Amended proposal for a EUROPEAN PARLIAMENT AND COUNCIL REGULATION (EC) concerning the creation of a supplementary protection certificate for plant protection products
Date: 1995-10-05
Institutions: European Commission
Subjects: consumer protection, environmental protection, health certificate, marketing standard, pharmaceutical product, plant health product

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) 

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 
Commission had presented  its proposal. 

to  Directive 91/414/EEC,  made  after 

the  amendments 

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 

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-

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 

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 

(EEC)  No  1768/92  concerning 

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 
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-

EUROPEAN  PARLIAMENT  AND COUNCIL REGULATION  ( EO 

Amended  proposal for a 

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 
AND THE COUNCIL OF THE 
EUROPEAN UNION, 

THE  EUROPEAN  PARLIAMENT 

AND THE COUNCIL  OF  THE 

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 
Commission,1 

Having regard to the proposal from the 
Commission,1 

Having regard to the opinion of the 
Economic and Social  Committee,2 

Unchanged 

(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  OJNoC 
2  OJ No C 

1  OJ No C 390, 31.12.1994, p. 21. 

OJNoC 

<> 

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 

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. 

\ 

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; 

? 

ORIGINAL  PROPOSAL 

AMENDED PROPOSAL 

(11)  Unchanged 

(8)  Whereas the 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 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 
as plant protection must 
nevertheless be taken into account; 
whereas, for this purpose, the 
certificate  cannot be granted for a 
period exceeding five years; 

a sector as complex and sensitive 
as plant protection must 
nevertheless be taken  into account; 
whereas, for this purpose, the 
certificate  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 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; 

°\ 

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; 

(15) Unchanged 

(10) Whereas a fair balance should also 
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: 

ORIGINAL PROPOSAL 

AMENDED PROPOSAL 

Article 1 
Definitions 

Article 1 
Definitions 

For the purposes of this Regulation, the 
following  definitions  shall apply: 

Unchanged 

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 

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 

ORIGINAL PROPOSAL 

AMENDED PROPOSAL 

7. 

8. 

9. 

"harmful  organisms": pests of 
plants or plant products belonging 
to the animal or plant kingdom, 
and also viruses, bacteria and 
mycoplasmas and other pathogens; 

"product": the active substance is 
defined  at point 3 or combination 
of active substances of a plant 
protection product; 

"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 

ORIGINAL PROPOSAL 

AMENDED PROPOSAL 

Article 2 
Scope 

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 protection product, to 
an administrative authorization 
procedure as laid down in Article 4 of 
Council Directive 91/414/EEC,4 or 
pursuant to an equivalent provision of 
national law if it is a plant protection 
product in respect of which the 
application for authorization was 
lodged before the entry into force of 
Directive 91/414/EEC for the Member 
State concerned, may, under the terms 
and conditions provided for in this 
Regulation, be the subject of a 
certificate. 

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 protection product, to an 
administrative authorization  procedure 
as laid down in Article 4 of Council 
Directive 91/414/EEC,4 or pursuant to 
an equivalent provision of national law 
if it is a plant protection product in 
respect of which the application  for 
authorization was lodged  before 
Directive 91/414/EEC was 
implemented by the Member State 
concerned, may, under the terms and 
conditions provided for in this 
Regulation, be the subject of a 
certificate. 

Article 3 
Conditions for obtaining a certificate 

Article 3 
Conditions for obtaining a certificate 

1 

Unchanged 

A certificate shall be granted if,  in the 
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 

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. 

\<> 

ORIGINAL PROPOSAL 

AMENDED PROPOSAL 

Article 4 
Subject-matter of protection 

Article 4 
Subject-matter of protection 

Unchanged 

Within the limits of the protection 
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 
Effects  of the certificate 

Article 5 
Effects of the certificate 

Unchanged 

Subject to the provisions of Article 4, 
the certificate shall confer the same 
rights as conferred  by the basic patent 
and shall be subject to the same 
limitations and the same obligations. 

Article 6 
Entitlement to the certificate 

Article 6 
Entitlement to the certificate 

The certificate shall be granted to the 
holder of the basic patent or his 
successor in title. 

Unchanged 

Article 7 
Application for a certificate 

Article 7 
Application for a certificate 

1.  The application for a certificate 

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 plant protection 
product was granted. 

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 as a plant protection 
product was granted. 

\l 

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 
Content of the application for a 
certificate 

Article 8 
Content of the application for a 
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 
the applicant; 

i)  Unchanged 

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 

ORIGINAL PROPOSAL 

AMENDED PROPOSAL 

iv) the number and date of 
the first authorization to 
place the product on the 
market, as referred  to in 
Article 3(b) and, if this 
authorization  is not the 
first authorization to 
place 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 authorization and the 
summary of the product 
characteristics listed in Part A.I 
or B.I of Annex II to Directive 
91/414/EEC or in equivalent 
national laws of the Member 
State in which the application 
was lodged; 

iv) the number and date of 
the first authorization to 
place the product on the 
market, as referred to in 
Article 3(1 )(b) and, if 
this authorization  is not 
the first authorization to 
place 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(1 )(b), in which the product is 
identified,  containing in 
particular the number and date 
of the authorization and the 
summary of the product 
characteristics listed in Part A.I 
(points  1-7) or B.I (points  1-7) 
of Annex II to Directive 
91/414/EEC or in equivalent 
national laws of the Member 
State in which the application 
was lodged; 

\S 

ORIGINAL PROPOSAL 

AMENDED PROPOSAL 

c)  if the authorization  referred  to 

c)  if the authorization  referred  to 

in (b) is not the first 
authorization to place the 
product on the market as a 
plant protection product in the 
Community,  information 
regarding the identity of the 
product thus authorized and the 
legal provision under which 
the authorization  procedure 
took place, together with a 
copy of the notice publishing 
the authorization  in the  Official 
Journal or any other document 
including the  information 
required. 

in (b) is not the first 
authorization to place the 
product on the market as a 
plant protection product in the 
Community,  information 
regarding the identity of the 
product thus authorized and the 
legal provision under which the 
authorization procedure took 
place, together with a copy of 
the notice publishing the 
authorization  in the appropriate 
official  gazette or, failing such 
publication, any other 
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 
fee is payable upon application  for 
a certificate. 

2.  Unchanged 

ft 

ORIGINAL PROPOSAL 

AMENDED PROPOSAL 

Article 9 
Lodging of an application for a 
certificate 

Article 9 
Lodging of an  application for a 
certificate 

The application for a certificate 
shall be lodged with the competent 
industrial property office  of the 
Member State which granted the 
basic patent or on whose behalf it 
was granted and in which the 
authorization 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. 

Unchanged 

The application for a certificate 
shall be lodged with the competent 
industrial  property office  of the 
Member State which granted the 
basic patent or on whose behalf it 
was granted and in which the 
authorization referred  to in 
Article 3(b) to place the product 
on the market was obtained, unless 
the Member State designates 
another authority for the purpose. 

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 

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 
authorization to place the 
product on the market,  referred 
to in Article 3(b), and the 
product identified  in that 
authorization; 

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 identified  in that 
authorization; 

I 0 

ORIGINAL PROPOSAL 

AMENDED PROPOSAL 

e)  where relevant, the number and 
date of the first  authorization 
to place the product on the 
market in the Community. 

e)  Unchanged 

Article 10 
Grant of the certificate or rejection 
of the application 

Article 10 
Grant of the certificate or rejection of 
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 
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 
the fee is not settled under 
paragraph 3 within the stated time, 
the authority shall reject the 
application. 

Unchanged 

Unchanged 

U 

ORIGINAL  PROPOSAL 

AMENDED PROPOSAL 

Member States may provide that 
the authority  referred  to in 
Article 9(1) is to grant  certificates 
without verifying  that the 
conditions laid down in 
Article 3(c) and (d) are met. 

Member States may provide that 
the authority referred  to in 
Article 9(1) is to grant  certificates 
without verifying  that the 
conditions laid down in 
Article 3(1 )(c) and (d) are met. 

Article 11 
Publication 

Article 11 
Publication 

Notification  of the  fact that a 
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 
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(b) and the 
product identified  in that 
authorization; 

e)  where relevant, the number and 
date of the first authorization 
to place the product on the 
market in the Community; 

Unchanged 

a) unchanged 

b) unchanged 

c) unchanged 

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 identified  in that 
authorization; 

e)  unchanged 

f) 

the duration of the  certificate. 

f)  unchanged 

11 

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 
Annual  fees 

Article 12 
Annual fees 

Member States may require that the 
certificate be subject to the payment of 
annual fees. 

Unchanged 

Article 13 
Duration of the certificate 

Article 13 
Duration of the certificate 

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 the Community, 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. 

1.  Unchanged 

Unchanged 

n 

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 
Expiry of the certificate 

Article 14 
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) 

d) 

if the annual fee laid down in 
accordance with Article  12 is not 
paid in time; 

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 

ORIGINAL PROPOSAL 

AMENDED PROPOSAL 

Article 15 
Invalidity of the certificate 

Article 15 
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 
Notification  of lapse or invalidity 

Article 16 
Notification  of lapse or invalidity 

Unchanged 

If the certificate  lapses in accordance 
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 

ORIGINAL PROPOSAL 

AMENDED PROPOSAL 

Article 17 
Appeals 

Article 17 
Appeals 

Unchanged 

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 open to the same 
appeals as those provided for in 
national law against similar decisions 
taken in respect of national patents. 

Article 18 
Procedure 

Article 18 
Procedure 

1. 

1. 

In the absence of procedural 
provisions in this Regulation, the 
procedural  provisions applicable 
under national  law to the 
corresponding basic patent shall 
apply to the certificate,  unless that 
law lays down special procedural 
provisions for  certificates. 

In the absence of procedural 
provisions in this Regulation, the 
procedural provisions applicable 
under national law to the 
corresponding basic patent and, 
where appropriate, the procedural 
provisions applicable to the 
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 
procedure for opposition to the 
granting of a certificate  shall be 
excluded. 

2.  Unchanged 

U 

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 

ORIGINAL PROPOSAL 

AMENDED PROPOSAL 

FINAL PROVISION 

FINAL PROVISION 

Article 20 
Entry into force 

Article 21 
Entry into force 

This Regulation shall enter into force 
three months after  its publication  in the 
Official  Journal of the European 
Communities. 

This Regulation shall enter into force 
six months after  its publication  in the 
Official  Journal of the European 
Communities. 

This Regulation shall be binding in its 
entirety and directly applicable in all 
Member States. 

Unchanged 

Done at Brussels, 

Done at Brussels, 

n 

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 

t°>