1992R1768 — EN — 01.05.2004 — 002.001 — 1
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►B COUNCILREGULATION(EEC)No1768/92
of18June1992
concerningthecreation ofasupplementaryprotectioncertificate formedicinalproducts
(OJ L 182, 2.7.1992, p. 1)
Amended by:
Official Journal
No page date
►A1 Actof Accession of Aust ria, Sweden and Finland C 241 21 29.8.1994
(adapted by Council Decision 95/1/EC, Euratom, ECSC) L 1 1 1.1.1995
►A2 Act concerning the conditions of accession of the Czech Republic, the
Republic of Estonia, the Republic of Cyprus, the Republic of Latvia,the Republic of Lithuania, the Republic of Hungary, the Republic ofMalta, the Republic of Poland, the Republic of Slovenia and the Slovak
Republic and the adjustments to the Treaties on which the European
Union is foundedL 236 33 23.9.2003
▼B
COUNCILREGULATION(EEC)No1768/92
of18June1992
concerning the creation of a supplementary protection certificate
formedicinal products
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European EconomicCommunity, and in particular Article 100a thereof,
Having regard to the proposal from the Commission (
1),
In cooperation with the European Parliament (2),
Having regard to the opinion of the Economic and Social
Committee (3),
Whereas pharmaceutical research plays a decisive role in the conti-
nuing improvementin public healt h;
Whereas medicinal products, especially those that are the result of
long, costly research will not continue to be developed in the Commu-nity and in Europe unless they are covered by favourable rules thatprovide for sufficient protection top 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 authorizationto place the medicinal product on the market makes the period of effec-
tive protection under the patent insufficient to cover the investment put
into the research;
Whereas this situation leads to a lack of protection which penalizes
pharmaceutical research;
Whereas the current situation is creating the risk of research centres
situated in the Member States relocating to countries that already offergreater 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 theCommunity and thus directly affect the establishment and the func-tioning of the internal market;
Whereas, therefore, the creation of a supplementary protection certifi-
cate granted, under the same conditions, by each of the MemberStates 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 mostappropriate legal instrument;
Whereas the duration of the protection granted by the certificate should
be such as to provide adequate effective protection; whereas, for thispurpose, the holder of both a patent and a certificate should be able to
enjoy an overall maximum of fifteen years of exclusively from the time
the medicinal product in question first obtains authorization to beplaced 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 mustnevertheless be taken into account; whereas, for this purpose, the certi-ficate 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 amedicinal product;1992R1768 — EN — 01.05.2004 — 002.001 — 2
(1) OJ No C 114, 8. 5. 1990, p. 10.
(2) OJ No C 19, 28. 1. 1991, p. 94 and
OJ No C 150, 15. 6. 1992.
(3) OJ No C 69, 18. 3. 1991, p. 22.
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Whereas a fair balance should also be struck with regard to the deter-
mination of the transitional arrangements; whereas such arrangementsshould 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 guaranteeing them more adequate protec-tion, while making sure that the arrangements do not compromise theachievement of other legitimate objectives concerning the health poli-cies pursued both at national and Community level;
Whereas the transitional arrangements applicable to applications for
certificates filed and to certificates granted under national legislationprior 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 productsonly very recently;
Whereas provision should be made for appropriate limitation of the
duration of the certificate in the special case where a patent term hasalready been extended under a specific national law,
HAS ADOPTED THIS REGULATION:
Article 1
Definitions
For the purposes of this Regulation:
(a) ‘medicinal product’ means any substance or combination of
substances presented for treating or preventing disease in humanbeings or animals and any substance or combination of substanceswhich may be administered to human beings or animals with aview to making a medical diagnosis or to restoring, correcting ormodifying physiological functions in humans or in animals;
(b) ‘product’ means the active ingredient or combination of active
ingredients of a medicinal product;
(c) ‘basic patent’ means a patent which protects a product as defined in
(b) as such, a process to obtain a product or an application of aproduct, and which is designated by its holder for the purpose ofthe procedure for grant of a certificate;
(d) ‘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 as a medicinal product,
to an administrative authorization procedure as laid down in Council
Directive 65/65/EEC (
1) or Directive 81/851/EEC (2) may, under the
terms and conditions provided for in this Regulation, be the subject ofa certificate.
Article 3
Conditionsforobtainingacertificate
A certificate shall be granted if, in the Member State in which the
application referred to in Article 7 is submitted and at the date of thatapplication:
(a) the product is protected by a basic patent in force;1992R1768 — EN — 01.05.2004 — 002.001 — 3
(1) OJ No L 22, 9. 12. 1965, p. 369. Lastamended by Direct ive 89/341/EEC
(OJ No L 142, 25. 5. 1989, p. 11).
(2) OJ No L 317, 6. 11. 1981, p. 1. Amended by Directive 90/676/EEC (OJ No
L 373, 31. 12. 1990, p. 15).
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(b) a valid authorization to place the product on the market as a medic-
inal product has been granted in accordance with Directive 65/65/EEC or Directive 81/851/EEC, as appropriate. ►
A1For the
purpose of Article 19 (1), an authorization to place the product on
the market granted inaccordance with the national legislation ofAustria, Finland or Sweden is treated as an authorization grantedin 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 authorization to place
the product on the market as a medicinal product.
Article 4
Subject-matterofprotection
Within the limits of the protection conferred by the basic patent, the
protection conferred by a certificate shall extend only to the productcovered by the authorization to place the corresponding medicinalproduct on the market and for any use of the product as a medicinalproduct that has been authorized before the expiry of the certificate.
Article 5
Effectsofthecertificate
Subject to the provisions of Article 4, the certificate shall confer the
same rights as conferred by the basic patent and shall be subject tothe same limitations and the same obligations.
Article 6
Entitlementtothecertificate
The certificate shall be granted to the holder of the basic patent or his
successor in title.
Article 7
Applicationforacertificate
1. 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.
2. Notwithstanding paragraph 1, where the authorization to place the
product on the market is granted before the basic patent is granted, theapplication for a certificate shall be lodged within six months of thedate on which the patent is granted.
Article 8
Contentoftheapplicationforacertificate
1. 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, ifthis 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 authorization1992R1768 — EN — 01.05.2004 — 002.001 — 4
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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 inthe Community, information regarding the identity of the product
thus authorized and the legal provision under which the authoriza-
tion procedure took place, together with a copy of the noticepublishing the authorization in the appropriate official publication.
2. Member States may provide that a fee is to be payable upon
application for a certificate.
Article 9
Lodgingofanapplicationforacertificate
1. The application for a certificate shall be lodged with the compe-
tent industrial property office of the Member State which granted thebasic patent or on whose behalf it was granted and in which the author-
ization referred to in Article 3 (b) to place the product on the market
was obtained, unless the Member State designates another authority forthe purpose
2. 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 identifiedin that authorization;
(e) where relevant, the number and date of the first authorization to
place the product on the market in the Community.
Article 10
Grantofthecertificate orrejection oftheapplication
1. Where the application for a certificate and the product to which it
relates meet the conditions laid down in this Regulation, the authorityreferred to in Article 9 (1) shall grant the certificate.
2. The authority referred to in Article 9 (1) shall, subject to para-
graph 3, reject the application for a certificate if the application or the
product to which it relates does not meet the conditions laid down inthis Regulation.
3. Where the application for a certificate does not meet the condi-
tions laid down in Article 8, the authority referred to in Article 9 (1)
shall ask the applicant to rectify the irregularity, or to settle the fee,
within a stated time.
4. If the irregularity is not rectified or the fee is not settled under
paragraph 3 within the stated time, the authority shall reject the appli-cation.
5. Member States may provide that the authority referred to in
Article 9 (1) is to grant certificates without verifying that the condi-tions laid down in Article 3 (c) and (d) are met.
Article 11
Publication
1. Notification of the fact that a certificate has been granted shall be
published by the authority referred to in Article 9 (1). The notificationshall contain at least the following information:
(a) the name and address of the holder of the certificate;1992R1768 — EN — 01.05.2004 — 002.001 — 5
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(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 identifiedin 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.
2. Notification of the fact that the application for a certificate has
been rejected shall be published by the authority referred to in Article9 (1). The notification shall contain at least the information listed in
Article 9 (2).
Article 12
Annualfees
Member States may require that the certificate be subject to the
paymentof annual fees.
Article 13
Durationofthecertificate
1. The certificate shall take effect at the end of the lawful term of
the basic patent for a perid 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 theCommunity reduced by a period of five years.
2. Notwithstanding paragraph 1, the duration of the certificate may
not exceed five years from the date on which it takes effect.
Article 14
Expiryofthecertificate
The certificate shall lapse:
(a) at the end of the period provided for in Article 13;
(b) if the certificate-holder surrenders it;
(c) if the annual fee laid down in accordance with Article 12 is not
paid in time;
(d) if and as long as the product covered by the certificate may no
longer be placed on the market following the withdrawal of theappropriate authorization or authorizations to place on the marketin accordance with Directive 65/65/EEC or Directive 81/851/EEC.
The authority referred to in Article 9 (1) may decide on the lapse
of the certificate either of its own motion or at the request of athird party.
Article 15
Invalidityofthecertificate
1. 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 hasexpired, grounds for revocation exist which would have justifiedsuch revocation or limitation.
2. Any person may submit an application or bring an action for a
declaration of invalidity of the certificate before the body responsibleunder national law for the renovation of the corresponding basic patent.1992R1768 — EN — 01.05.2004 — 002.001 — 6
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Article 16
Notificationoflapseorinvalidity
If the certificate lapses in accordance with Article 14 (b), (c) or (d) or
is invalid in accordance with Article 15, notification thereof shall bepublished by the authority referred to in Article 9 (1).
Article 17
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 opento the same appeals as those provided for in national law againstsimilar decisions taken in respect of national patents.
Article 18
Procedure
1. In the absence of procedural provisions in this Regulation, the
procedural provisions applicable under national law to the corre-
sponding basic patent shall apply to the certificate, unless that law
lays down special procedural provisions for certificates.
2. Notwithstanding paragraph 1, the procedure for opposition to the
granting of a certificate shall be excluded.
Article 19
Transitionalprovisions
1. Any product which on the date of accession is protected by a
valid patent and for which the first authorization to place it on themarket as a medicinal product in the Community or within the terri-tories of Austria, Finland or Sweden was obtained after 1 January1985 may be granted a certificate.
In the case of certificates to be granted in Denmark, in Germany and in
Finland, the date of 1 January 1985 shall be replaced by that of 1January 1988.
In the case of certificates to be granted in Belgium, in Italy and in
Austria, the date of 1 January 1985shall be replaced by that of 1January 1982.
2. An application for a certificate as referred to in paragraph 1 shall
be submitted within six months of the date on which this Regulationenters into force.
Article 19a
Additional provisions relating to the enlargement of the Commu-
nity
Without prejudice to the other provisions of this Regulation the
following shall apply:
(a) (i) any medicinal product protected by a valid basic patent in the
Czech Republic and for which the first authorisation to place it
on the market as a medicinal product was obtained in the
Czech Republic after 10 November 1999 may be granted acertificate, provided that the application for a certificate waslodged within six months of the date on which the first marketauthorisation was obtained,
(ii) any medicinal product protected by a valid basic patent in the
Czech Republic and for which the first authorisation to place iton the market as a medicinal product was obtained in theCommunity not earlier than six months prior to the date ofaccession may be granted a certificate, provided that the appli-1992R1768 — EN — 01.05.2004 — 002.001 — 7
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▼A2
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cation for a certificate was lodged within six months of the
date on which the first market authorisation was obtained;
(b) any medicinal product protected by a valid basic patent and for
which the first authorisation to place it on the market as a medic-inal product was obtained in Estonia prior to the date of accessionmay be granted a certificate, provided that the application for acertificate was lodged within six months of the date on which the
first market authorisation was obtained or, in the case of those
patents granted prior to 1 January 2000, within the six monthperiod provided for in the Patents Act of October 1999;
(c) a medicinal product protected by a valid basic patent and for which
the first authorisation to place it on the market as a medicinal
product was obtained in Cyprus prior to the date of accession maybe granted a certificate, provided that the application for a certifi-cate was lodged within six months of the date on which the firstmarket authorisation was obtained; notwithstanding the above,where the market authorisation was obtained before the grant of
the basic patent, the application for a certificate must be lodged
within six months of the date on which the patent was granted;
(d) any medicinal product protected by a valid basic patent and for
which the first authorisation to place it on the market as a medic-
inal product was obtained in Latvia prior to the date of accession
may be granted a certificate. In cases where the period providedfor in Article 7(1) has expired, the possibility of applying for acertificate shall be open for a period of six months starting no laterthan the date of accession;
(e) any medicinal product protected by a valid basic patent applied for
after 1 February 1994 and for which the first authorisation to placeit on the market as a medicinal product was obtained in Lithuaniaprior to the date of accession may be granted a certificate, providedthat the application for a certificate is lodged within six months of
the date of accession;
(f) any medicinal product protected by a valid basic patent and for
which the first authorisation to place it on the market as a medic-inal product was obtained after 1 January 2000 may be granted a
certificate in Hungary, provided that the application for a certificate
is lodged within six months of the date of accession;
(g) any medicinal product protected by a valid basic patent and for
which the first authorisation to place it on the market as a medic-inal product was obtained in Malta prior to the date of accession
may be granted a certificate. In cases where the period provided
for in Article 7(1) has expired, the possibility of applying for acertificate shall be open for a period of six months starting no laterthan the date of accession;
(h) any medicinal product protected by a valid basic patent and for
which the first authorisation to place it on the market as a medic-inal product was obtained after 1 January 2000 may be granted acertificate in Poland, provided that the application for a certificateis lodged within six months starting no later than the date of acces-sion;
(i) any medicinal product protected by a valid basic patent and for
which the first authorisation to place it on the market as a medic-inal product was obtained in Slovenia prior to the date of accessionmay be granted a certificate, provided that the application for a
certificate is lodged within six months of the date of accession,
including in cases where the period provided for in Article 7(1)has expired;
(j) any medicinal product protected by a valid basic patent and for
which the first authorisation to place it on the market as a medic-
inal product was obtained in Slovakia after 1 January 2000 may begranted a certificate, provided that the application for a certificatewas lodged within six months of the date on which the first marketauthorisation was obtained or within six months of 1 July 2002 ifthe market authorisation was obtained before that date.1992R1768 — EN — 01.05.2004 — 002.001 — 8
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Article 20
►A21.◄ This Regulation shall not apply to certificates granted
in accordance with the national legislation of a Member State before
the date on which this Regulation enters into force or to applications
for a certificate filed in accordance with that legislation before thedate of publication of this Regulation in the Official Journal of the
European Communities .
With regard to Austria, Finland and Sweden, this Regulation shall not
apply to certificates granted in accordance with their national legisla-
tion before the date of accession.
2. This Regulation shall apply to supplementary protection certifi-
cates granted in accordance with the national legislation of the CzechRepublic, Estonia, Cyprus, Latvia, Lithuania, Malta, Poland, Sloveniaand Slovakia prior to the date of accession.
Article 21
In those Member States whose national law did not on 1 January 1990
provide for the patentability of pharmaceutical products, this Regula-
tion shall apply five years after the entry into force of this Regulation.
Article 19 shall not apply in those Member States.
Article 22
Where a certificate is granted for a product protected by a patent
which, before the date on which this Regulation enters into force, hashad its term extended or for which such extension was applied for,under national patent law, the term of protection to be afforded underthis certificate shall be reduced by the number of years by which the
term of the patent exceeds 20 years.
FINALPROVISION
Article 23
Entryintoforce
This Regulation shall enter into force six months after its publication in
theOfficial Journal of the European Communities .
This Regulation shall be binding in its entirety and directly applicable
in all Member States.1992R1768 — EN — 01.05.2004 — 002.001 — 9
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