Patent relates to use of a low dose of finasteride for the treatment of androgenic alopecia in humans, specifically male pattern baldness (MPB).

Claim 1: The use of [finasteride] for the preparation of a medicament for oral administration useful for the treatment of androgenic alopecia in a person and wherein the dosage amount is about 0.05 to 1.0 mg (per day - post grant amendment).

Case turns on whether a novel dosage regime alone can confer novelty on a Swiss type claim (relevant law is unamended EPC 1973).

On policy grounds, Jacob considers there is no reason a novel dosage regime cannot confer novelty - research into new and better dosage regimes is desirable and there is no policy reason why, if a novel, non-obvious dosage regime is invented, it should not be appropriately awarded. Such a reward cannot extend to covering the actual treatment but a Swiss form claim which specifies the new, inventive regime is entirely in accordance with policy.

EPO has settled case law in Eisai and Genentech which hold that a novel dosage regime alone is sufficient to confer novelty on a Swiss type claim. The UK position has been considered to be different because of the Court of Appeal decision in Bristol Myers Squibb (BMS).

The UK courts would normally follow such settled EPO jurisprudence (Merrell Dow), however, because of BMS, Actavis contends the Court of Appeal are not permitted to follow the EPO.

Jacob considers that there is no clear ratio decidendi in BMS to say that a novel dosage regime cannot confer novelty on a Swiss type claim. It merely says that there must be a new "therapeutic application", not specifically a new illness or condition. The situation in BMS is also different from the present case because the dosage regime in BMS was already disclosed in the prior art so it wasn’t novel, thus BMS did not focus on the dosage regime part of the claim.

Thus J Warren was not bound to follow BMS because the ratio was unclear, so he was wrong to hold that the claim was not novel and wrong to hold that it was to a method of treatment.

Jacob considers the issue of precedent - Young v Bristol Aeroplane (1944)

If there is no clear ratio or the ratio is obscure then a court cannot be bound to try to find one to follow.

Further, there should be a further exception to the rules for following precedent as set out in Young, resulting from the influence of European law which didn’t exist when that case was decided.

Thus:

"There ought to be, and is, a specialist and very limited exception to the rule in Young. 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."

Jacob agreed with the judge at first instance.

Merck’s appeal is allowed and the order for revocation of the patent should be rescinded.

Considered that this referral to the Enlarged Board of Appeal was merely to confirm that the law under EPC 2000 is the same as under the unamended EPC with regard to dosage regimes.

This decision is under the unamended EPC and Kos is highly unlikely to decide contrary to Genentech, so Jacob decided to make this decision final. However, to allow for the unlikely event that the decision in Kos might affect this one he has extended the period for leave to appeal to the House of Lords to 28 days after the decision in Kos is issued.