Intellectual Property Law

The Court of Appeal has now reached its decision in Actavis UK v Merck Co, Inc.

By way of background, Merck is the proprietor of a number of patents related to a drug called Finasteride. That drug is the active pharmaceutical ingredient in a product called Propecia, a tablet form of Finasteride for the treatment of male pattern balding. Finasteride blocks the activity of an enzyme which causes the balding.

Actavis sought to revoke the patent under which Propecia was sold. At the priority date of the Propecia patent (October 1993), Merck was already marketing a product called Proscar, a tablet form of Finasteride for the treatment of prostate enlargement under an earlier patent. The specification of this earlier patent disclosed the treatment of androgenic alopecia with Finasteride, but at a much larger dosage than that claimed in the disputed patent.

Actavis' grounds of invalidity were that the claims in the Propecia patent were 1) a method of treatment; and 2) obvious in light of prior art and common general knowledge. In relation to the first ground, Actavis argued that for a Swiss-style claim to be valid, it needed to be directed to the use of a substance for the manufacture of a medicament for a specified new and inventive therapeutic application. In particular, following Bristol-Myers Squibb, a new dosing regime for the treatment of a previously disclosed disorder would not confer novelty. The EPC agreed with Actavis on lack of novelty and made an order for the revocation of the patent. It did not however hold that the claims were obvious.

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

The Court of Appeal held that Swiss-type claims were allowed under the European Patent Convention 1973 (art. 52(4)) and settled EPO case law where the novelty was conferred by a new dosing regime. It was further held that Bristol Myers Squibb did not contain a 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.  The EPC had erred in holding that the claim lacked novelty and was for a method of treatment. The Court also said that even if Bristol Myers Squibb was a binding precedent, it was not bound to follow it if it was inconsistent with settled EPO law.

Actavis was not successful in its cross-appeal and the order for the revocation of the patent was rescinded.