- Statutory Instrument
1997 No. 64
The Patents (Supplementary Protection Certificates) Rules 1997
© Crown Copyright 1997
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STATUTORY INSTRUMENTS
1997 No. 64
| Made | 16th January 1997 | ||
| Laid before Parliament | 17th January 1997 | ||
| Coming into force | 8th February 1997 |
The Secretary of State, in exercise of the powers conferred by section 123 of, and paragraph 14 of Schedule 4 to, the Patents Act 1977[1], of the power conferred upon him by the Department of Trade and Industry (Fees) Order 1988[2], and of all other powers enabling him in that behalf, after consultation with the Council on Tribunals pursuant to section 8(1) of the Tribunals and Inquiries Act 1992[3] and with the consent of the Treasury pursuant to subsection (4) of the said section 123, hereby makes the following Rules:
Citation, commencement and extent
1 . - (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.
Interpretation
2 . - (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[4];
-
"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[5];
-
"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 -
-
(i) paragraph (c) of Article 1 of the medicinal product Regulation; or
(ii) paragraph (9) of Article 1 of the plant protection product Regulation,
whichever is the relevant Regulation;
-
"certificate" has the meaning assigned to it by -
-
(i) paragraph (d) of Article 1 of the medicinal product Regulation; or
(ii) 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.
Application and fee in respect of application (Articles 8 and 9(1))
3 . - (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.
Certificate of grant (Article 10)
4
.
A certificate shall be in the form set out in Part 1 or Part 2 of Schedule 3 to these Rules.
Fees in respect of effective period of certificate (Article 12)
5
.
- (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.
6
.
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.
Declaration of lapse or invalidity of certificate (Articles 14(d) and 15(1)(a) and (c))
7
.
- (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.
8
.
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.
Forms for use in connection with certificates and applications for certificates (Article 18(1))
9
.
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.
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)
10
.
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.
Transitional provisions
11
.
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.
Revocations
12
.
The Patents (Supplementary Protection Certificate for Medicinal Products) Rules 1992[6] and the Patents (Supplementary Protection Certificate for Medicinal Products) (Amendment) Rules 1993[7] are hereby revoked.
Ian Taylor,
Parliamentary Under-Secretary of State for Science and Technology, Department of Trade and Industry
14th January 1997
We consent to the making of these Rules
Roger M. Knapman,
Bowen Wells
Two of the Lords Commissioners of Her Majesty's Treasury
16th January 1997
THE COUNCIL OF THE EUROPEAN COMMUNITIES
Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,
Having regard to the proposal from the Commission[8].
In cooperation with the European Parliament[9].
Having regard to the opinion of the Economic and Social Committee[10].
Whereas pharmaceutical research plays a decisive role in the continuing improvement in public health;
Whereas 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;
Whereas at the moment the period that elapses between the filing of an application for a patent for a new medicinal product and authorization 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;
Whereas this situation leads to a lack of protection which penalises pharmaceutical research;
Whereas the current situation is creating the risk of research centres situated in the Member States relocating to countries that already offer greater protection;
Whereas 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 establishment and the functioning of the internal market;
Whereas, therefore, the creation 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 authorization has been granted is necessary; whereas a Regulation is therefore the most appropriate legal instrument;
Whereas the duration of the protection granted by the certificate should be such as to provide adequate effective protection; whereas, for this purpose, the holder of both a patent and a certificate should be able to enjoy an overall maximum of fifteen years of exclusivity from the time the medicinal product in question first obtains authorization to be placed on the market in the Community;
Whereas all the interests at stake, including those of public health, in a sector as complex and sensitive as the pharmaceutical sector must nevertheless be taken into account, whereas, for this purpose, the certificate cannot be granted for a period exceeding five years; whereas the protection granted should furthermore be strictly confined to the product which obtained authorization to be placed on the market as a medicinal product;
Whereas a fair balance should also be struck with regard to the determination of the transitional arrangements; whereas such arrangements should enable the Community pharmaceu tical industry to catch up to some extent with its main competitors who, for a number of years, have been covered by laws guaranteeing them more adequate protection, while making sure that the arrangements do not compromise the achievement of other legitimate objectives concerning the health policies pursued both at national and Community level;
Whereas the transitional arrangements applicable to applications for certificates filed and to certificates granted under national legislation prior to the entry into force of this Regulation should be defined;
Whereas special arrangements should be allowed in Member States whose laws introduced the patentability of pharmaceutical products only very recently;
Whereas 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;
HAS ADOPTED THIS REGULATION:
Notes:
[1] 1977 c.37; the power of the Secretary of State to make rules in respect of patents under section 123 of the Patents Act 1977 was extended by the Patents (Supplementary Protection Certificate for Medicinal Products) Regulations 1992 (S.I. 1992/3091) and the Patents (Supplementary Protection Certificate for Plant Protection Products) Regulations 1996 (S.I. 1996/3120) so as to apply to supplementary protection certificates. Section 123 was amended by the Copyright, Designs and Patents Act 1988 (c.48), section 295 and Schedule 5, paragraph 29. back
[2] S.I. 1988/93, as amended by S.I. 1990/1473, which was made under section 102 of the Finance (No.2) Act 1987 (c.51). The relevant provisions of that Order are article 7 and part IV of Schedule 1. back
[4] OJ No. L182, 2.7.92, page 1. back
[5] OJ No. L198, 8.8.96, page 30. back
[8] OJ No. C114, 8.5.1990, p. 10. back
[9] OJ No. C19, 28.1.1991, p. 94 and OJ No. C150, 15.6.1992. back
[10] OJ No. C69, 18.3.1991, p. 22. back
