Protecting Biotech Invention Rights
In Poland the protection of intellectual property in biotechnology is highly similar to European Union. The Polish Industrial Intellectual Property Rights Law (2000) and its amendment (2002), concern inventions related to biotechnology and comply with the EU's and international conventions' norms. This legislation unified Polish law with EU norms, particularly with the European Parliament's Directive 98/44/WE and the Council's decision (1998). Dynamic development and continuous changes of the European industrial property law will force Poland to further harmonization.
The first Polish Patent Office was established by the order of the Commander of the State on December 13, 1919, shortly after the establishment of the Polish State. The same year, three decrees concerning paten-ting were published. It is worth to mention that the decree concerning patents for invention was one page long - just compare with the length of our directives, laws and norms today. The other two decrees concerned the protection of designs, models and trademarks. At the same time, Poland joined the Paris Convention for the Protection of Industrial Property (of March 20, 1883). In 1975 Poland joined the Stockholm Act of the Paris Convention and in the same year became the member of World Intellectual Property Organisation (WIPO). In 1993 the membership in the Budapest Treaty followed, which is particularly important for biotechnology patenting. It regulates the deposition of organisms instead of a description, which is required in patent applications (description of living microorganisms, organisms, tissues or cell cultures can be very difficult). Around 2000, an independent but strictly related new coherent national system of science-related ethical committees was successfully initiated.
Patenting Living Organisms
In contemporary Poland, a new system directed to biotechnology was initiated in 1992 with the amendment of an old Inventiveness Law from the year 1972. Before that date, Polish Patent Office rejected patents for live organisms per se with the substantiation that the invention did not have the technical character. The amendment of the Inventiveness Law with the quashing of the interdiction of chemical and pharmaceutical compounds, food and feed, gave the possibility to patent microorganisms. In 1993, the President of the Polish Patent Office issued the order concerning the inventions and utility models' protection which also concerned the documentation principles regarding microorganisms (Polish law §3 ust. 2 pkt 5 i §8).
The pressure of the scientific community, the need to adjust the Polish legislation to that of the EU, as well as economic considerations (applications for deliberate releases of GMO by commercial companies) have contributed to the advance of the legislation process towards the establishment of the “Gene Law” in 2002, followed by an amendment in 2003. The law regulates the majority of legal aspects related to genetic engineering technology (GMO). Exceptions concern e.g. intellectual property rights (IPR) which are regulated separately. The law is based on Directive 2001/18 and international conventions, including the Biosafety Protocol. The amendment turns the very restrictive regulation into a more friendly one towards GMO practitioners.
Adjusting Polish to EU Norms
The Polish Industrial Property Law (Dz. U. nr 49, 2001, poz. 508, June 30, 2000) and its amendment (Dz. U. nr 108, 2002, pos. 945, June 30, 2002 ) concern inventions related to biotechnology. This legislation adjusts the Polish Patent System to the European Union's norms, particularly with the Directive 98/44/WE of the European Parliament and of the Council (June 6, 1998), and also included biotechnology inventions (microorganisms and microbiological processes). The Directive 98/44/EC (July 6, 1998) aims to achieve the harmonization of these differences in legal protection for biotechnological inventions and in particular to ensure their effective protection.
Dynamic development and continuous changes of industrial property laws in Europe will force Poland towards further harmonization. The European Patent Convention (EPC) of October 5, 1973 - a unification of the European countries' systems -, will be ratified by Poland soon; the Polish Parliament already accepted this ratification in September last year.
The entire ratification of the biotechnological inventions in Poland concerned the amendment of the Industrial Property Law (act of 6.06.2002 Dz. U. No. 108 pos. 945 of 17.07.2002) which was implementing this European Directive; it was not uncontroversial and did not have any direct legal impact on any Member State for a long time. The Member States had to convert the directive into national law until 30 July 2000 by appropriate legal and administrative regulations; however, this process is far from a successful completion.
According to the current amended law, a biotechnological invention can be protected by means of national and European patents in Europe. For plant varieties special protection comes into consideration in accordance with the laws protecting plant varieties applying in the various Member States, as well as by Regulation No. 2100/94 (EC), the EC protection of new plant varieties (“Community plant variety right”). The “Particular Rules concerning the biotechnological inventions” of the new Chapter 9 of the Polish amendmends are similar to the European Rules.
Inventions in the field of biotechnology must meet patentability requirements in the same way as inventions in other technical areas. Owing to this the invention must be new, involve an inventive step, and be industrially applicable (Article 52 EPC). In deciding if a biotechnological invention is patentable in Poland as well as in EU, one must also consider the exceptions stated in Article 53(b) of the EPC:
“European Patents shall not be granted in respect of [...] b) Plant or animal varieties, or essentially biological processes for the production of plants or animals; this provision does not apply to microbiological processes and to the products thereof.” The rules of this chapter do not change the legal protection as such but terms like “plant varieties”, “animal varieties”, “biological processes for the production of plants or animals” , and “microbiological processes” are defined in more detail.
For now, it is clear how “genetic” inventions, which are not specifically directed towards the entire genome of the plant, but concern only a certain DNA sequence of the genome, are to be treated. Such an invention could also cover new plant varieties because due to fundamental biomolecular technologies such inventions regularly go far beyond the narrow taxonomical limit of an individual plant variety, and can be applicable to whole plant categories, if not to an indefinite multiplicity of plant varieties. A genetically altered plant could be patented if the claim is not restricted to a certain plant variety but to larger plant groupings. This decision is in accordance with Directive 98/44/EC where it is stated that: “Whereas a plant grouping which is characterised by a particular gene (and not its whole genome) is not covered by the protection of new varieties.”
According to the harmonisation (implementation) of the Polish rules with the European Union, Poland decided to accept the Supplementary Protection Certificate (SPC). This is a mechanism to guarantee a certain exclusive marketing period for medicines and plant protection compounds throughout the EU to allow for the extended development period they require. The current patents in the EU are valid for 20 years; an SPC applies from the date of the first marketing of a product within the EU, thereafter extends the effective patent life for up to 5 years. The SPC would work backwards for the products which have got the turnover admission after January l, 2000, as soon as Poland joins the EU on May l, 2004. On March l, 2004 Poland will become a member of the EPC and will have the same rights and a similar patent system as the other member countries of this Convention. After their registration on the European Patent Attorneys List Polish patent attorneys will have the authorization in front of the European Patent Office.
Most Patents are from Abroad
Unfortunately, most of the biotech patents registered in Poland come from abroad. The number of granted biotech patents from Polish laboratories was 7 compared with 72 from abroad (data for 2002). 41 Polish patent applications were filed while 322 applications came from abroad, mostly from multinational companies. However, the number of biotechnology related patents is difficult to determine because a separate register of biotechnology is not established. The industrial property law and particularly patenting in genetic engineering, are often miscalled “the patenting of life”. They are all the subject of very hot public discussions between lay people and experts. We have to remember that the present system of protection of inventions, trademarks and designs, is not the ideal one but the best we have right now. The co- operation of scientists, industrialists, judges and patent attorneys and last but not least non governmental organisations, is of critical value. We have to look for future harmonization of industrial property law not only within a united Europe, but on global level.
Tomasz Twardowski, Polish Federation of
Biotechnology, c/o Polish Academy of Science, Poznan, eMail: email@example.com
Witek-Twardowska-Sniezko Patent Attorneys,
Warsaw, eMail: firstname.lastname@example.org