EU & Competition news

Date:    Various

Court:   European Patent Office and Court of Appeal – England

EPO REFERS PATENTS FOR NEW DOSAGE REGIMES WHILE UK APPEAL COURT PROTECTS THEM

THE EPO REFERRAL

Summary

The EPO has made a referral to the Enlarged Board of Appeal regarding the patentability of a new dosage regime for a known medicament to treat an illness for which the medicament is currently used.Kos Life Sciences

Background

Kos Life Sciences filed a European Patent Application, No. 94306847.8, for a novel dosage regime for the use of nicotinic acid, or a compound metabolised to nicotinic acid in the body, to treat hyperlipidaemia. The Examiners refused the application on the grounds that that the use of nicotinic acid, and compounds metabolised to nicotinic acid, to treat this illness formed part of the state of the art at the time of the application, and thus had been anticipated. Additionally, the Examiners found that the dosage regime was excluded from patentability under Article 52(4) EPC 1973 on the grounds that it was an excluded medical activity. Kos appealed, arguing that the dosage "once per day prior to sleep" in claim one was novel and inventive, and as such, patentable.

Decision

The Board of Appeal commenced by stating that, as the application was pending at the date the EPC 2000 came into force, the application was to be considered under the provisions of the EPC 2000. It then reviewed the prior art documents cited by the examination division: as the prior art did not disclose the specific dosage regime of "once per day prior to sleep" it was therefore novel. The Board the found that the dosage regime involved an inventive step as "the skilled person would not have envisaged changing the usual regime for the treatment of hyperlipidaemia by oral administration from twice daily to once prior to sleep." The Board concluded its initial assessment of patentability by stating that as the application referred to the manufacture of a medicament the requirement for industrial applicability had been met. However, the Board was uncertain on the interpretation of the provisions under Article 54(5) EPC 2000 for the second medical use.

Previous decisions by the Board involving new dosage regimes had been decided on either lack of novelty or inventive step, or both. This case was the first to be presented to the Board where the question of patentability fell solely within Article 54(5) EPC 2000. In its referral the Board found that the legal question to be answered was "whether a use, which differs from uses already part of the state of the art only in the dosage regime for the substance to be administrated to treat a specific condition, can be considered as a new specific use under Article 54(5) EPC 2000." This, the Board felt, fell within the remit of the legislators, not those tasked with interpreting the law as this issue raised considerations of public health, medical confidentiality and the preservation of the freedom of doctors to treat their patients. However, the Board was agreed that this was an important point of law that required clarification given the frequency that situation arises. On these grounds, the Board referred the following questions to the Enlarged Board of Appeal:

1. Where it is already known to use a particular medicament to treat a particular illness, can this known medicament be patented under the provisions of Articles 53(c) and 54(5) EPC 2000 for use in a different, new and inventive treatment by therapy of the same illness?



2. If the answer to question 1 is yes, is such patenting also possible where the only novel feature of the treatment is a new and inventive dosage regime?



3. Are any special considerations applicable when interpreting and applying Articles 53(c) and 54(5) EPC 2000?

A decision is still pending from the Enlarged Board. In the meantime however a relevant question was the subject of UK proceedings.

THE UK DECISION

Summary

The Court of Appeal has allowed an appeal against the finding that a new dosage regime is not enough to confer novelty on a Swiss-type medical use claim. (Actavis UK Ltd v Merck & Co Inc [2008] EWCA Civ 444). The Court of Appeal is free but not bound to follow the jurisprudence of the European Patent Office (EPO) where the EPO Board of Appeal has formed a settled view of European patent law that is inconsistent with an earlier UK decision. It also recognised and applied a new exception to the general rule of precedent laid down in Young v Bristol Aeroplane Co Ltd. [1944] KB 718 CA.

Background

Merck was the owner of patent EP (UK) 0724 444, for the use of the drug Finasteride for the treatment of androgenic alopaecia, using a new dosage regime. Finasteride, as a substance, was already known at the priority date of the patent.  The High Court revoked the Merck patent for lack of novelty on the ground that it was not novel pursuant to Article 54 of the European Patent Convention (EPC) and was unpatentable as it was a method of medical treatment. The obviousness attack was rejected.

Merck appealed against this finding of lack of novelty and unpatentability and Actavis appealed against the non-obviousness finding.

Decision

The Court of Appeal reviewed European Patent Office, German and New Zealand decisions on Swiss-type claims for a new dosage regime or other form of administration of the substance which conferred novelty to that claim. It concluded that the case law on this matter was settled and based on this, held that the claims in the patent in question are novel and are not claims to a method of administration, subject to the binding effect to its precedent by is prior decision in Bristol Myers Squibb Co v Baker Norton Pharmaceuticals Inc (2000) ENPR 230 CA (Civ Div) (BMS). The BMS case was reviewed and it was found that there was no clear judicial decision (ratio decidendi) for the present question on patentability. The Court then discussed the issue of how the doctrine of precedent should apply if there is no ratio to follow. The purpose of the rule of precedent was to produce certainty. As following an obscure decision would perpetuate uncertainty, the Court held that it was free but not bound to depart from the ratio of its own earlier decision if it was satisfied that the EPO Board of Appeal had formed a settled view of European patent law which was inconsistent with earlier decisions. In the present case, the jurisprudence of the EPO would be followed. The Court of Appeal also recognised and applied a new exception to the general rule of precedent laid down in Young v Bristol Aeroplane Co Ltd. [1944] KB 718 CA. 

It re-examined the finding of non-obviousness and concluded that the invention was not obvious at its priority date. The appeal was allowed.

Comment

It is ironic that the Court of Appeal has based its decision on the "settled" case law of the EPO especially since the EPO had only recently referred questions to the Enlarged Board of Appeal with regard to this same matter of novelty of Swiss-type claims by a new dosage regime in Case G2/08. Although the Court of Appeal took notice of this referral, it nevertheless decided to hand down this judgment. However, the Court has extended the time for an appeal to 28 days after the decision of the Enlarged Board of Appeal.