Pharma 18(7), 459 (2007)). Please help improve this article by introducing appropriate citations of additional sources. Please help improve this article by introducing appropriate citations of additional sources. (June 2009)

Article 36 of Regulation 1901/2006 provides for a 6-month extension to SPC term. The extension is available only under certain conditions, the most notable being the requirement for the submission of a new MA application containing data from all trials conducted in accordance with an agreed Paediatric Investigation Plan (PIP).

Undisputed consequences of the introduction of the 6-month SPC extension are that:

• the maximum term of an SPC can now be up to 5.5 years; and
• the maximum duration of market exclusivity (patent + SPC) can now be up to at least 15.5 years.

The rewards provided in Regulation 1901/2006 (including the 6-month SPC extension) are intended to compensate pharmaceutical companies for the substantial costs of conducting clinical trials in the paediatric population. By way of contrast^{[original research?]}, the reasoning behind the creation of the original SPC system (as set out in Council Regulation (EEC) No 1768/92) was to compensate pharmaceutical companies for the loss of exclusivity caused by regulatory delays. Thus, the reasons for the introduction of the 6-month SPC extension are entirely independent^{[opinion needs balancing]} of the reasons for the creation of the original SPC system.^{[original research?]} Because of this, an issue arises in relation to whether the 6-month extension can be obtained even in circumstances where no SPC term would be available without the extension.^{[original research?]}

Because an extension of an SPC can only be awarded if there is an SPC to extend, the above issue can be addressed by answering the following two questions.

(1) Is an SPC available if less than 5 years have elapsed between filing of the corresponding patent and issuance of the first MA in the EEA?

(2) If the answer to (1) is yes, what term should be awarded to the (unextended) SPC?

These questions have yet to be answered by a European national court (or the European Court of Justice). According to a 2007 paper by Snodin and Miles,^[5] there are only three possible answers to this combination of two questions.

If the answer to question (1) is no, then it is not relevant to consider question (2). This corresponds to "Model B" of the 2007 Snodin and Miles paper, and produces a curious situation where longer marketing exclusivity can be obtained if the issuance of the first MA in the EEA is delayed (to at least 5 years from filing of the corresponding patent).

If the answer to question (1) is yes, then question (2) becomes relevant. This question can be answered in two ways, corresponding to either "Model A" or "Model C" of the 2007 Snodin and Miles paper.

Model A assumes that SPC term can validly be either zero or negative if 5 years or less have elapsed from filing of the corresponding patent to issuance of the first MA in the EEA. In this event, a positive (and non-zero) SPC term is obtained (after extension) if the time from patent filing to MA issuance is more than 4.5 years.

Model C assumes that all term calculations that provide a negative answer are 'rounded up' to zero. This has the consequence of providing a minimum of 6 months of SPC term, irrespective of how little time has elapsed from patent filing to MA issuance.

Although no European courts have yet decided which of Models A to C is correct, patent offices of various EU member states have reached decisions on this point (in connection with the product sitagliptin). Curiously, there has been no consensus on which model is correct, with, for example, the Netherlands and the UK favouring Model A (see the UKIPO decision^[6]), Germany favouring Model B and Greece favouring Model C. In the light of these differences of opinion, a reference to the European Court of Justice seems to be necessary.

[edit] Scope

According to Article 4 of Council Regulation (EEC) No 1768/92, the scope of an SPC extends "only to the product covered by the authorization to place the corresponding medicinal product on the market and for any use of the product as a medicinal product that has been authorized before the expiry of the certificate".

The European Court of Justice has decided, however, that the scope of an SPC is sometimes capable of encompassing more than just the single form of the active ingredient that is included in the medicinal product authorised for sale. Thus, in case C-392/97 ^[7], the European Court of Justice held that: "where an active ingredient in the form of a salt is referred to in the marketing authorisation concerned and is protected by a basic patent in force, the certificate is capable of covering the active ingredient as such and also its various derived forms such as salts and esters, as medicinal products, in so far as they are covered by the protection of the basic patent".

[edit] Legal basis

Supplementary protection certificates in the European Union are based primarily upon two regulations:

• Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products ^[8] which entered into force on January 2, 1993
• Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products ^[9] which entered into force on February 8, 1997

Supplementary protection certificates may come into life at the expiry of a national or European patent. However, the European Patent Convention (EPC) needed to be modified to allow such "extension" of the term of European patent. Article 63 of the EPC was modified on December 17, 1991 to specify to, although European patents have a term of 20 years as from the date of filing of the application (Art. 63(1)),

" nothing (...) shall limit the right of a Contracting State to extend the term of a European patent, or to grant corresponding protection which follows immediately on expiry of the term of the patent, under the same conditions as those applying to national patents: (...)

(b) if the subject-matter of the European patent is a product or a process of manufacturing a product or a use of a product which has to undergo an administrative authorisation procedure required by law before it can be put on the market in that State. " ^[10]

This constituted the first revision of the European Patent Convention since its signature in 1973.

The paediatric extension is based primarily upon:

• Regulation 1901/2006 of 12 December 2006 on medicinal products for paediatric use and amending Regulation 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 ^[11]
• Regulation 1902/2006 of 20 December 2006 amending Regulation 1901/2006 on medicinal products for paediatric use ^[12]

[edit] Statistics

According to research, more than 8,000 SPCs for medicinal and plant protection products have been filed in Europe between 1991 and 2003. ^[13]

[edit] See also

• European Medicines Agency (EMEA)
• Orphan drug
• European Federation of Pharmaceutical Industries and Associations (EFPIA)

[edit] References

[edit] External links

• Supplementary Protection Certificates for Medicinal Products and Plant Protection Products - A Guide for Applicants (PDF file 120Kb), by the UK Patent Office
• The SPC Blog, blog relating to supplementary protection certificates (SPCs) (contributors include Professor Jeremy Phillips)
• Generics (UK) Ltd v Daiichi Pharmaceutical Co Ltd & Anor [2008] EWHC 2413 (Pat) (15 October 2008), an example a SPC-related dispute in the UK, relating to the "(-) enantiomer of a racemic compound called ofloxacin"

[edit] Search

• Supplementary Protection Certificate Search at the UK Intellectual Property Office