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 ). 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.