Posted on 27/11/2015

Don’t Abuse Pharmaceutical Patent Litigation

We examine the latest case news regarding pharmaceutical patents in the UK.

There have been two recent judgments in relation to Warner-Lambert Co LLC’s patent for the use of pregabalin to treat neuropathic pain, which shed some light on how not to conduct patent litigation in the UK.

In Warner-Lambert Co, LLC vs. Sandoz and Lloyds Pharmacy [2015] EWHC3153 (PAT), Mr. Justice Arnold sitting in the Patents Court, England and Wales, granted an injunction against Sandoz and Lloyds Pharmacy selling generic pregabalin, despite the fact that in an earlier hearing, the Warner Lambert patent had been declared invalid.

There were two reasons why Mr Justice Arnold granted the injunction: (i) the defendants had already launched a full label generic pregabalin product without informing Warner-Lambert, which prevented Warner-Lambert from resolving the matter in an orderly manner; and (ii) the invalidity decision was under appeal, and could be reversed.

In relation to (i), Mr Justice Arnold stated that a generic supplier who intends to mark a product covered by a patent should “clear the path” for the launch of its product sufficiently in advance to enable the patent’s validity or non-infringement to be determined before the launch date. The fact that neither Sandoz nor Lloyds Pharmacy had done so was considered an abuse of process, which directly contributed to the granting of the injunction on what at the time was a patent already declared invalid.

In the second judgement, Generics (UK) Limited (t/a Mylan) vs. Warner-Lambert Co, LLC [2015] EWHC3370 (PAT), Warner-Lambert was refused permission to conditionally amend the patent claims.

Effectively, Mr Justice Arnold considered that there was no problem with deletion of the claims deemed invalid in the earlier judgments, but that an amendment to re-write a claim to cover only the use of pregabalin for neuropathic pain was an abuse of process.  Mr Justice Arnold stated that the re-writing of claim 3 would require a completely new trial to consider the allowability of the amendment, which amounted to an abuse of process, because it should have been made prior to the relevant trial.  Although this judgment may seem harsh, it is a consequence of Warner-Lambert not electing to request amendments though a conditional application before trial.  Many Patentees have made the same mistake and suffered the same consequences.

The standout point to take away from these judgements is that, if you are contemplating litigation or are currently running litigation in the UK, care should be taken to ensure that your actions are justifiable, that you have clean hands, and that you consider the consequences of all potential procedural actions, in order to avoid irreconcilable problems which fall within the “abuse of process” label.

If you need advice on any aspect of your intellectual property, contact us and one of our highly qualified attorneys will be in touch.

Wilson Gunn