1 Introduction
1. The draft Legislative Reform (Patents) Order
2014 (the draft Order) and Explanatory Document were laid before
Parliament on 6 May 2014 by the Department for Business, Innovation
and Skills (the Department).
2. The Patents Act 1977 (the "1977 Act")
sets out the legal rights and requirements for UK patents and
patent applications. A patent gives its owner the right to prevent
third parties from making use of, selling or importing their invention
for up to 20 years in return for disclosure of their invention.
If a third party does any of these things without the consent
of the patent owner, it is considered to be an infringement of
the patent and the owner is entitled to take legal action against
the infringement.[1]
3. Essentially, the proposals are intended to
allow clinical trials, field trials and health technology assessments
to be carried out without infringing a patent. Commercial use
of a patented product after obtaining regulatory approval or health
technology assessment (HTA)[2]
recommendation would not be covered by the provision (and so a
licence or other form of agreement would still be required before
an approved product could be supplied commercially).[3]
4. The draft Order would amend section 60 of
the 1977 Act to ensure that activities which are carried out for
the purposes of obtaining regulatory approval, or health technology
assessment (HTA) are exempt from patent infringement.
5. Products used as comparators in both clinical
trials and HTA may be protected by patents belonging to a third
party. As trials and studies are not considered exempt from infringement
under UK law, the Department indicates that stakeholders risk
patent infringement if they do this work in the UK.[4]
It argues that this may discourage them from conducting clinical
trials in this jurisdiction. The Department notes that it considered
two non-legislative options for change: industry agreements and
non-statutory guidance to clarify the current legislation.[5]
Following a formal consultation, it concluded that the non-legislative
options were not a viable way of achieving the policy objective.[6]
6. We are disappointed that the Impact Assessment
did not attempt to monetise the costs and benefits of the proposals.
We note that the IPO's explanation for this is that relevant information
from stakeholders is "commercially sensitive" and that
"the vast majority of respondents were unwilling to provide
it".[7] We further
note that the IPO states that the independent Regulatory Policy
Committee commented that, despite the lack of monetisation of
the costs and benefits of the proposals, the approach taken "appears
to be reasonable and proportionate".[8]
We disagree, and consider that the IPO could and should have made
greater efforts to provide projected monetised costs and benefits,
with the necessary caveats and health warnings in place. Without
this information, the evidence base for the proposals is considerably
weakened. We look to Departments to use a best efforts approach
to monetise costs and benefits to ensure that impact assessments
are robust and meaningful.
7. The Intellectual Property Office should consider
putting in place measures to ensure that data arising from clinical
trials and health technology assessments should be made available
to the relevant patent owners.
8. The Minister has recommended that the draft
Order be subject to the affirmative resolution procedure. We have
examined the draft Order in accordance with Standing Order No.
141(3) and recommend under 141(4) that the draft Order be approved.
1 Explanatory Document, paragraph 1.1 Back
2
A health technology assessment is carried out (e.g. by the National
Institute for Health and Care Excellence for England, the All
Wales Medicines Strategy Group and the Scottish Medicines Consortium)
to assess the benefits and costs of a drug or treatment and how
it compares with the available alternatives. See Explanatory Document,
paragraph 1.9. Back
3
Explanatory Document, paragraph 1.20 Back
4
Explanatory Document, paragraph 1.10 Back
5
Explanatory Document, paragraph 3.9 Back
6
Explanatory Document, paragraphs 3.10-3.11 Back
7
Annex, Q4 Back
8
Annex, Q4 Back
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