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Supplementary Protection Certificate for medicinal products

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					   Supplementary Protection
Certificate for medicinal products
                Jean-Claude Saisset
        Chairman of the Legal Board of Appeal
     and Member of the Enlarged Board of Appeal
                         and
              Yvonne Podbielski-Schadt
    Legal Research Service of the Boards of Appeal



                EC-ASEAN Intellectual Property Rights Co-operation Programme (ECAP II)
                           The problem

Global investment into research and development (R&D) of medicinal
products is vast - it amounts to between 40 and 45 billion dollars
annually. Prior to the implementation of the Supplementary Protection
Certificate investors faced the following problem in Europe:

     • The term of a European patent (patent granted by the EPO) and of most
       national patents in Europe is 20 years as from the date of filing of the
       application

     • Before a pharmaceutical product can be placed on the market
       authorisation from the relevant national authorities is required

     • The exploitation of the patent is thus reduced by the period which
       elapses between the filing of the patent application and the
       authorisation. This period was, in the late eighties/ early nineties, in the
       region of 9 to 12 years. Thus, before the introduction of the
       Supplemental Protection Certificate pharmaceutical products could be
       commercially exploited for a period of about 8 to 12 years. This was
       insufficient to cover the investment put into the research



                     EC-ASEAN Intellectual Property Rights Co-operation Programme (ECAP II)   2
                  The problem
The lack of protection in Europe stood in
contrast to a situation abroad where
pharmaceutical products enjoyed a longer
period of patent protection: the term of a
patent was extended for up to five years in the
USA in 1984 and in Japan in 1988.

There was a risk of research centres situated
in the Member States of the European Union
relocating to countries that offered greater
protection.
            EC-ASEAN Intellectual Property Rights Co-operation Programme (ECAP II)   3
          National solutions

France: a supplemental protection certificate
for medicaments was introduced in June
1990. It permitted an extension of up to seven
years of the period of patent protection for
medicaments and related products for which
authorisation was required.

Italy: introduced a supplemental protection
certificate in October 1991. The extension
period was to be no longer than 18 years from
the patent expiration date.

            EC-ASEAN Intellectual Property Rights Co-operation Programme (ECAP II)   4
The European Community solution


Council Regulation (EEC) No 1978/92 of 18
June 1992 concerning the creation of a
supplementary protection certificate for
medicinal products

The Regulation entered into force on 2nd
January 1993 and is binding in its entirety and
directly applicable in all Member States of the
EU.

            EC-ASEAN Intellectual Property Rights Co-operation Programme (ECAP II)   5
  Council Regulation (EEC) No
           1768/92 (1)
The Regulation applies to medicinal products. This is
defined in the following terms:

"'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;"




              EC-ASEAN Intellectual Property Rights Co-operation Programme (ECAP II)   6
  Council Regulation (EEC) No
           1768/92 (2)
At the date of the application the following conditions
must be met (Art.3):

    • (a) the product is protected by a basic patent in force (a
      basis patent is a patent which protects the active
      ingredient or combination of active ingredients of a
      medicinal product)

    • (b) a valid authorisation to place the product on the
      market as a medicinal product has been granted

    • (c) the product has not already been the subject of a
      certificate

    • (d) the authorisation is the first authorisation to place the
      product on the market as a medicinal product
                 EC-ASEAN Intellectual Property Rights Co-operation Programme (ECAP II)   7
  Council Regulation (EEC) No
           1768/92 (3)
Article 4:
"...the protection conferred by a certificate shall
extend only to the product covered by the
authorisation to place the corresponding medicinal
product on the market and for any use of the product
as a medicinal product that has been authorised
before the expiry of the certificate"

Article 5:
"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."

              EC-ASEAN Intellectual Property Rights Co-operation Programme (ECAP II)   8
  Council Regulation (EEC) No
           1768/92 (4)
Application for a certificate:

To be lodged within six months of
    • the date on which the authorisation was granted or
    • the date on which the patent was granted
    • whichever is the later date


To 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 authorisation was obtained, unless the Member
State designates another authority for that purpose

               EC-ASEAN Intellectual Property Rights Co-operation Programme (ECAP II)   9
  Council Regulation (EEC) No
           1768/92 (5)
Article 13:
"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 authorisation 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."

              EC-ASEAN Intellectual Property Rights Co-operation Programme (ECAP II)   10
                           Example

Imagine that an application for a patent was
lodged in 2000 and that authorisation to place
the product on the market is obtained in 2008.
Without the supplementary protection
certificate the protection conferred by the
patent would expire in 2020.
With the supplementary protection certificate
3 years are added (2008-2000-5 years) and
the product is thus protected until 2023.

            EC-ASEAN Intellectual Property Rights Co-operation Programme (ECAP II)   11
      Amendment of the EPC (1)

Article 63 EPC provides that the term of a European patent is 20
years as from the date of filing of the application.

Before July 1997, the only basis on which Contracting States
were permitted to extend the term of a European patent was to
take account of a "state of war or similar emergency conditions
affecting that State."

The introduction of the Supplementary Protection Certificate for
medicinal products in the EU members states which are also
EPC Contracting states meant that the period of protection of 20
years could be extended.

Thus, a change of Article 63 was required.



                 EC-ASEAN Intellectual Property Rights Co-operation Programme (ECAP II)   12
     Amendment of the EPC (2)
Article 63 was amended by an act of a Diplomatic
Conference which entered into force on 04.07.1997.
The new Article 63 provides that Contracting States
may extend the term of a European patent or grant
corresponding protection if the subject-matter of the
European patent is
    • a product or
    • a process of manufacturing a product or
    • a use of a product
which has to undergo an administrative authorisation
procedure required by law before it can be put on the
market in that State.


               EC-ASEAN Intellectual Property Rights Co-operation Programme (ECAP II)   13
                          Outlook (1)

Currently going through the EU legislative process is
a proposal for a Regulation on medicinal products for
paediatric use

Background: More than 50% of the medicines used to
treat children of Europe have not been tested and are
not authorised for use in children

Aim: to improve the health of the children of Europe
by increasing the research, development and
authorisation of medicines for use in children


              EC-ASEAN Intellectual Property Rights Co-operation Programme (ECAP II)   14
                          Outlook (2)
The draft Regulation requires pharmaceutical
companies to conduct clinical trials involving children
before product authorisation unless there is a waiver
or deferral of this requirement

It provides for a six-month extension of the
Supplementary Protection Certificate to medicinal
products where pharmaceutical companies have
conducted certain paediatric use studies

Regulation (EEC) No 1768/92 would have to be
amended


              EC-ASEAN Intellectual Property Rights Co-operation Programme (ECAP II)   15

				
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