Scope of Supplementary Protection Certificates (SPCs)

Jürgen DresselNovartis Pharma AGNew York, 29 April 2010

Scope of SPCs | J. Dressel | April 29, 2011| Business Use Only 1

2 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?

Term of SPC

Scope of SPCs | J. Dressel | April 29, 2011| Business Use Only 3

DevelopmentResearch Regulatory SPC

20y

<15y

<5y

patent filing

patent expiry

SPC expiry

marketing approval

Regulatory Approval of Combination Products

R&D&Reg (A) R&D&Reg (B)

R&D&Reg (A+B)

Scope of SPCs | J. Dressel | April 29, 2011| Business Use Only 4

SPCs and Combination Products

Scope of SPCs | J. Dressel | April 29, 2011| Business Use Only 5

SPC (A)R&D&Reg (A) Basic Patent (A)

SPC (B)R&D&Reg (B) Basic Patent (B)

R&D&Reg (A+B)

Gx B

Gx A

Gx A+B

What rights does an SPC give to the holder?

6 Scope of SPCs | J. Dressel | April 29, 2011| Business Use Only

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.”

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”

Interpretation of Art. 4 and 5

7 Scope of SPCs | J. Dressel | April 29, 2011| Business Use Only

Basic patent

Product = active(s) of approved medicinal product

Medical uses approved before SPC-expiry

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

2010 2011

PILo

PILo

SPC (A) covers A + B

SPC (A) does not cover A + B

merits Val

PI-appeal

Lo

Feb

PI-appeal

Lo

PIVal

MarJan

PI (final)Val

Feb

Scope of SPCs | J. Dressel | April 29, 2011| Business Use Only 10