No pain, no gain: Warner-Lambert v Actavis preview

At 10:30am on June 29, a London court room packed full of patent lawyers will fall silent as the trial in Warner-Lambert v Actavis commences.

This case has already attracted significant media attention because it will determine how generic manufacturers market drugs for which the primary patent protection has expired but a second medical use patent for the drug remains valid.

Warner-Lambert, owned by pharmaceutical company Pfizer, markets the drug pregabalin under the brand name Lyrica.

The original patent for the drug, which expired in 2013, covered its use for the treatment of epilepsy and general anxiety disorder. Warner-Lambert, however, owns a second medical use patent covering the use of pregabalin “for the preparation of a pharmaceutical composition for treating [neuropathic] pain”.

There have already been five interim judgments in the case.

Warner-Lambert failed in its interim injunction application against Actavis, but along the way received a very helpful judgment from the English Court of Appeal on the question of infringement.

The interim injunction was refused by Judge Richard Arnold at the first instance court, the English High Court, in January this year mainly because the balance of justice lay in favour of Actavis.

But, rather unexpectedly, judge Arnold also found there was no serious issue to be tried as to whether Actavis was directly infringing the Warner-Lambert patent for neuropathic pain. He subsequently refused Warner-Lambert permission to amend its case to allege indirect infringement.

The appeal court has overturned this refusal, allowing the indirect infringement claim to proceed to trial, and stated that the direct infringement claim is a serious issue to be tried.

In respect of direct infringement, the appeal court, led by Lord Justice Floyd, said that the test should be whether the manufacturer knows, or it is reasonably foreseeable, that the drug will ultimately intentionally be used for the patented indication.

The court gave no guidance as to the circumstances in which such an intention would, or would not, be reasonably foreseeable. In respect of indirect infringement, the court listed three possible scenarios, and said it was arguable that indirect infringement could be achieved in two steps: (i) manufacture of the drug by the generic; and (ii) use of the drug for the patented indication by another person.

Floyd’s comments on indirect infringement are rather different from judge Arnold—who described the indirect infringement claim as “simply hopeless”.

The judge at the trial in June will use the new ruling from the appeal court to form an opinion on whether Actavis infringed the patent.

But that is not the only issue the judge will need to determine. He will also be deciding whether the second medical use patent is valid in the first place because Actavis, along with Mylan, has applied separately to revoke the patent.

There will presumably be lengthy cross-examinations of experts from both sides to enable the judge to decide whether the patent lacks novelty or inventive step.

With the trial coming so soon, it is not appropriate to prejudge the result.

Steps sought by Warner-Lambert

Whether or not Warner-Lambert succeeds, it is clear that the skinny label used by Actavis was not acceptable to Warner-Lambert and, in its view, did not avoid liability for infringement.  A skinny label only identifies the non-patented indications in its summary of product characteristics and patient information leaflet.

“If it is later decided by the court that the injunction against the NHS should not have been granted, Actavis can claim compensation from Warner-Lambert.”

Warner-Lambert wanted Actavis to introduce a condition in its supply contracts for pregabalin requiring pharmacies to use reasonable endeavours not to dispense Actavis’s pregabalin product for pain.

Warner-Lambert also wanted Actavis to put a removable cellophane wrapper around the box stating: “This product is not authorised for the treatment of pain and must not be dispensed for such purposes.”

Even if the court had ordered Actavis to take those steps (which the court did not) Warner-Lambert did not concede that the Actavis product would not infringe, and wished to maintain a claim for damages on any sales.

One company, Consilient Health, is already taking steps to limit its liability by putting in place a scheme which means its pregabalin product will not be stocked on pharmacy shelves and will be supplied by the wholesaler only on receipt of a prescription for the non-patented indications.

As Actavis told the court, this scheme does not seem realistic and is unlikely to attract significant sales.

Of particular public interest is the injunction Warner-Lambert obtained against the NHS (largely by consent) to issue guidance to GPs and community pharmacies.

The guidance is relatively straightforward—“prescribe pregabalin for pain by reference to its brand name Lyrica”. That way, only Warner-Lambert’s drug should be dispensed for the patented indication.

This has already been described by judge Arnold as “the best solution to the problem” and the generic manufacturers are protected to some extent by a cross-undertaking in damages.

If it is later decided by the court that the injunction against the NHS should not have been granted, Actavis can claim compensation from Warner-Lambert for losses attributable to the injunction.

But, some GPs have been critical of the guidance saying that it adds to their already heavy workloads and that the issue should be resolved at pharmacy-dispensing level rather than doctor-patient level.

Furthermore, Warner-Lambert subsequently attempted to argue that the NHS guidance has not been effective so far, although the Court of Appeal refused to admit that evidence into the interim proceedings.

Either way, the NHS injunction sets a precedent for other similar second medical use patent cases.

Presumably the NHS will have to issue similar guidance in future cases. So, whatever happens in court later this month, this case has already changed the way in which second medical use patents are enforced in the UK and how doctors will need to prescribe in future.

Observers will be keeping a close eye on the outcome of the trial. And, as the first instance judge has already said, this case could go all the way to the Supreme Court.

Arty Rajendra is an IP litigation partner at law firm Rouse Legal. She can be contacted at:  arajendra@rouse.com