News – full story

THE UK government says it is looking to change its pharmaceutical patent laws, in a bid to revitalise the country’s status as an international R&D hub.

Starting today, it will run a two-month consultation over the best way to smooth out problems in the clinical trials process – a vital step of getting new drugs approved for sale in the UK. The government is asking for industry feedback on the proposals, which aim “to make the UK a more favourable place for pharmaceutical companies.”

Sean Dennehey, CEO of the UK’s Intellectual Property Office (IPO), claims that the government’s “previous discussions with the pharmaceutical industry revealed a widespread appetite for change in the way UK patent law treats clinical or field trials.”

“This consultation now offers a formal opportunity to shape the patent infringement provisions so that they can better support growth in this key industry sector,” he adds.

According to the Department for Business, Innovation and Skills (BIS), current laws prevent companies using patented drugs in trials. This can lead to problems if the company has a legitimate need to use another company’s drug, for example to compare their new drug to an existing product, or to develop therapies which combine a new drug with a previously patented one.

“Currently,” explains BIS, “if a pharmaceutical company uses a patented product as part of their trial they risk being sued by the patent holder.”

The UK has been looking to recapture its former position as a centre for pharmaceutical R&D efforts since falling profits and a so-called ‘patent cliff’ – when patent protection on several drugs expires  in a short period –  forced major players such as GlaxoSmithKline and AstraZeneca to scale back their operations in the country. The biggest loss came when Pfizer closed R&D operations at its enormous Sandwich site, cutting 2,400 jobs in the process.

This latest move follows in the wake of several other efforts to entice the majors back into the UK, including a ‘patent box’ that offers tax compensation for commercialising intellectual property developed in the country, and government protection for science spending.

“The UK needs an intellectual property system which supports our world class UK pharmaceutical industry that invests over £12m (US$19.25m) in R&D every day,” says the UK’s minister for intellectual property, Lord Marland. “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 “

The consultation is running until 19 December, with details available on the IPO’s website.