In an unprecedented move, a UK High Court judge has ordered NHS England to issue guidance to medical professionals to help ensure that a second medical use patent is not infringed. The decision is part of an ongoing dispute full of twists and turns.
If at first you don’t succeed…
Warner-Lambert (and its parent company Pfizer) recently unsuccessfully sought an interim order against a competitor company, Actavis concerning the marketing of pregabalin1. For a detailed discussion of the decision click here2, but brief details are summarised below.
Pregabalin is a drug which is effective in the treatment of a variety of conditions, including epilepsy, generalised anxiety disorder and neuropathic pain. The drug itself is no longer patented, but Warner-Lambert holds a second medical use patent directed to the use of pregabalin for the treatment of neuropathic pain. Warner-Lambert markets pregabalin under the trade mark LyricaTM.
Actavis makes a generic version of pregabalin under the trade mark LecaentTM. It plans to launch this for the treatment of epilepsy and generalised anxiety disorder, but not neuropathic pain, under a so-called “skinny label” marketing authorisation. However, Warner-Lambert is concerned that pharmacists may dispense LecaentTMnot only if the patient has been prescribed pregabalin for the treatment of epilepsy or generalised anxiety disorder, but also if the prescription was for the treatment of neuropathic pain.
This is because the NHS encourages physicians to prescribe generically, where possible, and prescriptions typically refer only to the product being prescribed, not to the indication for which it is being prescribed. If a prescription only states the generic name of a drug, the pharmacist may dispense the branded or generic form of that drug. However, if a prescription refers to a drug by its brand name, then only that brand may be dispensed.
Warner-Lambert sought interim relief to compel Actavis to carry out several particular steps to ensure that LecaentTM would not be dispensed for use in the patented indication. On 21 January 2015 UK High Court judge Mr Justice Arnold issued a decision refusing Warner-Lambert’s application for interim relief1.
…try, try again
The decision of 21 January 2015 was only one element in an ongoing saga and some of the recent key developments are discussed below.
Warner-Lambert was quick to react, applying for permission to appeal the above decision. Although Mr Justice Arnold refused this application, permission was subsequently granted by the Court of Appeal. We will report on the outcome of this appeal as soon as it is available.
A full trial pertaining to the validity and infringement of Warner Lambert’s patent is scheduled for June 2015. Following the 21 January 2015 decision, Actavis has unsuccessfully applied for a strike out or summary dismissal of Warner-Lambert's entire claim. The 21 January 2015 decision also prompted Warner-Lambert to apply to amend the particulars of its infringement to plead a case that Actavis intended LecaentTM to be used for the treatment of pain3. We will comment on this decision in a separate post.
Nevertheless, Warner-Lambert still had a problem: how to make sure that when pregabalin is prescribed for neuropathic pain, only LyricaTM will be dispensed remained. Mr Justice Arnold had acknowledged that it does not lie within the power of either Warner-Lambert or Actavis to ensure that this happens. He had indicated that he would urge NHS England to consider issuing guidance to physicians to prescribe pregabalin by reference to the brand name LyricaTM for the patented indication and by reference to the generic name pregabalin for non-patented indications.
In an extraordinary move, Warner-Lambert therefore applied to the court for an order requiring NHS England to issue guidance to physicians to prescribe pregabalin by reference to the brand name LyricaTM when prescribing it for the treatment of neuropathic pain. As foreshadowed by his earlier comments, on 26 February 2015 Mr Justice Arnold concluded that the issuing of guidance by NHS England would be “the most efficacious, dissuasive and cheapest solution to the problem which confronts Warner-Lambert”4. In making the order, he applied essentially the same approach he had previously adopted in a case relating to website blocking orders in respect of sites selling counterfeit goods5. Thus, NHS England was ordered to issue guidance to doctors and pharmacists setting out that Pregabalin should only be prescribed for the treatment of neuropathic pain under the brand name LyricaTM 4.
Of course, the order contains various safeguards. In particular, it will cease to apply if the patent is revoked or expires. Warner-Lambert also had to give a cross-undertaking in damages in favour of NHS England and the Department of Health, as well as Actavis and several other manufacturers of generic pregabalin.
Watch this space
Guidance from the NHS on prescription practices might well be a good way of minimizing infringement of second medical use patents by generics companies with skinny label marketing authorisations. It will be interesting to see whether this decision signals the start of a new trend in this regard.
As mentioned above, a full trial concerning validity and infringement issues pertaining to Warner-Lambert’s second medical use patent is expected to take place in June 2015. We will monitor the progress of this sage and report on any further developments.