NoC 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, 
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 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 discovery of a new medicinal product, at which time 
the application for a corresponding patent is filed, and 
authorization to place the medicinal product on the 
market is continually increasing, thereby making the 
period of effective protection under the patent insuf­
ficient to cover the investment put into the research; 
Whereas this lack of protection penalizes pharmaceutical 
research; 
Whereas the current situation is creating the risk of 
European research centres 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 to affect the establishment 
and the functioning of the internal market; 
Whereas 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 valid marketing authorization has 
been granted by the State concerned is necessary; whereas the legislative form of a Regulation is therefore 
the most appropriate; 
Whereas the duration of the protection granted by the 
new certificate should be determined to enable a 
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 
holder of both a patent and a certificate should be able 
to enjoy 16 years of exclusivity from the time the 
product is first 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 10 years; whereas the 
protection granted should furthermore be strictly 
confined to the product covered by the marketing auth­
orization; 
Whereas a fair balance should also be struck with regard 
to the determination of the transitional arrangements; 
whereas such arrangements should enable the 
Community pharmaceutical industry to catch up to some 
extent with its main competitors who, for a number of 
years, have been covered by laws assuring them of more 
adequate protection, while making sure that the 
arrangements do not compromise the achievement of 
other legitimate objectives concerning the health policies 
pursued at both national and Community level, 
HAS ADOPTED THIS REGULATION: 
Article 1 
Definitions 
For the purposes of this Regulation, 
(a) Product means any active substance or combination 
of substances presented for treating or preventing 
disease in human beings or animals and any active 
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; 
8. 5. 90 Official Journal of the European Communities NoC 114/11 
(b) Product protected by a patent means any product as 
defined in (a) protected by a patent covering the 
product itself, or a process to obtain the product, or 
an application of the product or a combination of 
substances containing the product; 
(c) Certificate means the supplementary protection 
certificate. 
Article 2 
Scope 
Any product protected by a patent in the territory of a 
Member State and subject, prior to being placed on the 
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 
and conditions provided for in this Regulation, be the 
subject of a certificate. 
Article 3 
Conditions for obtaining a certificate 
1. A certificate shall be granted if, in the Member 
State in which the application referred to in Article 6 is 
submitted and at the date of that application, 
(a) the product is protected by a patent in force, here­
inafter called basic patent; 
(b) a valid authorization to place the product on the 
market has been granted in accordance with 
Directive 65/65/EEC or Directive 81/851/EEC, as 
appropriate; 
(c) the product has not already been the subject of a 
certificate; 
(d) the authorization referred to in (b) is the first auth­
orization to place the product on the market. 
2. The certificate shall be granted to the holder of the 
basic patent. 
Article 4 
Subject matter of protection 
Within the limit of the protection conferred by the basic 
patent, the protection conferred by a certificate shall 
extend only to the product covered by the authorization 
to place it on the market and for any authorized use of 
the product before the expiry of the basic patent and as 
provided for in Directives 65/65/EEC or 81/851/EEC. 
(') OJ No 22, 9. 2. 1965, p. 369/65. 
O OJ No L 317, 6. 11. 1981, p. 1. Article 5 
Effects of the certificate 
Subject to the provisions of Article 4, the certificate shall 
confer the same rights as conferred by the basic patent 
and shall be subject to the same limitations. 
Article 6 
Application for a certificate 
1. The application for a certificate shall be lodged 
within six months of the date on which the authorization 
to place the product on the market referred to in Article 
3 (1) (b) was granted. 
2. Notwithstanding the provision of 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. 
3. The application for a certificate shall contain: 
(a) a request for the grant of a certificate; 
(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; 
(c) if the authorization referred to in (b) is not the first 
authorization for placing the product on the market 
in the Community, information regarding the date 
on which the first such authorization was granted, 
the identity of the product thus authorized, the legal 
provision under which the authorization procedure 
took place and a copy of the authorization; 
(d) identification of the basic patent; 
(e) information regarding the pharmocological prop­
erties of the product in the form of a summary as 
provided for in particular in Article 4a (4) of 
Directive 65/65/EEC. 
Article 7 
Lodging of an application for a certificate 
1. The application for a certificate shall be lodged 
with the central industrial property office of the Member 
State which granted the basic patent or on whose behalf 
it was granted and in which authorization to place the 
product on the market as referred to in Article 3 (1) (b) 
was obtained. 
2. Member States may require that the application for 
a certificate shall be subject to payment of a fee imposed 
by the authority referred to in paragraph 1. 
No C 114/12 Official Journal of the European Communities 8. 5. 90 
3. The application for a certificate shall be published 
by the authority referred to in paragraph 1. 
Article 8 
Duration of the certificate 
1. The certificate shall take effect on the day 
following 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, as referred 
to in Article 6 (3) (c), reduced by a period of four years. 
2. Notwithstanding paragraph 1, the duration of the 
certificate may not exceed 10 years from the date on 
which it takes effect. 
Article 9 
Grant of the certificate or rejection of the application 
1. The authority referred to in Article 7 (1) shall 
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. 
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 
(1) shall grant the certificate. 
3. The fact that a certificate has been granted shall be 
published by the authority referred to in Article 7 (1), 
giving in particular the following details: 
(a) name and address of the holder of the certificate; 
(b) number of the basic patent; 
(c) identity of the product covered by the certificate; 
(d) duration of the certificate; 
(e) a summary of the pharmacological properties as 
referred to in Article 6 (3) (e). 
Article 10 
Renewal fees 
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. The failure to pay such fees will result in the lapse 
of the certificate. Article 11 
Grounds for nullity of the certificate 
1. The certificate shall be void if: 
(a) it was granted contrary to the provisions of Article 3; 
(b) the basic patent is no longer in force when its lawful 
term expires; 
(c) the subject of the certificate is not covered by a basic 
patent. 
2. For the purposes of paragraph 1 (b), an application 
for a declaration of nullity of the basic patent may be 
presented before the lawful term of the patent expires. 
3. In the case referred to in paragraph 1 (c), if the 
subject of the certificate is only partially covered by the 
basic patent, the declaration of nullity shall take the form 
of a corresponding limitation of the certificate. 
4. Any person may request a declaration of nullity of 
the certificate from the authority which granted it. 
Article 12 
Appeals 
The decisions of the authority referred to in Article 7(1) 
taken under Articles 9 (1) and 11 shall be open to the 
same appeals as those provided for in national law 
against similar decisions taken in respect of national 
patents. 
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. 
TRANSITIONAL PROVISION 
Article 13 
1. Any product which, on the date on which this 
Regulation enters into force, is protected by a valid 
patent and for which authorization to place it on the 
market in the Community has not yet been obtained may 
benefit from the application of this Regulation. 
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 
first authorization to place it on the market in the 
Community was obtained after 1 January 1984 may also 
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be granted a certificate, the duration of which may not, 
however, exceed five years. 
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. 
FINAL PROVISIONS 
Article 14 
Implementing Regulation 
1. Detailed rules for the application of this Regu­
lation, in so far as they are necessary, shall be laid down 
by an implementing Regulation. 2. The implementing Regulation shall be adopted by 
the Commission. 
Articles 15 
Entry into force 
This Regulation shall enter into force 60 days after its 
publication in the Official Journal of the European 
Communities. 
This Regulation shall be binding in its entirety and 
directly applicable in all Member States.