Supplementary protection certificates for pharmaceutical and 2025

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The document is an application form for requesting an extension of a Supplementary Protection Certificate (SPC) for pharmaceutical products. It includes sections for applicant information, contact details, and declarations regarding marketing authorizations and orphan drug status. The form requires specific attachments and signatures, and emphasizes the need to fill out mandatory fields correctly.
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The specific formula for calculating the SPC protection period is the date of the first marketing authorization grant - the filing date of the basic patent - 5 years. If the resulting duration is less than 0, no SPC protection is provided.
An SPC is an intellectual property (IP) right extending a patent for an authorised pharmaceutical product by up to five years. Currently, Regulation (EC) No 469/2009 (the SPC Regulation) provides for SPCs to be granted at the national level on a country-by-country basis.
An SPC is only granted to the holder of the patent that protects the active ingredients and it only protects the active ingredients present in a medicinal or plant protection product. It does not extend the patent.
A Supplementary Protection Certificate (SPC) extends patent protection for medicinal products which must undergo lengthy testing and clinical trials before being authorised to be placed on the EU market.
Supplementary protection certificates (SPCs) are an intellectual property right that serve as an extension to a patent right. They apply to specific pharmaceutical and plant protection products that have been authorised by regulatory authorities.

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Supplementary protection certificate search SPC in pharmaceutical industry SPC pharmaceutical European patent Supplementary protection certificate SPC manufacturing waiver Regulation Regulation (EC) No 469/2009 SPC Regulation Supplementary protection certificate UK

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In the European Economic Area (European Union member countries, Iceland, Liechtenstein and Norway), a supplementary protection certificate (SPC) is a sui generis intellectual property (IP) right that extends the duration of certain rights associated with a patent.

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