Pregabalin: what the patent litigation means for doctors and drug companiesBMJ 2018; 361 doi: https://doi.org/10.1136/bmj.k2318 (Published 07 June 2018) Cite this as: BMJ 2018;361:k2318
- Darren Smyth, partner1,
- Richard Croker, honorary research fellow2,
- Ben Goldacre, director2
- 1EIP, London, UK
- 2EBM DataLab, Centre for Evidence Based Medicine, University of Oxford, Oxford, UK
- Correspondence to: B Goldacre
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.
How the pregabalin litigation unfolded
17 May 2013: Pfizer product patent on pregabalin expires (EP0641330)
14 October 2013: Lapse of supplementary protection certificate (SPC) because of non-payment of fees noted on Register of Patents in UK
19 March 2014: Generic firm Actavis becomes aware that SPC has not been activated
24 June 2014: Generic firm Mylan begins patent revocation action against Pfizer’s second medical use patent (EP0934061)
8 July 2014: Data exclusivity on Lyrica pregabalin marketing authorisation expires, meaning a generic firm can use Pfizer trial data to obtain a marketing authorisation
9 July 2014: Actavis applies for marketing authorisation for their form of pregabalin, Lecaent …