Thursday, 13 March 2014

10 Points on Research and Bolar Exemptions

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.

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