england-and-wales patents medical
Can one explicitly use medical research to offer unlicensed patented treatments?
<p><a href="https://www.legislation.gov.uk/ukpga/1977/37/section/60" rel="nofollow noreferrer">English Patent Law includes an exception for &quot;experimental purposes&quot;</a>:</p>
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<p>(5)An act which, apart from this subsection, would constitute an infringement of a patent for an invention shall not do so if—</p>
<p>(b)it is done for experimental purposes relating to the subject-matter of the invention;</p>
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<p>(6D)For the purposes of subsection (5)(b), anything done in or for the purposes of a medicinal product assessment which would otherwise constitute an infringement of a patent for an invention is to be regarded as done for experimental purposes relating to the subject-matter of the invention.</p>
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<p>Can this exception be used explicitly to offer medical treatments that would otherwise be restricted by patent law and require some form of licence agreement with the patent holder?</p>
<p><a href="https://www.nature.com/articles/d41586-022-04327-7" rel="nofollow noreferrer">The most expensive &quot;drug&quot; in the world</a> is Hemgenix from CSL Behring.  This is a viral particle that introduces a CRISPR mediated genetic modification that can dramatically improve the life of people suffering from haemophilia B for eight years, and potentially longer.  The treatment costs $3.5 million for a single treatment, and even at this cost plausibly saves the health system about $5 million per patient.</p>
<p>This is a very young feild, and their is a great need for more research.  This point is made most obviously by the fact that only 15% of people with haemophilia have haemophilia B. Most have haemophilia A, which is caused by a deficiency in a different gene for which there is currently no such treatment.</p>
<p>Suppose one set up an organisation in England, say down the road from the group that developed the viral vector in University College London, to do research in this field.  You selected the questions you would attempt to answer such that they required experiments that involved the application of this treatment.  You then provided this treatment to patients who need it without licencing the technology.  One funded the organisation either through charitable donations or payments from the participants at a level closer to the cost of administering the treatment than the $3.5 million price tag.</p>
<p>Would that constitute an infringement of any patents on the technology used?  This would be based on the defense that the use of the invention was &quot;done for experimental purposes relating to the subject-matter of the invention&quot;.</p>
<p>With respect to the question of payment for medical trials, there are a number of sources questioning the morality of this and refer to examples where the business model has been used.  None mention legal issues with the model.  I include them below for completeness, these are not legal documents.</p>
<ul>
<li><a href="https://doi.org/10.1093/jnci/82.2.84" rel="nofollow noreferrer">I only have access to the first page</a> but this discusses an extant US company <a href="https://www.biotherapeuticsinc.com/" rel="nofollow noreferrer">Biotherapeutics, Inc.
</a> that has used this model</li>
<li><a href="https://doi.org/10.1007/s11019-016-9741-2" rel="nofollow noreferrer">A 2016 paper</a> finds it ethical in the absence of other alternatives. No obvious mention of illegality</li>
<li><a href="https://doi.org/10.2217/rme.12.75" rel="nofollow noreferrer">This is a single author review of similar schemes</a> that does not mention it being unlawful and discusses them in context of charity funded schemes</li>
</ul>

<p>The sections you're asking about (as well as related 60(6E): this is an important limiting clause that you may have overlooked) were added by <a href="https://www.legislation.gov.uk/uksi/2014/1997/contents/made" rel="nofollow noreferrer">The Legislative Reform (Patents) Order 2014 (S.I. 2014/1997)</a>. Its <a href="https://www.legislation.gov.uk/uksi/2014/1997/note/made" rel="nofollow noreferrer">explanatory note</a> describes:</p>
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<p>Article 2 amends section 60 to ensure that the exception to patent infringement in subsection (5)(b) applies to anything done in or for the purposes of a medicinal product assessment</p>
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<p>New subsection (6D) provides that anything done in or for the purposes of a medicinal product assessment is to be regarded as done for experimental purposes relating to the subject-matter of the invention.</p>
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<p>New subsection (6E) defines what is meant by “medicinal product assessment”. A medicinal product assessment includes acts done in the United Kingdom or the Isle of Man in testing or in a course of testing or other activity undertaken with a view to providing data <strong>for a specified purpose</strong>.</p>
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<p>Those specified purposes are (paraphrasing): obtaining an authorisation to sell or supply, complying with regulatory requirements, or enabling a government or public authority to carry out an assessment of suitability.</p>
<p>Essentially, this allows competitors to do comparison/non-inferiority trials in order to obtain market authorisation for medicinal products without the risk of infringment. See <a href="https://gowlingwlg.com/en/insights-resources/articles/2014/patent-law-proposals-to-bring-clinical-trials-back/" rel="nofollow noreferrer">this explainer</a> by Gowling WLG. <a href="https://cms.law/en/int/expert-guides/cms-expert-guide-on-bolar-provisions/united-kingdom" rel="nofollow noreferrer">CMS describes this</a> as covering: &quot;any testing or other activity undertaken <strong>with a view to providing data in relation to marketing authorisations</strong> in the UK or elsewhere.&quot;</p>
