Scope of Supplementary Protection Certificates (SPCs) Jürgen Dressel Novartis Pharma AG New York, 29 April 2010 Scope of SPCs | J. Dressel | April 29, 2011| Business Use Only

Discussion Topic Would an SPC for active A be infringed by a drug containing actives A+B? 2 Scope of SPCs | J. Dressel | April 29, 2011| Business Use Only

Term of SPC 20y <15y <5y patent filing marketing approval Research Development Regulatory SPC patent filing marketing approval patent expiry SPC expiry Scope of SPCs | J. Dressel | April 29, 2011| Business Use Only

Regulatory Approval of Combination Products R&D&Reg (A+B) R&D&Reg (A) R&D&Reg (B) Scope of SPCs | J. Dressel | April 29, 2011| Business Use Only

SPCs and Combination Products Gx B Gx A R&D&Reg (B) Basic Patent (B) SPC (B) R&D&Reg (A) Basic Patent (A) SPC (A) R&D&Reg (A+B) Gx A+B Scope of SPCs | J. Dressel | April 29, 2011| Business Use Only

What rights does an SPC give to the holder? Article 5 – Effects of the Certificate “Subject to Article 4, the certificate shall confer the same rights as conferred by the basic patent and shall be subject to the same limitations and the same obligations” Article 4 – Subject Matter of Protection “Within the limits of the protection conferred by the basic patent, the protection conferred by a certificate shall extend only to the product covered by the authorisation to place the corresponding medicinal product on the market and for any use of the product as a medicinal product that has been authorised before the expiry of the certificate.” 6 Scope of SPCs | J. Dressel | April 29, 2011| Business Use Only

Interpretation of Art. 4 and 5 Product = active(s) of approved medicinal product Basic patent Medical uses approved before SPC-expiry 7 Scope of SPCs | J. Dressel | April 29, 2011| Business Use Only

Generics: A+B does not infringe an SPC for A SPC is different from patent. Protection of an SPC is strictly confined to the approved product. One product cannot be protected by more than one SPC. 8 Scope of SPCs | J. Dressel | April 29, 2011| Business Use Only

Originators: A+B infringes an SPC for A SPC-protection is for the approved uses of product. Art. 3(c) prohibits double grant, not double protection. Double protection is common for patents and regulatory – during RDP(A) generic A+B cannot rely on data for A. Strict limitation of the SPC to the approved product would allow easy circumvention and therefore be against the compensatory purpose of SPC-Regulation. 9 Scope of SPCs | J. Dressel | April 29, 2011| Business Use Only

Court Decisions SPC (A) covers A + B SPC (A) does not cover A + B 2010 merits Val PI-appeal Lo PI Lo PI (final) Val PI Val Feb Jan Feb Mar 2010 2011 PI Lo PI-appeal Lo SPC (A) does not cover A + B Scope of SPCs | J. Dressel | April 29, 2011| Business Use Only