Second medical use infringement

October 2015

Mr Justice Arnold has given his long-awaited judgment on the trial of Warner-Lambert's claim that Actavis would infringe its second medical use patent – claiming the use of pregabalin in the treatment of pain, and in particular neuropathic pain – by marketing Lecaent under a skinny label that excludes those indications. The case concerns both direct infringement under Section 60(1)(c) and indirect infringement under Section 60(2). The validity of the patent being asserted was also challenged by Mylan and Actavis. We reported the earlier stages of this case, up to and including an interim decision of the Court of Appeal, here.

In his judgment, Arnold J has decided that:

  • none of the claims of the patent is obvious over any of the prior art relied upon;
  • claims 1, 3, 4, 6, 13 and 14 of the patent are invalid on the ground of insufficiency; and
  • even if claims 1 and 3 are valid, Actavis have not infringed those claims either directly or indirectly.

Pfizer has also been held liable for making groundless threats of patent infringement proceedings, albeit not in all the cases alleged by Actavis.

A large part of the reasoning in the case focused on the important issue of how to test direct infringement of Swiss form claims under Section 60(1)(c) Patents Act 1977. The judge followed the approach set out by Floyd LJ in the earlier Court of Appeal decision: a manufacturer infringes when he knows or it is reasonable to foresee that users will intentionally administer the manufactured pregabalin for the treatment of pain. This intentional element of the user would be satisfied, Arnold J holds, in circumstances where the doctor has prescribed pregabalin for pain and the pharmacist dispenses Lecaent when he or she knows it has been prescribed for pain.

question marks

The question was then whether, in the 5% of cases where the prescription was written "pregabalin for pain", it was foreseeable to Actavis that pharmacists would dispense Lecaent. To decide this, the judge took particular consideration of Actavis' decision to notify superintendent pharmacists, at about the same time that the product was launched, specifically that Lecaent was not licensed for the treatment of pain. Holding that it was reasonable for Actavis to assume that this notification would be disseminated by superintendent pharmacists to those under their supervision, the judge held that dispensing for the treatment of pain was not foreseeable, and there was no direct infringement. Whilst there may be a small number of exceptional cases, these were de minimis.

In conclusion, the judge offered his views on the problem of protecting the monopoly conferred by a second medical use patent, whilst allowing lawful generic competition for non-patented indications of the substance in question. In Arnold J's view, the solution is eventually for prescribers to write prescriptions for the patented indication by reference to the patentee’s brand name and write prescriptions for non-patented indications by reference to the generic name of the substance. However, he acknowledged that this requires a system of guidance to be implemented, which is a difficult challenge for the de-centralised healthcare system in the UK. In the meantime, the judge suggested that originator and generic companies should cooperate with NHS England by supplying as much information as possible to enable them to issue the appropriate guidance on prescribing practice to doctors.

The decision

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Gavel

Paul England


Paul summarises Mr Justice Arnold's long-awaited judgment on the trial of Warner-Lambert's claim that Actavis would infringe its second medical use patent.

"The judge suggested that originator and generic companies should cooperate with NHS England by supplying as much information as possible"