A Supplementary Protection Certificate (short: certificate) is an intellectual property right, by which a pharmaceutical product or a plant protection agent is protected. With a certificate the proprietor of a » patent (basis patent) has the possibility to prolong the term of protection. This is because, for a pharmaceutical product or pesticide an authorisation is necessary prior to its sale on the market. The grant of such an official authorisation does often take years; however, with the authorisation a qualitativ product officially tested on compatibility is ensured. Due to the longterm procedure for an authorisation a patent proprietor may lose valuable time, in which he would have been able to market his product. Therefore, the possibility has been provided for a patent proprietor to "regain" (max. 5 years) the "loss" of time for full protection. Therewith the owner of a patent and a cerificate, at the same time, obtains a maximum of 15 years in total from the date of the first authorisation within the European Community.

Like a patent or a utility model, a supplementary protection certificate is a national protective right and underlies, therefore, the legal provisions of the respective state. In Austria the relevant legal provisions are laid down in the Supplementary Protection Certificates Act. The characteristic is, that the national regulations have been formed strongly by the European Legislation and, that nebst to the Austrian Supplementary Protection Certificates Act, EC-Rules are to be taken into account.

EFTA-Countries, due to the EEC-Treaty also had to install the possibility of an extension of the » patent term for registered pharmaceuticals, i.e. in form of Supplementary Protection Certificates. Contrary to Sweden, Austria had decided to accept these only in the framework on a Common EEC-Rule. The decision of the joint Committee necessary for it was issued under 7/94 on March 21st, 1994, namely with the known changes of the Council Regulation EEC No. 1768/92.

With the 635th Federal Law on Supplementary Protection Certificates (Protection Certificates Act), issued on August 19th, 1994, the legal basis for supplementary protection certificates was founded. This law came into effect retroactive as of first of July 1st, 1994.

In the meantime few changes on the Austrian Protection Certificates Act 1994 gave rise to a revision of the Protection Certificates Act 1996, which meanwhile has been amended twice. The Protection Certificates Act as present is in force since July 1st, 2005.

For filing of applications for SPC with the Austrian Patent Office it is sufficient to fulfill the requirements given in Article 8 of the corresponding EEC-Directive No. 1768/92 or EC-Directive No. 1610/96 (respective request, name and place of abode of the application, number of basic patent, number and date of first authorisation for the placing the product on the market, etc.). Legalisation or notarisation of the required copies of the first authorisation to place the product on the market is not required by the Austrian Patent Office. The filing of a protection certificate application underlies a filing fee of currently 250,-- EUR (excl. deposit fees and fees for enclosures). For the completion of the formalities required we recommend to consult an experienced patent attorney.

The application for the certificate has to be lodged within six months of the date on which to authorisation to place the product of the Austrian market as a medical product was granted; albeit, when the authorisation to place the product on the market is granted before the basic patent is granted, the application for the certificate has to be filed within six months of the date on which the patent is granted.

If the application does not meet the prescribed conditions, the applicant is asked to eliminate the deficiencies within an appropriate term (about two months). If the deficiencies are not eliminated within the term set, the application shall be rejected. Generally, the above mentioned term is extendable.

The Austrian Patent Office does not check whether a certificate for the product does already exist. It does also not check whether the marketing authorisation is indeed the first marketing authorisation to place the product on the Austrian market.

An Austrian protection certificate may be invalidated by a revocation decision of the Austrian Patent Office. Any person may lodge an action for declaration of revocation of the certificate before the Austrian Patent Office, wherein grounds of revocation are to be put forward, which are listed in Article 15 of the respective Council Regulation No. 1768/92 or No. 1610/96. One ground of revocation is e.g. a revocated basic patent of a contested certificate.

The invalidity action is handled by the Nullity Department of the Austrian Patent Office, wherein the revocation proceedings are – analogue to revocation proceedings of a patent – wound up in two instances.

Find more information on revocation proceedings in Austria under point » Nullity and Infringement of Patents under » Info – Patents.

Licences, prior user rights as well as interim user rights on the basic patent will extend to the supplementary protection certificate unless agreements to the contrary have been made or respective decisions have been issued. Furthermore, the Austrian Patent Office has installed a Register for Supplementary Protection Certificates, from which all important data with regard to certificates can be gathered and monitored. This Register is open to inspection. Online inspection on respective inquiries can, as a matter of course, be handled by our firm.

References regarding supplementary protection certificates are also published in the Austrian Patent Gazette.

For maintaining a supplementary protection certificate – as it is with respect to all other registered protective rights – annual fees are to be payed. Different from patent or utility models, the annual fees for a certificate are to be payed from the first year. The annual fees are in the range of 2.200,-- EUR for the 1^st year up to 3.400,-- EUR for the 5^th year. The annual fees are to be payed in advance, that is, for the forthcoming year, respectively. They can, of course, also be paid within six months after the due date; however, a late payment is subject to additional fees amounting to 20 % of the annuity.

As a matter of course, any payment of annual fees can be handled through our firm.

If you require additional information on this very specific topic, please, contact » Mr. Peter Pawloy from our firm.