BREAKING NEWS Full decision out in the Lyrica case, and it's a whopper

The judgment is a whopper, but not
a Whopper. Incidentally, the 81,423-word
judgment does not contain the W word ...

There has just fallen onto the desk of this Kat the judgment of Mr Justice Arnold at first instance following the full trial in the long-running case of Mylan and Actavis v Warner-Lambert.  It has just been posted on BAILII.  This has already been the subject of numerous preliminary judgments, including one from the Court of Appeal, and the trial took place over three weeks between 29 June and 17 July.  It has also been the subject of numerous Katposts (case management decision  here, Court of Appeal decision here and here,  and four first instance decisions  here,  here, here and here.)  This Kat thinks that it is the case of the year, concerning situation where there is a second medical use patent for a drug (pregabalin, sold by Pfizer under the trade mark Lyrica), and there are some authorised indications falling within the scope of the claims of the patent (neuropathic pain), and some that are not the subject of patent protection (epilepsy, general anxiety disorder).

Along the way, there has been argument about what a second medical use claim in the Swiss form actually covers - does an alleged infringer have to actively intend that their product be used for the patented indication (as Arnold J decided at first instance), or is it enough that they foresee that it will be (as the Court of Appeal decided)?  All have been agreed that a skinny label (where the package insert for the generic product does not mention the patented indication) is not of itself sufficient to avoid infringement, because neither the prescribing doctor nor the dispensing pharmacist is limited by the label.

Well, now the decision is out.

In one sense all is for naught since the patent has been found invalid in respect of the relevant claims (directed towards pain and neuropathic pain) on the ground of insufficiency.  (The inventive step of the claims was however upheld.)  So there is nothing to fight for.

However, Arnold J has nevertheless decided that Actavis does not infringe under the test put forward by the Court of Appeal as he understood it.  This test requires foreseeability, not intention, on the part of the manufacturer (Actavis), but it also requires intentional administration for the patented indication downstream, and Arnold J found that neither the doctor, nor the pharmacist, had the intention to administer the Actavis product Lecaent for pain.

He therefore granted declarations of non-infringement in respect of Actavis, wholesalers of Lecaent, doctors, pharmacists and patients.  He also found Pfizer liable for making groundless threats of patent infringement proceedings, albeit not in all the cases alleged by Actavis.

The decision is massive even by the standards of Mr Justice Arnold, running to 727 paragraphs and 174 pages.  This Kat will therefore post again when he has had a chance to study it.

This is probably not the end.  It is possibly not even the beginning of the end.  There will likely be an appeal, and possibly the case is even destined for the Supreme Court.