The Lyrica patent dispute – part the second - infringement

In his previous post, this Kat wrote about the validity aspect of the Lyrica decision.  Now, it is time for the infringement aspect.  Pfizer alleged that the patent was being infringed by Actavis, who were selling pregabalin with a “skinny label” – the package insert information being limited to the off-patent indications of epilepsy and generalised anxiety disorder and not stating the indication of neuropathic pain.  Nevertheless, Pfizer maintained, a proportion of the Actavis product would end up being used for the treatment of pain (since doctors usually prescribe by reference to the generic name, and pharmacists can dispense the generic product against this prescription irrespective of the skinny label), and therefore Actavis infringed.

Notwithstanding that he found the patent invalid, Mr Justice Arnold proceeded to consider the issue of infringement in full.

Background

The infringement aspect of the case already had a lengthy legal background, with four Patents Court decisions and one from the Court of Appeal.

First, Pfizer had sought an injunction which Arnold J refused (Warner-Lambert I), partly because he construed a Swiss claim such as that in the patent to require a mental element in order to infringe.  This mental element is required because a Swiss claim is a purpose-limited process claim, and the purpose (treatment of pain) is the novelty conferring feature of the claim.  What has been unclear before this case, however, is exactly what is needed in order to satisfy that mental element and so infringe the claim.  Arnold J decided that what is required to infringe the claim is subjective intent on the part of the manufacturer that their product be used for the patented indication.  Pfizer had alleged no such intent, and so he considered that they had not presented an arguable case of infringement.  But he also held that the balance of convenience favoured Actavis.

Emboldened by this, Actavis sought to strike out the action, which Arnold J declined to do (Warner-Lambert II), except in relation to the claim for contributory infringement under Section 60(2) of the Patents Act, which he did strike out (Warner-Lambert III).  Pfizer amended their pleadings in order to state a case of subjective intent.

In the meantime, Pfizer successfully obtained an injunction against NHS England (Warner-Lambert IV), requiring them to instruct doctors to prescribe pregabalin only by the Pfizer brand name Lyrica when it was for the treatment of pain.  Under prescribing rules, this would in turn require pharmacists to dispense only the Pfizer product against that prescription.  (If instead the doctor were to prescribe by reference to the generic name “pregabalin”, the pharmacist would be free to dispense either Lyrica or the Actavis product Lecaent, or indeed any other available generic product.)

Pfizer appealed both the refusal of the injunction and the strike out.  The Court of Appeal (Warner-Lambert CA) took a completely different approach to claim construction of the mental element of the claim from Arnold J, and considered that a Swiss claim was infringed if it was foreseeable to the manufacturer that the product would be intentionally administered for the claimed indication.  As will be analysed below, this left a number of questions outstanding.  The Court of Appeal agreed with Arnold J’s balance of convenience analysis and therefore maintained the refusal of injunctive relief, but they disagreed with the strike-out, and therefore the contributory infringement claim was reinstated.

This left in the present judgment important questions to decide, following the Court of Appeal’s decision, about how a Swiss-form claim should be construed: how and as of what date is foreseeability determined; whose intention is relevant for “intentional administration”; what is the role of NHS England and other health bodies; what are the duties of the patentee and the potential infringer.  The Secretary of State for Health sought and received permission to intervene in the trial so that the Government’s position was represented.

Could the Court of Appeal decision be disregarded?

First, however, Arnold J had to decide whether he needed to pay attention to the Court of Appeal decision at all.  The proposition, at first sight perhaps surprising in a precedent-based system, arises as follows.  As both Actavis and the Secretary of State for Health argued, and Arnold J agreed, the matter being appealed was the refusal of interim injunction.  On that matter, the Court of Appeal upheld Arnold J’s decision to refuse an injunction, because they agreed with the first instance analysis of the balance of convenience.  What was said about the interpretation of the mental element in infringement of Swiss form claims was therefore obiter dicta, and not part of the ratio decidendi of the decision.  Only the ratio decidendi of a decision is binding, obiter dicta are not.  So Arnold J was not bound by this part of the Court of Appeal decision.  However, he went on to say:

“Nevertheless, it is equally plain that, as a considered judgment of a unanimous Court of Appeal reached after full argument on the point, the Court of Appeal's judgment is highly persuasive. Accordingly, I should follow it unless I am entirely convinced that it is wrong.”

So then the question was whether the judgment of the Court of Appeal on what is needed as the mental element to infringe was clearly wrong.  Again perhaps surprisingly, both Actavis and the Secretary of State for Health argued that it was indeed wrong.  Arnold J considered this, and in particular a perhaps unintended consequence of the Court of Appeal construction, namely that if it was foreseeable to the manufacturer that their some of their product would be intentionally administered for the patented indication, then all of that product became infringing product.  Moreover, all of that product would be infringing as the “product of the process” under Section 60(1)(c) of the Patents Act, so that subsequent dealing with it would also be an infringement.  Arnold J believed that Lord Justice Floyd, giving the leading judgment, could not have intended this to actually be the outcome, but the only way to avoid it seemed to be in the realm of remedies – the injunction and damages might be varied from the usual form – but he saw difficulties with applying this in practice.  He therefore concluded:

“I have considerable doubts as to the correctness of Floyd LJ's interpretation. Nevertheless, I cannot say that I am entirely convinced that it is wrong. Accordingly, I propose to follow it.”

However, it is noticeable that he nevertheless also indicated at appropriate places later in the judgment what would have been his findings if applying his own original construction of the claims.

Under this construction of the claims, Arnold J pointed out that if the manufacturer infringed, then so did the pharmacist under Section 60(1)(c) of the Patents Act (albeit “unwittingly”), and for this reason, counsel for Pfizer had been legally correct to withdraw in closing their concession made in opening that pharmacists who dispensed Lecaent knowing or believing that the patient was being treated for a non-patented indication did not infringe the patent.

Does the Court of Appeal test require intention?

Pfizer argued that the test laid down by the Court of Appeal was actually simply of foreseeability – if it was foreseeable that product would be administered for pain, then it infringed.  Arnold disagreed, holding that Floyd LJ had:

“made it clear at [121] that intentional administration was at the heart of the invention, at [122] that the word "for" provided the link between the manufacture of pregabalin and the intentional use of the drug, at [127] that the word "for" required knowledge or foresight of the ultimate intentional use, at [128] that there were two mental states involved and at [129] that a manufacturer infringes when he knows or foresees that users will intentionally administer pregabalin for the treatment of pain. Thus the requirement of intention is central to his interpretation.”

Moreover, Arnold J pointed out that a “pure test of foreseeability would not be enough to confer novelty on the claim. It is the element of intention which ensures novelty.”

Whose intention and to do what?

Arnold J considered that the most relevant intention was that of the doctor.  But then the question that arose was whether it was sufficient that the prescribing doctor intended pregabalin from any source to be administered for the treatment of pain, or did the doctor have to intend the generic and potentially infringing pregabalin to be administered.  Arnold J considered that the Court of Appeal judgment made clear, by referring to the manufacturer foreseeing that “some of his drug will intentionally be used for pain”, that infringement required the doctor to intend specifically generic pregabalin to be administered, and that is what had to be foreseeable to the generic manufacturer.  This aspect is key for the finding of non-infringement on the facts of the case.

After some hesitation, he also concluded that relevant intention could come from the pharmacist.  He pointed out, however, that in general the pharmacist will not know what the indication is (since prescriptions rarely carry this information), in which case the pharmacist's intention adds nothing to that of the doctor.  So only if the pharmacist knows that the doctor has prescribed generic pregabalin for treating pain and the pharmacist dispenses the generic manufacturer's product could the necessary intention derive from the pharmacist.

In any case, Arnold J held that the intention cannot come from the patient.

When is foreseeability judged?

Since infringement depends on what the manufacturer can foresee, it was necessary to determine at what date this foreseeability was to be decided.  By the end of the trial, it emerged as common ground that the mental element must be satisfied as of the date of manufacture.  Since manufacture occurred in batches, it was to be determined as of the date of manufacture of each batch.  If product is then infringing, then each act of subsequent sale or dealing constitutes a separate act of infringement under Section 60(1)(c) of the Patents Act.  Overall, therefore, the judge assessed infringement as of three different dates: the date of the commencement of Pfizer's claim for infringement, namely 8 December 2014, the date when Actavis launched Lecaent, namely 17 February 2015 and the date when the evidence at trial was completed, namely 15 July 2015.

What are the duties of the patentee and the potential infringer?

Pfizer repeatedly maintained that the generic company was under a statutory duty not to infringe, and that the patentee was under no duty to assist them in that.  While Arnold J accepted this proposition in general, he also considered that injunctive relief and financial remedies should be proportionate and not be applied in such a way as to create barriers to legitimate trade.  Sale of generic pregabalin for the off-patent indications was not to be prevented by the steps taken to prevent sale for the patented indication.

Did Actavis infringe?

Applying these considerations to the facts and using the Court of Appeal construction of the claims, Arnold J concluded that at no point did Actavis infringe.  (Under his prior construction of the claims, he also naturally held that Actavis did not infringe).

Considering the situation at 8 December 2014, the judge reiterated that:

“I do not consider that there is intentional administration of Lecaent for the treatment of pain if Lecaent is dispensed in circumstances where the doctor has prescribed generic pregabalin for pain and the pharmacist does not know the indication for which it has been prescribed, but I consider that there is intentional administration of Lecaent for pain if the pharmacist dispenses Lecaent when he or she knows that pregabalin has been prescribed for pain. Thus the question to be resolved is whether it was foreseeable to Actavis that, in the 5% of cases where the prescription indicated that pregabalin had been prescribed for pain, the pharmacist would dispense Lecaent despite the fact that it was not licensed for pain?”

Since even at that early date, Actavis had already notified superintendent pharmacists specifically that Lecaent was not licensed for the treatment of neuropathic pain, Arnold J considered it was not foreseeable that Lecaent would be intentionally administered for the treatment of pain “save in a small number of exceptional cases which I consider that it is proper to regard as de minimis”.

By 17 February 2015 Actavis had notified Clinical Commissioning Groups, and therefore prescribing doctors in those groups, that Lecaent was not licensed for neuropathic pain; Actavis also knew that Pfizer had taken steps to prevent generic pregabalin being prescribed or dispensed for the treatment of pain.  Therefore by this date, it was not foreseeable that Lecaent would be intentionally administered for pain, even if it had been at 8 December 2014.

By 15 July 2015 the NHS England guidance that Lyrica should be prescribed for pain has been issued; prescribing software had been modified in many cases to reflect this; and as a result the proportion of pregabalin prescribed by reference to Lyrica had risen to 30% by May 2015 (from as little as 1% in January 2015) and there was no possibility of Lecaent being dispensed against prescriptions for Lyrica.  Therefore by this date, it was not foreseeable that Lecaent would be intentionally administered for pain, even if it had been at one of the earlier dates.

Conclusion

Therefore the judge concluded that Actavis did not infringe, and he granted a declaration of non-infringement in relation to Actavis and wholesalers who deal in Lecaent, doctors, pharmacists and patients.  He also upheld some, but not all, of Actavis’s claims that Pfizer had made unjustified threats of patent infringement against pharmacists and prescribers.

Afterword: the need for a system

I give the last word to Mr Justice Arnold, in a mere 5 of his 727 paragraphs:

I have now lived with this case for nine months. During that time, I have heard and determined the applications which led to the Warner-Lambert I, II, III and IV judgments, I have heard and determined a number of other case management applications, I have heard the trial and I have written this judgment. During that time, I have reflected repeatedly and at length on the issues raised by this litigation. At the end of that period of reflection, I remain more convinced than ever that the best solution to the problem of protecting the monopoly conferred by a second medical use patent while allowing lawful generic competition for non-patented indications of the substance in question is to separate the patented market for the substance from the non-patented market by ensuring that prescribers write prescriptions for the patented indication by reference to the patentee's brand name and write prescriptions for non-patented indications by reference to the generic name of the substance (the INN). 

Prescribers cannot be expected to know when this is required, nor should they be required to take steps to find out. What is needed is for centralised and authoritative guidance to be given to prescribers as to when this practice should be adopted. Such guidance also needs to be conveyed to other relevant stakeholders, and in particular to the software providers. The question is who is to issue such centralised and authoritative guidance. This is a particular challenge for the decentralised (some might say fragmented) English healthcare system since the 2012 Act. As I understand it, the Secretary of State considers that he lacks the power to issue such guidance (see Warner-Lambert I at [75]). That being so, the only body in England which appears to have the necessary power and authority is NHS England. In Wales, Scotland and Northern Ireland, the devolved governments appear to have the necessary power and authority. 

In the present case, NHS England issued guidance as a result of an order made by this Court on an application by Pfizer. Regardless of the legal soundness of that procedure, it had two practical advantages. The first was that it provided a convenient forum to enable the interested parties to negotiate what was to be done, when and by whom. In the end, this was all agreed. The second was that the procedure included the protection for the NHS and for the generic companies of a cross-undertaking in damages. This is particularly important because of the risk that the second medical use patent may prove to be invalid if challenged, as has transpired in the case of claims 1 and 3 of the Patent if I am right. 

Looking to the future, however, it does not seem to me to be in anyone's interests for these problems to be dealt with in the ad hoc manner in which they were addressed in this case. It is not as if the situation which arose in this case could not have been predicted. On the contrary, as soon as it was known that the SPC had lapsed, the resulting scenario was entirely predictable. (And if I am right that Pfizer planned to allow the SPC to lapse, for whatever reason, then Pfizer was in a position to predict it even before then.) In general, information as to patent expiry dates and loss of data exclusivity dates is in the public domain and can be ascertained in advance. I nevertheless recognise that it is probably too much to expect NHS England to keep track of such dates and to plan for the resulting situations. I consider that it behoves patentees who want their second medical use patents enforced to provide NHS England with all the information and assistance it requires to enable it to issue appropriate guidance as and when required. I also consider that it behoves generic companies who want their interests in obtaining untroubled access to lawful markets protected to cooperate with NHS England as well. I recognise that generic companies are always understandably reluctant to disclose their future commercial plans to anyone, but the potential interest of generic companies in a skinny label launch (whether or not pending a challenge to the validity of the patent) to avoid a second medical use patent will usually be obvious. In short, what is needed is a system for dealing with these situations. 

The Secretary of State's intervention in this case, and Ms Howe's evidence, demonstrate the seriousness with which the Secretary of State regards these issues. Moreover, Ms Howe's evidence and the closing submissions made by counsel for the Secretary of State make it clear that the Secretary of State accepts the desirability of the solution I have proposed. I therefore trust that the Secretary of State will take steps to ensure that a suitable system is put in place in England. I also trust that he will liaise with his counterparts in the Welsh, Scottish and Northern Irish administrations to try to ensure that the system operates across the whole of the UK.