Summary

The Court of Appeal has decided in the case of Actavis UK Ltd v Merck & Co Inc [2008] EWCA Civ 444, that a Swiss-type claim can be patentable where the novelty is only conferred by a new dosage regime or form of administration of a substance. This is surprising because previously, the same Court had found such a claim to lack patentability (Bristol-Myers Squibb v Baker Norton [2001] RPC 1 (“BMS”)). Accordingly, the Court has created a further exception to the rules of binding precedent (stare decisis), where the precedent is contrary to “settled” EPO law.

Background and facts

The case turned on the validity of Claim 1 of Merck’s patent. This claimed the use of finasteride for the treatment of androgenic alopecia (male pattern baldness (“MPB”)) administered in the amount of about 0.05 to 1.0 mg per day. At the filing date of the patent, finasteride was already known to be useful in treating benign prostatic hyperplasia and had been proposed for treating MPB, but with a daily dosage of 5mg or more.

At first instance, Mr Justice Warren had found the invention non-obvious, but had revoked the patent on the basis of the decision in BMS. Merck appealed and Actavis cross-appealed on obviousness.

The handing down of the judgment from the Court of Appeal was delayed due to a decision from the Technical Board of Appeal (“TBA”) of the EPO in T/1319/04 – KOS Life Sciences Inc, which had referred questions on the very point of patentability of dosing regimes to the Enlarged Board of Appeal (“EBA”). The Court of Appeal invited the parties to make written submissions in relation to this decision.

Court of Appeal decision

Despite the TBA reference in KOS, the Court of Appeal decided to hand down a final judgment.

The Court of Appeal distinguished the facts of BMS from the present case on the basis that there was no clear ratio that a Swiss-type claim lacked novelty if the only difference between it and the prior art was a new dosage regime for a known medical condition. Further, unlike in BMS, there was no disclosure in the prior art of the exact feature of the dosing-regime claimed.

The Court went on to hold that even if it was wrong on that, the BMS approach was not in line with that of the EPO, which permitted Swiss-type claims where the novelty is conferred only by a new dosing regime under Article 52(4) of the European Patent Convention (“EPC”), as they were not to methods of medical treatment. Indeed, the Court of Appeal held that this position is “settled” at the Board of Appeal level and that the UK Courts should strive to follow “settled” EPO jurisprudence, although it is not binding in the same way as decisions from the ECJ. The “special circumstances arising from the creation of the European patent system and the central importance given to decisions of the Boards of Appeal” required the Court to recognise a further but limited exception to the rules of binding precedent laid down in Young v Bristol Aeroplane Co Ltd (1944) KB 718, decided at a time when “international influences” had little significance in our law.

The Court of Appeal did not accept Actavis’ submissions that the pending reference in KOS demonstrated that the Court was “wrong in saying that the position as regards new dosage regimes conferring novelty was settled in the EPO”. The Court of Appeal agreed with Merck that the KOS reference made no difference at all as it involved a question under EPC 2000 which was not applicable to this case. The Court of Appeal noted that it was possible that the EBA would rule that the existing EPO approach to novel dosing regimes was wrong, but this was unlikely. In the circumstances, the Court decided it would stand over the hearing on permission to appeal until after the EBA decision in KOS.

On obviousness, the Court of Appeal held that no error of principle had been demonstrated. The Court of Appeal held that Mr Justice Warren had been correct to accept Merck’s argument that by the priority date of the patent, published research meant that, in the 2 month period before the priority date of the patent, the landscape had changed so much that the skilled person would not have considered using finasteride for MPB, and so “would never get to investigate suitable dosages forms for he would think there are none”. Mr Justice Warren had held that, absent the new published research, the patent would have been obvious.

Conclusion and comment

The position is on hold pending KOS. Although this is a reference under EPC 2000, it is clear from the TBA that they consider it the same as under EPC 1973 i.e., EPC 2000 merely sought to enshrine the case law evolved by the EBA.

However, Lord Justice Jacob did comment in the judgment that despite holding that such claims are allowable, they will nearly always be obvious as “... it is standard practice to investigate appropriate dosage regimes.”

The case is of further interest as the Court of Appeal has in effect said that it is free to follow EPO case law where it is considered to be “settled” at the Board of Appeal level, despite conflict with previous decisions of its own. This raises the question - when is EPO case law “settled”? The answer to this is not straightforward as there is no rule of binding precedent in the EPO system. As a consequence, conflicting decisions can arise and indeed there are such conflicting decisions from the EPO on the very issue of whether novelty can be conferred by a new dosing regime. A House of Lords decision would therefore be welcomed on this issue.

The finding that the patent was obvious 2 months before the priority date but not at the priority date due to intervening publications having changed the common general knowledge is also of interest, not least because it raises the possibility of deliberate steps being taken by patentees to muddy the waters in the months preceding the filing of a prospective patent application.