COMMON POSITION (EC) No 19/98 adopted by the council on 26 February 1998 with a view to adopting Directive 98/.../EC of the European Parliament and of the Council on the legal protection of biotechnological inventions
Date: 1998-02-26
Institutions: Council of the European Union
Subjects: biotechnology, invention, patent, patent law, right to justice

8.4.98

EN

Official  Journal  of  the  European  Communities

C  110/17

COMMON  POSITION  (EC)  No  19/98

adopted  by  the  council  on  26  February  1998

with a view to adopting Directive 98/. . ./EC of the European Parliament and of the Council on
the  legal  protection  of  biotechnological  inventions

(98/  110/02)

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
range  of 
the  protection  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 
of
protection 
determined 
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  1995  and  Decision  of  the  European  Parliament  of
...  (not  yet  published  in  the  Official  Journal).

(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.

C  110/18

EN

Official  Journal  of  the  European  Communities

8.4.98

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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C  110/19

(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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8.4.98

(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  are  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  Articles  3  and  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  last  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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8.4.98

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 sequenced 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  above  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
those 
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;

(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;

(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 twenty 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

1.
If  the  biological  material  deposited  in  accordance
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

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

(*) Two  years  after  the  date  of  its  publication  in  the  Official

Journal  of  the  European  Communities.

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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;

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  . . .,

(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

For  the  European  Parliament

For  the  Council

The  President

The  President

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STATEMENT  OF  THE  COUNCIL’S  REASONS

I. 

INTRODUCTION

1.  On  25  January  1996,  the  Commission  submitted  a  proposal  for  a  Directive  of  the
European  Parliament  and  of  the  Council  on  the  legal  protection  of  biotechnological
inventions (1),  based  on  Article  100a  of  the  EC  Treaty.

2.  The  Parliament  delivered  its  Opinion  on  first  reading  on  16  July  1997 (2).  Further  to
that Opinion the Commission sent an amended proposal for a Directive on 29 August
1997 (3).  The  Economic  and  Social  Committee  delivered  its  Opinion  on  11  July
1996 (4).

3.  The  Council  adopted  its  common  position  in  accordance  with  Article  189b  of  the

Treaty  on  26  February  1998.

II.  OBJECTIVE

4.  The aim of the proposal is to establish harmonised, clear and improved standards for
the  protection  of  biotechnological  inventions  with  a  view  to  furthering  the  innovative
potential  and  the  competitivity  of  Community  science  and  industry  in  this  important
area  of  modern  technology.  The  provisions  of  the  proposal  systematically  adapt  the
rules  of  patent  law  in  the  biotechnological  field  in  order  to  ensure  that  patent
legislation  is  more  effectively  applied  in  this  area.

III.  THE  COMMON  POSITION (5)

Recitals

5.  Comments  on  the  recitals  are  given  in  the  context  of  the  Articles  to  which  they

refer.

Articles  of  the  proposal

Article  1

6.  Paragraph  1  remains  as  it  was  in  the  original  Commission  proposal.

7.  The  European  Parliament  proposed  replacing  the  reference  to  national  and
Community legislation in paragraph 2 with a reference to the rights and obligations of
the  Member  States  pursuant  to  international  agreements,  and  in  particular  the
Convention  on  Biological  Diversity  and  the  agreement  on  aspects  of  intellectual
property  relating  to  trade  (the  TRIPs  Agreement)  (amendment  67).

The  Commission  incorporated  this  amendment  in  its  amended  proposal  while
maintaining  its  belief  that  the  reference  to  the  rights  of  Member  States  was  not
appropriate.

The  Council  concurred  with  the  Commission  on  that  point.

(1)  OJ  C  296,  8.10.1996,  p.  4.
(2)  OJ  C  286,  22.9.1997,  p.  87.
(3)  OJ  C  311,  11.10.1997,  p.  12.
(4)  OJ  C  295,  7.10.1996,  p.  11.
(5)  Unless otherwise stated, the numbering of Articles and recitals in this statement of reasons is that of the

common  position.

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8.  As regards the obligations arising from international conventions, reference should be
made  to  three  recitals  of  the  common  position.  Firstly,  the  European  Parliament
proposed two new recitals (amendments 10 and 33) which refer to conventions on the
protection  of  human  rights.

In  its  amended  proposal,  the  Commission  grouped  them  all  in  a  single  recital  (24b).

The  Council  thought  there  should  not  be  any  reference  to  the  Convention  on  the
Protection  of  Human  Rights  and  the  Dignity  of  the  Human  Person  with  respect  to
(Convention  on  Human  Rights  and
Applications  of  Biology  and  Medicine 
Biomedicine)  of  19  November  1996,  which  had  not  yet  come  into  force  and  had  not
been  signed  by  all  the  Member  States.  As  regards  the  way  reference  was  made  to  the
European Convention for the Protection of Human Rights and Fundamental Freedoms
of  4  November  1950,  the  Council  thought  in  would  be  more  proper  from  an
institutional  point  of  view  to  do  so  by  referring  to  Article  F(2)  of  the  Treaty  on
European  Union  (recital  43  of  the  common  position).

9. 

In  recital  37  of 
its  amended  proposal,  the  Commission  summarised  several
amendments  proposed  by  the  European  Parliament  (amendments  40,  41,  42,  43,  68
and  77)  regarding  the  Convention  on  Biological  Diversity.  Instead  of  citing  certain
Articles  of  the  Convention  in  full,  it  preferred  to  give  references  only.

The  Council  concurred  with  the  Commissions’s  approach,  pointing  out  that  the
Community  was  a  party  to  that  Convention  (recital  55  of  the  common  position).

10.  The European Parliament proposed a new recital which quoted from a decision of the

signatories  to  the  Convention  on  Biological  Diversity  (amendment  44).

The Commission and the Council accepted this new recital (recital 56 of the common
position).

Article  2

11.  The  Council  concurred  with  the  amended  Commission  proposal  which  incorporated
paragraphs 2 and 3a as in the European Parliament’s amendment 48 in paragraph 1 of
this  Article.

12.  The Commission incorporated paragraph 3b of the European Parliament’s amendment

48  in  paragraph  2  of  its  amended  proposal.

The  Council  tightened  up  the  definition  of  the  essentially  biological  notion  of
procedure  in  this  provision  on  the  basis  not  only  of  amendment  48  but  also  of
amendment 22 proposed by the European Parliament with regard to recital 18 of the
original proposal.

13.  Given  the  inclusion  of  a  complete  definition  in  Article  2(2),  the  Council  made  the

corresponding  recital  declaratory  in  tone  (recital  33  of  the  common  position).

14.  The  Council  concurred  with  the  amended  Commission  proposal  and  incorporated
paragraph  3c  as  in  the  European  Parliament’s  amendment  48  in  Article  2(3),  while
referring  to  the  definition  of  the  notion  of  plant  variety  given  in  Article  5  of
Regulation  (EC)  No  2100/94.

Article  3

15.  The  Council  concurred  with  the  amended  Commission  proposal  and  incorporated
paragraphs  1  and  3  as  in  the  European  Parliament’s  amendment  48  in  a  separate
Article.

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Article  4

16.  The  European  Parliament  proposed  a  new  Article  2a  (amendment  47).

The  Commission  incorporated  this  Article  in  its  amended  proposal  (Article  4)  while
amending  slightly  the  wording  of  paragraph  2.

The  Council  also  adopted  this  Article  and  found  that  the  European  Parliament’s
wording  of  paragraph  2  was  more  appropriate.

17.  In  conjunction  with  that  Article,  the  Parliament  proposed  amendments  to  recital  17
(amendment  18)  as  well  as  the  new  recitals  17a  to  17c  (amendments  19  to  21).

The  Commission  incorporated  these  recitals  in  its  amended  proposal  while  making
some  textual  changes  to  recitals  17  and  17  c.

The  Council  also  accepted  these  recitals  (recitals  29  to  32  of  the  common  position),
while  clarifying  the  wording  of  the  latter  one.

Article  5  (Article  3  in  the  original  Commission  proposal)

18.  This Article is one of the key provisions of the proposal for a Directive. It deals with
the  distinction  between  a  discovery  (excluded  from  patentability)  and  an  invention
(patentable).

19.  The  European  Parliament  proposed  clarifying  this  Article  (amendments  100  and  49).

20.  The  Commission  incorporated  in  its  amended  proposal  paragraph  1  of  this  Article  as

amended  by  the  European  Parliament.

The  Council  followed  suit  in  its  common  position  without  any  change,  on  the
understanding that the words ‘the human body, at the various stages of its formation
and  development’  covered  the  human  embryo.

21.  The  Commission  incorporated  the  amendment  proposed  by  the  European  Parliament
to  paragraph  2  but  by  analogy  with  the  terminology  in  paragraphs  1  and  3  replaced
‘the structure or partial sequence of a gene’ with ‘the sequence or partial sequence of a
gene’.

The  Council  accepted  the  Commission’s  amended  proposal.

22.  The  Commission  incorporated  the  amendment  proposed  by  the  European  Parliament

to  paragraph  3  but  put  ‘the  function’  instead  of  ‘the  industrial  application’.

The  Council  preferred  the  term  ‘industrial  application’  which  was  more  current  in
patent  law.

23.  In  conjunction  with  this  Article,  the  European  Parliament  proposed  amendments  to
recitals  13,  14,  15,  16  and  19  and  to  the  new  recitals  14a  and  16a  to  16g
(amendments  11  to  16,  99  and  23).

The  Commission  incorporated  these  amendments  in  its  amended  proposal  while
making textual amendments to several of them. In recital 16g of its amended proposal
it summarized recitals 16f (amendment 99) and 19b (amendment 79) proposed by the
European Parliament.

The  Council  incorporated  recitals  13  to  16,  16b,  16g  and  19  as  in  the  Commission’s
amended  proposal  (recitals  16  to  21,  23,  28  and  34  of  the  common  position).  It
simplified the matter by combining recitals 16a, 16c and 16e of the amended proposal
in a single recital (recital 22 of the common position). However, it divided recital 16d
of the amended proposal into two separate recitals (recitals 24 and 25 of the common
position), with the first dealing with the industrial application criterion and the second
with  interpreting  rights  conferred  by  a  patent.

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Articles  4  to  8  of  the  original  proposal

24.  The European Parliament proposed deleting Articles 4 to 8 of the original Commission
proposal  (amendments  50  to  54)  since  the  contents  thereof  were  to  be  found  in
amendments  48  and  47.

The  Commission  and  the  Council  agreed  to  the  deletion  of  these  Articles.

Article  8a  proposed  by  the  European  Parliament

25.  The  European  Parliament  proposed  a  new  Article  8a  containing  requirements
concerning an invention which consists of biological material of plant or animal origin
or  human  origin  (amendment  76).

The Commission did not accept that amendment in its amended proposal. It said that
the  first  paragraph  went  beyond  the  international  commitments  entered  into  by  the
Community  and  its  Member  States  within  the  framework  of  the  approval  and
ratification of the Convention on Biological Diversity of 5 June 1992 (1), and that the
second  paragraph  in  particular  did  not  comply  with  the  requirements  on  the
protection  of  personal  data (2).

The  Council  shared  the  Commission’s  misgivings  about  this  amendment  and  further
pointed out that the Patents Offices would not be able to verify that foreign legislation
was  complied  with  (paragraph  1)  or  that  the  agreement  of  the  person  concerned  had
been  given  (paragraph  2),  and  that  therefore  the  requirements  contained  in  the
amendment  could  not  be  conditions  for  patentability.

26.  However,  the  Council  incorporated  some  important  features  of  the  amendment  in
recitals 26 and 27 of its common position. These recitals state the principles whereby
the  person  from  whose  body  material  is  taken  must  have  had  an  opportunity  of
expressing free and informed consent thereto, in accordance with national law (recital
26), and an application for a patent for an invention which uses biological material of
plant  or  animal  origin  should,  where  appropriate,  contain  information  on  the
geographical place of origin of such material, if known, (recital 27), although the lack
of such agreement or information could not affect the patentability of the invention in
question.  Recital  26  of  the  common  position  is  an  adaptation  of  the  new  recital  16g
proposed  by  the  European  Parliament  (amendment  17)  and  adopted  by  the
Commission  in  its  amended  proposal  as  recital  16f.

Article  6  (Article  9  of  the  original  Commission  proposal)

27.  This Article, which covers the exclusion of the patentability of inventions commercial
exploitation  of  which  would  be  contrary  to  public  policy  or  morality,  is  the  second
key  provision  in  the  proposal  for  a  Directive.

28.  The  European  Parliament  proposed  changes  to  this  Article  (amendment  55).

29.  As regards paragraph 1 of this Article, the Commission did not include in its amended
proposal  the  words  ‘exploitation  or  publication’  proposed  by  the  Parliament,
preferring  the  words  ‘commercial  exploitation’  on  the  lines  of  Article  27(2)  of  the
TRIPs  Agreement.

The  Council  concurred  with  the  Commission.

(1)  Council Decision of 25 October 1993 on the conclusion of the Convention on Biological Diversity, OJ L

309,  13.12.1993,  p.  1.

(2)  Directive  No  95/46/EC  of  the  European  Parliament  and  of  the  Council  of  24  October  1995  on  the
protection  of  individuals  with  regard  to  the  processing  of  personal  data  and  on  the  free  movement  of
such  data,  OJ  L  281,  23.11.1995.

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30.  In  conjunction  with  Article  6(1),  the  European  Parliament  proposed  two  new  recitals
19c  and  19d  (amendment  26),  the  amendment  to  recital  20  (amendment  27)  and  the
deletion  of  recital  21  (amendment  28).

In its amended proposal the Commission aligned the wording of the first of these two
recitals (recital 19b of its amended proposal) on Article 27(2) of the TRIPs Agreement,
and  the  wording  of  recital  20  on  that  adopted  in  Article  6(1)  (point  29  above).

The  Council  concurred  with  the  Commission  in  this  respect  (recitals  36  and  37  of  its
common  position).

31.  As  regards  the  second  new  recital  proposed  by  the  European  Parliament,  the
Commission incorporated it in its amended proposal (recital 19c), apart from the last
part of the sentence, which did not take account of the fact that an invention could be
excluded  from  patentability  for  reasons  which  did  not  affect  authorization  for  the
marketing  of  the  product  in  question.

The  Council  preferred  to  delete  not  only  that  part  of  the  sentence  but  the  whole
recital,  which  it  thought  was  open  to  misinterpretation.

32.  The  Commission  and  the  Council  agreed  to  delete  recital  21  of  the  original

proposal.

33.  The  Commission  added  the  word  ‘notamment’  to  the  French  text  of  the  introductory
phrase in paragraph 2 of this Article in its amended proposal to make it clear that the
list  of  exclusions  from  patentability  under  paragraph  1  was  not  exhaustive.

The  Council  concurred  with  the  Commission.

34.  The Commission incorporated in paragraph 2 of its amended proposal the exclusions
from  patentability  listed  in  paragraph  2  of  amendment  55  from  the  European
Parliament, apart from the one under (bb). Since it thought that this last subparagraph
defined the concept of human cloning under (a), it preferred to transfer its content to
the  new  recital  24a  of  its  amended  proposal  in  order  to  avoid  repetition  in  the  terms
of  the  Directive.

The Council, in paragraph 2 of its common position, incorporated the same exclusions
as  the  Commission  together  with  the  clarifications  as  set  out  in  points  35  and  37
below.  It  agreed  with  the  Commission  that  it  was  better  to  put  the  definition  of
human  cloning  in  the  recitals,  and  it  tried  to  clarify  the  wording  proposed  by  the
Commission, in particular by the addition of a reference to the techniques for splitting
embryos  (recital  41  of  the  common  position).

35.  Under  (a)  in  paragraph  2  the  Council  replaced  ‘procedures  for  human  reproductive
cloning’  with  ‘  procedure  for  the  cloning  of  human  beings’,  since  it  thought  the
adjective  ‘reproductive’  could  be  too  restrictive.  It  was  understood  that  the  words
‘human  beings’  referred  to  the  human  being  from  the  embryionic  state.

36.  Subparagraphs  (b)  and  (d)  of  paragraph  2  in  the  common  position  remain  as  they

were  in  the  amended  Commission  proposal.

37.  In  subparagraph  (c)  of  paragraph  2,  the  Council  said  that  the  exclusion  of
patentability  for  human  embryo  uses  applied  when  the  uses  were  industrial  or
commercial. A new recital (recital 42 of the common position) makes it clear that the
Council wanted to make a distinction thereby between the uses of human embryos for
industrial  or  commercial  purposes,  which  were  excluded  from  patentability,  and
inventions  for  therapeutic  or  diagnostic  purposes  which  are  applied  to  the  human
embryo  and  are  useful  to  it,  which  were  not  excluded  from  patentability.

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38.  In  conjunction  with  Article  6(2),  the  European  Parliament  proposed  amendments  to

recitals  22,  23,  24  and  25  (amendments  80,  30,  31  and  34).

The  Commission  incorporated  these  amendments  in  its  amended  proposal  with  some
textual  changes.

The Council preferred to follow the wording proposed by the European Parliament as
regards  recital  22  (recital  38  of  the  common  position).  It  clarified  the  wording  of  the
beginning  of  recital  23  of  the  amended  proposal  (recital  39  of  the  common  position)
in  order  to  link  it  better  with  Article  6.  As  regards  recital  24  (recital  40  of  the
common position), it aligned the terminology on that used in Article 6(2). Finally, the
Council  preferred  to  include  not  only  diagnosis  and  therapy  but  also  research  and
prevention  in  recital  45  of  its  common  position  (recital  25  of  the  amended  proposal)
among  the  areas  where  it  could  be  determined  whether  the  procedures  for  changing
the genetic identity of animals which caused them suffering were of any major medical
value  or  not.

Article  7

39.  The  European  Parliament  proposed  a  new  Article  making  provision  for  setting  up  an
Ethics  Committee  to  assess  all  ethical  aspects  of  biotechnology  and  its  utilisation
(amendment  78).

Given that there was a Commission Group of Advisers on the Ethical implications of
Biotechnology,  and  given  its  terms  of  reference,  the  Commission  thought  it  more
appropriate  to  refer  to  that  Group  in  its  amended  proposal  rather  than  set  up  a  new
committee.

The Council followed the Commission approach while amending slightly the wording
proposed by the Commission. It also adjusted the name of the Group to that adopted
by  the  Commission  when  the  Group’s  term  of  office  was  renewed  in  December  1997
(European  Group  on  Ethics  in  Science  and  New  Technologies).

40.  The  Council  also  thought  there  should  be  a  new  recital  (recital  44  of  its  common
position)  which  states  that  this  Group  may  be  consulted  only  where  biotechnology  is
to  be  assessed  at  the  level  of  basic  ethical  principles  so  as  to  remove  all  doubt  about
the  possibility  of  the  Group  being  involved  in  the  procedure  for  issuing  a  specific
patent.

Article  8  (Article  10  of  the  original  Commission  proposal)

41.  Paragraph  1  remains  as  it  was  in  the  original  Commission  proposal.

42.  The  European  Parliament  proposed  an  amendment  to  paragraph  2  (amendment  57).

The  Commission  incorporated  this  amendment  in  its  amended  proposal.

The  Council  also  incorporated  this  amendment  in  its  common  position.

Article  9  (Article  11  of  the  original  Commission  proposal)

43.  The  European  Parliament  proposed  an  amendment  to  this  Article  (amendment  58).

The  Commission  did  not  accept  the  amendment,  which  involved  the  addition  of  a
reference to Article 2a(1)  (Article 4(1) of the amended proposal); it said that, in view
of Articles 11 and 12, the reference would limit the scope of the protection given by a
patent  in  a  way  which  ran  counter  to  current  patent  law  practice.

The council concurred with the Commission. It also thought it was more appropriate
to  use  the  words  ‘in  which  genetic  information  is  contained  and  expressed’.

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Article  10  (Article  12  of  the  original  Commission  proposal)

44.  This  Article  remains  as  it  was  in  the  original  Commission  proposal.

Article  11  (Article  13  of  the  original  Commission  proposal)

45.  The European Parliament proposed amendments to paragraph 1 of this Article, firstly,
restricting the reference to Article 14 of Regulation (EC) No 2100/94 to paragraphs 1
and  3  thereof  and  then  adding  a  new  sentence  (amendment  95).

The  Commission  did  not  include  these  amendments  in  its  amended  proposals.  It
pointed  out  that  Article  14(1)  and  (3)  of  Regulation  (EC)  No  2100/94  could  not
operate  without  paragraph  2  since  that  would  invalidate  the  notion  that  the
derogation  laid  down  in  Article  11  was  proposed  in  accordance  with  what  is  laid
down for new plant varieties. As regards the new sentence proposed by the European
Parliament, it noted that it repeated the content of the last sentence of the amendment
proposed  by  the  Parliament  to  paragraph  2;  this  was  not  appropriate  in  its  opinion
since the net result would be to transpose into the plant domain what was specifically
intended  for  breeding.

The Council concurred with the Commission on both these points. It also aligned the
terminology  of  this  paragraph  on  that  of  Article  13(2)(d)  of  Regulation  (EC)  No
2100/94.

46.  The  European  Parliament  proposed  amendments  to  paragraph  2  of  this  Article

(amendment  59).

The  Commission  incorporated  these  amendments  in  its  amended  proposal  together
with  some  textual  changes  to  the  last  sentence.

The  Council  sought  to  clarify  the  wording  of  the  paragraph  on  the  basis  of  the
changes  proposed  by  the  Parliament  and  the  Commission,  inter  alia  by  aligning  the
terminology  on  that  of  paragraph  1.

47.  Paragraph  3  remains  as  it  was  in  the  original  Commission  proposal.

48.  Among  the  recitals  which  relate  to  Article  11  (recitals  27  to  31  of  the  original
proposal;  recitals  47  to  51  of  the  common  position),  the  European  Parliament
proposed  an  amendment  to  recital  30  (amendment  35).

The Commission incorporated this amendment in its amended proposal together with
some  textual  changes.

The  Council  concurred  with  the  amended  Commission  proposal  (recital  50  of  its
common  position).

Article  12  (Article  14  of  the  original  Commission  proposal)

49.  Paragraphs  1,  2  and  3(a)  remain  as  they  were  in  the  original  Commission  proposal.

50.  The  European  Parliament  proposed  an  amendment  to  paragraph  3(b)  (amendment

60).

The  Commission  incorporated  the  amendment  in  its  amended  proposal,  aligning  the
wording  on  that  of  Article  31  (l)(i)  of  the  TRIPs  Agreement.

The  Council  aligned  the  wording  further  on  the  aforementioned  provision  of  the
TRIPs  Agreement.

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51.  The  European  Parliament  proposed  an  amendment  to  paragraph  4  (amendment  61).

The  Commission  incorporated  the  amendment  in  its  amended  proposal.

The Council also incorporated the amendment in its common position. Since only the
Community Plant Variety Office was intitled to grant a compulsory exploitation right
for a plant variety which is protected by a Community plant variety right, the Council
added  a  sentence  referring  to  Article  29  of  Regulation  (EC)  No  2100/94.

However, the Council noted that Article 29 of Regulation (EC) No 2100/94 laid down
that  the  grant  of  such  rights  by  the  Community  Plant  Variety  Office  was  solely  for
reasons of public interest, whereas the reasons laid down in Article 12 of the proposal
for a Directive for the grant of compulsory exploitation licences between an invention
patent and a plant variety right and vice versa were other than that of public interest.
Since  the  proposal  for  a  Directive  was  not  an  appropriate  instrument  for  amending
Regulation  (EC)  No  2100/94,  and  in  order  to  avoid  creating  an  incompatibility
between  Directive  and  Regulation,  the  Council  adopted,  at  the  same  time  as  its
common  position,  a  Decision  pursuant  to  Article  152  of  the  Treaty  calling  on  the
Commission  to  examine  the  implications  of  Article  12  of  the  common  position  on
Article  29  of  Regulation  (EC)  No  2100/94,  and  to  submit  the  results  of  that
examination,  together  with  any  appropriate  proposals,  as  soon  as  possible.

52.  Recitals  32  and  33  of  the  original  Commission  proposal  deal  with  Article  12.  The

European  Parliament  proposed  an  amendment  to  recital  33  (amendment  36).

In  its  amended  proposal,  the  Commission  incorporated  the  amendment  proposed  by
the European Parliament and aligned the wording of the two recitals on that of Article
31(1)(i)  of  the  TRIPs  agreement  along  the  lines  of  the  alignment  made  for  Article
12(3)(b)  (point  50  above).

The  Council  adopted  the  recitals  as  they  stand  in  the  amended  Commission  proposal
(recitals  52  and  53  of  the  common  position).

Articles  13  and  14  (Articles  15  and  16  of  the  original  Commission  proposal)

53.  These  Articles  remain  as  they  were  in  the  original  Commission  proposal.

Article  17  of  the  original  proposal

54.  The  European  Parliament  proposed  the  deletion  of  Article  17  of  the  original
Commission proposal (amendment 62), since the detailed rules on the burden of proof
in Article 34 of  the TRIPs  Agreement made it superfluous to have a provision on the
matter  in  the  proposal  for  a  Directive.

The  Commission  and  the  Council  agreed  to  delete  the  Article.

55.  The  European  Parliament  proposed  a  new  recital  33a  (amendment  37),  which

explained  why  Article  17  was  deleted  from  the  original  proposal.

The  Commission  incorporated  the  new  recital  in  its  amended  proposal  (recital  34).

The  Council  also  adopted  this  recital  (recital  54  of  the  common  position).

56.  Given  the  deletion  of  Article  17  from  the  original  proposal,  the  Council  deleted  from
recital  13  of  its  common  position  the  reference  to  a  reversal  of  the  burden  of  proof
which  appeared  in  recital  10  of  the  original  proposal.

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Article  15  (Article  18  of  the  original  Commission  proposal)

57.  In paragraph 1 of the Article, the European Parliament proposed that the deadline for
the  implementation  of  the  Directive  should  be  1  January  1999  instead  of  1  January
2000  as  proposed  by  the  Commission  in  its  original  proposal  (amendment  63).

The  Commission  incorporated  the  amendment  in  its  amended  proposal.

The  Council,  while  sharing  the  concern  that  the  Directive  should  be  transposed  into
national  law  as  soon  as  possible,  pointed  out  that,  in  the  light  of  the  internal
procedures  in  the  Member  States,  a  period  of  two  years  after  the  Directive  was
adopted would be necessary in several Member States for transposing it into national
law. The Council therefore amended the provision so that there would be a period of
two  years  for  transposing  the  Directive  after  it  was  published  in  the  Official
Journal.

58.  Paragraph  2  of  this  Article  remains  as  it  was  in  the  original  Commission  proposal.

Article  16

59.  The  European  Parliament  proposed  a  new  Article  18a  making  provision  for  a
Commission  report  to  be  published  every  five  years  after  the  transposition  of  the
Directive  and  for  it  to  be  forwarded  to  the  Parliament  and  the  Council  (amendment
64).

The  Commission  incorporated  the  new  Article  as  Article  16  in  its  amended
proposal.

The  Council  also  incorporated  the  provision  (Article  16a  of  its  common  position).  It
restricted the reference to international agreements on human rights to those to which
the  Member  States  were  parties  and  said  that  the  Directive  could  not  raise  problems
vis-à-vis  agreements  which  had  not  yet  come  into  force.

60.  The  European  Parliament  proposed  two  new  recitals  which  also  stipulate  the
preparation of reports by the Commission and their forwarding to the Parliament and
the  Council  (amendments  38  and  39).

The  Commission  incorporated  these  new  recitals  (recitals  35  and  36  in  its  amended
proposal).

While the Council agreed with the content of these recitals, it preferred to group in a
single  Article  of  the  Directive  all  the  provisions  requiring  the  Commission  to  submit
reports. It therefore incorporated the content of these two recitals in points (b) and (c)
of  Article  16  in  its  common  position.  It  thought  it  would  be  useful  to  lay  down  that
the annual report referred to in (c) covered not only the development of patent law in
the  field  of  biotechnology  and  genetic  engineering  but  also  the  implications  thereof.

IV.  CONCLUSIONS

61.  In  its  common  position,  the  Council  adopted  the  gist  of  almost  all  the  amendments
proposed  by  the  European  Parliament.  The  Commission  could  accept  the  common
position  of  the  Council  on  all  the  points.