Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions
Date: 1998-07-06
Institutions: Council of the European Union, European Parliament
Subjects: biotechnology, invention, patent law, right to justice

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DIRECTIVE  98/44/EC  OF  THE  EUROPEAN  PARLIAMENT  AND  OF  THE  COUNCIL

of  6  July  1998

on  the  legal  protection  of  biotechnological  inventions

THE  EUROPEAN  PARLIAMENT  AND  THE  COUNCIL  OF
THE  EUROPEAN  UNION,

Having  regard  to  the  Treaty  establishing  the  European
Community,  and  in  particular  Article  100a  thereof,

Having  regard  to  the  proposal  from  the  Commission (1),

Having regard to the opinion of the Economic and Social
Committee (2),

Acting  in  accordance  with  the  procedure  laid  down  in
Article  189b  of  the  Treaty (3),

(1)  Whereas biotechnology and genetic engineering are
playing  an  increasingly  important  role  in  a  broad
the  protection  of
range  of 
biotechnological  inventions  will  certainly  be  of
fundamental 
importance  for  the  Community’s
industrial  development;

industries  and 

(2)  Whereas,  in  particular  in  the  field  of  genetic
engineering,  research  and  development  require  a
considerable  amount  of  high-risk  investment  and
therefore  only  adequate  legal  protection  can  make
them  profitable;

(3)  Whereas  effective  and  harmonised  protection
throughout the Member States is essential in order
to  maintain  and  encourage  investment  in  the  field
of  biotechnology;

(4)  Whereas 

following 

the  European  Parliament’s
joint  text,  approved  by  the
rejection  of  the 
Conciliation  Committee, 
European
Parliament  and  Council  Directive  on  the  legal

for 

a 

protection  of  biotechnological  inventions (4),  the
the  Council  have
European  Parliament  and 
determined 
of
protection 
biotechnological  inventions  requires  clarification;

legal 

that 

the 

(5)  Whereas differences exist in the legal protection of
biotechnological inventions offered by the laws and
practices  of  the  different  Member  States;  whereas
such  differences  could  create  barriers  to  trade  and
hence 
impede  the  proper  functioning  of  the
internal  market;

(6)  Whereas  such  differences  could  well  become
greater  as  Member  States  adopt  new  and  different
legislation and administrative practices, or whereas
national  case-law 
legislation
develops  differently;

interpreting  such 

(7)  Whereas  uncoordinated  development  of  national
laws  on  the  legal  protection  of  biotechnological
inventions in the Community could lead to further
disincentives  to  trade,  to  the  detriment  of  the
industrial  development  of  such  inventions  and  of
the  smooth  operation  of  the  internal  market;

(8)  Whereas 

legal  protection  of  biotechnological
inventions  does  not  necessitate  the  creation  of  a
separate  body  of  law  in  place  of  the  rules  of
national  patent  law;  whereas  the  rules  of  national
patent  law  remain  the  essential  basis  for  the  legal
protection of biotechnological inventions given that
they  must  be  adapted  or  added  to  in  certain
specific  respects  in  order  to  take  adequate  account
of  technological  developments  involving  biological
material  which  also  fulfil  the  requirements  for
patentability;

(1)  OJ  C  296,  8.10.1996,  p.  4  and  OJ  C  311,  11.10.1997,  p.

12.

(2)  OJ  C  295,  7.10.1996,  p.  11.
(3)  Opinion  of  the  European  Parliament  of  16  July  1997  (OJ  C
286,  22.9.1997,  p.  87).  Council  Common  Position  of  26
February  1998  (OJ  C  110,  8.4.1998,  p.  17)  and  Decision  of
the  European  Parliament  of  12  May  1998  (OJ  C  167,
1.6.1998).  Council  Decision  of  16  June  1998.

(9)  Whereas  in  certain  cases,  such  as  the  exclusion
from  patentability  of  plant  and  animal  varieties
and  of  essentially  biological  processes  for  the
production  of  plants  and  animals,  certain  concepts

(4)  OJ  C  68,  20.3.1995,  p.  26.

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in  national  laws  based  upon  international  patent
and  plant  variety  conventions  have  created
uncertainty 
of
biotechnological 
certain  microbiological
inventions;  whereas  harmonisation  is  necessary  to
clarify  the  said  uncertainty;

protection 

regarding 

and 

the 

(10)  Whereas  regard  should  be  had  to  the  potential  of
the  development  of  biotechnology 
the
environment  and  in  particular  the  utility  of  this
technology  for  the  development  of  methods  of
cultivation  which  are  less  polluting  and  more
economical  in  their  use  of  ground;  whereas  the
patent  system  should  be  used 
to  encourage
research 
the  application  of,  such
processes;

into,  and 

for 

(11)  Whereas  the  development  of  biotechnology 

is
important to developing countries, both in the field
of  health  and  combating  major  epidemics  and
endemic  diseases  and  in  that  of  combating  hunger
in  the  world;  whereas  the  patent  system  should
likewise  be  used  to  encourage  research  in  these
fields;  whereas  international  procedures  for  the
dissemination  of  such  technology  in  the  Third
World and to the benefit of the population groups
concerned  should  be  promoted;

(12)  Whereas  the  Agreement  on  Trade-Related  Aspects
of  Intellectual  Property  Rights  (TRIPs) (1)  signed
by  the  European  Community  and  the  Member
States,  has  entered  into  force  and  provides  that
patent  protection  must  be  guaranteed  for  products
and  processes  in  all  areas  of  technology;

(13)  Whereas the Community’s legal framework for the
protection  of  biotechnological  inventions  can  be
limited  to  laying  down  certain  principles  as  they
apply  to  the  patentability  of  biological  material  as
such,  such  principles  being  intended  in  particular
to determine the difference between inventions and
discoveries  with  regard  to  the  patentability  of
certain  elements  of  human  origin,  to  the  scope  of
protection 
a
biotechnological  invention,  to  the  right  to  use  a
deposit  mechanism 
to  written
descriptions  and  lastly  to  the  option  of  obtaining
non-exclusive  compulsory  licences  in  respect  of
interdependence  between  plant  varieties  and
inventions,  and  conversely;

a  patent  on 

conferred  by 

in  addition 

(1)  OJ  L  336,  23.12.1994,  p.  213.

consequently, 

to  prohibit 
for 

(14)  Whereas  a  patent  for  invention  does  not  authorise
the holder to implement that invention, but merely
entitles  him 
from
third  parties 
exploiting 
industrial  and  commercial
it 
substantive
purposes;  whereas, 
patent  law  cannot  serve  to  replace  or  render
superfluous  national,  European  or  international
law  which  may  impose  restrictions  or  prohibitions
or  which  concerns  the  monitoring  of  research  and
of  the  use  or  commercialisation  of  its  results,
notably from the point of view of the requirements
of  public  health,  safety,  environmental  protection,
animal welfare, the preservation of genetic diversity
and  compliance  with  certain  ethical  standards;

(15)  Whereas  no  prohibition  or  exclusion  exists  in
(Munich
the

national  or  European  patent 
Convention)  which  precludes  a  priori 
patentability  of  biological  matter;

law 

(16)  Whereas  patent  law  must  be  applied  so  as  to
respect the fundamental principles safeguarding the
dignity  and  integrity  of  the  person;  whereas  it  is
important  to  assert  the  principle  that  the  human
body, at any stage in its formation or development,
including  germ  cells,  and  the  simple  discovery  of
its  products,
one  of 
including  the  sequence  or  partial  sequence  of  a
human  gene,  cannot  be  patented;  whereas  these
principles  are 
the  criteria  of
patentability proper to patent law, whereby a mere
discovery  cannot  be  patented;

its  elements  or  one  of 

line  with 

in 

(17)  Whereas  significant  progress  in  the  treatment  of
diseases  has  already  been  made  thanks  to  the
existence  of  medicinal  products  derived  from
elements  isolated  from  the  human  body  and/or
otherwise  produced,  such  medicinal  products
resulting 
technical  processes  aimed  at
obtaining  elements  similar  in  structure  to  those
existing naturally in the human body and whereas,
consequently,  research  aimed  at  obtaining  and
isolating  such  elements  valuable  to  medicinal
production  should  be  encouraged  by  means  of  the
patent  system;

from 

(18)  Whereas, 

since 

system  provides
the  patent 
insufficient  incentive  for  encouraging  research  into
and  production  of  biotechnological  medicines
which  are  needed  to  combat  rare  or  ‘orphan’
diseases,  the  Community  and  the  Member  States
have  a  duty  to  respond  adequately  to  this
problem;

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(19)  Whereas  account  has  been  taken  of  Opinion  No  8
of 
the  Ethical
Implications  of  Biotechnology  to  the  European
Commission;

the  Group  of  Advisers  on 

(20)  Whereas, therefore, it should be made clear that an
invention  based  on  an  element  isolated  from  the
human body or otherwise produced by means of a
technical process, which is susceptible of industrial
application,  is  not  excluded  from  patentability,
even  where  the  structure  of  that  element 
is
identical  to  that  of  a  natural  element,  given  that
the rights conferred by the patent do not extend to
the  human  body  and  its  elements  in  their  natural
environment;

(21)  Whereas such an element isolated from the human
body  or  otherwise  produced  is  not  excluded  from
patentability  since  it  is,  for  example,  the  result  of
technical  processes  used  to  identify,  purify  and
classify  it  and  to  reproduce  it  outside  the  human
body,  techniques  which  human  beings  alone  are
capable  of  putting  into  practice  and  which  nature
is  incapable  of  accomplishing  by  itself;

sequences  of  genes 

(22)  Whereas  the  discussion  on  the  patentability  of
sequences  or  partial 
is
controversial;  whereas,  according  to  this  Directive,
the  granting  of  a  patent  for  inventions  which
concern such sequences or partial sequences should
be subject to the same criteria of patentability as in
all  other  areas  of  technology:  novelty,  inventive
step  and 
the
industrial  application  of  a  sequence  or  partial
sequence  must  be  disclosed 
the  patent
application  as  filed;

industrial  application;  whereas 

in 

(26)  Whereas  if  an  invention  is  based  on  biological
material  of  human  origin  or  if  it  uses  such
material,  where  a  patent  application  is  filed,  the
person  from  whose  body  the  material  is  taken
must  have  had  an  opportunity  of  expressing  free
and  informed  consent  thereto,  in  accordance  with
national law;

(27)  Whereas  if  an  invention  is  based  on  biological
material of plant or animal origin or if it uses such
material,  the  patent  application  should,  where
appropriate, 
the
geographical  origin  of  such  material,  if  known;
whereas  this  is  without  prejudice  to  the  processing
of  patent  applications  or  the  validity  of  rights
arising  from  granted  patents;

information 

include 

on 

(28)  Whereas  this  Directive  does  not  in  any  way  affect
the basis of current patent law, according to which
a  patent  may  be  granted  for  any  new  application
of  a  patented  product;

(29)  Whereas  this  Directive  is  without  prejudice  to  the
exclusion  of  plant  and  animal  varieties  from
patentability; whereas on the other hand inventions
which  concern  plants  or  animals  are  patentable
provided  that  the  application  of  the  invention  is
not technically confined to a single plant or animal
variety;

(30)  Whereas  the  concept  ‘plant  variety’  is  defined  by
the legislation protecting new varieties, pursuant to
which a variety is defined by its whole genome and
therefore  possesses  individuality  and  is  clearly
distinguishable  from  other  varieties;

(23)  Whereas a mere DNA sequence without indication
of  a  function  does  not  contain  any  technical
information  and  is  therefore  not  a  patentable
invention;

(31)  Whereas  a  plant  grouping  which  is  characterised
by a particular gene (and not its whole genome) is
not covered by the protection of new varieties and
is therefore not excluded from patentability even if
it  comprises  new  varieties  of  plants;

(24)  Whereas,  in  order  to  comply  with  the  industrial
application criterion it is necessary in cases where a
sequence  or  partial  sequence  of  a  gene  is  used  to
produce  a  protein  or  part  of  a  protein,  to  specify
which  protein  or  part  of  a  protein  is  produced  or
what  function  it  performs;

(32)  Whereas,  however,  if  an  invention  consists  only  in
genetically  modifying  a  particular  plant  variety,
and  if  a  new  plant  variety  is  bred,  it  will  still  be
excluded  from  patentability  even  if  the  genetic
modification  is  the  result  not  of  an  essentially
biological  process  but  of  a  biotechnological
process;

(25)  Whereas,  for  the  purposes  of  interpreting  rights
conferred  by  a  patent,  when  sequences  overlap
only  in  parts  which  are  not  essential  to  the
invention,  each  sequence  will  be  considered  as  an
independent  sequence  in  patent  law  terms;

(33)  Whereas  it  is  necessary  to  define  for  the  purposes
of this Directive when a process for the breeding of
plants  and  animals  is  essentially  biological;

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(34)  Whereas  this  Directive  shall  be  without  prejudice
to  concepts  of 
invention  and  discovery,  as
developed  by  national,  European  or  international
patent  law;

(35)  Whereas  this  Directive  shall  be  without  prejudice
to  the  provisions  of  national  patent  law  whereby
processes  for  treatment  of  the  human  or  animal
body  by  surgery  or 
therapy  and  diagnostic
methods  practised  on  the  human  or  animal  body
are  excluded  from  patentability;

(36)  Whereas  the  TRIPs  Agreement  provides  for  the
possibility  that  members  of  the  World  Trade
Organisation  may  exclude 
from  patentability
inventions,  the  prevention  within  their  territory  of
the  commercial  exploitation  of  which  is  necessary
to  protect  ordre  public  or  morality,  including  to
protect human, animal or plant life or health or to
avoid  serious  prejudice 
the  environment,
provided  that  such  exclusion  is  not  made  merely
because  the  exploitation  is  prohibited  by  their
law;

to 

(37)  Whereas  the  principle  whereby  inventions  must  be
excluded 
their
commercial  exploitation  offends  against  ordre
public  or  morality  must  also  be  stressed  in  this
Directive;

patentability  where 

from 

list  of 

include  an 

(38)  Whereas the operative part of this Directive should
also 
inventions
illustrative 
excluded  from  patentability  so  as  to  provide
national  courts  and  patent  offices  with  a  general
guide  to  interpreting  the  reference  to  ordre  public
and  morality;  whereas  this  list  obviously  cannot
presume  to  be  exhaustive;  whereas  processes,  the
use of which offend against human dignity, such as
processes  to  produce  chimeras  from  germ  cells  or
totipotent  cells  of  humans  and  animals,  are
obviously  also  excluded  from  patentability;

(39)  Whereas  ordre  public  and  morality  correspond  in
particular  to  ethical  or  moral  principles  recognised
in a Member State, respect for which is particularly
important  in  the  field  of  biotechnology  in  view  of
the  potential  scope  of  inventions  in  this  field  and
their inherent relationship to living matter; whereas
such  ethical  or  moral  principles  supplement  the
standard  legal  examinations  under  patent  law
regardless  of  the  technical  field  of  the  invention;

(40)  Whereas 

there 

is  a 

consensus  within 

the
Community  that  interventions  in  the  human  germ
line  and  the  cloning  of  human  beings  offends
against  ordre  public  and  morality;  whereas  it  is
therefore  important  to  exclude  unequivocally  from
patentability  processes  for  modifying  the  germ  line
genetic  identity  of  human  beings  and  processes  for
cloning  human  beings;

(41)  Whereas  a  process  for  cloning  human  beings  may
be  defined  as  any  process,  including  techniques  of
embryo splitting, designed to create a human being
with  the  same  nuclear  genetic  information  as
another  living  or  deceased  human  being;

(42)  Whereas,  moreover,  uses  of  human  embryos  for
industrial  or  commercial  purposes  must  also  be
excluded  from  patentability;  whereas  in  any  case
such  exclusion  does  not  affect  inventions  for
therapeutic  or  diagnostic  purposes  which  are
applied  to  the  human  embryo  and  are  useful  to
it;

the  Union 

(43)  Whereas  pursuant  to  Article  F(2)  of  the  Treaty  on
European  Union, 
respect
fundamental rights, as guaranteed by the European
Convention  for  the  Protection  of  Human  Rights
and  Fundamental  Freedoms  signed  in  Rome  on  4
November  1950  and  as  they  result  from  the
constitutional  traditions  common  to  the  Member
States,  as  general  principles  of  Community  law;

to 

is 

(44)  Whereas  the  Commission’s  European  Group  on
Ethics  in  Science  and  New  Technologies  evaluates
all  ethical  aspects  of  biotechnology;  whereas  it
should  be  pointed  out  in  this  connection  that  that
Group may be consulted only where biotechnology
is  to  be  evaluated  at  the  level  of  basic  ethical
principles,  including  where  it  is  consulted  on
patent  law;

(45)  Whereas  processes 

for  modifying 

the  genetic
identity  of  animals  which  are  likely  to  cause  them
suffering without any substantial medical benefit in
terms of research, prevention, diagnosis or therapy
to man or animal, and also animals resulting from
from
such 
patentability;

processes,  must 

excluded 

be 

(46)  Whereas, in view of the fact that the function of a
patent  is  to  reward  the  inventor  for  his  creative
efforts  by  granting  an  exclusive  but  time-bound
right,  and  thereby  encourage  inventive  activities,

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the  holder  of  the  patent  should  be  entitled  to
prohibit  the  use  of  patented  self-reproducing
material  in  situations  analogous  to  those  where  it
would be permitted to prohibit the use of patented,
non-self-reproducing  products,  that  is  to  say  the
production  of  the  patented  product  itself;

the 

(47)  Whereas  it  is  necessary  to  provide  for  a  first
derogation  from  the  rights  of  the  holder  of  the
patent  when 
propagating  material
incorporating  the  protected  invention  is  sold  to  a
farmer  for  farming  purposes  by  the  holder  of  the
patent  or  with  his  consent;  whereas  that  initial
derogation  must  authorise  the  farmer  to  use  the
product of his harvest for further multiplication or
propagation  on  his  own  farm;  whereas  the  extent
and  the  conditions  of  that  derogation  must  be
limited 
the  extent  and
conditions  set  out  in  Council  Regulation  (EC)  No
2100/94  of  27  July  1994  on  Community  plant
variety rights (1);

in  accordance  with 

(48)  Whereas  only  the  fee  envisaged  under  Community
law  relating  to  plant  variety  rights  as  a  condition
for applying the derogation from Community plant
variety  rights  can  be  required  of  the  farmer;

(49)  Whereas,  however,  the  holder  of  the  patent  may
defend  his  rights  against  a  farmer  abusing  the
derogation or against a breeder who has developed
the  protected
a  plant  variety 
invention  if  the  latter  fails  to  adhere  to  his
commitments;

incorporating 

(50)  Whereas  a  second  derogation  from  the  rights  of
the  holder  of  the  patent  must  authorise  the  farmer
to  use  protected 
for  agricultural
purposes;

livestock 

(51)  Whereas  the  extent  and  the  conditions  of  that
second  derogation  must  be  determined  by  national
laws,  regulations  and  practices,  since  there  is  no
Community  legislation  on  animal  variety  rights;

(52)  Whereas,  in  the  field  of  exploitation  of  new  plant
characteristics  resulting  from  genetic  engineering,
guaranteed  access  must,  on  payment  of  a  fee,  be

granted in the form of a compulsory licence where,
in  relation  to  the  genus  or  species  concerned,  the
technical
plant  variety 
progress  of 
interest
compared  to  the  invention  claimed  in  the  patent;

represents 
considerable 

significant 

economic 

(53)  Whereas,  in  the  field  of  the  use  of  new  plant
characteristics resulting from new plant varieties in
genetic  engineering,  guaranteed  access  must,  on
payment  of  a  fee,  be  granted  in  the  form  of  a
compulsory  licence  where  the  invention  represents
significant 
technical  progress  of  considerable
economic  interest;

(54)  Whereas  Article  34  of  the  TRIPs  Agreement
contains detailed provisions on the burden of proof
which  is  binding  on  all  Member  States;  whereas,
therefore,  a  provision  in  this  Directive  is  not
necessary;

is  party 

(55)  Whereas  following  Decision  93/626/EEC (2)  the
the  Convention  on
to 
Community 
Biological  Diversity  of  5  June  1992;  whereas,  in
this  regard,  Member  States  must  give  particular
weight  to  Article  3  and  Article  8(j),  the  second
sentence  of  Article  16(2)  and  Article  16(5)  of  the
Convention  when  bringing  into  force  the  laws,
regulations and administrative provisions necessary
to  comply  with  this  Directive;

(56)  Whereas the Third Conference of the Parties to the
Biodiversity  Convention,  which  took  place 
in
November  1996,  noted  in  Decision  III/17  that
‘further  work 
is  required  to  help  develop  a
common  appreciation  of  the  relationship  between
intellectual  property  rights  and 
the  relevant
provisions  of  the  TRIPs  Agreement  and  the
Convention  on  Biological  Diversity,  in  particular
on 
issues  relating  to  technology  transfer  and
conservation  and  sustainable  use  of  biological
diversity  and  the  fair  and  equitable  sharing  of
benefits arising out of the use of genetic resources,
including the protection of knowledge, innovations
and  practices  of  indigenous  and  local  communities
embodying  traditional  lifestyles  relevant  for  the
conservation  and  sustainable  use  of  biological
diversity’,

(1)  OJ  L  227,  1.9.1994,  p.  1.  Regulation  as  amended  by
Regulation  (EC)  No  2506/95  (OJ  L  258,  28.10.1995,  p.  3).

(2)  OJ  L  309,  31.12.1993,  p.  1.

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HAVE  ADOPTED  THIS  DIRECTIVE:

Article  4

CHAPTER  I

Patentability

Article  1

States 

shall  protect  biotechnological
1. Member 
inventions  under  national  patent  law.  They  shall,  if
necessary,  adjust  their  national  patent  law  to  take
account  of  the  provisions  of  this  Directive.

2. This  Directive  shall  be  without  prejudice  to  the
obligations  of 
to
international  agreements,  and  in  particular  the  TRIPs
Agreement  and  the  Convention  on  Biological  Diversity.

the  Member  States  pursuant 

Article  2

1. For  the  purposes  of  this  Directive,

(a)  ‘biological  material’  means  any  material  containing
genetic  information  and  capable  of  reproducing  itself
or  being  reproduced  in  a  biological  system;

(b) ‘microbiological process’ means any process involving
or  performed  upon  or  resulting  in  microbiological
material.

1. The  following  shall  not  be  patentable:

(a)  plant  and  animal  varieties;

(b) essentially  biological  processes  for  the  production  of

plants  or  animals.

2.
Inventions  which  concern  plants  or  animals  shall  be
patentable  if  the  technical  feasibility  of  the  invention  is
not  confined  to  a  particular  plant  or  animal  variety.

3. Paragraph  1(b)  shall  be  without  prejudice  to  the
patentability 
a
microbiological  or  other  technical  process  or  a  product
obtained  by  means  of  such  a  process.

inventions  which 

concern 

of 

Article  5

1. 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,  cannot  constitute  patentable
inventions.

isolated  from  the  human  body  or
2. An  element 
otherwise  produced  by  means  of  a  technical  process,
including the sequence or partial sequence of a gene, may
constitute  a  patentable  invention,  even  if  the  structure  of
that  element  is  identical  to  that  of  a  natural  element.

2. A  process  for  the  production  of  plants  or  animals  is
essentially  biological  if  it  consists  entirely  of  natural
phenomena  such  as  crossing  or  selection.

3. The  industrial  application  of  a  sequence  or  a  partial
sequence  of  a  gene  must  be  disclosed  in  the  patent
application.

3. The  concept  of  ‘plant  variety’  is  defined  by  Article  5
of  Regulation  (EC)  No  2100/94.

Article  6

Article  3

1. For  the  purposes  of  this  Directive,  inventions  which
are  new,  which  involve  an  inventive  step  and  which  are
susceptible  of  industrial  application  shall  be  patentable
even if they concern a product consisting of or containing
biological  material  or  a  process  by  means  of  which
biological  material  is  produced,  processed  or  used.

2. Biological  material  which  is  isolated  from  its  natural
environment or produced by means of a technical process
may  be  the  subject  of  an  invention  even  if  it  previously
occurred  in  nature.

1.
Inventions  shall  be  considered  unpatentable  where
their commercial exploitation would be contrary to ordre
public  or  morality;  however,  exploitation  shall  not  be
deemed  to  be  so  contrary  merely  because  it  is  prohibited
by  law  or  regulation.

2. On  the  basis  of  paragraph  1,  the  following,  in
particular,  shall  be  considered  unpatentable:

(a)  processes  for  cloning  human  beings;

(b) processes  for  modifying  the  germ  line  genetic  identity

of  human  beings;

(c)  uses  of  human  embryos  for  industrial  or  commercial

purposes;

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(d) processes for modifying the genetic identity of animals
which  are  likely  to  cause  them  suffering  without  any
substantial  medical  benefit  to  man  or  animal,  and
also  animals  resulting  from  such  processes.

Article  7

The  Commission’s  European  Group  on  Ethics  in  Science
and  New  Technologies  evaluates  all  ethical  aspects  of
biotechnology.

CHAPTER  II

Scope  of  protection

Article  8

1. The  protection  conferred  by  a  patent  on  a  biological
material  possessing  specific  characteristics  as  a  result  of
the  invention  shall  extend  to  any  biological  material
derived 
through
propagation or multiplication in an identical or divergent
form  and  possessing  those  same  characteristics.

biological  material 

from 

that 

2. The  protection  conferred  by  a  patent  on  a  process
that  enables  a  biological  material  to  be  produced
possessing  specific  characteristics  as  a  result  of  the
invention  shall  extend  to  biological  material  directly
obtained through that process and to any other biological
material  derived  from  the  directly  obtained  biological
material  through  propagation  or  multiplication  in  an
identical  or  divergent  form  and  possessing  those  same
characteristics.

Article  9

The  protection  conferred  by  a  patent  on  a  product
containing  or  consisting  of  genetic  information  shall
extend to all material, save as provided in Article 5(1), in
which  the  product  in  incorporated  and  in  which  the
genetic 
its
function.

is  contained  and  performs 

information 

Article  10

from 

to  biological  material  obtained 

The  protection  referred  to  in  Articles  8  and  9  shall  not
the
extend 
propagation  or  multiplication  of  biological  material
placed  on  the  market  in  the  territory  of  a  Member  State
by the holder of the patent or with his consent, where the
multiplication or propagation necessarily results from the
application 
the  biological  material  was
marketed,  provided  that  the  material  obtained  is  not
subsequently 
or
multiplication.

propagation 

for  which 

other 

used 

for 

Article  11

1. By  way  of  derogation  from  Articles  8  and  9,  the  sale
or  other  form  of  commercialisation  of  plant  propagating
material  to  a  farmer  by  the  holder  of  the  patent  or  with
his  consent  for  agricultural  use  implies  authorisation  for
the  farmer  to  use  the  product  of  his  harvest  for
propagation  or  multiplication  by  him  on  his  own  farm,
this  derogation
the 
corresponding  to  those  under  Article  14  of  Regulation
(EC)  No  2100/94.

conditions  of 

extent 

and 

2. By  way  of  derogation  from  Articles  8  and  9,  the  sale
or any other form of commercialisation of breeding stock
or  other  animal  reproductive  material  to  a  farmer  by  the
holder  of  the  patent  or  with  his  consent 
implies
authorisation for the farmer to use the protected livestock
for  an  agricultural  purpose.  This  includes  making  the
animal  or  other  animal  reproductive  material  available
for  the  purposes  of  pursuing  his  agricultural  activity  but
not  sale  within  the  framework  or  for  the  purpose  of  a
commercial  reproduction  activity.

3. The  extent  and  the  conditions  of  the  derogation
provided  for  in  paragraph  2  shall  be  determined  by
national  laws,  regulations  and  practices.

CHAPTER  III

Compulsory  cross-licensing

Article  12

1. Where  a  breeder  cannot  acquire  or  exploit  a  plant
variety  right  without  infringing  a  prior  patent,  he  may
apply  for  a  compulsory  licence  for  non-exclusive  use  of
the  invention  protected  by  the  patent  inasmuch  as  the
licence  is  necessary  for  the  exploitation  of  the  plant
variety  to  be  protected,  subject  to  payment  of  an
appropriate  royalty.  Member  States  shall  provide  that,
where  such  a  licence  is  granted,  the  holder  of  the  patent
will  be  entitled  to  a  cross-licence  on  reasonable  terms  to
use  the  protected  variety.

2. Where 
the  holder  of  a  patent  concerning  a
biotechnological  invention  cannot  exploit  it  without
infringing  a  prior  plant  variety  right,  he  may  apply  for  a
compulsory  licence  for  non-exclusive  use  of  the  plant
variety  protected  by  that  right,  subject  to  payment  of  an
appropriate  royalty.  Member  States  shall  provide  that,
where  such  a  licence  is  granted,  the  holder  of  the  variety
right  will  be  entitled  to  a  cross-licence  on  reasonable
terms  to  use  the  protected  invention.

3. Applicants for the licences referred to in paragraphs 1
and  2  must  demonstrate  that:

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(a)  they  have  applied  unsuccessfully  to  the  holder  of  the
patent  or  of  the  plant  variety  right  to  obtain  a
contractual licence;

(b) the  plant  variety  or 

the 

technical  progress  of 

significant 
economic 
claimed  in  the  patent  or  the  protected  plant  variety.

interest  compared  with 

invention  constitutes
considerable
invention

the 

4. Each  Member  State  shall  designate  the  authority  or
authorities  responsible  for  granting  the  licence.  Where  a
licence  for  a  plant  variety  can  be  granted  only  by  the
Community  Plant  Variety  Office,  Article  29  of
Regulation  (EC)  No  2100/94  shall  apply.

CHAPTER  IV

Deposit,  access  and  re-deposit  of  a  biological  material

Article  13

1. Where  an  invention  involves  the  use  of  or  concerns
biological  material  which  is  not  available  to  the  public
and which cannot be described in a patent application in
such  a  manner  as  to  enable  the 
invention  to  be
reproduced by a person skilled in the art, the description
shall be considered inadequate for the purposes of patent
law  unless:

(a)  the  biological  material  has  been  deposited  no  later
than  the  date  on  which  the  patent  application  was
filed with a recognised depositary institution. At least
the 
international  depositary  authorities  which
acquired  this  status  by  virtue  of  Article  7  of  the
the
Budapest  Treaty  of  28  April  1977  on 
of
deposit 
international 
micro-organisms 
the  purposes  of  patent
procedure,  hereinafter  referred  to  as  the  ‘Budapest
Treaty’,  shall  be  recognised;

recognition 
for 

the 

of 

(b) the  application  as 

filed  contains  such  relevant
information  as  is  available  to  the  applicant  on  the
characteristics  of  the  biological  material  deposited;

(c)  the  patent  application  states  the  name  of  the
depository  institution  and  the  accession  number.

2. Access  to  the  deposited  biological  material  shall  be
provided  through  the  supply  of  a  sample:

(a)  up  to  the  first  publication  of  the  patent  application,
only  to  those  persons  who  are  authorised  under
national  patent  law;

(c)  after 

the 

patent 

and
has 
notwithstanding  revocation  or  cancellation  of  the
patent,  to  anyone  requesting  it.

granted, 

been 

3. The  sample  shall  be  supplied  only  if  the  person
requesting  it  undertakes,  for  the  term  during  which  the
patent  is  in  force:

(a)  not  to  make  it  or  any  material  derived  from  it

available  to  third  parties;  and

(b) not  to  use  it  or  any  material  derived  from  it  except
for experimental purposes, unless the applicant for or
proprietor  of  the  patent,  as  applicable,  expressly
waives  such  an  undertaking.

4. At  the  applicant’s  request,  where  an  application  is
refused  or  withdrawn,  access  to  the  deposited  material
shall  be  limited  to  an  independent  expert  for  20  years
from  the  date  on  which  the  patent  application  was  filed.
In  that  case,  paragraph  3  shall  apply.

5. The  applicant’s  requests  referred  to  in  point  (b)  of
paragraph 2 and in paragraph 4 may only be made up to
the  date  on  which  the  technical  preparations  for
publishing  the  patent  application  are  deemed  to  have
been  completed.

Article  14

If  the  biological  material  deposited  in  accordance
1.
with Article 13 ceases to be available from the recognised
depositary institution, a new deposit of the material shall
be permitted on the same terms as those laid down in the
Budapest  Treaty.

2. Any new deposit shall be accompanied by a statement
signed  by  the  depositor  certifying  that  the  newly
deposited biological material is the same as that originally
deposited.

CHAPTER  V

Final  provisions

Article  15

(b) between  the  first  publication  of  the  application  and
the granting of the patent, to anyone requesting it or,
if  the  applicant  so  requests,  only  to  an  independent
expert;

1. Member  States  shall  bring  into  force  the  laws,
regulations  and  administrative  provisions  necessary  to
comply  with  this  Directive  not  later  than  30  July  2000.
They  shall  forthwith  inform  the  Commission  thereof.

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When  Member  States  adopt  these  measures,  they  shall
contain  a  reference  to  this  Directive  or  shall  be
accompanied  by  such  reference  on  the  occasion  of  their
official  publication.  The  methods  of  making  such
reference  shall  be  laid  down  by  Member  States.

2. Member States shall communicate to the Commission
the  text  of  the  provisions  of  national  law  which  they
adopt  in  the  field  covered  by  this  Directive.

Article  16

The Commission shall send the European Parliament and
the  Council:

(a)  every  five  years  as  from  the  date  specified  in  Article
15(1)  a  report  on  any  problems  encountered  with
regard  to  the  relationship  between  this  Directive  and
international  agreements  on  the  protection  of  human
rights  to  which  the  Member  States  have  acceded;

(b) within two years  of entry  into  force of  this  Directive,
a  report  assessing  the  implications  for  basic  genetic
engineering  research  of  failure  to  publish,  or  late

publication  of,  papers  on  subjects  which  could  be
patentable;

(c)  annually as from the date specified in Article 15(1), a
report on the development and implications of patent
law 
in  the  field  of  biotechnology  and  genetic
engineering.

Article  17

This  Directive  shall  enter  into  force  on  the  day  of  its
publication  in  the  Official  Journal  of  the  European
Communities.

Article  18

This  Directive  is  addressed  to  the  Member  States.

Done  at  Brussels,  6  July  1998.

For  the  European  Parliament

For  the  Council

The  President

The  President

J. M.  GIL-ROBLES

R.  EDLINGER