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2008 EUROPEAN COMMUNITIES (SUPPLEMENTARY PROTECTION CERTIFICATE) REGULATIONS 2008 Notice
the making
this Statutory Instrument was published in “Iris Oifigiúil”
5th August, 2008. I, MARY COUGHLAN, Minister for Enterprise, Trade and Employment, in exercise
the powers conferred on me by section 3
the European Commun-ities Act 1972 (No. 27
1972), and for the purpose
giving effect to Council Regulation (EEC) No. 1768/92 1 , Regulation (EC) No. 1610/96 2 and Regulation (EC) No. 1901/2006 3 hereby make the following regulations:
1992” means the Patents Act 1992 (No. 1
1992), as amended by the Patents (Amendment) Act 2006 (No. 31
2006); “application for an extension
the duration” has the meaning assigned to it in Article 1(e)
the Medicinal Regulation as amended by Article 52
the Medicinal Products for Paediatric Use Regulation; “certificate” has the meaning assigned to it in Article 1(d)
the Medicinal Regulation; “Controller” means the Controller
Patents, Designs and Trade Marks; “Medicinal Products for Paediatric Use Regulation” means Regulation (EC) No. 1901/2006
the European Parliament and
the Council
12 December 2006 on medicinal products for paediatric use; “Medicinal Regulation” means Council Regulation (EEC) No. 1768/92
18 June 1992 concerning the creation
a supplementary protection certificate for medicinal products, as amended by Regulation (EC) No. 1901/2006
the European Parliament and
the Council
12 December 2006; “Plant Protection Regulation” means Regulation (EC) No. 1610/96
the European Parliament and
the Council
23 July 1996 concerning the creation
a supplementary protection certificate for plant protection products; “Regulations
1993” means the European Communities (Supplementary Protection Certificate) Regulations 1993 ( S.I. No. 125
1993 ). “Rules
1992” means the Patents Rules 1992 ( S.I. No. 179
1992 ).
a certificate in accordance with the Medicinal Regulation or the Plant Protection Regulation shall be made in the form set out in Schedule 1 and shall be accompanied by the fee prescribed in Schedule 3.
a certificate in accordance with the Medicinal Regulation or the Plant Protection Regulation shall be accompanied by the documents and information as appropriate, specified in paragraphs 1(b) and (c)
,
the corresponding Regulation.
the duration
a certificate in accordance with the Medicinal Regulation shall be made in the form set out in Schedule 2 and shall be accompanied by the fee prescribed in Schedule 3.
the duration
a certificate in accordance with the Medicinal Regulation shall be accompanied by the documents and information as appropriate, specified in paragraphs 1(b), (c) and (d)
that Regulation.
the duration
a supplementary protection certificate shall be in the form set out in Schedule 5. 4.
a certificate or an application for an extension
the duration
a certificate— (a) if the Controller notifies the applicant that it does not comply with a provision
these Regulations, the Medicinal Regulation or the Plant Protection Regulation, and the applicant, within 4 months from the date
the notification, fails to overcome the non-compliance or satisfy the Controller that the provision is complied with, or (b) if the prescribed fee remains unpaid on the expiry
one month from the date
a notification by the Controller that the fee has not been paid, the Controller shall refuse the request for the grant
a certificate or the application for an extension
the duration
a certificate.
a certificate or an application for an extension
the duration
a certificate may be reinstated in accordance with the provisions
the Rules
1992 as if, in the relevant Rule, there were substituted references to a request or an application for reference to an application for a patent. 5.
fice referred to in— (a) paragraph 1
the Medicinal Regulation, and (b) paragraph 1
the Plant Protection Regulation, shall be the Patents
fice.
a certificate or an application for an extension
the duration
a certificate shall be submitted to the Controller at thePatents
fice. 6.
an annual renewal fee, the amount
which said renewal fee shall be the same as that prescribed under the Rules
1992 in respect
the 20th year for renewal
a patent.
the Act
1992 and the Rules
1992 in relation to payment
patent renewal fees shall apply to renewal fees for certificates and extensions and shall operate in relation to certificates and extensions as if the term
the basic patent to which Article 8
the Medicinal or Plant Protection Regulation refers ran for a further period not exceeding the duration
the certificate or
its extension. 7. The provisions
the Act
1992 and the Rules
1992 relating to restoration
lapsed patents shall apply to certificates and extensions to certificates which have lapsed by reason
failure to pay any renewal fee. 8. The notifications referred to in the following provisions: (a) paragraphs 2 and 3
the Medicinal Regulation; (b) Article 11
the Medicinal Regulation; (c) Article 16
the Medicinal Regulation; (d) paragraphs 1 and 2
the Plant Protection Regulation; (e) paragraph 2
the Plant Protection Regulation; and (f) Article 16
the Plant Protection Regulation, shall be published in the Patents
fice Journal. 9.
Patents— (a) the fact that a request for the grant
a certificate has been filed, (b) the fact that a request for the grant
a certificate has been granted and the duration thereof, (c) rejection
a request for the grant
a certificate, (d) withdrawal
a request for the grant
a certificate, (e) payment
the annual renewal fee for a certificate, (f) lapse
a certificate through non-payment
a renewal fee or the reasons specified in paragraphs (b) and (d)
the Medicinal Regulation or the Plant Protection Regulation as appropriate, (g) the fact that a certificate which lapsed due to the non-payment
a renewal fee has been restored, (h) any termination
the grounds for lapse
a certificate as provided for under Article 14(d)
the Medicinal Regulation or the Plant Protection Regulation as appropriate, (i) the invalidity
a certificate as provided for under Article 15(a)
the Medicinal Regulation or Article 15
the Plant Protection Regulation as appropriate.
a certificate” includes an application for an extension
the duration
a certificate, “certificate” includes a certificate extended under these Regulations. 10. An application for a declaration
invalidity
a certificate or a certificate as extended under these Regulations may be made to the Controller or the High Court. 11. Wherever a procedure in relation to a certificate, a request for the grant
a certificate, a certificate as extended under these Regulations or an application for an extension
the duration
a certificate is not laid down in these Regulations, the Medicinal Regulation or the Plant Protection Regulation, the procedures
the Act
1992 and the Rules
1992 in relation to patents and patent applications shall, in the corresponding circumstances, apply. 12.
1992 in respect
any proceeding in relation to patents and patent applications shall (with the exception
the fee specified in Schedule 3) apply in the corresponding circumstances in relation to certificates, requests for the grant
certificates, certificates as extended under these Regulations and applications for extensions.
fees under these Regulations shall be made in accordance with Rule 89
the Rules
1992. 13.
1993 are revoked.
1993 that was in force immediately prior to the commencement
these Regulations shall, after the commencement
these Regulations, continue to operate as if it were a certificate under these Regulations. Regulation 3. SCHEDULE 1 REQUEST for the grant
a SUPPLEMENTARY PROTECTION CERTIFICATE The Applicant(
a Supplementary Protection Certificate on the basis
the information furnished hereunder: Medicinal Product Plant Protection Product
THE BASIC PATENT 3. TITLE
THE INVENTION 4. MARKET AUTHORISATION (i) The following information relates to the first authorisation to place the product, the subject
this request, on the market in Ireland:— Authorisation Number: Authorisation Date: Identity
product thus authorised: Legal provision under which such Authorisation took place: (
this request, on the market in the EU, please state:— Country which granted the first such Authorisation: Authorisation Number(s): Authorisation Date: Identity
product thus authorised: Legal provision under which such Authorisation took place: 5. PRODUCT IDENTITY (as defined in Article 1
Council Regulation (EEC) No. 1768/92 or Regulation (EC) No. 1610/96) (i) Product (i.e. active ingredient or combination
active ingredients) for which a certificate is requested: (
the authorisation specified in Article 8 1(b)
the corresponding Regulation in which the product is identified, containing in particular the number and date
the authorisation and the summary
the product characteristics listed in Article 4a
Directive 65/65/EEC, Article 5a
Directive 81/851/EEC or Article 4
Directive 91/414/EEC (iii) Where appropriate, the information and a copy
the notice specified in Article 8 l(c)
the corresponding Regulation. 7. AUTHORISED AGENT The following is authorised to act as agent in all proceedings connected with the obtaining
a supplementary protection certificate to which this request relates and in relation to any certificate granted: Name: Address: 8. ADDRESS FOR SERVICE (if different from that at item 7) Signed on behalf
Applicant(s): By: Date: (Note: this Request may be signed by the Applicant(s) or by the Agent authorised in connection with the basic patent. It may also be signed by another Agent provided an authorisation in favour
that Agent is submitted within 3 months after the filing
this Request). Regulation 3. SCHEDULE 2 APPLICATION for an EXTENSION
the DURATION
a SUPPLEMENTARY PROTECTION CERTIFICATE The Applicant(
an extension to the duration
a Supplementary Protection Certificate on the basis
the information furnished hereunder:
the SPC: (ii) where an SPC application no. has not yet been issued by the Patents
fice, any reference no. and the date upon which the relevant SPC application was made: 3. NUMBER
THE BASIC PATENT 4. TITLE
THE INVENTION 5. PRODUCT IDENTITY (as defined in Article 1
Council Regulation(EEC) No. 1768/92) Product (i.e. active ingredient or combination
active ingredients) for which a certificate is requested: 6. ITEMS ACCOMPANYING THIS REQUEST — tick as appropriate. (i) Request fee:- € (ii) Copy
the statement indicating compliance with an agreed completed paediatric investigation plan as referred to in Article 36
Regulation (EC) No. 1901/2006. (iii) Proof
authorisation(s) to place the product on the market
all Member States, as referred to in Article 36
Regulation (EC) No. 1901/
an extension
the duration
a supplementary protection certificate to which this request relates and in relation to any extension
the certificate granted: Name: Address: 8. ADDRESS FOR SERVICE (if different from that at item 7) Signed on behalf
Applicant(s): By: Date: (Note: this Request may be signed by the Applicant(s) or by the Agent authorised in connection with the basic patent. It may also be signed by another Agent provided an authorisation in favour
that Agent is submitted within 3 months after the filing
this Request). Regulation 3. SCHEDULE 3 Fee payable upon filing
a request for the grant
a certificate €95.00 Fee payable upon filing
an application for an extension
the duration
a certificate €95.00 Regulation 3. SCHEDULE 4 SUPPLEMENTARY PROTECTION CERTIFICATE Council Regulation (EEC) No. 1768/92 or Regulation (EC) No. 1610/96 In accordance with Article 10
the relevant Regulations above, Certificate no. ...................................... is granted to............................................................................ in respect
the product............................................................................. which is protected by patent no. ....................................which was granted for an invention entitled............................................................ This certificate will expire on.......................................... Dated this.....................day
......................20... Controller
Patents, Designs and Trade Marks Regulation 3. SCHEDULE 5 EXTENSION
THE DURATION
A SUPPLEMENTARY PROTECTION CERTIFICATE Council Regulation (EEC) No. 1768/92 as amended by Article 52
Regulation (EC) No. 1901/2006 In accordance with Article 10
the above Regulation, this Extension is granted to............................................................................................... in respect
the product........................................................ which is protected by patent no. ............................ which was granted for an invention entitled ....................................... ...................................................................................... and which has been granted a Supplementary Protection Certificate no. .............. in respect
the abovementioned product. This extension will expire on.......................................... Dated this.....................day
......................20... Controller
Patents, Designs and Trade Marks. GIVEN under my
ficial Seal, 25 July 2008 MARY COUGHLAN Minister for Enterprise, Trade and Employment. EXPLANATORY NOTE (This note is not part
the Instrument and does not purport to be a legal interpretation). These regulations lay down the fees and procedural requirements which apply to requests for supplementary protection certificates and to requests for extensions
the duration
supplementary protection certificates and to certificates granted and to extensions
the duration
certificates granted. The regulations are for the purpose
giving full effect to Council Regulation (EEC) No. 1768/92, Regulation (EC) No. 1610/96 and Regulation (EC) No. 1901/2006 concerning the creation
a supplementary protection certificate for medicinal products, and for plant protection products and the creation
an extension
the duration
a supplementary protection certificate for medicinal products for paediatric use with effect from 26th July 2008. (These regulations revoke the earlier Statutory Instrument No. 125
1993 concerning requests for and the grant
supplementary protection certificates. These regulations provide that a certificate issued under the Regulations
1993 and in force immediately prior to the entry into force
these regulations shall, after the commencement
these regulations continue to operate as if it were a certificate under these regulations). 1 O.J. No. L182,
02.07.1992, p. 1 2 O.J. No. L198,
08.08.1996, p. 30 3 O.J. No. L378,
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