The Court of Appeal has recently handed down a significant judgment in the case of Actavis v Merck, ruling that a Swiss form claim for the use of a pharmaceutical in the manufacture of a medicament could be allowed even where the novelty lay only in a new dosing regime. Emphasising the importance of taking an approach consistent with that of the EPO, the Court rejected arguments that it was bound not to allow such a claim on the basis of the Court of Appeal judgment in Bristol-Myers Squibb v Baker Norton. The case is likely to be of great interest to the pharmaceutical industry, as it provides a more consistent approach to patentability of Swiss claims across the European Patent Convention countries, and will improve the prospects of pharmaceutical companies seeking to obtain patent protection in the UK for new applications of known substances.
Swiss claims in the form ‘the use of compound X in the manufacture of a medicament for a specified therapeutic use Y’ have long been accepted by the EPO and UKIPO since the landmark case of Eisai (G5/83). Eisai allowed a Swiss form claim for a ‘new therapeutic use’ of a medicament, irrespective of whether or not the medicament was already known.
This form of claim is commonly used to overcome the two hurdles that had previously prevented such claims being granted, namely that (i) the drug itself is not novel, and (ii) that the use of the drug should not be patentable as it relates to a ‘method of treatment of the human or animal body’, which is excluded from patentability under the Patents Act 1977 and the European Patent Convention.
In the recent EPO case of Genentech (T1020/03), and in other similar cases, the EPO has confirmed that it follows from Eisai that a novel dosage regime can confer novelty to a Swiss form claim. However in recent years the UK courts have taken a different position. Although Swiss form claims are allowed, it was widely accepted that the Court of Appeal case of Bristol-Myers Squibb v Baker Norton (BMS) had established that Swiss claims would not be allowed in the UK where the only aspect claimed to be novel was a new dosage regime.
Actavis v Merck
Merck’s patent claimed the use of finasteride for the treatment of androgenic alopecia wherein the dosage amount is about 0.05 to 1.0 mg. However finasteride had previously been proposed to treat androgenic alopecia, albeit with a daily dosage of 5mg or more. In the High Court, Warren J held that following BMS, the claim lacked novelty and was for a method of treatment. Actavis appealed.
In a thorough and illuminating judgment on Swiss form claims, the Court performed a careful analysis of the BMS case and concluded that in fact, it had not, as many had thought, provided clear guidance on the patentability of dosing regimes. Lord Justice Jacob said, “we are not satisfied that BMS contains a clear ratio that a Swiss form claim lacks novelty if the only difference between it and the prior art is a new dosage regime for a known medical condition”.
Follow the EPO
In the absence of a clear decided point of law it was preferable to follow the EPO’s clear approach on the subject. In the EPO, Swiss form claims whose novelty depends on a new treatment by a different dosage regime or method of administration are treated as novel and not as claims to a method of administration. Referring to the fact that the Patents Act 1977 says in its preamble that it is intended to give effect to certain international treaties (particularly the EPC) and that under section 91 of the Act judicial notice shall be taken of relevant convention courts, Jacob LJ concluded he should strive to follow the EPO’s interpretation.
Jacob LJ also rejected arguments that Merck’s claim was excluded from patentability as it related to a method of treatment. In its essence the claim was to the use of finasteride for the preparation of a medicament of the specified dosages. It is not aimed at and does not touch the doctor; it is directed at the manufacturer.
The judgment shows a strong willingness to align the interpretation of UK patent law with that of the EPO:
“If the UK is out of line, it will either be going too far or not far enough; either recognising as valid patents which the EPO has held should not as a matter of law, be granted (this could happen, for instance, if the application were made to the UK Office) or holding invalid patents which the EPO considers are valid. Either situation would be bad for the European market.”
Rewriting the Rules
Unusually, Jacob LJ said that even if BMS had been sufficiently clear on the point, he would not have followed the precedent it set, despite it being a Court of Appeal decision. The case of Young v Bristol Aeroplane Company has established that the Court of Appeal should follow its own judgements unless (1) there were previous conflicting decisions, or (2) the previous decision is not compatible with a House of Lords decision or (3) if it is satisfied that the decision was given per incuriam (without reference to a relevant point of law).
Jacob LJ said that the special circumstances arising from creation of the European patent system and the central importance given to the EPO Boards of Appeal decisions required the court to recognise a further exception to the rule in Young v Bristol:
“Spelling it out it is that this court is free but not bound to depart from the ratio decidendi of its own earlier decision if it is satisfied that the EPO Boards of Appeal have formed a settled view of European Patent law which is inconsistent with that earlier decision. Generally this court will follow such a settled view.”
A Good Result
This judgment may herald the start of a period where UK patent case law aligns with that of the EPO. Jacob LJ has taken a practical and common sense approach to the issue as well as considering whether there are any policy reasons why the UK should have a different position to the EPO:
“Research into new and better dosage regimes is clearly desirable – and there is simply no policy reason why, if a novel non-obvious regime is invented, there should not be an appropriate patent reward”.
The case is refreshing in as much as it brings the UK in line with the EPO, which makes things easier for those seeking to file and rely upon pharmaceutical patents. Also Jacob LJ’s willingness to allow the Court of Appeal to choose not to follow its own precedents provides hope that in other areas of patent law where the UK case law is out of step with the EPO, such as the patentability of computer programs and business methods, harmonisation may be possible without recourse to the House of Lords.