11 Legal protection of biotechnological
inventions
| (23146)
5379/02
COM (02)2
| 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
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| Legal base | — |
| Department | Trade and Industry
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| Basis of consideration | Minister's letter of 7 April 2004 (received 10 September 2004)
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| Previous Committee Report | HC 152 -xxiii (2001-02), para 7 (10 April 2002)
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| To be discussed in Council | No date set
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| Committee's assessment | Politically important
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| Committee's decision | Cleared
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Background
11.1 Directive 98/44/EC on the legal protection of biotechnological
inventions[21] provides
for the harmonisation of the laws of Member States relating to
the legal protection of biotechnological inventions. Article 16b
of the Directive requires the Commission to publish a report assessing
the implications for basic genetic engineering research of failures
to publish, or late publication of, papers on subjects which could
be patentable. The requirement was included in the Directive to
address the concerns expressed, particularly in academic circles,
that the possibility that an invention might be the subject of
a patent might discourage or delay the publication of the results
of research. For the purposes of its report the Commission conducted
a survey of a wide range of scientists working in the area of
genetic engineering.
11.2 When we considered the report on 10 April 2002,
we noted the point made by the Commission that research institutes,
universities and small biotechnology companies are major contributors
to innovation in the life sciences and may wish to file patent
applications, but at the same time will wish to disclose as quickly
as possible the results of their research to the scientific community
and investors. The Commission drew attention to the conflict between
"protection" and "publication" strategies
as leading to delays in the publication of scientific results,
but acknowledged that the patent system ensures the publication
of results which might otherwise have been kept secret. The Commission
canvassed views on possible means of addressing some of these
difficulties, such as the adoption of "grace periods",
i.e. a period of time before a patent application is filed during
which the disclosure of an invention does not count in determining
whether the invention is novel or not, or "provisional patent
applications", i.e. applications which do not fulfil all
the formal requirements for a full patent application, but which
would be used for obtaining a filing date for determining the
question of novelty.
11.3 In commenting on the report, the then Minister
for Competition, Consumers, and Markets at the Department of Trade
and Industry (Miss Melanie Johnson) noted that experienced users
of the patent system, whether in industry or academia, did not
find publication of their work to have been delayed in most cases.
The Minister also noted a clear preference amongst the academics
for a grace period, with large firms being strongly against the
idea. The Minister commented that a grace period might reduce
any delays in publication, but that it would also create uncertainty,
since it would not be clear whether a particular disclosure had
the effect of destroying the novelty of an invention, thus preventing
the grant of a patent. The Minister also noted that adopting a
grace period in Europe whilst there was none in other jurisdictions
might also result in some applicants losing out on patents in
those jurisdictions through a mistaken reliance on a grace period.
11.4 We considered that the Commission had conducted
a thorough examination of the issue and had explained the present
situation and options for future action in clear terms. As the
Minister had explained to us that the Government was in the process
of consulting on the possible introduction of a grace period,
we held the document under scrutiny pending information on the
results of the consultation.
The Minister's reply
11.5 In his letter of 7 April 2004[22]
the Parliamentary Under-Secretary of State for Science and Innovation
(Lord Sainsbury) informs us that the results of the consultation
on grace periods have now been fully analysed. The Minister sent
us a copy of the report in September. The Minister explains that
respondents to the consultation were generally content with the
current situation in the United Kingdom and Europe, where a grace
period does not apply save in very limited circumstances. If such
a period were to be introduced, respondents would prefer an internationally
harmonised grace period and would not wish to see a grace period
introduced only in the UK or even in the EU. Their view was that
an internationally harmonised grace period should act as a safety
net for premature publication prior to the filing of a patent
application. The Minister adds that concerns were expressed that
a grace period should not hinder the rights of third parties.
11.6 The Minister refers us to the detailed analysis
made of the responses which is contained in the Patent Office
report. This shows that most respondents were content with the
current system. If it became necessary to introduce a grace period,
such a period should be for no longer than six months, with a
patent application published 18 months from the date of first
disclosure of the invention. Only disclosures made by the first
applicant would be exempted from affecting the patent by reason
of lack of novelty, and an independent third party disclosure
could be relied on to show lack of novelty if it is made before
the patent application is filed. If a grace period were to be
introduced, respondents regarded it as essential that the period
would still lead to a priority year[23]
and that only disclosures by the first applicant should be excluded
from affecting the validity of a patent on grounds of lack of
novelty.
11.7 The Patent Office report also explains further
the concerns that the rights of third parties should not be affected
by the introduction of a grace period. The report explains that
if a patent application is not published until 18 months after
the filing of the application at the Patent Office, this could
lead to a lengthy period of uncertainty for third parties. On
the other hand, if the application is published within 18 months
of the date of first disclosure of the invention this may lead
to some applications being published without their search reports.
The report concludes that the preference for early publication
will need to be balanced against the benefit to third parties
of providing the results of the search report with the published
application.
11.8 Summarising the views on the grace period, the
report found it surprising that the majority of academic and related
respondents were not in favour of the introduction of a grace
period, but considered that the reason for this was that the respondents
in the academic field were employed in the universities to make
best use of their institution's intellectual property. The report
concluded that this indicated that those in the academic sector
who had experience of the use of intellectual property recognised
that there were problems with the use of grace periods and that
their introduction into the UK patent system "may not be
as advantageous as has always been claimed".
Conclusion
11.9 We thank the Minister for his letter and
for the Patent Office report on the consultation which has been
conducted on the question of "grace periods". It is
evident from this that the matter has been considered in detail
and with great care, both at the European and domestic levels.
11.10 In the light of this further information
from the Minister we are content to clear the document.
21 OJ No. L 213, 30.7.98, p.13. Back
22
Received by us on 10 September 2004. Back
23
A "priority year" as defined in the Paris Convention,
is 12 months from the date of initial filing and is the period
within which a further application can be filed claiming the same
commencement date for protection of the invention. The grace period
should not have any effect on the filing of further applications
within that priority year. Back
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