Module 6

03/10/2024

What is the effect of an SPC?

• Protects specific active ingredients which are covered by an MA to place a corresponding drug on the market, and any use of that active ingredient in a drug that is authorised before expiry of the SPC.

• Confers same rights as conferred by basic patent.

Duration

=

Date of notification of grant of first MA in the UK or EEA

minus

Date of filing of patent

minus

5 years

Subject to a maximum term of 5 years (plus a six-month paediatric extension (PE) if applicable)

The Organisation for Professionals in Regulatory Affairs

SPCs

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SPC Requirements

A Product "protected by" a basic patent - all active ingredients in the Product must be:

• " specified " ( Medeva; C-322/10) or " identified " ( Yeda; C-518/10) in the wording of the claims of the basic patent - for a product claim patent. • where the claims were defined by functionality, they needed to relate " implicitly but necessarily and specifically " to the active ingredient ( Eli Lilly; C-493/12) • the claims must relate " necessarily and specifically " to the combination ( Teva; C-121/17)

The Organisation for Professionals in Regulatory Affairs

SPCs

34

17