Source: EURLEX
Language: en
Format: md

**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 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**

**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**

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-**

**Amended proposal for a**

**EUROPEAN PARLIAMENT AND COUNCIL REGULATION** **(EO**

**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,

```

**Having regard to the Treaty establishing**

**the European Economic 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 ]**

**1** **OJNoC**

**2** **OJ No C**

**THE EUROPEAN PARLIAMENT**

**AND THE COUNCIL OF THE**

**EUROPEAN UNION,**

**Unchanged**

**Having regard to the proposal from the**

**Commission,** **[1 ]**

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

**OJNoC**

_**<>**_

**ORIGINAL PROPOSAL** **AMENDED PROPOSAL**

**(1) Whereas plant protection research**

**contributes to the continuing**

**improvement in crop production;**

**(2) Whereas plant protection products,**

**especially those that are the result**

**of long, costly research, will not**

**continue to be developed in the**

**Community and in Europe unless**

**they are covered by favourable**

**rules that provide for sufficient**

**protection to encourage such**

**research;**

**(3) Whereas at the moment the period**

**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;**

**(2) Unchanged**

**(3) Whereas plant protection products,**

**especially those that are the result**

**of long, costly research, will**

**continue to be developed in the**

**Community and in Europe if they**

**are covered by favourable rules**

**that provide for sufficient**

**protection to encourage such**

**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;**

**(5) Unchanged**

_**C**_

**ORIGINAL PROPOSAL** **AMENDED PROPOSAL**

**(4) Whereas this situation leads to a**

**lack of protection which** **penalizes**

**plant protection research and the**

**competitiveness of** **the** **sector;**

**(5) Whereas, in its Resolution of**

**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;**

**(6) Unchanged**

**(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;**

**(8) Unchanged**

**OJNoC** **138,** **17.5.1993,** **p. 1.** **OJNoC138,** **17.5.1993, p. 1.**

_**\**_

**ORIGINAL** **PROPOSAL** **AMENDED PROPOSAL**

**(6) Whereas a uniform solution at**

**Community level should be**

**provided for, thereby preventing**

**the heterogeneous development of**

**national laws leading to further**

**disparities which would be likely**

**to create obstacles to the free**

**movement of 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**

**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;**

**(9) Unchanged**

**(10)** **Unchanged**

**?**

ORIGINAL PROPOSAL AMENDED PROPOSAL

(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

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;

(11) Unchanged

(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;

(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;

(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

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:**

(15) Unchanged

(16) Unchanged

ORIGINAL PROPOSAL AMENDED PROPOSAL

**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:

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;

Unchanged

**Article 1**

**Definitions**

**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. "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**

ORIGINAL PROPOSAL AMENDED PROPOSAL

**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.

**Article 3**

**Conditions for obtaining a certificate**

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;**

**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

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**

1 Unchanged

**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**

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**

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**

The certificate shall be granted to the

holder of the basic patent or his

successor in title.

**Article 7**

**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.

**Article 4**

**Subject-matter of protection**

Unchanged

**Article 5**

**Effects of the certificate**

Unchanged

**Article 6**

**Entitlement to the certificate**

Unchanged

**Article 7**

**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(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,

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**

1. The application for a certificate

shall contain:

a) a request for the grant of a

certificate, stating in particular:

i) the name and address of

the applicant;

ii) if he has appointed a

representative, the name

and address of the

representative;

iii) the number of the basic

patent and the title of the

invention;

2. Unchanged

**Article 8**

**Content of the application for a**

**certificate**

1. Unchanged

a) Unchanged

i) Unchanged

ii) Unchanged

iii) Unchanged

###### **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

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.

2. Member States may provide that a

**fee** is **payable upon** application for

**a certificate.**

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 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. Unchanged

**ft**

ORIGINAL PROPOSAL AMENDED PROPOSAL

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(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

applicant;

b) the number of the basic patent;

c) the title of the invention;

d) the number and date of the

authorization to place the

product on the market, referred

to in Article 3(b), and the

product identified in that

authorization;

**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

 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;

_**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.

**Article 10**

**Grant of the certificate or rejection**

**of the application**

1. Where the application for a

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

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.

e) Unchanged

**Article 10**

**Grant of the certificate or rejection of**

**the application**

1. Unchanged

Unchanged

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.

**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;

f) the duration of the certificate.

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**

```
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) 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**

Member States may require that the

certificate be subject to the payment of

annual fees.

**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.

**Article 12**

**Annual fees**

Unchanged

**Article 13**

**Duration of the certificate**

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**

The certificate shall lapse:

a) at the end of the period provided

for in Article 13;

b) if the certificate-holder surrenders

it;

c) if the annual fee laid down in

accordance with Article 12 is not

paid in time;

d) if and as long as the product

covered by the certificate may no

longer be placed on the market

following the withdrawal of 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.

**Article 14**

**Expiry of the certificate**

Unchanged

##### **H**

ORIGINAL PROPOSAL AMENDED PROPOSAL

**Article 15**

**Invalidity of the certificate**

1. The certificate shall be invalid if:

a) it was granted contrary to the

provisions of Article 3;

b) the basic patent has lapsed

before its lawful term expires;

c) the basic patent is revoked or

limited 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**

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).

**Article 15**

**Invalidity of the certificate**

Unchanged

**Article 16**

**Notification of lapse or invalidity**

Unchanged

**?S**

ORIGINAL PROPOSAL AMENDED PROPOSAL

**Article 17**
**Appeals**

The decisions of the authority referred

to in Article 9(1) or of the body referred

to in Article 15(2) taken under this

Regulation shall be open to the same

appeals as those provided for in

national law against similar decisions

taken in respect of national patents.

**Article 18**

**Procedure**

1. In the absence of procedural

provisions in this Regulation, the

procedural provisions applicable

under national law to the

corresponding basic patent shall

apply to the certificate, unless that

law lays down special procedural

provisions for certificates.

Notwithstanding paragraph 1, the

procedure for opposition to the

granting of a certificate shall be

excluded.

1. 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.

2. Unchanged

_**U**_

Unchanged

**Article 17**
**Appeals**

**Article 18**

**Procedure**

ORIGINAL PROPOSAL AMENDED PROPOSAL

**TRANSITIONAL PROVISIONS**

**Article 19**

1. Any product which, on the date on

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.

**TRANSITIONAL PROVISIONS**

**Article 19**

Unchanged

**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**

**Article 20**

**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 be binding in its

entirety and directly applicable in all

Member States.

Done at Brussels,

**FINAL PROVISION**

**Article 21**

**Entry into force**

This Regulation shall enter into force

six months after its publication in the

Official Journal of the European

Communities.

Unchanged

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°>**