Amended proposal for a European Parliament and Council Directive on the legal protection of biotechnological inventions
Date: 1997-08-29
Institutions: European Commission
Subjects: approximation of laws, biotechnology, genetically modified organism, invention, patent

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels,  29.08.1997 
COM(97) 446  final 

95/ 0350 (COD) 

Amended proposal  for a 

EUROPEAN PARLIAMENT  AND  COUNCIL  DIRECTIVE 

on the legal protection of biotechnological inventions 

(presented by the Commission  pursuant to Article  189 a (2) 
of the EC-Treaty) 

EXPLANATORY MEMORANDUM 

GENERAL COMMENTS 

In February  1996, the Commission  presented  to  European  Parliament  and the  Council  a 
new proposal for a Directive on the legal protection of biotechnological  inventions.1 

The  Economic  and  Social  Committee  adopted  its  opinion  regarding  this  proposal  on 
11 July  1996.2 

European  Parliament  adopted  66  amendments  at  its  first  reading  of  the  proposal  during 
its plenary part-session of  14-18 July  1997.3 

These  amendments  reflect  European  Parliament's  concerns  regarding  the  need  (a)  to 
clarify  the  difference  between  discoveries  and  inventions  where  the  patentability  of 
elements of human origin is concerned and (b) to introduce an ethical dimension  into the 
proposal for a Directive. 

In  this  respect,  this  amended  proposal  takes  account  of  all  of  European  Parliament's 
amendments. 

There is only one amendment, amendment 76, which the Commission is unable to accept. 
This proposed  the  introduction  of an Article  8a.  The first paragraph  of this  amendment 
required  a patent  application  for an invention  consisting  of biological  material  of animal 
or plant origin to indicate the geographical place of origin of the material  in question and 
to provide  evidence  that the  material  had  been  used  in  accordance  with  the  legal  access 
and export provisions in force in the place of origin.  The second paragraph required that, 
if the biological  material  was of human  origin, the patent  application  should publish  the 
name  and  address  of  the  person  of  origin  or  his  or  her  legal  representative  and  also 
provide  evidence  that  the  material  had  been  used  and  the  patent  applied  for  with  the 
agreement of the person of origin or of his or her legal representative. 

The first paragraph of this amendment goes beyond the international  commitments  which 
the  Community  and  its Member States have  entered  into  in  approving  and  ratifying  the 
Convention  on  Biological  Diversity  of  5 June  1992.4  Moreover,  the  second  paragraph 
does not meet the requirements governing the protection of personal data.5 

1  OJ No C 296, 8.10.1996,  p. 4. 

2  OJ NO C 295, 7.10.1996, p. 11. 

3  Not yet published. 

4  Council  Decision  of  25  October  1993  concerning  the  conclusion  of  the  Convention  on  Biological 

Diversity, OJNo L 309, 13.12.1993, p. 1. 

5  Directive  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 No L 281, 23.11.1995. 

COMMENTS ON THE RECITALS 

From  a general point of view 

The table below indicates the numbers of the recitals into which the amendments adopted 
by Parliament have been incorporated. 

Recitals 
3 
4 
8a 
9a 
9b 
9c 
11 
13 
14 
14a 
14b 
15 
16 
16a-e 
16f 
16g 
17 
17a 
17b 
17c 
18 
19 
19a 
19b-c 
20 
22 
23 
24 
24a 
24b 
25 
30 
32 
33 
34 
35 
36 
37 
38 

Amendments 
2 
3 
5 
6 
7 
8 
9 
11 
12 
13 
1 
14 
15 
16 
17 
99 and 79 
18 
19 
20 
21 
22 
23 
24 
26 
27 
80 
30 
31 
new 
10 and 33 
34 
35 
new 
36 
37 
38 
39 
40,41,42,43,68,77 
44 

From an individual point of view 

All  the  amendments  to  the  recitals  have  been  incorporated  in  full,  except  as  far  as  the 
following  aspects are concerned: 

Recital  13 incorporates  amendment  11.  Its middle section has been  slightly  reworded  in 
order to align it on the wording of Article 5(1). 

Recital  14a  incorporates  amendment  13. The  beginning  has  been  slightly  reworded  in 
order  to  take  better  account  of  the  need  to  finance  research  against  rare  or  so-called 
orphan diseases. 

Recital  15 incorporates amendment  14.  It has been  slightly  reworded at the end  because 
it is the rights conferred  by a patent and not the patent itself which are concerned. 

Recital  16b incorporates amendment  16b.  It has been slightly reworded in order to make 
it  clearer  that  it  is  a  DNA  sequence's  lack  of  biological  function  which  makes  it 
unpatentable. 

Recital  16f incorporates amendment  17.  It has been slightly reworded in order to align it 
on  point  2.4.  of  Opinion  No  8 of  the  Group  of  Advisers  on  the  Ethical  Implications  of 
Biotechnology. 

Recital  16g  summarises  amendments  79  and  99  in  the  light  of  the  consequences  of 
Article 28(1 )(a) of the TRIPs Agreement. 

Recital  17 incorporates  amendment  18, with one slight change: the word  "practicability" 
has been replaced by  "application". 

Recital  19 incorporates amendment  23.  Its wording has been amended to make it legally 
more certain. 

Recital  19c incorporates the second part of amendment 26.  The final  clause has been  left 
out because there  is nothing  to prevent the patent on a product, e.g. a medicinal  product, 
whose  commercial  exploitation  has been authorised from being annulled  if a judge  finds 
that  one of the conditions  for  its patentability  is not met.  Annulment  of the patent  does 
not  involve  withdrawal  of  the  authorisation  to  exploit  the  product  commercially.  The 
two procedures are independent of each other. 

Recital  22  incorporates  amendment  80.  The end has been  slightly  reworded  in order  to 
avoid  any  incorrect  scientific  interpretation  which  would  be  inconsistent  with  the 
amendment's purpose. 

Recital  23  incorporates  amendment  30.  The  wording  has  been  amended  following  the 
deletion of recital 21 by amendment 28 because recital 23 is linked to it. 

Recital 24a is new.  It refers to the definition  of human reproductive cloning contained in 
Opinion No 9 of the Group of Advisers on the Ethical Implications of Biotechnology.  At 
the  same  time,  it  incorporates  what  was  intended  by  amendment  55,  paragraph  2(bb). 
This subparagraph better explains why the patentability  of human reproductive cloning is 
to  be  ruled  out. 
In  view  of  the  need  for  proper  drafting,  any  redundant  information 
should  be  avoided  in  the  operative  part  of  the  Directive  and  the  explanation  should  be 
incorporated into the recitals. 

Recital 24b is a summary of amendments  10 and 33. 

Recital 32 has been given a new wording.  It is aligned on the wording of Article  31(l)(i) 
of  the  TRIPs  Agreement  in  view  of the  fact  that  amendment  67  expressly  introduces  a 
reference  to the rights and obligations arising out of that agreement,  inter alia,  in Article 
1 (2) of the proposal for a Directive. 

Recital 35  incorporates  amendment  38.  The  words  "because otherwise  patenting  would 
be precluded on the grounds of lack of novelty of the invention" have been left out for the 
sake of clarity and in order to avoid any incorrect technical  interpretation. 

Recital  37  summarises  amendments  40,  41,  42,  43,  68  and  77.  Some  of  these 
amendments  proposed  introducing  complete  quotations  of  articles  from  the  Convention 
on Biological Diversity.  It would appear more appropriate, in view of the fact that recital 
40  states  that  this  Directive  does  not  affect  the  rights  and  obligations  of  Member  States 
arising from international agreements, and that amendment  67, cited above, also refers  to 
this Convention, to refer  globally to the Council Decision of 25 October  1993 concerning 
the conclusion of the Convention on Biological Diversity. 

COMMENTS ON THE INDIVIDUAL ARTICLES 

Article 1(2) incorporates amendment 67. 

Article 2 incorporates amendment 48, paragraphs 2, 4, 5 and 6. 

Article 3 incorporates amendment 48, paragraphs  1  and 3. 

Amendment 48 has been divided into two articles for the sake of clarity. 

Article  4 incorporates  amendment  47.  Paragraph  2 of this Article has been  amended  in 
the  same  way  as  recital  17, amended  by  amendment  18.  The  word  "practicability"  is 
replaced by "application". 

Article 5 incorporates amendments  100 and 49.  It corresponds to the former  Article 3 

Articles 4, 5, 6, 7 and  8 have been deleted  in accordance  with amendments  50. 51. 52.  5"* 
and 54 respectively.  This is basically  because they have been incorporated  into Article 2, 
3 and 4 of the amended proposal. 

Article 6 incorporates amendment  55.  It corresponds to the former  Article 9. 

It should  be noted  that the word  "publication" bus not been  included  in paragraph  1. The 
paragraph is thus consistent with Article 27(2) of the TRIPs Agreement. 

Paragraph  2(bb)  of  the  amendment  is  not  incorporated  as  such  into  Article  6.  See  the 
explanation given regarding  the new recital 24a. 

Article 7 incorporates  amendment  78.  As the Commission  announced  during the plenary 
debate,  it considers  that,  in  the  context  of the  request  for  proposals  to  be  formulated  on 
the composition  and terms of reference  of an ethics committee before  the Directive enters 
into  force,  its Group of Advisers on the  Ethical  Implications  of Biotechnology  should  be 
In  so  doing,  the  Commission  will  take  account  of  Parliaments 
made  competent. 
Resolution  B4-0484/97  of  13 June  1997  on  the  terms  of  reference  of  the  Group  of 
Advisers on the Ethical Implications of Biotechnology. 

Article 8(1) is unchanged.  It corresponds to the former  Article  10. 

Article 8(2) incorporates amendment 57. 

It  corresponds  to  the  former  Article  11. 
Article  9  is  inspired  by  amendment  58. 
However,  the  reference  in  this  amendment  to  Article  2a(l)  (i.e.  Article  4(1)  of  the 
amended  proposal)  is technically  and  legally  incomprehensible  in the  light  of Article  11 
of  the  proposal,  which  introduces  a  derogation  for  farmers,  and  Article  12,  which 
provides  for  a  system  of  compulsory  cross-licensing  where  a  patent  dominates  a  plant 
variety. 
It  would  therefore  not  be  appropriate  to  include  this  reference  because,  in 
practice, this would  limit the scope of protection conferred  by a patent in such a way as to 
go against current practice under patent law. 

Article  10 is unchanged.  It corresponds to the former  Article  12. 

Article  11 incorporates amendment  59.  It corresponds to the former  Article  13. 

It should be noted that amendment 95, which aimed to amend paragraph 2 of this Article, 
gives rise to  a number  of practical  difficulties.  The reference  to Article  14(1) and  (3) of 
Regulation  No  2100/94  is  incomplete.  Those  two  paragraphs  cannot  function  without 
paragraph  2  because  it  that  would  render  meaningless  the  idea  that  the  derogation 
provided  for  in  Article  11  is  in  accordance  with  the  provisions  on  plant  varieties. 
Moreover, farmers  might be confronted  with different  legal situations.  This would not be 
desirable. 

The  final  sentence  of  amendment  95  repeats  the  final  sentence  of  amendment  59. 
However,  this  applies  to plants what  is  specifically  laid down  for  animals, which  would 
not be appropriate. 

Article  12(1) and  (2) remain unchanged.  They correspond to the former  Article  14. 

Article  12(3)(b)  incorporates  amendment  60, in  accordance  with  Article  31(l)(i)  of  the 
TRIPs Agreement. 

Article  12(4) incorporates amendment 61. 

Article  13 is unchanged.  It corresponds to the former  Article  Î5. 

Article  14 is unchanged.  It corresponds to the former  Article  16. 

Article  17 of the initial proposal  is deleted in accordance with amendment 62. 

Article 15(1) incorporates amendment 63.  It corresponds to the former  Article  18. 

Article  16 is new.  It corresponds to amendment 64. 

Articles 17 and 18 are unchanged.  They correspond to the former Articles  19 and 20 
respectively. 

Amended proposal for a 
EUROPEAN  PARLIAMENT AND COUNCIL  DIRECTIVE 
on the legal protection of biotcchnological  inventions 
THE EUROPEAN  PARLIAMENT AND THE COUNCIL OF THE  EUROPEAN 
UNION, 

Initial  proposal 

Amended  proposal 

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

Having  regard  to  the  proposal  from  the  Unchanged 
Commission,1 

Having  regard 
Economic and Social Committee,2 

to  the  Opinion  of  the  Unchanged 

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

(1) 

Unchanged 

(2) 

Unchanged 

arc 

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

importance 

for 

of 

research 

(2)  Whereas  the  investments  required 
in 
development, 
and 
particularly  for  genetic  engineering, 
are  especially  high  and  especially 
of 
risky 
recouping  that  investment  can  only 
be  guaranteed  effectively 
through 
adequate legal protection; 

possibility 

and 

the 

and 
(3)  Whereas  without  effective 
throughout 
harmonised  protection 
such 
Member States 
the 
investments  might  well  not  be 
made; 

(3) 

1  OJ No C 296, 8.10.1996, p. 4. 
2  OJ No C 295, 7.10.1996, p. 11. 
3  European  Parliament Opinion of 

Whereas  effective  and  harmonised 
protection  throughout  the  Member 
to 
States 
maintain  and  encourage  investment 
in the field  of biotechnology; 

is  essential 

in  order 

Initial  proposal 

Amended  proposal 

(4)  Whereas  following 

a 

for 

the  European 
Parliament's  rejection  of  the  joint 
text,  approved  by  the  Conciliation 
Committee, 
European 
Parliament  and  Council  Directive 
of 
legal 
the 
on 
the 
biotechnological 
European Parliament 
the 
Council  have  determined  that  the 
legal  protection  of  biotechnological 
inventions  cannot  be 
left  as  it 
currently stands; 

protection 
inventions,1 

and 

(4.) 

a 

for 

Whereas  following 
the  European 
Parliament's  rejection  of  the  joint 
text,  approved  by  the  Conciliation 
Committee, 
European 
Parliament and  Council  Directive on 
of 
the 
the 
biotechnological 
European 
the 
Parliament 
Council  have  determined  that  the 
legal  protection  of  biotechnological 
inventions requires clarification: 

protection 
inventions, 
and 

Êegai 

(5) 

Unchanged 

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

(6) 

Unchanged 

(7) 

Unchanged 

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

legislation 

different 

(7)  Whereas 

the 

legal 

protection 

uncoordinated 
development  of  national  laws  on 
the 
of 
biotechnological  inventions  in  the 
the 
Community  could  result 
creation  of  new  disincentives  to 
trade, 
the 
industrial  development  of  such 
smooth 
inventions  and  of 
operation of the internal market; 

the  detriment  of 

the 

in 

to 

OJ No C 68, 20.3.1995, p. 26. 

Initial  proposal 

Amended  proposal 

(8)  Whereas  the  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 
of 
biotechnological 
inventions; 
whereas,  however,  they  must  be 
in  certain 
adapted  or  added 
specific  respects  in  order  to  take 
full 
technological 
of 
developments  involving  biological 
material  which  also 
the 
fulfil 
requirements for patentability; 

protection 

account 

legal 

to 

(8) 

Unchanged 

the 
in  such  cases  as 
(8a)  Whereas 
exclusion 
from  patentability  of 
plant  and  animal  varieties  and  of 
essentially  biological  processes  for 
and 
the  production  of  plants 
concepts 
certain 
animals, 
in 
upon 
national 
based 
laws 
plant 
patent 
international 
variety  conventions  have  created 
uncertainty  regarding  the  protection 
of  biotechnological  and  certain 
inventions; 
microbiological 
whereas harmonisation  is  necessary 
to clarify  the said  uncertainty; 

and 

Initial  proposai 

Amended  proposal 

in 

national 

concepts 

(9)  Whereas  harmonisation  of  the  laws 
of the Member States is necessary to  clarify 
laws 
certain 
originating  in  certain  international  patent 
and  plant  variety  conventions  which  have 
led to some uncertainty  as to the possibility 
of  protecting  biotechnological  inventions 
concerning  plant  matter 
certain 
microbiological  inventions,  concepts  such 
as the  exclusion  from  patentability  of plant 
and  animal  varieties  and  of  essentially 
biological  processes  for  the  production  of 
plants and animals; 

and 

(9) 

Deleted 

(9a) 

and 
of 

Having  regard  to  the  potential  of 
the  development  of  biotechnology 
environment 
for 
in 
the 
this 
utility 
the 
particular 
technology  for  the  development  of 
methods  of  cultivation  which  are 
less polluting  and  more  economical 
in  their  use  of  land;  whereas  the 
patent  system  should  be  used  to 
encourage  research  into,  and  the 
application of,  such procedures; 

10 

Initial proposal 

Amended  proposal 

(9b)  Having  regard  to  the  importance  of 
the  development  of  biotechnology 
to developing  countries, both  in  the 
field  of health  and combating  major 
epidemics  and  endemic  diseases 
and  in  that  of  combating  hunger  in 
the  patent 
the  world;  whereas 
system  should  likewise  be  used  to 
encourage  research  in  these  fields; 
whereas 
international  procedures 
such 
the  dissemination  of 
for 
technology  in  the  Third  World  and 
to  the  benefit  of  the  population 
be 
groups 
promoted; 

concerned 

should 

(9c)  Whereas 

the  TRIPs  Agreement 
signed by the European  Community 
and  the  Member  States  has  entered 
into  force  and  provides  that  patent 
protection  shall  be  guaranteed  for 
products  and  processes  in  all  areas 
of technology; 

11 

Initial proposal 

Amended  proposal 

(10)  Whereas 

to 

the  Community's 

legal 
framework 
for  the  protection  of 
biotechnological  inventions  can  be 
laying  down  certain 
limited 
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  -  and  can  be  further 
limited  to  defining  the  scope  of  the 
protection accorded by a patent on a 
biotechnological  invention,  to  the 
right to use a deposit  mechanism  in 
addition to written descriptions, to a 
reversal  of  the  burden  of  proof  and 
to 
obtaining 
non-exclusive  compulsory  licences 
interdependence 
in 
between 
and 
varieties 
inventions; 

respect  of 
plant 

option 

the 

of 

the 

that 

from 

authorise 

exploiting 

(11)  Whereas a patent for  invention  does 
holder 
to 
not 
implement 
invention,  but 
merely entitles him to prohibit  third 
parties 
for 
it 
industrial 
commercial 
and 
purposes;  whereas,  consequently, 
substantive  patent  law  cannot  serve 
to  call  into  question  national  and 
Community  law  on  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; 

(10)  Unchanged 

the 

that 

from 

authorise 

exploiting 

(11)  Whereas a patent for  invention  does 
to 
holder 
not 
implement 
invention,  but 
merely  entities him to prohibit  third 
it 
parties 
for 
industrial 
commercial 
and 
puiposes;  whereas,  consequently, 
substantive  patent  law cannot  serve 
to  replace  or  render  superfluous 
nationals 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,  animal  welfare,  the 
preservation  of  genetic  diversity 
and compliance  with  certain  ethical 
standards; 

12 

(12) 

(13) 

(14) 

Initial proposal 

Amended proposal 

(12) 

Unchanged 

no 

Whereas 
exclusion  exists 
European  patent 
Convention)  which 
a priori 
biological  matter; 

prohibition 
or 
in  national  or 
(Munich 
precludes 
of 

patentability 

law 

the 

(13) 

Whereas  it  should  be  specified  that 
knowledge  relating  to  the  human 
body  and  to  its  elements  in  their 
natural  state  falls  within  the  realm 
of scientific  discovery  and may not, 
therefore,  be  regarded  as  patentable 
inventions; whereas  it follows  from 
this  that  substantive  patent  law  is 
not  capable of prejudicing  the basic 
ethical  principle 
all 
ownership of human beings; 

excluding 

or 

dignity 

fundamental 

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

the 

body, 

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

aimed 
similar 

isolating 

and 

the 

body, 

Whereas  significant  progress  in  the 
treatment  of  diseases  has  already 
to  medicinal 
thanks 
been  made 
products  derived  or  otherwise 
isolated 
produced  from  elements 
from 
and 
human 
medicinal  products resulting  from  a 
at 
process 
technical 
obtaining 
in 
elements 
structure  to  those  existing  naturally 
in  the  human  body  and  whereas, 
consequently, 
the  patent  system 
should  promote  research  aimed  at 
obtaining such elements; 

aimed 
similar 

(14) 

13 

Initial proposal 

Amended  proposal 

(14a)  Whereas,  since  the  patent  system 
provides  insufficient  incentive  for 
and 
research 
financing 
into 
biotechnological 
production 
of 
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; 

(14b)  Having  regard  to  Opinion  No  8 by 
the 
of 
the  European 

the  Group  of  Advisers  on 
Ethical 
Biotechnology 
Commission; 

Implications 

to 

(15)  Whereas,  therefore, 

is  capable  of 

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 
industrial 
application,  is  not  excluded  from 
patentability, 
the 
structure of that element  is identical 
to  that  of  a  natural  element,  while 
the rights conferred  by the patent do 
not  extend  to  the  human  body  and 
their  natural 
in 
elements 
its 
environment; 

even  where 

that  an 

it  should  be 
(15)  Whereas,  therefore, 
invention 
made  clear 
capable  of 
industrial  application 
and  based  on  an  element  isolated 
from  the  human  body  or  otherwise 
produced  by  means  of  a  technical 
process  is  patentable,  even  where 
the  structure  of  that  element  is 
that  of  a  natural 
identical 
element,  since  no  patent  may  be 
interpreted  as  covering  an  element 
of  the  human  body  in  its  natural 
environment 
the  basic 
forming 
subject of the invention. 

to 

14 

Initial proposal 

Amended  proposal 

(16) 

(16)  Whereas  such  an  element  isolated 
from  the human  body  or  otherwise 
produced  may  not  be  regarded  as 
unpatentable  in the same way as an 
element  of  the  human  body  in  its 
natural  state, that is to say, may not. 
be  equated  with  a  discovery,  since 
the  element  isolated  is the result of 
the 
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; 

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

incapable 

(16a) 

(16b) 

(16c) 

the  discussion  on  the 
Whereas 
patentability  of sequences or partial 
sequences of genes is controversial; 
whereas, 
this 
according 
Directive,  the  granting  of  a  patent 
for  inventions  which  concern  such 
sequences  or  partial 
sequences 
require  the  same  criteria  to  be 
applied  as  in  all  other  areas  of 
technology; 

to 

Whereas  a  mere  sequence  of DNA 
segments  without  indication  of  a 
biological  function  does not contain 
a technical teaching and is therefore 
not a patentable invention; 

Whereas  a  sequence  or  partial 
sequence  can  be  the  subject  of  a 
patentable  invention  when  all  the 
necessary  conditions  for  a  patent 
are  satisfied:  novelty, 
level  of 
invention and industrial  application; 

15 

Initial proposal 

Amended proposal 

to 

for 

the  criterion  of 
(16d)  Whereas 
industrial 
be 
application 
complied with, the genetic sequence 
or partial sequence and thus also the 
protein  for  which  a  DNA  sequence 
codes  must  be determined;  whereas 
for  sequences  which  overlap,  each 
sequence  will  be  considered  as  an 
independent  sequence  in patent  law 
terms; 

(16e)  Whereas 

of 

the 

the 

requirements 

for 
disclosure 
industrial 
application  of  the  sequences  or 
partial  sequences do not differ  from 
those  in  other  areas  of  technology; 
industrial 
whereas  at 
application  must 
actually 
disclosed in the patent  application; 

least  an 
be 

(16f)  Whereas  the  free  and 

informed 
consent  of  the  person  from  whose 
body material is taken is required  in 
order  for  an application  to be  made 
for  a patent  in respect  of the  use  of 
that material; 

(16g)  Whereas  this  Directive  in  no  way 
affects  the  basis  of  current  patent 
law,  according  to  which  a  patent 
may  be  granted 
for  any  new 
application of a patented product; 

16 

Initial proposal 

Amended  proposal 

(17)  Whereas,  in  order  to  determine  the 
extent  to  which  piant  and  animr.1 
varieties  are  to  be  excluded  from 
patentability,  it  should  be  specified 
those 
the  exclusion  concerns 
that 
varieties 
that, 
and 
consequently, it does not prejudice the 
patentability  of  plants  or  animals 
obtained  by  means  of  a  process  at 
least  one  stage  of which  is  essentially 
microbiological,  irrespective  of  the 
basic biological material to which that 
process is applied; 

such 

as 

(17)  Whereas 

this  Directive  shall  be 
without  prejudice  to  the  exclusion 
of  plant  and  animal  varieties  from 
patentability;  whereas  on  the  other 
hand 
inventions  which  concern 
plants  or  animals  are  in  general 
ppovided 
the 
patentable 
application  of  the  invention  is  not 
technically  confined 
to  a  single 
plant or animal variety; 

that 

(17a)  Whereas  the  concept  'plant  variety' 
is  defined  by  the  law  protecting 
new  varieties,  pursuant  to  which  a 
variety  is  defined  by 
its  whole 
genome  and 
therefore  possesses 
individuality;  whereas  it  is  clearly 
distinguishable from  other varieties; 

(17b)  Whereas  a  plant  totality  which  is 
characterised  by  a  particular  gene 
(and  not  its  whole  genome)  is  not 
covered  by  the  protection  of  new 
therefore  not 
is 
varieties  and 
excluded  from  patentability  even  if 
it comprises plant varieties; 

17 

Initial proposa! 

Amended  proposal 

(17c) 

in 

only 

shall 

Whereas,  however,  if  an  invention 
consists 
genetically 
modifying  a particular plant variety, 
it 
from 
if  the  genetic 
patentability  even 
is  the  result  not  of 
modification 
genetic 
a 
breeding 
engineering procedure; 

excluded 

but 

be 

of 

(18) 

for 

the 
Whereas  a  procedure 
breeding  of  plants  and  animals  is 
essentially  biological  if  it  is  based 
on  crossing  whole  genomes  (with 
subsequent  selection  and  perhaps 
further  crossing of whole genomes); 

(19)  Whereas  this  Directive  shall  be 
without  prejudice  to  concepts  of 
invention 
as 
developed  by  national,  European  or 
international patent laws; 

discovery, 

and 

(18)  Whereas, 

to 

for 

patent 

the  purposes 

of 
is 
it 
determining  whether  or  not 
essentially 
possible 
biological  processes 
for  obtaining 
plants  or animals, human  intervention 
and the effects  of that  intervention  on 
the result  obtained  must  be taken  into 
account; 

(19)  Whereas  national  patent 

laws  for 
inventions contain provisions as to the 
criteria  for  allowing  or  excluding 
patentability,  including  provisions  to 
the  effect  that  a  patent  may  not  be 
granted 
inventions 
respect  of 
whose  publication  or  exploitation 
would  be  contrary  to public  policy  or 
morality; 

in 

(19a)  Whereas  this  Directive  shall  be 
without  prejudice  to  the  provisions 
of  national  patent 
law  whereby 
treatment 
surgical  or  therapeutic 
procedures  applicable  to the  human 
body  or  the  bodies  of  animals  and 
diagnostic  procedures  which  are 
carried  out  on  the  human  body  or 
the  bodies  of  animals  are  excluded 
from  patentability; 

18 

Initial proposal 

Amended  proposal 

(19b)  Whereas 

the  TRIPs  Agreement 
the  possibility 
that 
provides  for 
the  World  Trade 
members  of 
from 
Organisation  may  exclude 
inventions  whose 
patentability 
commercial 
exploitation  within 
their  territory  must  be  prevented  in 
order  to  protect  public  policy  or 
morality, 
to  protect 
human  or  animal  life  or  health,  to 
preserve plants or to prevent  serious 
harm  to  the  environment,  provided 
is  not 
that  such  an  exclusion 
because 
undertaken 
exploitation  is  prohibited  by  their 
legislation; 

including 

solely 

(19c)  Whereas  other  prohibitions  on 
exploitation  under  national  law  are 
exclude 
not 
to 
sufficient 
patentability;  whereas 
an 
such 
the 
that 
exclusion  presupposes 
the 
commercial  exploitation  of 
invention 
the 
in 
is  prohibited 
Member State in question; 

(20)  Whereas  such  a  reference  to  public 
policy 
should  be 
and  morality 
included  in  the  operative  part  of  this 
Directive in order to bring out the  fact 
that 
of 
biotechnological  inventions, by  virtue 
of  some  of  their  consequences  or 
effects,  are  capable  of  offending 
against them; 

applications 

some 

(20)  W7hereas 

the  principle  whereby 
inventions  must  be  excluded  from 
their 
patentability 
commercial 
offends 
against  public  policy  or  morality 
must  also  be  stressed 
this 
Directive; 

where 
exploitation 

in 

19 

Initial proposai 

Amended  proposal 

(21)  Deleted 

(21)  Whereas 

it  must  be  determined 
whether  applications  offend  against 
public  policy  and  morality  in  each 
specific  case,  by  means  of  an 
appraisal  of  the  values  involved, 
whereby  the  benefit  to  be  derived 
the  invention,  on  the  one 
from 
is  weighed  and  evaluated 
hand, 
against 
associated 
therewith,  and  any objections  based 
on  fundamental  principles  of  law, 
on the other hand; 

risks 

any 

list 

(22)  Whereas  the  operative  part  of  this 
Directive  should  also  include  an 
illustrative 
inventions 
excluded  from  patentability  so as to 
provide  national  courts  and  patent 
offices  with  a  general  guide  to 
inteqsreting  the  reference  to  public 
policy or morality; 

of 

of 

list 

(22)  Whereas  the  operative  part  of  this 
Directive  should  also  include  an 
illustrative 
inventions 
excluded  from  patentability  so as to 
provide  national  courts  and  patent 
offices  with  a  general  guide  to 
interpreting  the  reference  to  public 
policy  and  morality;  whereas  this 
list 
be 
exhaustive;  whereas  processes  the 
use  of  which  offend  against  human 
to 
dignity, 
produce chimeras from  a mixture of 
human  and  animal  genomes,  are 
also excluded  from  patentability; 

such  as  processes 

presume 

cannot 

to 

20 

Initial  proposal 

Amended  proposal 

Whereas  morality  represents 
the 
ethical or moral principles  generally 
in  a  Member State  or 
observed 
the 
scientific  or 
accepted  by 
professional 
concerned; 
circles 
whereas  it  is  particularly  important 
that these principles be respected  in 
the  field  of  biotechnology  in  view 
of the potential  scope  of  inventions 
in  this  field  and 
inherent 
living  matter; 
relationship 
whereas  such  ethical  or  moral 
principles  supplement  the  standard 
law 
of 
legal 
regardless  of  the  technical  field  of 
the invention; 

checks 

patent 

their 

to 

a 

is 

consensus 

Whereas  in  the  European  Union 
that 
there 
interventions  in  the  human  germ 
line  and  the  cloning  of  human 
beings offends  against public policy 
and morality; whereas it is therefore 
important  to  exclude  unequivocally 
from  patentability  methods 
for 
intervention  in  the  germ  line  of 
human  beings  and  processes  for 
cloning human beings; 

(23) 

(24) 

inventions 

(23)  Whereas  such  moral  considerations 
must  be  given  greater  weight  in 
appraising 
the  patentability  of 
inventions,  both 
biotechnological 
on  account  of  the  subject-matter  of 
this  branch  of  science,  namely 
living  matter,  and  because  of  the 
often  far-reaching  implications  of 
the 
to  be  examined; 
whereas 
these  considerations  do 
not,  however,  change  the  nature  of 
patent  law  as  a  primarily  technical 
body  of  law  and  are  no  substitute 
for  the  other  legal  checks  which 
biotechnological 
are 
required  to  undergo  from  the  start 
of 
the 
their  development  or  at 
marketing  stage,  particularly  with 
regard to  safety; 

inventions 

(24)  Whereas, in view of the importance 
and  the  controversial  nature  of  the 
unprecedented  questions  raised  by 
germ 
is 
important  to  exclude  unequivocally 
from  patentability  methods  of 
treatment of human beings based on 
it; 

line  gene 

therapy, 

it 

21 

Initial proposal 

Amended proposai 

is 

consensus 

(24a)  Whereas  in  the  European  Union 
there 
that 
a 
interventions  in  the  human  germ 
line  and 
the  cloning  of  human 
beings offends  against public policy 
and morality; whereas it is  therefore 
important  to  exclude  unequivocally 
from  patentability  methods 
for 
intervention  in  the  germ  line  of 
human  beings  and  processes  for 
cloning human beings; 

22 

Initial proposal 

Amended  proposal 

of 

the 

Freedoms 

application  of 

(24b)  Whereas  this  Directive  does  not 
affect 
the 
Convention  on  Human  Rights  and 
4 
Fundamental 
November  1950,  the  Convention 
for  the  protection  of  human  rights 
and the dignity of the human person 
with 
to  applications  of 
biology  and  medicine:  Convention 
on human rights and biomedicine of 
19  November  1996,  or  any  other 
international  instrument  concerning 
the  protection  of  human  rights  on 
the  Member  States  have 
which 
cooperated  or  to  which  they  have 
acceded; 

respect 

(25)  Whereas  processes  for  modifying 
the  genetic 
identity  of  animals 
which  are  likely  to  cause  them 
suffering  or  physical  handicaps 
without  any  substantial  benefit  to 
man  or  animal,  and  also  animals 
resulting  from  such  processes  must 
from  patentability 
be  excluded 
insofar  as  the  suffering  or  physical 
handicaps  inflicted  on  the  animals 
concerned  are  out  of  proportion  to 
the objective  pursued; 

(25)  Whereas  processes  for  modifying 
the  genetic 
identity  of  animals 
which  are  likely  to  cause  them 
suffering  without  any  substantial 
medical  (diagnostic  or  therapeutic) 
benefit  to  man  or  animal,  and  also 
animals 
such 
processes,  must  be  excluded  from 
patentability; 

resulting 

from 

23 

Initial  proposal 

Amended  proposal 

(26)  Unchanged 

(27)  Unchanged 

an 

exclusive 
and 

(26)  Whereas, in view of the fact that the 
function  of a patent  is to reward the 
inventor  for  his  creative  efforts  by 
but 
granting 
time-bound 
thereby 
right, 
encourage  inventive  activities,  the 
holder  of  the  patent  should  be 
entitled 
the  use  of 
patented  self-reproducible  material 
in  situations  analogous  to  those 
where  it  would  be  permitted  to 
prohibit  such  use  of  patented, 
non-self-reproducible 
products, 
namely  in respect  of the  production 
of the patented product itself; 

to  prohibit 

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

that 
authorise 

Regulation 

extent 

and 

the 

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

(28)  Unchanged 

OJNoL227,  1.9.1994, p. 1. 

24 

Initial proposal 

Amended  proposal 

Unchanged 

(29)  Whereas, however, the holder of the  (29) 
patent may defend  his rights against 
a  farmer  abusing  the  derogation  or 
the  breeder  who  has 
against 
variety 
developed 
plant 
incorporating 
protected 
invention  if the latter fails to adhere 
to his commitments; 

the 

the 

(30)  Whereas  a  second  derogation  from 
the rights of the holder of the patent 
must authorise the farmer  to use the 
protected 
for  breeding 
purposes  on his  own  farm,  in  order 
to replenish their numbers; 

livestock 

(30) 

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

(31 )  Unchanged 

(31)  Whereas 

of 

the 

and 

extent 
that 

the 
second 
conditions 
derogation  may  be  determined  by 
and 
national 
practices, 
no 
Community  legislation  on  animal 
variety  rights; 

regulations 
is 
there 

laws, 

since 

new 

plant 

access  must, 

Whereas, in the field of exploitation 
of 
characteristics 
resulting  from  genetic  engineering, 
guaranteed 
on 
payment  of  a  fee,  be  granted  in  the 
form  of  a  compulsory 
licence 
where,  in  relation  to  the  genus  or 
species  concerned, the plant  variety 
technical 
significant 
represents 
progress  of  considerable  economic 
interest  compared  to  the  invention 
claimed in the patent; 

(32) 

new 

plant 

access  must, 

(32)  Whereas, in the field of exploitation 
of 
characteristics 
resulting  from  genetic  engineering, 
guaranteed 
on 
payment  of  a  fee,  be  granted  in  a 
Member State  in  the  form  of  a 
compulsory 
in 
relation  to  the  genus  or  species 
concerned,  public  interest  demands 
the  exploitation  of the  plant  variety 
for  which  the  licence  is  requested 
and  the  plant  variety  represents 
significant  technical progress; 

licence  where, 

25 

Initial proposal 

Amended  proposal 

guaranteed 

(33)  Whereas,  in  the  field  of  the  use  of 
new  plant  characteristics  resulting 
from  new  plant  varieties  in  genetic 
engineering, 
access 
against  a fee  must be granted  in the 
form  of a compulsory  licence where 
the 
public 
exploitation  of  the  invention  for 
which  the  licence  is  requested  and 
represents 
invention 
where 
significant  technical progress, 

demands 

interest 

the 

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

guaranteed 

(34)  Whereas 

the  TRIPs  Agreement 
contains  detailed  provisions  on  the 
burden  of  proof  which  are  binding 
on  all  Member  States;  whereas, 
therefore,  a  provision 
this 
Directive is not necessary; 

in 

(35)  Whereas 

the  Commission  will 
investigate  whether,  in  the  field  of 
basic  genetic  engineering  research, 
scientific 
free  and  unimpeded 
exchanges  are  hampered  because 
publications  containing  information 
which  might  be  patentable  are 
delayed  or  not  undertaken,  as  a 
result  of  which  patentability  would 
be  excluded  because  of  the  lack  of 
novelty  on  the part  of  the  inventor; 
whereas the  Commission  will  carry 
out  a  comparison  with  the  patent 
law  of the  United  States  and  Japan 
in  this  respect  and  report  to  the 
European  Parliament 
the 
Council  two  years  after  the  entry 
into force of this Directive; 

and 

26 

Initial proposal 

Amended  proposal 

(36)  Whereas 

the  Commission  will 
report  [annually]  to  the  European 
Parliament  on  the  development  of 
field  of 
patent 
biotechnology 
genetic 
engineering; 

the 
and 

law 

in 

(37)  Whereas  the  rights  and  obligations 
of  the  Member  States  derived  from 
international 
agreements, 
particularly  further  to  the  Council 
Decision of 25 October  1993 on the 
conclusion  of  the  Convention  on 
Biological  Diversity,1  and  Articles 
3,  8(j),  16(2),  second  sentence,  and 
on 
16(5)  of 
Biological 
of 
5 June  1992, are not affected  by this 
Directive; 

the  Convention 
Diversity 

1  OJ No L 309,13.12.1993, p. 1. 

27 

Initial proposal 

Amended  proposal 

a 

the 

develop 

(38)  Whereas  the  Third  Conference  of 
the  Parties  of 
the  Biodiversity 
Convention  ,  which  took  place  in 
November  1996,  noted  in  Decision 
HI/17 that  'further  work  is  required 
to  help 
common 
relationship 
appreciation  of 
between  intellectual  property  rights 
and  the  relevant  provisions  of  the 
the 
TRIPs  Agreement 
and 
Convention 
Biological 
on 
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, 
of 
including 
knowledge, 
and 
practices  of  indigenous  and  local 
communities  embodying  traditional 
lifestyles 
the 
relevant 
conservation  and  sustainable  use  of 
biological  diversity'; 

protection 
innovations 

the 

for 

28 

Initial proposal 

Amended  proposal 

HAVE ADOPTED THIS DIRECTIVE:  HAVE ADOPTED THIS  DIRECTIVE: 

CHAPTER I 

Patentability 

Article 1 

shall 

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

law.  Member  States 

shall, 

CHAPTER  I 

Patentability 

Article 1 

1.  Unchanged 

2. This Directive shall be without  prejudice 
to  national  and  Community  laws  on  the 
monitoring  of  research  and  of  the  use  or 
commercialisation  of its results. 

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

Article 2 

Article 2 

For the purposes of this Directive, 

1. For the purposes of this Directive, 

Biological  material  means  any 
genetic 
containing 
material 
of 
information 
and 
self-reproduction 
being 
reproduced  in a biological  system; 

capable 
of 

or 

Microbiological process  means  any 
process 
involving  or  performed 
upon or resulting  in  microbiological 
material;  a  process  consisting  of  a 
succession  of  steps  shall  be  treated 
as  a  microbiological  process  if  at 
the 
least  one  essential  step  of 
process is microbiological; 

(a) 

(b) 

Biological  material  means  any 
genetic 
containing 
material 
and 
information 
of 
reproducing 
being 
itself 
reproduced in a biological  system; 

capable 
or 

Microbiological process  means  any 
process 
involving  or  performed 
upon or resulting  in  microbiological 
material. 

29 

Initial proposai 

Amended  proposa! 

Essentially  biological  process  for 
the production  of plants  or animals 
means  any  process  which,  taken  as 
a  whole,  exists  in  nature  or  is  not 
more  than  a  natural  plant-breeding 
or animal-breeding process. 

2. A procedure for the breeding of plants or 
animals  shall  be  defined  as  essentially 
biological  if  it  is  based  on  crossing  and 
selection. 

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

Article 3 

the  purposes  of 
are 

this  Directive, 
1. For 
imply 
novel, 
inventions  which 
inventive  activity  and  are  capable  of 
industrial  application  shall  be  patentable 
even if they concern a product consisting of 
or  containing  biological  material  or  a 
procedure  by  means  of  which  biological 
material is produced, processed or used. 

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

Article 4 

1. The following  shall not be patentable: 

(a) 

(b) 

plant and animal varieties, 

essentially biological  procedures  for 
the breeding of plants and animals. 

2. Inventions  which  concern  plants  or 
animals  may  be  patented  if  the  application 
of the  invention  is not technically  confined 
to a particular plant or animal variety. 

30 

Initial proposal 

Amended  proposal 

1(b) 

shall 

3. Paragraph 
be  without 
prejudice  to  the  patentability  of  inventions 
which  concern  a  microbiological  or  other 
technical  procedure  or  a  product  obtained 
by means of such a procedure. 

31 

Initial proposal 

Amended  proposal 

Article 3 

Article 5 

I. The  human  body  and  its  elements  in 
their  natural  state  shall  not  be  considered 
patentable inventions. 

invention  capable  of 

2. Notwithstanding  paragraph  1, the  subject 
of  an 
industrial 
application  which  relates  to  an  element 
isolated  from  the human  body  or  otherwise 
produced  by  means  of  a  technical  process 
shall  be patentable,  even  if the  structure  of 
that  element  is identical  to that of a natural 
element. 

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. 

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

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

Article 4 

Deleted 

1. The  subject  of  an  invention  shall  not  be 
considered  unpatentable  merely  on 
the 
grounds  that  it  is  composed  of,  uses,  or  is 
applied to biological material. 

2. Biological  material, including plants and 
animals,  as  well  as  elements  of  plants  and 
animals obtained by means of a process not 
essentially  biological,  except  plant  and 
animal  varieties 
shall  be 
as 
patentable. 

such, 

Article 5 

Deleted 

Microbiological  processes  and  products 
obtained  by means  of  such processes  shall 
be patentable. 

32 

Initial proposal 

Amended  proposal 

Article 6 

Deleted 

Essentially  biological  processes  for  the 
production of plants or animals shall not be 
patentable. 

Article  7 

Deleted 

Uses  of  plant  or  animal  varieties  and 
processes  for  their  production,  other  than 
the 
essentially  biological  processes  for 
production  of  plants  or  animals,  shall  be 
patentable. 

Article 8 

Deleted 

The  subject  of  an  invention  concerning  a 
biological  material  shall  not  be  considered 
a discovery  or lacking  in novelty  merely on 
the  grounds  that  it  already  formed  part  of 
the natural  world. 

Article 9 

Article 6 

be 

shall 

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

be 
their 

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

the  basis  of  paragraph  1, 

the 
2. On 
following  shall be considered  unpatentable: 

the  basis  of  paragraph  1, 

the 
2. On 
following  shall be considered  unpatentable: 

(a) 

methods 
involving germ line gene therapy; 

human 

treatment 

of 

(a) 

procedures  for  human  reproductive 
cloning; 

33 

Initial proposal 

Amended proposal 

(b)  processes  for  modifying  the  genetic 
identity  of animals which arc likely  to 
them  suffering  or  physical 
cause 
handicaps  without  any  substantial 
benefit  to  man  or  animal,  and  also 
such 
animals 
processes,  whenever  the  suffering  or 
physical  handicaps  inflicted  on  the 
animals 
are 
the  objective 
disproportionate 
pursued. 

concerned 

resulting 

from 

to 

(b) 

processes  for  modifying  the  germ 
line  genetic 
identity  of  human 
beings; 

(c) 

(d) 

methods  in  which  human  embryos 
are used; 

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  Group  of  Advisers  on 
the  Ethical  Implications  of  Biotechnology 
shall 
aspects  of 
assess 
biotechnology. 

ethical 

all 

34 

Initial  proposal 

CHAPTER II 

Scope of protection 

Article 10 

Amended proposal 

CHAPTER II 

Scope of protection 

Article 8 

1. Unchanged 

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 
that  biological  material 
derived 
through  multiplication  or propagation  in an 
identical  or  divergent  form  and  possessing 
those same characteristics. 

from 

produced 

possessing 

2. The protection conferred  by a patent on a 
process that enables a biological material to 
specific 
be 
characteristics  as  a  result  of  the  invention 
shall  extend  to  biological  material  directly 
obtained  using  that  process  and  to  any 
other  biological  material  derived  from  the 
biological  material 
obtained 
through multiplication  or propagation  in an 
identical  or  divergent  form  and  possessing 
those  same  characteristics.  That  protection 
shall  not  affect 
from 
patentability  of  plant  and  animal  varieties 
as such, pursuant to Article 4(2). 

the  exclusion 

directly 

produced 

possessing 

2. The protection conferred  by a patent on a 
process that enables a biological  material to 
specific 
be 
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 
biological  material 
obtained 
through multiplication  or propagation  in an 
identical  or  divergent  form  and  possessing 
those same characteristics. 

directly 

Article 11 

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  3(1),  in  which 
the  product  is  incorporated  and  in  which 
the  genetic  information  is  contained  and 
expressed. 

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  is  incorporated  and  in  which 
the  genetic  information  is  contained  and 
expressed. 

35 

Initial proposal 

Article 12 

Amended  proposal 

Article 10 

The  protection  referred  to  in  Articles  10 
and  11  shall  not  extend  to  biological 
material  obtained  from  the  multiplication 
or  propagation  of  biological  material 
marketed  in the territory of a Member State 
by  the  holder  of  the  patent  or  with  his 
consent, 
or 
propagation  necessarily  results  from  the 
application 
the  biological 
material  was  marketed,  provided  that  the 
obtained  material  is  not  subsequently  used 
for other multiplication or propagation. 

the  multiplication 

for  which 

if 

of 

from 

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

if 

Article 13 

Article 11 

1. By  way  of  derogation  from  Articles  10 
and  11, the  sale  of 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  reproduction  or 
propagation  by  him  on  his  own  farm,  the 
scope  of  and  procedure  for  this  derogation 
corresponding  to  those  under  Article  14 of 
Regulation (EC) No 2100/94. 

1. By  way  of  derogation  from  Articles  8 
and 9, the sale of 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  reproduction  or 
propagation  by  him  on  his  own  farm.,  the 
scope  of  and  procedure  for  this  derogation 
coiTesponding  to  those  under  Article 4  of 
Regulation (EC) No 2100/94. 

2. By  way  of  derogation  from  Articles  10 
and  11,  the  sale  of  breeding  stock  to  a 
farmer  by  the  holder  of  the  patent  or  with 
his  consent  implies  authorisation  for  the 
farmer  to  use  the  protected  livestock  for 
breeding  purposes  on  his  own  farm,  in 
order to replenish their numbers. 

2. By  way  of  derogation  from  Articles  8 
and  9,  the  sale  of  breeding  stock  or  other 
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  the  sate  for  the 
purposes  of  pursuing  agricultural  activities 
but not the sale within the framework, or for 
the  purpose  of  a  commercial  breeding 
activity. 

36 

Initial  proposal 

Amended proposal 

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

CHAPTER  III 

CHAPTER III 

Compulsory  cross-licensing 

Compulsory  cross-licensing 

Article 14 

Article 12 

1. Unchanged 

2.  Unchanged 

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 
to  payment  of  an 
protected, 
appropriate  royalty.  Member States  shall 
provide 
is 
granted,  the  holder  of  the  patent  will  be 
entitled  to  a  cross-licence  on  reasonable 
terms to use the protected  variety. 

that  where  such  a 

licence 

subject 

2. Where  the  holder  of  a  patent  on  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 
royalty. 
Member States  shall  provide  that  where 
such  a licence  is granted,  the  holder  of the 
variety 
to  a 
right  will  be  entitled 
cross-licence  on  reasonable  terms  to  use 
the protected  invention. 

appropriate 

an 

37 

Initial  proposal 

Amended  proposal 

3. Applicants  for  the  licences  referred  to in 
paragraphs 
above  must 
demonstrate that: 

and 

2 

1 

(a) 

(b) 

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

exploitation  of  the  plant  variety  or 
the  invention  for  which  the  licence 
is  requested 
the 
public  interest  and  the plant  variety 
constitutes 
invention 
or 
significant  technical progress. 

is  dictated  by 

the 

4. Each  Member State  shall  designate  the 
authority  or  authorities  responsible  for 
granting  the  licence.  The  licence  shall  be 
granted  principally  for  the  supply  of  the 
the  Member State 
domestic  market  of 
which has granted the licence. 

3.  Unchanged 

(a) Unchanged 

(b) 

the  plant  variety  or  the  invention 
constitutes 
technical 
significant 
progress  of  considerable  economic 
interest. 

4. Each  Member State  shall  designate  the 
authority  or  authorities  responsible 
for 
granting the licence. 

CHAPTER IV 

CHAPTER IV 

Deposit, access and re-deposit of a 
biological  material 

Deposit, access and re-deposit of a 
biological  material 

Article 15 

Article 13 

1. Unchanged 

1. Where  an  invention  involves  the  use  of 
or  concerns  a  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: 

38 

Initial  proposal 

Amended  proposal 

international 

(a)  the  biological  material  has  been 
deposited,  no  later  than  the  date 
on  which  the  patent  application 
was  filed,  with  a  recognised 
institution.  At  least 
depositary 
the 
depositary 
authorities  which  acquired  this 
status  by  virtue  of  Article 7  of 
of 
the 
2SAprill977 
the 
International  Recognition  of  the 
deposit  of  micro-organisms  for 
the purposes  of patent procedure, 
the 
hereinafter 
referred 
shall  be 
"Budapest  Treaty", 
recognised; 

Treaty 
on 

Budapest 

to  as 

(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 
depository 
the  accession 

name 
institution  and 
number. 

the 

of 

to  the  deposited  biological  2. Unchanged 

2.  Access 
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 
anyone 
requesting  it  or,  if  the  applicant 
so 
an 
requests, 
independent expert; 

patent, 

only 

the 

to 

to 

(c)  after  the patent  has been  granted, 
and  notwithstanding  revocation 
or  cancellation  of  the  patent,  to 
anyone requesting it. 

39 

Initia! proposal 

Amended  proposal 

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

3. Unchanged 

(a)  not  to  make  it  or  any  matter 
derived  from  it  available  to  third 
parties and 

(b)  not  to  use 
from 
derived 
experimental  purposes, 

it  or  any  matter 
for 
it  except 

the 

unless 
or 
patent 
applicant,  as  applicable,  expressly 
waives such an undertaking. 

holder 

4. At  the  applicant's  request,  where  an  4. Unchanged 
application  is refused  or withdrawn,  access 
to the deposited  material  shall be limited to 
an  independent  expert  for  twenty  years 
the  patent 
from 
application  was 
that  case, 
paragraph 3 shall apply. 

the  date  on  which 
In 

filed. 

5. The  applicant's  requests  referred  to  in  5. Unchanged 
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 16 

Article 14 

1. If  the  biological  material  deposited  in  1. Unchanged 
accordance  with  Article  15  ceases  to  be 
available  from  the  recognised  depositary 
institutions,  a  new  deposit  of  the  material 
shall  be  permitted  on  the  same  terms  as 
those laid down in the Budapest Treaty. 

40 

Initial  proposal 

Amended  proposal 

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

the  newly 

that 

Unchanged 

CHAPTER V 

Deleted 

Burden of proof 

Article 17 

l.If  the  subject-matter  of  a  patent  is  a 
process  for  obtaining  a  new  product,  then, 
when the  same product  is produced  by  any 
other party, it shall, in the absence of proof 
to  the  contrary,  be  deemed  to  have  been 
obtained by the patented process. 

2. In the adduction  of proof to the contrary, 
the  legitimate  interests  of  the  defendant  in 
protecting  his  manufacturing  and  business 
secrets shall be taken into account. 

CHAPTER VI 

Final  provisions 

Article 18 

CHAPTER VI 

Final provisions 

Article 15 

and 

regulations 

1. Member  States  shall  bring  into  force  the 
laws, 
administrative 
provisions  necessary  to  comply  with  this 
Directive  not  later  than  1  January 2000. 
They 
the 
immediately 
shall 
Commission thereof 

inform 

and 

regulations 

1. Member States  shall  bring  into  force  the 
laws, 
administrative 
provisions  necessary  to  comply  with  this 
Directive  not  later  than  1  January  1999. 
They 
the 
immediately 
shall 
Commission thereof. 

inform 

41 

Initial proposal 

Amended  proposal 

Unchanged 

adopt 

When  Member States 
these 
measures, these shall contain a reference  to 
this  Directive  or  shall  be  accompanied  by 
such  reference  at  the  time  of  their  official 
The  procedure  for  such 
publication. 
by 
reference 
Member States. 

adopted 

shall 

be 

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

text  of 

the 

Article 16 

a 

report  on 

the  Commission 

Every  five  years  after  the  transposition  of 
shall 
this  Directive 
publish 
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  or on which they have  cooperated. 
The  report  shall  be  forwarded  to  European 
Parliament and the Council. 

Article 19 

Article 17 

This  Directive  shall  enter  into force  on the  Unchanged 
20th day following that of its publication in 
the  Official 
the  European 
Journal  of 
Communities. 

Article 20 

Article 18 

This  Directive 
Member States. 

is  addressed 

to 

the  Unchanged 

42 

ISSN 0254-1475 

COM(97) 446 final 

DOCUMENTS 

EN 

05  06  08  15 

Catalogue  number  :  CB-CO-97-455-EN-C 

ISBN  92-78-24376-0 

Office  for Official  Publications of the European  Communities 

L-2985  Luxembourg 

43