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The Practice of Granting SUPPLEMENTARY
PROTECTION CERTIFICATES in the German Patent and
Trademark Office (GPTO)
Andrea Münzberg Chemical Patent Division of the
GPTO
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• 1. Introduction

• 1.1 Quantity of SPCs
• Since 1993 more than 8000 SPCs have been
  granted in the EU.
• In the German Office from 1993 up to now
  about 700 certificates
• have been handled.
• 220 applications for a certificate are
  examined at present in the
• German Office.
• 75 belong to applications for products with
  biochemical active
• ingredients.

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• 1.2 Responsibility for SPCs in the German Office

• Examination of applications for a certificate is
  done by the
• examiners who are responsible for patent
  applications.
• Responsibility of single examiner is determined
  by the International Patent Classification
  (IPC) of the basic patent.
• Decisions are made by a committee of three
  persons
• the responsible
  examiner
• a second examiner
  of the same patent division
• the head of the
  patent division

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2. Examination procedure in the German Office
2.1 Check of formalities 2.1.1 Time limit of
6 months (Article 7) 2.1.2 Identity of
applicant and the owner of the pantent (Article
6) 2.1.3 Basic patent in force at the date of
the application (Article 3a) 2.1.4 Already
granted German certificate (Article 3c) 2.1.5
First marketing authorisation (Article 3b and
Article 13 (1))
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• 2.1.5 Notes to marketing authorisations

2.1.5.1 A complete or even certified copy of the
MA is not necessary. 2.1.5.2 A copy of the first
German MA has to prove the following data
the date of authorisation the
number of the authorisation the
chemical structure of the therapeutic active
ingredient 2.1.5.3 A copy of the newsletter in
which the European MA was published. 2.1.5.4
Translation of a foreign MA 2.1.5.5 A change of
MAs during the examination is possible. 2.1.5.6
A Swiss MA is a valid first MA in the Community
June 2005 modification of the
bilateral agreement between Liechtenstein and
Switzerland ? Swiss MA becomes
valid in the Community with a delay of 12 months
(NCE negative list)
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Judgment Omeprazol (2000) The German Federal
Supreme Court stated that according to the
Council Regulation the first marketing
authorisation in the Community is an
accreditation of a medicinal product to protect
the health of the public, so that further
accreditations - like the authorisation of the
price are not relevant. Decision confirmed by
the European Court of Justice in 2004
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• 2.2 Substantive examination

2.2.1 Identification of the chemical structure
of the active ingredient in the
marketing authorisation Article 1
DEFINITIONS (b) product means the
active ingredient or combination of active
ingredients of a medicinal
product
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• 2.2.1 Identification of the chemical structure
• Marketing authorisations International
  non-proprietary name (INN)
• Basic patent Chemical
  structure
• Search for chemical structure of INN in database
  e.g. Registry file of STN

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• Example (negative case)
• Basic Patent
• Monoclonal antibodies are characterised by
  single peptide sequences
• of the antigen TNF alpha, against which the
  antibodies are directed.
• Marketing authorisation
• INN for the active monoclonal antibody
• Search in Registry file
• Complete amino acid sequence for the
  monoclonal antibody with the
• INN of the marketing authorisation
• ? Rejection of application

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• Example (positive case)
• Basic patent
• Monoclonal antibody described by amino acid
  sequences of the variable and constant region of
  heavy and light chain.
• Marketing authorisation
• INN for the active monoclonal antibody
• Search in Registry file
• Short amino acid sequences for a monoclonal
  antibody with the INN of the marketing
  authorisation
• ? Certificate granted

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• 2.2.2 Title of the certificate

In the past
A certificate is granted for the active
ingredient of the medicinal product TRADE NAME
in all forms protected by the basic patent.
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• Idarubicin / Farmitalia case
• Salt-problem
• Facts
• Chemical formula for Idarubicin (free base) in
  claim 1 of the basic patent.
• Production of Idarubicin-hydrochlorid in one
  example of the description.
• Idarubicin-hydrochlorid is the active ingredient
  in the marketing authorisation.

Which salts or derivatives of a free base have
to be (can be) considered in the title of a
certificate ?
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• Applications and decisions

The applicant requested a certificate with the
following title The German Office granted
a certificate with the following title
Idarubicin and its salts, inclusive
Idarubicin-hydrochlorid or Idarubicin and
Idarubicin-hydrochlorid
Certificate for the medicinal product ZAVEDOS,
containing Idarubicin-hydrochlorid as active
ingredient.
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• Basic information of Idarubicin /
  Farmitalia case
• A certificate for a free base (Idarubicin) covers
  all derivatives of the free base which are
  covered by the scope of the basic patent.
• A certificate for a free base can be granted even
  if the active ingredient of the marketing
  authorisation is a salt of this base provided
  that the free base and the salt are covered by
  the scope of the basic patent.
• Is the free base subject matter of a claim in the
  basic patent and the active ingredient of the
  licensed medicinal product is a salt of this
  base, then the owner of the patent can not demand
  a certificate for the free base and any
  derivatives of the base, which are not subject
  matter of a claim in the basic patent.

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• Current title of a certificate
• provided that the pharmaceutical acceptable salts
  are subject matter
• of the basic patent and
• that the salts have the same therapeutic activity
  like the active ingredient of the
• marketing authorisation (Sumatriptan).

A certificate is granted for INN and its
pharmaceutical acceptable salts
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• The subject matter of the basic patent
• DEFINITION
• 1. the claims
• 2. the description
  including the examples and
• 3. everything which
  the expert is reading along
• in the disclosure
  of the basic patent without doubt.

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• Example

• Basic patent
• A free base and its pharmaceutical acceptable
  salts are subject matter of
• the claims.
• The hydrochlorid and the hydrogensuccinate of
  the free base are named as
• pharmaceutical acceptable salts in the
  examples.
• Marketing authorisation
• Active ingredient of the German authorisation
  is the hydroxysuccinate of the base.
• Active ingredient of the Spanish authorisation
  is the free base in form of a salt of
• malic acid.
• ? The active ingredients of the authorisations
  are considered as subject matter of the basic
  patent even if they are not named in the basic
  patent because these salts are well known
  additives in food and drugs and are therefore
  well known pharmaceutical acceptable salts.

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• 2.2.3 Combination of active ingredients

• A marketing authorisation for a combination
  of two therapeutic active
• ingredients is at the same time not also
  a marketing authorisation for one
• of these therapeutic active ingredients.
• The combination per se has to be subject
  matter of the basic patent.
• Therapeutic non active ingredients (like
  impurities, additives or supports) are
• not able to determine new products.
• Products which differ in the amount of
  their therapeutic active ingredients are
• identical products.
• There is no definition for the term
  combination in Article 1 of the Regulation.

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• Judgment Polifeprosan
• (German Federal Patent Court, 2002)

• Basic information
• A certificate for one active ingredient is
  granted if the subject matter of the
• marketing authorisation is a medicinal
  product with only one therapeutic active
• ingredient combined with usual additives.
• A certificate for a combination of active
  ingredients is granted if the subject
• matter of the marketing authorisation is a
  medicinal product with a combination
• of at least two therapeutic active
  ingredients combined with usual additives.
• A single therapeutic active ingredient in
  combination with a further substance
• which itself is not therapeutic active is
  not a combination in the meaning of Article
• 1b) of the Regulation.

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• Thank you for your attention
• and your patience!