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Regulation (EC) No 469/2009 of the European Parliament and of the Council

of 6 May 2009

concerning the supplementary protection certificate for medicinal products

(Codified version)

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and Social Committee(1),

Acting in accordance with the procedure laid down in Article 251 of the Treaty(2),

Whereas:

(1)Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products(3) has been substantially amended several times(4). In the interests of clarity and rationality the said Regulation should be codified.

(2)Pharmaceutical research plays a decisive role in the continuing improvement in public health.

(3)Medicinal products, especially those that are the result of long, costly research will not continue to be developed in the Community and in Europe unless they are covered by favourable rules that provide for sufficient protection to encourage such research.

(4)At the moment, the period that elapses between the filing of an application for a patent for a new medicinal product and authorisation to place the medicinal product on the market makes the period of effective protection under the patent insufficient to cover the investment put into the research.

(5)This situation leads to a lack of protection which penalises pharmaceutical research.

(6)There exists a risk of research centres situated in the Member States relocating to countries that offer greater protection.

(7)A uniform solution at Community level should be provided for, thereby preventing the heterogeneous development of national laws leading to further disparities which would be likely to create obstacles to the free movement of medicinal products within the Community and thus directly affect the functioning of the internal market.

(8)Therefore, the provision of a supplementary protection certificate granted, under the same conditions, by each of the Member States at the request of the holder of a national or European patent relating to a medicinal product for which marketing authorisation has been granted is necessary. A regulation is therefore the most appropriate legal instrument.

(9)The duration of the protection granted by the certificate should be such as to provide adequate effective protection. For this purpose, the holder of both a patent and a certificate should be able to enjoy an overall maximum of 15 years of exclusivity from the time the medicinal product in question first obtains authorisation to be placed on the market in the Community.

(10)All the interests at stake, including those of public health, in a sector as complex and sensitive as the pharmaceutical sector should nevertheless be taken into account. For this purpose, the certificate cannot be granted for a period exceeding five years. The protection granted should furthermore be strictly confined to the product which obtained authorisation to be placed on the market as a medicinal product.

(11)Provision should be made for appropriate limitation of the duration of the certificate in the special case where a patent term has already been extended under a specific national law,

HAVE ADOPTED THIS REGULATION:

Article 1Definitions

For the purposes of this Regulation, the following definitions shall apply:

(a)

‘medicinal product’ means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

(b)

‘product’ means the active ingredient or combination of active ingredients of a medicinal product;

(c)

‘basic patent’ means a patent which protects a product as such, a process to obtain a product or an application of a product, and which is designated by its holder for the purpose of the procedure for grant of a certificate;

(d)

‘certificate’ means the supplementary protection certificate;

(e)

‘application for an extension of the duration’ means an application for an extension of the duration of the certificate pursuant to Article 13(3) of this Regulation and regulation 58A(3) of the Human Medicines Regulations 2012 ;

(f)

‘comptroller’ means the Comptroller-General of Patents, Designs and Trade Marks;

(g)

‘court’ means—

(i)

as respects England and Wales, the High Court;

(ii)

as respects Scotland, the Court of Session;

(iii)

as respects Northern Ireland, the High Court in Northern Ireland;

(ga)

“Windsor Framework” means the part of the EU withdrawal agreement known as the Windsor Framework by virtue of Joint Declaration No. 1/2023 of 24 March 2023 made between the European Union and the United Kingdom in the Joint Committee established by the EU withdrawal agreement;

(h)

“EEA authorisation” means an authorisation to place a medicinal product on the market which has effect in an EEA state in accordance with Directive 2001/83/EC, Directive 2001/82/EC or Regulation (EU) 2019/6;

(i)

‘patent’ means a patent which has effect in the United Kingdom;

(j)

‘UK authorisation’ means, in relation to a product, an authorisation to place that product on the market in the United Kingdom as a medicinal product granted or having effect as if granted in accordance with—

(i)

Part 5 of the Human Medicines Regulations 2012; or

(ii)

regulation 4(3) of, and Schedule 1 to, the Veterinary Medicines Regulations 2013.

(ja)

“GB authorisation” means, in relation to a product, an authorisation to place that product on the market in England and Wales and Scotland as a medicinal product granted or having effect as if granted in accordance with—

(i)

Part 5 of the Human Medicines Regulations 2012; or

(ii)

regulation 4(3) of, and Schedule 1 to, the Veterinary Medicines Regulations 2013 as they have effect in England and Wales and Scotland;

(jaa)

“transitioned-UK authorisation” means a GB authorisation for a medicinal product in force immediately before 1 January 2025 which, pursuant to Schedule 33B to the Human Medicines Regulations 2012 , has effect on and after that date as a UK authorisation;

(jb)

“NI authorisation” means, in relation to a product, an authorisation to place that product on the market in Northern Ireland as a medicinal product granted or having effect as if granted in accordance with Directive 2001/83/EC, Directive 2001/82/EC or Regulation (EU) 2019/6 as they have effect by virtue of the Windsor Framework;

(jc)

“former NI authorisation” means a NI authorisation for a medicinal product for human use that is prohibited from being placed on the market in Northern Ireland by Article 4(1) of Regulation (EU) 2023/1182 of the European Parliament and of the Council of 14 June 2023 on specific rules relating to medicinal products for human use intended to be placed on the market in Northern Ireland and amending Directive 2001/83/EC;

(k)

‘maker’ means the person, established in the United Kingdom, on whose behalf the making of a product, or a medicinal product containing that product, for the purpose of export to ... countries outside the United Kingdom, the Isle of Man and the Member States of the European Union or for the purpose of storing, is carried out.

(l)

“prescribed” means prescribed by rules under section 123 of the Patents Act 1977.

Article 2Scope

A product may, under the terms and conditions provided for in this Regulation, be the subject of a certificate if it is—

(a)protected by a patent; and

(b)the subject of a UK , GB or NI authorisation prior to being placed on the market as a medicinal product.

Article 3Conditions for obtaining a certificate

Where an application is submitted under Article 7, a certificate shall be granted if, at the date of submission of that application—

(a)

the product is protected by a basic patent in force;

(b)

there is a valid UK, GB or NI authorisation to place the product on the market;

(c)

the product has not already been the subject of a certificate;

(d)

the authorisation referred to in point (b) is the first UK, GB or NI authorisation to place the product on the market as a medicinal product in the territory of the United Kingdom, the territory of England and Wales and Scotland or the territory of Northern Ireland as the case may be.

Article 4Subject matter of protection

Within the limits of the protection conferred by the basic patent, the protection conferred by a certificate shall extend only to the product covered by the UK, GB or NI authorisation to place the corresponding medicinal product on the market and for any use of the product as a medicinal product that has been authorised in the United Kingdom before the expiry of the certificate.

Article 5Effects of the certificate

1.Subject to the provisions of Article 4 and paragraphs 1a and 1b, the certificate shall confer the same rights as conferred by the basic patent and shall be subject to the same limitations and the same obligations.

1a.The protection conferred by a certificate in accordance with paragraph 1 shall extend only to the territory in respect of which a valid, UK, GB or NI authorisation has been issued and where the authorisation—

(a)is the first authorisation for the product in the territory in accordance with Article 3(b) and (d), and

(b)has been issued before the certificate takes effect in accordance with Article 13(1).

1b.Where after the submission of an application for a certificate in accordance with Article 7(1) or (2) and before the certificate takes effect in accordance with Article 13(1), a UK, GB or NI authorisation is granted in respect of the same product and the authorisation would have met the requirements of Article 3(b) and (d) had it been granted on the date of submission of the application, the protection conferred by a certificate in accordance with paragraph 1 shall extend to the territory of the United Kingdom, the territory of England and Wales and Scotland or the territory of Northern Ireland as the case may be.

1c.Where after the submission of an application for a certificate in accordance with Article 7(1) or (2) in respect of a GB authorisation and before the certificate takes effect in accordance with Article 13(1), that authorisation becomes a transitioned-UK authorisation, the protection conferred by a certificate in accordance with paragraph 1 shall extend to the territory of England and Wales, Scotland and Northern Ireland.

2.By way of derogation from paragraph 1, the certificate referred to in paragraph 1 shall not confer protection against certain acts which would otherwise require the consent of the holder of the certificate (‘the certificate holder’), if the following conditions are met:

(a)the acts comprise:

(i)

the making of a product, or a medicinal product containing that product, for the purpose of export to ... countries outside the United Kingdom, the Isle of Man and the Member States of the European Union; or

(ii)

any related act that is strictly necessary for the making, in the United Kingdom, referred to in point (i), or for the actual export; or

(iii)

the making, no earlier than six months before the expiry of the certificate, of a product, or a medicinal product containing that product, for the purpose of storing it in the United Kingdom, in order to place that product, or a medicinal product containing that product, on the market of the United Kingdom, the Isle of Man or one or more Member States of the European Union after the expiry of the corresponding certificate; or

(iv)

any related act that is strictly necessary for the making, in the United Kingdom, referred to in point (iii), or for the actual storing, provided that such related act is carried out no earlier than six months before the expiry of the certificate.

(b)the maker, through appropriate and documented means, notifies the comptroller, and informs the certificate holder, of the information listed in paragraph 5 of this Article no later than three months before the start date of the making in the United Kingdom, or no later than three months before the first related act, prior to that making, that would otherwise be prohibited by the protection conferred by thatcertificate, whichever is the earlier;

(c)if the information listed in paragraph 5 of this Article changes, the maker notifies the comptroller and informs the certificate holder, before those changes take effect;

(d)in the case of products, or medicinal products containing those products, made for the purpose of export to ... countries outside the United Kingdom, the Isle of Man and the Member States of the European Union, the maker ensures that the words ‘UK export’ are affixed so as to be sufficiently clear and visible to the naked eye to the outer packaging of the product, or the medicinal product containing that product, referred to in point (a)(i) of this paragraph, and, where feasible, to its immediate packaging;

(e)the maker complies with paragraph 9 of this Article ....

3.The exception referred to in paragraph 2 shall not apply to any act or activity carried out for the import of products, or medicinal products containing those products, into the United Kingdom merely for the purpose of repackaging, re-exporting or storing.

4.The information provided to the certificate holder for the purposes of points (b) and (c) of paragraph 2 shall be used exclusively for the purposes of verifying whether the requirements of this Regulation have been met and, where applicable, initiating legal proceedings for non-compliance.

5.The information to be provided by the maker for the purposes of point (b) of paragraph 2 shall be as follows:

(a)the name and address of the maker;

(b)an indication of whether the making is for the purpose of export, for the purpose of storing, or for the purpose of both export and storing;

(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(d)the number of the certificate...; and

(e)for medicinal products to be exported to ... countries outside the United Kingdom, the Isle of Man and the Member States of the European Union, the reference number of the marketing authorisation, or the equivalent of such authorisation, in each ... country of export, as soon as it is publicly available.

6.For the purposes of notification to the comptroller under points (b) and (c) of paragraph 2, the maker shall use the standard prescribed form ....

7.Failure to comply with the requirements of point (e) of paragraph 5 with regard to a ... country outside the United Kingdom, the Isle of Man and the Member States of the European Union shall only affect exports to that country, and those exports shall, therefore, not benefit from the exception.

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9.The maker shall ensure, through appropriate and documented means, that any person in a contractual relationship with the maker who performs acts falling under point (a) of paragraph 2 is fully informed and aware of the following:

(a)that those acts are subject to paragraph 2;

(b)that the placing on the market, import or re-import of the product, or the medicinal product containing that product, referred to in point (a)(i) of paragraph 2 or the placing on the market of the product, or the medicinal product containing that product, referred to in point (a)(iii) of paragraph 2 could infringe the certificate referred to in paragraph 2 where, and for as long as, that certificate applies.

10.Paragraph 2 shall apply to certificates that are applied for on or after 1 July 2019.

Paragraph 2 shall also apply to certificates that have been applied for before 1 July 2019 and that take effect on or after that date. Paragraph 2 shall only apply to such certificates from 2 July 2022.

Paragraph 2 shall not apply to certificates that take effect before 1 July 2019.

11.The Secretary of State may by regulations make further provision as to the manner and form (including design and colour) of affixing the words “UK export” to the outer packaging of the product, or the medicinal product containing that product, referred to in paragraph 2(a)(i) of this Article, and, where feasible, to its immediate packaging.

12Those regulations are to be made by statutory instrument which is subject to annulment pursuant to a resolution of either House of Parliament.

Article 6Entitlement to the certificate

The certificate shall be granted to the holder of the basic patent or his successor in title.

Article 7Application for a certificate

1.The application for a certificate shall be lodged within six months of the date on which the UK, GB or NI authorisation referred to in Article 3(b) and (d) to place the product on the market as a medicinal product was granted.

Where more than one such authorisation is granted before the application for a certificate is lodged, the application shall be lodged within six months of the date of grant of the earliest of such authorisations.

2.Notwithstanding paragraph 1, where the authorisation to place the product on the market is granted before the basic patent is granted, the application for a certificate shall be lodged within six months of the date on which the patent is granted.

2a.Where an application for a certificate lodged before 1 January 2025 in accordance with paragraph 1 or 2 contains a NI authorisation granted pursuant to Regulation (EU) 2019/6, that authorisation shall be treated on and after 1 January 2025 as if it were a valid NI authorisation for the purpose of Article 3(b) and (d) at the time the application was lodged.

3.The application for an extension of the duration may be made when lodging the application for a certificate or when the application for the certificate is pending and the appropriate requirements of Article 8(1)(d) or Article 8(2), respectively, are fulfilled.

4.The application for an extension of the duration of a certificate already granted shall be lodged not later than two years before the expiry of the certificate.

5.Notwithstanding paragraph 4, for five years following the entry into force of Regulation (EC) No 1901/2006, the application for an extension of the duration of a certificate already granted shall be lodged not later than six months before the expiry of the certificate.

Article 8Content of the application for a certificate

1.The application for a certificate shall contain:

(a)a request for the grant of a certificate, stating in particular:

(i)

the name and address of the applicant;

(ii)

if the applicant has appointed a representative, the name and address of the representative;

(iii)

the number of the basic patent and the title of the invention;

(iv)

the number and date of the UK, GB or NI authorisation, or where there is more than one such authorisation, of each authorisation as referred to in Article 3(b) and (d);

(v)

the number and date of the earliest of any EEA authorisation, the granting of which predates the granting of the UK , GB or NI authorisation as referred to in Article 3(b) and (d);

(b)a copy of the UK, GB or NI authorisation or, where there is more than one such authorisation, of each authorisation to place the product on the market, as referred to in Article 3(b) and (d), in which the product is identified, containing in particular the number and date of the authorisation and the summary of the product characteristics listed in Article 11 of Directive 2001/83/EC, Article 14 of Directive 2001/82/EC, Article 35 of Regulation (EU) 2019/6, Part 2 to Schedule 8 of the Human Medicines Regulations 2012 or Part 1 of Schedule 1 to the Veterinary Medicines Regulations 2013;

(c)where the product is the subject of one or more EEA authorisations granted prior to the UK, GB or NI authorisation referred to in Article 3(b) and (d), the applicant must provide in relation to the earliest of any such EEA authorisations—

(i)information regarding the identity of the product thus authorised;

(ii)information regarding the legal provision under which the authorisation procedure took place; and

(iii)a copy of the notice publishing the authorisation in the appropriate official publication;

(d)where the application for a certificate includes a request for an extension of the duration:

(i)

a copy of the statement indicating compliance with an agreed completed paediatric investigation plan as referred to in regulation 58A(2)(a) of the Human Medicines Regulations 2012 ;

(ii)

details of the territory in respect of which the statement referred to in sub-paragraph (i) has been made.

2.Where an application for a certificate is pending, an application for an extended duration in accordance with Article 7(3) shall include the particulars referred to in paragraph 1(d) of this Article and a reference to the application for a certificate already filed.

3.The application for an extension of the duration of a certificate already granted shall contain the particulars referred to in paragraph 1(d) and a copy of the certificate already granted.

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Article 9Lodging of an application for a certificate

1.An application for a certificate (or an extension of the duration of a certificate) shall be lodged with the comptroller.

2.Notification of the application for a certificate shall be published by the comptroller . The notification shall contain at least the following information:

(a)the name and address of the applicant;

(b)the number of the basic patent;

(c)the title of the invention;

(d) the number and date of the UK, GB or NI authorisation or, where there is more than one such authorisation, each authorisation provided under Article 8(1)(b), the product identified in the authorisation or each authorisation and the territory in respect of which the authorisation has been granted or has effect as if granted;

(e)where there are authorisations granted in the EEA before any UK, GB or NI authorisation provided under Article 8(1)(b), the number and date of the earliest EEA authorisation;

(f)where applicable, an indication that the application includes an application for an extension of the duration.

(g)where an indication is given in accordance with sub-paragraph (f), details of the territory in respect of which an extension has been applied for.

3.Paragraph 2 shall apply to the notification of the application for an extension of the duration of a certificate already granted or where an application for a certificate is pending. The notification shall additionally contain an indication of the application for an extended duration of the certificate.

Article 10Grant of the certificate or rejection of the application for a certificate

1.Where the application for a certificate and the product to which it relates meet the conditions laid down in this Regulation, the comptroller shall grant the certificate.

2.The comptroller shall, subject to paragraph 3, reject the application for a certificate if the application or the product to which it relates does not meet the conditions laid down in this Regulation or any prescribed fee is not paid .

3.Where the application for a certificate does not meet the conditions laid down in Article 8 or the prescribed fee relating to the application has not been paid , the comptroller shall ask the applicant to rectify the irregularity, or to settle the fee, within a stated time.

4.If the irregularity is not rectified or the fee is not settled under paragraph 3 within the stated time, the comptroller shall reject the application.

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6.Paragraphs 1 to 4 shall apply mutatis mutandis to the application for an extension of the duration.

Article 11Publication

1.Notification of the fact that a certificate has been granted shall be published by the comptroller . The notification shall contain at least the following information:

(a)the name and address of the holder of the certificate;

(b)the number of the basic patent;

(c)the title of the invention;

(d)the number and date of the UK, GB or NI authorisation or, where there is more than one such authorisation, of each authorisation provided under Article 8(1)(b) or Article 13A(1), the product identified in the authorisation and the territory in respect of which the authorisation has been granted or has effect as if granted;

(e)where there are EEA authorisations granted before any UK, GB or NI authorisation provided under Article 8(1)(b), the number and date of the earliest EEA authorisation;

(f)the duration of the certificate.

2.Notification of the fact that the application for a certificate has been rejected shall be published by the comptroller . The notification shall contain at least the information listed in Article 9(2).

3.Paragraphs 1 and 2 shall apply to the notification of the fact that an extension of the duration of a certificate has been granted or of the fact that the application for an extension has been rejected.

3a.Where notification is made that an extension of the duration of a certificate has been granted, the notification shall specify the territory in respect of which the extension has been granted.

4.The comptroller shall publish, as soon as possible, the information listed in Article 5(5), together with the date of notification of that information. The comptroller shall also publish, as soon as possible, any changes to the information notified in accordance with point (c) of Article 5(2).

Article 12 Fees

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Article 13Duration of the certificate

1.The certificate shall take effect at the end of the lawful term of the basic patent for a period equal to the period which elapsed between the date on which the application for a basic patent was lodged and the date of the first authorisation to place the product on the market in the area comprising the European Economic Area and the United Kingdom , reduced by a period of five years.

2.Notwithstanding paragraph 1, the duration of the certificate may not exceed five years from the date on which it takes effect.

3.The periods laid down in paragraphs 1 and 2 shall be extended by six months in the case where regulation 58A of the Human Medicines Regulations 2012 applies. In that case, the duration of the period laid down in paragraph 1 of this Article may be extended only once.

4.Where a certificate is granted for a product protected by a patent which, before 2 January 1993, had its term extended or for which such extension was applied for, under national law, the term of protection to be afforded under this certificate shall be reduced by the number of years by which the term of the patent exceeds 20 years.

5.An extension of the duration of a certificate in accordance with paragraph 3 in respect of—

(a)a UK authorisation shall apply in the United Kingdom,

(b)a GB authorisation shall apply in only England and Wales and Scotland, and

(c)a NI authorisation shall apply in Northern Ireland only,

on condition that the territorial protection conferred by the extension does not exceed that conferred by the certificate.

Article 13AAuthorisation granted after submission of an application for a certificate

1.Where after the date of submission of an application under Article 7(1) or (2), but before the grant of a certificate under Article 10(1) in relation to a NI authorisation, a valid UK or GB authorisation is granted which, at its date of grant, is the first authorisation to place the product on the market as a medicinal product in the territory of the United Kingdom or the territory of England and Wales and Scotland as the case may be, the applicant shall notify the comptroller of the grant of the authorisation, within six months of its date of grant and before the certificate takes effect under Article 13(1), and provide the details set out in Article 8(1)(a)(iv) and (b) on the prescribed form.

2.Where after the submission of an application under Article 7(1) or (2), but before the grant of a certificate under Article 10(1) in relation to a UK or GB authorisation, a valid NI authorisation is granted which, at its date of grant, is the first authorisation to place the product on the market as a medicinal product in the territory of Northern Ireland, the applicant shall notify the comptroller of the grant of the authorisation, within six months of its date of grant and before the certificate takes effect under Article 13(1), and provide the details set out in Article 8(1)(a)(iv) and (b) on the prescribed form.

3.Where after the grant of a certificate under Article 10(1) in relation to a UK or GB authorisation, but before expiry of the basic patent, a valid NI authorisation is granted which, at its date of grant, is the first authorisation to place the product on the market as a medicinal product in the territory of Northern Ireland, the certificate holder shall notify the comptroller of the grant of the authorisation, within six months of its date of grant and before the certificate takes effect under Article 13(1), and provide the details set out in Article 8(1)(a)(iv) and (b) on the prescribed form.

4.Where after the grant of a certificate under Article 10(1) in relation to a NI authorisation, but before expiry of the basic patent, a valid UK or GB authorisation is granted which, at its date of grant, is the first authorisation to place the product on the market as a medicinal product in the territory of the United Kingdom or the territory of England and Wales and Scotland as the case may be, the certificate holder shall notify the comptroller of the grant of the ... authorisation, within six months of its date of grant and before the certificate takes effect under Article 13(1), and provide the details set out in Article 8(1)(a)(iv) and (b) on the prescribed form.

5.If the applicant or the certificate holder fails to notify the comptroller of the grant of an authorisation in accordance with paragraph 1, 2, 3 or 4 the protection conferred by a certificate granted under Article 10 shall not extend to any additional territory covered by that authorisation.

6.On receipt of a notification under any of paragraphs 1 to 4, the comptroller shall publish:

(a)the number and date of the authorisation,

(b)the product identified in that authorisation, and

(c)the territory in respect of which the authorisation has been granted or has effect as if granted.

Article 13BExtension of the duration of a certificate

1.Where after an application for an extension of the duration of a certificate in accordance with Article 7(3) or (4) has been made in respect of a GB authorisation, but before the application is granted, an application is also made for an extension of the duration of the certificate in respect of a NI authorisation in accordance with Article 7(3) or (4), the duration of the certificate, if the extension is granted, shall be extended in accordance with Article 13(3) and (5) to include the territory of Northern Ireland.

2.Where after an application for an extension of the duration of a certificate in accordance with Article 7(3) or (4) has been made in respect of a NI authorisation, but before the application is granted, an application is also made for an extension of the duration of the certificate in respect of a UK orGB authorisation in accordance with Article 7(3) or (4), the duration of the certificate shall be extended in accordance with Article 13(3) and (5) to include the territory of England and Wales and Scotland.

2a.Where after an application for an extension of the duration of a certificate in accordance with Article 7(3) or (4) has been made in respect of a GB authorisation, but before the application is granted, the GB authorisation becomes a transitioned-UK authorisation, the duration of the certificate if the extension is granted shall be extended in accordance with Article 13(3) and (5) to include the territory of England and Wales, Scotland and Northern Ireland.

3.Where after the grant in accordance with Article 10(6) of an application for an extension of the duration of a certificate in respect of a GB authorisation, an application is made, in accordance with Article 7(4), for an extension of the certificate in respect of a NI authorisation, the duration of the certificate shall be extended in accordance with Article 13(3) and (5) to include the territory of Northern Ireland.

4.Where after the grant, in accordance with Article 10(6) of an application for an extension of the duration of a certificate in respect of a NI authorisation, an application is made, in accordance with Article 7(4), for an extension of the certificate in relation to a UK orGB authorisation, the duration of the certificate shall be extended in accordance with Article 13(3) and (5) to include the territory of England and Wales and Scotland.

5.Where after the grant, in accordance with Article 10(6), of an application for an extension of the duration of a certificate in respect of a GB authorisation, the authorisation becomes a transitioned-UK authorisation, the duration of the certificate shall be extended in accordance with Article 13(3) and (5) to include the territory of England and Wales, Scotland and Northern Ireland.

Article 14Expiry of the certificate

1.The certificate shall lapse:

(a)

at the end of the period provided for in Article 13;

(b)

if the certificate holder surrenders it;

(c)

if the prescribed annual fee is not paid in time; or

(d)

if and as long as the product covered by the certificate may no longer be placed on the market following the withdrawal of all UK, GB and NI authorisations to place on the market. The comptroller may decide on the lapse of the certificate either of the comptroller's own motion or at the request of a third party.

2.Where a UK authorisation is withdrawn and replaced simultaneously with a GB authorisation and a NI authorisation, the certificate granted in respect of the UK authorisation shall not lapse.

3.Where a UK, GB or NI authorisation is withdrawn, but one or more such authorisations remain valid, the protection conferred by the certificate shall, as from the date of withdrawal, no longer extend to the territory covered by the authorisation withdrawn but shall continue in respect of the territory covered by any remaining authorisation.

Article 15Invalidity of the certificate

1.The certificate shall be invalid if:

(a)it was granted contrary to the provisions of Article 3;

(b)the basic patent has lapsed before its lawful term expires;

(c)the basic patent is revoked or limited to the extent that the product for which the certificate was granted would no longer be protected by the claims of the basic patent or, after the basic patent has expired, grounds for revocation exist which would have justified such revocation or limitation.

2.Any person may submit an application or bring an action for a declaration of invalidity of the certificate before the comptroller or the court .

Article 16Revocation of an extension of the duration

1.The extension of the duration may be revoked if it was granted contrary to the provisions of regulation 58A(3) of the Human Medicines Regulations 2012 .

2.Any person may submit an application for revocation of the extension of the duration to the comptroller or the court .

Article 17Notification of lapse or invalidity

1.If the certificate lapses in accordance with point (b), (c) or (d) of Article 14 (1) , or is invalid in accordance with Article 15, or if the territorial extent of the certificate is limited in accordance with Article 14(3), notification thereof shall be published by the comptroller .

2.If the extension of the duration is revoked in accordance with Article 16, notification thereof shall be published by the comptroller .

Article 18Appeals

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 19Procedure

1.In the absence of procedural provisions in this Regulation, the procedural provisions applicable to the corresponding basic patent (as modified by section 128B of, and Schedule 4A to, the Patents Act 1977) shall apply to the certificate.

2.Notwithstanding paragraph 1, the procedure for opposition to the granting of a certificate shall be excluded.

Article 19ATransitional provisions

Annex III contains transitional provisions concerning the implementation of the Windsor Framework that apply to applications and certificates in relation to medicinal products for human use.

Article 20Additional provisions relating to the enlargement of the Community

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 21Transitional provisions

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 21a Evaluation

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 22Repeal

Regulation (EEC) No 1768/92, as amended by the acts listed in Annex I, is repealed.

References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex II.

Article 23Entry into force

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

...

ANNEX I

REPEALED REGULATION WITH LIST OF ITS SUCCESSIVE AMENDMENTS

(referred to in Article 22)

Council Regulation (EEC) No 1768/92

(OJ L 182, 2.7.1992, p. 1)

Annex I, point XI.F.I, of the 1994 Act of Accession

(OJ C 241, 29.8.1994, p. 233)

Annex II, point 4.C.II, of the 2003 Act of Accession

(OJ L 236, 23.9.2003, p. 342)

Annex III, point 1.II, of the 2005 Act of Accession

(OJ L 157, 21.6.2005, p. 56)

Regulation (EC) No 1901/2006 of the European Parliament and of the Council

(OJ L 378, 27.12.2006, p. 1)

Only Article 52

ANNEX -I. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

ANNEX -Ia

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

ANNEX II

CORRELATION TABLE

Regulation (EEC) No 1768/92This Regulation
—Recital 1
Recital 1Recital 2
Recital 2Recital 3
Recital 3Recital 4
Recital 4Recital 5
Recital 5Recital 6
Recital 6Recital 7
Recital 7Recital 8
Recital 8Recital 9
Recital 9Recital 10
Recital 10—
Recital 11—
Recital 12—
Recital 13Recital 11
Article 1Article 1
Article 2Article 2
Article 3, introductory wordingArticle 3, introductory wording
Article 3, point (a)Article 3, point (a)
Article 3, point (b), first sentenceArticle 3, point (b)
Article 3, point (b), second sentence—
Article 3, points (c) and (d)Article 3, points (c) and (d)
Articles 4 to 7Articles 4 to 7
Article 8(1)Article 8(1)
Article 8(1a)Article 8(2)
Article 8(1b)Article 8(3)
Article 8(2)Article 8(4)
Articles 9 to 12Articles 9 to 12
Article 13(1), (2) and (3)Article 13(1), (2) and (3)
Articles 14 and 15Articles 14 and 15
Article 15aArticle 16
Articles 16, 17 and 18Articles 17, 18 and 19
Article 19—
Article 19a, introductory wordingArticle 20, introductory wording
Article 19a, point (a), points (i) and (ii)Article 20, point (b), introductory wording, points (i) and (ii)
Article 19a, point (b)Article 20, point (c)
Article 19a, point (c)Article 20, point (d)
Article 19a, point (d)Article 20, point (e)
Article 19a, point (e)Article 20, point (f)
Article 19a, point (f)Article 20, point (g)
Article 19a, point (g)Article 20, point (h)
Article 19a, point (h)Article 20, point (i)
Article 19a, point (i)Article 20, point (k)
Article 19a, point (j)Article 20, point (l)
Article 19a, point (k)Article 20, point (a)
Article 19a, point (l)Article 20, point (j)
Article 20Article 21
Article 21—
Article 22Article 13(4)
—Article 22
Article 23Article 23
—Annex I
—Annex II

Article 19A

ANNEX IIITransitional provisions in relation to applications and certificates for medicinal products for human use concerning the implementation of the Windsor Framework

1.New applications

(1)

This paragraph applies to applications lodged under Article 7 on or after 1 January 2025.

(2)

For applications lodged in accordance with Article 7(1)—

(a)

a NI authorisation under Article 3(b) and Article 3(d) includes a former NI authorisation granted as a NI authorisation during the period commencing on 1 July 2024 and ending on 31 December 2024; and

(b)

any certificate granted under Article 10 in relation to a former NI authorisation of the type referred to in sub-paragraph (a) shall only have effect if a UK authorisation for the same product has been notified to the comptroller in accordance with Article 13A or a copy of such a UK authorisation is contained in the application.

(3)

For applications lodged in accordance with Article 7(2), a former NI authorisation that was granted as a NI authorisation for the product specified in the application shall not be considered, for the purpose of Article 3(d), to be the first authorisation to place the product on the market as a medicinal product in the territory of the United Kingdom.

2.Certificates in effect in Northern Ireland

Where a certificate granted solely on the basis of a NI authorisation was in effect before 1 January 2025, and a GB authorisation for the same product—

(a)

was granted on or after the date on which the certificate took effect but before 1 January 2025,

(b)

is in effect on or before 31 December 2024 but a valid notification has not been made to the comptroller in accordance with Article 13A, and

(c)

becomes a transitioned-UK authorisation,

the certificate shall continue, on and after 1 January 2025, to have effect solely in the territory of Northern Ireland on the basis of the transitioned-UK authorisation for that product.

3.Notification of authorisations

For the purposes of Article 13A, the applicant or the certificate holder—

(a)

shall notify the comptroller of the grant of a NI authorisation granted before 1 January 2025 in accordance with paragraphs 2 and 3 of Article 13A notwithstanding that it becomes a former NI authorisation on and after 1 January 2025;

(b)

shall not be required to notify the comptroller where before the certificate takes effect a GB authorisation becomes a transitioned-UK authorisation.

4.Lapse or withdrawal of certificates

For the purposes of Article 14—

(a)

where a NI authorisation in respect of a product becomes a former NI authorisation and a GB authorisation for the same product becomes a transitioned-UK authorisation, a certificate based upon the NI and GB authorisations before 1 January 2025 shall not lapse;

(b)

any reference to the withdrawal of a NI authorisation under Article 14 includes a case where a NI authorisation becomes a former NI authorisation, and in such a case, the authorisation shall be treated as being withdrawn in relation to the territory of Northern Ireland on 1 January 2025.

5.Paediatric extensions

(1)

This paragraph applies to—

(a)

an application for an extension of the duration of a certificate, lodged in accordance with Article 7(3) or (4) but not determined before 1 January 2025; and

(b)

an extension of the duration of a certificate granted in accordance with Article 10—

(i)

before 1 January 2025; or

(ii)

on or after 1 January 2025, pursuant to an application falling within sub-paragraph (a).

(2)

Where this paragraph applies, regulation 58A(3) of the Human Medicines Regulations 2012 applies without the amendments made by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024.

(3)

This paragraph applies only to an application for an extension of the duration of a certificate which has not been determined before 1 January 2025 where—

(a)

the condition set out in sub-paragraph (a) or (b) in regulation 58A(3) of the Human Medicines Regulations 2012 was met before 1 January 2025; or

(b)

the period for lodging an application for an extension of the duration of a certificate in Article 7(4) expires before 1 January 2025.

(2)

Opinion of the European Parliament of 21 October 2008 (not yet published in the Official Journal) and Council Decision of 6 April 2009.

(4)

See Annex I.

(2)

Opinion of the European Parliament of 21 October 2008 (not yet published in the Official Journal) and Council Decision of 6 April 2009.

(4)

See Annex I.

Status: There are currently no known outstanding effects by UK legislation for Regulation (EC) No 469/2009 of the European Parliament and of the Council.
Regulation(EC) No 469/2009of the European Parliament and of the Council (2009/469)

Displaying information

Status of this instrument

footnotecommentarytransitional and savingsin force statusrelated provisionsgeo extentinsert/omitsource countin force adj
F1Words in Art. 1(e) substituted (31.12.2020) by The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801), regs. 1, 52(2) (with reg. 69) (as amended by S.I. 2020/1050, regs. 1(2), 37); 2020 c. 1, Sch. 5 para. 1(1)this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary.substituted
F2Art. 1(f)-(j) inserted (31.12.2020) by The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801), regs. 1, 52(3) (as amended by S.I. 2020/1471, reg. 3(3) and S.I. 2020/1050, reg. 34(a)(b)); 2020 c. 1, Sch. 5 para. 1(1)inserted
F3Art. 1(ga) inserted (1.1.2025) by The Supplementary Protection Certificates (Amendments Relating to the Windsor Framework) Regulations 2024 (S.I. 2024/1075), regs. 1(1), 3(a)inserted
F4Words in Art. 1(h) substituted (1.1.2025) by The Supplementary Protection Certificates (Amendments Relating to the Windsor Framework) Regulations 2024 (S.I. 2024/1075), regs. 1(1), 3(b)substituted
F5Art. 1(ja)(jb) inserted (31.12.2020) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), reg. 1(2), Sch. para. 11(a) (with reg. 7)this amendment (text inserted) should be read in conjunction with other related provisions, see the commentary.inserted
F6Art. 1(jaa) inserted (1.1.2025) by The Supplementary Protection Certificates (Amendments Relating to the Windsor Framework) Regulations 2024 (S.I. 2024/1075), regs. 1(1), 3(c)inserted
F7Words in Art. 1(jb) substituted (1.1.2025) by The Supplementary Protection Certificates (Amendments Relating to the Windsor Framework) Regulations 2024 (S.I. 2024/1075), regs. 1(1), 3(d)substituted
F8Art. 1(jc) inserted (1.1.2025) by The Supplementary Protection Certificates (Amendments Relating to the Windsor Framework) Regulations 2024 (S.I. 2024/1075), regs. 1(1), 3(e)inserted
F9Art. 1(f) renumbered as Art. 1(k) (31.12.2020) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 2(d) (with reg. 43)this amendment (text renumbered) should be read in conjunction with other related provisions, see the commentary.renumbered
F10Inserted by Regulation (EU) 2019/933 of the European Parliament and of the Council of 20 May 2019 amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products (Text with EEA relevance).
F10Inserted by Regulation (EU) 2019/933 of the European Parliament and of the Council of 20 May 2019 amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products (Text with EEA relevance).
F11Words in Art. 1 substituted (31.12.2020) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 2(a) (with reg. 43)this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary.substituted
F12Word in Art. 1 omitted (31.12.2020) by virtue of The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 2(b) (with reg. 43)this amendment (text omitted) should be read in conjunction with other related provisions, see the commentary.omitted
F13Words in Art. 1 inserted (31.12.2020) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 2(c) (with reg. 43)this amendment (text inserted) should be read in conjunction with other related provisions, see the commentary.inserted
F14Art. 1(l) inserted (31.12.2020) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), reg. 1(2), Sch. para. 11(b) (with reg. 7)this amendment (text inserted) should be read in conjunction with other related provisions, see the commentary.inserted
F15Art. 2 substituted (31.12.2020) by The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801), regs. 1, 54 (as amended by S.I. 2020/1471, regs. 1(2), 3(4)); 2020 c. 1, Sch. 5 para. 1(1)substituted
F16Art. 3 substituted (31.12.2020) by The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801), regs. 1, 54 (as amended by S.I. 2020/1471, regs. 1(2), 3(5)); 2020 c. 1, Sch. 5 para. 1(1)substituted
F17Words in Art. 4 inserted (31.12.2020) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), reg. 1(2), Sch. para. 12(a) (with reg. 7)this amendment (text inserted) should be read in conjunction with other related provisions, see the commentary.inserted
F18Words in Art. 4 inserted (31.12.2020) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), reg. 1(2), Sch. para. 12(b) (with reg. 7)this amendment (text inserted) should be read in conjunction with other related provisions, see the commentary.inserted
F19Substituted by Regulation (EU) 2019/933 of the European Parliament and of the Council of 20 May 2019 amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products (Text with EEA relevance).
F20Words in Art. 5(1) inserted (31.12.2020) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), reg. 1(2), Sch. para. 13(a) (with reg. 7)this amendment (text inserted) should be read in conjunction with other related provisions, see the commentary.inserted
F21Art. 5(1a)(1b) inserted (31.12.2020) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), reg. 1(2), Sch. para. 13(b) (with reg. 7)this amendment (text inserted) should be read in conjunction with other related provisions, see the commentary.inserted
F22Word in Art. 5(1b) inserted (1.1.2025) by The Supplementary Protection Certificates (Amendments Relating to the Windsor Framework) Regulations 2024 (S.I. 2024/1075), regs. 1(1), 4(a)inserted
F23Words in Art. 5(1b) inserted (1.1.2025) by The Supplementary Protection Certificates (Amendments Relating to the Windsor Framework) Regulations 2024 (S.I. 2024/1075), regs. 1(1), 4(b)inserted
F24Art. 5(1c) inserted (1.1.2025) by The Supplementary Protection Certificates (Amendments Relating to the Windsor Framework) Regulations 2024 (S.I. 2024/1075), regs. 1(1), 4(c)inserted
F25Word in Art. 5(2)(a)(i) omitted (31.12.2020) by virtue of The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(a)(i)(aa) (with reg. 43)this amendment (text omitted) should be read in conjunction with other related provisions, see the commentary.omitted
F26Words in Art. 5(2)(a)(i) inserted (31.12.2020) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(a)(i)(bb) (with reg. 43)this amendment (text inserted) should be read in conjunction with other related provisions, see the commentary.inserted
F27Words in Art. 5(2)(a)(ii) substituted (31.12.2020) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(a)(ii) (with reg. 43)this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary.substituted
F28Words in Art. 5(2)(a)(iii) substituted (31.12.2020) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(a)(iii)(aa) (with reg. 43)this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary.substituted
F29Words in Art. 5(2)(a)(iii) substituted (31.12.2020) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(a)(iii)(bb) (with reg. 43)this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary.substituted
F30Words in Art. 5(2)(a)(iv) substituted (31.12.2020) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(a)(iv) (with reg. 43)this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary.substituted
F31Word in Art. 5(2)(b) substituted (31.12.2020) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(b)(i) (with reg. 43)this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary.substituted
F32Words in Art. 5(2)(b) substituted (31.12.2020) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(b)(ii) (with reg. 43)this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary.substituted
F33Word in Art. 5(2)(b) substituted (31.12.2020) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(b)(iii) (with reg. 43)this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary.substituted
F34Word in Art. 5(2)(c) substituted (31.12.2020) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(c) (with reg. 43)this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary.substituted
F35Word in Art. 5(2)(d) omitted (31.12.2020) by virtue of The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(d)(i) (with reg. 43)this amendment (text omitted) should be read in conjunction with other related provisions, see the commentary.omitted
F36Words in Art. 5(2)(d) inserted (31.12.2020) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(d)(ii) (with reg. 43)this amendment (text inserted) should be read in conjunction with other related provisions, see the commentary.inserted
F37Words in Art. 5(2)(d) substituted (31.12.2020) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(d)(iii) (with reg. 43)this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary.substituted
F38Words in Art. 5(2)(e) omitted (31.12.2020) by virtue of The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(e) (with reg. 43)this amendment (text omitted) should be read in conjunction with other related provisions, see the commentary.omitted
F39Words in Art. 5(3) substituted (31.12.2020) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(f) (with reg. 43)this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary.substituted
F40Art. 5(5)(c) omitted (31.12.2020) by virtue of The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(g)(i) (with reg. 43)this amendment (text omitted) should be read in conjunction with other related provisions, see the commentary.omitted
F41Word in Art. 5(5)(d) omitted (31.12.2020) by virtue of The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(g)(ii) (with reg. 43)this amendment (text omitted) should be read in conjunction with other related provisions, see the commentary.omitted
F42Word in Art. 5(5)(e) omitted (31.12.2020) by virtue of The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(g)(iii)(aa) (with reg. 43)this amendment (text omitted) should be read in conjunction with other related provisions, see the commentary.omitted
F43Words in Art. 5(5)(e) inserted (31.12.2020) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(g)(iii)(bb) (with reg. 43)this amendment (text inserted) should be read in conjunction with other related provisions, see the commentary.inserted
F44Word in Art. 5(6) substituted (31.12.2020) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(h)(i) (with reg. 43)this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary.substituted
F45Word in Art. 5(6) inserted (31.12.2020) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), reg. 1(2), Sch. para. 13(c)(i) (with reg. 7)this amendment (text inserted) should be read in conjunction with other related provisions, see the commentary.inserted
F46Words in Art. 5(6) omitted (31.12.2020) by virtue of The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), reg. 1(2), Sch. para. 13(c)(ii) (with reg. 7)this amendment (text omitted) should be read in conjunction with other related provisions, see the commentary.omitted
F47Word in Art. 5(7) omitted (31.12.2020) by virtue of The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(i)(i) (with reg. 43)this amendment (text omitted) should be read in conjunction with other related provisions, see the commentary.omitted
F48Words in Art. 5(7) inserted (31.12.2020) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(i)(ii) (with reg. 43)this amendment (text inserted) should be read in conjunction with other related provisions, see the commentary.inserted
F49Art. 5(8) omitted (31.12.2020) by virtue of The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(j) (with reg. 43)this amendment (text omitted) should be read in conjunction with other related provisions, see the commentary.omitted
F50Art. 5(11)(12) inserted (31.12.2020) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(k) (with reg. 43)this amendment (text inserted) should be read in conjunction with other related provisions, see the commentary.inserted
F51Words in Art. 7(1) inserted (31.12.2020) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), reg. 1(2), Sch. para. 14(a) (with reg. 7)this amendment (text inserted) should be read in conjunction with other related provisions, see the commentary.inserted
F52Words in Art. 7(1) inserted (31.12.2020) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), reg. 1(2), Sch. para. 14(b) (with reg. 7)this amendment (text inserted) should be read in conjunction with other related provisions, see the commentary.inserted
F53Words in Art. 7(1) inserted (31.12.2020) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), reg. 1(2), Sch. para. 14(c) (with reg. 7)this amendment (text inserted) should be read in conjunction with other related provisions, see the commentary.inserted
F54Art. 7(2a) inserted (1.1.2025) by The Supplementary Protection Certificates (Amendments Relating to the Windsor Framework) Regulations 2024 (S.I. 2024/1075), regs. 1(1), 5inserted
F55Words in Art. 8(1)(a)(ii) substituted (31.12.2020) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), reg. 1(2), Sch. para. 15(a) (with reg. 7)this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary.substituted
F56Art. 8(1)(a)(iv)(v) substituted for Art. 8(1)(a)(iv) (31.12.2020) by The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801), regs. 1, 55(2) (as amended by S.I. 2020/1471, regs. 1(2), 3(6)); 2020 c. 1, Sch. 5 para. 1(1)substituted
F57Art. 8(1)(b)(c) substituted (31.12.2020) by The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801), regs. 1, 55(3) (as amended by S.I. 2020/1471, regs. 1(2), 3(7); 2020 c. 1, Sch. 5 para. 1(1)substituted
F58Words in Art. 8(1)(b) inserted (1.1.2025) by The Supplementary Protection Certificates (Amendments Relating to the Windsor Framework) Regulations 2024 (S.I. 2024/1075), regs. 1(1), 6inserted
F59Words in Art. 8(1)(d)(i) substituted (31.12.2020) by The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801), regs. 1, 55(4)(a) (with reg. 69 as amended by S.I. 2020/1050, regs. 1(2), 37); 2020 c. 1, Sch. 5 para. 1(1)this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary.substituted
F60Art. 8(1)(d)(ii) inserted (31.12.2020) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), reg. 1(2), Sch. para. 15(b) (with reg. 7)this amendment (text inserted) should be read in conjunction with other related provisions, see the commentary.inserted
F61Art. 8(4) omitted (31.12.2020) by virtue of The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801), regs. 1, 55(5); 2020 c. 1, Sch. 5 para. 1(1)omitted
F62Art. 9(1) substituted (31.12.2020) by The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801), regs. 1, 56(2); 2020 c. 1, Sch. 5 para. 1(1)substituted
F63Words in Art. 9(2) substituted (31.12.2020) by The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801), regs. 1, 56(3); 2020 c. 1, Sch. 5 para. 1(1)substituted
F64Art. 9(2)(d)(e) substituted (31.12.2020) by The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801), regs. 1, 56(4) (as amended by S.I. 2020/1471, regs. 1(2), 3(8)); 2020 c. 1, Sch. 5 para. 1(1)substituted
F65Art. 9(2)(g) inserted (31.12.2020) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), reg. 1(2), Sch. para. 16 (with reg. 7)this amendment (text inserted) should be read in conjunction with other related provisions, see the commentary.inserted
F66Words in art. 10(1)-(3) substituted (31.12.2020) by The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801), regs. 1, 57(2); 2020 c. 1, Sch. 5 para. 1(1)substituted
F67Words in Art. 10(2) inserted (31.12.2020) by The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801), regs. 1, 57(3); 2020 c. 1, Sch. 5 para. 1(1)inserted
F68Words in Art. 10(3) inserted (31.12.2020) by The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801), regs. 1, 57(4); 2020 c. 1, Sch. 5 para. 1(1)inserted
F69Words in Art. 10(4) substituted (31.12.2020) by The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801), regs. 1, 57(5); 2020 c. 1, Sch. 5 para. 1(1)substituted
F70Art. 10(5) omitted (31.12.2020) by virtue of The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801), regs. 1, 57(6); 2020 c. 1, Sch. 5 para. 1(1)omitted
F71Words in Art. 11(1) substituted (31.12.2020) by The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801), regs. 1, 58(2); 2020 c. 1, Sch. 5 para. 1(1)substituted
F72Art. 11(1)(d) substituted by virtue of (31.12.2020) by The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801), regs. 1, 58(3)(a) (as amended by S.I. 2020/1471, regs. 1(2), 3(10)(a)); 2020 c. 1, Sch. 5 para. 1(1)substituted
F73Art. 11(1)(e) substituted (31.12.2020) by The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801), regs. 1, 58(3)(b) (as amended by S.I. 2020/1471, regs. 1(2), 3(10)(b)); 2020 c. 1, Sch. 5 para. 1(1)substituted
F74Words in Art. 11(2) substituted (31.12.2020) by The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801), regs. 1, 58(2); 2020 c. 1, Sch. 5 para. 1(1)substituted
F75Art. 11(3a) inserted (31.12.2020) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), reg. 1(2), Sch. para. 17 (with reg. 7)this amendment (text inserted) should be read in conjunction with other related provisions, see the commentary.inserted
F76Word in Art. 11(4) substituted (31.12.2020) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 4(a) (with reg. 43)this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary.substituted
F77Words in Art. 11(4) substituted (31.12.2020) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 4(b) (with reg. 43)this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary.substituted
F78Art. 12 omitted (31.12.2020) by virtue of The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801), regs. 1, 59; 2020 c. 1, Sch. 5 para. 1(1)omitted
F79Words in Art. 13(1) substituted (31.12.2020) by The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801), regs. 1, 60(2); 2020 c. 1, Sch. 5 para. 1(1)substituted
F80Words in Art. 13(3) substituted (31.12.2020) by The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801), regs. 1, 60(3) (with reg. 69) (as amended by S.I. 2020/1050, regs. 1(2), 37); 2020 c. 1, Sch. 5 para. 1(1)this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary.substituted
F81Art. 13(5) inserted (31.12.2020) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), reg. 1(2), Sch. para. 18 (with reg. 7)this amendment (text inserted) should be read in conjunction with other related provisions, see the commentary.inserted
F82Arts. 13A, 13B inserted (31.12.2020) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), reg. 1(2), Sch. para. 19 (with reg. 7)this amendment (text inserted) should be read in conjunction with other related provisions, see the commentary.inserted
F82Arts. 13A, 13B inserted (31.12.2020) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), reg. 1(2), Sch. para. 19 (with reg. 7)this amendment (text inserted) should be read in conjunction with other related provisions, see the commentary.inserted
F83Word in Art. 13A(4) omitted (1.1.2025) by virtue of The Supplementary Protection Certificates (Amendments Relating to the Windsor Framework) Regulations 2024 (S.I. 2024/1075), regs. 1(1), 7omitted
F84Words in Art. 13B(2) inserted (1.1.2025) by The Supplementary Protection Certificates (Amendments Relating to the Windsor Framework) Regulations 2024 (S.I. 2024/1075), regs. 1(1), 8(a)inserted
F85Art. 13B(2a) inserted (1.1.2025) by The Supplementary Protection Certificates (Amendments Relating to the Windsor Framework) Regulations 2024 (S.I. 2024/1075), regs. 1(1), 8(b)inserted
F86Words in Art. 13B(4) inserted (1.1.2025) by The Supplementary Protection Certificates (Amendments Relating to the Windsor Framework) Regulations 2024 (S.I. 2024/1075), regs. 1(1), 8(c)inserted
F87Art. 13B(5) inserted (1.1.2025) by The Supplementary Protection Certificates (Amendments Relating to the Windsor Framework) Regulations 2024 (S.I. 2024/1075), regs. 1(1), 8(d)inserted
F88Art. 14 renumbered as Art. 14(1) (31.12.2020) by The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801), regs. 1, 61(2) (as amended by S.I. 2020/1471, regs. 1(2), 3(11)); 2020 c. 1, Sch. 5 para. 1(1)renumbered
F89Art. 14(1)(c)(d) substituted (31.12.2020) by The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801), regs. 1, 61(3); 2020 c. 1, Sch. 5 para. 1(1)substituted
F90Art. 14(2)(3) inserted (31.12.2020) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), reg. 1(2), Sch. para. 20 (with reg. 7)this amendment (text inserted) should be read in conjunction with other related provisions, see the commentary.inserted
F91Words in Art. 15(2) substituted (31.12.2020) by The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801), regs. 1, 62 (as amended by S.I. 2020/1050, regs. 1(2), 36); 2020 c. 1, Sch. 5 para. 1(1)substituted
F92Words in Art. 16(1) substituted (31.12.2020) by The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801), regs. 1, 63(2) (with reg. 69) (as amended by S.I. 2020/1050, regs. 1(2), 37); 2020 c. 1, Sch. 5 para. 1(1)this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary.substituted
F93Words in Art. 16(2) substituted (31.12.2020) by The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801), regs. 1, 63(3); 2020 c. 1, Sch. 5 para. 1(1)substituted
F94Word in Art. 17(1) inserted (31.12.2020) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), reg. 1(2), Sch. para. 21(a) (with reg. 7)this amendment (text inserted) should be read in conjunction with other related provisions, see the commentary.inserted
F95Words in Art. 17(1) inserted (31.12.2020) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), reg. 1(2), Sch. para. 21(b) (with reg. 7)this amendment (text inserted) should be read in conjunction with other related provisions, see the commentary.inserted
F96Words in Art. 17 substituted (31.12.2020) by The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801), regs. 1, 64; 2020 c. 1, Sch. 5 para. 1(1)substituted
F97Art. 18 omitted (31.12.2020) by virtue of The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801), regs. 1, 65; 2020 c. 1, Sch. 5 para. 1(1)omitted
F98Art. 19(1) substituted (31.12.2020) by The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801), regs. 1, 66; 2020 c. 1, Sch. 5 para. 1(1)substituted
F99Art. 19A inserted (1.1.2025) by The Supplementary Protection Certificates (Amendments Relating to the Windsor Framework) Regulations 2024 (S.I. 2024/1075), regs. 1(1), 9inserted
F100Art. 20 omitted (31.12.2020) by virtue of The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801), regs. 1, 67; 2020 c. 1, Sch. 5 para. 1(1)omitted
F101Art. 21 omitted (31.12.2020) by virtue of The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801), regs. 1, 67; 2020 c. 1, Sch. 5 para. 1(1)omitted
F102Art. 21a omitted (31.12.2020) by virtue of The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 5 (with reg. 43)this amendment (text omitted) should be read in conjunction with other related provisions, see the commentary.omitted
F103Words in Signature omitted (31.12.2020) by virtue of The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801), regs. 1, 68; 2020 c. 1, Sch. 5 para. 1(1)omitted
F104Annex -1 omitted (31.12.2020) by virtue of The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 6 (with reg. 43)this amendment (text omitted) should be read in conjunction with other related provisions, see the commentary.omitted
F105Annex -1a omitted (31.12.2020) by virtue of The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 6 (with reg. 43)this amendment (text omitted) should be read in conjunction with other related provisions, see the commentary.omitted
F106Annex 3 inserted (1.1.2025) by The Supplementary Protection Certificates (Amendments Relating to the Windsor Framework) Regulations 2024 (S.I. 2024/1075), regs. 1(1), 10inserted
Defined TermSection/ArticleIDScope of Application
application for an extension of the durationart. Article 1applicatio_rt9xhir
basic patentart. Article 1basic_pate_rtR17mp
certificateart. Article 1certificat_rt5eu0A
comptrollerart. Article 1comptrolle_rtac8rD
courtart. Article 1court_rtgMLGa
EEA authorisationart. Article 1EEA_author_lgKh5qi
former NI authorisationart. Article 1former_NI__lgJ4APr
GB authorisationart. Article 1GB_authori_rt6oNbp
makerart. Article 1maker_rt6sAjT
medicinal productart. Article 1medicinal__rtoQ0pE
NI authorisationart. Article 1NI_authori_rtXBu9Q
patentart. Article 1patent_rtAFPdl
prescribedart. Article 1prescribed_rt1qrnM
productart. Article 1product_rt8Pil7
the certificate holderart. Article 5the_certif_rt8bYVd
transitioned-UK authorisationart. Article 1transition_lgc4o1W
UK authorisationart. Article 1UK_authori_rtXqgNk
UK exportart. Article 5UK_export_rtzV4bf
Windsor Frameworkart. Article 1Windsor_Fr_lg3k2nO

Status of changes to instrument text

The list includes made instruments, both those in force and those yet to come into force. Typically, instruments that are not yet in force (hence their changes are not incorporated into the text above) are indicated by description 'not yet' in the changes made column.