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UK could allow patented drugs to be used in clinical trials

Government proposes update to Patents Act to restrict when companies can sue for infringement

Pharma companies that use drugs patented by other companies during their clinical trials in the UK should not have to worry about being sued for patent infringement, according to the government's Intellectual Property Office (IPO).

The IPO, which is part of the Department for Business, Innovation, and Skills (BIS), has proposed updating the Patents Act to allow companies to use a patented medicine in both human clinical trials, and trials for veterinary products, without infringing the rights of the company that owns the patent.

This would align the law regarding research into investigational drugs more closely to that of generic drugs, for which some, limited, research can be conducted using patented medicines to ensure the products are comparable under the 'Bolar' provision.

The proposal is now up for consultation, and was hailed as a boost to pharma research in the current by the Department for BIS, which noted several areas of research into new drugs where patented products could potentially be used.

These included companies using a patented product as a comparison to their own medicine in development, as well as research into a treatment that combines the use of an investigational drug with a patented product.

The Intellectual Property Office's chief executive Sean Dennehey said: “Previous discussions with the pharmaceutical industry revealed a widespread appetite for change in the way UK patent law treats clinical or field trials.

“This consultation now offers a formal opportunity to shape the patent infringement provisions so that they can better support growth in this key industry sector.”

The consultation was welcomed by UK trade body the BioIndustry Association (BIA), which had previously raised the issue with the government during an informal consultation last year.

John Murphy, chair of the BIA's intellectual property advisory committee, said: "Companies need to have confidence and certainty in the legal framework within which they operate particularly where intellectual property is concerned."

"It is important to provide clarity regarding the UK's interpretation of the Research and Bolar Exceptions so that innovative drug developers operate on a level playing field and we hope this consultation will provide the opportunity to address these issues."

25th October 2012

From: Research



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