The UK Government has announced plans to exempt clinical and field trials from patent infringement, following a period of consultation by the UK Intellectual Property Office (IPO). This experimental use exemption from patent law will mean that parties are free to use innovative drugs for clinical and field trials to obtain regulatory approval for them in any country, even if the innovative drugs, or aspects of them, are covered by other parties' patents.
Currently, organisations undertaking the necessary activities required to secure regulatory approval to market innovative drugs, such as clinical trials for human drugs and field trials for veterinary drugs, can run the risk of infringing other parties' patents. Responses to the UK IPO's consultation suggested that existing UK law causes legal uncertainty and significant expense for affected organisations. According to participants in the consultation, because of the current legal situation, clinical and field trials are being "off-shored" to more innovator-friendly countries such as Germany, manufacturing of innovative new drugs is taking place outside the UK and, consequently, there are delays in innovative new drugs going to market and reaching patients in the UK.
Under the Government’s plans, which are scheduled to come into effect on Tuesday 1 October 2013, the Patents Act will be amended by a Legislative Reform Order. The exact changes to the law to be made have not yet been proposed.
Gareth Williams, Life Sciences Patent Attorney and Cambridge-based Partner at Marks & Clerk, comments: “This is excellent news for many in the UK life sciences industry, including originator drugs companies, clinical research organisations, publicly funded research bodies and charities. The Government’s plans to exempt clinical and field trials involving innovative drugs from patent infringement will reduce the current legal uncertainty and costs associated with possible infringement. This will help remove the need to off-shore clinical and field trials, encourage UK manufacturing, and give UK patients earlier access to innovative new drugs.
"Since the new exemption to patent infringement will apply to the use of innovative drugs for clinical and field trials to obtain regulatory approval for them in any country, this may help the UK become a more attractive centre for international clinical trials."
Gareth Williams continues: “By adopting this research exemption, the UK Government is bringing UK patent law in line with patent laws in other European countries. In the UK, although an exception already exists in the Patents Act, it has been subject to many court cases, which have narrowed its interpretation and shorn it of its power. The Government is now seeking to redress this imbalance, and ensure that the UK's intellectual property system supports the life sciences sector.”
A copy of the Government’s response to the consultation can be found here: http://www.ipo.gov.uk/response-2012-bolar.pdf
About Marks & Clerk
www.marks-clerk.com
Marks & Clerk is recognised as one of the world's leading intellectual property firms. The firm’s patent and trade mark attorneys together with associated firm of solicitors offer clients a comprehensive range of intellectual property services – covering patents, trade marks, designs and copyright. This includes obtaining protection worldwide, portfolio management, strategic advice, commercial advice, licensing, enforcement, due diligence and litigation. Marks & Clerk has expertise in a whole range of commercial sectors and technologies.
With a network of 18 offices across the UK (10 locations), Europe, North America, the Far East and Australia, and long-established relationships with other leading IP firms worldwide, the firm is able to meet clients' IP requirements on a local and global basis.
*******
If you would like to speak to Gareth Williams at Marks & Clerk, please contact:
Richard Holme
Marks & Clerk
E: rholme@marks-clerk.com
T: +44 (0) 20 7420 0104
___________________________________________________________
Clinical research 'likely to return to the UK' following change in patent law
27 February 2013
Intellectual Property specialists Marks & Clerk comment on the Government decision to exempt clinical and field trials from patent infringement.