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UK researchers able to use patented drugs in trials

Patents Act updated to allow comparator studies without risk of patent infringement

UK patents act updateThe UK Patents Act is to be updated to allow companies to run comparator studies involving patented drugs without facing the risk of patent infringement.

The ruling, which was announced by the Department for Business, Innovation and Skills (BIS), means that companies conducting investigational studies for a new medicine in the UK will be able to use a rival product from another company during the study.

This is especially important for studies to support health technology assessment (HTA), which often necessitate a comparison between a new drug and the market-leading product to ensure a product is a cost-effective use of resources before approval.

The move was welcomed by the industry, with Stephen Whitehead, chief executive of trade body the Association of the British Pharmaceutical Industry (ABPI), commenting on the potential benefit for research in the UK.

“This is a welcome development that will make the UK a more attractive place in which to conduct clinical trials, which in turn will encourage pharmaceutical companies to continue operating here,” he said.

The UK biotech trade body the BioIndustry Association (BIA) also welcomed the decision as a boost for UK research, which has faced increased competition in recent years from emerging markets, such as India and China.

The BIA's CEO Steve Bates said: "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 consultation period ran for eight weeks from October 24, when the proposal was first put forward by the Intellectual Property Office (IPO) – part of BIS.

According to BIS, there were an “overwhelming majority of responses supporting a change to the law” during this period.

Lord Younger, minister for intellectual property, said: “The government is keen to create a supportive environment for pharmaceutical research and development in the UK. Helping the industry get their products to market as quickly as possible will benefit patients, the industry and the economy.“

Speaking to PMLiVE, a BIS spokesperson could not confirm an exact date for the update to be implemented, but said BIS was expecting it some time in October 2013.

27th February 2013

From: Research, Sales



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