UK protection for pharmaceutical research companies

A new consultation sets out proposals to make the UK a more favourable place for pharmaceutical companies to carry out research and development of new drugs.

The UK needs an intellectual property system which supports our world class UK pharmaceutical industry that invests over £12m in research and development every day. Our proposals look to remove the uncertainty around patent infringement in clinical and field trials, so that our life sciences sector continues to create jobs and growth in the UK economy. Lord Marland: Minister for Intellectual Property.

The Intellectual Property Office (IPO) is proposing to make changes 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 human clinical trials or animal field trials to show the product is safe and effective.

Under current UK patent law, limited research and tests can be conducted using patented products required for the regulatory approval of generic drug products without infringing the rights of the patent owners. However, clinical and field trials for new drugs are not exempt from patent infringement.

There are many instances where a company may legitimately need to use a patented drug in a clinical trial, for example to compare its new drug with a patented product, or to develop therapies which combine the use of the new drug and a patented product. Currently, if a pharmaceutical company uses a patented product as part of its trial it risks being sued by the patent holder. Today’s proposals would remove this risk and create a more supportive environment for pharmaceutical research and development in the UK.

The consultation will run for eight weeks from 24 October to 19 December 2012.