From October 2016 to March 2017 the team is joined by Guest Kats Rosie Burbidge and Eibhlin Vardy, and by InternKats Verónica Rodríguez Arguijo, Tian Lu and Hayleigh Bosher.

Monday, 24 October 2016

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.


Proof of the pudding said...

I disagree that the test set out by the CoA is "clear". Stating that the generic manufacturer must take "all reasonable steps within his power to prevent the consequences occurring" merely begs the question as to what is "reasonable".

The answer on this point will presumably be highly dependent upon the facts of each case. Indeed, the record shows that even Warner-Lambert had difficulty deciding which "reasonable" steps should be taken by Actavis, or even whether all of those steps, if taken, would be sufficient to avoid infringement.

A few examples from the CoA of what might count as "reasonable" steps (at least in the context of current prescribing and dispensing systems and practices in the UK) would certainly have been useful. It looks like we will just have to wait for the boundaries to be defined in future cases.

Anonymous said...

"ALL" is the defining word. As is the term "within his power".

The word "reasonable" is the least important.

Anonymous said...

Anonymous @ 12:43: You could not be more mistaken.

ALL is not "every for every possible avenue"

ALL is severely constrained by ONLY the paths deemed "reasonable."

Anonymous said...

"All steps within his power" - seems reasonable to me. "He" has an obligation no to infringe or knowingly contribute to others' infringement.

Simon said...

It's a little bit odd for the infringement test for a Swiss style claim to be evolving in this way. Infringement is about whether an act falls within the claims. In this case the Court decided it requires foreseeing whether the manufactured medicament would have been used for the intended purpose and taking steps to prevent that. That is a very complex test just to decide on what actions fall within the claim. It does of course reflect the reality of the events on the ground, but one wonders whether the Courts have now gone to far in formulating a test that does justice in this situation but makes determination of infringement a lot more difficult.

Anonymous said...

The reality of events on the ground is what matters. This is not an academic exercise.

Proof of the pudding said...

I agree with Anon 09:55. However, this merely amounts to re-stating the point that I made yesterday. That is, the conclusion on infringement will be highly dependent upon the facts of each case (and therefore very difficult to predict if the facts differ in any way from those of a previous case). Not the most ideal of outcomes, eh?

The most peculiar outcome, however, is that a generic manufacturer is likely to be required to take all sort of actions that (to a greater or lesser extent) will be essentially ineffective in preventing infringement. This is because, at least in the UK, infringement occurs due to circumstances outside of the control of the generic. The best that they can hope for is a (small) degree of influence.

In this circumstance, it will always be possible to level an accusation that the generic has not done enough. Prescribing and dispensing by INN will continue, and therefore use of the generic product in the patented indication will be inevitable, no matter the lengths to which the generics go to avoid this.

This is why it would have been so much more helpful if the court had provided a few examples of actions that would (if taken) be sufficient to avoid a finding of infringement. Different actions have different implications, ranging from the relatively straightforward (writing to NHS England and CCGs) to the expensive (covering the product with a wrapper stipulating the indications for which it cannot be used) and even to the impossible (imposing contractual conditions that oblige purchasers to not use the product for certain indications).

I fully support the position that patentees should be able to enforce their second medical use patents. However, it would be disappointing if all this case succeeded in achieving is to make the sale of "skinny label" products either practically impossible or commercially non-viable.

Anonymous said...

"The most peculiar outcome, however, is that a generic manufacturer is likely to be required to take all sort of actions that (to a greater or lesser extent) will be essentially ineffective in preventing infringement. "

But if we remember about the reality on the ground, it will be clear that total elimination of infringement is not the goal of the patentee. Just thinking about the Pfizer case, the goal of the patentee is/as to prevent the decimation of their market for pain treatment by a generic being sold for epilepsy/GAD. If Actavis had simply launched with a skinny label and made no reference in their promotions to pain, Pfizer's market would have been hit hard.

There is much that can be done by generics that could only be considered reasonable, so it is not as if they are being required to take extreme measures. They have the right to sell products in accordance with their skinny label, but not for pain (had the patent been upheld).

Different countries will require different actions from the generics due to the differences in how the drug markets work. In the UK, the answer lies within the doctor's prescribing software such that the doctor inputs the drug they want to prescribe by its INN (generic) name, e.g. pregabalin and they then tick a box advising on the condition(s) to be treated, e.g. epilepsy/GAD/pain. The software then prints the description which the pharmacist should follow. If pain is ticked as the indication, Lyrica would be prescribed by brand and the pharmacist is already obliged to dispense as prescribed.

Arnold wasn't keen on finding any infringers in Swiss-type claims, bless him, but there are several parties infringing. It is therefore in the interests of all parties in the chain to agree to a reasonable, sensible, workable, solution that will not cause problems or extra work for the doctors.

Even with such mechanisms in place, will it stop all instances of a doctor prescribing generic pregabalin for pain? No. Will Pfizer fight to the ends of the earth to block such anarchistic behavior? No. They themselves will act reasonably.

Simon said...

The UK Courts have decided to treat Swiss style claims as directed to an actual manufacture. However they were not obliged to do that. They could have considered it to be a purpose limited product claim, i.e. equivalent to the EPC 2000 medical use claim, given that it is essentially a legal fiction whose validity is considered in the same way as the EPC 2000 claim. So now we are having to go through all sort of hoops to work out how the thoughts and actions of the manufacturer has to relate to prescribing/treatment simply to determine direct infringement, with no apparent possibility to changing how pharmacists or doctors are acting (which is really where infringement should be judged to be occurring rather than at the manufacturing level).

Kant said...

Generics will also have to be considering second medical use claims in the EPC2000 format. Presumably, if in the present case the claim had been an EPC2000 claim it would have looked something like "Pregabalin for treating pain". For such a claim, it is reasonable to expect the generic manufacturers to use all reasonable steps to prevent such use.

Proof of the pudding said...


I completely agree that there are perfectly reasonable actions that a generic could take and that might help to discourage infringement. I also agree that the facts "on the ground" will help to determine what those actions could be.

However, the main problem (as I see it) is that there is no bright line between infringement and non-infringement, as (under the standard proposed by the CoA) the precise boundary in cases having "new" facts can only really be determined by the courts.

There are also numerous other problems. The first and foremost of these is when is enough enough? This is a real concern, as illustrated in Warner-Lambert ([2015] EWHC 72 (Pat)): "A final point to note at this stage is that counsel for Warner-Lambert did not concede that Actavis would not infringe the Patent if it took all the steps required by Warner-Lambert’s proposed order despite being invited to do so by counsel for Actavis".

I also struggle to get my head around the concept that liability for infringement can arise due to the failure to take certain (unspecified, non-statutory and variable) actions. One could of course make a case that failure to take certain, precautionary actions would amount to acting recklessly. However, that only really works if what counts as acting prudently is clear to all.

I fully support the view that patentees should (as you put it) be able to act to prevent "the decimation of their market" for patented indications. I am just not sure that this can sensibly be achieved by generating huge uncertainties for suppliers who (in the end) have little or no control over whether infringement occurs.

Would it not be better to instead aim for an effective solution, such as changes to prescribing and dispensing practices in the UK?

Anonymous said...

@ proof of the pudding

Would it not be better to instead aim for an effective solution, such as changes to prescribing and dispensing practices in the UK?

Undoubtedly it would be better, but that would only be possible to enforce if those responsible for the prescribing and dispensing could be taken to court but those responsible for dispensing can't infringe due to section 60(5)(c) and the whole raison d'etre for the medical exclusions is to eliminate the possibility of suing doctors i.e. those doing the prescribing.

Anonymous said...

Simon, the decision stated after discussing the Danish case "The court was able to find that the pharmacists were directly infringing in those circumstances, it appears by treating the application of the label as the final step in the "manufacturing" required by the claim."

As a long-term drafter of Swiss-type claims, this has always been my consideration of manufacture, as well as direct promotion etc. Swiss claims were noted as a legal fiction, but in reality they are not fictional. They derive from method of treatment claims. Concert an MOT claim into Swiss format and you won't get an added-matter objection, even from the EPO. They are still method claims, hence their difference in scope from purpose limited product claims, which is a discussion for another day. So, I consider 'promotion for the patented use' as infringing.

As for the UK pharmacist, well all they do is add a label with a name, address and dosage regime, so no infringement unless knowledge etc. If they deliberately prescribe generic pregabalin instead of prescribed branded Lyrica, they are infringing in my book, which is the Cipa Guide, which should then be thrown at them.

PoP: There is always a grey area in these things, but I agree that the biggest grey area is who is or who is not an infringer based on their actions. But this ultimately becomes irrelevant if procedures are put in place to deal with the generic/brand prescription aspect. it is in the interest of all parties to agree a mechanism such as I suggested above. The only losers will be those generics who want to game the system by eating into the patented market.

"Would it not be better to instead aim for an effective solution, such as changes to prescribing and dispensing practices in the UK?" Absolutely yes, I agree.

We should remind ourselves about the controlled nature of the pharmaceutical market, such as doctors' prescribing software automatically selecting the generic name, (agreed) set price, sand the reimbursement mechanisms where pharmacists receive full brand price even when supplying the generic, at considerable profit to themselves. It is a complicated system designed (badly) to minimize the NHS drug bill, but cannot be allowed to operate at the expense of patent monopolies awarded for innovation and considerable financial risk-taking. Obviously it will be bad PR for drug companies such as Pzizer suing Health Trusts directly, but it can happen. It used to be considered a bad idea to challenge the regulators, especially the FDA, but now they are fair game.

Anonymous said...

Who says we can't sue doctors? The US patent statutes don't apply on this side of the pond. Section 60(5)(c) certainly doesn't do the trick. That covers the pharmacist for reformulating a patented drug to meet the needs of a patient.

Proof of the pudding said...

How about joining in those responsible for designing prescribing policies (and the software that implements them) as joint tortfeasors? That would not touch the doctors now, would it?

?s? said...

I don't know why people keep saying plausibility is a low hurdle. It seems to be being decided on how the experimental work can be interpreted, i.e. how much extrapolation can be done rather than 'is there a reason to doubt this?'. Whilst the EPO or a Court might give a party the benefit of the doubt the test seems to be a scientific one and not one where case law can make it a low hurdle.

Anonymous said...

Under English common law it wouldn't surprise me if you could sue old wives for their tales of off-label uses.

An earlier comment of mine responding to PoP and Simon Says has gone awol.

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