Module 6

03/10/2024

SPC Requirements

Article 3(a)

• If patent claims A and MA is granted for A+B – no SPC for A+B ( Medeva ) • If patent claims A+B and MA is granted for A – no SPC for A ( Yeda )

Article 3(b)

• The MA must cover the Product (i.e. the active ingredient or combination of active ingredients) for which the SPC is sought • If patent claims A and MA is granted for A+B, you can get an SPC for A ( Medeva )

The Organisation for Professionals in Regulatory Affairs

SPCs

35

Paediatric Extension

• Paediatric Regulation (Regulation (EC) 1901/2006)

• Has the aim to "facilitate the development and accessibility of medicinal products for use in the paediatric population, to ensure that medicinal products used to treat the paediatric population are subject to ethical research of high quality and are appropriately authorised for use in the paediatric population, and to improve the information available on the use of medicinal products in the various paediatric populations. These objectives should be achieved without subjecting the paediatric population to unnecessary clinical trials and without delaying the authorisation of medicinal products for other age populations."

The Organisation for Professionals in Regulatory Affairs

SPCs

36

18