Patent infringement exemptions in the UK to life sciences products are confusing which is not surprising considering that there are three reference points:
- Original Experimental Use Exemption(Section 60(5)(b) Patents Act 1977). This is still in force and applies to all patents e.g. medicines, medical devices and agrochemicals.
- Bolar Exemption – based on European law but enacted in Section 60(5)(i). This exemption is still in force but only applies to medicinal products governed by European Directive 2001/83/EC (the “Directive”).
- New Experimental Use Exemption– introduced into the UK in October 2014. This exemption expands the scope of experimental purposes of the Original Experimental Use Exemption and is now part of Section 60(6D) and (6E) Patents Act 1977. Like the Bolar Exemption, it applies only to medicinal products under the Directive.
THE ORIGINAL EXPERIMENTAL USE EXEMPTION IN THE UK
The Original Exemption applies to all subject matter, with leading cases on agrochemicals and medical devices.
Monsanto v Stauffer (agrochemical case)
In this case the defendants wanted to amend an injunction which was ordered against the manufacture and sale of their herbicide. The Court of Appeal permitted limited modifications to the injunction so that it didn’t prevent the defendants from conducting experiments on the herbicide in laboratories or glasshouses in the UK to find out more about it. But the court wouldn’t allow field trials for the purpose of full commercial clearance from the Pesticides Safety Precautions Scheme and the Agricultural Chemicals Approval Scheme.
The line between exempted and non-exempted experiments under the Original Experimental Use Exemption was explained by the Judge as follows:
Trials carried out in order to discover something unknown, or to test an hypothesis, or even in order to find out whether something which is known to work in specific conditions, e.g. of soil or weather, will work in different conditions can fairly … be regarded as experiments. But trials carried out in order to demonstrate to a third party that a product works or, in order to amass information to satisfy a third party, whether a customer or a [regulatory] body such as the PSPS or ACAS, that the product works as its maker claims are not to be regarded as acts done for ‘experimental purposes’.
In other words, the court reasoned that exempted experiments are those that generate new knowledge, but not those that verify existing knowledge, for example for getting regulatory clearance.
The Auchincloss decision is consistent with this, holding that making and experimenting with a patented invention merely for the purposes of gaining official approval would not fall within the Original Experimental Use Exemption.
CoreValve v Edwards Lifesciences (medical device case)
The experimental use exemption permits trials to be conducted on a patented drug to ascertain its effect in non-patented medical indications. However, it was still held that the trials at issue did not benefit from the exemption. The reason was that the activity in question was the supply of the defendant’s valve device to selected hospitals as part of a clinical programme to train cardiologists for which Corevalve invoiced a “very substantial” amount.
The authorities draw a distinction between the application of the experimental use exemption to activity conducted for the purpose of discovering something new about the subject matter of the invention, and merely verifying what is already known. In particular, it is generally accepted that this is the case as regards bioequivalence studies for an abridged application – they would not be protected – and it is uncertain that full clinical trials would be protected either.
The UK implementation of Bolar is linked by explicit reference to the abridged application procedures for marketing authorisations in the Directive.
Even though there is no case law on the precise scope of the exemption, the UKIPO and the Medicines and Healthcare Products Regulatory Agency (MHRA) published a practice note to explain their understanding that UK Bolar Exemption exempts from patent infringement activities conducted only for the purpose of obtaining an abridged marketing authorisation application by a generic and no more.
NEW EXPERIMENTAL USE EXEMPTION IN THE UK
The New Exemption came into force in October 2014 as an addition to the Original Exemption. However, the Original Experimental Use Exemption and the Bolar Exemption, remain in force. The New Experimental Use Exemption, covers activity that is conducted “for the purpose of a medicinal product assessment”. A medicinal product assessment is defined as “any testing, course of testing or other activity undertaken with a view to providing data for purposes which include the following: ”
- 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.
Therefore, in addition to the Bolar Exemption, the preparation and running of clinical trials on medicinal products (i.e. any substance or combination of substances), for marketing authorisation are also exempt. Furthermore, work undertaken in the UK in support of a regulatory filing in a country outside of the EU is also now covered.
The result is that, as far as medicinal products are concerned, the distinction drawn in Monsanto v Stauffer and Auchinloss between experiments designed to test for new properties, rather than verify known properties for a regulatory body, seems to have been revised by the New Exemption.
Although there are three exemptions potentially applicable to patent infringements concerning life sciences products in the UK, the application and development of the Original Experimental Use Exemption and then the Bolar Exemption in UK law has very limited scope. The legal extent of the scope of the New Experimental Use Exemption in the UK is yet to be decided in court. Possible clarifications would be directed to the reference to medicinal product which can be any substance i.e. something which is administered to a human with a view to restore, correct or modify a physiological, immunological or metabolic action. The New Experimental Use Exemption however does not provide clarity on suppliers. Further clarity would be necessary suppliers who supply the materials for the gene therapy trials in the UK who may not be covered.
Please contact us directly if you would like further information or need to discuss any issues.