New patent law proposals laid in Parliament earlier this week could result in clinical trials being brought back to the UK. Our experts address some of the key points and take a look at what they could mean for businesses within the industry.
In our previous Alert, we reported on a consultation being undertaken by the UK Intellectual Property Office (UKIPO) on extending the various exemptions from patent infringement, for acts done for the purposes of obtaining marketing authorisation for medicinal products.
At present, there are two principal exemptions:
- The first comes under s.60 5(b) Patents Act and exempts acts "done for experimental purposes relating to the subject matter of the invention". The UK courts have traditionally interpreted this phrase narrowly, and more narrowly than similar provisions, for example, in German patent legislation.
- The second was inserted as s.60 5(i) Patents Act (by SI 2005/2759) and implemented an EU version of the exemption known in the US as the "Bolar" provision (Article 10(6) of Directive 2004/27/EC). The EU Bolar provision exempts from patent infringement trials done for the purposes of obtaining marketing approval for generic medicinal products. In a parallel fashion to the experimental use exemption, the provision in this EU Directive was implemented by the UK very narrowly, and much more narrowly than that implemented in other EU states, for example, in Germany.
The "lacuna" left by these provisions as far as the UK was concerned is discussed in our previous Alerter. In essence, it left research-based pharmaceutical companies in the UK at risk of patent infringement when conducting activities related to obtaining marketing approval for their own new medicinal products.
The practical consequence was a significant drop in clinical trials and other tests related to new drugs being conducted in the UK, with other EU countries benefitting from the wider exemptions from patent infringement afforded to regulatory activities.
The New legislation proposals
The Legislative Reform (Patents) Order 2014 was laid in Parliament earlier this week (06 May 2014) for consideration by the relevant Parliamentary committees. A copy of the Order can be found on the legislation.gov.uk website . The substantive text of the proposal is in clause 2 of the Order, which states:
Amendments of the Patents Act 1977
- In section 60 of the Patents Act 1977(a) (meaning of infringement), after subsection (6C) insert -
"(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.
(6E) In subsection (6D), "medicinal product assessment" means any testing, course of testing or other activity undertaken with a view to providing data for any of the following purposes -
- obtaining or varying an authorisation to sell or supply, or offer to sell or supply, a medicinal product (whether in the United Kingdom or elsewhere);
- complying with any regulatory requirement imposed (whether in the United Kingdom or elsewhere) in relation to such an authorisation;
- enabling a government or public authority (whether in the United Kingdom or elsewhere), or a person (whether in the United Kingdom or elsewhere) with functions of -
- providing health care on behalf of such a government or public authority, or
- providing advice to, or on behalf of, such a government or public authority about the provision of health care, to carry out an assessment of suitability of a medicinal product for human use for the purpose of determining whether to use it, or recommend its use, in the provision of health care.
(6F) In subsection (6E) and this subsection -
"medicinal product" means a medicinal product for human use or a veterinary medicinal product;
"medicinal product for human use" has the meaning given by article 1 of Directive 2001/83/EC(b);
"veterinary medicinal product" has the meaning given by article 1 of Directive 2001/82/EC(c).
(6G) Nothing in subsections (6D) to (6F) is to be read as affecting the application of subsection (5)(b) in relation to any act of a kind not falling within subsection (6D)."
Clause 1 of the Order currently states it will come into force on 01 October 2014, although this date, along with the substantive text above, may change during the Parliamentary debates relating to the Order.
Nevertheless, we set out below some comments on the PROPOSED text. We will circulate an updating Alerter, with a commentary on the likely effects of the new legislation, once there is certainty over the precise wording.
Comment
The original policy objectives and intended effects of the new legislation, stated by the UKIPO, were as follows:
- UK law should be changed to exempt from infringement activities involved in clinical trials, field trials and health technology assessment (HTA) for innovative drugs/therapies or drug/therapy combinations.
- Changing the law will reduce the cost to industry as it will no longer be necessary to assess the infringement position prior to carrying out trials. Additionally, this will make the UK a more attractive location for clinical/field trials which may bring economic benefits to the UK.
The current proposed wording would appear to achieve these objectives and intended effects and will be welcomed by the innovative pharma industry. However, there are some potential causes for concern with the wording.
One of the issues debated during the consultation related to 'research tool' patents; these are patents that claim methods or products that are used to find new compounds or to test them, rather than patents that claim the compounds themselves or their method of use.
A range of views was expressed as to whether the use of research tools for the purposes of obtaining data for regulatory approval, should be exempted. Research tools, once deployed, have no further value, so a strong view expressed by stakeholders in the research tool industry was that their use should not be exempted by this new legislation.
Despite this debate, the proposed wording exempts, "anything done in or for the purposes of" "any testing, course of testing or other activity" to obtain data for "obtaining or varying an authorisation" or "complying with any regulatory requirement". This provision clearly covers the use of a patented research tool. Such activities will (from implementation of the new legislation) be taken to be done for "experimental purposes relating to the subject matter of the patent" and therefore fall within the experimental use exemption from patent infringement. This is despite the fact that such "experiments" will clearly NOT relate to the "subject matter" of the research tool patent under current UK case-law.
Although in theory the EU Bolar exemption covers research tools in the context of generic medicines, they are much more likely to be used in innovative research.
Another point to note is that the proposed exemption is limited to "medicinal product[s] for human use or a veterinary medicinal product". It does not include within the exemption plant protection products (such as pesticides). As noted in our earlier Alerter, there is a certain irony in that the whole experiment use exemption debate was started off by the Monsanto v Stauffer case which related to such a product.
Finally, if the proposed exemption survives in its current form, as noted in our earlier Alerter, it would result in a significant conflict with the Agreement on a Unified Patents Court. Article 27 of that Agreement (signed by the majority of EU states) sets out "experimental use" (27(b)) and "Bolar-type" (27(d)) exemptions from patent infringement using the wording of the current UK legislation (i.e. both narrow). Assuming the UPC Agreement is ratified and comes into force, there will, on the face of the various sources of legislation, be a conflict in the extent of the exemptions from patent infringements between this new UK proposal, and the UPC law.
While patents with unitary effect (i.e. those not opted-out of the UPC system) will (on its face) be subject to the narrower exemptions from patent infringement set out in the Agreement, there remains a debate as to which law will apply to patents which have been opted-out of the UPC. It may be that such UK designated 'opted-out' patents will be subject to the wider exemptions of this new proposal, while Unitary patents are subject to the much narrower exemptions of the Agreement.
However, there are also those who express the opinion that once in force, all European patents - whether of unitary effect, or opted-out - will be subject to the law of the agreement and therefore be subject only to narrow exemptions from infringement. This debate is one for further down the line.
Footnotes
[] Contains public sector information licensed under the Open Government Licence v2.0.