Warner-Lambert v Actavis Mark 3: a "lyrical" solution to a painful patent dispute

On 21 January fellow Kat Darren posted "No pain for Actavis - Warner-Lambert fail to stop launch of generic pregabalin" (here).  This blogpost reported the Patents Court ruling of Mr Justice Arnold in Warner-Lambert Company, LLC v Actavis Group Ptc EHF & Others [2015] EWHC 72 (Pat). In short, Warner-Lambert (part of the Pfizer group) had a patent for pregabalin, which it sold as a treatment for epilepsy, generalised anxiety disorder ("GAD") and neuropathic pain under the romantic-sounding trade mark LYRICA. While the original product patent expired, leaving competitors free to make and sell their own pregabalin, Warner- Lambert received a "second medical use" patent claiming the use of pregabalin or a pharmaceutically acceptable salt of it for the preparation of a pharmaceutical composition for treating pain, and use according to Claim 1 where the pain for which it is prescribed is neuropathic pain. A generic pharmaceutical company marketing pregabalin for that purpose (but for no other) would infringe this indication.

What normally happens here is that the generic company can launch a product with a "skinny label", this being edited product leaflet that mentions only the permitted indications. However, in reality, since prescriptions do not mention the indication for which a drug is prescribed, neither a pharmacist nor a generic manufacturer will know the reason why pregabalin was prescribed. This poses huge practical problems for Warner-Lambert when pondering how best to enforce its patent rights. Refusing interim injunctive relief, Arnold J noted:

" ... the best solution to the problem which arises in this case is to try to ensure that prescribing doctors prescribe pregabalin for the treatment of pain by reference to the brand name Lyrica rather than by reference to the generic name pregabalin. That will ensure that pharmacists only dispense Lyrica when presented with prescriptions for pregabalin which are (at least so far as the prescriber is concerned) for pain without requiring the pharmacist to know the indication for which pregabalin has been prescribed.

The parties were back in court again pretty soon, as Darren's follow-up post explains. In "Warner-Lambert v Actavis Mark 2, still at first instance: more on Swiss claims, Skinny Labels, and no Strikeout" (here), posted on Friday 6 February. This time, at [2015] EWHC 223 (Pat), Actavis sought to strike out Warner-Lambert's action while Warner-Lambert applied to amend its particulars to as to plead a case of subjective intention.  Arnold J refused to strike out the infringement action and to allow amendment of the particulars of claim in what he described as a "developing area of the law".

Today's news was broken to this Kat by a couple of comments posted by anonymous readers.  One read

"Today was the showstopper! Pfizer sought and got a High Court Order against the NHS [that's the National Health Service] requiring it to issue central guidance that when pregabalin is prescribed for pain the prescription must say LYRICA. This is a big first in the enforcement of a second medical use patent. Very innovative Court application by Pfizer based on the NHS being an intermediary or conduit and relying on jurisprudence from trade mark and ISP cases eg Cartier [this being another Arnold J decision, extending relief through blocking injunctions against ISPs from copyright infringements to trade mark infringements: judgment here, Eleonora's Katpost here]. So, there will be no pain for anyone now- the position is clear and simple!"

Another said:

"After today the IPKat can change its headline " Pfizer gets the best pain relief imaginable" - an Order from the High Court that NHSE must issue central guidance that prescribers must prescribe LYRICA when using pregabalin for pain and for those prescriptions pharmacists must dispense LYRICA. That's a super neat solution and is far better than any preliminary injunction against one or more generics. Pretty impressive strategy by Pfizer!"

Darren will surely be adding to this topic when the opportunity arises.