CELEX: 51995PC0456
Language: en
Date: 1995-10-05
Title: Amended proposal for a EUROPEAN PARLIAMENT AND COUNCIL REGULATION (EC) concerning the creation of a supplementary protection certificate for plant protection products

COMMISSION OF THE EUROPEAN COMMUNITIES
                                          Brussels, 05.10.1995
                                          COM(95) 456 final
                                          94/0285 (COD)
                     Amended proposal for a
EUROPEAN PARLIAMENT AND COUNCIL REGULATION (EC)
  concerning the creation of a supplementary protection certificate
                    for plant protection products
   (presented by the Commission pursuant to Article 189 a (2)
                         of the EC-Treaty)
 ---pagebreak---  ---pagebreak---                            EXPLANATORY MEMORANDUM
                               GENERAL PRESENTATION
In December 1994 the Commission presented to Parliament and to the Council a
proposal for a Regulation concerning the creation of a supplementary protection
certificate for plant protection products.1
The Economic and Social Committee adopted its opinion on 27 April 1995.2
Parliament discussed the proposal in detail in its various committees and during its
plenary session in June 1995.3
The purpose of the amended proposal is to take account of these opinions and to clarify,
where necessary, the wording of a number of provisions. In particular, the amended
proposal allows for the amendments to Directive 91/414/EEC, made after the
Commission had presented its proposal.
Parliament examined the economic conditions in which the plant protection industry
operates within the Community and set out the specific characteristics of this sector in
relation to its objectives and in view of its international competitors.
The Commission is willing to accept the four amendments adopted by Parliament, all of
which aim to clarify the economic and legal conditions under which the plant protection
sector in the Community operates.
1
     OJNoC39(), 31.12.1994, p. 21.
2
    OJ No C
3
    OJNoC
                                             CD
 ---pagebreak---                               EXAMINATION OF THE RECITALS
RECITAL NO 1
The purpose of this new recital, which adopts in full Amendment 1 adopted by
Parliament, is to make clear that plant protection research contributes to improvements in
production and procurement of good-quality food.
RECITAL NO 3
This recital has been amended to include the full text of Amendment 2 adopted by
Parliament. It states that plant protection products will continue to be developed if there
is adequate protection in the Community to encourage research.
RECITAL NO 4
This new recital, which adopts almost the same wording as Amendment 3 adopted by
Parliament, states that the plant protection sector is in a situation similar to that of the
pharmaceuticals industry when an equivalent measure to restore the effective duration of
patent protection was proposed and adopted.4
RECITAL NO 7
This new recital, which adopts almost the same wording as Amendment 4 adopted by
Parliament, states that one of the proposal's objectives is to place European industry on
the same competitive footing as its international competitors.
RECITALS NOS 13 AND 14
These two new recitals set out the scope of protection conferred by the supplementary
certificate and clarify the links between the basic patent covering a plant protection
product and the supplementary certificate for the same product. They also state the
conditions under which a supplementary certificate may be obtained for the derivatives
of a plant protection product already covered by a supplementary certificate.
    Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary
    protection certificate for medicinal products; OJ No L 182, 2.7.1992, p. 1.
                                                    -2-
 ---pagebreak---                         EXPLANATION OF THE PROVISIONS
ARTICLE 2
The slightly revised wording takes account of any problems that could arise in the
Member States which were not able to transpose Directive 91/414/EEC concerning the
placing of plant protection products on the market by the required deadline, and in the
new Member States which have transitional periods in which to transpose Community
directives.
ARTICLE 3 (2)
This new paragraph states that, as a rule, the holder of a number of patents for the same
plant protection product may not be granted a number of certificates for that product, and
sets out the specific circumstances (where two or more applications are pending) in
which two or more certificates may be issued for the same product.
ARTICLE 8 (1)
Since the Commission presented its proposal, Directive 91/414/EEC concerning the
placing of plant protection products on the market has been amended by Directive
94/37/EEC of 22 July 1994. Annex II to Directive 91/414/EEC has also been amended.
The new wording of Article 8(l)(b) takes account of this amendment.
In addition, the new Article 8(c)(1) allows for the situation in Member States in which
the authorization to place plant protection products on the market is not published in an
Official Journal or another official publication. In those Member States, the application
for a certificate must be accompanied by any other document proving that the
authorization has been issued, the date on which it was issued and the identity of the
product authorized.
ARTICLE 13 (3)
This new paragraph takes account of the special features of the authorization procedure
for placing plant protection products on the market. For the purposes of calculating the
duration of the supplementary protection certificate, provisional authorization is taken
into account only if it is subsequently followed by a definitive authorization concerning
the same product. This provision applies equally to the system under Directive
91/414/EEC and, where appropriate, to equivalent provisions of national law.
                                             -3
 ---pagebreak--- ARTICLE 18
There has been a Community Regulation concerning the creation of a supplementary
protection certificate for medicinal products since 1992; under that Regulation, a number
of Member States have adopted special procedural provisions concerning the issue of
those supplementary certificates. The amendment to Article 18 allows the Member States
which already have special provisions for supplementary protection certificates for
medicinal products to apply them, mutatis mutandis, to supplementary protection
certificates for plant protection products.
ARTICLE 20
This new Article takes account of the specific situation of Member States which have
recently introduced into national law the principle of patentability of plant protection
products. Under Regulation (EEC) No 1768/92 concerning the creation of a
supplementary protection certificate for medicinal products, it was decided that the
Member States whose laws introduced the patentability of pharmaceutical products only
very recently would be able to implement the Regulation five years later than the other
Member States. This deferral means that an application for a supplementary protection
certificate for a medicinal product will be acceptable in the Member States concerned
only from 2 January 1998. Under this Regulation, account should be taken of the similar
situation existing in a number of Member States with regard to the patentability of plant
protection products; for those Member States, the date of application of this Regulation
should coincide with that of Regulation No 1768/92 for medicinal products.
ARTICLE 21
This amendment takes account of the situation in Member States in which the national
parliament must adopt implementing rules for this Regulation (statutory regulations
allowing taxes to be levied, etc.) and which need time to do so. In order to allow for this
difficulty, the Article states that the Regulation is to enter into force six months after its
publication in the Official Journal of the European Communities.
                                               4-
 ---pagebreak---                                    Amended proposal for a
        EUROPEAN PARLIAMENT AND COUNCIL REGULATION ( E O
                  concerning the creation of a supplementary protection
                          certificate for plant protection products
         (presented by the Commission under Article 189a(2) of the EC Treaty)
       ORIGINAL PROPOSAL                             AMENDED PROPOSAL
THE EUROPEAN PARLIAMENT                       THE EUROPEAN PARLIAMENT
AND THE COUNCIL OF THE                        AND THE COUNCIL OF THE
EUROPEAN UNION,                               EUROPEAN UNION,
Having regard to the Treaty establishing      Unchanged
the European Economic Community,
and in particular Article 100a thereof,
Having regard to the proposal from the        Having regard to the proposal from the
Commission,   1
                                              Commission,1
Having regard to the opinion of the           Unchanged
                                    2
Economic and Social Committee,
                                              (1 ) Whereas research into plant
                                                   protection products contributes to
                                                   the continuing improvement in the
                                                   production and procurement of
                                                   plentiful food of good quality at
                                                   affordable prices;
1                                               1
    OJNoC                                          OJ No C 390, 31.12.1994, p. 21.
2
    OJ No C                                        OJNoC
                                                         <>
 ---pagebreak---         ORIGINAL PROPOSAL                       AMENDED PROPOSAL
(1) Whereas plant protection research     (2) Unchanged
     contributes to the continuing
     improvement in crop production;
(2) Whereas plant protection products,    (3) Whereas plant protection products,
     especially those that are the result     especially those that are the result
     of long, costly research, will not       of long, costly research, will
     continue to be developed in the          continue to be developed in the
     Community and in Europe unless           Community and in Europe if they
     they are covered by favourable           are covered by favourable rules
     rules that provide for sufficient        that provide for sufficient
     protection to encourage such             protection to encourage such
     research;                                research;
                                          (4) Whereas, by its very nature, the
                                              competitiveness of the plant
                                              protection sector calls for the same
                                              protection to be afforded to
                                              innovation as that granted to
                                              medicinal products by Regulation
                                              (EEC) No 1768/92 concerning the
                                              creation of a supplementary
                                              protection certificate for medicinal
                                              products;
 (3) Whereas at the moment the period     (5) Unchanged
     that elapses between the filing of
     an application for a patent for a
     new plant protection product and
      authorization to place the product
     on the market makes the period of
      effective protection under the
      patent insufficient to cover the
      investment put into the research
      and to generate the resources
      needed to maintain a high level of
      research;
                                                        C
 ---pagebreak---        ORIGINAL PROPOSAL                       AMENDED PROPOSAL
(4) Whereas this situation leads to a    (6) Unchanged
    lack of protection which penalizes
    plant protection research and the
    competitiveness of the sector;
                                         (7) Whereas one of the main
                                             objectives of the supplementary
                                             protection certificate is to place
                                             European industry on the same
                                             competitive footing as its
                                              American and Japanese
                                             counterparts;
(5) Whereas, in its Resolution of        (8) Unchanged
     1 February 1993^ on a Community
     programme of policy and action in
     relation to the environment and
     sustainable development, the
     Council adopted the general
     approach and strategy of the
     programme presented by the
     Commission, which stressed the
     interdependence of economic
     growth and environmental quality;
     whereas improving protection of
     the environment means
     maintaining the competitiveness of
     industry; whereas, accordingly, the
     issue of a supplementary
     protection certificate can be
     regarded as a positive measure in
     favour of envi ronmental
     protection;
    OJNoC 138, 17.5.1993, p. 1.              OJNoC138, 17.5.1993, p. 1.
                                                        \
 ---pagebreak---        ORIGINAL PROPOSAL                       AMENDED PROPOSAL
(6) Whereas a uniform solution at        (9) Unchanged
    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 plant protection
    products within the Community
    and thus directly affect the
    establishment and the functioning
    of the internal market; whereas
    this is in accordance with the
    principle of subsidiarity as defined
    by Article 3b of the Treaty
    establishing the European
    Community;
(7) Whereas, therefore, the creation of  (10) Unchanged
    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 plant protection
    product for which marketing
    authorization has been granted is
    necessary; whereas a Regulation is
    therefore the most appropriate
    legal instrument;
                                                       ?
 ---pagebreak---        ORIGINAL PROPOSAL                          AMENDED PROPOSAL
(8) Whereas the duration of the           (11) Unchanged
    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 certificate should be
    able to enjoy an overall maximum
    of fifteen years of exclusivity from
    the time the plant protection
    product in question first obtains
    authorization to be placed on the
    market in the Community;
(9) Whereas all the interests at stake in (12) Whereas all the interests at stake in
    a sector as complex and sensitive           a sector as complex and sensitive
    as plant protection must                    as plant protection must
    nevertheless be taken into account;         nevertheless be taken into account;
    whereas, for this purpose, the              whereas, for this purpose, the
    certificate cannot be granted for a         certificate cannot be granted for a
    period exceeding five years;                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 a plant protection
     product;
                                           (13) Whereas the certificate grants the
                                                same rights as those conferred by
                                                the basic patent; whereas,
                                                consequently, where the basic
                                                patent covers an active substance
                                                and its various derivatives (salts
                                                and esters), the certificate grants
                                                the same protection;
                                                            °\
 ---pagebreak---         ORIGINAL PROPOSAL                       AMENDED PROPOSAL
                                         (14) Whereas the issue of a certificate
                                              for a product consisting of an
                                              active substance does not prejudge
                                              the issue of other certificates for
                                              derivatives (salts and esters) of the
                                              product, provided that the
                                              derivatives are the subject of
                                              patents specifically covering them;
(10) Whereas a fair balance should also  (15) Unchanged
     be struck with regard to the
     determination of the transitional
     arrangements; whereas such
     arrangements should enable the
     Community plant protection
     industry to catch up to some extent
     with its main competitors, while
     making sure that the arrangements
     do not compromise the
     achievement of other legitimate
     objectives concerning the
     agricultural and environment
     policies pursued both at national
     and Community level;
(11) Whereas only action at              (16) Unchanged
     Community level can be effective
     in attaining the objective, which
     consists in ensuring adequate
     protection for innovation in the
     field of plant protection, while
     guaranteeing the proper
     functioning of the internal market
     for plant protection products;
HAVE ADOPTED THIS
REGULATION:
 ---pagebreak---         ORIGINAL PROPOSAL                       AMENDED PROPOSAL
                Article 1                            Article 1
               Definitions                          Definitions
For the purposes of this Regulation, the  Unchanged
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:
     1.1. protect plants or plant
            products against all harmful
            organisms or prevent the
            action of such organisms, in
            so far as such substances or
            preparations are not
            otherwise defined below;
      1.2. influence the life processes
            of plants, other than as a
            nutrient (e.g. plant growth
            regulators);
      1.3. preserve plant products, in
            so far as such substances or
            products are not subject to
            special Council or
            Commission provisions on
            preservatives;
      1.4.  destroy undesired plants; or
      1.5.  destroy parts of plants,
             check or prevent undesired
            growth of plants;
                                                      u
 ---pagebreak---       ORIGINAL PROPOSAL                  AMENDED PROPOSAL
2. "substances": chemical elements
   and their compounds, as they
   occur naturally or by manufacture,
   including any impurity inevitably
   resulting from the manufacturing
   process;
3. "active substances": substances or
   micro-organisms including viruses,
   having general or specific action:
   3.1.   against harmful organisms;
          or
   3.2.   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
   undergone only simple preparation
   such as milling, drying or pressing,
   derived from plants, but excluding
   plants themselves as defined at
   point 5;
                                             \l
 ---pagebreak---        ORIGINAL PROPOSAL               AMENDED PROPOSAL
7.  "harmful organisms": pests of
    plants or plant products belonging
    to the animal or plant kingdom,
    and also viruses, bacteria and
    mycoplasmas and other pathogens;
8.  "product": the active substance is
    defined at point 3 or combination
    of active substances of a plant
    protection product;
9.  "basic patent": a patent which
    protects a product as defined at
    point 8 as such, a preparation as
    defined at point 4, a process to
    obtain a product or an application
    of a product, and which is
    designated by its holder for the
    purpose of the procedure for grant
    of a certificate;
10. "certificate" : the supplementary
    protection certificate.
                                            U
 ---pagebreak---          ORIGINAL PROPOSAL                          AMENDED PROPOSAL
                  Article 2                                  Article 2
                   Scope                                      Scope
Any product protected by a patent in      Any product protected by a patent in the
the territory of a Member State and       territory of a Member State and subject,
subject, prior to being placed on the     prior to being placed on the market as a
market as a plant protection product, to  plant protection product, to an
an administrative authorization           administrative authorization procedure
procedure as laid down in Article 4 of    as laid down in Article 4 of Council
Council Directive 91/414/EEC,4 or         Directive 91/414/EEC,4 or pursuant to
pursuant to an equivalent provision of    an equivalent provision of national law
national law if it is a plant protection  if it is a plant protection product in
product in respect of which the           respect of which the application for
application for authorization was         authorization was lodged before
lodged before the entry into force of     Directive 91/414/EEC was
Directive 91/414/EEC for the Member       implemented by the Member State
State concerned, may, under the terms     concerned, may, under the terms and
and conditions provided for in this       conditions provided for in this
Regulation, be the subject of a           Regulation, be the subject of a
certificate.                              certificate.
                  Article 3                                 Article 3
 Conditions for obtaining a certificate    Conditions for obtaining a certificate
A certificate shall be granted if, in the 1       Unchanged
Member State in which the application
referred to in Article 7 is submitted, at
the date of that application:
a)    the product is protected by a basic
      patent in force;
    OJ No L 230, 19.8.1991, p. 1.              OJ No L 230, 19.8.1991, p. 1.
                                                             \S
 ---pagebreak---       ORIGINAL PROPOSAL                   AMENDED PROPOSAL
b) a valid authorization to place the
   product on the market as a plant
   protection product has been
   granted in accordance with
   Article 4 of Directive 91/414/EEC
   or an equivalent provision of
   national law;
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
   plant protection product.
                                        The holder of a number of patents
                                        for the same product may not be
                                        granted a number of certificates
                                        for that product. However, where
                                        two or more applications are
                                        pending, two or more certificates
                                        may be issued for the same
                                        product to two or more holders of
                                        different patents for the same
                                        product.
                                                     \<>
 ---pagebreak---         ORIGINAL PROPOSAL                       AMENDED PROPOSAL
                 Article 4                               Article 4
     Subject-matter of protection             Subject-matter of protection
Within the limits of the protection       Unchanged
conferred by the basic patent, the
protection conferred by a certificate
shall extend only to the product covered
by the authorizations to place the
corresponding plant protection product
on the market and for any use of the
product as a plant protection product
that has been authorized before the
expiry of the certificate.
                 Article 5                               Article 5
        Effects of the certificate              Effects of the certificate
Subject to the provisions of Article 4,   Unchanged
the certificate shall confer the same
rights as conferred by the basic patent
and shall be subject to the same
limitations and the same obligations.
                 Article 6                               Article 6
      Entitlement to the certificate          Entitlement to the certificate
The certificate shall be granted to the   Unchanged
holder of the basic patent or his
successor in title.
                 Article 7                               Article 7
      Application for a certificate           Application for a certificate
 1.   The application for a certificate   1.  The application for a certificate
      shall be lodged within six months       shall be lodged within six months
      of the date on which the                of the date on which the
      authorization referred to in            authorization referred to in
      Article 3(b) to place the product       Article 3(1 )(b) to place the product
      on the market as a plant protection     on the market as a plant protection
      product was granted.                    product was granted.
                                                            \l
 ---pagebreak---        ORIGINAL PROPOSAL                           AMENDED PROPOSAL
2.  Notwithstanding paragraph 1,             2.  Unchanged
    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.
                  Article 8                                 Article 8
   Content of the application for a             Content of the application for a
                certificate                                certificate
1.  The application for a certificate        1.  Unchanged
    shall contain:
     a) a request for the grant of a             a) Unchanged
        certificate, stating in particular:
            i) the name and address of                 i) Unchanged
                 the applicant;
            ii) if he has appointed a                  ii) Unchanged
                 representative, the name
                 and address of the
                 representative;
            iii) the number of the basic               iii) Unchanged
                 patent and the title of the
                 invention;
                                                                U
 ---pagebreak---   ORIGINAL PROPOSAL                     AMENDED PROPOSAL
      iv) the number and date of            iv) the number and date of
          the first authorization to            the first authorization to
          place the product on the              place the product on the
          market, as referred to in             market, as referred to in
          Article 3(b) and, if this             Article 3(1 )(b) and, if
          authorization is not the              this authorization is not
          first authorization to                the first authorization to
          place the product on the              place the product on the
          market in the                         market in the
          Community, the number                 Community, the number
          and date of that                      and date of that
          authorization;                        authorization;
b) a copy of the authorization to     b) a copy of the authorization to
   place the product on the              place the product on the
   market, as referred to in Article     market, as referred to in Article
   3(b), in which the product is         3(1 )(b), in which the product is
   identified, containing in             identified, containing in
   particular the number and date        particular the number and date
   of the authorization and the          of the authorization and the
   summary of the product                summary of the product
   characteristics listed in Part A.I    characteristics listed in Part A.I
   or B.I of Annex II to Directive       (points 1-7) or B.I (points 1-7)
   91/414/EEC or in equivalent           of Annex II to Directive
   national laws of the Member           91/414/EEC or in equivalent
    State in which the application       national laws of the Member
   was lodged;                           State in which the application
                                         was lodged;
                                                     \S
 ---pagebreak---      ORIGINAL PROPOSAL                        AMENDED PROPOSAL
   c) if the authorization referred to      c) if the authorization referred to
       in (b) is not the first                 in (b) is not the first
       authorization to place the              authorization to place the
       product on the market as a              product on the market as a
       plant protection product in the         plant protection product in the
       Community, information                  Community, information
       regarding the identity of the           regarding the identity of the
       product thus authorized and the         product thus authorized and the
       legal provision under which             legal provision under which the
       the authorization procedure             authorization procedure took
       took place, together with a             place, together with a copy of
       copy of the notice publishing           the notice publishing the
       the authorization in the Official       authorization in the appropriate
       Journal or any other document           official gazette or, failing such
       including the information               publication, any other
       required.                               document proving that the
                                               authorization has been issued,
                                               the date on which it was issued
                                               and the identity of the product
                                               authorized.
2. Member States may provide that a      2. Unchanged
   fee is payable upon application for
   a certificate.
                                                            ft
 ---pagebreak---     ORIGINAL PROPOSAL                   AMENDED PROPOSAL
             Article 9                            Article 9
Lodging of an application for a      Lodging of an application for a
            certificate                          certificate
 The application for a certificate    The application for a certificate
 shall be lodged with the competent   shall be lodged with the competent
 industrial property office of the    industrial property office of the
 Member State which granted the       Member State which granted the
 basic patent or on whose behalf it   basic patent or on whose behalf it
 was granted and in which the         was granted and in which the
 authorization referred to in         authorization referred to in
 Article 3(b) to place the product    Article 3(1 )(b) to place the product
 on the market was obtained, unless   on the market was obtained, unless
 the Member State designates          the Member State designates
 another authority for the purpose.   another authority for the purpose.
 Notification of the application for  Unchanged
 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       a) Unchanged
     applicant;
 b) the number of the basic patent;   b) Unchanged
 c) the title of the invention;       c) Unchanged
 d) the number and date of the        d) the number and date of the
     authorization to place the           authorization to place the
     product on the market, referred      product on the market, referred
     to in Article 3(b), and the          to in Article 3(1 )(b), and the
     product identified in that           product identified in that
     authorization;                       authorization;
                                                     I0
 ---pagebreak---        ORIGINAL PROPOSAL                          AMENDED PROPOSAL
   e) where relevant, the number and           e) Unchanged
        date of the first authorization
        to place the product on the
        market in the Community.
               Article 10                                 Article 10
 Grant of the certificate or rejection      Grant of the certificate or rejection of
           of the application                          the application
1. Where the application for a              1.  Unchanged
    certificate and the product to
    which it relates meet the
    conditions laid down in this
    Regulation, the authority referred
    to in Article 9(1) shall grant the
    certificate.
2.  The authority referred to in Article        Unchanged
    9(1) shall, subject to paragraph 3,
    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.
3.  Where the application for a                 Unchanged
    certificate does not meet the
    conditions 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     Unchanged
    the fee is not settled under
    paragraph 3 within the stated time,
    the authority shall reject the
     application.
                                                               U
 ---pagebreak---    ORIGINAL PROPOSAL                         AMENDED PROPOSAL
Member States may provide that             Member States may provide that
the authority referred to in               the authority referred to in
 Article 9(1) is to grant certificates     Article 9(1) is to grant certificates
without verifying that the                 without verifying that the
 conditions laid down in                   conditions laid down in
Article 3(c) and (d) are met.              Article 3(1 )(c) and (d) are met.
           Article 11                                Article 11
          Publication                               Publication
Notification of the fact that a        Unchanged
certificate has been granted shall
be published by the authority
referred to in Article 9(1). The
notification shall contain at least
the following information:
a) the name and address of the            a) unchanged
    holder of the certificate;
b) the number of the basic patent;        b) unchanged
c) the title of the invention;            c) unchanged
d) the number and date of the              d) the number and date of the
    authorization to place the                authorization to place the
    product on the market referred            product on the market referred
    to in Article 3(b) and the                to in Article 3(1 )(b) and the
    product identified in that                product identified in that
    authorization;                             authorization;
e) where relevant, the number and         e) unchanged
    date of the first authorization
    to place the product on the
    market in the Community;
f) the duration of the certificate.       f) unchanged
                                                          11
 ---pagebreak---          ORIGINAL PROPOSAL                      AMENDED PROPOSAL
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                             Article 12
                Annual fees                            Annual fees
Member States may require that the         Unchanged
certificate be subject to the payment of
annual fees.
                  Article 13                            Article 13
        Duration of the certificate             Duration of the certificate
 1.   The certificate shall take effect at 1.  Unchanged
      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, reduced by a
       period of five years.
2.     Notwithstanding paragraph 1, the        Unchanged
       duration of the certificate may not
       exceed five years from the date on
       which it takes effect.
                                                             n
 ---pagebreak---          ORIGINAL PROPOSAL                       AMENDED PROPOSAL
                                              For the purposes of calculating the
                                              duration of the certificate, account
                                              is taken of a provisional first
                                              marketing authorization only if it
                                              is subsequently followed by a
                                              definitive authorization concerning
                                              the same product.
                Article 14                               Article 14
         Expiry of the certificate               Expiry of the certificate
The certificate shall lapse:              Unchanged
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 the
     appropriate authorization or
     authorizations to place it on the
     market in accordance with
     Article 4 of Directive 91/414/EEC
     or equivalent provisions of
      national law. The authority
      referred to in Article 9(1) may
      decide on the lapse of the
      certificate either on its own
      initiative or at the request of a
      third party.
                                                               H
 ---pagebreak---         ORIGINAL PROPOSAL                        AMENDED PROPOSAL
                 Article 15                              Article 15
       Invalidity of the certificate            Invalidity of the certificate
1.   The certificate shall be invalid if:  Unchanged
     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 so 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 has expired, grounds for
          revocation exist which would
          have justified such 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                              Article 16
   Notification of lapse or invalidity       Notification of lapse or invalidity
If the certificate lapses in accordance    Unchanged
with Article 14(b), (c) or (d), or is
invalid in accordance with Article 15,
notification thereof shall be published
by the authority referred to in Article
9(1).
                                                                ?S
 ---pagebreak---         ORIGINAL PROPOSAL                         AMENDED PROPOSAL
                Article 17                                 Article 17
                 Appeals                                    Appeals
The decisions of the authority referred     Unchanged
to in Article 9(1) or of the body referred
to in Article 15(2) taken under this
Regulation shall be open to the same
appeals as those provided for in
national law against similar decisions
taken in respect of national patents.
                Article 18                                 Article 18
                Procedure                                  Procedure
 1.   In the absence of procedural          1.  In the absence of procedural
      provisions in this Regulation, the        provisions in this Regulation, the
      procedural provisions applicable          procedural provisions applicable
      under national law to the                 under national law to the
      corresponding basic patent shall          corresponding basic patent and,
      apply to the certificate, unless that     where appropriate, the procedural
      law lays down special procedural          provisions applicable to the
      provisions for certificates.              certificates referred to in
                                                Regulation 1768/92, shall apply to
                                                the certificate, unless national law
                                                lays down special procedural
                                                provisions for certificates as
                                                referred to in this Regulation.
      Notwithstanding paragraph 1, the      2.  Unchanged
      procedure for opposition to the
      granting of a certificate shall be
      excluded.
                                                                   U
 ---pagebreak---       ORIGINAL PROPOSAL                             AMENDED PROPOSAL
    TRANSITIONAL PROVISIONS                       TRANSITIONAL PROVISIONS
              Article 19                                      Article 19
1. Any product which, on the date on    Unchanged
   which this Regulation enters into
   force, is protected by a valid basic
   patent and for which the first
   authorization to place it on the
   market as a plant protection
   product in the Community was
   obtained after 1 January 1985
   under Article 4 of Directive
   91/414/EEC or an equivalent
   national provision may be granted
   a certificate.
2. An application for a certificate as
   referred to in paragraph 1 shall be
   submitted within six months of the
   date on which this Regulation
   enters into force.
                                                              Article 20
                                        In those Member States whose national
                                        law did not, on 1 January 1990, provide
                                        for the patentability of plant protection
                                        |it#t«fiff to, llito I'.MgulrtllMit «JIIMII M|i|jlv
                                        from 2 January 1998.
                                        Article 19 shall not apply in those
                                        Member States.
                                                                     n
 ---pagebreak---          ORIGINAL PROPOSAL                        AMENDED PROPOSAL
          FINAL PROVISION                           FINAL PROVISION
                Article 20                               Article 21
            Entry into force                          Entry into force
This Regulation shall enter into force    This Regulation shall enter into force
three months after its publication in the six months after its publication in the
Official Journal of the European          Official Journal of the European
Communities.                              Communities.
This Regulation shall be binding in its   Unchanged
entirety and directly applicable in all
Member States.
Done at Brussels,                         Done at Brussels,
                                                                n
 ---pagebreak---  ---pagebreak---                                                                      ISSN 0254-1475
                                                             COM(95) 456 final
                                              DOCUMENTS
EN                                                                         08 15
                                     Catalogue number : CB-CO-95-501-EN-C
                                                               ISBN 92-77-94028-X
Office for Official Publications of the European Communities
L-2985 Luxembourg
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