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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
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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.
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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
2.1.3
2.1.4
2.1.5
Identity of applicant and the owner of the pantent (Article 6)
Basic patent in force at the date of the application (Article 3a)
Already granted German certificate (Article 3c)
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:
Basic patent:
International non-proprietary name (INN)
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.
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Marketing authorisation
INN for the active monoclonal antibody
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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:
„Which salts or derivatives of a free base have to be
(can be) considered in the title of a certificate ?“
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.
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Applications and decisions
The applicant requested a certificate with the following title:
„Idarubicin and its salts, inclusive Idarubicin-hydrochlorid“
or
„Idarubicin and Idarubicin-hydrochlorid“
The German Office granted a certificate with the following title:
„Certificate for the medicinal product ZAVEDOS, containing
Idarubicin-hydrochlorid as active ingredient.“
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Basic information of „Idarubicin / Farmitalia“ case
1.
A certificate for a free base (Idarubicin) covers all derivatives of the free
base which are covered by the scope of the basic patent.
2.
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.
3.
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:
„A certificate is granted for INN and its
pharmaceutical acceptable salts“
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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“).
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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
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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
1.
2.
3.
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!
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