UK Supreme Court rules against Pfizer in landmark second medical use patent case

Pfizer’s original patent for its epilepsy treatment pregabalin expired in 2014, but the company also secured a second-use patent protecting the drug as a treatment for pain until July 2017. They think generic alternatives infringe this patent as they would also be prescribed for pain despite targeting non-protected indications. In October 2016, the Court of Appeal upheld a previous High Court decision that the patent covering pregabalin for pain was not infringed by generics, and also that patent claims directed generally to pain and neuropathic pain are invalid. The Supreme Court has now agreed with this ruling that patent claims relevant to the neuropathic pain indications are invalid. And thus Pfizer’s battle to uphold pregabalin’s protection as a treatment for pain has come to an end.

Pfizer said: “This ruling has significant impact on innovation in public health. The period that a medicine is under patent is a critical phase in its lifecycle that fuels innovation, as science evolves and knowledge grows, patients increasingly benefit from ongoing research into new uses for existing medicines. As situations such as these are expected to become more common, it’s important for patients that pharmaceutical companies are able to protect patents, including second medical use patents.”

Mewburn Ellis partner, Nick Sutcliffe, said it is “potentially bad news for patentees, not least in the biotechnology and pharmaceutical fields. The ruling will make patents easier to avoid and more vulnerable to invalidation and thus weaken patent holders’ rights and ability to innovate with confidence. The ruling confirms that patentees need to provide a significantly broader range of evidence to justify the scope of their patent protection – which risks placing an onerous burden on rights holders and thus increases the cost and uncertainty of obtaining and enforcing patent rights.”