CELEX: 51992EC1768
Language: en
Date: 2006-12-08
Title: Proposal for a Regulation (EC) No …/.. of the European Parliament and of the Council of […] concerning the supplementary protection certificate for medicinal products (Codified version)

EN

|[pic]                     |COMMISSION OF THE EUROPEAN COMMUNITIES                                                                           |

                                        Brussels,
                                        COM

                                                                  Proposal for a

                                      REGULATION (EC) No …/.. OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

                                                                      of […]

                                    concerning the supplementary protection certificate for medicinal products

                                                                (Codified version)

                                                              EXPLANATORY MEMORANDUM

1.    In the context of a people’s Europe, the Commission attaches great importance to simplifying and clarifying Community law so as to make  it
       clearer and more accessible to the ordinary citizen, thus giving him new opportunities and the chance to make use of the  specific  rights
       it gives him.

       This aim cannot be achieved so long as numerous provisions that have  been  amended  several  times,  often  quite  substantially,  remain
       scattered, so that they must be sought partly in the original instrument and partly in later amending ones.  Considerable  research  work,
       comparing many different instruments, is thus needed to identify the current rules.

       For this reason a codification of rules that have frequently been amended  is  also  essential  if  Community  law  is  to  be  clear  and
       transparent.

2.    On 1 April 1987 the Commission therefore decided[1] to instruct its staff that all legislative acts should be codified after no  more  than
       ten amendments, stressing that this is a minimum requirement and that departments should endeavour to codify at even shorter intervals the
       texts for which they are responsible, to ensure that the Community rules are clear and readily understandable.

3.    The Conclusions of the Presidency of the  Edinburgh  European  Council  (December 1992)  confirmed  this[2]  stressing  the  importance  of
       codification as it offers certainty as to the law applicable to a given matter at a given time.

       Codification must be undertaken in full compliance with the normal Community legislative procedure.

       Given that no changes of substance may be made to the instruments affected by codification, the European Parliament, the Council  and  the
       Commission have agreed, by an interinstitutional agreement dated 20 December 1994, that an accelerated procedure may be used for the fast-
       track adoption of codification instruments.

4.    The purpose of this proposal is to undertake a codification of Council Regulation (EEC) N° 1768/92 of the  18  June  1992,  concerning  the
       creation of a supplementary protection certificate for medicinal products[3]. The new Regulation  will  supersede  the  previous  Act,  as
       amended[4]; the process of bringing together provisions of the Basic Act and those of modifying Amendments does not affect  their  content
       in any way, and displays only such formal amendments as are required by the codification exercise itself.

5.    The codification proposal was drawn up on the basis of a preliminary consolidation, in all  official  languages,  of  Regulation  (EEC)  No
       1768/92 and the instruments amending it, carried out by the Office for Official Publications of the European Communities, by  means  of  a
       data-processing system. Where the Articles have been given new numbers, the correlation between the old and the new numbers is shown in  a
       table set out in Annex II to the codified Regulation.

                                            ê 1768/92 (adapted)

                                                                  Proposal for a

                                      REGULATION (EC) No …/... OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

                                                                      of […]

                                    concerning the supplementary protection certificate for medicinal products

                                                            (Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article Article Ö95Õ thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and Social Committee[5],

Acting in accordance with the procedure laid down in Article 251 of the Treaty[6],

Whereas:

                                            ê

   1) Regulation (EEC) No 1789/92 of the European Parliament and of the Council of 18th June 1992 concerning  the  creation  of  a  supplementary
      protection certificate for medicinal products[7] has been  substantially  amended  several  times[8].  In  the  interests  of  clarity  and
      rationality the said Regulation should be codified.

                                            ê 1768/92 Recital 1

   2) Pharmaceutical research plays a decisive role in the continuing improvement in public health.

                                            ê 1768/92 Recital 2

   3) Medicinal 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.

                                            ê 1768/92 Recital 3

   4) At the moment the period that elapses between the filing of an application for a patent for a new medicinal product  and  authorization  to
      place the medicinal product on the market makes the period of effective protection under the patent insufficient to  cover  the  investment
      put into the research.

                                            ê 1768/92 Recital 4

   5) This situation leads to a lack of protection which penalizes pharmaceutical research.

   6) ê 1768/92 Recital 5 (adapted)

   7) Ö There exists Õ Ö a Õ risk Ö that Õ research centres situated in the Member States relocatÖ e Õ to countries that  already  offer  greater
      protection.

                                            ê 1768/92 Recital 6 (adapted)

   8) A uniform solution at Community level should be provided for, thereby preventing the heterogeneous development of national laws leading  to
      further disparities which would be likely to create obstacles to the free movement of medicinal products  within  the  Community  and  thus
      directly affect the functioning of the internal market.

                                            ê 1768/92 Recital 7 (adapted)

   9) Therefore, the Ö provision Õ 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 medicinal product  for  which  marketing  authorization  has  been
      granted is necessary. A Regulation is therefore the most appropriate legal instrument.

                                            ê 1768/92 Recital 8

  10) The duration of the protection granted by the certificate should be such as to provide adequate effective protection. For this purpose, the
      holder of both a patent and a certificate should be able to enjoy an overall maximum of fifteen years of  exclusively  from  the  time  the
      medicinal product in question first obtains authorization to be placed on the market in the Community.

                                            ê 1768/92 Recital 9

  11) All the interests at stake, including those of public health, in a sector as complex  and  sensitive  as  the  pharmaceutical  sector  must
      nevertheless be taken into account. For this purpose, the certificate cannot be granted for a period exceeding five years.  The  protection
      granted should furthermore be strictly confined to the product which obtained authorization to be placed  on  the  market  as  a  medicinal
      product.

                                            ê 1768/92 Recital 10 (adapted)

                                            ê 1768/92 Recital 11 (adapted)
                                            1610/96 Recital 17 (adapted)

  12) The detailed rules in Recitals 12, 13 and 14 and in Articles 3(2), 4, 8(1) (c) and 17(2) of  Regulation  Ö 1610/96  (EC)  of  the  European
      Parliament and Council, of 23 July  1996,  concerning  the  creation  of  a  supplementary  protection  certificate  for  plant  protection
      products Õ[9] are also valid, mutatis mutandis for the implementing in particular of Recital 9 and Articles 3, 4,  8(1)(c)  and  1  (f)  of
      Council Regulation (EEC) No. 1768/92.

                                            ê 1768/92 Recital 12 (adapted)

;

                                            ê 1768/92 Recital 13

  13) Provision should be made for appropriate limitation of the duration of the certificate in the special case where a patent term has  already
      been extended under a specific national law,

                                            ê 1768/92

HAVE ADOPTED THIS REGULATION:

                                                                    Article 1

                                                                   Definitions

For the purposes of this Regulation:

(a)   «medicinal product» means any substance or combination of substances presented for treating  or  preventing  disease  in  human  beings  or
       animals and any substance or combination of substances which may be administered to human beings or  animals  with  a  view  to  making  a
       medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

(b)   «product» means the active ingredient or combination of active ingredients of a medicinal product;

(c)   «basic patent» means a patent which protects a product as defined in (b) as such, a process to 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;

(d)   «certificate» means the supplementary protection certificate.

                                                                    Article 2

                                                                      Scope

                                            ê 1768/92 (adapted)

Any product protected by a patent in the territory of a Member State and subject, prior to being placed on the market as a medicinal product,  to
an administrative authorization procedure as laid down in Council  Directive  Ö 2001/83/EC of  the  European  Parliament  and  Council  Õ[10]  or
Directive Ö 2001/82/EC of the European Parliament and Council Õ[11] may, under the terms and conditions provided for in this Regulation,  be  the
subject of a certificate.

                                            ê 1768/92

                                                                    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 and at  the  date  of  that
application:

(a)   the product is protected by a basic patent in force;

                                            ê 1768/92 (adapted)
                                            è1°1994 Act of Accession, Art. 29 and Annex I.XI.F.I (a), p.233

(b)   a valid authorization to place the product  on  the  market  as  a  medicinal  product  has  been  granted  in  accordance  with  Directive
       Ö 2001/83/EC Õ or Directive Ö 2001/82/EC Õ, as appropriate.è1  ç

                                            ê 1768/92

(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 medicinal product.

                                                                    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 authorization to place the corresponding medicinal product on the market and for any use of the product  as  a  medicinal  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 medicinal product was granted.

2. Notwithstanding paragraph 1, where the authorization to place the product on the market is granted before the basic  patent  is  granted,  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;

       (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 for placing the product on the market in the Community, the  number  and  date  of  that
           authorization;

                                            ê 1768/92 (adapted)

(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 Article  Ö 11 Õ
       of Directive Ö 2001/83/EC Õ or Article Ö 14 Õ of Directive Ö 2001/82/EC Õ;

                                            ê 1768/92

(c)   if the authorization referred to in (b) is not the first authorization for placing the product on the market as a medicinal 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 publication.

2. Member States may provide that a fee is to be payable upon application for a certificate.

                                                                    Article 9

                                                   Lodging of an application for a certificate

1. 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

2. Notification of the application for a certificate shall be published by the authority referred to  in  paragraph  1.  The  notification  shall
contain at least the following information:

(a)   the name and address of the applicant;

(b)   the number of the basic patent;

(c)   the title of the invention;

(d)   the number and date of the authorization to place the product on the market, referred to in Article 3(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.

                                                                    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.

5. 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

1. 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.

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 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;

                                            ê 1768/92 (adapted)

(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 on the market in accordance  with  Directive  Ö 2001/83/EC Õ  or  Directive  Ö 2001/82/EC Õ.  The
       authority referred to in Article 9(1), may decide on the lapse of the certificate either of its own motion or at the request  of  a  third
       party.

                                            ê 1768/92

                                                                    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 to the extent that the product for which the certificate was granted would no  longer  be  protected
       by the claims of the basic patent or, after the basic patent 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 renovation 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 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.

2. Notwithstanding paragraph 1, the procedure for opposition to the granting of a certificate shall be excluded.

                                            ê 1768/92 (adapted)

                                            ê 1994 Act of Accession Art. 29 and Annex I.XI.F.I (b) p. 233 (adapted)

                                            ê 1768/92 (adapted)

                                            ê 2003 Act of Accession, Art. 20 and Annex II pt. 4.C.II.1.(a), p. 342

                                                                    Article 19

                                        Additional Provisions relating to the enlargement of the Community

Without prejudice to the other provisions of this Regulation, the following shall apply:

(a)   (i)   any medicinal product protected by a valid basic patent in the Czech Republic and for which the first authorisation to  place  it  on
           the market as a medicinal product was obtained in the Czech Republic after 10 November 1999 may be granted  a  certificate,  provided
           that the application for a certificate was lodged within six months of the date on which the first market authorisation was obtained,

       (ii) any medicinal product protected by a valid basic patent in the Czech Republic and for which the first authorisation to  place  it  on
           the market as a medicinal product was obtained in the Community not earlier than six months prior to the date  of  accession  may  be
           granted a certificate, provided that the application for a certificate was lodged within six months of the date on  which  the  first
           market authorisation was obtained;

(b)   any medicinal product protected by a valid basic patent and for which the first authorisation to place it on  the  market  as  a  medicinal
       product was obtained in Estonia prior to the date of accession may  be  granted  a  certificate,  provided  that  the  application  for  a
       certificate was lodged within six months of the date on which the first market authorisation was obtained or, in the case of those patents
       granted prior to 1 January 2000, within the six month period provided for in the Patents Act of October 1999;

(c)   any medicinal product protected by a valid basic patent and for which the first authorisation to place it on  the  market  as  a  medicinal
       product was obtained in Cyprus prior to the date of accession  may  be  granted  a  certificate,  provided  that  the  application  for  a
       certificate was lodged within six months of the date on which the first market authorisation  was  obtained;  notwithstanding  the  above,
       where the market authorisation was obtained before the grant of the basic patent, the application for a certificate must be lodged  within
       six months of the date on which the patent was granted;

(d)   any medicinal product protected by a valid basic patent and for which the first authorisation to place it on  the  market  as  a  medicinal
       product was obtained in Latvia prior to the date of accession may be granted a certificate. In cases where  the  period  provided  for  in
       Article 7(1) has expired, the possibility of applying for a certificate shall be open for a period of six months starting  no  later  than
       the date of accession;

(e)   any medicinal product protected by a valid basic patent applied for after 1 February 1994 and for which the first  authorisation  to  place
       it on the market as a plant protection was obtained in Lithuania prior to the date of accession may be  granted  a  certificate,  provided
       that the application for a certificate is lodged within six months of the date of accession;

(f)   any medicinal product protected by a valid basic patent and for which the first authorisation  to  place  it  on  the  market  as  a  plant
       protection product was obtained after 1 January 2000 may be granted a  certificate  in  Hungary,  provided  that  the  application  for  a
       certificate is lodged within six months of the date of accession;

(g)   any medicinal product protected by a valid basic patent and for which the first authorisation to place it on  the  market  as  a  medicinal
       product was obtained in Malta prior to the date of accession may be granted a certificate. In cases  where  the  period  provided  for  in
       Article 7(1) has expired, the possibility of applying for a certificate shall be open for a period of six months starting  no  later  than
       the date of accession;

(h)   any medicinal product protected by a valid basic patent and for which the first authorisation to place it on  the  market  as  a  medicinal
       product was obtained after 1 January 2000 may be granted a certificate in Poland, provided that  the  application  for  a  certificate  is
       lodged within six months of the date of accession;

(i)   any medicinal product protected by a valid basic patent and for which the first authorisation to place it on  the  market  as  a  medicinal
       product was obtained in Slovenia prior to the date of accession may be  granted  a  certificate,  provided  that  the  application  for  a
       certificate is lodged within six months of the date of accession, including in cases where the period provided for  in  Article  7(1)  has
       expired;

(j)   any medicinal product protected by a valid basic patent and for which the first authorisation to place it on  the  market  as  a  medicinal
       product was obtained in Slovakia after 1 January 2000 may be granted a certificate, provided that the application  for  a  certificate  is
       lodged within six months of the date on which the first market authorisation was obtained or within six months  of  1  July  2002  if  the
       market authorisation was obtained before that date.

                                            ê 1768/92 (adapted)
                                            è1 2003 Act of Accession, Art.20 and Annex II pt.4.C.II.1.b, p.343

                                                                    Article 20

                                                           Ö Transitional Provisions Õ

è1 1. ç This Regulation shall not apply to certificates granted in accordance with the national legislation of a Member State before  Ö2  January
1993Õ, or to applications for a certificate filed in accordance with that legislation before Ö18 June 1992Õ.

                                            ê 1994 Act of Accession Art. 29 and Annex I.XI.F.I.(c) p. 233 (adapted)

With regard to Austria, Finland and Sweden, this  Regulation  shall  not  apply  to  certificates  granted  in  accordance  with  their  national
legislation before Ö1 January 1995Õ.

                                            ê 2003 Act of Accession, Art. 20 and Annex II, pt. 4.C.II.1.(b), p. 343

2. This Regulation shall apply to supplementary protection certificates granted  in  accordance  with  the  national  legislation  of  the  Czech
Republic, Estonia, Cyprus, Latvia, Lithuania, Malta, Poland, Slovenia and Slovakia prior to the date of accession.

                                            ê 1768/92 (adapted)

.

                                                                    Article 21

                                                             Ö Extension of patent Õ

Where a certificate is granted for a product protected by a patent which, before Ö2 January 1993Õ, has had its term extended or  for  which  such
extension was applied for, under national patent law, the term of protection to be afforded under  this  certificate  shall  be  reduced  by  the
number of years by which the term of the patent exceeds 20 years.

                                            ê

                                                                    Article 22

                                                                      Repeal

Regulation (EEC) No 1768/92 is repealed.

References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance  with  the  correlation
table in Annex II.

                                            ê 1768/92 (adapted)

                                                                    Article 23

                                                                 Entry into force

This Regulation shall enter into force Öon the twentieth day following that of Õ  its  publication  in  the  Official  Journal  of  the  European
Ö Union Õ.

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

Done at Brussels, […]

For the European Parliament  For the Council
The President    The President
[…]   […]

                                            é

                                                                     ANNEX I

                                                                      Part A

                                                               Repealed Regulation

|Council Regulation (EEC) No 1768/92                                                   |(OJ L 182, 2.7.1992, p.1.)                  |

                                                                      Part B

                                                                Non- Repealed Acts

1994 Act of Accession

2003 Act of Accession

                                                                  _____________

                                                                     ANNEX II

                                                                Correlation Table

|Regulation (EEC) No 1768/92                                          |This Regulation                                                      |
|Article 1                                                            |Article 1                                                            |
|Article 2                                                            |Article 2                                                            |
|Article 3, introductory wording                                      |Article 3, introductory wording                                      |
|Article 3 (a)                                                        |Article 3 (a)                                                        |
|Article 3 (b), first sentence                                        |Article 3 (b)                                                        |
|Article 3 (b), second sentence                                       |-                                                                    |
|Article 3 (c) and (d)                                                |Article 3 (c) and (d)                                                |
|Articles 4 to 18                                                     |Articles 4 to 18                                                     |
|Article 19                                                           |-                                                                    |
|Article 19a                                                          |Article 19                                                           |
|Article 20                                                           |Article 20                                                           |
|Article 21                                                           |-                                                                    |
|Article 22                                                           |Article 21                                                           |
|-                                                                    |Article 22                                                           |
|Article 23                                                           |Article 23                                                           |
|-                                                                    |Annex I                                                              |
|-                                                                    |Annex II                                                             |

                                                                  _____________

                                                             -----------------------
[1]   COM(87) 868 PV.
[2]   See Annex 3 to Part A of the Conclusions.
[3]   Carried out pursuant to the Communication from the Commission to the European Parliament and the  Council  –  Codification  of  the  Acquis
      communautaire, COM(2001) 645 final.
[4]   See Annex I to this proposal.
[5]   OJ C
[6]   OJ C
[7]   OJ L 182 of 2.7.1992, p. 1. Regulation as last amended by 2003 Accession Treaty.
[8]   See Annex I.
[9]   OJ L 198, 8.8.1996, p. 30.
[10]  OJ Ö L 311 Õ Ö 28.11.2001 Õ, p. Ö 67 Õ.
[11]  OJ L Ö311Õ, Ö 28.11.2001 Õ , p. 1.