1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. Interpretation of Art. 4 and 5
Product = active(s) of approved medicinal product
Basic patent
Medical uses approved before SPC-expiry
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8. 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.
Scope of SPCs | J. Dressel | April 29, 2011| Business Use Only

9. 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

10. 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