Glossary

Here you will find explanations of the terms used in the SPC / paediatric SPC database.

 

A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z

 

A

  • Application, Application date

    Date on which the application for the grant of an SPC or a paediatric SPC was filed with the IPI. For postal filings, the date in the postmark is the applicable date.

     

    Please note that this affects the IP right phase and Application date filters as well as the information under Application in the detailed view of the result.

     

    Information on authorisation/approval (in the filter and in the detailed results view), on the other hand, is about applications for the authorisation of a product with an associated paediatric investigation plan in the European Economic Area (EEA) and/or Switzerland.

  • Authorisation body

    FOPH: Federal Office of Public Health (until 31.12.2001; after that Swissmedic)

    FOAG: Federal Office for Agriculture

    IOCM: Intercantonal Office for the Control of Medicines (until 31.12.2001; after that Swissmedic)

    IVI: Institute of Virology and Immunology, authorisation body for vaccines and serums for animals. The IVI is affiliated to the Federal Food Safety and Veterinary Office (FSVO).

    Swissmedic: since 1.1.2002; previously Intercantonal Office for the Control of Medicines (IOCM)

    EEA: European Economic Area

    In the detailed view of the result, information on the date of submission of the EEA application and the associated paediatric investigation plan is shown for applications for the extension of an SPC and for applications for paediatric SPCs. The application for the authorisation of a paediatric medicinal product in Switzerland must be filed no later than six months after the application for authorisation in the European Economic Area.

 

B

  • Basic patent, Basic patent type

    The basic patent protects the product for which an SPC or a paediatric SPC has been applied for or granted. This can be a Swiss patent (CH patents) or a European patent (EP) with effect in Switzerland and Liechtenstein.

    A basic patent may have several SPCs and/or paediatric SPCs if they concern different products.

 

C

  • Cancellation, Cancellation date
    Date on which an application for the grant of an SPC or a paediatric SPC was removed from the register.
  • Category

    The category concerns the different certificates for different products:

    Medicinal product: SPCs for medicinal products incl. paediatric extensions of SPCs

    Paediatric: paediatric SPCs

    Plant protection product: SPCs for plant protection products

 

D

 

E

 

F

 

G

  • Grant, Grant date
    Date of the grant of an SPC or a paediatric SPC.
 

H

  • History
    In the history, you will find all publications on the SPC or paediatric SPC: the publication of the application, the grant of the certificate, if applicable, and any subsequent changes. In the case of applications, no changes are published except for cancellations.
 

I

  • Information on authorisation/approval

    Approval: official approval to place a plant protection product on the market in Switzerland. The date in the detailed view of the result refers to the first official approval from the Federal Office for Agriculture (FOAG).

     

    Application: application for the authorisation of a product with an associated paediatric investigation plan in the European Economic Area (EEA) or in Switzerland. In the detailed view of the result, information on the date of submission of the EEA application is shown for applications for the extension of an SPC and for applications for paediatric SPCs.

     

    Authorisation: the authorisation granted for a product (medicinal product) in Switzerland. The date in the detailed view refers to the first authorisation.

  • IP right phase, Phase​​​​​​​

    Granted phase: see Grant, Grant date

    Application phase: see Application

 

  • IP right status, Status​​​​​​​

    Active status: includes all published, pending SPC and paediatric SPC applications as well as all granted SPCs and paediatric SPCs that have not been cancelled.

    Cancelled status: the SPC / paediatric SPC database contains all SPCs and paediatric SPCs as well as applications that have been cancelled since September 1995.

 

J

 

K

 

L

 

M

  • Maximum term of protection

    The term of an SPC or a paediatric SPC begins immediately after the expiry of the maximum term of the basic patent. SPCs are valid for a maximum of five years from this date, or a maximum of five and a half years with a paediatric extension. Paediatric SPCs are valid for six months from this date. After this term has expired, they are permanently cancelled.

     

    The detailed view of the result shows the maximum term of protection for the SPC or paediatric SPC, provided that all required fees are paid and the IP right does not expire prematurely. Any extension of an SPC for medicinal products will only be taken into account once it has been approved.

 

N

 

O

  • Owner
    Address of the owner of the certificate.
 

P

  • Paediatric extension of an SPC
    An SPC may be extended by six months for the protected medicinal product if clinical trials have been conducted on children in accordance with a paediatric investigation plan. This extension is also called a paediatric extension.
  • Paediatric supplementary protection certificate, paediatric SPC

    A paediatric supplementary protection certificate (paediatric SPC) extends protection for six months after the expiry of patent protection for patented medicinal products for which clinical trials have been conducted on children in accordance with a paediatric investigation plan.

     

    More information on SPCs

  • Product
    A product is an active ingredient or a combination of active ingredients (Art. 140a para. 2 PatA).

  • Publication date, Publication
    Date of publication of an application for the grant of an SPC or a paediatric SPC.

  • Publication of the application for a paediatric extension​​​​​​​

    Date on which the application for a paediatric extension of an SPC was published.

    Please note that the maximum term of protection indicated in the detailed view of the result still corresponds to the term of protection of the SPC at this point in time. The maximum term of protection will only be extended by six months after the paediatric extension has been granted.

 

Q

 

R

  • Reason for cancellation

    Expiry of max. term of protection: the certificate has been cancelled after reaching the maximum term of protection.

    Application rejected: the IPI has rejected the application.

    Application withdrawn: the applicant has withdrawn the application.

    Dismissal: the IPI has dismissed the application.

    This reason for cancellation was published until the end of 2018. With effect from 1 January 2019, applications are only published after formal examination has been successfully completed.

    Nullity: the SPC has been declared null and void.

    Non-payment of renewal fee: the renewal fee for the SPC has not been paid.

    Surrender: the owner has surrendered the SPC.

    Revocation of authorisation/approval: the authorisation of the medicinal product or approval of the plant protection product has been revoked.

  • Representative
    Address of the representative who represents the IP right owner in the IPI’s procedures.

 

S

  • SPC / paediatric SPC number

    A basic patent may have several SPCs and/or paediatric SPCs if they concern different products (Art. 140a para. 1 sentence 2 and 140t para. 2).

     

    The SPC or paediatric SPC number consists of a C followed by the basic patent number and the number of the certificate (/01, /02, etc.). The format of the SPC number depends on the basic patent:

     

    CH: C123456/01

    EP: C12345678/01

     

    Example: C00124495/01 = first SPC for EP patent no. EP0124495

  • Start of term of protection
    The term of protection of an SPC or a paediatric SPC begins one day after the expiry of the maximum term of the basic patent.

  • Supplementary protection certificate, SPC

    A supplementary protection certificate (SPC) extends the protection of patented medicinal products and plant protection products by up to five years after the expiry of patent protection.

     

    More information on SPCs

 

T

 

U

 

V

 

W


 

X

 

Y

 

Z

 
 
 

Jobs