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Important news for pharmaceuticals companies: the Bolar exemption is about to be broadened

Lab technician with a pipette Print publication

08/07/2014

Before a medicinal product can be marketed in the UK, it must first be given regulatory approval following clinical tests to show that the product is safe and effective. Producers of generic medicines can use the original manufacturer’s approval provided they can show that the generic product is bioequivalent to the approved medicine. However, the generic producer may face an action for patent infringement if it conducts clinical trials on a patented product before the expiry of the patent. The Bolar exemption means that such clinical trials will not constitute patent infringement.

The exemption sits within two EU directives, the directive on medicinal products for human use [1]; and a directive on veterinary medicinal products [2], and the relevant provisions are transposed into English law by section 60(5) of the Patents Act 1977.

The Government has been consulting on broadening the scope of the Bolar exemption and, to that end, the draft Legislative Reform (Patents) Order 2014 (the draft Order) was laid before in Parliament on 6 May 2014. Broadly, the draft Order will extend the Bolar exemption to cover the conducting of necessary trials and health technology assessments of all drugs, both novel and generic, and all applications for marketing authorisations.

The test to be applied under the draft Order is whether the study is carried out for the purposes of a “medicinal product assessment”. This is defined as meaning any testing, course of testing or other activity undertaken with a view to providing data for any of the following:

  • obtaining or varying an authorisation to sell or supply, or offer to sell or supply, a medicinal product (in the UK or elsewhere)
  • complying with any regulatory requirement imposed (in the UK or elsewhere) in relation to such authorisation
  • enabling any government or public authority 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.

A medicinal product for these purposes covers products for both human and animal use.

In particular, two types of study, not previously permitted in the UK, will now be permitted:

  • clinical trial studies required to obtain regulatory approval or market authorisation for a new drug from a Competent Authority, such as the Medical and Healthcare Products Regulatory Agency. These trial studies often require comparative work against currently available patented drugs
  • health technology assessment carried out by organisations like the National Institute for Health and Clinical Excellence (NICE), which are necessary for a new treatment to be recommended to the NHS. These too can require comparative work against currently available patented drugs.

The broadening of the Bolar exemption to permit trials conducted for the purpose of generating data to support an application for market approval for a new drug in the UK without the risk of infringing UK patents will be welcomed by innovator drug companies. The new legislation will bring the UK into line with other EU Member States, which already operate a broader Bolar exemption, and should therefore help to improve the UK’s competitiveness as a forum for innovators seeking to trial new drugs.

The current intention is for the legislation to come into effect on 1 October 2014.

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[1] 2001/23/ETC
[2]
[2001/82/EC

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