Romania: Supplementary Protection Certificate For Medicinal Products Or For Plant Protection Products – New Title Of Protection In Romania

As Romania became part of the European Community since January 1^st, 2007, new regulation regarding protecting the industrial property came into force. So, according to Art. 19a from the Accession Treaty of Romania to European Union: "to any medicinal product protected by a valid patent and whose first authorization for the placing on market was obtained after January 1^st, 2000, could be granted a certificate in Romania. For the situations in which the period provided by Art. 7(1) has expired, the solicitation for a certificate is possible within a term of six months, staring at latest, at the date of accession". The period referred to in Art. 7(1) is six months starting with the date to which the product, as a medicament, obtained the authorization to place it on the market.

Short historical review of Supplementary Protection Certificate

The Supplementary Protection Certificate has its origin in the case of the medicament talidomida, famous in the early 60’ years. Further to this tragic case, the competent European authorities decided to establish a rigorous control of the medicine products before their placing on the market and so came to life Directive 65/65/EEC, amended by the Directive 2001/83/EC, and the Directive 81/851/EEC, as appropriate.

The Supplementary Protection certificate is a title of protection born from the following reasons:

• The improvement of the public health system
• Protecting the innovation activity in the pharmaceutical industry
• Providing an uniform solution at the Community level
• Getting equilibrium between the compensation offered for the results of the expensive, long term pharmaceutical research and the needs and budget of the public health system.

Legal basis for the Supplementary Protection Certificate in Romania

• The following European Regulations

• Council Regulation (EEC) no. 1768/92 concerning the creation of a supplementary certificate for medicinal products
• Regulation (EC) no. 1610/96 concerning the creation of a supplementary certificate for plant protection products

• Romanian Patent and Trademark Office issued specific instructions regarding the application of the two European Regulations in Romania, under the number 146 in December 28, 2006.
• Regarding the specific regime of the market authorization for medicinal products, this is comprised in:

• Law 95/2006, Title XVII – The Medicament
• Order 1199 of October 2, 2006 for approving the withdrawal / suspending by the National Medicament Agency of certain authorizations for placing on the market of the medicaments, before Romania’s accession to European Union, issued by the Ministry of the Public Health

The European regulations are directly applicable to all member states of the European Union. However, the certificate is asked and is granted on national way.

Definitions

Based on the above-mentioned legislation, it is understood the meaning of the following terms:

• "Medicinal product" – any substance or combination of substances presented for treating or preventing disease in human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals.
• "Product" means the active ingredient or combination of active ingredients of a medicinal product – in this context the term ‘active ingredient’ has to be interpreted as including related derivatives thereof, especially a salt or an ester, which obtained an authorization for placing on the market and which is protected by the basic patent. There is an exception the situation in which the derivative itself is a new active substance.

The term ‘basic’ does not mean that the patent has to be the first one that protects the product.

In Romania, a basic patent may be:

a patent in force, granted in Romania, in accordance with the Romanian Patent Law 64/1991, as amended and republished in 2002;

• an European Patent validated or extended in/ to Romania, granted in accordance with the Law 611/2002 or the Law 32/1997, respectively;
• a certificate for transitional protection in force, granted according to the Law 93/1998 for the transitional protection of patents.

Subject of a Supplementary Protection Certificate in Romania

• any product in the above-identified meaning, including its salts or esters as long as these are also protected by the same patent, product which

• is protected on the territory of Romania by a patent being in force;
• before commercialization, it was authorized as a medicament or as a plant protection product, respectively;
• it was authorized before the expiry of the patent;

• any use thereof as a medicament or as a plant protection product.

A certificate may be granted in Romania for a product that received a first authorization for placing on the market in Romania in accordance with the Directive 2001/83/EC, respectively 2001/82/EC, after January 1, 2000.

A certificate may protect a single product, namely a single active substance or a combination of active substances.

Conditions to be accomplished for the granting of a Supplementary Protection Certificate

These conditions have to be fulfilled in Romania at the date an application for a certificate is submitted with the Office. Consequently, at the date of submitting the application for a certificate:

• the basic patent protecting the product has to be in force in Romania;
• the product has not already been the subject of another certificate in Romania;
• to exist a valid authorization to place the product on market in Romania, issued in accordance with the Directive 2001/83/EC, respectively 2001/82/EC and dated after 1.01.2000;
• the mentioned authorization has to be the first market authorization of the product in Romania, even it could not be the first one in the European Economic Community.

Entitlement to the certificate

The certificate will be granted to the holder of the basic patent or to his successor in title.

A single certificate will be granted to the owner of more patents for the same product.

When two or more applications for a certificate for the same product, coming from two or more different patent holders, are in the same time subjected to the granting procedure, it is possible to be granted a certificate for the mentioned product for each patent owner.

The supplementary protection certificate confers to its holder the same rights as the basic patent and it is subjected to the same limitations and to the same obligations.

The protection conferred by the certificate extends:

• only within the limits of the protection conferred by the basic patent;
• only to the product covered by the authorization to place it on the market;
• only for those uses of the medicament authorized before the expiry of the certificate.

The application for certificate

The application for a certificate will be lodged:

• within a six months period of the date on which was granted in accordance with the Directives 2001/83/EC and 2001/82/EC, the first authorization to place the product on the market in Romania, or
• within a six months period from the date of granting of the basic patent, if the market authorization was granted before the basic patent is granted; in Romania, if the basic patent is a European patent, then the six months term starts at the date on which the Romanian translation of the European patent is filed with the Office.

ROPTO considers the application as filed if this contains at least the following:

• an indication of the request for the issuance of the certificate;
• identification data of the applicant;
• the number of the basic patent and the title of the of the invention;
• the number and the date of the first authorization to place on the market in Romania;
• if the authorization for placing on the market in Romania is not the first one in the European Economic Community, the number, the date and the country of the first authorization in EEC.

The certificate application will be subjected to a formal and to a substantive examination.

Grant of the certificate or rejection of the application

ROPTO decides the grant of the certificate or the rejection of the certificate application. The certificate is granted to the owner of the basic patent or to his successor in rights.

Within one month from the decision, ROPTO will publish in the Inventions Section of the Official Gazette the mention of granting the certificate, as well as the following information:

• the certificate owner’s name and address;
• the number of the basic patent;
• the number and date of the first marketing authorization, as well as the product identified thereby;
• the number and date of the first market authorization in EEC, if applicable;
• the duration of the certificate.

In the case of rejection of the certificate application, ROPTO will publish this decision in one month, with the same additional information as for granting.

Term of protection

The certificate is effective from the date of expiry of the legal term of protection of the basic patent, for a period established in accordance with the Art. 13 of the European Regulations, taking into the consideration the reasons for expiry and invalidity of the certificate, as exposed in articles 14 and 15 of the mentioned Regulations.

The duration of the certificate may not exceed five years from the date on which it takes effects.

A first provisional marketing authorization shall not be taken into account for the calculation of the certificate validity period, unless said authorization is not followed directly by a final authorization for the same product.

Defense of the Rights Conferred by the Certificate

• the certificate was granted without fulfilling the legal requirements;
• the validity of the basic patent ceased before the expiry of the legal validity term;
• the basic patent is cancelled either wholly or in part, so the product is no longer protected by the claims of the basic patent

• the ROPTO decisions to grant the certificate or to reject the certificate application may be appealed against by the owner within three months from the communication.
• Any interested person may ask to ROPTO to revoke the certificate within six months from the publication of the decision to grant in the Official Gazette, for the reasons provided by the Article 15 from the Regulations.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.