MPA Business Services
 
 
 
 
 
MPA Business Services Home Our Services Our Clients Resources Contact Us Who We Are
 

Our Services

Pharmaceutical Patent & SPC Expiry Database >

1st EU Marketing Authorisations >

Product Licences >

Parallel Import Certificates >

PCA Data England 2010 >

Tell Us What You Need >

Register With MPA Now >

Client Login >

 

Patent Intelligence Briefings

Pharmaceutical Patents

Supplementary Protection Certificates (SPCs)

Paediatric Extensions

Data & Marketing Exclusivity

Exclusivity vs. Patent Cover

Paediatric Use Marketing Authorisations

The Specific Mechanism

Patents, Trademarks, Copyrights

Product, Process & Formulation Patents

Key Patent Definitions

 

News

Singulair - Sigma Pharmaceuticals Plc vs Merck Sharpe & Dohme

Specific Mechanism – Ambiguity, Confusion and Conflict

Medeva and Georgetown - Combination Drugs and SPCs

 

<< Patent Intelligence Briefings / << Patent Cover vs. Data and Marketing Exclusivity / Paediatric Use Marketing Authorisations (PUMAs) >>

The Specific Mechanism

MPA's European Drug Patent Status Review database allows the filing dates of product/preparation patents in member countries to be checked and therefore it can be determined if the specific mechanism may apply.

If the filing date of a patent in a member state into which importation is being contemplated precedes the date at which it was possible to obtain such protection in a new member state from which exportation of the same product is being considered, then the specific mechanism may be envoked. This allows the IP holder to rely on the cover it has in the destination state to prevent imports of the product from the new member state.

With regard to Bulgaria, the Czech Republic, Estonia, Latvia, Lithuania, Hungary, Poland, Romania, Slovenia or Slovakia, the holder, or his beneficiary, of a patent or supplementary protection certificate for a pharmaceutical product filed in a Member State at the time when such protection could not be obtained in one of the above mentioned “new” Member States for that product, may rely on the rights granted by the patent or supplementary protection certificate in order to prevent the import and marketing of that product in the Member State or States where the product in question enjoys patent protection or supplementary protection, even if the product was put on the market in that “new” Member State for the first time by him or with his consent.

Any person intending to parallel import or market a pharmaceutical product covered by the above paragraph in a Member State where the product enjoys patent or supplementary protection shall demonstrate to the competent authorities in the application regarding that import that one month’s prior notification has been given to the holder or beneficiary of such protection.

Dates when new laws came into force allowing patentability of pharmaceuticals. These dates will act as a guide towards applicability of the Specific Mechanism:

Country Date When Law Came Into Force
Czech Republic 1st January 1991
Slovak Republic 1st January 1991
Romania 21st January 1992
Latvia 31st March 1993
Slovenia * 4th April 1992
Poland 16th April 1993
Bulgaria 1st June 1993
Lithuania 1st February 1994
Estonia 23rd May 1994
Hungary 1st July 1994

* Slovenia was granted independence from Yugoslavia on 25th June 1991

EU ENLARGEMENT SIGNIFICANT PHARMACEUTICAL ISSUES

On 1st May 2004 Cyprus, the Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Slovakia and Slovenia joined the European Union. A number of issues arose concerning cross border trading arising from this enlargement that needed to be addressed.

There were three that concerned the pharmaceutical industry

(a) Marketing Authorisations

(b) Supplementary Protection Certificates

(c) Parallel Importation (including Specific Mechanism)

Marketing Authorisations

Under EU law, a medicinal product for human use must have a marketing authorisation before it can be placed on the market of a member state. There are two procedures for obtaining authorisations: the ‘centralised procedure’, compulsory for biotechnology products and optional for other innovative new medicines, where an application is made to the European Agency for the Evaluation of Medicinal Products (EMA); and the ‘mutual recognition’ procedure, based on mutual recognition by the EU member states’ pharmaceutical regulatory bodies of each other’s national marketing authorisations.

Under the Accession Treaty new member states had to comply with EU law by 1st May 2004, in the absence of a specific derogation. Cyprus, Lithuania, Malta, Poland and Slovenia have negotiated transitional periods during which marketing authorisations (for medicinal products) granted under national legislation not compliant with EU law will continue to be valid in that country, but not in the rest of the EU. (Poland has also negotiated a transitional period for marketing authorisations for medical devices.) Existing national marketing authorisations in the Czech Republic, Estonia, Hungary, Latvia and Slovakia must be upgraded to comply with EU law by 1st May 2004.

From 1st May 2004, a marketing authorisation granted under the centralised procedure will be valid in all member states of the enlarged EU. An authorisation applied for under the mutual recognition procedure may designate one or more of the new member states.

Supplementary Protection Certificates (SPCs)

The SPC system aims to compensate patentees for time lost in the commercialisation of medicinal products due to delays in obtaining marketing authorisations. An SPC extends the protection of the basic patent beyond the term of the patent, but only in respect of the active ingredient of a medicinal product that is the subject of a marketing authorisation. An SPC must be applied for separately in each country where protection is required. Generally, the SPC allows fifteen years of exclusivity, based on the first authorisation in the EU, providing up to but not exceeding five years on patent duration.

The Accession Treaty amends the EU SPC regulation, introducing transitional arrangements in the new member states. It addressed the extent to which marketing authorisations granted in new member states before 1st May 2004 can be used as the basis for an SPC application in that country. The provisions vary considerably, resulting from political negotiation and historical differences in national patent, SPC and pharmaceutical legislation. They can, in very general terms, be divided into two categories – those that allow SPC applications:

• Within six months of the date of the first marketing authorisation of the medicinal product in the relevant new member state; and

• In a six-month period after 1st May 2004 for medicinal products authorised in the new member state within a certain period before 1st May 2004.

The Accession Treaty is silent on the effect of existing medicinal products for which the first marketing authorisation (in the enlarged EU) was obtained in a new member state before accession. It is not clear what, for the purposes of calculating the duration of an SPC, will be the first marketing authorisation in the European Economic Area (EEA). If it is the first marketing authorisation in the new member states (which was obtained before the first marketing authorisation in the current 15 member states), then this would effectively reduce the term of an SPC.

Parallel Imports

In general, from 1st May 2004 the principle of ‘exhaustion of rights’ will apply to the new member states (as it does to existing member states and the other three members of the EEA: Iceland, Liechtenstein and Norway). So, once a product has been put on the market in the area comprising the enlarged EU and EEA by an IP right holder, or with his consent, the IP right holder will not be able to prevent the product being resold anywhere within the 28 countries of the enlarged EU and EEA.

Specific Mechanism

However, the Accession Treaty contains a ‘specific mechanism’ relating to parallel imports of patented pharmaceutical products. This special measure allows for the fact that patent protection for pharmaceutical products was introduced only relatively recently (in the 1990’s) in all the new member states except Cyprus and Malta:

‘With regard to [new member states other than Cyprus or Malta], the holder, or his beneficiary, of a patent or supplementary protection certificate for a pharmaceutical product filed in a Member State at a time when such protection could not be obtained in one of the abovementioned new Member States for that product, may rely on the rights granted by that patent or [SPC] in order to prevent the import and marketing of that product in the Member State or States where the product in question enjoys patent protection or [SPC] protection, even if the product was put on the market in that new Member State for the first time by him or with his consent.’

Illustrated Example:

A patent application for a pharmaceutical product was filed in the UK in 1992. The patent was granted in 1998 and the first marketing authorisation for the product was obtained in the EEA in 2000.

In Estonia, there was no patent protection for pharmaceutical products in 1992, so the special mechanism is triggered. The UK patent expires in 2012 and UK SPC expires in 2015. Applying the special mechanism, the patented product may not be exported from Estonia to the UK until expiry of the SPC in 2015, approximately 11 years after Estonia joined the EU on 1st May 2004.

The period of transitional protection against parallel imports of medicinal products from the new member states must be examined on a product-by-product basis for each new member state.

 

 
   
 
 
 
::  News  ::  About Us  ::  Contact Us  ::  Site Map  ::  Terms & Conditions
 
EC Regulation 469/2009 Article 20 EU Supplementary Protection Certificates | Pharmaceutical Patent Term Extensions
Pharmaceutical Patent Intelligence | French Generics Market | UK Parallel Imports and Pharmaceutical Patents
 
© MPA Business Services Limited 2011. All Rights Reserved.