Supplementary protection certificate

General Information

The supplementary Protection Certificate extends the life-span of a patent for compulsory approval pharmaceuticals or pesticides for up to 5 years, but the scope of protection of the Protection Certificate is usually more limited than that of a patent. 
This opportunity for extending the life-span of patents for approved pharmaceuticals in the form of a supplementary Protection Certificate was created when Austria joined the European Union in order to make the costly and protracted development of pharmaceuticals and pesticides more financially bearable.

Legal Provisions

Regulation No. 469/09 (for pharmaceuticals)
Regulation (EG) No. 1610/96 (for pesticides)
Supplementary Protection Certificates Act  (SchZG 1996) 
Patentamtsgebührengesetz (goes into effect on July 1, 2005)

Note: The changes to the Patent Law and Fees Amendment of 2004, Federal Law Gazette I 2004/149 for the Supplementary Protection Certificate Act of 1996 go into effect on July 1, 2005.

Application

A supplementary Protection Certificate can be applied for at the Austrian Patent Office. For this, there is also an appropriate Application Form
SZ 1(including help for filling it out in the appendix to the form) available. Submitting an application by email is not possible at this time due to legal considerations.

An application fee in the amount of € 250 (through June 30, 2005: € 218) must be paid for the application.

For the submission of applications for supplementary Protection Certificates, only the requirements listed in Article 8 of the corresponding EWG regulations (EWG Regulation No. 1768/92 or Regulation (EG) No. 1610/96) are imposed. A notarization of the required copies of the first approval for marketing is not demanded.

Deadlines
The application for the Certificate must be made either six months after the granting of an approval for marketing (market approval) in Austria or six months after the granting of the patent (if the granting of the patent does not take place until after the market approval).

Granting

If an application for a supplementary Certificate does not correspond to the prescribed requirements, then the applicant will be informed of the existing deficiency. The applicant is permitted to correct the indicated deficiency within an appropriate deadline, usually two months. If the deficiency is not corrected within the deadline set, then the application is refused.

The granting of the supplementary Protection Certificate is done without examining whether a supplementary Protection Certificate has already been granted for the product and whether the presented approval is actually the first approval for the marketing of the product in Austria.

Life-span of the Certificate 

The Protection Certificate connects seamlessly with the protection of the patent and applies from the expiration date of the maximum legal life-span of the patent, for a duration that corresponds to the period of time between the submission of the patent application and the date of the first approval for marketing in the European economic region, minus a period of five years.

The maximum life-span of the Protection Certificate, however, is five years from its effective date.

Fees

An application fee of € 250 is due with the application for a supplementary Protection Certificate. The application fee is not to be paid, however, until you have received an appropriate demand for payment from the Austrian Patent Office.

Due for granted Protection Certificates based on yearly fees.  The amount for yearly fees is:

• for the first year € 2200 (through June 30, 2005 € 2034)
• for the second year € 2500 (through June 30, 2005 € 2325)
• for the third year € 2800 (through June 30, 2005 € 2616)
• for the fourth year € 3100 (through June 30, 2005 € 2906)
• for the fifth year € 3400 (through June 30, 2005 € 3197)

The yearly fees are due each time in advance for the coming year. The due date is indicated in the decision to grant the Certificate. The yearly fees can be paid three months before the due date and up to six months after the due date. If the yearly fees are paid after the due date, then an additional fee of 20% is due with the yearly fee.

Note: You can find more detailed information on payment methods in § 4 of the PGMMV  PGMMV (Payments to the Patent Office).

Veröffentlichungen

A Protection Certificate Register is kept by the Austrian Patent Office in which the most important data on Protection Certificates is provided. This Protection Certificate Register may be viewed by anyone. It is also possible to obtain a certified excerpt from the Register. Notes regarding supplementary Protection Certificates are also published in the Austrian Patent Gazette.

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