Report from the Commission to the European Parliament and Council - an assessment of the implications for basic genetic engineering research of failure to publish, or late publication of, papers on subjects which could be patentable as required under Article 16(b) of Directive 98/44/EC on the legal protection of biotechnological inventions [SEC(2002) 50]
Date: 2002-01-14
Institutions: European Commission
Subjects: World Intellectual Property Organisation, biotechnology, dissemination of information, genetic engineering, intellectual property, patent, scientific press

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 14.01.2002
COM(2002) 2 final

REPORT FROM THE COMMISSION
TO THE EUROPEAN PARLIAMENT AND COUNCIL

An assessment of the implications for basic genetic engineering research of failure to
publish, or late publication of, papers on subjects which could be patentable as required
under Article 16(b) of Directive 98/44/EC on the legal protection of biotechnological
inventions

[SEC(2002) 50]

REPORT FROM THE COMMISSION
TO THE EUROPEAN PARLIAMENT AND COUNCIL

An assessment of the implications for basic genetic engineering research of failure to
publish, or late publication of, papers on subjects which could be patentable as required
under Article 16(b) of Directive 98/44/EC on the legal protection of biotechnological
inventions

(Text with EEA relevance)

TABLE OF CONTENTS

EXECUTIVE SUMMARY........................................................................................................ 4

INTRODUCTION...................................................................................................................... 6

1.

1.1.

1.2.

1.3.

2.

2.1.

2.2.

2.3.

2.4.

2.5.

3.

3.1.

3.2.

Biotechnology and genomics ....................................................................................... 6

Biotechnology and genomics – a frontier technology of the third millennium ........... 6

Advancing the knowledge base and competitiveness of industry................................ 7

The development of basic genetic engineering research: Patenting and scientific
publication statistics..................................................................................................... 7

The role of scientific publications and patents............................................................. 8

Different strategies to manage intellectual property: publish – patent - keep secret ... 8

Protection of creative inventions and dissemination of knowledge – the two
objectives of the patent system .................................................................................... 9

The role of patents for commercialisation of publicly funded research....................... 9

Possible conflicts between “publishing” and “patenting” strategies.......................... 10

Does patenting delay scientific publication? ............................................................. 10

patenting and delay of scientific publications – results of a survey........................... 11

Questionnaire survey – target audience and response................................................ 11

Statistical analysis of survey responses...................................................................... 12

3.2.1. Delay of publication on subjects that could be patentable......................................... 12

3.2.2. Measures to avoid delays ........................................................................................... 12

3.2.3. Additional results ....................................................................................................... 14

3.2.4.

Summary of comments provided by the respondents ................................................ 15

2

4.

Measures to avoid publication delays ........................................................................ 15

4.1.

The grace period......................................................................................................... 15

4.1.1.

Possible benefits and drawbacks of the grace period – Results of an EC hearing..... 15

4.1.2.

Expert opinions for and against a grace period.......................................................... 16

4.1.3.

The work undertaken under the auspices of WIPO (World Intellectual Property
Organisation).............................................................................................................. 19

4.2.

4.3.

4.4.

5.

The provisional patent application............................................................................. 19

Support and awareness activities, in particular for public researchers ...................... 20

Legal framework, regulations and other policies related to intellectual property rights20

Summary and conclusions ......................................................................................... 21

3

EXECUTIVE SUMMARY

This report is requested in accordance with Article 16b of Directive 98/44/EC on “The legal
protection  of  biotechnological  inventions”,  which  requires  the  Commission  to  produce
“within two years of entry into force of this Directive, a report assessing the implications for
basic  genetic  engineering  research  of  failure  to  publish,  or  late  publication  of,  papers  on
subjects which could be patentable”.

The Stockholm Council has identified biotechnology, and in particular genetic engineering, as
a new frontier technology. In the last decade, the number of publications in the biotechnology
sector  in  the  OECD  countries  has  more  than  doubled.  In  the  same  period,  the  number  of
patents filed in the biotechnology sector at the United States Patent and Trademark Office and
the European Patent Office on average increased by 13-15% p.a., compared to overall annual
growth rates of only 5%.

Research institutes, universities and small biotech companies, which are major contributors to
innovation in the life sciences, may wish to file patent applications but at the same time they
will  want  to  disclose  as  quickly  as  possible  the  results  of  their  research  to  the  scientific
community  and/or  investors.  The  conflict  between  these  “protection”  and  “publication”
strategies  may  lead  to  a  delay  in  publication  of  scientific  results  and  hinder  the  rapid
dissemination of scientific knowledge, thereby slowing down scientific progress. On the other
hand, the patent system ensures the publication of results that might otherwise have been kept
secret.

A  survey  has  been  performed  among  public  and  private  researchers  and  institutions  in
industry  and  public  research,  as  well  as  those  involved  in  intellectual  property  rights  issues
(e.g.,  patent  agents)  to  investigate  the  issue  of  publication  delay.  The  major  results  of  this
survey are:

(cid:1)  Only  a  very  small  fraction  of  researchers  and  organisations  actually  experience  a
considerable  delay  in  publication  of  research  results  that  are  the  subject  of  a  patent
application, and this fraction  is  lowest for  the  most  experienced  users  (10%)  and  highest
for the less experienced users of the patent system (40%).

(cid:1)  The  public  research  sector  strongly  favours  the  introduction  of  a  grace  period  and  large
industry strongly opposes it, with both positions being present in small and medium sized
enterprises. There is no clear position among patent agents, which reflects the varied nature
of their customers.

(cid:1)  The  possibility  of  filing  a  provisional  patent  application  also  ranks  high  in  importance,
both  with  industry  and  academia,  while  understandably  it  is  of  low  priority  for  patent
agents. Researchers from academia consider support for patent filing as an important issue,
while industry and patent agents consider awareness activities to be of some importance.

The survey confirms the positions of academia and industry towards the possible introduction
of a grace period which were brought forward at the hearing on the grace period organised by
the European Commission in October 1998 and the expert opinions recently published on the
web-site of the European Patent Office (EPO).

Despite  a  number  of  studies,  no  precise  figures  are  available  which  quantify  the  economic
effects  for  industry  or  which  assess  the  value  in  practical  terms  for  academia  of  the

4

introduction of a grace period. Throughout the member states of WIPO, different concepts of
a “grace period” have been developed (e.g., in US, JP), which should be investigated in detail
concerning  the  balance  they  provide  between  the  interests  of  the  academic  sector  and  of
industry.  The  US  concept  of  a  “grace  period”  together  with  the  “first-to-invent”  system  is
considered to  provide  the  highest  level  of  “legal  uncertainty”  and  should  not  serve  as  “best
practice” example. In view of the increasing internationalisation of research both of the public
and private sector  and  their  importance  for  innovation,  and  the  fact  that  the  public  research
sector has become a more experienced and major user of the patent system, efforts to define
and harmonise the concept of the ‘grace period’ should be considered. However, this concept
will only work at a global level if it provides ‘legal certainty’, which is the major concern of
the industrial users of the patent system. This should be taken  into account by  the  Standing
Committee on Patent Law (SCP) of WIPO during the current discussions taking place on the
possible introduction of a grace period.

Framework  conditions  should  be  further  optimised  to  ease  the  use  of  the  patent  system  by
academics and small and medium sized enterprises. These should include, among others:

(cid:1)  The  introduction  of  a  provisional  patent  application  in  all  member  states  in  line  with

Article 5 of the Patent Law Treaty, adopted in Geneva on June 2, 2000.

(cid:1)  Support and advice for academic and SMEs in the proper use of the patent system and the
strategic use of intellectual property rights as well as teaching and training on these issues.

(cid:1)  A  simple  and  cost-effective  patent  system,  as  will  be  provided  through  the  proposed

Community Patent.

5

INTRODUCTION

Directive  98/44/EC  on  “The  legal  protection  of  biotechnological  inventions”1  has  been
adopted  by  the  European  Parliament  and  the  Council  on  6  July  1998.  Article  16b  of  this
directive  requires  the  Commission  to  produce  “within  two  years  of  entry  into  force  of  this
Directive,  a  report  assessing  the  implications  for  basic  genetic  engineering  research  of
failure to publish, or late publication of, papers on subjects which could be patentable”.

This report has been prepared jointly by the Internal Market Directorate General (DG Internal
Market) and the Research Directorate General (DG Research) of the European Commission in
full consultation with other relevant Commission services.

The objective of this report is to investigate:

(cid:1)  Is there any  delay  in scientific  publication in  the area of  genetic  engineering research  on

subjects that could be patentable?

(cid:1)  What  are  the  possible  implications  of  this  delay,  if  significant,  for  basic  genetic

engineering research?

(cid:1)  What  are  the  possible  measures  to  remedy  negative  implications,  if  significant,  in

particular policy initiatives at Community or Member State level?

Biotechnology,  and  in  particular  genomics,  is  considered  to  be  a  frontier  technology  of  the
knowledge-based society, with a huge potential for health, food and  environment. Section 1
provides data on the increasing number of patent applications and publications in the EU, and
compares  it  to  US  figures.  Section  2  reviews  the  general  role  of  patenting  and  scientific
publications for research and innovation. Section 3 provides results of a questionnaire survey
on  the  question  of  patenting  and  publication  delay  carried  out  among  EU  scientists  and
organisations from industry and academia working in basic genetic engineering research and
amongst a number of industrial, private and academic organisations involved in patenting the
results of such research. Section 4 summarises the current discussions on the possible benefits
and drawbacks of a grace period and discusses other alternatives and possible policy measures
to  avoid  and/or  minimise  any  delays  in  the  publication  of  scientific  papers  which  contain
research results that could be the subject of patent applications.

1. 

BIOTECHNOLOGY AND GENOMICS

1.1. 

Biotechnology and genomics – a frontier technology of the third millennium

Recent decades have seen fundamental advances in the human understanding of the biology,
molecular  structure,  genetic  basis  and  ecology  of  all  living  entities.  The  new  life  sciences
knowledge  has  stimulated  a  series  of 
innovations,  broadly  described  as
biotechnology, which includes such techniques as genetic engineering, cloning, bio-catalysis,
genetic testing, gene therapy and monoclonal antibodies. These techniques may be applied to
many  of  the  challenges  faced  by  the  health,  food  and  environmental  sectors.  Examples

technical 

1

OJ L213 of 30.7.98

6

                                                
include new drugs for the treatment of formerly incurable diseases and renewable sources of
energy based on biomass fermentation (“bio-fuel”).

The  Stockholm  European  Council2  has  identified  biotechnology  as  a  frontier  technology.
Research, entrepreneurship and a regulatory framework that encourages innovation have been
identified  as  the  most  important  factors  that  enable  EU  businesses  to  embrace  these  new
technologies and utilise their full potential.

1.2. 

Advancing the knowledge base and competitiveness of industry

The knowledge base in biotechnology is characterised by intense scientific rivalry and strong
industrial  competition  on  a  worldwide  level  and  being  built  at  a  rapid  pace.  The  speed  of
genome sequencing has typically doubled each year while the costs have dropped markedly.
Scientific and technological progress in genetic engineering is largely dependent on the rapid
dissemination of and easy access to scientific data, in particular raw genome data. This has,
among  others,  been  pointed  out  in  the  statement  of  March  14,  2000  by  UK  Prime  Minister
Blair and (then) US President Clinton:

“To realise the full promise of (human  genome)  research,  raw  fundamental  data on
the  human  genome,  ….,  should  be  made  freely  available  to  scientists  everywhere.
Unencumbered  access  to this information  will  promote  discoveries  that  will  reduce
the burden of disease, improve health  around  the  world  and  enhance  the  quality  of
life for all mankind.”

The  Blair-Clinton  statement  also  recognises  that  “Intellectual  property  protection  for  gene
based inventions will also play an important role in stimulating the development of important
new  health  care  products”.  Handling  the  rapid  spread  of  new  knowledge  through  scientific
publications  while  at  the  same  time  ensuring  strong  and  effective  protection  of  intellectual
property for the development of new technologies and products is thus a major issue.

1.3. 

The development of basic genetic engineering research: Patenting and scientific
publication statistics

The  increased  importance  of  the  biotechnological  sciences,  and  in  particular  genetic
engineering,  is  evident  from  the  patenting  and  publication  activity  in  this  sector.  Patenting
activity3 in the biotechnology sector in the 1990-1999 period has seen yearly growth rates of
around  15%  at  the  United  States  Patent  and  Trademark  Office  (USPTO)  and  13%  at  the
European Patent Office (EPO), compared to overall growth rate in total patent number of only
5% in both the USPTO and the EPO. In the genetic engineering sector, USPTO statistics4 has
shown that the average growth rate between 1985 and 1997 has been around 30% p.a., with
average figures of around 60% in recent years.

However,  the  EU  lags  behind  the  US  in  the  patenting  of  biotechnological  inventions.  As
shown in Table 1, the share of biotechnology patents, both in terms of patents granted in 2000
at the USPTO and patents applied for in 1997 at the EPO, is  lower  for  applicants  from  EU
member states than those from US applicants. Government organisations and public research
organisations are among the top patentees in the genetic engineering sector in the US. In the

2

3

4

Stockholm  European  Council  -  23  and  24  March  2001;  Presidency  conclusions  available  at
http://ue.eu.int/en/Info/eurocouncil/index.htm
Sources: OECD, USPTO, EPO
“Technology Profiling Report: Genetic Engineering 1977-1997”, USPTO, August 1998

7

                                                
period 1977 to 1997, the US Department of Health and Human Services and the University of
California led the ranking list for biotechnology based patents granted in the US, followed by
the California-based company Genentech.

%  of  biotechnology
patents  granted  at
USPTO in 2000

%  of  biotechnology
patents  applied  for
at the EPO in 1997

US

EU

JP

65.5

18.7

7.5

48

33

10

Table 1: Share of biotechnology patents of applicants from US, EU and JP at the USPTO and
EPO

From 1986 to 1997, scientific publications from the biotechnology sector more than doubled,
from 1574 to 3261 papers. EU member states together accounted for the largest share, 34%,
while the US accounted for 23.9%, although US papers on average were cited more often than
papers originating from the EU5.

The above statistics show that Europe on average has a high quality science base (measured
through  the  rate  of  publication)  but  that  it  is  weak  in  its  technological  and  economic
exploitation  (as  measured  through  patenting  activity).  This  “European  paradox”,  which  is
typical also in other sectors and seems to indicate a weakness of the EU innovation system,
has been analysed and discussed in detail elsewhere6.

2. 

THE ROLE OF SCIENTIFIC PUBLICATIONS AND PATENTS

2.1. 

Different  strategies  to  manage  intellectual  property:  publish  –  patent  -  keep
secret

The way intellectual property generated through public and private research is managed may
have  a  strong  impact  on  scientific  progress  and  the  competitiveness  of  industry.  There  are
basically three different strategies:

(cid:1)  To  publish  the  results  and  thereby  obtain  “copyright”  or  other  “authors’  rights”  on  the
published  subject  matter,  while  in  most  cases  leaving  the  inventions  themselves
unprotected  (public  domain  approach).  Public  research  organisations  and  the  scientific
community  largely  pursue  this  strategy  of  rapid  publication  and  the  “publication”  list
usually determines the reputation of a researcher, the quality of his/her work and the career
development.

(cid:1)  To  patent  the  results  or  obtain  another  form  of  industrial  property  right.  In  return  for  a
limited period of exclusive protection in the country  or countries concerned, the inventor
agrees to the publication of the details of his invention, usually after a period of 18 months.
This allows third parties to improve the patented invention or invent alternative solutions,

5

6

Source: OECD, based on data from NUTEK, the Swedish Business Development Agency
European Commission, “2nd European Report on Science and Technology Indicators”, Dec. 1997

8

                                                
thereby advancing the state of the art. This strategy is largely used by commercial entities
the
in  order 
commercialisation of the patented invention. It is also increasingly used by public research
institutions for the exploitation of research results through licensing or spin-off generation.

in  further  research  and  development  or 

investments 

to  protect 

(cid:1)  The “secrecy” strategy, i.e., to keep the results secret thus strongly restricting the use and
dissemination  of  these  results.  It  is  often  used  for  results  that  cannot  be  protected,  or
sufficiently protected, through the use of intellectual property rights. This strategy is used
mainly by commercial entities in order to obtain and maintain a competitive advantage.

2.2. 

Protection  of  creative  inventions  and  dissemination  of  knowledge  –  the  two
objectives of the patent system

The  patent  system  thus  provides  protection  for  inventions  that  have  a  strong  commercial
potential  for  industry  and  at  the  same  time  are  valuable  for  scientific  and  technological
progress. The mandatory publication of the patent application (after 18 months in EU member
states)  ensures  dissemination  of  information  on  important  technological  inventions,  in
particular those from the industrial sector, which might have been kept secret otherwise. The
publication  delay  is  considered  acceptable  in  view  of  the  implications  of  the  alternative
“secrecy”  strategy,  which  would  result  in  a  complete  failure  of  publication  to  occur.  Thus
while  patenting  may  lead  to  a  delay  in  publication,  it  does  avoid  the  complete  failure  to
publish the results of scientific research.

2.3. 

The role of patents for commercialisation of publicly funded research

Since  the  1970’s,  the  public  research  sector  has  been  using  the  “patent  strategy”  to  support
commercialisation of the results of their research through contract research, licensing and the
creation of spin-off companies. Public policies, in particular in the US and,  recently, also in
European  member  states,  have  supported  commercialisation  of  publicly  funded  research
results  by  creating  a  favourable  regulatory  environment  and  suitable  infrastructure.  For
example,  partners  in  research  and  development  (RTD)  projects  funded  through  the  multi-
annual  Framework  Programmes  of  the  European  Communities,  may,  in  exceptional
circumstances, acquire exclusive exploitation rights to the results of their research in view of
the  high  market 
(successful)
commercialisation.  Research  partners  in  these  publicly  funded  programmes  also  have  the
obligation to protect and/or to make use of the results of their research. Similar rules apply for
national RTD programmes in most EU Member States.

investment  necessary 

to  achieve 

risk  and 

large 

In the US, policy measures in the early 80’s led to the creation of technology licensing offices
at all major US universities,  hospitals and  large  research organisations.  These  are organised
under a national umbrella organisation, the Association of University Technology Managers
(AUTM). The enormous success of these US policy measures can be shown from the data in
the  latest  annual  report  of  the  AUTM7,  which  discloses  licensing  fee  income  and  details  of
spin-off companies generated at US public research organisations for the year 1999:

(cid:1)  5545 U.S. patent applications were filed and 3914 new licenses and options were granted

in 1999.

(cid:1)  344 new companies were formed based on university inventions.

7

AUTM Licensing Survey, FY 1999 Survey Summary at http://www.autm.net/surveys/99/survey99A.pdf

9

                                                
(cid:1)  Life  sciences  contributed  86%  to  the  total  licensing  income  of  US$  862  million,
comparable to the proportion of the 5th EU RTD Framework Programme that is dedicated
to life sciences.

The exploitation of patented inventions generated through publicly funded research can thus
have a major effect on competitiveness and economic development. This effect may increase
further in the future as a consequence of the important role academic research and university-
industry  collaboration  play  in  advancing  the  “knowledge  based  society”  and  new
technologies.  This  applies,  in  particular,  to  the  areas  of  biotechnology  and  genetic
engineering.

2.4. 

Possible conflicts between “publishing” and “patenting” strategies

Industrial  strategies  for  intellectual  property  management  focus  more  strongly  on  effective
protection and less on the rapid publication of research results, which may or may not occur
before  the  “built-in”  18-month  period  foreseen  in  the  patent  system  in  Europe.  Early
disclosure  of  research  and  development  results  may  be  important  for  some  young  biotech
companies in order to attract investors.

In  particular  for  researchers  from  the  public  research  sector,  who  are  obliged  to  rapidly
disclose  their  results  to  the  scientific  community,  a  conflict  may  arise  between  the  “rapid
publication”  strategy  and  the  “patent  protection”  strategy.  In  most  national  patent  systems,
which have strict novelty requirements  and are based on the  “first-to-file” system  without a
grace  period,  this  conflict  may  result  in  a  delay  of  scientific  publication.  This  conflict  may
arise for a number of reasons, such as:

(cid:1)  Publication may not occur before the patent application has been filed;

(cid:1)  The  patent  application  procedure  may  be  delayed  because  of  delays  in  securing  the

financing of the application;

(cid:1)  Lack  of  know-how  of  the  inventor  about  the  patent  system  and/or  missing  support
infrastructures  that  advise  and  support  public  researchers  in  obtaining  patent  protection
may delay the patent application and therefore the scientific publication.

A  public  research  policy  that  supports  both  rapid  dissemination  to  foster  scientific  progress
and patenting to  support exploitation of  results  of  publicly  funded  research  has  to  establish
framework conditions that helps researchers to avoid a conflict of interest, e.g. ensures rapid
publication while allowing to protect results.

2.5. 

Does patenting delay scientific publication?

Patenting  of  biotechnological  inventions  was  possible  in  Europe  prior  to  the  adoption  of
Directive  98/44.  However,  the  main  effect  of  the  directive  was  to  confer  greater  legal
certainty on patents related to biotechnological inventions. Therefore, it may be assumed that
Directive 98/44 had no  major impact on the protection or publication strategies of  industry.
However, protection of scientific results from basic genetic engineering research by the public
research  sector  and  its  exploitation  through  contract  research,  licensing  to  industry,  or
generation of spin-off companies, is set to become an important factor for the competitiveness
of EU industries. The publication strategies of public researchers may thus come into conflict
with  the  commercial  interest  of  their  industrial  research  partners  or  licensees.  The  delay  in
publication  of  the  results  of  scientific  research,  which  may  be  the  subject  of  a  patent

10

application  under  the  terms  of  Directive  98/44,  could  hinder  the  rapid  dissemination  of
scientific knowledge and hence may slow down further advances in science and technology.

3. 

PATENTING AND DELAY OF SCIENTIFIC PUBLICATIONS – RESULTS OF A SURVEY

In order to determine whether the patenting of results from basic genetic engineering research
actually  delays  the  scientific  publication  of  these  results,  the  Commission  services  have
performed a survey among scientists and organisations involved in basic genetic engineering
research. The main objective of this survey was to identify whether a delay exists and if so,
whether it is marginal or considerable and how it could be minimised.

3.1. 

Questionnaire survey – target audience and response

The survey was carried out using a questionnaire, which was mailed to two target groups: the
first  (and  largest  group),  concerning  those  working  in  the  area  of  genetic  research,  were
contacted by DG Research while the second group, concerning those with responsibility for
the  filing  and  maintenance  of  patents,  were  contacted  by  DG  Internal  Market.  This
necessitated  that  the  questions  for  both  groups  be  framed  in  a  slightly  different  manner.
Examples  of  the  questionnaire  distributed  by  DG  Research,  denoted  as  QRES,  and  that
distributed by DG Internal Market, denoted as QPAT, are included in Annex I of this report.
Both groups were asked the same questions regarding the delays, if any, experienced with the
publication  of  scientific  results  which  were  also  the  subject  of  patent  applications  and  the
frequency  of  such  delays.  They  were  also  asked  the  same  question  regarding  possible
measures to avoid such delays

QRES was sent  to some 1500  scientists  from academia  and industry working in  the  area of
genetic engineering. The contact data were extracted from the EU RTD projects database of
its  4th  and  5th  Multiannual  Framework  Programmes  for  Research  and  Technological
Development by selecting specific calls for proposals dealing with genetic engineering and/or
by identifying, through keyword searches in the title, appropriate projects in this field. Around
240 answers were received which represents a response rate of approximately 16%. Of these
answers 191 were from individual persons or private or public institutions that were using the
patent  system  at  present  and/or  intended  to  use  it  in  the  future.  The  data  of  these  191
responses and data of 11 responses  from large industry taken from the  QPAT questionnaire
response were used for a statistical analysis. In total, 48 (24%) of these responses were from
industry  (large  industry,  SMEs  and  start-ups)  and  the  remaining  154  (76%)  from  academia
(public  research  organisations,  universities,  and  hospitals).  One  half  of  the  questionnaires
used  for  the  statistical  analysis  were  answered  on  a  personal  level  and  the  other  half  on  an
institutional level.

QPAT  was  sent  to  approx.  150  individuals,  companies  and  organisations  identified  from  a
database of entities involved with obtaining Intellectual Property Rights (IPRs). A total of 34
answers  were  received,  of  which  30  were  from  entities  that  have  actually  used  the  patent
system and were suitable for inclusion in the analysis. This corresponds to a response rate of
20%. Of these replies, 13 (43%) were from the Patent or IP departments of Large Companies;
11  (37%)  were  from  independent  patent  agencies,  individual  patent  practitioners  or  their
representative organisation; 4 (13%) were  from entities  involved in providing  IP services to
academia  (public  research  organisations,  universities,  hospital  or  health  institutions)  and  1
each (7%) were received from an inventors organisation and a public organisation concerned
with the ethics of biotechnological patents. The vast majority of the replies were answered at
the institutional level, with only 2 being answered on a personal level.

11

3.2. 

Statistical analysis of survey responses

3.2.1.  Delay of publication on subjects that could be patentable

The  respondents  were  asked  whether  a  delay  in  scientific  publication  had  occurred  (could
occur) on results that had been (could be) the subject of a patent application (Questions 3a and
3b of questionnaire QRES and questions 2d and 2e of QPAT). The possible answers ranged
from “no delay”, “marginal delay”, “considerable delay” to “Not relevant/no opinion”. Figure
1  shows  the  distribution  of  answers  (in  percentage  of  total)  for  three  groups:  “Industry”,
“academics with patenting experience” and “academics without patenting experience”.

Academics / no past patenting
Academics /past patenting
Industry

no opinion

considerable delay

marginal delay

no delay

% of responses

0%

10%

20%

30%

40%

50%

60%

FIG. 1: Actual (and perceived) delay of publication

The results presented in Fig. 1 clearly show that those scientists and organisations in industry
and academia that have previously made use of the patent system experience no, or a marginal
delay, in around 80-90% of  all cases.  The  perceived delay  of  publication  by academics that
had not previously made use of the patent system is much higher (40%) than by academics or
industry that had experience with the patent system (20% and 8% respectively).

3.2.2.  Measures to avoid delays

The  respondents  that  did  experience  (or  perceived)  delays  were  asked  to  comment  on  the
importance of measures to avoid or minimise the delay (Question 3c of Questionnaire QRES
and question 2f of Questionnaire QPAT). Possible answers offered were

1.

2.

3.

4.

5.

revise corporate/university IP strategy/policy,

introduce a grace period,

provide support and assistance in patent filing,

allow a “provisional patent application” (see section 4.2),

initiate awareness measures or

12

6.

others.

The  respondents  were  asked  to  rank  these  measures  in  order  of  importance.  The  responses
varied  strongly  for  the  different  groups  (industry,  academia)  and  were  therefore  analysed
separately for each group.

industry

academia

5,00

4,00

3,00

2,00

1,00

IP strategy
change

grace period

support
measures

prov. application

awareness

Figure 2: Importance of measures to avoid publication delay: industry response vs. academia

Figure 2 shows the average level of importance for each measure (on a scale from 1 lowest to
5  highest)  for  respondents  from  industry  and  from  academia.  In  addition,  an  analysis  of
specific  groups  and  the  variation  of  responses  among  different  groups  have  been  analysed.
The results can be summarised as follows:

Industry response:

(cid:1)  Industry  of  all  sizes,  whether  on  a  company  level  or  from  researchers  or  patent  agents
within  industry,  favour  the  provisional  patent  application  (PPA)  as  the  most  important
measure to avoid delay in scientific publications of results that are the subject of a patent
application. However, the level of importance only reaches a figure of 3.68 on a scale of 1
to 5.

(cid:1)  Large  industry  is  strictly  against  a  “grace  period”  (level  of  1.7)  and  strongly  favours  the
provisional patent application (level of 4.3) together with awareness measures (3.9 of 5).

(cid:1)  The consensus among industry on the PPA is much stronger than on the grace period, with

some SMEs and start-ups being in favour of a grace period.

Response from public researchers and research organisations:

(cid:1)  Academia  clearly  favours  the  grace  period  as  the  most  important  measure  to  minimise

delays in scientific publication.

13

(cid:1)  Support  and  advice  for  patent  filing  is  ranked  second  as  a  measure  to  avoid  publication
delay  directly  followed  by  the  “provisional  patent  application”  measure.  (The  level  of
importance for the PPA is comparable to that of the industry!)

(cid:1)  Scientists  in  academia  rank  “awareness  measures”  lowest  on  their  importance  scale  of
measures  to  take  to  avoid  publication  delay.  Industry,  who  ranks  it  No.  2,  believes
scientists are not sufficiently aware of this issue.

Views of independent patent agents reflect the diverse nature of their customers:

Although only a small number of replies were  received from independent patent agents and
therefore  they  are  not  included  in  the  statistical  analysis,  it  is  useful  to  consider  these
responses. As most large companies have  their  own patent  and  IP departments,  it is usually
SMEs,  academia  (including  hospital/health  institutes,  public  research  organisations  (PROs),
universities), start-up companies and individuals who use the services of independent patent
agents.  However,  the  replies  received  from  the  independent  patent  agents  do  not  show  any
consistent  opinion  on  the  merits  of  a  grace  period  or  the  provisional  patent  application.
Increasing  awareness  of  IP,  support  and  assistance  for  filing  of  patents  and  revising  IP
strategy/policy  were  all  considered  to  be  of  higher  importance  than  the  grace  period  or  the
provisional  patent  application  by  those  who  provide  advice  on  patents  to  all  classes  of
applicants.

3.2.3.  Additional results

Patent filing by academia and industry

The 49 academic institutions that had given data on the numbers of patent filings in the 1996-
2000  period  had  on  average  filed  57  patents  (in  total  2779)  in  this  period,  50%  of  these
institutions  having  filled  less than 10 patents. This  compares  with the  figure  of  5320  patent
filings  given  by  one  single  large  company  alone,  although  one  large  public  research
organisation (PRO) had also filed about 900 patents in this period.

The data collected through the questionnaire is in line with the fact that large industry files the
majority of patent applications in the biotechnology sector. USPTO statistics covering genetic
engineering patents in the 1984 to 1997  period indicate that  around 91%  of  all  patents with
US ownership are granted to US corporations, while the remaining 9% go to US government
and individuals. However, large public research organisations are among the top patentees, as
shown in section 1.3.

Patent system promotes publication of results:

About 25% of industry responses and 8% of academia responded positively to the question on
whether  “…  the  change  in  the  legal  framework  allowed  you  to  publicise  scientific  results
(through scientific publications and/or patent applications), that would have been kept secret
without  patent  protection?”  The  majority  of  cases  occurred  in  large  industry  and  with  large
public research organisations. This gives some evidence that, in some cases, the patent system
actually facilitated publication of research results.

Partnerships in patent filing:

Patentees  were asked whether patents were  filed in  collaboration with  other partners,  and  if
so, whether the main partners were academia, industry or both. The results show that around
¾ of large industry (76.5%) file patents in collaboration with academia and/or industry. The

14

percentage  of  academic  institutions  collaborating  with  third  parties  is  only  slightly  lower
(73.4%).  SME  and  start-ups  file  patents  both  on  their  own  (50%)  and  in  collaboration  with
academia  (40%).  Inventions  in  SMEs  and  start-ups  thus  seem  to  be  generated  within  the
company or through collaboration with academia but to a much lesser extent in collaboration
with large industry. This demonstrates the importance of the academic sector for SMEs and
start-ups, in particular regarding transfer and/or generation of new knowledge.

3.2.4. 

Summary of comments provided by the respondents

Numerous written comments have been received; the majority of them highlighting the issues
addressed in the above analysis, but additional issues of importance were raised. Among those
that were mentioned repeatedly are:

(cid:1)  the need for a cost-effective European patent system,

(cid:1)  international harmonisation of patent law,

(cid:1)  the need for advice and support infrastructures at universities, including improvements in

teaching patent law to academics.

Other important issues were brought forward, such as:

(cid:1)  The need for information dissemination on European regulations and law, for instance via

a central European web site;

(cid:1)  Provisional patent filing is not required in Europe, as low-cost or free application processes

already exist in countries such as UK and Sweden.

Finally, it was mentioned in some responses that the solution to the problem of the publication
delay could be addressed as one gained more experience with the patent system because the
level of detail required in a patent application, i.e., to demonstrate the 'proof of concept' is less
than  that  required  for  a  successful  scientific  publication.  Thus  scientists  with  experience  of
both  processes  should  in  general  prepare  the  patent  application  at  an  earlier  stage  than  the
submission  of  the  scientific  paper  for  publication  in  order  to  eliminate  publication  delays
arising from an application for a patent.

4. 

MEASURES TO AVOID PUBLICATION DELAYS

4.1. 

The grace period

4.1.1.  Possible benefits and drawbacks of the grace period – Results of an EC hearing

The grace period has been identified by the academic sector as the most important measure to
avoid publication delay. Large industry however, is strongly opposed to the introduction of a
grace period into the national or EU patent systems.

Similar positions were presented in a hearing on the grace period organised by the European
Commission in October 1998, to which 150 persons have participated. The arguments brought
forward  by  the  different  parties  are  documented  in  a  summary  of  this  meeting8.  The

8

http://europa.eu.int/comm/internal_market/fr/intprop/430.htm

15

                                                
proponents  of  the  grace  period  point  out  that  under  the  present  system,  any  inadvertent
disclosure  leads  to  the  total  loss  of  intellectual  property  rights.  However,  academic
researchers  and  small  companies  may  need  to  disclose  the  invention  to  potential  future
partners  (industry,  financiers,  etc.)  in  order  to  develop  the  invention  further.  Large  industry
argues  that  a  grace  period  will  lead  to  legal  uncertainty  that  may  cause  a  disincentive  for
industry to invest in areas where it is uncertain whether intellectual property rights are/will be
filed. The discussion also identified possible alternative solutions, in particular, the option of
filing a provisional patent application or broadening the exemptions that apply to the principle
of  complete  novelty,  which  currently  only  apply  in  the  case  of  “evident  abuse”  and
“disclosure  at  international  exhibitions”.  The  need  for  international  harmonisation  was  also
expressed.

4.1.2.  Expert opinions for and against a grace period

The Intergovernmental Conference of the member states of the European Patent Organisation
on the reform of the patent system in Europe (Paris, 24 to 25 June 1999) mandated the EPO to
“examine, under what conditions the effects of disclosure prior to filing could be taken into
account in European Patent Law”. This was done considering the facts that:

(cid:1)  Public  research  organisations,  universities  and  certain  firms  may  wish  to  be  able  to  file
patent  applications  while  at  the  same  time  being  obliged  to  practice  certain  forms  of
disclosure.

(cid:1)  In addition, certain forms of communication, for example the Internet, increase the risk that

the results of research might be disclosed involuntarily.

(cid:1)  In Europe and in other countries, such disclosures prevent inventors from obtaining patent

protection for their inventions.

The  EPO  requested  opinions  from  two  experts,  Mr  Jan  Galama  and  Professor  Dr  Joseph
Straus9  on  the  case  for  and  against  a  so-called  "grace  period",  protecting  an  inventor  from
being harmed by a disclosure of his invention prior to the filing of a patent application. These
opinions are brought to the attention of the interested public via the EPO website9 in order to
stimulate  the  ongoing  debate  on  this  controversial  issue  and  to  provide  a  basis  for  a  broad
public consultation at European and national level. A summary of  their arguments has been
reproduced in Box 1 and 2 respectively.

9

see details of opinions at http://www.european-patent-office.org/news/headlns/2000_07_25_e.htm

16

                                                
Box 1: The case against a grace period – summary of Mr. Galama’s opinion

The  thrust  of  Mr  Galama's  opinion  is  that  the  introduction  of  a  grace  period  into  European
patent law would be detrimental and should not be supported because it  would  reduce legal
certainty for third parties and may confuse individual inventors giving them a false sense of
security.  Global  high-speed  communication  through  the  Internet,  the  growing  economic
significance of patents and world-wide competition require a clear-cut patent system on which
every one can and must rely. Personal inventors would be most at risk from a grace period in
that  third  parties  may  derive  intervening  rights  from  an  early  disclosure.  This  would
effectively  diminish  the  inventor's  rights  especially  in  highly  competitive  fields  such  as
information  technology  and  biotechnology.  If  academics  wish  to  compete  in  the  economic
world they should be prepared to relinquish old habits, such as early publication.

The  introduction  of  a  general  grace  period  by  revision  of  the  EPC  would  put  European
inventors  in  a  disadvantageous  position  because  there  would  be  no  guarantee  of  reciprocity
from other countries.

The  introduction  of  a  grace  period  within  the  context  of  an  international  treaty  without
substantive  patent  law  harmonisation  would  still  leave  the  problem,  encountered  during  the
negotiations on the "old" Patent Law Treaty in the early 1990's that, due to the peculiarities of
the US "first-to-invent" system, the US understanding of the notion of grace period is not the
same  as  in  Europe.  In  particular  the  issue  of  prior  user  rights  and  European  insistence  that
disclosures during the grace period should not be understood as creating a priority date may
prove "impossible" to reconcile with the US position.

The introduction of a grace period as part of broad international harmonisation of patent law
remains somewhat hypothetical given that the US show no willingness to abandon the first-to-
invent system, and even if it did, it is likely that in any negotiations elements of the first-to-
invent system would be  retained,  threatening  to  "compromise"  the integrity  of the  clear  and
well functioning first-to-file system.

Mr Galama concludes that even if the US were willing to move on first-to-invent, this would
not  be  sufficient  reason  to  adopt  a  grace  period  due  to  the  uncertainties  and  likely
misconceptions involved.

Jan E. Galama, Corporate Intellectual Property, Philips International B.V., Eindhoven

17

Box 2: The case in favour of a grace period – summary of Professor Straus’s opinion

Professor Straus argues that the introduction  of a  general  grace period into European  patent
law is desirable since some form of grace period is currently provided for in the patent laws of
thirty  eight  countries  world-wide  including  three  countries,  Estonia,  Romania  and  Slovenia
which  may  join  the  EPO  in  2002.  The  absence  of  such  provision  in  Europe  could  have
negative  economic  consequences  including  the  shifting  of  investment  and  technological
development  out  of  Europe  to  countries  where  pre-filing  disclosures  are  not  necessarily
prejudicial to patent filing.

(cid:1)  Both  the  United  Kingdom  and  Germany  previously  recognised  a  grace  period  in  their
patent  laws  and  this  did  not  give  rise  to  any  difficulty.  Neither  does  experience  in
jurisdictions such as Canada and Japan suggest that such a provision gives rise to problems
and it is primarily used as a "safety net".

(cid:1)  Even  existing  European  patent  law  cannot  guarantee  absolute  legal  certainty.  In  patent
grant proceedings account has to be taken of oral disclosures and public use in determining
the state of the art. The situation will become more difficult with the increased use of the
Internet.  Legal  certainty  is  therefore  a  relative  concept  and  does  not  depend  upon  the
existence or otherwise of a grace period.

(cid:1)  Furthermore,  third  parties  already  have  to  cope  with  some  degree  of  uncertainty.  Patent
applications are not published until eighteen months from the priority date and even then it
is not clear until the grant procedure has finished what exactly the nature of the exclusive
rights claimed will be.

(cid:1)  Account has to be taken of the growing significance of academic and research institutes as
patent  applicants  and  generators  of  innovation  relevant  knowledge.  There  is  a  need  to
facilitate early publication of research results. Disclosure in parallel to or only after filing a
patent application does not entirely meet this need since it is not always feasible to file a
patent  application  at  an  early  stage  and  in  any  event  the  absolute  bar  on  filing  for
previously disclosed inventions is disproportionate to any inadvertence on the part of the
inventor. It is not only inventors who suffer whenever a useful invention is excluded from
patent protection but society at large. Statistics from Japan, US and Germany make clear
that  early  disclosure  is  of  particular  importance  for  academic/research  institutions  and
independent  inventors  and  the  needs  of  this  sector  should  be  given  more  recognition  in
Europe.  However,  statistics  from  Japan,  where  the  grace  period  has  to  be  invoked,  also
clearly reveal its importance for large industry: 47% of applications invoking grace period
in 1999 were filed by large companies.

(cid:1)  Provisional  applications  do  not  offer  a  satisfactory  remedy  because  they  do  not  address
inadvertent  disclosures  at  all  and  even  in  other  cases  they  pose  a  risk  that  the  original
disclosure will prove inadequate as a basis for any subsequent application.

Prof. Dr. Joseph Straus, Max-Planck Institute for Foreign and International Patent, Copyright
and Competition Law, Munich

18

4.1.3.  The  work  undertaken  under  the  auspices  of  WIPO  (World  Intellectual  Property

Organisation)

Within the framework of the Standing Committee on Patent Law (SCP) of WIPO, discussions
have been undertaken in order to harmonise substantial patent law worldwide. This on-going
work  covers  important  issues  such  as  novelty,  inventive  step  or  non-obviousness  and
industrial application or utility. A draft article dedicated to the introduction of a grace period
into the national legislation has also been discussed. It should be noted that a decision on the
adoption of a grace period has not yet been reached. The provisions contained in this article
are very close to those that were proposed in 1991 (first draft Treaty on the harmonisation of
patent law, which failed).

The main principles are as follows:

(cid:1)  Introduction  of  a  grace  period  for  any  disclosure  of  the  invention  (by  the  inventor,  by  a
third party or by a National Patent Office – NPO) within 12 months before the filing date
of the request or 12 months before the priority date;

(cid:1)  The inventor may always invoke this grace period;

(cid:1)  The  inventor  has  to  prove  that  the  disclosure  took  place  less  than  12  months  before  the

filing date (or where priority is claimed, the priority date of the application).

The  discussions  both  on  the  principle  of  the  introduction  of  such  a  grace  period  and  on  its
content will continue during the coming meetings of the SCP.

4.2. 

The provisional patent application

The  PLT  (Patent  Law  Treaty)10  was  adopted  in  Geneva  on  June  2nd  2000  aiming  at
harmonising  the  formal  requirements  of  patent  law.  One  of  the  most  important  provisions
deals with the possibility for the applicant to obtain a filing date without fulfilling the formal
requirements  generally requested to examine the  application, in  particular  the  obligation  for
the applicant to provide a description and some claims and to file it in one of the languages
accepted by the Office.

New  article  5  of  the  PLT  allows  any  applicant  to  obtain  a  filing  date  provided  that  the
application  was  transmitted  to  the  Office  on  paper  or  by  any  other  means  (including
electronic)11:

(cid:1)  an  express  or  implicit  indication  to  the  effect  that  the  elements  are  intended  to  be  an

application;

(cid:1)  indications allowing the identity of the applicant to be established or allowing the applicant

to be contacted by the Office;

(cid:1)  a part which on the face appears to be a description (any Contracting Party might allow the
filing of drawing instead of the aforementioned part). Moreover, it is not necessary that the
communicated part is written in one of the official languages of the Office

10

11

http://www.wipo.int/treaties/ip/plt/treaty.html
The  European  Community,  after  the  introduction  of  an  effective  Community  patent  system,  could
become a party to the Patent law Treaty

19

                                                
The interest of such provision is to confer on the applicant a filing date. As from this date, he
is allowed to disclose his invention without prejudice to the patentability.

These  provisions  are  new  in  the  European  legislation.  However,  these  rules  are  already  in
force  in  the  USA.  The  European  Patent  Convention  has  been  amended  to  take  into
consideration  these  new  conditions  for  obtaining  a  filing  date  (Diplomatic  Conference,
Munich, 20-29 November 2000)12.

4.3. 

Support and awareness activities, in particular for public researchers

A  large  number  of  small  enterprises  and  public  research  organisations  have  neither  the
personnel nor the financial resources to manage their intellectual property.

For public researchers, the complexity of regulations concerning employee inventions, (such
as ownership, “professor privilege”, regulations concerning ownership of and access rights to
IP  in  publicly  funded,  collaborative  research,  etc.)  by  itself  is  a  hurdle  to  application  for
intellectual  property  protection  of  their  research  results.  While  large  research  organisations
may have the necessary resources to define an IP policy and provide a support infrastructure
to scientists, similar infrastructures and IP policies are largely missing at universities. Ideally,
these support infrastructures should provide, among others:

(cid:1)  advice  and  expertise  on  the  valuation  of  the  intellectual  property  and  the  best  protection

strategy,

(cid:1)  legal advice on employee invention law, IP law and regulations concerning IP,

(cid:1)  help with and financial support for patent filing, and

(cid:1)  support for exploiting the intellectual property (licensing, start-ups).

The  European  Commission  and  member  states  are  supporting  or  initiating  a  number  of
activities that are geared to raise awareness for patenting issues  or  provide  direct support to
researchers for preparing,  filing  and  financing patent  applications and  exploitation  of  patent
rights.  Among  those  are  the  IPR-Helpdesk  financed  by  DG  Enterprise  of  the  European
Commission13  and  the  new  “Patent  academia”  initiative  to  be  launched  by  the  same
directorate-general.  The  latter  will  provide  a  network  of  technology  licensing  offices  of
European  research  organisations  in  order  to  exchange  best  practice  and  experience  in
protection  and  exploitation  of  publicly  funded  research.  The  European  Commission  is  also
supporting  national  Patent  Offices  to  develop  patenting  support  initiatives  and  services  in
particular for academia and small and medium sized enterprises.

4.4. 

Legal framework, regulations and other policies related to intellectual property
rights

A number of other factors may contribute to the delay of publication of subjects that may be
patentable:

12

13

These provision shall enter into force two  years after the  fifteenth Contracting State  has  deposited  its
instrument of ratification.
http://www.ipr-helpdesk.org

20

                                                
(cid:1)  The lack of a cost-effective and simple Community Patent may cause delays because of the
difficulty of finding the finance for patent applications. Some inventions may not be filed
due to the high costs associated with patent protection and may be kept secret instead, in
particular with SMEs.

(cid:1)  Regulations concerning ownership and use of inventions, such as employees law, and the
lack  of  knowledge  of  this  legal  framework  in  particular  in  SMEs  and  universities  may
complicate  and  delay  the  decision  process  related  to  patent  filing  and  therefore  delay
publication.

(cid:1)  Inventions  generated  in  research  collaborations  between  university  and  industry  may  be
delayed because no clear agreements have been made beforehand on how best to manage
the  intellectual  property  generated  within  such  consortia  while  taking  into  account  the
different interests and strategies of the partners. Academic partners sometimes lack a clear
understanding  and/or  policy  on  IP  matters  as  well  as  the  necessary  negotiating  skills  to
achieve  their  goals  when  such  collaboration  agreements  are  being  drawn  up.  Industrial
partners do not always take into account the importance of rapid publication of scientific
results to their academic partners .

While  some  of  these  policy  issues  are  currently  under  consideration  at  European  Union  or
member  state  level  (i.e.,  Community  Patent14;  employee  invention  law  in  Germany15,  etc.),
other issues need to be considered in more detail and possible policy measures on these issues
need to be identified.

5. 

SUMMARY AND CONCLUSIONS

(cid:1)  Providing  patent  protection  for  results  of  genetic  engineering  research  usually  facilitates
publication  and  avoids  secrecy  strategies.  Papers  are  published  after  filing  of  the  patent
application(s),  at  the  latest,  through  the  publication  of  the  patent  application  (up  to  18
months after the application date).

(cid:1)  The  public  research  sector  has  become  a  major  user  of  the  patent  system.  The  conflict
between  the  scientific  “publication  and  dissemination”  strategy  and  the  “protection  and
exploitation” strategy may cause delays in publication of scientific results that might be the
subject of patent applications.

(cid:1)  A  survey  among  EU  researchers  and  research  organisations  from  both  industry  and
academia has shown that publication  delays  do occur, but less so with more experienced
users  of  the  patent  system.  With  experienced  users  significant  delays  occur  in  less  than
20% of all cases (20% for academic institutions and 8% in industry).

(cid:1)  Almost half of the surveyed researchers from academia that have no previous experience
with the patent system but intend to use it in the future are of the opinion that considerable

14

15

“Proposal  for  a  Council  Regulation  on  the  Community  patent”,  COM/2000/0412  final,  OJ  C  337  E,
28/11/2000, p278
A  draft  law  (14/5975  of  09.052001:  http://dip.bundestag.de/btd/14/059/1405975.pdf)  has  been
introduced  by  members  of  the  German  Parliament  to  drop  the  “professors’  privilege”,  which  gave
professors full ownership and rights to inventions made in the course of their work, and assign rights to
the  university,  in  order  to  stimulate  the  setting  up  of  university  licensing  and  technology  transfer
infrastructures

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delays will occur. There is a need for awareness actions and support activities to counteract
these  (inaccurate)  perceptions  and  to  help  researchers  to  become  more  familiar  with  the
patent system itself. This should be done on all levels - regional, national and European.

(cid:1)  The survey showed a clear preference of the academic sector for a grace period in order to
avoid and/or minimise any delays of publication of research results that may be the subject
of  a  patent  application.  In  contrast,  large  industry  is  strongly  against  a  grace  period  and
favours  rather  the  introduction  of  a  provisional  patent  application  (PPA)  into  European
legislation. The replies received from medium sized industry and from independent patent
agents did not  show any consistent opinion on  the merits  of a  grace period.  In  particular
patent agents stressed the needs for awareness activities, assistance and support measures.
A  comparably  high  level  of  importance  was  attributed  to  the  PPA  by  both  industry  and
academia.

(cid:1)  Experience  has  shown  that  the  level  of  detail  required  in  a  patent  application,  i.e.,  to
demonstrate  the  'proof  of  concept'  is  less  than  that  required  for  a  successful  scientific
publication.  Thus  scientists  with  experience  of  both  processes  should  learn  to  make  the
patent  application  at  an  earlier  stage  than  the  submission  of  the  scientific  paper  for
publication and thus avoid any delay in publication of the scientific paper.

(cid:1)  Despite a number of studies, no precise figures are available which quantify the economic
effects  for  industry,  or  which  assess  the  value  in  practical  terms  for  academia,  of  the
introduction of a grace period. Throughout the member states of WIPO, different concepts
of a “grace period” have developed (e.g., in US, JP), all of which should be investigated in
detail concerning the balance they provide between the interests of the academic sector and
those of industry. The US structure involving a “grace period” coupled with the “first-to-
invent” system provides the highest level of “legal uncertainty” and should not serve as the
“best practice” example.

(cid:1)  In  view  of  the  increasing  internationalisation  of  research,  in  particular  in  the  genetic
engineering sector (both public and private sector funded research), and also given the fact
that the public research sector has become a more experienced and major user of the patent
system,  efforts  to  define  and  harmonise  the  concept  of  the  ‘grace  period’  should  be
considered.  However,  this  concept  will  only  work  at  a  global  level  and  will  only  be
effective if it provides ‘legal certainty’, which is the major concern of industry. This should
be taken into account during the current discussions by the Standing Committee on Patent
Law (SCP) of WIPO on the possible introduction of a grace period.

(cid:1)  In  1991  WIPO  discussed  the  inclusion  of  an  article  into  the  first  draft  of  a  “Treaty  on
Harmonisation of Patent Law” concerning the introduction of a grace period into national
laws.  This  was  rejected  based  on  the  grounds  that  a  grace  period  would  be  counter  to
education  and  awareness  campaigns  among  academic  researchers  concerning  the  proper
use of the patent system. These arguments clearly no longer hold good today.

(cid:1)  The legal framework conditions should be further optimised to ease the use of the patent
system  by  academics  and  small  and  medium  sized  enterprises.  These  should  include,
among others:

– 

the introduction of a provisional patent application in all member states in line
with Article 5 of the Patent Law Treaty, adopted in Geneva on June 2, 2000.

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– 

– 

support  and  advice  for  academic  bodies  and  SMEs  in  the  proper  use  of  the
patent  system  and  the  strategic  use  of  intellectual  property  rights  as  well  as
teaching and training on these issues.

a  simple  and  cost-effective  patent  system,  as  will  be  provided  through  the
proposed Community Patent.

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