This is based on a talk by Graham Stuart given to the CIPA
Life Sciences Conference on 14 November 2013.
The talk was essentially focused on the position of the exemptions in
the UK.
1. When analysing
whether something falls within the research exemption one should determine
whether one is working ‘on’ the invention or ‘with’ the invention. So generally if one is looking at the
underlying principles of a patent and building on it then that should fall in
the exemption. However in the case of
research tools one will be using them (working with them) in one’s research,
rather than seeking to study them or build on them, and so they will not fall
within the research exemption.
2. Developing a drug
requires many different activities that will fall within the research exemption.
The exploratory and drug discovery phase should fall within the research exemption. Essentially making, testing and validating
patented subject matter should be exempt.
3. However Inhale v
Quadrant confirmed that supplying the means to make and test patented subject
matter did not fall within the exemption when this was done by another company. That means smaller companies that cannot
themselves make the patented products are at a disadvantage because they cannot
outsource this. However a third party
contracted to do the experimental use is considered exempted because it is viewed
as a co-experimenter.
4. In the case of research
tools it is generally difficult to argue that the exemption applies. In general large companies with patents on research
tools may find that they are best used to obtain injunctions against others. In Switzerland and Belgium though there are
provisions which make it easier to use patented research tools.
5. Testing candidate
drugs in preclinical studies will probably be exempt given that one is trying
to find out something new (Monsanto v Stauffer). Clinical trials would also usually be
exempted.
6. The Bolar exemption
covers work carried out to obtain regulatory approval for a generic drug. In the EU this came into being through a
Directive. It has been incorporated into national provisions either broadly or
narrowly. ‘Broadly’ means work to obtain any marketing approval is covered,
whilst ‘narrowly’ means only work relating to approval of a generic drug is
covered. The UK has a narrow provision,
and at the moment it seems the Unified Patent Court will adopt a narrow
provision.
7. The activities
which are allowable under the Bolar exemption in the UK are well established,
i.e. carrying out tests, manufacturing enough to test, developing the pharmaceutical
composition, etc. The German Courts decided in Astellas v Polpharma that supplying
of a substance was not covered by the Bolar exemption.
8. In the US Merck v
Integra determines the extent to which work is covered by the safe harbour
provision, which concerns generating data for submission to the FDA.
9. There is
uncertainty in many territories over the extent to which research tools are covered
by the Bolar exemption.
10. One hot area which
may lead to these provisions being tested in litigation is biomarkers, i.e.
personalised medicines. The use of biomarkers
is often covered by layers of patents, and companies will want to test to what
extent exemptions apply to testing biomarkers.
In fact it may be in the interests of companies that own patents to
biomarkers to let them be used during clinical trials so that they become a companion
diagnostic to the drug.
You may also wish to see related articles 10
Points on the Pharma/Biotech Sector and 10
Observations on Different Types of Research.
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