STATUTORY INSTRUMENTS
S.I. No. 408 of 2008
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EUROPEAN COMMUNITIES (COMPULSORY LICENSING OF
PATENTS RELATING TO THE MANUFACTURE OF
PHARMACEUTICAL PRODUCTS FOR EXPORT TO COUNTRIES
WITH PUBLIC HEALTH PROBLEMS) REGULATIONS 2008
(Prn. A8/1651)2[408]
S.I. No. 408 of 2008
EUROPEAN COMMUNITIES (COMPULSORY LICENSING OF
PATENTS RELATING TO THE MANUFACTURE OF
PHARMACEUTICAL PRODUCTS FOR EXPORT TO COUNTRIES
WITH PUBLIC HEALTH PROBLEMS) REGULATIONS 2008
I, MARY COUGHLAN, Minister for Enterprise, Trade and Employment, in
exercise of the powers conferred on me by section 3 of the European Communi-ties Act 1972 (No. 27 of 1972) and for the purpose of giving effect to CouncilRegulation (EC) No. 816/2006 of the European Parliament and of the Councilof 17 May 2006
1, hereby make the following regulations:
1. These Regulations may be cited as the European Communities
(Compulsory Licensing of Patents relating to the Manufacture of Pharmaceut-ical Products for Export to Countries with Public Health Problems) Regu-lations 2008.
2. (1) In these Regulations—
“Controller” means the Controller of Patents, Designs and Trade Marks;“Council Regulation” means Regulation (EC) No. 816/2006 of the European
Parliament and of the Council of 17 May 2006
1;
“proceedings” means proceedings or an application under the Council Regu-
lation and these Regulations.
(2) A word or expression that is used in these Regulations and is also used
in the Council Regulation has the same meaning as in the Council Regulation.
(3) A reference to an Article in these Regulations is a reference to an Article
of the Council Regulation.
(4) A reference to a Patent Rule in these Regulations is a reference to a Rule
in the Patent Rules 1992 (S.I. No. 179 of 1992).
3. (1) The competent authority in the State for the purposes of the Council
Regulation (including Article 14) shall be the Controller.
(2) The body referred to in Article 14(1) with the authority to review as
provided therein shall be the Irish Medicines Board.
(3) The appropriate body within the meaning of Article 17 shall be the
High Court.
1OJ No. L157, 9.6.2006, p.1.
Notice of the making of this Statutory Instrument was published in
“Iris Oifigiu ´il” of 24th October , 2008.[408] 3
4. (1) An application under Article 6 for a compulsory licence shall be made
to the Controller in the form as set out in the Schedule.
(2) The application and supporting evidence shall be filed with the Controller
in duplicate.
(3) The Controller shall afford the rights-holder a reasonable period to com-
ment and provide relevant information pursuant to Article 7.
5. The Controller shall determine the application—
(a) on receipt of comments and relevant information by the rights-
holder, or
(b) where the rights-holder has not provided comments and relevant
information, after the termination of a reasonable period.
6. A request—
(a) where applicable, under Article 5( c), or
(b) under Article 16(1),
shall be made to the Controller and contain—
(i) the name and address of the person making the request,
(ii) information identifying the compulsory licence,
(iii) the name of the importing country, and(iv) the facts and the grounds upon which the person making the
request relies,
and shall be accompanied by evidence supporting the request.
7. The Controller may give such directions as he or she thinks fit with regard
to proceedings, including—
(a) the requirement to reply to the Controller with comments and docu-
ments within a period of time that the Controller considers reason-able, and
(b) the extension of any period of time for the filing of any document.
8. Where Article 17(2) applies, the Controller and the High Court shall have
the power to rule that an appeal referred to therein shall have suspensory effect.
9. (1) Subject to these Regulations and the Council Regulation—
(a) sections 92 to 94 of the Patents Act 1992 (No. 1 of 1992), and
(b) Patent Rules 67, 69, 71 to 74, 76 and 91 to 97,4[408]
shall apply with any necessary modifications in relation to proceedings.
(2) Subject to Patent Rule 95, documents filed under these Regulations or
the Council Regulation shall be in the Irish or English language.[408] 5
SCHEDULE
Application for a Compulsory Licence of a Patent relating to the Manufacture
of Pharmaceutical Products for Export to Countries with Public Health Prob-lems under Regulation (EC) No. 816/2006
1.Applicant:
Name
Address
2.Number of the Patent/Supplementary Protection Certificate:
Patent No(s).
SPC No(s).
3.Name and address of the Rights-Holder:
Please list the names and addresses of all rights-holders of the patent or Sup-
plementary Protection Certificate:
Name
Address
4.Product identity:
Please state the non-proprietary name or other description by which the product
for which a compulsory licence is requested is known:
5.Duration of licence sought:Regulation 4.6[408]
6.Amount to be produced and importing countries:
(i)In respect of this application:
The importing country or countries The amount of the product
which the applicant seeks toproduce under thecompulsory licence
Country 1
Country 2
Country 3
Country 4
(If the applicant is submitting applications for compulsory licences to auth-
orities in other countries, please indicate below the countries in which appli-cations are being made together with details of the quantities to be producedand the names of the importing countries which are listed in those otherapplications).
(ii)Details of applications made in other countries:
Name of other country where an application for a compulsory
licence has been made:
Duration of licence sought:
The importing country or countries The amount of the product
which the applicant seeks toproduce under thecompulsory licence
Country 1
Country 2
Country 3
Country 4
7.Documents accompanying this application:
(a) Evidence of a specific request indicating the quantity of product
required from one or more of the following:
(i) an authorised representative of the importing country or
countries;
(ii) a non-governmental organisation acting with the formal authoris-
ation of one or more of the importing countries;
(iii) a competent organ of the United Nations or an international
health organisation acting with the formal authorisation of one ormore of the importing countries.[408] 7
(b) Evidence of prior negotiation with the rights-holder, including details
of the terms, conditions and price proposed in respect of each pharm-aceutical product, pursuant to Article 9(1) of Regulation (EC) No.816/2006 (unless not necessary by virtue of Article 9(2) of thatRegulation).
8.Authorised Agent
(Please provide the name and address of the agent (if any) who is authorised
to act as agent in all proceedings connected with this application for a compul-sory licence and in relation to any licence granted ).
Name of Agent
Address of Agent
Telephone No.
Fax No.
E-mail
9.Address for Service (if different from that at No. 8)
Address for service
Telephone No.
Fax No.
E-mail
Signed by or on behalf of applicant:
Dated:8[408]
GIVEN under my Official Seal,
10 October 2008
MARY COUGHLAN
Minister for Enterprise, Trade and Employment.[408] 9
EXPLANATORY NOTE
(This note is not part of the Instrument and does not purport to be a legal
interpretation).
These regulations lay down the procedural requirements which apply to requests
for compulsory licensing of patents relating to the manufacture of pharmaceut-ical products for export to countries with public health problems. The purposeof the regulations is to give full effect to Council Regulation (EC) No. 816/2006regarding conditions for granting compulsory licences to companies intendingto manufacture medicinal products for export to developing countries whichdo not have sufficient production capacity of their own and which have publichealth problems.BAILE A ´THA CLIATH
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