1992R1768 — EN — 01.01.1995 — 001.001 — 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
►A1Act of Accession of Austria, Sweden and Finland C241 21 29.8.1994
(adapted by Council Decision 95/1/EC, Euratom, ECSC) L 1 1 1.1.1995
▼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),
Incooperationwith the EuropeanParliamen t(2),
Having regard to the opinion of the Economic and Social
Committee(3),
Whereas pharmaceutical research plays a decisive role inthe con ti-
nuing 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 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 situationleads to a lack of protectionwhich pen alizes
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 creationof a supplemen tary protectioncertifi-
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 durationof the protectiongran ted 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 onthe market inthe Commun ity;
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 — 01.01.1995 — 001.001 — 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.
▼B
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 provisionshould be made for appropriate limitationof the
durationof the certificate inthe special case where a paten t 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 obtaina product or anapplicationof 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 gran ted if, inthe Member State inwhich the
applicationreferred to inArticle 7 is submitted an d at the date of thatapplication:
(a) the product is protected by a basic patent in force;1992R1768 — EN — 01.01.1995 — 001.001 — 3
(1) OJ No L 22, 9. 12. 1965, p. 369. Last amended by Directive 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).
▼B
(b) a valid authorizationto place the product onthe 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), anauthorizationto place the product on
the market granted inaccordance with the national legislation ofAustria, Finland or Sweden is treated as an authorization grantedinaccordan ce 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 authorizationreferred to in(b) is the first authorizationto place
the product onthe market as a medicin al 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 beenauthorized 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 intitle.
Article 7
Applicationforacertificate
1. The applicationfor a certificate shall be lodged withinsix mon ths
of the date onwhich the authorizationreferred to inArticle 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, theapplicationfor a certificate shall be lodged withinsix mon ths 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 onthe market, as referred to inArticle 3 (b) an d, ifthis authorizationis n ot the first authorizationfor placin g the
product on the market in the Community, the number and date
of that authorization;
(b) a copy of the authorizationto place the product onthe market, as
referred to inArticle 3 (b), inwhich the product is iden tified,containing in particular the number and date of the authorization1992R1768 — EN — 01.01.1995 — 001.001 — 4
▼B
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 authorizationreferred to in(b) is n ot 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-
tionprocedure took place, together with a copy of the n oticepublishing the authorization in the appropriate official publication.
2. Member States may provide that a fee is to be payable upon
applicationfor a certificate.
Article 9
Lodgingofanapplicationforacertificate
1. The applicationfor 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-
izationreferred to inArticle 3 (b) to place the product onthe market
was obtained, unless the Member State designates another authority forthe purpose
2. Notificationof the applicationfor a certificate shall be published
by the authority referred to inparagraph 1. The n otificationshall
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 identifiedinthat authorization ;
(e) where relevant, the number and date of the first authorization to
place the product onthe market inthe Commun ity.
Article 10
Grantofthecertificate orrejection oftheapplication
1. Where the applicationfor a certificate an d the product to which it
relates meet the conditions laid down in this Regulation, the authorityreferred to inArticle 9 (1) shall gran t the certificate.
2. The authority referred to inArticle 9 (1) shall, subject to para-
graph 3, reject the applicationfor a certificate if the applicationor 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-
tion s laid downinArticle 8, the authority referred to inArticle 9 (1)
shall ask the applicant to rectify the irregularity, or to settle the fee,
withina stated time.
4. If the irregularity is not rectified or the fee is not settled under
paragraph 3 withinthe 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. Notificationof the fact that a certificate has beengran ted shall be
published by the authority referred to inArticle 9 (1). The n otificationshall contain at least the following information:
(a) the name and address of the holder of the certificate;1992R1768 — EN — 01.01.1995 — 001.001 — 5
▼B
(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 identifiedinthat authorization ;
(e) where relevant, the number and date of the first authorization to
place the product onthe market inthe Commun ity;
(f) the durationof the certificate.
2. Notificationof the fact that the applicationfor a certificate has
beenrejected shall be published by the authority referred to inArticle9 (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
payment of 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 authorizationto place the product onthe market intheCommunity 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 intime;
(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 authorizationor authorization s to place onthe marketinaccordan ce with Directive 65/65/EEC or Directive 81/851/EEC.
The authority referred to inArticle 9 (1) may decide onthe lapse
of the certificate either of its ownmotionor 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 revocationor 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 — 01.01.1995 — 001.001 — 6
▼B
Article 16
Notificationoflapseorinvalidity
If the certificate lapses inaccordan ce with Article 14 (b), (c) or (d) or
is invalid in accordance with Article 15, notification thereof shall bepublished by the authority referred to inArticle 9 (1).
Article 17
Appeals
The decisions of the authority referred to in Article 9 (1) or of the body
referred to inArticle 15 (2) takenun der this Regulationshall 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 lawlays downspecial procedural provision s 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 January
1985 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.
Inthe case of certificates to be gran ted inBelgium, inItaly an d in
Austria, the date of 1 January 1985shall be replaced by that of 1
January 1982.
2. Anapplicationfor a certificate as referred to inparagraph 1 shall
be submitted withinsix mon ths of the date onwhich this Regulationenters into force.
Article 20
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 certifi-
cate filed inaccordan ce with that legislationbefore the date ofpublicationof this Regulationinthe 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-tionbefore 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.1992R1768 — EN — 01.01.1995 — 001.001 — 7
▼A1
▼B
▼A1
▼B
▼B
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 under
this certificate shall be reduced by the number of years by which theterm 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
inall Member States.1992R1768 — EN — 01.01.1995 — 001.001 — 8