Act No. 206 / 2000 Coll.
Act on the protection of biotechnology inventions and amending Act No. 132 / 1989 Coll., on the Protection of Rights to New Plant Varieties and Animal Breeds, as amended by Act No. 93 / 1996 Coll.
Valid
Law
Effective from 01.10.2000
Text versions:
01.10.2000
21.07.2000
206
THE LAW
of 21 June 2000
on the protection of biotechnology inventions and amending Act No. 132 / 1989 Coll., on the Protection of Rights to New Plant Varieties and Animal Breeds, as amended by Act No. 93 / 1996 Coll.
Parliament has decided on this law of the Czech Republic:
PROTECTION OF BIOTECHNOLOGICAL EXPENSES
Definition of terms
For the purposes of this Act:
(a) the biological material is any material containing genetic information and capable of self-reproduction or reproduction in the biological system;
(b) the microbiological process is any process using microbiological material or carried out on microbiological material or any process resulting in microbiological material;
(c) in principle, the biological way of growing plants or keeping animals is such that it is based entirely on natural phenomena such as cross-breeding and selection.
Patentable biotechnology inventions
Biotechnology inventions are patentable if related
(a) biological material which is isolated from its natural environment or produced by a technical process, even if already occurring in nature,
(b) plants or animals, unless the technical feasibility of the invention is limited to a plant variety (1) or breed (2); or
(c) the microbiological or other technical process and of a product other than a plant variety or animal breed obtained in this manner.
Exemptions from patentability
Patents not granted
(a) inventions whose commercial use would be hampered by public order or good manners, in particular the methods of cloning human beings, the methods of modification of the germ line of the genetic identity of human beings, the ways in which the human embryo is used for industrial or commercial purposes, or the ways in which the genetic identity of animals which may cause them suffering without significant medical use for humans or animals, and also animals resulting from such a method; However, a contradiction with public policy or good manners cannot be inferred only from the fact that the use of the invention is prohibited by law,
(b) to the human body at different stages of formation or development and the mere discovery of any of its elements, including the sequence or sub-sequence of the gene; This does not apply to an element isolated from the human body or otherwise manufactured in a technical way, including a sequence or sub-sequence of a gene, even if the structure of that element is identical to that of a natural element; and
(c) varieties of plants and breeds of animals or, in principle, biological methods of growing plants or keeping animals.
The provisions of the Specific Legislation (3) shall apply to the application for an invention and its particulars and to the patent for an invention consisting of or containing biological material or relating to the manner in which it is produced, processed or used by biological materials.3)
Specific provisions on the application for a biotechnology invention
(1) Where the invention contains the use of biological material or concerns biological material which is not accessible to the public and which cannot be described in the patent application so that the expert can carry out the invention, the description shall be considered sufficient only if:
(a) no later than the date from which the applicant's right of priority is due, biological material has been deposited with a recognised deposit institution which has acquired such status in accordance with Article 7 of the Budapest Treaty of 28 April 1977 on the international recognition of the imposition of micro-organisms for patent proceedings (hereinafter referred to as the "Budapest Treaty"), 4)
(b) the application for invention, as submitted, contains relevant information on the characteristics of the stored biological material at the applicant's disposal; and
(c) the application for the invention indicates the designation of the storage institution and the deposit number of the sample.
(2) Access to stored biological material will take the form of a sample
(a) between the first publication of the application and the grant of the patent to any person who so requests (hereinafter referred to as the applicant) or, at the request of the applicant, only to an independent expert; or
(b) after the patent has been granted, irrespective of its revocation, to any person who so requests.
(3) The sample may only be provided if the applicant or, where appropriate, the expert designated in accordance with paragraph 2 undertakes that, during the period of validity of the patent:
(a) the sample or any material derived from it shall not be made available to a third party; and
(b) the sample or any derived material shall be used only for experimental purposes, unless the holder of the patent or, where appropriate, the applicant expressly relieves him of the obligation.
(4) The applicant shall be entitled to restrict access to the stored material for a period of 20 years from the date of filing of the application for an invention to each, with the exception of an independent expert, and in the event of refusal of the published application for an invention or termination of the procedure for it; in that case, paragraph 3 shall apply.
(5) The applicant shall notify the restrictions on access to the stored biological material referred to in paragraph 2 (a) and paragraph 4 of the Industrial Property Office (hereinafter referred to as "the Office") at the latest on the date on which the preparations for the publication of the invention application are completed. The Office shall publish such restrictions on access to stored biological material together with an application for invention in the Industrial Property Office Bulletin.
(6) Where biological material stored in accordance with paragraph 1 ceases to be available at a recognised storage institution, the redeposit of such material shall be permitted under the conditions laid down in the Budapest Treaty.
(7) Each redeposit shall be accompanied by a declaration signed by the depositor certifying that the newly stored biological material is the same as that originally stored.
(8) If the application concerns the invention of a sequence or subsequence of a gene, their industrial usefulness must be explained in the patent application.
Scope of protection
(1) Protection resulting from a patent on biological material which, as a result of invention, has specific characteristics also applies to any biological material derived from such biological material by sexual or non-sexual reproduction in the same or different form and having the same characteristics.
(2) The protection resulting from a patent in a manner which allows the production of biological material having specific characteristics as a result of the invention shall apply both to biological material directly obtained in that manner and to any other biological material derived from biological material directly derived from sexual or non-sexual reproduction in the same or different form and having the same characteristics.
(3) The protection resulting from the patent on a product containing genetic information or consisting of genetic information also applies to all material in which the product is included or in which it is contained and fulfils its function as genetic information, with the exception of the human body at different stages of origin or development.
Exhaust of rights
The holder of the patent shall not be entitled to prohibit the sexual or sexual reproduction of the biological material which is the subject of the patent if its placing on the market has been made by him or with his consent and if the sexual or sexual reproduction necessarily results from the use for which the biological material was placed on the market, unless the material obtained is subsequently used for further sexual or non-sexual reproduction.
Limitation of patent holder rights
(1) Any person who has obtained plant propagating material which is the subject of a patent, from his owner or with his consent, is entitled to use the product of his harvest for reproduction in his agricultural activity except for commercial use.
(2) He who has obtained animal propagating material which is the subject of a patent, from his owner or with his consent, is entitled to use it in his agricultural activity, except for commercial use, including making available the animal or other animal propagating material.
Forced and forced cross licences
(1) If a breeder (5) cannot acquire or use the right to a plant variety or breed of animals without infringing an earlier patent, he may apply for a compulsory licence for the non-exclusive use of an invention protected by the patent. The Office shall grant the compulsory licence if the holder of the breeding certificate has unsuccessfully requested the holder of the patent to grant a contract licence and if the plant variety or animal breed constitutes an important technical advance of significant economic importance compared to the invention protected by the patent. In this case, the holder of the patent shall be entitled to a cross-licence (counter-licence) for the commercial exploitation of the protected variety under the same conditions as those applicable to a compulsory licence under a special legislation. 6)
(2) Where the holder of a patent has been granted a compulsory licence for the commercial exploitation of a plant variety or of an animal breed under a special legislation, (6) the holder of the breeding certificate has the right to cross-licence (counter-licence) to use the patent for the invention.
Amendment to Act No. 132 / 1989 Coll., on the Protection of Rights to New Plant Varieties and Animal Breeds, as amended by Act No. 93 / 1996 Coll.
In Article 10 of Act No. 132 / 1989 Coll., on the Protection of Rights to New Plant Varieties and Animal Breeding, as amended by Act No. 93 / 1996 Coll., paragraphs 3 and 4 are added:
"(3) If the holder of a patent for a biotechnology invention cannot use the patent without infringing an earlier right to a plant variety or breed, he may apply for a compulsory licence for the non-exclusive use of the variety or breed. The Ministry shall grant the compulsory licence if the holder of the patent has unsuccessfully applied to the holder of the breeding certificate for the grant of a contract licence and if the invention protected by the patent represents important technical progress of significant economic importance compared to a plant variety or animal breed. Paragraph 2 shall apply to determine the amount of the licence fees in the case of the grant of a compulsory licence. In this case, the owner of the breeding certificate shall be entitled to a cross-licence (counter-licence) for the use of a biotechnology invention.
(4) Where the holder of a breeding certificate has been granted a compulsory licence for the use of a biotechnology invention, the holder of the patent is entitled to a cross-licence (counter-licence) for the commercial exploitation of a plant variety or animal breed. '
EFFECTIVE
This Act shall take effect on 1 October 2000.
Klaus v. r.
Havel v. r.
Zeman v. r.
1) § 2 (a) of Act No. 132 / 1989 Coll., on the Protection of Rights to New Plant Varieties and Animal Breeds, as amended by Act No. 93 / 1996 Coll.
2) § 2 (c) of Act No. 132 / 1989 Coll.
3) Act No. 527 / 1990 Coll., on inventions, designs and improvements, as amended.
4) Decree No. 212 / 1989 Coll., on the Budapest Treaty on International Recognition of the Storage of Microorganisms for the purposes of Patent Procedure and Implementation Code.
5) § 2 (g) of Act No. 132 / 1989 Coll.
6) § 10 of Act No. 132 / 1989 Coll.
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Regulation Information
| Citation | Act No. 206 / 2000 Coll., on the protection of biotechnology inventions and amending Act No. 132 / 1989 Coll., on the Protection of Rights to New Plant Varieties and Animal Breeds, as amended by Act No. 93 / 1996 Coll. |
|---|---|
| Regulation Type | Law |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 21.07.2000 |
|---|---|
| Effective from | 01.10.2000 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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