Current Situation
The Proposed Law
Biological Materials

Current Situation

The Czech Parliament is attempting to harmonize its patent law with that of the European Union. The new legislation will bring Czech law on the patenting of biotechnology inventions into line with EU Directive 98/44/EC (dated 6 July 1998). It will also fulfil obligations arising from the treaty on Trade Related Aspects of Intellectual Property Rights (TRIPS).

The patent protection of inventions is currently regulated by the Law on Inventions, Industrial Designs and Rationalisation Proposals (527/1990 Coll. of Laws). This does not exclude biotechnological inventions from patent protection, but it does stipulate that the result to be protected should be reached by a technological process. In spite of this limitation, some 600 biotechnology patents have been granted since 1991.

The Proposed Law

Underlying principles
The proposed law is based largely on the existing legal framework, but it contains a number of provisions relating specifically to biotechnological inventions. These define the scope of patent protection for biotechnological inventions and any exclusions from such protection, as well as set out detailed rules for the deposit of biological materials at certified institutions.

Patentable inventions
The new law extends patent protection to:

  • biological material which has been isolated from its natural environment or produced by a technical process, even if it could be found in nature. Biological material is any material containing genetic information and which is capable of self-reproduction in a biological system;

  • biotechnological inventions relating to plants or animals, provided their technical application is not limited to particular plant or animal species; and

  • microbiological or other technological processes or products, excluding any plant or animal produced by such a process.

Exclusion from protection
Patents may not be granted for inventions where their business use would conflict with public order or would be contrary to morality. Thus, the following cannot be patented:

  • the cloning of human beings;

  • modification of the genetic identity of humans;

  • the use of human embryos for industrial or business purposes;

  • any modification of the genetic identity of animals resulting in severe suffering, without substantial medical benefit for humans or animals; and

  • biological methods of propagating plants or animals or any plants or animals produced by such methods.

The law also excludes the patenting of the human body, including partial or complete gene sequences. However, this does not apply to elements isolated from the human body or produced by a technical process, including partial or complete gene sequences, even if the resulting structure is identical to that of a natural element.

Biological Materials

Required deposits
Where an invention incorporates the use of biological material, it must be deposited with a certified institution. This rule applies where the biological material is not publicly accessible and cannot be described in such a way that an expert could understand the content of the relevant patent application. The biological material must be deposited by the priority date, at the latest (in accordance with the Budapest Treaty on the International Recognition of the Deposit of Micro-organisms for the Purposes of Patent Procedure).

Scope of patent protection
Once granted, a patent on biological material or on a process will extend to any biological material that is derived from the protected material or process by means of either sexual or non-sexual reproduction. This is so whether the reproduced material is identical to, or different from, the biological material.

A patent on a product containing or based on genetic information will cover all materials in which that product or genetic information is contained. For example, a sequence or partial sequence of DNA can be protected if it acts as genetic information. Patent protection can cover a single cell, or extend to tissue culture or a complete organism, but the human body cannot be the subject of a patent.


The rapid development of biotechnology in recent years has created a need for more up-to-date patent law and the new legislation should put the protection of biotechnological inventions on a more solid footing. Moreover, because this legislation will be consistent with EU law, it should meet the needs of modern industry and help to attract more investment to the Czech Republic.

For more information on this topic please contact Karel Cermak at Cermák Horejš Myslil by telephone (+420 2 9616 7401) or by fax (+420 2 2494 6724) or by e-mail ([email protected]).
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