The Romanian Patent Law No. 64/1991 is currently undergoing review with a proposal to introduce amendments in order to meet the current economical needs and largely ties with TRIP's Agreement and European Union requirements. At this stage, the draft of amendments is under the Parliament approval. There is much hope that the draft will be approved by the end of 1999.

The major aspects of the draft are related with patent protection of products and in particular pharmaceutical and biotechnological products and are briefly highlighted below.

1. The supplementary protection certificate for medicinal products protected by valid basic patents

The term of protection for valid patents having pharmaceutical or phytopharmaceutical products as subject matter may be extended on the patentee request. The supplementary patent protection gives to the basic patent until 5 years. This period is obtained after having subtracted 5 years from the period between the date of patent application and the date of the first marketing authorization of the pharmaceutical product on market.

The procedure of granting supplementary certificate of protection shall be settled through the Implementing regulation of the Patent Law.

2. Right conferred by the patent

Extension of Process Patents to Products

According to the draft, a patent shall confer on its owner the following exclusive rights:

a) where the subject matter of a patent is a product, to prevent third parties not having his consent from the acts of: making using, offering for sale, selling, or importing for these purposes that product;

b) where the subject matter of the patent is a process, to prevent third parties not having his consent from the acts of: using the process and for the acts of: using, offering for sale, selling or importing for these purposes at least the product obtained directly by that process.

3. Scope of protection related to biotechnological inventions

Extension of Process Patents to Products for biotechnological products is expressly mentioned as a new feature in the draft.

The protection conferred by a patent on a biological material possessing, as a result of invention, specific characteristics shall extend to any biological material derived from that biological material through multiplication or propagation in an identical or different form and possessing those same characteristics.

The patent protection for a process for producing of a biological material possessing specific characteristics shall extend to the product directly obtained, products derived from the material initially obtained by the patented process, whether such derivation is through replication or differentiation on the basis of said genetic information, or through both replication and differentiation carried out in any sequence, provided that the said derived products have essentially the same genetic characteristics as the said initial material.

4. Right of prior use

The patent has no effect against a person who has already used the invention on the Romanian territory, or made the necessary arrangements for using it prior to the filing or priority date of that patent.

The new feature brought by the draft of amendments is that after the grant of the patent of invention, the said person is not allowed anymore to use the patented invention.

NOTE:. THIS ARTICLE IS WRITTEN BY MRS. MARGARETA OPROIU WITH THE PURPOSE OF INFORMATION ONLY AND CAN NOT BE CONSIDERED AS A PROFESSIONAL CONSULTATION. FOR FURTHER INFORMATION PLEASE CONTACT US.