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Drug researchers could run comparator studies concerning patented drugs in the UK, without infringement consequences, as a result of an update of the country’s Patents Act.

By Anonymous on Feb 27, 2013

This update, declared by the Department for Business, Innovation and Skills (BIS) will mean that companies could conduct investigational studies for a new medicine in the UK, using a competing product from another company.

The consultation period for this proposed update was put forward on October 24 2012, by the Intellectual Property Office (IPO), who are part of BIS and then ran for eight weeks. 

Minister for Intellectual Property Lord Younger 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.”

Chief executive of trade body the Association of the British Pharmaceutical Industry Stephen Whitehead also supported this ruling as he said, “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.”  

The update of the Act is an important development for studies in order to support health technology assessment (HTA). This form of analysis often requires a comparison between an established market product and a new drug so as to determine whether a product enables a cost-effective use of resources before approval.

Additionally, the BioIndustry Association (BIA), which is the UK’s biotech trade body, also welcomed this decision as it offers a potential improvement for UK research. In recent years, the UK research sector faced ongoing competition from emerging markets like India and China. 

CEO of the BIA 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.”

An exact date for the implementation of this change is not known although BIS has estimated that it will take place during October 2013.