Court of Appeal on Pregabalin - Pfizer still in pain, but Swiss claims re-interpreted again

While this moggy was struggling to get back from Indonesia, the Court of Appeal handed down its decision in the pregabalin appeal Warner-Lambert Company LLC v Generics (UK) Ltd (t/a Mylan) & Ors [2016] EWCA Civ 1006 (13 October 2016), and finally the IPKat has managed to blog about it (the lateness by no means reflecting on the importance of the judgment).

It is very much a judgment of three halves.

In the first part of the judgment (up to [135]), which substantively disposes of the case, Lord Justice Floyd (with whom Lord Justic Kitchin and Lord Justice Patten agreed) upheld the decision of Mr Justice Arnold on the validity of the patent.  Arnold J had considered that the claims of the patent that were alleged to be infringed were insufficient, and in particular claim 3 directed towards use of pregabalin for neuropathic pain, because the patent did not render it plausible that pregabalin would be effective at treating central neuropathic pain, only peripheral neuropathic pain.  Floyd LJ agreed with Arnold J's construction of the claims, and rejected the challenge to the finding that claim 3 was not plausible across its breadth.

On the other hand, Floyd LJ also rejected a cross-appeal from Mylan and Actavis challenging the finding that the patent did make a plausible claim that pregabalin was effective to treat peripheral neuropathic pain (that is, seeking to widen the scope of the finding of invalidity of the patent).  Thus, the first instance judgment on validity was completely upheld.

The second part of the judgment, which procedurally disposes of the case (subject to any appeal to the Supreme Court, which Pfizer is reportedly seeking) relates to the refusal to allow Warner-Lambert (the patentee and Pfizer subsidiary) the opportunity to amend claim 3 after the end of the trial.  Arnold J considered that this was an abuse of process.  After a detailed analysis, Floyd LJ concluded "I therefore do not consider that there is any basis for this court to interfere with the judge's evaluation on the issue of abuse of process."

Then we come to the third part of the judgment, relating to infringement.  Merpel gleefully reminds the IPKat that this part of the decision is strictly obiter and therefore non-binding (since the findings on validity and abuse of process make the infringement issue moot), but only a fool would disregard it.  Moreover, this is really where it starts to get interesting.

In the Court of Appeal decision relating to interim relief before the main trial before Arnold J, Floyd LJ had examined the proper interpretation of Swiss-form, second medical use claims (the present judgment states that this was at the behest of the parties: "The court was invited by both parties at that stage to decide the issue of law so that the parties knew where they stood for the purposes of the trial").  The problem was, the parties disagreed on what was the test that the Court of Appeal had laid down.  At the first instance interim proceedings, faced with a choice of foreseeability and intention, Arnold J had in his substantive decision in the case plumped for the latter:  for a Swiss form claim to be infringed, it had to be not just foreseeable to the manufacturer that his product would be used for the claimed indication, but the manufacturer had to actively intend (or, as Arnold J put it "subjectively intend") that it be so used.  The Court of Appeal judgment had referred to both foreseeability and intention, and Arnold J thought the test laid down by the Court of Appeal was that it had to be foreseeable to the manufacturer that this product would be intentionally administered for the claimed indication, the intention coming from a doctor, or, under rare circumstances, a pharmacist.

It now turns out that when referring to "intention" in the earlier judgment, Floyd LJ had not meant what Arnold J understood, but rather a much narrower sense that: "Intentional use is to be distinguished from use where the drug is prescribed for a different indication and, without it in any sense being the intention of the treatment, a pain condition is in fact treated."  Thus, unsurprisingly in the present judgment, Floyd LJ thought that "the judge [Arnold J] fell into error in seeking to dissect the requirement for intentional treatment of pain in this way".  Instead, for a Swiss form claim to be infringed "it is only essential that the manufacturer is able to foresee that there will be intentional use for the new medical indication" (where "intentional use" has the meaning just stated).

Thus, Floyd LJ has now clearly laid down a test which is close to the pure "foreseeability" test that Warner-Lambert originally contended for:

The issue which the judge was called upon to decide was whether Actavis knew or could foresee that at least some of the prescriptions written generically for pregabalin to treat pain would in fact be fulfilled with Lecaent. Had Warner-Lambert succeeded in upholding valid claims on which they relied for infringement, it would then have been necessary to decide whether, at any of the various dates analysed by the judge, that test of knowledge or foresight was satisfied. If so the judge should have gone on to consider whether Actavis had taken all reasonable steps in their power to prevent Lecaent from being used to treat pain.

Moreover, and very helpfully, he has also laid down what kind of steps taken by the generic manufacturer would be sufficient to be the "reasonable steps" (in the last sentence just quoted) required to prevent liability for infringement|:

If that is the basic test to be adopted, what is sufficient to negative the existence of intention? In my judgment the absence of the patented indication from the label cannot conceivably be sufficient to negative the intention. ...
Viewed in this way I think the answer becomes clear. The intention will be negatived where the manufacturer has taken all reasonable steps within his power to prevent the consequences occurring. In such circumstances his true objective is a lawful one, and one would be entitled to say that the foreseen consequences were not intended, but were an unintended incident of his otherwise lawful activity. 

This Kat is a little disappointed that the judgment refers to the judge falling into error with no apparent acknowledgement that the source of the error is in fact the lack of a clear test being laid down in the earlier Court of Appeal judgment.  However, a clear exposition of what the Court of Appeal regards as the correct test is most welcome, and the IPKat eagerly awaits a case in which it can be applied.