The SPC Blog: Resources

Reference and source materials relating to supplementary protection certificates and patent extension. This weblog holds material for The SPC Blog. While we'll be keeping it as up-to-date as we can, we can't guarantee that we haven't missed anything. We're delighted to receive any more cases from readers.

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Scope of an SPC

What is the scope of an SPC?

C-392/97 Farmitialia Carlo Erba, 16 September 1999

• German Supreme Court - Idarubicin II – GRUR 2000, 683-685

• CNRS and PFM v Ajinomoto Omnichem SA (Belgium)

• E.I. Du Pont de Nemours and Co. and Merck Sharp & Dohme B.V. v N.V. Apotex and Mylan B.V.B.A in Brussels Commercial Court, 12 February 2010)-(English translation) and Brussels Court of Appeal decision (8th Chamber of the Brussels Court of Appeal)-(English translation)

• Societe E.I. Du Pont de Nemours and Company et S.N.C. Laboratoires Merck Sharp & Dohme-Chibret v S.A.S. Mylan, Tribunal de Grande Instance de Paris, 12 Feburary 2010 (English translation)

Valsartan (Germany) - District Court of Dusseldorf - 8 March 2011

Valsartan (Norway) - Oslo District Court - 10 February 2011 (engl. trans. here)

• Novartis AG v Teva Pharma Belgium NV Court of Appeal(8th Chamber of the Court of Appeal of Antwerp)(English translation)

· Pharmaq v. Intervet (Norway) - Oslo District Court Judgment – 10 August 2015

Duration of an SPC

When does the six-month time period to file an SPC application start?

• Case C-452/07 Health Research Inc. (referral, however appears to have been dropped)

Abbott Laboratories' SPC Application [2004] RPC 20

Product for an SPC

Can I get an SPC in light of a patent disclosure?

Takeda Chemical Industries SPC Applications (No. 3) [2003] EWHC 649 (Pat), [2004] RPC 37 (UK) • AB Hässle, 2 January 2000, Supreme Administrative Court Case No. 3248-1996 (Sweden) - informal translation • Merck and Co, Inc. v The Patent Board of Appeal, 12 December 2003, Eastern Division of the Hight Court, B-2667-01 (Denmark) • Abbott Laboratories v M. le Directeur de l'INPI 19 January 2005, Cour d'Appel, 04/14435 (France) • Du Pont de Nemours (PIBD No 828-III-275) (France) • Squibb – Spanish Supreme Court decision of 4 July 2007 • Novartis v Controller General [2007] IEHC 442 • Gilead Sciences, Inc.'s SPC Application [2008] EWHC 1902 (Pat) • Centocor's SPC Application [1996] RPC 118 • Astellas Pharma Inc's application, BL O/052/09 (UK); Astellas Pharma Inc v Comptroller-General of Patents [2009] EWHC 1916 (Pat) • Stallergenes S.A. v BIE, AWB 08/9394 OCT95, Rechtbank 's-Gravenhage

Daiichi Sankyo Company Limited v INPI, Cour d'Appel, 6 November 2009

• Case 6/11 - Daiichi Sankyo Company v Comptroller-General of Patents (referral); [2010] EWHC 2897

• Imclone Systems Inc. and Aventis Holdings Inc's SPC appkications, BL O/066/10; Yeda Research and Development Company Ltd v Comptroller General of Patents [2010] EWHC 1733 (Pat); Order to CJ; CJ Case C-518/10 (Referral)

University of Queensland and CSL Limited's SPC applications, BL O/335/10, CJ Case C-630/10 (referral)

Can I get an SPC in light of what has been approved before?

• Draco's SPC Application [1996] RPC 417 • Case 431/04 Massachusetts Institute of Technology v Deutsches Patentamt • Clarithromycin, 15 (W) Pat 106/96 (Germany) • Case 202/05 Yissum Research & Development Company of the Hebrew University of Jerusalem v Comptroller-General of Patents [2004] EWHC 2880 • Daunorubicin - 14 W (pat) 13/05 - German Federal Patent Court • Case 258/99 BASF v Bureau voor de Industriele Eigendom • Fusilade - 15 W (pat) 26/98 - German Patent Court Cabergolin II - X ZB 30/05 - German Federal Supreme Court • Generics (UK) v Daiichi Pharmaceutical Co Ltd [2008] EWHC 2413 (Pat), [2009] EWCA Civ 646 Chiron and Novo-Nordisk's SPC Application [2005] RPC 24 • Knoll AG's Application BL O/138/05 • Case C-482/07 AHP Manufacturing BV v BIE • Abelcet - INPI decision - 27 February 2009

Marketing Authorisation

What constitutes the first marketing authorisation for a product?

Case C-207/03 - Novartis v Comptroller General

Case C-252/03 Ministre de l'Economie v Millenium Pharmaceuticals [2005] RPC 33

Doxorubicin Sulfate - FSC X ZB 4/08 - German Federal Supreme Court

C-31/03 - Pharmacia Italia v Deutsches Patentamt [2005] RPC 27

Triptorelin - 14 W (pat) 9/06 - German Federal Patent Court

Neurim Pharmaceuticals (1991) Ltd's Application, BL O/384/09, [2010] EWHC 976 (Pat), [2011] EWCA Civ 228

Can a marketing authorisation prior to Directive 65/65/EEC constitute a valid first marketing authorisation for a product?

• Merck v Almirall Prodesfarma (24th Chamber of the Brussels Court of First Instance, 15 June 2007) and Court of appeal decision (8th Chamber of the Brussels Court of Appeal, 23 June 2009)

Aceclofenac - 14 W (pat) 42/04 - German Patent Court

Synthon v Merz Pharma [2009] EWHC 656 (Pat) – referral to ECJ

Synthon v Merz Pharma (Brussels Commercial Court, 21st Chamber, 11 January 2011) (English translation)

Memantine 3 Ni 59/05 (joined with 3 Ni 20/07, 3 Ni 34/07, 3 Ni 54/07) German Federal Patent Court 11 December 2007

Memantine decision, Dutch patent office

Generics (UK) Ltd v Synaptech Inc [2009] EWHC 659 (Ch), 20 May 2009

Can the holder of a basic patent, who is not the holder of the marketing authorisation for the medicinal product, apply for an SPC based on said marketing authorisation?

Case 181/95Biogen v SmithKline Beecham [1997] RPC 833

What is the first marketing authorisation in an EEA state?

Pantoprazol - FSC X ZB 31/06 - German Federal Supreme Court – 27 May 2008

Negative Term SPCs

Can a negative term SPC be granted?

• UK: Merck and Co. Inc. BL O/108/08 (UK)

Germany: German Patent and Trademark Office of 20 March 2008 2/08 (Decision issued but not copy available, here for case summary); German Federal Patent Court (English summary here, full translation here), 15 W (pat) 36/08

ECJ: Case C-125/10 Merck & Co Inc. v Deutsche Patent- und Markenamt (referral, English translation of AG Opinion)

The Netherlands: Dutch patent office, Negative term decision

France: France Patent Office decision (Decision issued but no copy available)

SPCs for Devices and Diagnostics

• Genzyme Biosurgery Corp v Industrial Property Office, BIE 70 (2002) 360-362 (Netherlands) DC (the Hague); Rechtsbank 's-Gravenhage, AWB 02/1729 OCT (English translation)

Yttrium-90 Glass Microspheres (German text here), 14 W (pat) 12/07, German Federal Patent Court

• Chiron Corp. v Institut National de la Propriété Industrielle, Cour de Cassation 3 Avril 2007 (No. 05-13855) (France)