SGCR - Intellectual Property Experts Simões Garcia Corte-Real & Associados
  • About Us
    • Office
    • Our team
    • Memberships
    • Contacts
  • Services
    • Patents | Utility Models
    • Trademarks
    • Designs
    • Domain Names
    • IP Searches
    • IP Litigation
    • Licensing
    • IP due diligences
  • Resources
    • News
    • Brochure
    • ECTA Round Table: IP TRANSLATOR
    • Site Map
    • ECTA Round Table 2015: Hague System
  • IP Basics
    • Portugal
    • Macao
    • Angola
    • Mozambique
    • Sao Tome and Prince
    • Cabo Verde
    • European Union
  • Home

PORTUGAL | EUROPEAN UNION
MACAO | ANGOLA | MOZAMBIQUE
SAO TOME AND PRINCE | CABO VERDE

  • English
  • Português
SGCR - Intellectual Property Experts Simões Garcia Corte-Real & Associados

Saturday, 12 July 2014 21:42

Maximum period of patent exclusivity conferred by an SPC

Written by Cristina Brites
  • font size decrease font size increase font size
  • Print
  • Email
Rate this item
  • 1
  • 2
  • 3
  • 4
  • 5
(0 votes)
Maximum period of patent exclusivity conferred by an SPC Maximum period of patent exclusivity conferred by an SPC

The Court of Justice of the European Union (ECJ) issued an order on February 13th 2014 regarding the interpretation of Article 13 of Regulation (EC) No 469/2009 concerning SPCs, that is, the supplementary protection certificate for medicinal products.

The ECJ was requested to clarify the interpretation by an Arbitral Tribunal established in Portugal for solving a patent litigation case involving generic drugs under the Law 62/2011. Although a conventional arbitration tribunal is not a 'court or tribunal of a Member State' within the meaning of Article 267 TFEU (Treaty on the Functioning of the European Union) the ECJ admitted the request because this Arbitral Tribunal was established on a legislative basis with permanent compulsory jurisdiction (jurisdiction does not depend on the parties' agreement). The ECJ stressed that the decisions are taken by the Arbitral Tribunals under Law 62/2011 in accordance to national legislation which defines the applicable procedural rules and are binding on the parties.

On the substance, the ECJ reaffirmed that Article 13 of Regulation (EC) No 469/2009 concerning SPCs, read in conjunction with recital 9 to the same regulation, must be interpreted as meaning that it precludes the holder of both a patent and a supplementary protection certificate from relying on the entire period of validity of such a certificate, calculated in accordance with Article 13, in a situation where, pursuant to such a period, it would enjoy a period of exclusivity as regards an active ingredient, of more than 15 years from the first authorisation to be placed on the market, in the European Union, of a medicinal product consisting of that active ingredient, or containing it. In short, exclusivity conferred by an SPC cannot extend beyond 15 years after the first marketing authorisation of the relevant medicinal product.

This decision of the ECJ took the simple form of a reasoned order since the reply was deemed clear or could be concluded from past case-law.

Read 1290 times Last modified on Tuesday, 14 April 2015 21:20
Tweet
Published in News
Tagged under
  • arbitration in intellectual property
  • pharma patents
  • supplementary protection certificates
Cristina Brites

Cristina Brites

Latest from Cristina Brites

  • New Domain Names .PT with two characters only
  • The importance of being Magenta – judgment of Lisbon IP Court
  • Macao court confirms PAIR PLUS not a trademark
  • Cape Verde – New IP Office name: IGQPI
  • Mopping up the sauce: La Comadre

Related items

  • Arbitration in patent pharma disputes becomes voluntary
  • Brexit: preparing for 30 March 2019
  • Court of Appeal confirms the IP Court on Supplementary Protection Certificates: the product is not protected by the basic patent
  • Portugal offers to host the European Medicines Agency after Brexit
  • Rules for domain names .PT amended
More in this category: « Rules for domain names .PT amended How trademarks looked like 100 years ago (II) »
back to top
  • English
  • Português

© SGCR

  • About Us
    • Office
    • Our team
    • Memberships
    • Contacts
  • Services
    • Patents | Utility Models
    • Trademarks
    • Designs
    • Domain Names
    • IP Searches
    • IP Litigation
    • Licensing
    • IP due diligences
  • Resources
    • News
    • Brochure
    • ECTA Round Table: IP TRANSLATOR
    • Site Map
    • ECTA Round Table 2015: Hague System
  • IP Basics
    • Portugal
      • National Law for IP matters
      • International Law
      • Portuguese Patents
      • European Patents – National Validation
      • Utility Patents
      • Designs
      • Trade and Service Marks
    • Macao
      • National Law for IP matters
      • International Law
      • Patents
      • Utility Patents
      • Designs
      • Trade and Service Marks
    • Angola
      • National Law for IP matters
      • International Law
      • Patents
      • Designs
      • Trade and Service Marks
    • Mozambique
      • National Law for IP matters
      • International Law
      • Patents
      • Designs
      • Trade and Service Marks
    • Sao Tome and Prince
      • National Law for IP matters
      • International Law
      • Patents
      • Designs
      • Trade and Service Marks
    • Cabo Verde
      • National Law for IP matters
      • International Law
      • Patents
      • Designs
      • Trade and Service Marks
    • European Union
      • European Union Trademarks
      • Community Designs
  • Home