STATUTORY INSTRUMENTS. 
S.I. No. 247 of 2000. 
 
EUROPEAN COMMUNITIES (LEGAL PROTECTION OF BIOTECHNOLOGICAL 
INVENTIONS) REGULATIONS, 2000. 
S.I. No. 247 of 2000. 
EUROPEAN COMMUNITIES (LEGAL PROTECTION OF BIOTECHNOLOGICAL 
INVENTIONS) REGULATIONS, 2000. 
I, MARY HARNEY, Minister for Enterprise , Trade and Employment, in exercise of 
the powers conferred on me by section 3 of  the European Communities Act, 1972 ( No. 
27 of 1972 ), and for the purpose of giving eff ect to Directive 98/44/EC of the European 
Parliament and of the Council of 6 July 19981 on the legal protecti on of biotechnological 
inventions, hereby make the following Regulations: 
1. (1) These Regulations may be cited as th e European Communities (Legal Protection 
of Biotechnological Inventions) Regulations, 2000. 
(2) These Regulations shall come  into operation on 30 July 2000. 
2. (1) In these Regulations, unless the context otherwise requires— 
“Act of 1980” means the Plant Varieties (Pr oprietary Rights) Act, 1980 (No. 24 of 1980) 
; 
“Act of 1992” means the Patents Act, 1992 (No. 1 of 1992) ; “Act of 1998” means the Plant Varieties (P roprietary Rights) (A mendment) Act, 1998 
(No. 41 of 1998) ; “Controller” means the Controller of Patents, Designs and Trade Marks; 
“Controller of Plant Breeders' Rights” has the meaning assigned to it by the Act of 1980; 
“Council Regulation” means Council Regulation (EC) No. 2100/94
2 ; 
“Directive” means Directive 98/44/EC3 of the European Parliament and of the Council of 
6 July, 1998 on the legal protecti on of biotechnological inventions; 
“holder” has the meaning assigned to  it by section 15 of the Act of 1998; 
“Rules of 1992” means the Patents Rules, 1992 ( S.I. No. 179 of 1992 ); (2) A word or expression that is used in these Regulations and is also used in the 
Directive, has, unless the contrary intent ion appears, the same meaning in these 
Regulations that it has in the Directive. 
(3) In these Regulations— 
(a) a reference to a Regulation is a refere nce to a Regulation of these Regulations 
unless it is indicated that reference to  some other Regulations is intended, 
(b) a reference to a paragraph or a subparagr aph, is a reference to the paragraph or 
the subparagraph of the provision in wh ich the reference occurs unless it is 
indicated that reference to some  other provision is intended, and 
(c) a reference to any enactment is a refe rence to that enactment as amended or 
extended by or under any subsequent en actment including these Regulations. 
3. Subject to the provisions  of these Regulations, the Act of 1992 and the Rules of 
1992 shall apply to patent a pplications and patents c oncerning biotechnological 
inventions. 
4. (1) An invention that complies with sec tion 9(1) of the Act of 1992 is patentable 
even if it concerns a product consisting of or containing biological material or a process 
by means of which biological materi al is produced, processed or used. 
(2) Biotechnological inventions shall be pa tentable, in particular, if they concern— 
(a) biological material which is isolated fr om its natural environment or produced by 
means of a technical process even if  it previously occu rred in nature, 
(b) plants or animals if the technical feasibility of the invention is not confined to a 
particular plant or animal variety, or 
(c) a microbiological or othe r technical process, or a product obtained by means of 
such a process other than a plant or animal variety. 
5. (1) The human body, at the various stages of  its formation and development, and the 
simple discovery of one of its elements, in cluding the sequence or partial sequence of a 
gene, shall not be patentable. 
(2) An element isolated from the human  body or otherwise produced by means of a 
technical process, including the sequence or partial sequence of a gene, may constitute a 
patentable invention, even if th e structure of that element is identical to that  of a natural 
element. 
(3) If an invention concerns the sequence or  partial sequence of a gene the industrial 
application thereof shall be disclosed in the patent application as filed. 6. (1) A patent shall not be granted in respect of a biotechnol ogical invention the 
commercial exploitation of which would be contrary to public order or morality, provided 
that the exploitation shall not be deemed to be so contrary only because it is prohibited by 
law. 
(2) Any of the following, in particular, shall not be regarded as a patentable invention, 
on the basis of paragraph (1)— 
(a) a process for cloning human beings, 
(b) a process for modifying the germ lin e genetic identity of human beings, 
(c) the use of human embryos for industrial or commercial purposes, 
(d) a process for modifying the genetic identi ty of animals which is likely to cause 
them suffering without any substantial medical benefit to man or animal, and 
animals resulting from such a process. 
7. (1) If the subject-matter of a patent is  a biological materi al having specific 
characteristics as a result of the invention, the protection conferre d by the patent shall 
extend to any biological material derived from that biological material through 
propagation or multiplication in an identical or divergent form and possessing those same 
characteristics. 
(2) If the subject-matter of a patent is a process for th e production of a biological 
material having specific characteristics as  a result of the invention, the protection 
conferred by the patent shall extend to biologi cal material directly obtained through that 
process and to any other biologi cal material derived from the directly obtained biological 
material through propagation or multiplication in an identical or divergent form and 
possessing those same characteristics. 
8. If the subject matter of a patent is a product containing or consisting of genetic 
information, the protection conferred by the patent shall extend, subject to Regulation 
5(1), to all material in which the product is incorporated and in which the genetic 
information is contained and performs its function. 
9. The protection referred to in Regulations 7 and 8 shall not extend to biological 
material obtained from the propagation or multiplication of biological material placed on the market in the State by the proprietor of  the patent or with  the consent of the 
proprietor, where the propagation or multiplication necessarily results from the application for which the biological material  was marketed, provide d that the material 
obtained is not subsequently used  for propagation or multiplication. 
10. (1) Regulations 7 and 8 shall not extend to— (a) the use by a farmer of the product of his harvest for propagation or multiplication 
by him on his own farm, where there ha s been a sale or other form of 
commercialisation of plant propagati ng material to the farmer by the 
proprietor of the patent or with the cons ent of the proprietor of the patent for 
agricultural use, subject to conditions corresponding to the derogation set out 
in Article 14 of the Council Regulation, and 
(b) the use for an agricultural purpose by a farmer of protec ted livestock, where 
there has been a sale or other form of  commercialisation of breeding stock or 
other animal reproductive mate rial to the farmer by the proprietor of the patent 
or with the consent of th e proprietor of the patent. 
(2) The use for an agricultural purpose by a fa rmer of protected lives tock referred to in 
paragraph 1( b) includes making the animal or ot her animal reproductive material 
available for the purposes of pursuing the agricu ltural activity of the farmer but not sale 
within the framework or for the purpose of a commercial reproduction activity. 
11. (1) Where a holder cannot acquire or expl oit in the State a plant breeders' right 
granted by the Controller of Plant Breeders' Rights without infringing a prior patent for a 
biotechnological invention, and where the ho lder has applied unsuccessfully to the 
proprietor of the patent concerned for a c ontractual licence under the patent, the holder 
may apply to the Controller for a licence under the patent to the extent necessary for the 
exploitation of the plant br eeders' right concerned: 
Provided that the plant variety protected by the plant breeders' right involves an 
important technical advance of considerab le economic significance in relation to the 
invention claimed in the patent. 
(2) When granting a licence on an application under paragraph (1) the Controller shall 
ensure that the licence is subject to the payment of an appropriate royalty to the 
proprietor of the patent. 
(3) The Controller shall not grant a licence referred to in paragraph (1) unless the 
holder is able and willing to  grant the proprieto r of the patent a cross-licence, on 
reasonable terms, to use the variety protected by the plant breeders' right. 
(4) Part IV of the Act of 1992 shall appl y with any necessary modifications to 
applications for licences and licences under this Regulation. 
12. (1) Where the proprietor of a patent for a biotechnological inve ntion cannot exploit 
it in the State without infringi ng a prior plant breeders' right , and where the proprietor has 
applied unsuccessfully to th e holder of the plant breeders' right concerned for a 
contractual licence under the plant breeders' ri ght, the proprietor of the patent may apply 
to the Controller of Plant Breeders' Rights fo r a licence under the plant breeders' right to 
the extent necessary for the exploi tation of the patent concerned: Provided that the patent i nvolves an important technical  advance of considerable 
economic significance in relation to the plan t variety protected by the plant breeders' 
right. 
(2) When granting a licence on an applicati on under paragraph (1) the Controller of 
Plant Breeders' Rights shall ensure that th e licence is subject to the payment of an 
appropriate royalty to the holde r of the plant breeders' right. 
(3) The Controller of Plant Breeders' Right s shall not grant a licence referred to in 
paragraph (1) unless the proprieto r of the patent is able and willing to grant the holder of 
the plant breeders' right a cross-licence, on reaasonable terms, to use the invention 
claimed in the patent. 
(4) The provisions of secti on 8 of the Act of 1980 (as amended by section 9 of the Act 
of 1998) shall apply with any necessary modi fications to applications for licences and 
licences under this Regulation. 
13. (1) Where the proprietor of a patent fo r a biotechnological i nvention which cannot 
be exploited in the State without infringing a Community plant variety right has been 
granted a compulsory exploitation right by the Community  Plant Variety Office under 
Article 29 of the Council Regulation, the hol der of the Community plant variety right 
may apply to the Controller for a cross-licence to use the invention cl aimed in the patent. 
(2) Where an application is made under para graph (1), the Controller may grant the 
holder of the Community plant variety right a cross-licence, on reasonable terms, to use 
the invention claimed in the patent concerned. 
(3) Part IV of the Act of 1992 shall apply with any necessary modifications to an 
application for a cross-li cence under this Regulation. 
14. (1) Section 19 of the Act of 1992 is ame nded in sub-section (2) by the substitution 
of “biological material” for “micro-organism”. 
(2) Rule 14 of the Rules of 1992 is amended— 
(a) by the substitution of “biological material” for “micro-organism” in each place 
where it occurs, 
(b) by the substitution of “sample” for “culture”, and 
(c) in paragraph (21)(a ) by the substitution of “biological material” for “micro-
organisms”. 
 GIVEN under my Official Seal , this 28th day of July, 2000.  MARY HARNEY, 
 Minister for Enterprise , Trade and Employment 
EXPLANATORY NOTE. 
(This note is not part of the Instrume nt and does not purport to be a legal 
interpretation.)  
The purpose of these Regulations is to give  statutory effect in the State to the 
requirements of Directive 98/44/EC of the Eu ropean Parliament and of the Council of 6 
July 1998 on the legal protection of biotechnological inventions. 
Inventions in the field of biotechnology must meet patentability requirements in the 
same way as inventions in other technical areas. The Regulations contain a non-exclusive 
list of subject-matter which are consid ered patentable a nd non-patentable. 
The Regulations include provisi ons concerning the sc ope of protection of a patent for 
self-replicable material or material containing genetic information which permits its 
multiplication or propagation. The protection conf erred by such a patent will extend to all 
material obtained from the multiplication or propagation. An exemption is made for farmers to whom the Regulations give an im plied right to use the seed obtained from 
their harvest for further propagation on their own farm. 
The Regulations also deal with compulsory licences and cross-licences between the 
proprietor of a patent and the holder of plant variety right where one cannot be exploited without infringement of the other. 
1 O.J. No. L.213, 30.07.1998, p.13 
2 O.J. No. L.277, 01.09.1994, p.1 
3 O.J. No. L.213, 30.07.1998, p.13