Seminar 11 - 12: SPC's Flashcards
What is a Supplementary Protection Certificate (SPC)?
An SPC extends patent protection for medicinal products to compensate for time lost during regulatory approval.
What is the maximum duration of SPC protection?
SPCs provide up to 5 additional years of protection, with a 6-month extension for compliance with a Paediatric Investigation Plan (PIP).
Why are SPCs important for pharmaceutical development?
They allow recovery of R&D investments by extending market exclusivity, compensating for the time lost in obtaining regulatory approval.
What is the scope of SPC protection under Regulation 469/2009?
SPCs protect the specific product covered by the marketing authorisation (MA), including salts, esters, and solvates within the scope of the basic patent
What are the four conditions for granting an SPC under Article 3 of Regulation 469/2009?
The product must be protected by a basic patent, have a valid first MA, not previously be the subject of an SPC, and the MA must be the first authorisation for the product in the EEA.
What is the CJEU ruling in Medeva (C-322/10) regarding combination products?
An SPC can be granted for active ingredients protected by the basic patent even if the MA also includes additional active ingredients. (later amended in Teva and Royalty Pharma)
What was clarified in the Santen case (C-673/18) regarding the definition of “first marketing authorisation”?
The first MA for the active ingredient as a medicinal product precludes SPCs for subsequent MAs for new therapeutic uses of the same active ingredient.
What does Article 3(a) of Regulation 469/2009 require for SPC eligibility?
The product must be explicitly or implicitly protected by the claims of the basic patent.
What is the difference between literal and functional claims in SPC eligibility?
Literal claims explicitly specify the active ingredient, while functional claims describe the product in terms of its activity or characteristics.
How does the Neurim case (C-130/11) differ from Santen regarding SPC eligibility?
Neurim allowed SPCs for second MAs in distinct therapeutic contexts, while Santen limited eligibility to the first MA for the active ingredient as a medicinal product, regardless of use.
What is the significance of Article 9 of the Biotech Directive for SPCs?
It extends patent protection to genetic material only if it performs its intended function, ensuring alignment with the patented invention.
What is the “SPC export waiver” under Regulation 2019/933?
It allows EU manufacturers to produce generics or biosimilars during the SPC term for export to non-EU countries without SPC protection and to prepare for EU market entry immediately after SPC expiry.
What are the key conditions for using the SPC export waiver?
Manufacturers must notify authorities and SPC holders three months in advance, comply with labeling requirements, and limit manufacturing to export or post-SPC entry preparation.
How is the SPC term calculated under Article 13 of Regulation 469/2009?
The SPC term is the time between the patent filing date and the first MA date in the EU, minus 5 years, capped at 5 years.
What is the purpose of the paediatric extension to SPCs?
It incentivizes paediatric research by extending SPC protection by 6 months if the applicant complies with an approved Paediatric Investigation Plan (PIP).
What exclusions apply to paediatric extensions for SPCs?
Orphan drugs are not eligible for SPC paediatric extensions but receive 2 additional years of market exclusivity instead.
What is the impact of the Abraxis case (C-443/17) on SPC eligibility?
It clarified that new formulations of existing active ingredients, even if innovative, do not qualify for SPCs as they are not new products.
What is the CJEU ruling in Royalty Pharma (C-650/17) on functional claims for SPCs?
Functional claims can justify SPCs if the product is specifically identifiable based on the patent and prior art and falls under the scope of the invention.
How do “negative term SPCs” address short patent and MA timelines?
Negative term SPCs allow for a virtual extension when the time between the patent filing and the MA is less than 5 years, enabling paediatric extensions to be applied.
How does the SPC system balance public and private interests?
It incentivizes innovation by extending exclusivity for patentees while ensuring generic competition and affordable medicines after SPC expiry.
