Supplementary Protection Certificates (SPC)

Marco Stief

doi:10.17104/9783406779275

Summary

Stief

Supplementary Protection Certificates Supplementary protection certificates (SPC) extend the effects of patents for medicinal products by a maximum of five and a half years, i.e. the certificate becomes effective at a time when the respective pharmaceutical is widely known on the market and thus generates the maximum revenue. This explains the enormous economic value of SPCs. They protect some of the most valuable products in the pharmaceutical industry. The legal basis for the SPC for medicinal products is a European Regulation. The obtaining provisions of that Regulation, the scope of protection etc. are highly disputed and have been the subject of numerous decisions of the CJEU. This handbook provides valuable insights into the world of SPCs and the most significant case law and legal sources at EU and national level of Germany, the UK, France, Italy, the Netherlands and Switzerland. The second completely revised edition specifically addresses recent developments of SPCs including manufacturing waivers and the implications of “Brexit”.

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Bibliographic data

Copyright year: 2022
ISBN-Print: 978-3-406-76240-6
ISBN-Online: 978-3-406-77927-5
Publisher: C.H.BECK Recht - Wirtschaft - Steuern, München
Series: Beck International
Language: English
Pages: 354
Product type: Edited Book

Titelei/Inhaltsverzeichnis No access Pages I - XIV
1. 1. I. Overview No access
  2. II. Relationship between Grant of the Patent and Authorisation under Pharmaceutical Law No access
  3. III. History No access
  4. IV. Legal Character No access
2. 1. I. General No access
  2. II. Product No access
  3. III. Basic Patent No access
  4. IV. First Marketing Authorisation No access
  5. V. No Earlier Certificate – Multiple SPCs for the Same Product No access
3. 1. I. General No access
  2. II. Relevant Date for the Calculation of Term No access
  3. III. Negative Terms No access
4. D. Subject Matter No access Pages 38 - 38
5. 1. I. Rights of the Certificate Holder No access
  2. II. Limitations and Obligations No access
6. 1. I. Scope of Protection: “Salt Issue” No access
  2. II. First Marketing Authorisation: Use Patents No access
  3. III. Substance Combinations No access
7. 1. I. General No access
  2. II. Application No access
  3. III. Grant and Announcement No access
  4. IV. Fees to Maintain the SPC No access
8. 1. I. Reasons for Expiry No access
  2. II. Reasons for Invalidity No access
  3. III. Revocation of a Term Extension No access
  4. IV. Announcement No access
9. J. Remedies No access Pages 68 - 68
10. 1. I. Intentions to Revise and Amendments to the RegSPC No access
  2. II. Calls for the Creation of SPC Regulations for Other Products No access
  3. III. Accession of New Member States to the European Union No access
  4. IV. Withdrawal of the United Kingdom from the European Union No access
1. 1. I. National Pharmaceutical and Patent Law No access
  2. II. Application of the Art. 3 RegSPC Conditions No access
  3. III. Calculation of the Term of the SPC No access
  4. IV. Rights, Limitations and Obligations No access
  5. V. SPC Grant, Termination and Remedies No access
2. 1. I. National Law relating to SPCs No access
  2. II. Application of the Art. 3 RegSPC Conditions No access
  3. III. SPC application procedure No access
  4. IV. Transitional Provisions relating to Pre-existing SPCs and Applications from before or during the Transitional Period No access
  5. V. Invalidation of SPCs and/or SPC Extensions No access
3. 1. I. French National Patents and Pharmaceutical Law No access
  2. II. The Conditions for Obtaining an SPC No access
  3. III. Grant Procedure for SPCs in France No access
  4. IV. Scope of Protection No access
  5. V. Duration of SPCs No access
  6. VI. Waiver of SPCs No access
  7. VII. Paediatric Extensions No access
4. 1. I. National Pharmaceutical and Patent Law No access
  2. II. SPC Obtaining Provisions and Term No access
  3. III. Subject Matter and Scope of Protection No access
  4. IV. Rights, Limitations and Obligations No access
  5. V. SPC Grant, Termination and Remedies No access
5. 1. I. National Pharmaceutical and Patent Law No access
  2. II. SPC Obtaining Provisions and Term in the Dutch Context No access
  3. III. Substantive Requirements No access
  4. IV. Rights, Limitations and Obligations No access
  5. V. License No access
  6. VI. Termination and Remedies No access
  7. VII. Court Proceedings No access
6. 1. I. Sources of Law and Legislative History No access
  2. II. Substantive Granting Prerequisites No access
  3. III. Subject-Matter of Protection and Effects No access
  4. IV. Term of Protection No access
  5. V. SPC for Plant Protection Products No access
  6. VI. Application, Fees, Examination and Remedies No access
  7. VII. Nullity No access
  8. VIII. Swiss Federal Patent Court No access
1. 1. A1. Court of Justice of the European Union No access
  2. A2. German Courts No access
  3. A3. British Courts No access
  4. A4. French Courts No access
  5. A5. Italian Courts No access
  6. A6. Dutch Courts No access
  7. A7. Swiss Courts No access
2. 1. B1. International Treaties No access
  2. B2. European Primary Law No access
  3. B3. European Regulations No access
  4. B4. European Directives No access
  5. B5. National Law No access