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BioIndustry Association Release: IPO Decision on Research and Bolar Exemptions Should Encourage Clinical Trials in UK



2/26/2013 11:19:54 AM

26 February 2013 -- The BIA has welcomed the UK Intellectual Property Office decision on the Research and Bolar Exceptions, which will make the UK a more favourable location for innovative biopharmaceutical research and development.

Today's announcement provides clarity regarding the UK's interpretation of the Research and Bolar Exceptions so that developers of innovative products are afforded the same level of protection and certainty as others. The BIA recommended this course of action when it first responded, on behalf of the bioscience sector, to the IPO consultation in 2008.

Steve Bates, BIA Chief Executive Officer, said:

"The BioIndustry Association (BIA) welcomes the government's activity in the area and their recognition that an amendment to the Patent Act, to remove the risk of drug development companies infringing patents while conducting research, could improve the UK as a location for clinical trials. We are pleased to see this now being taken forward."

"The BIA is particularly pleased that the government has listened to the sector and that its proposed course of action is exactly that which the BIA proposed in its consultation response."

The BIA's Intellectual Property Advisory Committee has engaged with the UK IPO on this issue over a number of years, contributing to the IPO consultation in 2008. The BIA also responded to the informal and formal consultations announced following the government's decision to review the Bolar exemption in its Plan for Growth.

For further information, please contact Robert Winder, Head of Communications, rwinder@bioindustry.org, 020 7630 2191; mobile 07825 942 934.

Government response to the UK Intellectual Property Office consultation: Research and Bolar Exception: Proposals to exempt clinical and field trials using innovative drugs from patent infringement http://www.ipo.gov.uk/response-2012-bolar.pdf

BIA response to IPO formal consultation: http://bit.ly/BIA_bolar

BioIndustry Association

Founded over 20 years ago at the infancy of biotechnology, the BioIndustry Association (BIA) is the trade association for innovative enterprises involved in UK bioscience. Members include emerging and more established bioscience companies; pharmaceutical companies; academic, research and philanthropic organisations; and service providers to the bioscience sector. The BIA represents the interests of its members to a broad section of stakeholders, from government and regulators to patient groups and the media. Our goal is to secure the UK's position as a global hub and as the best location for innovative research and commercialisation, enabling our world-leading research base to deliver healthcare solutions that can truly make a difference to people's lives. For further information, please go to www.bioindustry.org


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