The Intellectual Property Office is proposing a change to the Patents Act to make the system fairer by allowing clinical and field trials for new drugs to be carried out without risking being sued for patent infringement.
Marketing a drug in the UK needs regulatory approval which requires conducting clinical trials or animal field trials to show that the product is safe and effective. Under current UK law, limited research and tests can be conducted without infringing the rights of a patent holder. For instance an exemption from infringement is given for the use of a patented product required for the regulatory approval of generic drug products. However, clinical and field trials for new drugs are not exempt from patent infringement.
There are instances where a company may legitimately need to use a patented drug in a clinical trial, for example to compare their new drug to a patented product, or to develop therapies that combine the use of their new drug and a patented product. Currently, if a company uses a patented product as part of their trail they risk being sued by the patent holder. The aim of the proposal would be to remove this risk and create a more supportive environment for pharmaceutical research and development in the UK.
The potential costs to patent holders include the loss of licensing fees and earlier reduction in market share for the patent holder after patent expiry. The first assumes that patentees currently licence their products to third parties for use in clinical trials. The second assumes that third parties seeking to produce a competitor drug either do not run a clinical trial until there is no risk of infringement or that they do not currently run trials while the patent is still in force.