The Bolar exemption allows a generic medicine developer to avoid infringement of patents covering the drug being copied when carrying out the necessary studies, trials and consequential practical requirements to obtain market authorisation from the regulatory authorities.
Conducting the necessary studies and trials with a view to the application of … [paragraphs 1 to 4 of this Article – relating to obtaining generic authorisations] … and the consequential practical requirements shall not be regarded as contrary to patent rights or to supplementary protection certificates for medicinal products.
Paragraphs 1 to 4 relate to approval of ‘generic medicinal products’ that may require bioavailability studies to demonstrate bioequivalence to a reference product, approval of products that are not strictly classified as ‘generic medicinal products’ and may require pre-clinical tests or clinical trials, and biological medicinal products which are similar to reference product and may require pre-clinical tests or clinical trials.
Paragraph 5 of the Article, which is not exempted from infringement under the Directive, relates to pre-clinical tests or clinical trials to obtain approval for use of a known medicinal product in a new indication.
National Implementation in the UK
This European legislation, being a Directive, required implementation in individual member states. The UK implemented the Directive by introducing wording very closely corresponding to Article 10.6 into Section 60(5) of the Patents Act 1977. The Section provides that:
An act which, apart from this subsection, would constitute an infringement of a patent for an invention shall not do so if –
(i) it consists of – (i) an act done in conducting a study, test or trial which is necessary for and is conducted with a view to the application of paragraphs 1 to 5 of article 13 of Directive 2001/82/EC or paragraphs 1 to 4 of article 10 of Directive 2001/83/EC, or (ii) any other act which is required for the purpose of the application of those paragraphs.
This statutory exemption has not been tested in a court in England, but it is likely from the language of the Section and the Directive that it does not provide protection:
for acts done to obtain authorisation for new indications using existing products;
for acts done comparing a new product to a reference medicinal product in clinical trials as is seen where a standard of care exists for a given indication; or
for acts done to develop new products using existing platforms or enabling technologies.
National Implementation in the UK
This narrow implementation of the Directive stands in stark contrast to the broad implementation seen in other member states including Germany. There the broad statutory exemption extends to acts carried out to obtain approval for any medicinal product in any country in the world.
Surveying all EU member states it appears that the majority have broad implementation. Cyprus, Spain, Greece, Ireland, Luxembourg, Netherlands and Sweden are the only other members having a narrow implementation similar to that described for the UK.
Informal UKIPO Consultation on Bolar
The UK Intellectual Property Office (UKIPO) launched an informal public consultation on the Bolar-type exemption in June 2011. This process was “in part, a response to stakeholder concerns that the current regulatory framework puts them at a risk of patent infringement when carrying out clinical and field trials for non-generic products, resulting in an unwillingness to conduct such trials in the UK.”
The consultation asked respondents to comment on the UK Bolar regime and to indicate how it balanced parties’ rights, how particular circumstances influence risk, how it impacted on business decision making and how it might be changed for the better.
Consultation process results were published in November 2011, and all but one of the parties that provided input indicated that there is a need for change. There was consensus around the need for legislative change, and most indicated that similar scope to the current German law was desirable.
The major outcome of this process was a commitment from the UKIPO to begin formal consultation on proposals to amend the Patents Act and address the concerns it had identified.
Formal UKIPO Consultation on Bolar
UKIPO initiated a formal consultation on the Bolar exemption in October 2012. The consultation provided three discrete proposals for legislative change, and it asked participants to rank them in order of preference and to provide detailed information on the economic impact of their effects on all parties involved. Participation in the consultation was very broad and included innovator and generic pharmaceutical and biopharmaceutical companies, pharmaceutical and biotechnology trade associations, legal professional bodies representing patent attorneys and solicitors, trade associations of patent owners, universities and others.
The response to the consultation was published by the UKIPO in December 2012. It opened by stating that “[t]he overwhelming majority of responses to this consultation agree that section 60(5) of the Patents Act 1977 should be changed to exempt from infringement activities which are carried out when preparing, or running, clinical or field trials using innovative drugs.”
On considering the responses provide the government accepted the need to amend the Patents Act to include an exemption from infringement for activities involved in preparing or running clinical or field trials involving innovative drugs for the purpose of gaining regulatory approval in any country. This exemption should also cover activities involved in health technology assessment (HTA) required to ensure reimbursement for drugs from the National Health Service.
The UKIPO issued a press release early in 2013 indicating that the Patents Act is to be amended and highlighting the Government’s commitment to supporting pharmaceutical development in the UK. The IP Bill published in May 2013 did not address this issue, but the UKIPO is directing the enactment of secondary legislation that is expected to come into effect by 1 April 2014, and it is hoped that pharmaceutical development in the UK will increase as a result.
It should be noted that the Unified Patent Court agreement as signed by the UK and 24 other EU member states appears to limit the scope of the Bolar exemption to that provided by EU Directives. This offers the prospect of different exemptions being available within an individual member state depending on whether a medicinal product is protected by a national patent, a non-opted out European patent, a unitary patent or an SPC.
It is clear that this story has a long way yet to run.
For further information or to discuss any particular concerns, please contact your us.