The Intellectual Property Office is consulting on changes to the Patents Act that would see developers of innovative drugs use patented drugs in order to secure regulatory approval for new drugs, without fear of being sued for patent infringement. In the UK, the so-called Bolar exception only applies to acts done in the course of seeking regulatory approval for generic drugs. Changes made pursuant to the IPO consultation would see the UK position come more into line with other pro-innovative countries in Europe such as Germany. The IPO has requested comments from all interested parties and it is open until 19 December 2012. It can be found here: http://www.ipo.gov.uk/pro-policy/consult/consult-live/consult-2012-bolar.htm.
Stephen Whitehead, the Chief Executive of the ABPI, which represents many big pharma companies, says: “I am pleased to welcome the Government’s consultation in to Research and Bolar Exceptions. The pharmaceutical industry researches and develops new life changing treatments every year and adds billions to the UK economy as well supporting many thousands of jobs. It is important therefore industry operates in an environment that supports its continued success and we remove barriers that could hinder on-going investment in to medical research in the UK. The legal framework in the UK needs to support companies so that their intellectual property rights are not infringed whilst conducting clinical trials. This will give innovators the freedom to undertake comparative studies so they can provide data on clinical effectiveness. This small but significant proposed amendment to the current Research and Bolar Exceptions will help to clarify the law in this area and support the research based pharmaceutical industry in their discovery of innovative new medicines.”
Meanwhile, Steve Bates, CEO of the BioIndustry Association, which represents many biotech companies, has also welcomed the move: “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.”