POLAND (PL) - Amendments to Polish Patent Law (2004/07)

There have been enacted several amendments to the Polish Industrial Property Law of June 20, 2000 in respect to its Title II governing inventions. The Law of June 6, 2002 revising the Law on Industrial Property entered into effect on October 18, 2002. It introduced following changes: One of the substantive prerequisites of patentability - the requirement of industrial applicability - has been revised by adding that inventions (novel, having inventive step and susceptible of industrial application) are patentable irrespective of the technical field of their applicability. Article 35 consisting of three following sections: "1. An applicant wishing to take advantage of the priority of an earlier application shall be required to make, in a request, a declaration to that effect in a form of a statement and enclose a document in confirmation that the earlier patent application was filed in the indicated country or certifying that the invention was exhibited at the indicated exhibition. The document concerned may also be furnished within three months of the filing date. In case of late furnishing of the said declaration or document, the priority claim shall be without effect. 2. If, for the purpose of describing an invention in a complete manner, a reference to a deposited microorganism has been made in the patent application, the applicant shall be required to enclose a certificate issued by the relevant depositary institution in confirmation that the deposit has been made therein. The certificate may also be furnished within six months of the filing date. In case of late furnishing of the said certificate, the deposit of the microorganism shall not be considered equivalent to its disclosure in the application. 3. For the purpose of enabling the deposit to be recognised as fulfilling the requirements of disclosure of the invention, a depositary institution shall ensure that the deposit is available to third parties in the course of patent granting proceedings and at least throughout the duration of the patent." has been amended by deleting the last two sections. After Poland accession to the European Union, provisions relating to the exhaustion of the patent right, that have been amended several times, eventually read as follows: "(1) The rights conferred by a patent shall not extend to acts concerning a product embodying the invention or manufactured by means of the invention, consisting in particular of its offering for sale or further putting on the market, if that product has been put on the market on the territory of the Republic of Poland by the patent holder or with his consent. (2) A patent shall neither be considered infringed by an act of importation into the territory of the Republic of Poland or other acts referred to in paragraph (1) in respect of a product that has earlier been put on the market on the territory of the European Economic Area by the patent holder or with his consent.". One of the most important changes introduced by the Law of June 6, 2002 is a new regulation governing the Supplementary Protection Certificate that took effect beginning from May 1, 2004 (i.e. date of Poland accession to the European Union). Intellectual Property Law provides that SPC can be granted in Poland on conditions laid down in the regulations concerning the creation in the European Union of supplementary protection certificates for medicinal products and plant protection products. Particular requirements have been introduced by the Regulation of the Prime Minister of July 28, 2003. According to the Polish provisions, SPC may be granted for active substance or combination of such substances if substance or combination of substances are protected by basic patent in force at the date of the accession of Poland to the EU and the first authorization to place a product on the Polish or the EU market has been granted before May 1, 2004 but not earlier than January 1, 2000. The request for granting SPC for active substances and combinations of such substances, which fulfill above conditions shall be filed within 6 months from the date of the accession of Poland to the EU (November 1, 2004). This term is non-extendible one. Simultaneously, it is not easy to give clear interpretation of the term "first marketing authorization". It may be understood as first marketing authorization on the Polish market. Such an answer is provided by the PPO on its website. However, this approach is contrary to the interpretation provided by the Office of the Committee for European Integration which prefers first authorization on the European Union market. In the future the application shall be filed within 6 months from the date on which the authorization to place a product on the market was granted. The possible extension of the patent will be a up to 5 years. The certificate will 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 the 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. The SPC will confer the same rights as conferred by the basic patent. However the protection will be extended only to the product cover by the authorization to place the corresponding medicinal product (plant protection product) on the market and for any use of the product as a medicinal product (plant protection product) that has been authorised before the expiry of the certificate. All requirements or formalities which are provided in EU regulations will be also applied to the SPC in Poland. It is worth to draw readers attention to the fact that Poland has recently adopted provisions concerning the legal protection of biotechnological inventions. This has been implemented by revision of the Industrial Property Law so as to adjust it to the provisions of Directive 98/44/EC of the European Parliament and of the Council of July 6, 1998. The respective revision of the Industrial Property Law became effective as from October 18, 2002. A biotechnological invention, being an invention in the meaning of the general prerequisites of patentability, is defined as relating to a product consisting of or containing biological material or a process by means of which biological material is produced, processed or used. Biological material is defined as any material containing genetic information and capable of reproducing itself or being reproduced in a biological system. Biological material which is isolated from its natural environment or produced by means of a technical process may be patented even if it previously occurred in nature. It is a very important provision, as previously applicants encountered difficulties in patenting biological materials (such as microorganisms) isolated from natural environment, which were automatically qualified as not patentable discoveries, even if technical utility was found for them. The human body or the mere discovery of one of its elements does not constitute an invention. Elements isolated from the human body or made by means of a technical process, including genes and gene sequences, can however be patented provided that the technical utility of the gene or sequence is disclosed. Plant or animal varieties as such are excluded from patentability, as they are protected in Poland by a separate system. Plants or animals shall be patentable, only if the technical feasibility thereof is not confined to a particular plant or animal variety. This creates the situation where dependence on two different types of protection rights may arise, that is dependence on the patent right and the right to the plant or animal variety. In order to comply with the obligation resulting from Article 12.4 of the Directive, the Polish Patent Office has been designated as the authority responsible for granting a compulsory licence for the breeder and a cross-licence for the patent owner in case of cross-dependence of the patent right and the plant/animal variety right. Also excluded from patentability are essentially biological processes for the production of plants or animals, that is the processes consisting entirely of natural phenomena such as crossing or selection. The exclusion of essentially biological processes does not apply to microbiological processes performed on microbiological material. Finally, those biotechnological inventions which are contrary to order public or morality are excluded from patentability. Although (as in the Directive) there is no general definition of an invention contravening order public or morality, certain particular types of such inventions are indicated in the patent law itself. These are the inventions relating to the processes of cloning or modifying the identity performed on humans and human germ lines and uses of human embryos for industrial purposes. Genetically modified animals and processes for genetic modification of animals can be patented, unless such patenting may cause suffering of an animal which is unjustified in comparison with the medical benefit obtained. Although the new provisions became effective as from October 18, 2002, they may also be helpful in the construction of the substantive law in respect of earlier applications. Until October 18, 2002, patenting biotechnological inventions was in principle possible, product claims being also allowable since 1993. However, significant doubts and problems have arisen in relation to the construction of the law, in particular in respect of such issues as: the difference between discovery and patentable biological product; refusal of grant in case of the inventions in the field of genetic modification of plants or animals on the grounds that they contravene order public, for example because of their unknown ultimate effect on the natural environment; patentability of plants and animals which are not limited to particular variety; and patentability of genetic material. There have also been another amendment to the Act in question that have been effective since March 2004. It introduced following changes: Not only the patent claims shall be entirely supported by the description and shall define, in a clear and concise manner, the invention claimed and the scope of the protection sought (a characterising portion of the claim) by way of indicating the technical features of the solution but also each claim should be formulated clearly, in one sentence or equivalent thereof (art. 33 sec. 3(1)). Moreover according to article 33 sec. 4 and 4(1) in addition to an independent claim or independent claims, which should present the combination of the technical features of the invention or a group of inventions covered, by one patent application, in one patent application a relevant number of dependent claims may be included, which are necessary to present various elaborations of the invention or to specify the features indicated in a characterising part of an independent claim or another dependent claim. Interrelations between an independent claim and dependent claims shall be clearly reflected in the application. Where the statutory requirements for the grant of a patent are not satisfied only in respect of some of the inventions covered by one application and the applicant refrains from reducing the scope of the protection sought, the Patent Office at first refuses to grant a patent in respect of these inventions. After the decision in this case is implemented, the Patent Office decides on making the relevant amendments in the application specification as filed. The last but not least amendment introduced by ordinance of Council of Ministry of March 2, 2004 refers to the payments for patent protection. They should be paid more frequently than under previous provisions as every single year except first annuity that includes three years of protection. Reported by Iwona Kowalik

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