A battle has been going on in the UK courts between Warner-Lambert, owner of a patent for a second medical use for pregabalin, and Actavis, a generic manufacturer intent on supplying pregablin for its off-patent indications. The off-patent indications are generalised anxiety disorder (“GAD”) and epilepsy. The patented second medical use is the treatment of neuropathic pain.
Actavis disclosed to Warner Lambert that they had applied for a marketing authorisation for their pregabalin product “Lecaent” and were preparing to launch this in the UK with a skinny label limited to the treatment of epilepsy and GAD.
But a skinny label only goes so far. A problem is that a dispensing chemist does not know for what purpose a prescription has been written and is being presented.
Warner-Lambert’s product “Lyrica” had global sales in 2013 of US$ 4.6 billion, of which UK sales were about US$ 310 million. Data indicates that half these sales were for treating pain, a third were for unspecified diseases and only a small (but significant) percentage was for off-patent GAD and epilepsy.
Others (e.g. Consilient Health Ltd) have put in place schemes (“the Rewisca scheme”) under which the generic brand is not stocked on pharmacists’ shelves, so a copy of a prescription for the non-patented indication must be sent to the wholesaler who then sends the product to the pharmacy. This is a cumbersome and unsatisfactory scheme.
In January and February 2015, the parties appeared before the High Court, and Mr. Justice Arnold ruled that the word “for” in the Swiss claim “for treating pain” had a subjective element. There must be intent on the part of the manufacturer.
This decision was unusual. Subjective intent is sufficient for indirect infringement under Section 60(2) of the Patents Act 1977 (“. . . when he knows, or it is obvious to a reasonable person in the circumstances, that those means are suitable for putting, and are intended to put, the invention into effect”) but is not necessary. Its objective equivalent will suffice.
Arnold J. held that subjective intent was necessary, because the parties agreed that the word “for” in a Swiss claim were to be understood as “suitable and intended for”. The question before him boiled down to whose intention was relevant, and whether it was sufficient if Actavis knew that pharmacists were likely to dispense their product for treating neuropathic pain in the absence of positive steps to prevent this or whether there must be a subjective intention on the manufacturer’s part that the product should be used for treating pain.
A Novel Court Order
Arnold J. issued a novel form of order. He ordered that Actavis make it a condition of any agreement entered into with a pharmacy (or through a distributor) that the pharmacy shall use reasonable endeavours not to supply or dispense the generic brand to patients who have been prescribed pregabalin for the treatment of pain, and that product supplied to pharmacists in the UK bears a notice stating that the product “should not be dispensed for pain.’ He also ordered that NHS England should issue guidance concerning the prescribing of pregabalin for pain.
Warner-Lambert appealed. On appeal, the parties retreated from their agreement that “for” means “suitable and intended for”. The word in the claim is “for”. Attempting to construe “suitable and intended for” is a distraction. The real issue is what the mental element in the claim is. The Court of Appeal agreed that a search for the appropriate meaning of “intention” which does not appear in the claim, is “likely to throw one off the scent.” The Court of Appeal, narrowed down the options to: (a) foreseeability that the drug will intentionally be used for the patented indication and (b) a subjective intention to that effect. In its decision of 28 May 2015, the Court ruled that the skilled person would understand that the patentee was using the word “for” in the claim to require that the manufacturer knows or can reasonably foresee the ultimate intentional use for pain, not that he have that specific intention or desire himself.
On that basis, the matter is remitted for trial to determine whether Actavis infringed on a reasonable foreseeability standard. The Court of Appeal also decided to permit the case for indirect infringement to go to trial, not least because other courts in Europe have held that indirect infringement can arise in similar circumstances.
This unwholesome muddle calls out for regulatory reform. The parties in the dispute agreed that the best solution to the problem of how to prevent Actavis’s drug “Lecaent” being dispensed for pain was to try to ensure that, when doctors prescribe pregabalin for pain, they always do so only by reference to Warner-Lambert’s brand name “Lyrica”. The best way forward would be by guidance from NHS England. But representations by the government were that NHS England was an autonomous body and it was not a priority for the Department of Health to intervene.
AIPPI passed a resolution on 17 September 2014 urging “relevant health authorities to implement the necessary measures so that effective protection of second medical uses is not jeopardized by regulatory frameworks.”
The Secretary of State is not motivated to encourage prescribing by brand. His department only issued guidance when ordered by the Court. Perhaps, having been forced to hurry up once, his department will be in a better position to do so more promptly in future.
When a generics company seeks a marketing authorisation for an off-patent drug and there is a patent still in force for a second (or subsequent) medical use, it is normal to identify the off-patent indications in the accompanying summary of product characteristics and the patient information leaflet. The patented indication is said to have been “carved out”. This is known as a “skinny label”.