1996R1610 — EN — 01.05.2004 — 001.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B REGULATION (EC) No 1610/96 OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL
of23July1996
concerningthecreation ofasupplementaryprotectioncertificate forplantprotectionproducts
(OJ L 198, 8.8.1996, p. 30)
Amended by:
Official Journal
No page date
►A1Act 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 of
Malta, the Republic of Poland, the Republic of Slovenia and the Slovak
Republic and the adjustments to the Treaties on which the EuropeanUnion isfoundedL 236 33 23.9.2003
▼B
REGULATION (EC) No 1610/96 OF THE EUROPEAN PARLIA-
MENTANDOFTHECOUNCIL
of23July1996
concerning the creation of a supplementary protection certificate
forplantprotection products
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and
in particular Article 100a thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the Economic and Social
Committee (2),
Acting in accordance with the procedure referred to in Article 189b of
the Treaty (3),
(1)Whereasres earch into plant protection productscontributestothe continuing improvement in the production and procurementof plentiful food of good quality at affordable prices;
(2)Whereasplant protection res earch contributesto the continuingimprovement in crop production;
(3)Whereas plant protection products, especially those that are theresult of long, costly research, will continue to be developed inthe Community and in Europe if they are covered by favourablerules that provide for sufficient protection to encourage such
research;
(4)Whereas the competitiveness of the plant protection sector, by
the very nature of the industry, requires a level of protectionfor innovation which isequivalent to that granted to medicinalproductsby Council Regulation (EEC) No 1768/92 of 18 June1992 concerning the creation of a supplementary protection
certificate for medicinal products(
4);
(5)Whereas, at the moment, the period that elapses between the
filing of an application for a patent for a new plant protectionproduct and authorization to place the said plant protectionproduct on the market makesthe period of effective protectionunder the patent insufficient to cover the investment put into
the research and to generate the resources needed to maintain a
high level of research;
(6)Whereasthiss ituation leadsto a lack of protection which pena-lizes plant protection research and the competitiveness of thesector;
(7)Whereasone of the main objectivesof the s upplementary protec-
tion certificate is to place European industry on the same
competitive footing asitsNorth American and Japanes e counter-parts;
(8)Whereas, in its Resolution of 1 February 1993 (5) on a Commu-
nity programme of policy and action in relation to theenvironment and sustainable development, the Council adopted
the general approach and strategy of the programme presented
by the Commission, which stressed the interdependence ofeconomic growth and environmental quality; whereasimproving1996R1610 — EN — 01.05.2004 — 001.001 — 2
(1) OJ C 390, 31. 12. 1994, p. 21 and OJ C 335, 13. 12. 1995, p. 15.
(2) OJ No C 155, 21. 6. 1995, p. 14.
(3) Opinion of the European Parliament of 15 June 1995 (OJ C 166, 3. 7. 1995,
p. 89), common position of the Council of 27 November 1995 (OJ C 353,
30. 12. 1995, p. 36) and decision of the European Parliament of 12 March
1996 (OJ C 96, 1. 4. 1996, p. 30).
(4) OJ No L 182, 2. 7. 1992, p. 1.
(5) OJ No C 138, 17. 5. 1993, p. 1.
▼B
protection of the environment meansmaintaining the economic
competitiveness of industry; whereas, accordingly, the issue ofa supplementary protection certificate can be regarded as a posi-
tive measure in favour of environmental protection;
(9)Whereas a uniform solution at Community level should be
provided for, thereby preventing the heterogeneousdevelopmentof national lawsleading to further dis paritieswhich would belikely to hinder the free movement of plant protection products
within the Community and thusdirectly affect the functioning
of the internal market; whereasthisisin accordance with theprinciple of subsidiarity as defined by Article 3b of the Treaty;
(10)Whereas, therefore, there is a need to create a supplementaryprotection certificate granted, under the same conditions, by
each of the Member Statesat the reques t of the holder of a
national or European patent relating to a plant protection productfor which marketing authorization has been granted is necessary;whereasa Regulation istherefore the mos t appropriate legalinstrument;
(11)Whereasthe 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 certi-ficate should be able to enjoy an overall maximum of fifteenyearsof exclus ivity from the time the plant protection productin question first obtains authorization to be placed on the market
in the Community;
(12)Whereas all the interests at stake in a sector as complex and
sensitive as plant protection must nevertheless be taken intoaccount; whereas, for this purpose, the certificate cannot begranted for a period exceeding five years;
(13)Whereas the certificate confers the same rights as those
conferred by the basic patent; whereas, consequently, where the
basic patent covers an active substance and its various deriva-tives (salts and esters), the certificate confers the sameprotection;
(14)Whereas the issue of a certificate for a product consisting of an
active substance does not prejudice the issue of other certificates
for derivatives (salts and esters) of the substance, provided thatthe derivatives are the subject of patents specifically coveringthem;
(15)Whereas a fair balance should also be stuck with regard to the
determination of the transitional arrangements; whereas such
arrangementss hould enable the Community plant protectionindustry to catch up to some extent with its main competitors,while making sure that the arrangements do not compromisethe achievement of other legitimate objectivesconcerning theagricultural policy and environment protection policy pursued at
both national and Community level;
(16)Whereasonly action at Community level will enable the objec-
tive, which consists in ensuring adequate protection forinnovation in the field of plant protection, while guaranteeingthe proper functioning of the internal market for plant protection
products, to be attained effectively;
(17)Whereasthe detailed rulesin recitals12, 13 and 14 and in Arti-
cles3 (2), 4, 8 (1) (c) and 17 (2) of thisRegulation are als ovalid,mutatis mutandis, for the interpretation in particular of
recital 9 and Articles3, 4, 8 (1) (c) and 17 of Council Regula-tion (EEC) No 1768/92,1996R1610 — EN — 01.05.2004 — 001.001 — 3
▼B
HAVE ADOPTED THIS REGULATION:
Article 1
Definitions
For the purposes of this Regulation, the following definitions shall
apply:
1. ‘plant protection products’: active substances and preparations
containing one or more active substances, put up in the form in
which they are supplied to the user, intended to:
(a) protect plants or plant products against all harmful organisms
or prevent the action of such organisms, in so far as suchsubstances or preparations are not otherwise defined below;
(b) influence the life processes of plants, other than as a nutrient
(e.g. plant growth regulators);
(c) preserve plant products, in so far as such substances or
products are not subject to special Council or Commission
provisions on preservatives;
(d) destroy undesirable plants; or
(e) destroy parts of plants, check or prevent undesirable growth of
plants;
2. ‘substances’: chemical elements and their compounds, as they
occur naturally or by manufacture, including any impurity inevi-tably resulting from the manufacturing process;
3. ‘active substances’: substances or micro-organisms including
viruses, having general or specific action:
(a) against harmful organisms; or
(b) on plants, parts of plants or plant products;
4. ‘preparations’: mixtures or solutions composed of two or more
substances, of which at least one is an active substance, intended
for use as plant protection products;
5. ‘plants’: live plants and live parts of plants, including fresh fruit
and seeds;
6. ‘plant products’: products in the unprocessed state or having under-
gone only simple preparation such as milling, drying or pressing,derived from plants, but excluding plants themselves as defined inpoint 5;
7. ‘harmful organisms’: pests of plants or plant products belonging to
the animal or plant kingdom, and also viruses, bacteria and myco-plasmas and other pathogens;
8. ‘product’: the active substance as defined in point 3 or combination
of active substances of a plant protection product;
9. ‘basic patent’: a patent which protects a product as defined in point
8 ass uch, a preparation asdefined in point 4, a proces sto obtain a
product or an application of a product, and which isdes ignated by
itsholder for the purpos e of the procedure for grant of a certificate;
10. ‘certificate’: 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 plant protectionproduct, to an administrative authorization procedure as laid down in
Article 4 of Directive 91/414/EEC (
1), or pursuant to an equivalent
provision of national law if it is a plant protection product in respectof which the application for authorization waslodged before Directive1996R1610 — EN — 01.05.2004 — 001.001 — 4
(1) OJ L 230, 19. 8. 1991, p. 1. Directive aslas t amended by Directive 95/36/
EC (OJ L 172, 22. 7. 1995, p. 8).
▼B
91/414/EEC wasimplemented by the Member State concerned, may,
under the termsand conditionsprovided for in thisRegulation, be thesubject of a certificate.
Article 3
Conditionsforobtainingacertificate
1. A certificate shall be granted if, in the Member State in which the
application referred to in Article 7 iss ubmitted, at the date of thatapplication:
(a) the product isprotected by a bas ic patent in force;
(b) a valid authorization to place the product on the market asa plant
protection product hasbeen granted in accordance with Article 4 ofDirective 91/414/EEC or an equivalent provision of national law;
(c) the product hasnot already been the s ubject of a certificate;
(d) the authorization referred to in (b) isthe firs t authorization to place
the product on the market asa plant protection product.
2. The holder of more than one patent for the same product shall not
be granted more than one certificate for that product. However, wheretwo or more applicationsconcerning the s ame product and emanatingfrom two or more holdersof different patentsare pending, one certifi-
cate for this product may be issued to each of these holders.
Article 4
Subject-matterofprotection
Within the limitsof the protection conferred by the bas ic patent, the
protection conferred by a certificate shall extend only to the productcovered by the authorizationsto place the corres ponding plant protec-
tion product on the market and for any use of the product as a plant
protection product that hasbeen authorized before the expiry of thecertificate.
Article 5
Effectsofthecertificate
Subject to Article 4, the certificate shall confer the same rights as
conferred by the basic patent and shall be subject to the same limita-tions 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 (1) (b) to
place the product on the market asa plant protection product wasgranted.
2. Notwithstanding paragraph 1, where the authorization to place the
product on the market isgranted before the bas ic patent isgranted, theapplication for a certificate shall be lodged within six months of thedate on which the patent isgranted.1996R1610 — EN — 01.05.2004 — 001.001 — 5
▼B
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) the name and address of the representative, if any;
(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, asreferred to in Article 3 (1) (b) and,if thisauthorization isnot the firs t authorization to place theproduct on the market in the Community, the number anddate of that authorization;
(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 isidentified,
containing in particular the number and date of the authorizationand the summary of the product characteristics listed in Part A.I(points1-7) or B.I (points1-7) of Annex II to Directive 91/414/EEC or in equivalent national lawsof the Member State in which
the application waslodged;
(c) if the authorization referred to in (b) isnot the firs t authorization to
place the product on the market asa plant protection product in theCommunity, information regarding the identity of the product thusauthorized and the legal provision under which the authorizationprocedure took place, together with a copy of the notice publishingthe authorization in the appropriate official publication or, failing
such a notice, any other document proving that the authorization
has been issued, the date on which it was issued and the identityof the product authorized.
2. Member Statesmay require a fee 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 (1) (b) to place the product on the
market was obtained, unless the member State designates another
authority for the 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 (1) (b), and the product identi-fied in 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
relatesmeet the conditionslaid down in thisRegulation, the authority
referred 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 the1996R1610 — EN — 01.05.2004 — 001.001 — 6
▼B
product to which it relatesdoesnot meet the conditionslaid down in
thisRegulation.
3. Where the application for a certificate doesnot meet the condi-
tionslaid 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 isnot rectified or the fee isnot s ettled under
paragraph 3 within the stated time, the application shall be rejected.
5. Member Statesmay provide that the authority referred to in
Article 9 (1) isto grant certificateswithout verifying that the condi-
tionslaid down in Article 3 (1) (c) and (d) are met.
Article 11
Publication
1. Notification of the fact that a certificate hasbeen granted s hall 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;
(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 (1) (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 Article
9 (1). The notification shall contain at least the information listed in
Article 9 (2).
Article 12
Annualfees
Member Statesmay require the certificate to be s ubject 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 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 theCommunity, reduced by a period of five years.
2. Notwithstanding paragraph 1, the duration of the certificate may
not exceed five yearsfrom the date on which it takeseffect.
3. For the purposes of calculating the duration of the certificate,
account shall be taken of a provisional first marketing authorizationonly if it isdirectly followed by a definitive authorization concerningthe same product.
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;1996R1610 — EN — 01.05.2004 — 001.001 — 7
▼B
(c) if the annual fee laid down in accordance with Article 12 isnot
paid in time;
(d) if and aslong asthe product covered by the certificate may no
longer be placed on the market following the withdrawal of theappropriate authorization or authorizationsto place it on the marketin accordance with Article 4 of Directive 91/414/EEC or equivalentprovisions of national law. The authority referred to in Article 9 (1)may decide on the lapse of the certificate either on its own initia-
tive or at the request of a third party.
Article 15
Invalidityofthecertificate
1. The certificate shall be invalid if:
(a) it wasgranted contrary to the provis ionsof 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 wasgranted would no longer be protectedby 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 responsible
under national law for the revocation of the corresponding basic patent.
Article 16
Notificationoflapseorinvalidity
If the certificate lapses in accordance with Article 14 (b), (c) or (d) or
isinvalid in accordance with Article 15, notification thereof s hall bepublished by the authority referred to in Article 9 (1).
Article 17
Appeals
1. The decisions of the authority referred to in Article 9 (1) or of the
body referred to in Article 15 (2) taken under thisRegulation s hall beopen to the same appeals as those provided for in national law againstsimilar decisions taken in respect of national patents.
2. The decision to grant the certificate shall be open to an appeal
aimed at rectifying the duration of the certificate where the date of
the first authorization to place the product on the market in the
Community, contained in the application for a certificate asprovidedfor in Article 8, isincorrect.
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 and, where appropriate, the proceduralprovisions applicable to the certificates referred to in Regulation(EEC) No 1768/92, shall apply to the certificate, unless national lawlays down special procedural provisions for certificates as referred to
in thisRegulation.
2. Notwithstanding paragraph 1, the procedure for opposition to the
granting of a certificate shall be excluded.
TRANSITIONAL PROVISIONS
Article 19
1. Any product which, on the date on which thisRegulation enters
into force, is protected by a valid basic patent and for which the first1996R1610 — EN — 01.05.2004 — 001.001 — 8
▼B
authorization to place it on the market asa plant protection product in
the Community wasobtained after 1 January 1985 under Article 4 ofDirective 91/414/EEC or an equivalent national provision may be
granted a certificate.
2. An application made under paragraph 1 for a certificate shall be
submitted within six months of the date on which this Regulation
entersinto force.
Article 19a
Provisionsrelatingtotheenlargement oftheCommunity
Without prejudice to the other provisions of this Regulation, the
following shall apply:
(a) (i) any plant protection product protected by a valid basic patent
in the Czech Republic and for which the first authorisation toplace it on the market asa plant protection product wasobtained in the Czech Republic after 10 November 1999 maybe granted a certificate, provided that the application for acertificate waslodged within s ix monthsof the date on which
the first market authorisation was obtained,
(ii) any plant protection product protected by a valid basic patent
in the Czech Republic and for which the first authorisation toplace it on the market asa plant protection product wasobtained in the Community not earlier than six months prior
to the date of accession may be granted a certificate, provided
that the application for a certificate waslodged within s ixmonths of the date on which the first market authorisationwasobtained;
(b) any plant protection product protected by a valid basic patent and
for which the first authorisation to place it on the market as a plantprotection product wasobtained in Es tonia prior to the date of
accession may be granted a certificate, provided that the applica-
tion for a certificate waslodged within s ix monthsof the date onwhich the first market authorisation was obtained or, in the caseof those patents granted prior to 1 January 2000, within the sixmonth period provided for in the PatentsAct of October 1999;
(c) any plant protection product protected by a valid basic patent and
for which the first authorisation to place it on the market as a plant
protection product wasobtained in Cyprusprior to the date ofaccession may be granted a certificate, provided that the applica-tion for a certificate waslodged within s ix monthsof the date onwhich the first market authorisation was obtained; notwithstandingthe 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 wasgranted;
(d) any plant protection product protected by a valid basic patent and
for which the first authorisation to place it on the market as a plantprotection product wasobtained in Latvia prior to the date ofaccession may be granted a certificate. In cases where the period
provided for in Article 7(1) has expired, the possibility of applying
for a certificate shall be open for a period of six months starting nolater than the date of accession;
(e) any plant protection product protected by a valid basic patent
applied for after 1 February 1994 and for which the first authorisa-tion to place it on the market asa plant protection product wasobtained in Lithuania prior to the date of accession may be granted
a certificate, provided that the application for a certificate islodged
within six months of the date of accession;
(f) any plant protection product protected by a valid basic patent and
for which the first authorisation to place it on the market as a plantprotection product wasobtained after 1 January 2000 may begranted a certificate in Hungary, provided that the application fora certificate is lodged within six months of the date of accession;1996R1610 — EN — 01.05.2004 — 001.001 — 9
▼A1
▼A1
(g) any plant protection product protected by a valid basic patent and
for which the first authorisation to place it on the market as a plantprotection product wasobtained in Malta prior to the date of acces -
sion may be granted a certificate. In cases where the period
provided for in Article 7(1) has expired, the possibility of applyingfor a certificate shall be open for a period of six months starting nolater than the date of accession;
(h) any plant protection product protected by a valid basic patent and
for which the first authorisation to place it on the market as a plantprotection product wasobtained after 1 January 2000 may begranted a certificate in Poland, provided that the application for acertificate is lodged within six months starting no later than the
date of accession;
(i) any plant protection product protected by a valid basic patent and
for which the first authorisation to place it on the market as a plantprotection product wasobtained in Slovenia prior to the date ofaccession may be granted a certificate, provided that the applica-
tion for a certificate islodged within s ix monthsof the date of
accession, including in cases where the period provided for inArticle 7(1) hasexpired;
(j) any plant protection product protected by a valid basic patent and
for which the first authorisation to place it on the market as a plant
protection product wasobtained in Slovakia after 1 January 2000may be granted a certificate, provided that the application for acertificate waslodged within s ix monthsof the date on which thefirst market authorisation was obtained or within six months of 1July 2002 if the market authorisation was obtained before that date.
Article 20
►
A11.◄In those Member States whose national law did not, on
1 January 1990, provide for the patentability of plant protectionproducts, this Regulation shall apply from 2 January 1998.
Article 19 shall not apply in those Member States.
2. This Regulation shall apply to supplementary protection certifi-
catesgranted in accordance with the national legis lation of the CzechRepublic, Estonia, Cyprus, Latvia, Lithuania, Malta, Poland, Slovenia
and Slovakia prior to the date of accession.
FINAL PROVISION
Article 21
Entryintoforce
This Regulation shall enter into force six months after its publication in
theOfficial JournaloftheEuropeanCommunities .
ThisRegulation s hall be binding in itsentirety and directly applicable
in all Member States.1996R1610 — EN — 01.05.2004 — 001.001 — 10
▼B
▼A1
▼B