LEGAL PROTECTION OF BIOTECHNOLOGICAL INVENTIONS
Commission Report: 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.
|Document originated:||14 January 2002
|Forwarded to the Council:
||15 January 2002|
|Deposited in Parliament:
||4 February 2002|
|Department:||Trade and Industry
|Basis of consideration:
||EM of 22 February 2002|
|Previous Committee Report:
|To be discussed in Council:
||No date set|
|Committee's assessment:||Politically important
|Committee's decision:||Not cleared; further information requested
7.1 Directive 98/44/EC harmonises the patent laws for
the protection of biotechnological inventions across the European
Union. Article 16b required the Commission to provide the present
report within two years of the Directive coming into force, so
it was due by 30 July 2000. The Directive requires the Commission
to assess "the implications for basic genetic engineering
research of failure to publish, or late publication of, papers
on subjects which could be patentable".
7.2 This requirement was included in the Directive to
take account of concerns expressed, particularly by academia,
that the ability to patent inventions in this area might discourage
or delay publication of results. As the Commission explains:
"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
7.3 Before producing this report, the Commission conducted
a survey of scientists who were carrying out research on genetic
engineering to investigate the question of patenting and publication
delay. They included people from academia, large and small companies,
start-ups, and those involved in intellectual property rights
issues, such as patent agents. It found that:
" 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%);
- 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; and
- 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."
7.4 Apart from asking whether there was any significant
delay and what the implications were for basic genetic engineering
research, the Commission asked what possible steps respondents
considered appropriate to remedy possible negative effects. The
report summarises the possible benefits and drawbacks of "grace
periods" and "provisional patent applications"
and discusses other alternatives and policy measures to prevent
or minimise any delays in the publication of scientific papers
which contain research results that could be the subject of patent
7.5 In her Explanatory Memorandum, the Minister for Competition,
Consumers and Markets (Miss Melanie Johnson) notes that:
"A 'grace period' is a period of time before a patent
application is filed in which disclosure of an invention may not
count in determining whether the invention is new or not. There
is no such grace period in Europe (except for certain highly restricted
circumstances involving breaches of confidence or some international
exhibitions), but there are various forms of grace periods in
other jurisdictions, notably the US.
"The Commission refers to 'provisional patent applications'
as applications used to obtain a filing date (for the purposes
of novelty determination) without necessarily fulfilling all the
formal requirements for a full patent application. Such applications
are already accorded a filing date in the UK."
7.6 Summarising the results of the survey, the Minister
"The responses showed that experienced users of the patent
system, both in industry and academia, did not find the publication
of their work delayed, or only encountered a marginal delay, in
80-90% of cases. The belief that the publication would be delayed
by use of the patent system was strongest among academics who
had not used the system.
"The survey showed a clear preference among academics for
a 'grace period', while large industry was strongly against the
idea. The provision of a grace period might reduce any delays
to publication. However, it might also create uncertainty, as
it would not necessarily be clear where a certain disclosure was
novelty-destroying and so prevented the grant of a patent. Adopting
a grace period in Europe while there is none in other jurisdictions
might also result in some applicants losing out on patents in
those jurisdictions because they mistakenly relied on the grace
"Industry and academia both endorsed the value of provisional
patent applications in avoiding publication delays. The low-cost
UK application system is highlighted in the survey results by
some respondents as making a specific provisional patent system
7.7 The report provides statistics which 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 elsewhere".
7.8 Commenting on the different strategies employed to
manage intellectual property generated through public and private
research, the report notes that there are basically three different
"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.
"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 invest alternative solutions, thereby advancing
the state of the art. This strategy is largely used by commercial
entities in order to protect investments in further research and
development or the 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
"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."
7.9 The Commission comments that the value of the patent
system is that, though it may lead to a delay in publication,
it does avoid complete failure to publish results. Publication
of the patent application is mandatory after 18 months in EU Member
States. There are possible conflicts between the "publishing"
and "patenting" strategies, particularly for researchers
from the public research sector, as they are obliged to disclose
their results rapidly to the scientific community. What is needed
is a public research policy that establishes framework conditions
to help prevent a conflict of interest.
7.10 The Minister draws attention to two particular points
made by the Commission:
" the need to secure funding for a patent
application as a possible cause of delay in application (and hence
publication). The Commission argues that a cost-effective Community
patent system would reduce these costs, and hence help to tackle
this issue; and
- a lack of understanding of the patent system as a factor leading
to delays in applications and publication. The Commission emphasises
the need to provide support and advice for academic bodies and
SMEs in particular in the proper use of patents and intellectual
property rights in general."
The Government's view
7.11 Addressing the policy implications of the report,
the Minister comments:
"The report makes clear that providing patent protection
for results of genetic engineering research usually facilitates
publication and avoids secrecy strategies. It makes no suggestion
that there is a need to reconsider the patenting criteria for
biotechnology as a result of its findings.
"There is a need to consider the question of whether the
adoption, on an international basis, of some form of grace period,
would be beneficial, and the Government is actively consulting
on this issue.
"In the current negotiations on the Community Patent, the
Government continues to stress the need for the Community Patent
to be cost-effective for users, the importance of which is highlighted
in this report.
"The report also highlights the need to ensure that academia
and SMEs are aware of how to effectively use the intellectual
property system. The Government is committed to this aim; for
example in December it published guidelines for public sector
research establishments on the management of intellectual property.
"The Government is currently conducting a consultation on
the possible introduction of a grace period, which can be accessed
through the Patent Office website http://www.patent.gov.uk. The
consultation runs until 30 April 2002."
7.12 The Commission has conducted a thorough examination
of the issue and explained in clear terms the situation and options
for future action.
7.13 We ask the Government to inform us of the results
of its consultation and meanwhile do not clear the document.
Commission, "2nd European Report on Science and Technology
Indicators", December 1997. Back