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
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
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.
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.
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.
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)
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
(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
(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
(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.
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.
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
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
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
(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.
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.
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. ".
The EFFECTIVENESS of the
This Act shall take effect on 1 January 2000. October 2000.
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
5) § 2 (b). g) Act No. 132/1989 Coll.
6) § 10 of the Act No. 132/1989 Coll.