This article was first published in Life Sciences Intellectual Property Review, March 2016

In the last year the English courts have produced several judgments on infringement of second medical use claims as part of the continuing litigation between Warner-Lambert (Pfizer) and Actavis and Mylan. While there are still questions to be answered on determining infringement of second medical use patents, there are some practical steps which patentees and future competitors can consider taking that may assist in trying to reach a non-contentious solution before the launch of any potentially infringing medicine. There is also some guidance from the courts on what relief patentees can expect the courts to provide if an infringement action relating to a second medical use patent is successful. 

As an obvious first step in advance of any potentially infringing launch, it is essential that a patentee looks to the summary of product characteristics of its future competitor’s medicine and reviews the therapeutic indications which the competitor medicine lists as approved. If the medicine has listed a patent-protected indication (a so-called full label) as an indication, it seems foreseeable that the competitor’s medicine will be intentionally used for the patented indication. At this time, a patentee should therefore consider writing to the competitor company to notify it of the second medical use patent and to request that the protected indication is removed from the medicine’s label.

However, even if the protected indication is removed (creating a so-called skinny label), this will not be enough in the UK to ensure that the competitor medicine, once launched, will not be prescribed, dispensed and used for the patent-protected indication. This is because:

  1. medicines are often prescribed by their international non-proprietary name rather than the branded medicine name;
  2. prescriptions do not contain information on the indication for which the drug is prescribed; and
  3. pharmacists are encouraged and incentivised to dispense the cheapest medicine.

Even if a medicine has a skinny label it can be dispensed to a patient and used for a patent-protected indication. Therefore, more needs to be done.   

Warner-Lambert case

In the Warner-Lambert litigation, both parties had taken steps to try to prevent the patent from being infringed. What steps are appropriate, who should take them and when they should be taken are key considerations for a patentee to think about as early as possible. The steps a patentee may consider include contacting the National Health Service (NHS) and equivalent bodies to seek the issuance of guidance on prescribing. As set out below, this is one of the key areas which the courts now consider to be the best way to achieve effective enforcement of second medical use patents.

Further, a patentee may write to pharmacies, hospitals and other stakeholders to inform them of the patent. A patentee may also seek to contact prescription software providers to see if software changes can be made to assist in ensuring that when a doctor writes a prescription, it is aware of the need to prescribe it in a particular manner for particular uses of a medicine. This can help with the effective implementation of any guidance on prescribing. For compliance with such a system, the burden on the healthcare professional needs to be minimal.   

What steps to take will depend on the particular prescribing, dispensing and method of sales of a given medicine. For example, if a medicine is sold through tenders, a patentee may consider writing to tendering authorities about the possibility of opening different tenders for different indications.

Patentees may also consider contacting healthcare professionals. However, caution should be exercised in such communications in order not to antagonise busy healthcare professionals, whose focus is on patient care. It is also important to ensure that such correspondence does not constitute any potential action for threats.

Some ideas, however, may not be permitted. For example, to avoid ambiguity, labelling guidelines for medicines say that negative statements should not be allowed (eg, “not for use in [disease]”).

Further, a patentee may request, or some commercially aware competitors may suggest, steps which the competitor can take to minimise the risk of infringement on launch. As in the Warner-Lambert case, competitors may also write to hospitals, health authorities and pharmacists to note that their medicine is not to be used for the patent-protected indication.

This approach could also be taken in terms of tenders, where competitors inform tendering authorities that any offer made does not include an offer for use in the patent-protected indication. In some instances, it may be helpful for the patentee and competitor to approach relevant authorities together, particularly at the present time when the system is developing.

Relief options available

In the event that proceedings for infringement are brought, a patentee may seek to be granted the usual relief provided in patent infringement proceedings, ie, an injunction that the infringer be prohibited from infringing the patent. From the current case law it seems that such an injunction will be more likely to be considered if the competitor has a full label; when the competitor has a skinny label the relief available from the court seems less clear. The problem is, of course, how to ensure that the exclusivity for the protected indication is respected while allowing free competition for non-patented indications.

In its resolution no. 238, passed at the conference in September 2014, the International Association for the Protection of Intellectual Property considered that injunctive relief should not be denied solely because such relief would prevent a pharmaceutical from being sold for non-patented uses.

However, this resolution also recognised that all the circumstances of the case need to be considered. One of the circumstances which should be considered is how would a potential infringer know it has complied with an injunction? It may not be straightforward as the potential infringer may consider that it has done enough not to infringe the patent by completing a small number of the possible steps outlined above, while the patentee expects more steps to be taken to consider that the injunction has been complied with.

In these circumstances, and as noted by Mr Justice Arnold in his September 2015 judgment in the Warner-Lambert case, an injunction may need to be more specific than the usual injunction prohibiting patent infringement. Not to put such specificities in an injunction would, Arnold considered, lead to a disproportionate injunction and one which could create legitimate barriers to trade where in all likelihood a competitor would have to withdraw its product from the market altogether. Similar sentiments were echoed by the English Court of Appeal in the Warner-Lambert case.

In addition, damages, another classic form of relief for infringement, could carry a heavy price tag if an infringer is required to pay an account of profits for any loss suffered for infringement. Bearing in mind that the originator’s medicine will inevitably be priced more highly than a generic competitor’s, it is not hard to see that this may make the sales of a product in the non-infringing market not worthwhile.

Arnold’s answers

So what is the answer? After much consideration, Arnold considered that the best solution was for prescriptions for medicines protected by a second medical use patent to be written by reference to the brand name. He added that “centralised and authoritative guidance” should be given to prescribers to inform them when they need to prescribe in this manner. There is, as yet, no uniform understanding of who will issue this guidance or when it should be issued.

However, as in the Warner-Lambert case, it would make sense for this to come from NHS England and the respective bodies in Scotland, Wales and Northern Ireland, and for it to be issued before a patentee seeks to rely on its second medical use patent. In this way there will be time for prescribers to become aware of and used to a new practice, and allow the guidance to be effective.

In his judgment from the proceedings between Warner-Lambert and Sandoz in November last year, Arnold noted the evidence of Warner-Lambert that the NHS guidance issued following a hearing in February was not as effective as had been expected for seven months later. Several months may therefore be needed for compliance.

If such guidance is the court’s preferred system for handling enforcement of second medical use patents, then it is imperative that patentees provide the relevant information to the health authorities with sufficient time for them to act on that information and issue guidance.

This approach was supported by Arnold in his decision in the Warner-Lambert proceedings last September. The judge also considered that those who wish to bring a product to market should also cooperate with the health authorities. Through a joint effort from all those involved, it is hoped that fair access to the market can be provided.