Second medical use patents: a solution to the enforcement issue?

Introduction

In Warner-Lambert v NHS England [2015] EWHC 485 (Pat), Mr Justice Arnold has made an unprecedented order against NHS England which offers a promising solution to many of the difficulties associated with the enforcement of second medical use patents.  His order requires NHS England to issue guidance advising doctors to prescribe only by brand name when prescribing for the patented indication.

This decision follows hot on the heels of Cartier v BSkyB [2014] EWHC 3354 (Ch), where third parties to the underlying infringement dispute (in that case internet service providers) were ordered to take positive steps to safeguard the rights of trade mark holders, and suggests that the courts are becoming increasingly willing to make orders against third parties to ensure the orderly functioning of the intellectual property system.

Background

Pregabalin is the active ingredient in a drug sold by Warner-Lambert under the brand name Lyrica. Lyrica is approved for the treatment of neuropathic pain, epilepsy and generalised anxiety disorder.  There is no patent protection in respect of the latter two indications.  However, in respect of neuropathic pain Warner-Lambert holds a second medical use patent with claims in Swiss form.

Actavis and several other generic manufacturers have obtained (or are close to obtaining) marketing authorisation for pregabalin with a skinny label which carves out the treatment of neuropathic pain.  However, because most prescriptions are written by international non-proprietary name (INN) (i.e. pregabalin) and do not mention the indication for which the drug is prescribed, in most cases pharmacists will dispense generic pregabalin products (because of the financial incentives to do so) and will be unable to tell if in doing so they are dispensing the generic product for the patented indication.  As a result, these skinny label products will inevitably be dispensed to some patients who are taking pregabalin for the treatment of neuropathic pain and Warner-Lambert will lose exclusivity for this indication notwithstanding that it holds a second medical use patent directed to this indication.

To try and prevent Actavis’ skinny label product from being dispensed for the treatment of neuropathic pain pending trial, Warner-Lambert sough interim relief requiring Actavis to take certain steps including writing to pharmacists and healthcare professionals (via Clinical Commissioning Groups (CCGs)) informing them of the patent dispute, that its pregabalin product is not authorised and should not be prescribed for the treatment of neuropathic pain and that Lyrica should be prescribed for this indication while Warner-Lambert’s patent is in force.  Although Actavis was broadly willing to take these steps and it was common ground that the best solution to the problem was “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”, Arnold J refused to grant the relief sought on the basis that Warner-Lambert had failed to establish that there was a serious issue of infringement to be tried (see here).

In his decision refusing Warner-Lambert’s application for interim relief against Actavis, Arnold J also noted that it did not lie within the power of either party to change the behaviour of prescribers so as to ensure that prescriptions for neuropathic pain specify Lyrica. Furthermore, in the light of submissions made on behalf of the Department of Health to the effect that it was not within the Department of Health’s terms of reference to issue guidance on the relevance of Warner-Lambert’s patent for the prescribing of pregabalin, the judge encouraged NHS England to consider issuing such guidance as a matter of urgency.  Notwithstanding this encouragement from the court, NHS England indicated that it would not issue guidance on the proper prescribing practice for pregabalin within a timescale that would be helpful for the litigation.

It was against this background that Warner-Lambert applied for an unprecedented form of relief against NHS England, requiring NHS England to issue guidance advising doctors (via CCGs) to write only the brand name, Lyrica, and not the generic name, pregabalin, when prescribing pregabalin for the treatment of neuropathic pain and community pharmacies (via the NHS Business Services Authority) to dispense only Lyrica when they are told that the patient is taking pregabalin for the treatment of neuropathic pain.

The Decision

Arnold J allowed the application, although it should be noted that the application was essentially unopposed.  NHS England accepted for the purpose of this application only that the court had the power to grant the relief sought and Actavis and the other generic companies could hardly resist the application whilst maintaining their stance that they intend that their generic products will only be supplied for the off patent indications.

The judge considered that ordering NHS England to issue prescribing guidance fell within the jurisdiction of the court by virtue of section 37(1) of the Senior Courts Act 1981 which recognises that the court has the power to grant an injunction in all kinds of case.

In the correspondence NHS England had suggested that the relief sought by Warner-Lambert was analogous to Norwich Pharmacal relief (where relief, typically in the form of disclosure, may be sought against a third party) and Warner-Lambert agreed stating that NHS England was “an innocent party who is mixed up in the wrongdoing of others”.  Warner-Lambert submitted that, being aware that it was mixed up in some wrongdoing by others, NHS England was under an equitable protective duty which the court had jurisdiction to enforce pursuant to section 37(1) of the Senior Courts Act 1981.

Arnold J accepted that such a duty would arise if there was an arguable case of wrongdoing on the part of Actavis, but noted that if his previous decision was correct (namely, that Actavis was not likely to infringe Warner-Lambert’s patent by selling its generic pregabalin product under a skinny label), it was not seriously arguable that Actavis was involved in any wrongdoing and no such duty would arise.  Nevertheless, he was prepared to assume that an equitable protective duty did arise in the light of the following factors: (1) he had refused Actavis’ application to strike out Warner-Lambert’s infringement claim on the basis that this was a developing area of law; (2) the Court of Appeal had given Warner-Lambert permission to appeal his earlier decision; and (3) there were parallels to be drawn with Novartis v Hospira [2013] EWCA Civ 583 where an interim injunction was granted pending appeal, notwithstanding that the patent had been held invalid at first instance.

Furthermore, Arnold J was satisfied that the making of the order complied with the requirements of Article 3 of the Enforcement Directive (2004/48/EC), namely that the order is proportionate, does not create barriers to legitimate trade and contains safeguards against abuse.  He concluded that “the issuing of guidance by NHS England is the most efficacious, dissuasive and cheapest solution to the problem which confronts Warner-Lambert.”

Comment

This is another example of a novel form of relief being granted against a third party to prevent infringements of intellectual property rights and of an injunction being granted notwithstanding serious doubts about the merits of the underlying infringement claim.  Indeed, Arnold J referred to and relied upon his reasoning in Cartier v BSkyB where he ordered internet service providers to block access to certain websites selling counterfeit products, although in that case the alleged infringement was blatant and uncontested.  He also relied upon and drew an analogy with Novartis v Hospira where an interim injunction was granted pending an appeal of the decision revoking the patent.  However, Novartis v Hospira was decided on the basis that the first limb of the American Cyanamid [1975] AC 396 test was satisfied where there was a real prospect of success of establishing (validity and) infringement on appeal, whereas in this case relief appears to have been granted on the basis of a lower standard, namely, that there is a real prospect of success of establishing on appeal that there is a serious issue of infringement to be tried, albeit in the context of a developing area of law.  It may be that had the application been opposed and fully argued, this issue would have attracted more attention.

Requiring NHS England to issue guidance to help prevent generic pregabalin products from being prescribed and dispensed for neuropathic pain does appear to be a workable solution to the problem and has much to commend it. This is not least because it is anticipated to be more effective than any steps that generic manufacturers would be able to take without adversely affecting their ability to access the segment of the market for off patent indications.  However, it may not be a perfect solution because notwithstanding the guidance some doctors may continue to write INN scripts for pregabalin for the treatment of neuropathic pain and some pharmacies may continue to dispense generic products against INN scripts which they are told have been prescribed for the treatment of pain.  Indeed, the guidance which NHS England has been ordered to issue requires doctors and pharmacists to comply with the stipulated practices only “so far as is reasonably possible” suggesting that absolute compliance is likely to be difficult to achieve in practice. Conversely, in the event that the patent is revoked or when it expires and the guidance is changed, prescribing habits are unlikely to change across the board overnight meaning that some scripts are likely to be written by brand name even though the basis for doing so has fallen away resulting in a continuing benefit for the originator.  Suitable adjustments made in a timely way to the software used by prescribing doctors would seem likely to help to minimise these issues.

A further issue which may present itself in the event that such prescribing guidance remains in place for more than a few months is that the originator may find it difficult to lower its price for the off patent indications to compete with the generic products in this segment of the market while still maintaining a higher price for the patented indication.  The extent to which such issues concern the originator is likely to depend upon the relative sizes of and pricing differentials between the patented and off patent markets and they may be overcome to some extent by creative pricing arrangements or the originator launching its own generic product.  A more ideal solution would be to allow different reimbursement prices for a product depending upon the indication for which it has been dispensed, but this would require significant changes to be made to the regulatory framework for which there may be little political appetite.

As Arnold J noted in the opening paragraph of his first judgement in this litigation ([2015] EWHC 72 (Pat)), the enforcement of second medical use patents gives rise to competing policy considerations: the policy of incentivising medical research into finding new applications for known drugs with a proven safety profile on the one hand, and the policy underpinning the system and practices by which drugs are prescribed and dispensed in the UK on the other.  Therefore, although this solution involves a degree of policy intervention, this was perhaps inevitable if an effective solution to the enforcement second medical use patents was to be found.

Now that the precedent has been established, further applications for similar relief seem quite likely and it will be interesting to see how the practice develops.  At what stage will relief against NHS England be sought – prior to the grant of the generic marketing authorisation and without first asking the generic manufacturer to take steps to prevent its product from being dispensed against prescriptions for the patented indication?  Will NHS England contest similar applications in the future, which it reserved the right to do?  Will pharmacies also request that a cross-undertaking in damages be given in their favour, which seems possible in view of the fact that they may suffer also loss as a result of the guidance?

Published with minor amendments in CIPA Journal Vol. 44, No. 3 March 2015.