Supplementary protection certificates for pharmaceutical and 2026

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  1. Click ‘Get Form’ to open it in the editor.
  2. Begin by filling in the applicant's details. Include your given name or company name, surname, postal address, postal code, city, country, and organization number if applicable. Ensure all mandatory fields are completed using capital letters.
  3. Designate a contact person by providing their email and telephone number. If you have appointed an agent, fill in their details as well.
  4. Indicate whether you are filing this application simultaneously with the SPC application. Provide the application number and filing date if applicable.
  5. Complete the sections regarding active ingredients and basic patent information. Make sure to declare any relevant marketing authorizations and orphan drug classifications.
  6. Attach necessary documents such as copies of marketing authorizations and any declarations required. Check that all fields are filled before finalizing your submission.
  7. Sign the application at the designated area, including your name in capital letters, place, and date of signing.

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New applications after 1 January 2025 You will generally not be able to rely on centralised authorisations as the basis for a new SPC application after 1 January. This is because the authorisation must be valid on the date of application, and these authorisations will no longer be effective in Northern Ireland.
The CSP regime implements Canadas commitment in CETA by providing for an additional period of protection for drugs containing a new medicinal ingredient, or a new combination of medicinal ingredients, protected by an eligible patent.
A form of IP that extends the protection of patented active ingredients present in pharmaceutical or plant protection products.
Under the SPC Manufacturing Waiver, manufacturing (and acts strictly necessary thereto) are exempted during the SPC term for two purposes only: (1) exporting to countries where IP protection does not exist or has expired; and (2) stockpiling in the country of manufacture during the last six months of a given SPC term,
The term of an SPC depends on the date of issuance of the first marketing authorization (MA) within the EEA and can be determined by the equation: Term = date of 1st MA in the EEA date of filing of corresponding patent 5 years.

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People also ask

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.
Supplementary protection certificates (SPC) may be obtained in relation to individual medicinal and plant protection products disclosed in a patent. The certificate extends the protection conferred by the patent beyond its 20-year term for a period of up to five years.
SPCs come in different flavours The two types are: SPCs for active substances of human or veterinary medicinal products; and. SPCs for active substances of plant protection.

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