Lithuania: Lithuania Grants Extra Protection for Medicine & Plant Protection Patents

Starting from January 1, 2002 amendments to Lithuanian Patent law, which are adopted following EC Regulations No 1768/92¹ and No 1610/96², have come into force. New provision of law creates the possibility for the owners of the patents on pharmaceutical and plant protection products to receive supplementary protection certificates granting extended protection for up to additional five years to the patents. All the procedure and requirements for the applications for supplementary protection certificates are set in the Regulation PA/01/2001 of Lithuanian State Patent Bureau. The Regulation closely follows mentioned EC Regulations, which it implements.

A supplementary protection certificate may be granted to a patent owner or his successor in title for a period not exceeding five years, if legal protection is conferred to:

1) active ingredients of a medicine;

2) active substances of a plant protection product.

Following Regulation PA/01/2001, which provides for the definitions, "medicine" and "plant protection product" should be understood similarly as in corresponding EC Regulations. But the definition of the "patent" on the basis of which supplementary protection may be granted is narrower than the one in said EC Regulations. Following Lithuanian rules "patent" is valid in the Republic of Lithuania patent, which grants protection for active ingredients of a medicine or plant protection product, while EC Regulations define "patent" as a patent which protects medicinal or plant protection products as such, a process to obtain those products or an application of the products. Thus the scope of the protection following both instruments, i.e. national Lithuanian laws and EC Regulations is different. In Lithuania supplementary protection certificate may be granted only for patented active substance of medicine or plant protection product within the limits of basic patent, which may not include process to obtain or application of the product.

Supplementary protection certificate is granted upon the application to Lithuanian State Patent Bureau. Foreign applicants may file an application only through licensed patent attorneys of Lithuania.

An application shall include a request to grant supplementary protection certificate, copy of the document authorizing to place a product on Lithuanian market for the first time and document certifying the payment of official fees. It should be noted that State Patent Bureau performs only formal examination of the documents and does not examine whether provided authorization to place medicine or plant protection product on the market was issued for the first time. This may be challenged only by interested persons in the courts.

An application for supplementary protection certificate must be lodged with the Lithuanian State Patent Bureau within the period of six months form the date on which the authorization to place product on the market for the first time was issued or the date on which patent was granted (if it was granted later), but in any case before the expiration of the validity of basic patent.

Granted supplementary protection certificate takes effect at the end of lawful term of basic patent and is valid for the period equal to the period which elapses between the date on which basic patent application was lodged and the date of the authorization to place a medicine or plant protection product on the market, reduced by a period of five years, but not exceeding five years from the date on which it takes effect. Therefore it is useful to apply for supplementary protection certificate only if the time period between the date of patent application for pharmaceutical or plant protection product and the date of firs authorization to place a product on Lithuanian market is more than five years. It is also should be noted that the duration of supplementary protection certificate depends on the payment of annual fees.

The grounds of expiration or invalidity of supplementary protection certificate are also the same as in before mentioned EC Regulations, the only difference being that Lithuanian rules do not indicate such ground of invalidity as "the lapse of basic patent before the expiration of its lawful term". But having in mind the basic idea of supplementary protection certificate to prolong the term of lawful protection of research results of the applicants and the fact that Lithuanian rules are the result of implementation of EC Regulations this ground should also be taken in account when deciding the issue of certificate's invalidity in Lithuania.

In order to protect the interests of those patent owners for whom the time period to apply for supplementary protection certificate has expired before the date on which Lithuanian patent law was amended, the law provides for exception. Differently from EC Regulations, which also provided for transitional periods, but in the way of giving additional time period to apply for certificates after the Regulations enter into force, without taking into account that lawful time period has expired, Lithuanian rules provide for conditional exception, which takes effect on the date when and if Lithuania joins European Communities. Following the exception the patent owners, for whom the time period to apply for supplementary protection certificates has expired on the entering into force of amendments to Lithuanian patent law, will have a right to apply for such supplementary protection after the date on which Lithuania joins European Communities and will have this right for six months. The problem with such exception is that until Lithuania joins EC some of the patents, which are valid at the moment, may expire and the owners thereof will have no right to receive supplementary protection, but should the transitional provisions be such as in EC Regulations, they would have such right. On the other hand, the exception provided in Lithuanian law is anyway valid only for those patent owners, who applied for their patents after 1 February 1994. And the Lithuania plans to be accepted as new member of EC at the beginning of 2004. So there should not be a lot of patents, which elapse during this period.

During the first several months of the validity of new Lithuanian Patent law provision allowing to receive supplementary protection certificate none of such certificates were issued or applied for.³

1 Council Regulation No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medical products, OJ L 182, 02/07/1992, p. 0001.

2 Council Regulation No 1910/96 of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products, OJ L 198, 08/08/1996.

3 The data of State Patent Bureau for March 4, 2002.