The government is likely to change patent laws because some pharmaceutical companies are at risk of breaking patent law when carrying out clinical testing, the Intellectual Property Office (IPO) has said.
The IPO said that three-quarters of respondents to its recent consultation on patent infringement in pharmaceutical clinical and field trials had backed changes to the UK's Patents Act. Companies in the pharmaceuticals industry had said that the threat of legal action was stifling the development of innovative new drugs.
"The government acknowledges that the current wording of UK patent legislation does put some parties at risk of patent infringement when preparing and running UK clinical or field trials involving innovative drugs," the IPO said in publishing the results of its consultation. (16-page/480KB PDF)
"From the empirical evidence received, it is apparent that current legislation results in a cost burden to some stakeholders. The scale of these costs varies depending on the patent landscape that surrounds the drug/s used in a trial. However, it is clear that amending the legislation to remove risk of patent infringement would result in a cost saving to those companies who are considering using the UK for clinical trials with innovative drugs," it said.
In 2005 changes were made to the Patents Act to make the use of patented material during some clinical testing of human and animal medicines exempt from being an infringement of patent owners' rights. This is called the 'Bolar exemption' and stems from EU law. Under the Patents Act any act "done for experimental purposes" relating to the subject-matter of an invention are also exempt from being classed as acts of infringement.
The IPO said that research had shown that the UK had become a less popular place for clinical trials to take place. It said that pursuing changes to EU law to clarify the scope of the Bolar exemption would be "slow" and that industry agreements would offer "unacceptable" solutions to the problem.
"Proposing legislative change at the EU level may not receive support from EU Member States whose domestic legislation already deals with this matter," the IPO said. "Industry agreements are considered unacceptable as they may lead to an uncertain infringement situation."
“Although the so called 'Bolar exemption' to patent infringement derives from EU law, member states have implemented it differently in national laws. This has created practical differences and uncertainty from country to country in relation to what acts are considered to be non-infringing,” Camilla Balleny, expert in life sciences at Pinsent Masons, the law firm behind Out-Law.com, said.
“Organisations from across the pharmaceutical industry – including those represented by both the Association of the British Pharmaceutical Industry and those Represented by the European Generics Association - responded to the consultation. The vast majority of respondents have called on changes to be made to UK law to provide further certainty, particularly in relation to clinical trials," Balleny said.
"In October 2005 the UK implemented the Bolar exemption in the same terms as the European Directive. The IPO also issued further guidance on what activities the exemption would cover but there has, despite this, been uncertainty and it is this which the industry has now seemingly confirmed it wants to be clarified by further amendments to the UK law,” Balleny said.
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