CELEX: 51990PC0101
Language: en
Date: 1990-04-11
Title: PROPOSAL FOR A COUNCIL REGULATION ( EEC ) CONCERNING THE CREATION OF A SUPPLEMENTARY PROTECTION CERTIFICATE FOR MEDICINAL PRODUCTS

N o C 114/10                         Official Journal of the European Communities                                    8. 5. 90
               Proposal for a Council Regulation (EEC) concerning the creation of a supplementary
                                        protection certificate for medicinal products
                                              (COM(90)    101 final — SYN      255)
                                      (Submitted by the Commission on 3 April 1990)
                                                        (90/C 114/11)
 THE COUNCIL OF THE EUROPEAN COMMUNITIES,                           whereas the legislative form of a Regulation is therefore
                                                                    the most appropriate;
 Having regard to the Treaty establishing the European
 Economic Community, and in particular Article 100a
 thereof,                                                          Whereas the duration of the protection granted by the
                                                                    new certificate should be determined to enable a
 Having regard to the proposal from the Commission,                medicinal product to be given the effective protection it
                                                                   would have if it were not subject to authorization to be
                                                                   placed on the market; whereas, for this purpose, the
 In cooperation with the European Parliament,                      holder of both a patent and a certificate should be able
                                                                   to enjoy 16 years of exclusivity from the time the
 Having regard to the opinion of the Economic and                  product is first placed on the market in the Community;
 Social Committee,
Whereas pharmaceutical research plays a decisive role in           Whereas all the interests at stake, including those of
the continuing improvement in public health;                       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
Whereas medicinal products that are the result of long,            be granted for a period exceeding 10 years; whereas the
 costly research will not continue to be developed in the          protection granted should furthermore be strictly
 Community and in Europe unless they are covered by                confined to the product covered by the marketing auth-
 favourable rules that provide for sufficient protection to        orization;
 encourage such research;
Whereas at the moment the period that elapses between             Whereas a fair balance should also be struck with regard
the discovery of a new medicinal product, at which time            to the determination of the transitional arrangements;
the application for a corresponding patent is filed, and          whereas such arrangements            should    enable    the
authorization to place the medicinal product on the                Community pharmaceutical industry to catch up to some
market is continually increasing, thereby making the              extent with its main competitors who, for a number of
period of effective protection under the patent insuf-            years, have been covered by laws assuring them of more
ficient to cover the investment put into the research;             adequate protection, while making sure that the
                                                                  arrangements do not compromise the achievement of
Whereas this lack of protection penalizes pharmaceutical          other legitimate objectives concerning the health policies
research;                                                         pursued at both national and Community level,
Whereas the current situation is creating the risk of
European research centres relocating to countries that            HAS ADOPTED THIS REGULATION:
already offer greater protection;
Whereas a uniform solution at Community level should                                        Article 1
be provided for, thereby preventing the heterogeneous
development of national laws leading to further                                            Definitions
disparities which would be likely to create obstacles to
                                                                  For the purposes of this Regulation,
the free movement of medicinal products within the
Community and thus directly to affect the establishment
and the functioning of the internal market;                       (a) Product means any active substance or combination
                                                                       of substances presented for treating or preventing
Whereas the creation of a supplementary protection                     disease in human beings or animals and any active
certificate granted, under the same conditions, by each                substance or combination of substances which may
of the Member States at the request of the holder of a                 be administered to human beings or animals with a
national or European patent relating to a medicinal                    view to making a medical diagnosis or to restoring,
product for which valid marketing authorization has                    correcting or modifying physiological functions in
been granted by the State concerned is necessary;                      humans or in animals;
 ---pagebreak--- 8. 5. 90                               Official Journal of the European Communities                             N o C 114/11
(b) Product protected by a patent means any product as                                      Article 5
    defined in (a) protected by a patent covering the
    product itself, or a process to obtain the product, or                          Effects of the certificate
     an application of the product or a combination of           Subject to the provisions of Article 4, the certificate shall
    substances containing the product;                           confer the same rights as conferred by the basic patent
                                                                 and shall be subject to the same limitations.
(c) Certificate    means   the   supplementary    protection
    certificate.
                                                                                            Article 6
                                                                                  Application for a certificate
                          Article 2
                                                                  1.    The application for a certificate shall be lodged
                            Scope
                                                                 within six months of the date on which the authorization
Any product protected by a patent in the territory of a          to place the product on the market referred to in Article
Member State and subject, prior to being placed on the           3 (1) (b) was granted.
market, to an administrative authorization procedure as
laid down in Council Directive 65/65/EEC (') or
Council Directive 81/851/EEC (2) may, under the terms            2.     Notwithstanding the provision of paragraph 1,
and conditions provided for in this Regulation, be the           where the authorization to place the product on the
subject of a certificate.                                        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.
                          Article 3
           Conditions for obtaining a certificate                3.     The application for a certificate shall contain:
1.    A certificate shall be granted if, in the Member
                                                                 (a) a request for the grant of a certificate;
State in which the application referred to in Article 6 is
submitted and at the date of that application,
                                                                 (b) a copy of the authorization to place the product on
                                                                      the market, as referred to in Article 3 (1) (b), in
(a) the product is protected by a patent in force, here-
                                                                      which the product is identified;
    inafter called basic patent;
                                                                 (c) if the authorization referred to in (b) is not the first
(b) a valid authorization to place the product on the
                                                                      authorization for placing the product on the market
    market has been granted in accordance with
                                                                      in the Community, information regarding the date
    Directive 65/65/EEC or Directive 81/851/EEC, as
                                                                      on which the first such authorization was granted,
    appropriate;
                                                                      the identity of the product thus authorized, the legal
                                                                      provision under which the authorization procedure
(c) the product has not already been the subject of a                 took place and a copy of the authorization;
    certificate;
                                                                  (d) identification of the basic patent;
(d) the authorization referred to in (b) is the first auth-
    orization to place the product on the market.
                                                                  (e) information regarding the pharmocological prop-
                                                                      erties of the product in the form of a summary as
2.    The certificate shall be granted to the holder of the           provided for in particular in Article 4a (4) of
basic patent.                                                         Directive 65/65/EEC.
                          Article 4                                                         Article 7
                 Subject matter of protection                             Lodging of an application for a certificate
Within the limit of the protection conferred by the basic         1.    The application for a certificate shall be lodged
patent, the protection conferred by a certificate shall          with the central industrial property office of the Member
extend only to the product covered by the authorization          State which granted the basic patent or on whose behalf
to place it on the market and for any authorized use of          it was granted and in which authorization to place the
the product before the expiry of the basic patent and as         product on the market as referred to in Article 3 (1) (b)
provided for in Directives 65/65/EEC or 81/851/EEC.              was obtained.
                                                                 2.     Member States may require that the application for
(') OJ No 22, 9. 2. 1965, p. 369/65.                              a certificate shall be subject to payment of a fee imposed
O OJ No L 317, 6. 11. 1981, p. 1.                                by the authority referred to in paragraph 1.
 ---pagebreak---   N o C 114/12                           Official Journal of the European Communities                                    8. 5. 90
 3.     The application for a certificate shall be published                                  Article 11
 by the authority referred to in paragraph 1.
                                                                                Grounds for nullity of the certificate
                                                                     1.    The certificate shall be void if:
                            Article 8
                  Duration of the certificate                       (a) it was granted contrary to the provisions of Article 3;
  1.    The certificate shall take effect on the day
 following the end of the lawful term of the basic patent
                                                                    (b) the basic patent is no longer in force when its lawful
 for a period equal to the period which elapsed between
                                                                         term expires;
 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, as referred            (c) the subject of the certificate is not covered by a basic
 to in Article 6 (3) (c), reduced by a period of four years.             patent.
 2.     Notwithstanding paragraph 1, the duration of the
 certificate may not exceed 10 years from the date on               2.     For the purposes of paragraph 1 (b), an application
which it takes effect.                                              for a declaration of nullity of the basic patent may be
                                                                    presented before the lawful term of the patent expires.
                           Article 9
                                                                    3.    In the case referred to in paragraph 1 (c), if the
Grant of the certificate or rejection of the application            subject of the certificate is only partially covered by the
                                                                   basic patent, the declaration of nullity shall take the form
 1.    The authority referred to in Article 7 (1) shall
                                                                   of a corresponding limitation of the certificate.
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.
                                                                   4.     Any person may request a declaration of nullity of
                                                                   the certificate from the authority which granted it.
2.     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 7                                   Article 12
(1) shall grant the certificate.
                                                                                              Appeals
3.     The fact that a certificate has been granted shall be       The decisions of the authority referred to in Article 7 ( 1 )
published by the authority referred to in Article 7 (1),           taken under Articles 9 (1) and 11 shall be open to the
giving in particular the following details:                        same appeals as those provided for in national law
                                                                   against similar decisions taken in respect of national
                                                                   patents.
(a) name and address of the holder of the certificate;
(b) number of the basic patent;                                    The same shall apply in respect of decisions taken
                                                                   pursuant to Article 9 (2) which are alleged to be invalid
                                                                   on grounds other than those referred to in Article 11.
(c) identity of the product covered by the certificate;
(d) duration of the certificate;
                                                                                   TRANSITIONAL PROVISION
(e) a summary of the pharmacological properties as                                           Article 13
     referred to in Article 6 (3) (e).
                                                                   1.     Any product which, on the date on which this
                                                                   Regulation enters into force, is protected by a valid
                          Article 10                               patent and for which authorization to place it on the
                                                                   market in the Community has not yet been obtained may
                        Renewal fees                               benefit from the application of this Regulation.
1.     Member States may require that the certificate shall
be subject to the payment of renewal fees imposed by the
authority referred to in Article 7 (1).                            2.     Any product which, on the date on which this
                                                                   Regulation enters into force, is protected by a valid
                                                                   patent which expires after 1 July 1992 and for which a
2.     The failure to pay such fees will result in the lapse       first authorization to place it on the market in the
of the certificate.                                                Community was obtained after 1 January 1984 may also
 ---pagebreak--- 8. 5. 90                              Official Journal of the European Communities                        N o C 114/13
be granted a certificate, the duration of which may not,        2.    The implementing Regulation shall be adopted by
however, exceed five years.                                     the Commission.
3.    An application for a certificate, made under
paragraph 2, shall be submitted within six months of the
date on which this Regulation enters into force.                                         Articles 15
                    FINAL PROVISIONS                                                  Entry into force
                                                                This Regulation shall enter into force 60 days after its
                          Article 14                            publication in the Official Journal of the European
                  Implementing Regulation                        Communities.
1.    Detailed rules for the application of this Regu-
lation, in so far as they are necessary, shall be laid down     This Regulation shall be binding in its entirety and
by an implementing Regulation.                                  directly applicable in all Member States.