Statutory Instrument 1997 No. 64
The Patents (Supplementary Protection Certificates) Rules 1997
(The document as of February, 2008. Arhiv.Online Library)
1997 No. 64
The Patents (Supplementary Protection Certificates) Rules 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, of the power conferred upon him by the Department of Trade and Industry (Fees) Order 1988, 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 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.
2. - (1) In these Rules -
(ii) paragraph (9) of Article 1 of the plant protection product Regulation,
whichever is the relevant Regulation;
(ii) paragraph (10) of Article 1 of the plant protection product Regulation,
whichever is the relevant Regulation;
(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.
Application and fee in respect of application (Articles 8 and 9(1))
3. - (1) The application for a certificate shall be -
(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.
(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.
(b) in respect of each of the effective years, by the prescribed fees in force -
(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.
(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.
(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.
(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 -
(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),
(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.
(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.
(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.
(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.
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.
In cooperation with the European Parliament.
Having regard to the opinion of the Economic and Social Committee.
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:
 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
 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
 1992 c.53.back
 OJ No. L182, 2.7.92, page 1.back
 OJ No. L198, 8.8.96, page 30.back
 S.I. 1992/3162.back
 S.I. 1993/947.back
 OJ No. C114, 8.5.1990, p. 10.back
 OJ No. C19, 28.1.1991, p. 94 and OJ No. C150, 15.6.1992.back
 OJ No. C69, 18.3.1991, p. 22.back