" ... [all parties agreed that] the best solution to the problem which arises in this case is to try to ensure that prescribing doctors prescribe pregabalin for the treatment of pain by reference to the brand name Lyrica rather than by reference to the generic name pregabalin. That will ensure that pharmacists only dispense Lyrica when presented with prescriptions for pregabalin which are (at least so far as the prescriber is concerned) for pain without requiring the pharmacist to know the indication for which pregabalin has been prescribed.”
|It was only after the pharmacist had queried|
his third prescription for Lycra that Dr Mog
realised that there might be problems ...
“obvious difficulty with this submission in the circumstances of the present case is that, if my previous judgments are correct, then it is not seriously arguable that Actavis are infringing the Patent.”
“it is well established that Norwich Pharmacal relief is available where there is an arguable case of wrongdoing based on the evidence available at the time of the application…[and that]… in my first judgment of 6 February 2015, I declined to strike out Warner-Lambert’s claim under section 60(1)(c), on the ground that this was a developing area of law and therefore the facts should be found before attempting definitively to decide what the law was, as being sufficient for this purpose.”
- Warner-Lambert Company LLC is engaged in a dispute with a number of generic pharmaceutical suppliers regarding pregabalin, which remains on patent for one indication, namely, the treatment of pain. As part of that dispute, the Court has required NHS England to issue this guidance. Our guidance is that, because of Warner-Lambert's patent rights:
1. Pregabalin should only be prescribed for the treatment of neuropathic pain under the brand name Lyrica® (unless there are clinical contra-indications or other special clinical needs e.g. patient allergic to an excipient, branded product unavailable etc which apply to Lyrica®, when you should not prescribe Lyrica® or pregabalin)
2. When prescribing pregabalin for the treatment of neuropathic pain to patients you should (so far as reasonably possible):
a. prescribe by reference to the brand name Lyrica®; and
b. write the prescription with only the brand name "Lyrica", and not the generic name pregabalin or any other generic brand.3. When prescribing pregabalin for the treatment of anything other than pain, you should continue to prescribe by reference to the generic name pregabalin.
4. When dispensing pregabalin, if you have been told that it is for the treatment of pain, you should ensure, so far as reasonably possible, that only Lyrica®, the branded form of pregabalin, is dispensed. However, when dispensing pregabalin for the treatment of anything other than pain, you are not restricted to dispensing Lyrica®.
To ensure that practitioners are readily able to recall and follow the guidance above, you should consider amending the operation of any electronic prescription system that is within your power or control to include a notice or advice box which uses the following or similar wording:
"If treating neuropathic pain, prescribe Lyrica (brand) due to patent protection. For all other indications, prescribe generically."We will let you know should this position change.