European Patent Convention
Additional Certificates of Protection
The long-awaited Act Amending Some Acts for the Protection of Industrial Property came into force on May 10 2000. The act amends the following legislation:
- Act 527/1990 on Inventions, Industrial Designs and Rationalization Proposals (Patent Act);
- Act 478/1992 on Utility Models;
- Act 529/1991 on Protection of Layout Designs; and
- Act 137/1995 on Trademarks.
The new act is important since it implements the legislative amendments necessary for the Czech Republic's accession to the European Patent Convention. It also introduces additional certificates of protection for pharmaceutical and plant protection preparations.
The amendments relating to the Czech Republic's accession to the European Patent Convention will take effect on July 1 2002. From this date, European patents and patent applications which affect the Czech Republic will have the same effects in the Czech Republic as national patents and patent applications. Patent claims of published European patent applications must be disclosed by the Czech Industrial Property Office to the public in Czech translation. Within three months from the date on which a granted European patent is published, the patent owner must submit a Czech translation of the letters patent to the Czech Industrial Property Office for publication.
Supplemental Protection Certificates
Provisions that introduce supplemental protection certificates (SPCs) for pharmaceutical and plant protection preparations took effect on May 10 2000. It is now possible to require the Czech Industrial Property Office to issue an SPC for the active ingredients of preparations which are subject to registration before their introduction into the market, pursuant to the Act on Pharmaceuticals and the Act on Plant Protection Preparations. An 'active ingredient' is a chemically produced substance or microorganism, or composition thereof, which:
- has general or specific therapeutic or preventive effects in relation to diseases of humans or animals;
- may be administered to humans or animals in order to determine, improve or amend their health condition; or
- is intended to protect plants or plant products.
Filing an application
The following patent owners may file an application for an SPC:
- owners of patents protecting substances, except for patents granted pursuant to Article 82 of the Patent Act (ie, so-called 'pipeline protection' of pharmaceuticals and other subject matter, which is excluded from patent protection under patent law in force before January 1 1991);
- owners of patents protecting preparation methods of substances;
- owners of patents protecting methods of using a substance as a pharmaceutical or plant protection preparation; and
- their legal successors (eg, assignees and heirs).
The application must be filed within six months of the preparation's date of registration or, if the preparation is registered before the grant of the basic patent, within six months of the date on which the patent was granted. The application will be entered into the Patent Register and published in the Official Gazette.
An SPC will be issued under the following conditions:
- The basic patent is valid in the territory of the Czech Republic;
- The preparation contains an active ingredient, protected by the basic patent, which is validly registered as a pharmaceutical or plant protection preparation;
- No prior SPC on the substance has been issued; and
- The preparation's registration is the first of a generic pharmaceutical or plant protection preparation onto the Czech market.
The SPC will remain in force for a period that corresponds in length to the period between the filing date of the basic patent and the date of the first registration which permits the preparation's introduction to the Czech market, minus five years. However, the maximum period for which the additional certificate may remain in force is five years from the day on which it became effective. The additional certificate becomes effective once the term of validity of the basic patent expires. Certain fees, which will be set out in the Act on Administrative Fees, must be paid in order to keep the SPC in force.
The SPC gives its owner the same rights as those given by the basic patent. However, this protection is restricted to (i) the chemical substance, microorganism or composition thereof which is an active ingredient of a registered preparation, and (ii) each use of the subject matter of the patent as a pharmaceutical or plant protection preparation that is permitted before the SPC expires.
The SPC will lapse in the following circumstances:
- on expiry of the term of its effectiveness;
- by waiver of its owner;
- if fees are not duly paid;
- if the preparation may no longer be marketed because of a cancellation or lapse of the registration; or
- if SPC is cancelled by the Industrial Property Office.
The SPC will be cancelled in the following circumstances:
- if conditions upon which it was granted are not met;
- if the basic patent lapses before the term of its validity expires; or
- if the basic patent is cancelled or restricted so as to exclude the substance protected by the SPC from patent protection.
For further information on this topic please contact Karel Cermák at Cermák Horejš Myslil by telephone (+420 2 9616 7401) or by fax (+420 2 2494 6724) or by e-mail ([email protected]).
The materials contained on this web site are for general information purposes only and are subject to the disclaimer.