The government is looking to make it easier to allow pharma firms to use patented drugs in clinical trials in the hope of making the UK more attractive to researchers.
Currently under UK law, only limited research can be done when using patented products in trials in order to gain approval of generic drug products, without infringing the rights of the patent owners. But clinical and field trials for new drugs are not exempt from patent infringement, meaning they can face legal issues when pitting one drug against a patented medicine.
The new proposals seek to add clarity to the UK’s position on the types of research and clinical trials that can be carried out in the country, without giving rise to a risk of patent infringement.
There are many instances where a company may need to use a patented drug in a clinical trial, for example to compare their new drug to a patented product in a head-to-head trial, or to develop therapies which combine the use of their new drug and a patented treatment.
Currently, if a pharma company uses a patented product as part of their trial they risk being sued by the patent holder. These new proposals would remove this risk and create a more supportive environment for pharmaceutical research and development in the UK.
Steve Bates, chief executive of the BIA, said: “We welcome the government’s commitment to reviewing this issue and ensuring everything is done to make the UK an attractive location to conduct research and clinical trials.
“Biopharmaceutical companies invest more in R&D in the UK than any other sector and we have all the tools to continue to develop new medicines for patients. We look forward to engaging with government on this issue to ensure any barriers to continued such investment is removed.”
