High Court orders NHS to give guidance on the prescribing of pregabalin in Warner-Lambert v Actavis

05 March 2015


In a judgment published on 2 March 2015, the fascinating saga between Warner-Lambert and Actavis takes yet another turn. Arnold J has delivered a pragmatic solution to the difficult issue of a patent with claims in the tricky "Swiss form", but this is unlikely to be the last word in the saga - life sciences companies should all watch this space.

Facing difficulties with enforcing Swiss-form claims (addressed in his previous judgments between the parties - see our previous alert here), Arnold J has taken the creative, if somewhat surprising, step of ordering that the NHS issue guidance on the prescribing and dispensing of pregabalin: for the treatment of pain (Warner-Lambert's patented indication) it is the branded medicine, Lyrica, which should be prescribed and dispensed. In doing so Arnold J has created a practical solution, drawing on the reasoning of his October 2014 judgment in Cartier International v British Sky Broadcasting [2014] EWHC 3354 (Ch) about a website blocking order, to do so.

Background

To briefly recap on the history of the case; Warner-Lambert (a member of the Pfizer group) markets a drug, Lyrica (generic name, pregabalin), for indications including the treatment of pain. Patent protection for the drug itself has expired, but Warner-Lambert's patent EP0934061 (the "'061 Patent") is still in force. The '061 Patent contains Swiss form claims directed at the use of Lyrica/pregabalin for the treatment of pain.

Actavis had applied for marketing authorisation to make generic pregabalin under the trade name Lecaent. Actavis applied to revoke the '061 Patent and Warner-Lambert claimed that Actavis would infringe it.

Warner-Lambert then applied for an interim injunction to force Actavis to take various steps with a view to ensuring that Lecaent would not be prescribed for pain. On 21 January 2015, Arnold J refused that application, but did note that:

"the best solution to the problem is for doctors to prescribe Lyrica for pain. If the NHS issues appropriate guidance, that is likely to happen […]"

On 22 January 2015, following Arnold J's decision, Warner-Lambert wrote to the NHS Commissioning Board (NHS England) asking for it to issue such guidance to Clinical Commissioning Groups (CCGs).

NHS England refused to do so without an order from the court. This led to Warner-Lambert issuing an application on 20 February 2015 to compel NHS England to issue such guidance. Warner-Lambert's application against NHS England was served on Actavis, Teva, Consilient, Mylan, Sandoz and the Department of Health as interested parties. None of them, not even NHS England, opposed the order being made in principle.

In the meantime several other events had occurred in the background to this application:

  1. In the Court of Appeal, Lord Justice Floyd LJ granted Warner-Lambert permission to appeal Arnold J's 21 January 2015 decision refusing Warner-Lambert's application for an interim injunction;
  2. Warner-Lambert commenced infringement proceedings against Dr Reddy's and Teva; and
  3. Dr Reddy's and Actavis obtained marketing authorisations (MAs) and launched generic pregabalin in the UK.

NHS England

NHS England is an executive non-departmental public body established under the National Health Service Act 2006 as amended by the Health and Social Care Act 2012. Under the 2006 Act, NHS England has a duty to publish guidance for CCGs on the discharge of their commissioning functions. CCGs are statutory bodies responsible for commissioning a range of medical services in their respective areas of England.

Legal basis for making the order

For the purposes of the application it was agreed that the court had jurisdiction to make the order sought pursuant to the power recognised by s.37(1) of the Senior Courts Act 1981.

Both NHS England's and Warner-Lambert's solicitors agreed that the present situation was "comparable to Norwich Pharmacal" and that, as Warner-Lambert put it, "NHS England is an innocent party who is mixed up in the wrongdoing of others".

Norwich Pharmacal concerned orders made against parties for disclosure of documents where the party is not likely to be involved in the claim but is mixed up in the wrongdoing it involves, whether innocently or not.

Arnold J found difficultly with the analogy and expressed doubt as to whether Norwich Pharmacal was relevant. However, for the present purposes he was "prepared to assume that the equitable protective duty and duties analogous thereto can be enforced by injunction in parallel circumstances".

Arnold J noted that before he could make the order against NHS England, he would need to be satisfied that it complied with Article 3 of the Enforcement Directive (2004/48/EC), and in particular that "the order is proportionate, does not create barriers to legitimate trade and contains safeguards against abuse".

Article 3 of the Enforcement Directive reads:

"Article 3

General obligation

1. Member States shall provide for the measures, procedures and remedies necessary to ensure the enforcement of the intellectual property rights covered by this Directive. Those measures, procedures and remedies shall be fair and equitable and shall not be unnecessarily complicated or costly, or entail unreasonable time-limits or unwarranted delays.

2. Those measures, procedures and remedies shall also be effective, proportionate and dissuasive and shall be applied in such a manner as to avoid the creation of barriers to legitimate trade and to provide for safeguards against their abuse."

Arnold J explained that he had followed the same approach as in his previous decision in Cartier International v British Sky Broadcasting [2014] EWHC 3354 (Ch) (17 October 2014) (see our previous alert here).

In Cartier, Arnold J granted orders against Internet Service Providers to block access to websites selling counterfeit goods that infringed trademarks. Trademark law contained no express provisions permitting the granting of such injunctions, unlikely copyright law, and so Arnold J had instead relied on the general powers of the court to grant injunctions as confirmed by s.37(1) of the Senior Courts Act 1981 (the same provision he now relied on in this case).

In the present case, Arnold J considered the following factors to be relevant to his conclusion that the order sought by Warner-Lambert was proportionate:

  • a patent is an IP right which is to be protected in accordance with Article 17(2) of the Charter of Fundamental Rights of the European Union;
  • the freedom of generic suppliers to conduct business would be protected by a cross-undertaking in damages;
  • the impact on dispensing by pharmacists, and the potential for the order to cause them to make lower profits, was justified by the existence of the '061 Patent (assuming it was valid).

Arnold J was therefore satisfied that he could grant the order sought against NHS England. He was satisfied that the order contained appropriate safeguards, in particular the fact that it would cease to apply if the Patent was revoked or expired, and that it included the cross undertaking in damages and the liberty to apply. Arnold J summarised the rationale behind his decision as "the issuing of guidance by NHS England is the most efficacious, dissuasive and cheapest solution to the problem which confronts Warner-Lambert."

Terms of the order

The terms of the order are annexed to the judgment and make for interesting reading. NHS England must issue (and at the time of writing this article has now issued) guidance to be distributed to GP practices and pharmacies that:

"Pregabalin should only be prescribed for the treatment of neuropathic pain under the brand name Lyrica® (unless there are clinical contra-indications or other special clinical needs e.g. patient allergic to an excipient, branded product unavailable etc which apply to Lyrica®, when you should not prescribe Lyrica® or pregabalin)".

A cross-undertaking in damages would also be given by Warner-Lambert to NHS England, the Department of Health, Actavis (for the benefit of the companies in the Actavis group, without having to identify the individual entities involved), Teva (again, for the group) and Dr Reddy's (again for the group).

Comment

This decision represents a bold and pragmatic step by Arnold J in addressing the enforcement of Swiss-form second medical use claims. It reduces the likelihood of generic pregabalin being prescribed for the patented indication in a practical way, thereby enforcing the patent. By doing so it also offers comfort to generic manufacturers as regards their potential liability for potential infringement. The breadth of the cross-undertaking also reduces the prospect that Warner-Lambert would 'profit' from the order, in the event that the patent is later found invalid.

However, eyebrows might be raised among doctors and pharmacists who now find themselves at the front line of patent enforcement.

This decision also represents an extension of the principle developed by Arnold J in the Cartier decision. In the Cartier decision, the trademark infringement was blatant - the goods were counterfeit. However, in this instance, Arnold J acknowledged it was not so straightforward; if his construction of the patent is right, then it is not seriously arguable that Actavis infringes the '061 Patent at all.

While this decision seems a sensible outcome for the parties concerned in practice, the fact that permission to appeal has been given by the Court of Appeal regarding the interim injunction refusal appears to have been persuasive in Arnold J's exercise of the court's jurisdiction in this case. It may be that the Court of Appeal reaches a different conclusion to Arnold J on the construction of the Swiss form claim in issue, and that this could impact the basis for the award of relief pursuant to the Enforcement Directive.

The inherent jurisdiction of the court is very wide, but at what point is the remit for its use, in reliance upon the Enforcement Directive, exhausted? Upon Arnold J's reasoning an IP right can effectively be 'enforced' by forcing a change in prescribing practices where there is no infringement, in reliance upon its existence (presuming that it is valid).

This decision indicates that the courts are not afraid to extend the use of the inherent jurisdiction beyond that seen in cases of more blatant infringement of IP rights (such as in Cartier) to deliver a practical solution to a commercial dispute.

The decision marks a major change in how second medical use claims will be enforced but there is likely more to come yet; this is surely a case the life science industry will be keeping a close eye on for some time to come.


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