206/2000 Sb.



LAW



of 21 June 1999. June 2000



on the protection of biotechnological inventions and amending Act No. 132/1989 Coll.,

on the protection of rights to new varieties of plants and breeds of animals, as amended by

Act No. 93/1996 Coll.



Parliament has passed the following Act of the United States:



PART THE FIRST



PROTECTION OF BIOTECHNOLOGICAL INVENTIONS



§ 1



Definition of terms



For the purposes of this Act,



and) biological material is any material containing genetic

information and capable of samoreprodukce or reproduction in the biological

the system,



b) microbiological procedure is any procedure that uses

involving or performed upon the material

or procedure, resulting in microbiological material,



(c)), in principle, organic cultivation of plants or animals is

such a way that is based entirely on natural phenomena, such as the

crossing or selection.



§ 2



Patentable biotechnological inventions



Biotechnological inventions are patentable, if they relate to



and) biological material which is isolated from its natural

environment or produced by a technical procedure even though it is no longer in nature

There was a problem,



(b)) of plants or animals, if the technical feasibility of the invention

confined to a particular plant variety ^ 1) or animal, ^ 2) or



c) microbiological or other technical process or a product of another

than the plant variety or animal breed, obtained in this way.



§ 3



Exclusions from patentability



Patents do not confer



and inventions whose) to commercial use would be reluctant public

order or good morals, in particular ways of cloning human

beings, processes for modifying the germ line genetic identity

human beings, on the ways in which a human embryo is used for

industrial or commercial purposes, or on ways of modifying the genetic

identity of animals that may cause them suffering without any substantial

a medical benefit to man or animal, and also animals which

are the result of such a method; conflict with public policy or

morality, however, cannot be inferred merely from the fact that the use of the invention is

prohibited by law or regulation,



(b)) on the human body at the various stages of its formation and development, and the simple discovery of

one of its elements, including the sequence or partial sequence of a gene; It

does not apply to an element isolated from the human body or otherwise produced

a technical process, including the sequence or partial sequence of a gene, even if

the structure of that element is identical to that of a natural element, and



(c)) on plant varieties and animal breeds or essentially biological processes for the

the production of plants or animals.



§ 4



For the procedure for the application of the invention and its elements and for the patent on

an invention consisting of biological material or contains

biological material or relates to the manner in which it is produced, processed

or uses biological material (hereinafter referred to as "Biotech

inventions "), the provisions of special legislation. ^ 3)



§ 5



Special provisions for the application of a biotechnology invention



(1) where an invention involves the use of a biological material or where the

biological material which is not available to the public and which cannot be

described in a patent application, so that an expert could make the invention,

description shall be considered as sufficient only if the



and no later than on the date) from which it is for the applicant for the right of priority,

the biological material was deposited with a recognised depositary institution, which

acquired such status in accordance with article 7 of the Budapest Treaty of 28.

April 1977 on the international recognition of the deposit of microorganisms for the purposes of

of patent procedure (hereinafter referred to as "Budapest Treaty") ^ 4)



(b) the application of the invention) in the text as filed contains such relevant

information about the characteristics of the biological material deposited, which had

the applicant has available, and



(c) the application for the invention) designation of the depository institution and the deposit

the number of the sample.



(2) access to the deposited biological material shall be made in the form of

the provision of the sample



and) between the first publication of the patent application and the granting to anyone on

requested, (hereinafter referred to as "the applicant"), or at the request of the applicant, only

the independent expert, or



(b)) after the grant of a patent, regardless of its abolition, to anyone about it

so requests.



(3) a sample can be provided only when the applicant, where appropriate, the expert

determined under paragraph 2 undertakes, for the term of validity of the patent



and) it or any material derived from it available to a third

person, and



(b)) or any material derived from it will be used only for

experimental purposes, unless the proprietor of the patent, or

the applicant expressly relieved of this obligation.



(4) the applicant is entitled to restrict access to the deposited material after

for 20 years from the filing date of the invention to anyone, with the exception of

the independent expert, as well as in case of rejection of the published

the invention or stop the proceedings for her; in this case, paragraph

3.



(5) the applicant shall notify the restrictions in access to the deposited biological

the material referred to in paragraph 2 (a). a) and in paragraph 4 of the Office

industrial property (hereinafter referred to as "the authority") no later than on the date on

which are completed preparations for publication of the patent application. The Office of the

such restrictions on access to the deposited biological material shall be published

along with the application of the invention in the Bulletin of the industrial property office.



(6) if the biological material deposited in accordance with paragraph 1

ceases to be available from the recognised depositary institution, a new permissible

store this material, under the conditions laid down in the Budapest Treaty.



(7) any new deposit shall be substantiated by a declaration signed by the

depositor certifying that the newly saved biological material is

the same as the material that was originally saved.



(8) where the application for the invention of the sequence or partial sequence of a gene,

their industrial applicability must be clarified in a patent

the application form.



§ 6



The scope of protection



(1) the protection conferred by a patent on a biological material that has in

due to the specific characteristics of the invention shall extend to any

biological material derived from that biological material through sexual

nepohlavním or multiplication in an identical or divergent form and possessing those

the same properties.



(2) the protection conferred by a patent on the method that enables the production of

biological material that has as a result of the invention of specific

the property applies both to biological material directly obtained by that

in a way, as to any other biological material derived from the biological

material directly obtained by sexual or nepohlavním multiplication in

identical or divergent form and possessing those same characteristics.



(3) the protection conferred by a patent on a product containing genetic

or consisting of genetic information shall extend to

all material in which the product is incorporated or in which it is contained

fulfil their function and genetic information, except the human body in the

the various stages of its formation and development.



§ 7



Exhaustion of rights



The patent owner is not entitled to prohibit sexual or asexual

the reproduction of biological material which is the subject of the patent,

If its marketing was done by himself or with his

consent, and if sexual or asexual reproduction is strictly

resulting from the application for which the biological material was marketed,

If the obtained material is not subsequently used for other sexual or

asexual reproduction.



§ 8



Limitation of the rights of the patent owner



(1) a person who obtained the plant propagation material which is the subject of

the patent, from its owner or with his consent, is entitled to use for

reproduction in their agricultural activities, with the exception of the commercial use of

also the product of his harvest.



(2) a person who has obtained the animal propagation material which is the subject of

the patent, from its owner or with his consent, is entitled to this

the material used in its agricultural activities, with the exception of the business

the use, including disclosure of the animal or other animal

propagation material.



§ 9



Forced and compulsory cross-licence



(1) where a breeder cannot ^ 5), the right to acquire or exploit a plant

variety or breed of animals, without infringing a prior patent, he may

apply for a compulsory licence for non-exclusive use of the invention protected by the

rib. The authority of a compulsory licence shall be granted if the owner of the breeding

certificate of patent owners unsuccessfully requested a contractual licence

and if the plant variety or animal breed represents an important

technical progress of considerable economic interest compared with the invention,

that is patent protected. In this case, the patent owner has the right to

cross-licensing agreement (protilicenci) to the commercial exploitation of the protected variety

under the same conditions as those applicable to compulsory licence under a special

legislation. 6)



(2) the holder of a patent has been granted a compulsory licence to a business

the use of a plant variety or an animal breed under the Special

legislation, ^ 6), the owner of a breeding certificate the right to


cross-licensing agreement (protilicenci) to use the patent for the invention.



PART TWO



Amendment to Act No. 132/1989 Coll., on the protection of rights to new varieties of plants and

breeds of animals, as amended by Act No. 93/1996 Coll.



§ 10



In section 10 of Act No. 132/1989 Coll., on the protection of rights to new varieties of plants and

breeds of animals, as amended by Act No. 93/1996 Coll., shall be added to paragraph 3

and 4 are added:



"(3) if the holder of a patent concerning a biotechnological invention patent

exploit it without infringing a plant variety or

animal breed, you may apply for a compulsory licence for non-exclusive

the use of the variety or the breed. The Ministry of the compulsory licence shall be granted

If the patent owner unsuccessfully requested the owner of the breeding

the certificate of a contractual licence (a) if the invention protected

a patent is an important technical progress of considerable economic

importance in comparison with the plant variety or animal breed. For

determination of the amount of the royalties in the case of granting a compulsory licence

paragraph 2 shall apply. In this case, the owner of a breeding certificate

the right to a cross-licence (protilicenci) to the use of biotechnology

of the invention.



(4) if the owner of a breeding certificate granted a compulsory licence to the

the use of a biotechnology invention, the patent owner has the right to

cross-licensing agreement (protilicenci) to the commercial exploitation of the plant variety

or an animal breed. ".



PART THREE



The EFFECTIVENESS of the



§ 11



This Act shall take effect on 1 January 2000. October 2000.



Klaus r.



Havel, v. r.



Zeman in r.



1) § 2 (b). and) Act No. 132/1989 Coll., on the protection of the rights of new varieties

of plants and breeds of animals, as amended by Act No. 93/1996 Coll.



section 2 (b) 2). c) of Act No. 132/1989 Coll.



3) Act No. 527/1990 Coll., on inventions, industrial designs and

rationalization proposals, as amended.



4) Decree No. 212/1989 Coll., on the Budapest Treaty on the international

recognition of the deposit of microorganisms for the purposes of patent procedure and

The CCIP.



5) § 2 (b). g) Act No. 132/1989 Coll.



6) § 10 of the Act No. 132/1989 Coll.