Supplementary Protection Certificates (SPC)

Dr. Marco Stief; Dr. Dirk Bühler

doi:10.5771/9783845259048

Summary

The supplementary protection certificate (SPC) prolongs the term of patents for pharmaceutical products for a maximum of five additional years. Thus, the certificate becomes effective at a time when the given pharmaceutical is widely known on the market and is generating the maximum of revenue, which explains its enormous economic value.The SPC’s legal bases are two European SPC regulations. SPCs are based upon European or national patents. They protect some of the most valuable products in the pharmaceutical industry, where each day of additional protection may be worth millions of euros. At the same time, the requirements for obtaining such protection, the scope of protection, etc. are highly disputed and have been the subject of numerous decisions by the ECJ.German jurisprudence on SPCs is of special importance, since this has often been the basis for decisions of the ECJ. Moreover, the German market is one of the leading markets for pharmaceuticals and thus for SPCs. For this reason, German case law is used to illustrate the comments.

Keywords

Search publication

Bibliographic data

Copyright year: 2015
ISBN-Print: 978-3-8487-0299-2
ISBN-Online: 978-3-8452-5904-8
Publisher: Nomos, Baden-Baden
Series: Kooperationswerke Beck - Hart – Nomos
Language: German
Pages: 260
Product type: Comment

Titelei/InhaltsverzeichnisPages 1 - 18 Download chapter (PDF)
1. 1. 1. Background and Economic Relevance of the Supplementary Protection Certificate No access
    2. Area of Application No access
  2. 1. Overview of the Drug Authorisation Procedures No access
    2. Differentiation between Preparatory Actions and Actual Authorisation Procedure No access
    3. The Early Patent Application No access
    4. The Reduction of the Patent Duration and its ‘Countermeasures’ No access
    5. Possible Alternatives to the Supplementary Protection Certificate No access
  3. History No access
  4. Legal Character No access
2. 1. General No access
  2. Product No access
  3. 1. Discrepancy between Basic Patent and Authorisation No access
    2. Multiple Basic Patents and Patentees No access
  4. 1. General Principles No access
    2. Senior and Extraterritorial Authorisations No access
  5. No Earlier Certificate – Multiple SPCs for the same product No access
3. 1. General No access
  2. 1. Grant of the Basic Patent No access
    2. Lodging the Basic Patent Application No access
    3. Grant of the First Marketing Authorisation No access
  3. Negative Terms No access
4. 1. General No access
  2. 1. Salt Issue No access
    2. Use Patents No access
    3. Substance Combinations No access
5. 1. 1. Rights of Use and Exclusivity No access
    2. Licenses No access
    3. Right to the SPC (Art. 6 RegSPC) No access
  2. Limitations and Obligations No access
6. 1. General No access
  2. 1. General Application Requirements No access
    2. Form and Content of the Application No access
    3. Application Period No access
    4. Application regarding the Term Extension of an SPC No access
    5. Application Fees No access
    6. Publication of an Application Notice No access
  3. Grant and Announcement No access
  4. Fees to Maintain the SPC No access
7. 1. Reasons for Expiry pursuant to Art. 14 RegSPC No access
  2. Reasons for Invalidity pursuant to Art. 15 RegSPC No access
  3. Revocation of a Term Extension No access
  4. Announcement No access
8. Remedies No access
1. The SPC in Germany No access
2. National Pharmaceutical and Patent Law No access
3. Application of the Art. 3 RegSPC conditions No access
4. Calculation of the term of the SPC No access
5. Rights, Limitations and Obligations No access
6. 1. Grant No access
  2. 1. The SPC in the United Kingdom No access
7. National Law relating to SPCs No access
8. 1. Article 3(a) RegSPC No access
  2. Article 3(b) RegSPC No access
  3. Article 3(c) RegSPC No access
  4. Article 3(d) RegSPC No access
  5. Third party MAs No access
9. 1. Applications for SPCs No access
  2. Applications for SPC extensions No access
10. 1. The SPC in France No access
11. French national patents and pharmaceutical law No access
12. 1. Article 3(a) of the Regulation No access
  2. Article 3(b) of the Regulation No access
  3. Article 3(c) of the Regulation No access
  4. Article 3(d) of the Regulation No access
13. Grant procedure for SPCs in France No access
14. Scope of protection No access
15. Duration of SPCs No access
16. Waiver of SPCs No access
17. 1. The SPC in Italy No access
18. National Pharmaceutical and Patent Law No access
19. SPC Obtaining Provisions and Term No access
20. Subject Matter and Scope of Protection No access
21. Rights, Limitations and Obligations No access
22. 1. Grant No access
  2. 1. The SPC in The Netherlands No access
23. 1. Patents No access
  2. NLOC and Dutch patent register No access
  3. Medicines Evaluation Board No access
24. 1. Application No access
  2. Publication No access
  3. Grant procedure No access
  4. Third party observations No access
25. 1. Product protected No access
  2. One SPC per patent? No access
  3. Further medical use No access
26. Rights, Limitations and Obligations No access
27. License No access
28. Termination and Remedies No access
29. 1. The SPC in Switzerland No access
30. 1. Patent Law No access
  2. Pharmaceutical Law No access
  3. Legislative History No access
31. 1. Overview No access
  2. The Term “Product” No access
  3. Protection by a Basic Patent No access
  4. First MA of the Product No access
  5. First SPC for the Product No access
  6. Time Limit for Filing the Application No access
32. 1. Application and Fees No access
  2. Examination and Announcement No access
  3. Grant No access
  4. Remedies No access
33. 1. Subject-Matter of Protection No access
  2. Effects No access
34. 1. General No access
  2. Paediatric Extension No access
35. Premature Lapse and Suspension No access
36. Nullity No access
37. Swiss Federal Patent Court No access
1. 1. 1. Biogen v. SmithKlineBeecham Biologicals, C-181/95 of 23 January 1997 No access
    2. Yamanouchi v. Comptroller-General of Patents, Designs and Trademarks, C-110/95 of 12 June 1997 No access
    3. Idarubicin Farmitalia v. Deutsches Patent- und Markenamt, C-392/97 of 16 September 1999 No access
    4. Omeprazol Ha¨ssle v. ratiopharm, C-127/00 of 11 December 2003 No access
    5. Pharmacia Italia v. Deutsches Patent- und Markenamt, C-31/03 of 19 October 2004 No access
    6. Novartis Novartis v. Comptroller-General of Patents, Designs and Trademarks, C-207/03, Ministre de’Economie v. Millenium Pharmaceuticals, C-252/03 of 24 January 2005 No access
    7. Massachusetts Institute of Technology v. Deutsches Patent- und Markenamt, C-431/04 of 4 May 2006 No access
    8. i-21 Germany v. Arcor, C-392/04, C-422/04 of 19 September 2006 No access
    9. Yissum Research and Development Company v. Comptroller-General of Patents, C-202/05 of 17 April 2007 No access
    10. AHP Manufacturing v. Bureau voor de Industrie¨le Eigendom, C-482/07 of 3 September 2009 No access
    11. Memantine Synthon v. Merz Pharma, C-195/09 of 28 July 2011 No access
    12. Galantamin Generics UK v. Synaptech, C-427/09 of 28 July 2011 No access
    13. Medeva v. Comptroller-General of Patents, Designs and Trademarks, C-322/10 of 24 November 2011 No access
    14. Georgetown University v. Comptroller-General of Patents, Designs and Trademarks, C-422/10 of 24 November 2011 No access
    15. Daiichi Sankyo Company v. Comptroller-General of Patents, Designs and Trademarks, C-6/11 of 25 November 2011 No access
    16. Yeda Research and Development Company, Aventis Holdings v. Comptroller-General of Patents, Designs and Trademarks, C-518/10 of 25 November 2011 No access
    17. University of Queensland v. Comptroller-General of Patents, Designs and Trademarks, C-630/10 of 25 November 2011 No access
    18. Merck Sharpe & Dohme v. Deutsches Patent- und Markenamt, C-125/10 of 8 December 2011 No access
    19. Novartis v. Actavis Deutschland, C-574/11 of 9 February 2012 and with the same result: Novartis v. Actavis UK, C-442/11 of 9 February 2012 No access
    20. Neurim Pharmaceuticals v. Comptroller-General of Patents, Designs and Trademarks, C-130/11 of 19 July 2012 No access
    21. AstraZeneca v. European Commission, C-457/10 of 6 December 2012 No access
    22. Referral: Actavis UK v. Sanofi, C-443/12 of 3 October 2012 No access
    23. Referral: AstraZeneca v. Comptroller-General of Patents, Designs and Trademarks, C-617/12 of 18 December 2012 No access
    24. Referral: Bayer CropScience v. Deutsches Patent- und Markenamt, C-11/13 of 6 December 2012 No access
    25. Referral: GlaxoSmithKline Biologicals v. Comptroller-General of Patents, Designs and Trademarks, C-210/13 of 21 March 2013 No access
    26. Eli Lilly and Company Ltd. V. Human Genome Sciences Inc., C-493/12 of 12 December 2013 No access
    27. Georgetown University v. Octroicentrum Nederland (referred to as Georgetown II in the text) C-484/12 of 12 December 2013 No access
    28. Merck Canada Inc. v. Accord Healthcare Ltd. and others, C-555/13 of 13 February 2014 No access
    29. Referral: Seattle Genetics, C-471/14 of 15 October 2014 No access
    30. Novartis v. Actavis Deutschland, C-574/11 of 9 February 2012 No access
    31. Actavis v. Boehringer Ingelheim, C-577/13 of 14 November 2013 No access
    32. Arne Forsgren v. Comptroller-General of Patents, Designs and Trademarks, C-631/13 of 15 January 2015 No access
  2. 1. 1. Trioxan, X ZB 9/70 of 6 July 1971 No access
      2. Idarubicin III, X ZB 21/00 of 17 July 2001 No access
      3. Sumatriptan, X ZB 12/01 of 29 January 2002 No access
      4. Custodiol II, X ZR 73/01 of 12 March 2002 No access
      5. Anti-Helicobacter-Pra¨parat, X ZB 1/08 of 8 July 2008 No access
      6. Doxorubicin, X ZB 4/08 of 14 October 2008 No access
    2. 1. Abamectin, 15 W (pat) 71/97 of 21 June 1999 No access
      2. Porfimer, 15 W (pat) 59/03 of 23 June 2005 No access
      3. Finasterid, 3 Ni 2/06 of 15 March 2007 No access
      4. Subdiuretische Dosis, 3 Ni 49/07 of 16 June 2009 No access
      5. Tenofovir, 15 W (pat) 24/07 of 12 May 2011 No access
      6. Ranibizumab, 3 Ni 28/11 of 2 May 2012 No access
      7. Insulin Glargine 14 W (pat) 13/07 of 31 May 2011 No access
      8. Telmisartan, 3 Ni 5/13 of 4 February 2013 No access
    3. 1. Valsartan, 4 b O 280/10 of 8 March 2011 No access
  3. 1. 1. E I Du Pont Nemours & Co. v UK Intellectual Property Office 2009 EWCA Civ 966, 2010 R.P.C. 6 No access
      2. Medeva BV v Comptroller General of Patents, Designs and Trade Marks 2010 EWCA Civ 700; 2010 R.P.C. 27 No access
      3. Neurim Pharmaceuticals (1991) Ltd v Comptroller General of Patents 2011 EWCA Civ 228; 2011 R.P.C. 19 No access
      4. Medeva BV v Comptroller General of Patents, Designs and Trade Marks 2012 EWCA Civ 523; 2012 R.P.C. 26 No access
    2. 1. Takeda Chemical Industries Ltd v Comptroller General of the Patent Office (No.3) 2003 EWHC 649 (Pat); 2004 R.P.C. 3 No access
      2. Gilead Sciences, Inc’s SPC Applications 2008 EWHC 1902 (Pat) No access
      3. Astellas Pharma Inc v Comptroller-General of Patents 2009 EWHC 1916 (Pat) No access
      4. Novartis Pharmaceuticals UK Ltd v MedImmune Ltd 2012 EWHC 181 (Pat); 2012 F.S.R. 23 No access
      5. Eli Lilly & Company v Human Genome Sciences Inc 2012 EWHC 2290 (Pat) No access
      6. Actavis Group PTC EHF and Actavis UK Limited v Sanofi and Sanofi Pharma Bristol-Myers Squibb SNC 2012 EWHC 2545 (Pat); 2013 R.P.C. 24 No access
      7. Eli Lilly & Company v Human Genome Sciences Inc 2012 EWHC 2857 (Pat) No access
      8. Dr Reddy’s Laboratories (UK) Ltd and Dr Reddy’s Laboratories Ltd v Warner-Lambert Company LLC 2012 EWHC 3715 (Pat); 2013 R.P.C. 31 No access
      9. Glaxosmithkline Biologicals SA v Comptroller-General of Patents, Designs and Trade Marks 2013 EWHC 619 (Pat); 2013 R.P.C. 26 No access
      10. Actavis Group and Actavis UK v Boehringer Ingelheim Pharma 2013 EWHC 2927 (Pat) No access
      11. Eli Lilly & Company v Human Genome Sciences Inc 2014 EWHC 2404 (Pat) No access
    3. 1. Takeda Chemical Industries Ltd’s Applications 2004 R.P.C. 2 No access
      2. Abbott Laboratories’ SPC Application 2004 R.P.C. 20 No access
  4. 1. 1. Decision of 3 April 2007 of the Supreme Court of Paris, “Diagnosis of AIDS” No access
      2. Decision of 19 March 2013 of the Supreme Court, “azoxystrobine + folpel” No access
    2. 1. Decision of 14June 2010 of the Court of Appeal of Nancy, “Extract of Timothy-Grass” No access
    3. 1. Decision of 15 February 2013 of the Court of Appeal of Paris, “varicella-zoster virus” No access
      2. Decision of 5 July 2013 of the Court of Appeal of Paris, “Peginterferon alpha 2a” No access
      3. Decision of 11September 2013 of the Court of Appeal of Paris, “perflutren” No access
  5. 1. Decision 20/1978 Constitutional Court No access
    2. Court of Milan Irbesartan Hydrochlorotiazide 57598/12 of 22/12/2012 No access
    3. Court of Rome case 23499 of 19/05/2003 No access
    4. Court of Milan case 57598/2012 of 10 July 2014 No access
    5. Commissione dei Ricorsi case 6895 of 20/06/2002 No access
    6. Commissione dei Ricorsi case 6353 of 19/04/1996 No access
    7. Commissione dei Ricorsi case 6491 of 16/12/1997 and 6497 of 17/01/2000 No access
  6. 1. 1. Genzyme Biosurgery v. NLOC of 3 June 2004 No access
      2. Stallergenes v. NLOC of 4 November 2009 No access
      3. Aventis v. NLOC of 28 May 2008 No access
      4. Actavis v. NLOC of 23 September 2009 No access
    2. 1. Sanofi v. Teva of 14 September 2012 (later revoked, see Teva v. Sanofi of 27 August 2013) No access
      2. Mylan B.V. v. Janssen Pharmaceuticals Inc. of 11 December 2013 No access
    3. 1. SKF v. Centrafarm of 19 May 1994 No access
      2. Pfizer v. UVIT & Pfiver v. VGZ of 24 July 2012 No access
      3. APE v. PTC of 23 April 2013 No access
      4. Teva v. Sanofi of 27 August 2013 No access
    4. 1. Yeda v. NLOC of 19 August 2009 No access
      2. Yeda v. Aventis en NLOC of 27 May 2009 No access
      3. Syngenta v. NLOC of 18 February 2015 No access
  7. 1. 1. “Panitumumab”, No. B-3245/2010, Decision of 18 August 2011 of the Federal Administrative Court No access
      2. “Exenatide”, No. B-1019/2010, Decision of 20 October 2010 of the Federal Administrative Court No access
      3. “Etanercept”, BVGE 2010/48, No. B-3064/2008, Decision of 13 September 2010 of the Federal Administrative Court No access
    2. 1. “Alendronsa¨ure II”, No. 4A_52/2008, Decision of 29 April 2008 of the Federal Supreme Court No access
      2. “Fluoxetin”, No. 4P.11/1999, Decision of 27 May 1999 of the Federal Supreme Court No access
      3. “Arzneimittel”, No. 4A.7/1998, Decision of the Federal Supreme Court of 17 November 1998 No access
      4. “Fosinopril”, 124 III 375, Decision of the Federal Supreme Court of 10 July 1998 No access
    3. 1. “Differin Gel”, No. PA 02/03, Decision of 21 January 2005 of the Federal Appeal Commission for Intellectual Property No access
      2. “Ciclosporin”, No. PA 03/97, Decision of the former Federal Appeal Commission for Intellectual Property of 30 April 1999 No access
2. 1. International Treaties No access
  2. European Primary Law No access
  3. European Regulations No access
  4. European Directives No access
  5. 1. Germany No access
    2. United Kingdom No access
    3. France No access
    4. Italy No access
    5. Netherlands No access
    6. Switzerland No access