SPC developments in Europe AIPPI Marjan Noor Simmons & Simmons

Transcription

1 SPC developments in Europe AIPPI 2012 Marjan Noor Simmons & Simmons

2 Requirements for obtaining an SPC (Reg 469/2009) The product is protected by a patent (Art 3(a)) There is a marketing authorisation (MA) for the product (Art 3(b)) The product is not already the subject of an SPC (Art 3(c) ) by same patentee (AHP/Biogen) MA is the first for the product in that country (Art 3(d)) Product means the active ingredient or combination of active ingredients of a medicinal product (Art 1(b)) Patent means a patent which protects a product as such, a process to obtain a product or an application of a product (Art 1(c)) 2 / Doc ID: L_LIVE_EMEA1: v1

3 Scope and Effects of an SPC Scope of an SPC restricted to scope of patent extends only to product covered by MA extends to any authorised use of the product before SPC expiry (Article 4) Subject to Article 4, SPC shall confer the same rights as conferred by the basic patent and shall be subject to the same limitations and the same obligations (Art 5) 3 / Doc ID: L_LIVE_EMEA1: v1

4 SPC decisions from CJEU in the last year! Medeva and Georgetown University C-322/10 and C-422/10 (24 November 2011) University of Queensland, CSL Ltd -Case C-630/10 (25 November 2011) Yeda Research and Development /Aventis -Case C-518/10 (25 November 2011) Daiichi Sankyo Case C-6/11 (25 November 2011) Merck Sharpe & Dohme Case C-125/10 (8 December 2011) Novartis v Actavis Case C-442/11 (9 February 2012) Neurim - Case C-130/11 (19 July 2012) 4 / Doc ID: L_LIVE_EMEA1: v1

5 What these decisions have established SPC product must be specified in wording of patent claim (Medeva) SPC product may exclude actives in the MA (Medeva) No SPC for active identified in patent claim as part of combination (Medeva/Yeda) Only one SPC may be granted per patent (Medeva) Process claim must identify product as that deriving from patented process to permit an SPC on that product (Queensland) SPC on single active can be enforced against combination containing the active (Novartis) Existence of an earlier marketing authorisation for product A does not preclude SPC for product A as long as different application of A and covered by patent (Neurim) 5 / Doc ID: L_LIVE_EMEA1: v1

6 Uncertainties: what does specify/identify mean? What is meant by specified or identified in the wording of the claims? Is it sufficient for product to fall within scope of claim? NB infringement test was rejected by Medeva Is the inventive concept relevant? (Actavis v Sanofi/Dutch approach) Would an active in Markush formula be specified/identified? Is it sufficient if patent describes products in functional terms (eg an X inhibitor or an antibody to X)? In combination cases, would a claim to A and an antihypertensive specify/identify a particular hypertensive? Claim to a phage display method does not specify antibody (Medimmune v Novartis - English Court, 10 February 2012) Uncertainty drives CJEU reference by English Court (Actavis v Sanofi - 20 September 2012) 6 / Doc ID: L_LIVE_EMEA1: v1

7 Uncertainties: one SPC per patent? One SPC per product per patent (UKIPO)? Patent claiming A and (separately) B entitled to SPC on each of A and B? Patent claim to A and to combination of A+B can have SPC on either A or A+B? Quid pro quo for being able to enforce A against A+B Reference by English Court (Actavis v Sanofi pending) One SPC per patent regardless of number of products in patent (Dutch Patent Office) Reference by Dutch Court (Georgetown University/Queensland University 11 July 2012) 7 / Doc ID: L_LIVE_EMEA1: v1

8 Uncertainties: Different application of known product? Shift from previous case law where different species or indication for a known product precluded SPC (Pharmacia Italia/Yissum) Recital 14 of Plant Protection Regulation: Whereas the issue of a certificate for a product consisting of an active substance does not prejudice the issue of other certificates for derivatives (salts and esters) of the substance, provided that the derivatives are the subject of patents specifically covering them What is the limit of different application? SPCs on New formulations? New indications? Medical device/active combinations? 8 / Doc ID: L_LIVE_EMEA1: v1

9 Further uncertainties SPC based on unconnected third party MA? Eli Lilly v HGS (English Court 3 August 2012) SPC application on a pending MA/expired MA? Sumitomo (CJEU reference Case C-210/12) Abandoning one SPC in favour of another SPC covering different product, both products being claimed by same patent? Reference by Dutch Court (Georgetown University/Queensland University 11 July 2012) 9 / Doc ID: L_LIVE_EMEA1: v1

10 Thank you simmons-simmons.com elexica.com 10 / Doc ID: L_LIVE_EMEA1: v1