Pregabalin: what the patent litigation means for doctors and drug companies

Generic prescribing is near universal in the UK, taught in all medical schools, and recommended (with few exceptions) in the BNF.1 It has substantial clinical and cost benefits: generic drugs are usually cheaper than branded products and the generic names make it easier for clinicians and patients to know which class each drug belongs to, providing a harmonised nomenclature that can help reduce the risk of drug errors.

However, in an unprecedented step, in 2015, NHS England wrote to all clinical commissioning groups (CCGs) instructing them to ensure that doctors prescribe pregabalin as branded Lyrica when it was being used to treat pain. The letter, which caused clinicians much concern, was the most visible output from a complex and extensive web of interlocking legal battles about patent protection (box 1). Collectively, these cases have enormous financial consequences for the NHS and raise important issues around medical autonomy, incentives for innovation, the role of regulators, and the entire legal framework around new uses for old drugs.