29 April 2011 Brian Cordery Bristows London Fordham IP Conference 2011 Supplementary Protection Certificates Recap and Current Status 29 April 2011 Brian Cordery Bristows London

Agenda Reminder of some basic concepts and definitions Current References to the Court of Justice

SPCs – Basic Concepts and Definitions SPC regime introduced in Europe in 1992 to provide partial compensation to patent holders in the pharmaceutical field for the patent life lost in obtaining regulatory approval The SPC regime was deemed necessary to encourage pharmaceutical research and development in Europe; and to keep up with the USA and Japan which introduced similar regimes in the 1980s Original Regulation 1768/92 was codified and consolidated into Regulation 469/2009 A “uniform solution” is contemplated...

SPCs – Basic Concepts and Definitions Three key definitions: Basic patent: a patent protecting: (i) a product as such; (ii) a process or (iii) an application for a product Product: the active ingredient or combination of active ingredients of a medicinal product Medicinal Product: the substance presented for treating or preventing desease in humans “Protected” is not defined: “a matter of national law” (CJEU Farmitalia [1997])

SPCs Conditions for Obtaining a Certificate (Article 3) the product is protected by a basic patent in force; a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate; (c) the product has not already been the subject of a certificate; the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product.” (Emphasis added)

What does “Protected by a Basic Patent” mean? “Subject matter”; “Identifiable”; “Disclosure”; “Clear Pointer”; “Inventive Concept” tests To be protected, the product must be disclosed/claimed in a specific/class/generic/not limited way Infringement test A product is protected if it would infringe the designated basic patent e.g. a patent for X would be infringed by X+Y and therefore X+Y is protected by a basic patent for X

A uniform landscape? Apply the infringement test Uncertain / changing Very strict ( must be specifically claimed) Strict (combination must be disclosed) Less strict (any reference to a combination will suffice)

References to the Court of Justice Patent claims MA SPC sought Outcome Medeva (1) Queensland (1) A A+B Denied – Art 3(a) Referred Medeva (2) Georgetown Queensland (2) Denied – Art 3(b) Daiichi Yeda Medeva / Georgetown hearing is set for 12 May 2011

Other Issues Reference to the CJ on Article 3(d) in Neurim [8 March 2011] – does a patent and MA for the use of melatonin to advance the breeding season of sheep count as the first authorisation to place the product on the market, thus depriving a later invention for use of melatonin in the treatment of sleep disorders in humans from the opportunity to obtain an SPC? Synthon v Merck; Generics v Synaptech – Questions to the CJ on the meaning of “first authorisation to place the product on the market”: opinion of AG Mengozzi delivered on 31 March 2011. Further reference on negative SPCs in the Sitagliptin case

Thank you for your attention Bristows 100 Victoria Embankment London EC4Y 0DH T +44(0)20 7400 8000 F +44(0)20 7400 8050 brian.cordery@bristows.com www.bristows.com 22574666