1 / 10

Scope of Supplementary Protection Certificates (SPCs)

Scope of Supplementary Protection Certificates (SPCs). Jürgen Dressel Novartis Pharma AG New York, 29 April 2010. Discussion Topic. Would an SPC for active A be infringed by a drug containing actives A+B?. Term of SPC. 20y. < 15y. < 5y. Research. Regulatory. Development. SPC.

bin
Download Presentation

Scope of Supplementary Protection Certificates (SPCs)

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

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

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

More Related