ON SUPPLEMENTARY PROTECTION CERTIFICATES FOR MEDICINAL PRODUCTS AND PLANT PROTECTION PRODUCTS (SPC)
1. The supplementary protection certificate (hereinafter referred to as "certificate") aims at extending the term of protection of a patented medicinal product or plant protection product in the framework of a sui generis title of protection.
In the European Communities the supplementary protection certificate for medicinal products was introduced by Council Regulation(EEC) No 1768/92 and the supplementary protection certificate for plant protection products was introduced by Regulation (EC) No 1610/96 of the European Parliament and of the Council.
Within the limits of the protection conferred by the basic patent, the protection conferred by a certificate shall extend only to the product covered by the authorizations to place the corresponding product on the market and for any use of the product as a medicinal product or plant protection product that has been authorized before the expiry of the certificate.
The certificate shall confer the same rights as conferred by the basic patent and shall be subject to the same limitations and the same obligations.
Regulation 1901/2006 / EC on medicinal products for pediatric use, entered into force on 26th January 2007, amending the wording of Regulation 1768/92 / EC. Thus fulfilling the legal requirements for the implementation of the pediatric investigation plan ,it is possible 6 months extension of the duration of a supplementary protection certificate.
2. Supplementary protection certificates in Hungary
With Hungary's accession to the European Union the application of these Community regulations are to be applied in Hungary as well.
The rules necessary for the implementation of the European Community Regulations are contained in Act XXXIII of 1995 on the Protection of Inventions by Patents (hereinafter referred to as "the PA") and Decree No 26/2004 (II.26.) Korm. on the rules necessary for the implementation of the European Community Regulations concerning the creation of a supplementary protection for certain products (hereinafter referred to as "the Decree").
The Treaty of Accession between the present Member States and the Accession States contains the conditions and provisional rules of the introduction of supplementary protection.
3. The Hungarian Patent Office (hereinafter referred to as "the Office") shall have the authority in the following matters concerning certificates:
- grant of certificates,
- decision on lapse of certificates and restoration of certificates,
- decision on invalidity of certificates,
- decision on lack of infringement,
- interpretation of certificates,
- keeping registers of applications and certificates, including matters concerning their maintenance; official information on applications and certificates.
4. A supplementary protection certificate shall be granted if in Hungary on the filing date:
- the product is protected by a basic patent in force;
- a valid authorization to place the product on the market as a medicinal product or a plant protection product has been granted in accordance with the provisions of the relevant EEC Directives in force;
- the product has not already been the subject of a certificate; and
- the authorization referred to in (b) is the first authorization to place the product on the market as a medicinal product or as a plant protection product.
The holder of more than one patent for the same product shall not be granted more than one certificate for that product. However, where two or more applications concerning the same product and emanating from two or more holders of different patents are pending, one certificate for this product may be issued to each of these holders.
5. Time limit for application for certificates
The application for a certificate shall be filed within six months of the date on which the authorization to place the product on the market as a medicinal product was granted or, if it is of a later date, on which the basic patent was granted.
After Hungary's accession to the European Communities a certificate may be obtained for a medicinal or a plant protection product in Hungary, which
- is under protection of a patent in force in Hungary;
- for which the first authorization to place it on the market as a medicinal product or as a plant protection product was issued after 1 January 2000; and
- the application for the certificate was submitted within six months of the date of accession.
6. Procedure for the grant of certificates
Following the filing of an application, the Office shall examine, whether the application meets the conditions laid down for according a filing date, and the filing fee has been settled.
6.1 The accorded filing date
The accorded filing date shall be the date on which the application filed with the Office contains at least: an indication that a certificate is sought; information identifying the applicant (the name and the address of the applicant); the number of the basic patent and the title of the invention, the number and date of the first authorization to place the product on the market and, if this authorization is not the first authorization to place the product on the market in the Community, the number and date of that authorization.
If the date of filing may not be accorded, the applicant shall be invited to rectify the irregularities within 30 days. If the irregularities are rectified within the specified time limit, the date of receipt of the rectification of irregularities shall be accorded as the filing date. Otherwise, the application shall be considered withdrawn.
6.2. Filing fee
Where the filing fee is not settled within two months of the filing date, the application shall be considered withdrawn.
6.3. Publication of applications
Where the application meets the conditions laid down for according a filing date, the Office shall in its official journal publish a notification of the application for a certificate and shall record it referring to the basic patent in the patent register. The notification shall contain at least the following information: the name and address of the applicant, the number of the basic patent, the title of the invention, the number and date of the authorization to place the product on the market in Hungary, the product identified in that authorization, and where relevant, the number and date of the first authorization to place the product on the market in the Community.
Where the application meets the conditions laid down for according a filing date and the filing fee has been settled, the Office shall examine whether the application meets the requirements laid down in the Community Regulations, the PA and the Decree.
The application may not be amended in a way that the certificate refers to a different product, to a different authorization to place the product on the market or to a different basic patent than the one indicated in the application filed at the filing date.
6.6. Time limits - restitutio in integrum
For the procedure for grant of certificates, the general rules of patent procedures of the PA shall be applied mutatis mutandis, however, restitutio in integrum is excluded in the event of failing the six-month time limits for filing the application, prescribed by the Community Regulations.
6.7. Grant of certificates or rejection of applications
Where the application for a certificate meets the conditions laid down in the Community Regulations, the PA and the Decree, the Office shall grant a certificate for the subject of the application.
Where the application does not meet the conditions, the applicant shall be invited to rectify the irregularities or submit comments. The application shall be rejected, if it does not meet the conditions examined even after rectification of irregularities and submission of comments.
6.8. Publication of the rejection of applications or grant of certificates
Notification of the fact that an application has been rejected or a certificate has been granted shall be published in the official journal of the Office.
7. Duration of certificates
The certificate shall take effect at the end of the lawful term of the basic patent for a period equal to the period which elapsed between the date on which the application for a basic patent was filed and the date of the first authorization to place the product on the market in the Community, reduced by a period of five years, provided that the duration of a certificate may not exceed five years.
8. Annual (maintenance) fees
For the duration of the certificate a maintenance fee shall be payable annually. The annual fee for the first year of protection shall be due on the date of filing the basic patent; the annual fees for the subsequent years shall be payable in advance on the anniversaries of the filing date. If the last year of the duration of the certificate is an incomplete year a proportionate part of the maintenance fee for the relevant year shall be payable together with the annual fee for the last complete year. The annual maintenance fees are contained in point 5 of the Schedule of Fees.
9. Lapse or invalidity of certificates
The certificate lapses:
- if the holder of the certificate relinquishes it,
- if the annual fee is not settled,
- if the authorization to place the product on the market is withdrawn.
The certificate shall be invalid if:
- it was granted contrary to the provisions of Article 3 of the Community Regulation,
- the basic patent has lapsed before its lawful term expires,
- the basic patent is revoked or limited.
10. Restoration of certificates
In the event of lapse of a certificate due to failure to pay the annual fee, the restoration of the certificate may be requested within three months of the expiry of the six-month grace period.
The substantive decisions of the Hungarian Patent Office concerning the certificates shall be open to the same appeals as those provided for in the national law against similar decisions taken in respect of national patents. The substantive decisions concerning patents of the Office, may be altered by the Court, on the basis of a request for review.