The Practice of Granting SUPPLEMENTARY PROTECTION CERTIFICATES in

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

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. 2

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 3

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 3 a) Already granted German certificate (Article 3 c) First marketing authorisation (Article 3 b and Article 13 (1)) 4

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 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“) 5

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 6

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; 7

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 8

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 9

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 10

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. “ 11

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. 12

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. “ 13

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. 14

Current title of a certificate: „A certificate is granted for INN and its pharmaceutical acceptable salts“ • • 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“). 15

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. 16

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. 17

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. 18

Judgment „Polifeprosan“ (German Federal Patent Court, 2002) Basic information 1. 2. 3. 4. 5. 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 19 1 b) of the Regulation.

Thank you for your attention and your patience! 20