LSIPR Newsletter 02:13
UK patent change paves way for pharma innovation The UK government has announced a change to the Patent Act that will allow parties to run drug trials without infringing other parties’ patents. The change is in response to a consultation carried out by the UK Intellectual Property Office late last year, in which life sciences stakeholders were invited to give their views on the proposed amendment. A summary of the consultation said that the proposal to change the law was supported by the “overwhelming majority”. After the law is changed, drug development companies may trial new innovative drugs, whatever country they are seeking regulatory approval in. This covers all situations where another company’s patent is implicated in the research. It is hoped to make the UK a more attractive location for carrying out innovative clinical and field trials. The minister for Intellectual Property Lord Younger said: “The government is keen to create a supportive environment for pharmaceutical research and development in the UK. Helping the industry get their products to market as quickly as possible will benefit patients, the industry and the economy.” James Robertson, partner at Marks & Clerk in London, said: “This is excellent news for many in the UK life sciences industry, including originator drugs companies, clinical research organisations, publicly funded research bodies and charities.” He added that the plans will reduce the costs and “legal uncertainty” associated with
UK patent law has been brought in line.
“The plans will reduce the costs and ‘legal uncertainty’ associated with patent infringement.” patent infringement, adding: “This will help remove the need for off-shore clinical and field trials, encourage UK manufacturing, and give UK patients earlier access to innovative new drugs.” Participants in the consultation described Germany as a more “industry-friendly” location for carrying out drug trials, as it exempts from patent infringement any studies
Life Sciences IP Review
or trials necessary to bring a drug to the market in any country. “By adopting this research exemption, the UK government is bringing UK patent law in line with patent laws in other European countries,” Robertson said. “By removing the risk of patent infringement, this change will remove some of the costly obstacles to undertaking clinical and field trials in the UK, specifically those required by the MHRA and EMA to obtain regulatory approval to market, and those required by NICE to support health technology assessments. “This will be of particular benefit to pharmaceutical companies developing new drugs, and to clinical trials companies.” The amendments to the UK Patent Act are proposed to come into effect on October 1, 2013. n