The Patents (Supplementary Protection Certificates) Rules 1997

• Citation: S.I. 1997/64
• Sections: 69

Section 1 Citation, commencement and extent

(1) These Rules may be cited as the Patents (Supplementary Protection Certificates) Rules 1997 and shall come into force on 8th February 1997.

(2) These Rules extend to Great Britain and Northern Ireland.

Section 2 Interpretation

(1) In these Rules—

“the 1977 Act ” means the Patents Act 1977;

“the EC Regulations ” means the medicinal product Regulation and the plant protection product Regulation and any reference in these Rules to an Article followed by a number is a reference to the Article so numbered in the relevant Regulation ;

“the medicinal product Regulation ” means Council Regulation ( EEC ) No. 1768/92 of 18th June 1992 concerning the creation of a supplementary protection certificate for medicinal products, a copy of the English language version of which is set out in Part 1 of Schedule 1 to these Rules ;

“the plant protection product Regulation” means Regulation ( EC ) No. 1610/96 of the European Parliament and of the Council of 23rd July 1996 concerning the creation of a supplementary protection certificate for plant protection products, a copy of the English language version of which is set out in Part 2 of Schedule 1 to these Rules ;

“the relevant Regulation” means the EC Regulation under which the application for a supplementary protection certificate is made or such a certificate is granted;

“basic patent” has the meaning assigned to it by—

paragraph (c) of Article 1 of the medicinal product Regulation; or

paragraph (9) of Article 1 of the plant protection product Regulation,

whichever is the relevant Regulation;

“certificate” has the meaning assigned to it by—

paragraph (d) of Article 1 of the medicinal product Regulation; or

paragraph (10) of Article 1 of the plant protection product Regulation,

whichever is the relevant Regulation;

“the comptroller” and “the journal” have the same meanings as they have in the 1977 Act;

“the court” has the same meaning as it has in the 1977 Act; and

“register of patents” means the register of patents maintained pursuant to section 32 of the 1977 Act.

(2) Subject to paragraph (3), the forms of which the use is required by these Rules are those set out in Schedule 2 to these Rules.

(3) A requirement under these Rules to use such a form is satisfied by the use either of a replica of that form or of a form which is acceptable to the comptroller and contains the information required by the form set out in Schedule 2 to these Rules.

(4) The fees to be paid in respect of any matter arising under these Rules shall be those (if any) prescribed in relation to such matter in Schedule 4 to these Rules; and any reference to“prescribed fee” and “fees” in these Rules shall be construed accordingly.

Section 3 Application and fee in respect of application (Articles 8 and 9(1))

(1) The application for a certificate shall be—

(a) subject to the payment to the Patent Office of a prescribed fee; and

(b) lodged with the Patent Office accompanied by the prescribed fee.

(2) An application for the grant of a certificate shall be made on Form SP1.

Section 4 Certificate of grant (Article 10)

A certificate shall be in the form set out in Part 1 or Part 2 of Schedule 3 to these Rules.

Section 5 Fees in respect of effective period of certificate (Article 12)

(1) A reference in this rule to—

(a) “due date” means the date on which a certificate, subject to the requirement to pay fees, would take effect at the end of the lawful term of the basic patent; and

(b) “maximum period” means the maximum possible period of duration of a certificate as determined in accordance with Article 13.

(2) A certificate shall not take effect, and its actual duration shall not be determined, until payment is made of the fees prescribed in accordance with paragraphs (3) to (10) below.

(3) Subject to paragraph (9), the amount of fees payable in order for a certificate to take effect in respect of any period (“the appropriate fees”) shall be the amount calculated by reference to the length of the maximum period, less any period deducted from the end of the maximum period during which it is desired by the holder of a certificate that the certificate shall not have effect, the resulting period, whether reduced from the maximum period or not, being referred to hereafter as the “effective period”.

(4) The appropriate fees payable in respect of any effective period shall be the cumulative amount of fees prescribed—

(a) by reference to the successive twelve month periods of which an effective period is made up (any period of less than twelve months being treated as a twelve month period of which that lesser period forms part); the first such period shall commence on the due date (“the first year”); the second shall commence immediately upon expiry of the first (“the second year”), with corresponding provision in respect of each successive year up to a maximum of five years (“the fifth year”) which years shall be referred to herein generally as “effective years”; and

(b) in respect of each of the effective years, by the prescribed fees in force—

(i) where payment is made before the due date, on the date on which payment is made;

(ii) in any other case, on the due date.

(5) Subject to paragraphs (7) and (9), the appropriate fees in respect of an effective period shall be paid not later than the due date but may not be paid earlier than three months preceding the due date.

(6) Without prejudice to the provisions of paragraphs (2) and (5), the comptroller shall write to the holder of a certificate not later than two months before the due date—

(a) notifying him of the due date;

(b) indicating the prescribed fees applicable in respect of each of the effective years of which the maximum period of the certificate is made up; and

(c) specifying the period within which fees must be paid to the Patent Office in order for the certificate to take effect;

and the holder of the certificate shall, within the period specified under paragraph (c), notify the Patent Office on Form SP2 of the effective period of the certificate, which notification shall be accompanied by the appropriate fees payable in respect of that period.

(7) Where a certificate is granted later than three months before the end of the lawful term of the basic patent, the provisions of paragraphs (5) and (6) shall be modified as follows—

(a) the due date for the purposes of payment of the appropriate fees shall be the date three months after the date of grant of the certificate; and

(b) the comptroller shall write to the applicant for the certificate in the terms prescribed by paragraph (6), subject to subparagraph (a) of this paragraph, on the date on which he notifies him of the grant thereof.

(8) Where the effective period is less than the maximum period of the certificate it shall not subsequently be extended.

(9) Where the period for payment of fees under paragraph (5) or (7), as the case may be, has expired—

(a) the comptroller shall, not later than six weeks after the applicable due date and if the fees remain unpaid, notify the holder of the certificate—

(i) that the fees remain unpaid; and

(ii) of the consequences of non-payment; and

(iii) of the provisions of subparagraph (b);

(b) the holder, subject to the payment within a period of six months after the applicable due date of the unpaid fees and an additional late payment fee of an amount equal to one half of the amount of the unpaid fees, shall be treated as having paid the fees on the applicable due date.

(10) The notices under paragraphs (6) and (9) of this rule shall be sent by the comptroller to—

(a) the address for service furnished in writing by the applicant for a certificate or any address replacing it, and,

(b) in relation to the basic patent in respect of which the certificate is granted, where it differs from the address referred to in subparagraph (a),

(i) the address in the United Kingdom to which any renewal reminder is to be sent as specified by the proprietor on payment of the last renewal fee or any address replacing it, or

(ii) where no such address is specified, the address for service (if any) entered in the register of patents.

Section 6 Fees in respect of effective period of certificate (Article 12)

If the certificate is surrendered or declared invalid on or with effect from a date earlier (“the earlier date”) than the date of expiry of the effective period, where the appropriate fees in respect of that period have been paid, the comptroller shall remit the fee paid in respect of any effective year which falls after the end of the effective year (if any) into which the earlier date falls.

Section 7 Declaration of lapse or invalidity of certificate (Articles 14(d) and 15(1)(a) and (c))

(1) On the application of any person, the comptroller may, as the case may be, declare—

(a) that a certificate has lapsed on the ground set out in Article 14(d); or

(b) that the ground for lapse under Article 14(d) no longer exists.

(2) The court or the comptroller may declare that a certificate is invalid in accordance with the provisions of Article 15.

(3) An application to the comptroller for a declaration under paragraph (1)(a) or paragraph (2) shall be—

(i) subject to payment of the prescribed fee, and

(ii) made on Form SP3, and

(iii) accompanied by a copy thereof and a statement in duplicate setting out fully the grounds and the facts upon which the applicant relies and the relief which he seeks.

(4) The comptroller shall send a copy of the application and the statement to the holder of the certificate.

(5) Within the period of two months beginning on the date on which such copies are sent to him, the holder of the certificate shall, if he wishes to contest the application, file a counter-statement in duplicate at the Patent Office setting out fully the grounds on which the application is contested; and the comptroller shall send a copy of the counter-statement to the applicant.

(6) No further statement or counter-statement shall be served by either party without the leave or direction of the comptroller.

(7) The comptroller may give such directions as he may think fit with regard to the subsequent procedure.

Section 8 Declaration of lapse or invalidity of certificate (Articles 14(d) and 15(1)(a) and (c))

If it appears to the comptroller that a certificate has lapsed in accordance with Article 14(d) he may on his own initiative declare that the certificate has lapsed but shall not do so without giving the holder of the certificate notice of his intention to make such a declaration and affording him an opportunity to make representations within two months of the date of the notice.

Section 9 Forms for use in connection with certificates and applications for certificates (Article 18(1))

Those forms of which use is required by any provision of the 1977 Act or any rules made thereunder in relation to patents or applications for patents, except where replaced by the forms set out in Schedule 2 to these Rules, shall also be used, with the necessary changes, in the corresponding circumstances in relation to certificates or applications for certificates.

Section 10 Publication of: application, grant of certificate, rejection of application, declaration of lapse or of invalidity or of termination of grounds of lapse of certificate (Articles 9(2), 11(1) and (2) and 16)

Notification of—

(a) the application for a certificate;

(b) the fact that a certificate has been granted;

(c) the fact that the application for a certificate has been rejected;

(d) lapse of a certificate;

(e) invalidity of a certificate;

(f) termination of grounds for lapse of a certificate under Article 14(d),

shall be published by the comptroller in the journal.

Section 11 Transitional provisions

Rule 7(3)(i) and (iii) shall apply only to applications under rule 7(1)(a) and (2) made on or after 8th February 1997.

Section 12 Revocations

The Patents (Supplementary Protection Certificate for Medicinal Products) Rules 1992 and the Patents (Supplementary Protection Certificate for Medicinal Products) (Amendment) Rules 1993 are hereby revoked.

Section 1 Application for a certificate

The application for a certificate shall be lodged within six months of the date on which the authorization referred to in Article 3(b) to place the product on the market as a medicinal product was granted.

Section 1 Content of the application for a certificate

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 he 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 first authorization to place the product on the market, as referred to in Article 3(b) and, if this authorization is not the first authorization for placing the product on the market in the Community, the number and date of that authorization;

(b) a copy of the authorization to place the product on the market, as referred to in Article 3(b), in which the product is identified, containing in particular the number and date of the authorization and the summary of the product characteristics listed in Article 4a of Directive 65/65/EEC or Article 5a of Directive 81/851/EEC ;

(c) if the authorization referred to in (b) is not the first authorization for placing the product on the market as a medicinal product in the Community, information regarding the identity of the product thus authorized and the legal provision under which the authorization procedure took place, together with a copy of the notice publishing the authorization in the appropriate official publication.

Section 1 Lodging of an application for a certificate

The application for a certificate shall be lodged with the competent industrial property office of the Member State which granted the basic patent or on whose behalf it was granted and in which the authorization referred to in Article 3(b) to place the product on the market was obtained, unless the Member State designates another authority for the purpose.

Section 1 Grant of the certificate or rejection of the application

Where the application for a certificate and the product to which it relates meet the conditions laid down in this Regulation, the authority referred to in Article 9(1) shall grant the certificate.

Section 1 Publication

Notification of the fact that a certificate has been granted shall be published by the authority referred to in Article 9(1). 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 authorization to place the product on the market referred to in Article 3(b) and the product identified in that authorization;

(e) where relevant, the number and date of the first authorization to place the product on the market in the Community;

(f) the duration of the certificate.

Section 1 Duration of the certificate

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 authorization to place the product on the market in the Community reduced by a period of five years.

Section 1 Invalidity of the certificate

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.

Section 1 Procedure

In the absence of procedural provisions in this Regulation, the procedural provisions applicable under national law to the corresponding basic patent shall apply to the certificate, unless that law lays down special procedural provisions for certificates.

Section 1 Transitional provisions

Any product which, on the date on which this Regulation enters into force, is protected by a valid basic patent and for which the first authorization to place it on the market as a medicinal product in the Community was obtained after 1 January 1985 may be granted a certificate.

In the case of certificates to be granted in Denmark and in Germany, the date of 1 January 1985 shall be replaced by that of 1 January 1988.

In the case of certificates to be granted in Belgium and in Italy, the date of 1 January 1985 shall be replaced by that of 1 January 1982.

Section 1 Definitions

“plant protection products”: active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to:

(a) protect plants or plant products against all harmful organisms or prevent the action of such organisms, in so far as such substances or preparations are not otherwise defined below;

(b) influence the life processes of plants, other than as a nutrient (e.g. plant growth regulators);

(c) preserve plant products, in so far as such substances or products are not subject to special Council or Commission provisions on preservatives;

(d) destroy undesirable plants; or

(e) destroy parts of plants, check or prevent undesirable growth of plants;

Section 1 Conditions for obtaining a certificate

A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted, at the date of that application:

(a) the product is protected by a basic patent in force;

(b) a valid authorization to place the product on the market as a plant protection product has been granted in accordance with Article 4 of Directive 91/414/EEC or an equivalent provision of national law;

(c) the product has not already been the subject of a certificate;

(d) the authorization referred to in (b) is the first authorization to place the product on the market as a plant protection product.

Section 1 Application for a certificate

The application for a certificate shall be lodged within six months of the date on which the authorization referred to in Article 3(1)(b) to place the product on the market as a plant protection product was granted.

Section 1 Content of the application for a certificate

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) the name and address of the representative, if any;

(iii) the number of the basic patent and the title of the invention;

(iv) the number and date of the first authorization to place the product on the market, as refered to in Article 3(1)(b) and, if this authorization is not the first authorization to place the product on the market in the Community, the number and date of that authorization;

(b) a copy of the authorization to place the product on the market, as referred to in Article 3(1)(b), in which the product is identified, containing in particular the number and date of the authorization and the summary of the product characteristics listed in Part A.I (points 1—7) or B.I (points 1—7) of Annex II to Directive 91/414/EEC or in equivalent national laws of the Member State in which the application was lodged;

(c) if the authorization referred to in (b) is not the first authorization to place the product on the market as a plant protection product in the Community, information regarding the identity of the product thus authorized and the legal provision under which the authorization procedure took place, together with a copy of the notice publishing the authorization in the appropriate official publication or, failing such a notice, any other document proving that the authorization has been issued, the date on which it was issued and the identity of the product authorized.

Section 1 Lodging of an application for a certificate

The application for a certificate shall be lodged with the competent industrial property office of the Member State which granted the basic patent or on whose behalf it was granted and in which the authorization referred to in Article 3(1)(b) to place the product on the market was obtained, unless the member State designates another authority for the purpose.

Section 1 Grant of the certificate or rejection of the application

Where the application for a certificate and the product to which it relates meet the conditions laid down in this Regulation, the authority referred to in Article 9(1) shall grant the certificate.

Section 1 Publication

Notification of the fact that a certificate has been granted shall be published by the authority referred to in Article 9(1). 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 authorization to place the product on the market referred to in Article 3(1)(b) and the product identified in that authorization;

(e) where relevant, the number and date of the first authorization to place the product on the market in the Community;

(f) the duration of the certificate.

Section 1 Duration of the certificate

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 authorization to place the product on the market in the Community, reduced by a period of five years.

Section 1 Invalidity of the certificate

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.

Section 1 Appeals

The decisions of the authority referred to in Article 9(1) or of the body referred to in Article 15(2) taken under this Regulation shall be open to the same appeals as those provided for in national law against similar decisions taken in respect of national patents.

Section 1 Procedure

In the absence of procedural provisions in this Regulation, the procedural provisions applicable under national law to the corresponding basic patent and, where appropriate, the procedural provisions applicable to the certificates referred to in Regulation (EEC) No 1768/92 , shall apply to the certificate, unless national law lays down special procedural provisions for certificates as referred to in this Regulation.

Section 1

Any product which, on the date on which this Regulation enters into force, is protected by a valid basic patent and for which the first authorization to place it on the market as a plant protection product in the Community was obtained after 1 January 1985 under Article 4 of Directive 91/414/EEC or an equivalent national provision may be granted a certificate.

Section 2 Application for a certificate

Notwithstanding paragraph 1, where the authorization 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.

Section 2 Content of the application for a certificate

Member States may provide that a fee is to be payable upon application for a certificate.

Section 2 Lodging of an application for a certificate

Notification of the application for a certificate shall be published by the authority referred to in paragraph 1. 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 authorization to place the product on the market, referred to in Article 3(b), and the product identified in that authorization;

(e) where relevant, the number and date of the first authorization to place the the product on the market in the Community.

Section 2 Grant of the certificate or rejection of the application

The authority referred to in Article 9(1) 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.

Section 2 Publication

Notification of the fact that the application for a certificate has been rejected shall be published by the authority referred to in Article 9(1). The notification shall contain at least the information listed in Article 9(2).

Section 2 Duration of the certificate

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

Section 2 Invalidity of the certificate

Any person may submit an application or bring an action for a declaration of invalidity of the certificate before the body responsible under national law for the revocation of the corresponding basic patent.

Section 2 Procedure

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

Section 2 Transitional provisions

An application for a certificate as referred to in paragraph 1 shall be submitted within six months of the date on which this Regulation enters into force.

Section 2 Definitions

“substances”: chemical elements and their compounds, as they occur naturally or by manufacture, including any impurity inevitably resulting from the manufacturing process;

Section 2 Conditions for obtaining a certificate

The holder of more than one patent for the same product shall not be granted more than one certificate for that product. However, where two or more applications concerning the same product and emanating from two or more holders of different patents are pending, one certificate for this product may be issued to each of these holders.

Section 2 Application for a certificate

Notwithstanding paragraph 1, where the authorization 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.

Section 2 Content of the application for a certificate

Member States may require a fee to be payable upon application for a certificate.

Section 2 Lodging of an application for a certificate

Notification of the application for a certificate shall be published by the authority refered to in paragraph 1. 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 authorization to place the product on the market, referred to in Article 3(1)(b), and the product identified in that authorization;

(e) where relevant, the number and date of the first authorization to place the product on the market in the Community.

Section 2 Grant of the certificate or rejection of the application

The authority referred to in Article 9(1) 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.

Section 2 Publication

Notification of the fact that the application for a certificate has been rejected shall be published by the authority referred to in Article 9(1). The notification shall contain at least the information listed in Article 9(2).

Section 2 Duration of the certificate

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