The patent in suit covered the second medical use of a known pharmaceutical product. Actavis sought to sell the product without the claimed indication being referred to in its patient information leaflet (skinny label). The High Court refused to grant an interim injunction aimed at preventing pharmacists from dispensing a generic product for the claimed use, despite the fact that it was known that off-label sales were likely to occur. Warner-Lambert Company, LLC v Actavis Group Ptc EHF & Others [2015] EWHC 72 (Pat).

Business impact  

  • Where a generic applies for an MA with a skinny label, there is limited recourse an originator may have against a generic at court to prevent off-label sales. Applications compelling generics to change their package labels or enter into contractual terms with pharmacists not to sell off-label are unlikely to succeed. The court may compel the generic to notify pharmacists and government/regulatory bodies of the existence of the patent rights preventing off-label use, however off-label sales are still likely to occur, in particular, as in this case, where the branded drug has been approved for the off-label indication.
  • Patentees should not delay in corresponding with generic companies to open discussions on package labelling, and to seek to agree a communications strategy to inform third parties of the "skinny" generic product.
  • There is judicial backing for NHS England and NHS Wales to provide guidance to doctors to prescribe by reference to the brand name for patented indications and by reference to the generic name for non-patented indications, and the judge noted that there is a reasonable prospect of this happening in the near future.
  • The courts are increasingly keen to involve the Department of Health in interim injunction hearings, and the Department is likely to ask for any indemnity relating to a wrongly granted injunction to extend to the Department and the NHS. Where a generic company has applied for an MA with a skinny label, this alone may be sufficient to show non-infringement of a second medical use claim in the Swiss form. 
  1. The second medical use patent
  2. The genetic threat
  3. Involvement of the Department of Health
  4. Measures to prevent third parties assisting or making off-label sales
  5. The relief sought
  6. No serious issue to be tried
  7. Balance of the risk of injustice

1. The second medical use patent

Warner-Lambert (part of the Pfizer group) market a prescription-only drug (pregabalin) for three different indications under the same brand (Lyrica). Patent protection for the drug itself has expired, but the patentee has a patent directed to the use of pregabalin for the preparation of a pharmaceutical composition for treating pain, in particular neuropathic pain (a Swiss form second medical use claim).

2. The generic threat

At the date of the judgment, Actavis were on the verge of obtaining a marketing authorisation ("MA") for generic pregabalin limited to the two off-patent indications. The application for the MA was made with what is known as a "skinny label"; the Summary of Product Characteristics and Patient Information Leaflet did not include reference to the patented indication. However, skinny labels do not prevent doctors from prescribing, or pharmacists from dispensing, the generic drug for the patented off-label indication. Further, doctors are encouraged to (and in the great majority of cases do) prescribe drugs using their generic name, rather than their brand name1. Faced with a generic prescription, pharmacists are free to prescribe a branded or generic drug, and it is very rare that the prescription will identify the condition for which the drug has been prescribed. The only reliable way to ascertain the intended use of the drug would be for the pharmacist to contact the prescriber – an impractical solution.

Warner-Lambert filed a claim for patent infringement by Actavis, and applied for an interim injunction (pending trial) requiring Actavis to take a number of steps to prevent their generic product from being dispensed for treating pain. Proceedings against Actavis for patent infringement will be tried later this year, alongside revocation proceedings brought by Actavis and another generic supplier (Mylan).

3. Involvement of the Department of Health

Warner Lambert had notified the Department of Health of its application, and following repeated requests by the judge, the Department of Health was represented at the trial by the Treasury Solicitor. They requested that, if relief was granted, Warner-Lambert's cross-undertaking in damages should extend to the Department and the NHS.

4. Measures to prevent third parties assisting or making off-label sales 

The parties agreed that the problem would be solved if prescribing doctors would prescribe the drug for the treatment of pain by reference to the brand name rather than by reference to the generic name. However, it was not in the power of either party to ensure this happened.

Pfizer has taken a number of actions to prevent off-label sales, by correspondence with its pharmacy customers, the Pharmaceutical Advisers Group, Clinical Commissioning Groups ("CCGs") (in England) and Health Boards (in Wales), NICE, and the Department of Health, with varying degrees of success. For example, NICE agreed to amend their Clinical Guidance to reflect the fact that off-label prescriptions may be infringing, though it was questioned whether this change would have any practical implications on the actions of prescribers.

Warner-Lambert noted, with agreement from Actavis, that the best resolution (for doctors to prescribe Lyrica for pain) could be achieved if, for example, the prescribers were given clear guidance to prescribe by reference to the brand name for the patented indication and by reference to the generic name for non-patented indications. Counsel for the Department of Health informed Mr Justice Arnold that though the Department could not give this guidance itself, they would not consider it inappropriate for NHS England to issue such guidance. Mr Justice Arnold concluded "for my part I would encourage them to consider doing so as a matter of urgency". He also noted that there is a reasonable prospect of this happening in the near future.

5. The relief sought 

The parties had agreed that, once Actavis obtained their MA, they would send a letter to the CCGs (and Health Boards in Wales) and to superintendent pharmacists notifying them that their generic product should not be sold for the treatment of pain. Mr Justice Arnold agreed.

However, Warner-Lambert also sought the following (unprecedented) mandatory injunctions:

  1. Actavis should enter into contractual terms with pharmacists to ensure they do not sell the generic drug off-label; and
  2. Actavis should put a notice on its packaging warning against dispensation for the treatment of pain.

In relation to (1), Mr Justice Arnold noted that that this was likely to be impractical because the pharmacists would have difficulty in ascertaining what the drug had been prescribed for. In relation to (2), there were regulatory concerns with Actavis amending their packaging which had not been completely clarified at the time of the trial. 

6. No serious issue to be tried  

The court will only grant an injunction if it finds that the claim for patent infringement raises a serious issue to be tried.

It was held by Mr Justice Arnold that the word "for" in Swiss form claims imports a requirement of subjective intention on the part of the manufacturer that the medicament will be used for treating the specified condition. His reasoning was that the wording of the claim ("use of pregabalin … for the preparation of a pharmaceutical composition") is directed towards the manufacturer, not the later "users" of the drug. Hence it is the intention of the manufacturer that is relevant. This follows the reasoning of Jacob LJ in Actavis v Merck [2008] EWCA Civ 444, where he notes at [75] that a Swiss form claim "is not aimed at and does not touch the doctor – it is directed at the manufacturer".

The fact that Actavis had applied for a skinny label was sufficient to show this subjective intention was lacking, and the fact that Actavis knew that pharmacists would be likely to dispense off-label was not relevant. Mr Justice Arnold therefore found that there was no serious issue to be tried.

7. Balance of the risk of injustice  

Notwithstanding his finding that there was no serious issue to be tried, Mr Justice Arnold went on to consider the other factors in granting an injunction. He found that though it would be difficult to quantify Warner-Lambert's loss if no relief was granted pending trial, nonetheless the scale of that loss is not likely to be substantial. Warner-Lambert would only suffer recoverable loss if and to the extent that the steps the parties had already taken to discourage the prescribing/dispensing of the generic product for pain were ineffective. Furthermore, if the NHS were to issue guidance to doctors to prescribe Lyrica for pain, then Warner-Lambert would be unlikely to suffer recoverable loss. Mr Justice Arnold also considered it relevant that even if Warner-Lambert is successful at trial, it is very unlikely to obtain relief against Actavis which makes it absolutely certain that the generic product is not dispensed for pain in the future.

On the other hand, Actavis are likely to suffer substantial unquantifiable loss because (i) the notice and the contractual terms requested by Warner-Lambert are likely to deter pharmacists from stocking Actavis's product and (ii) putting a notice on their packaging will delay market entry.

Taking this into account, along with the likely efficacy of the measures sought, Mr Justice Arnold found that even if there was a serious question to be tried, the balance of the risk of injustice would favour refusal of the injunctive relief sought.