Bad Hair Day For Swiss Style

Article by Dr. Frederick Chen

A

recent decision of the Patents Court highlights what appears to be an important

gap between European Patent Office (EPO) jurisprudence on second medical use

and the approach of the English courts.

†Merck

& Co., Inc. (Merck) is the proprietor of a number of patents related to a

drug called finasteride. Finasteride is the active pharmaceutical ingredient in

a product called PROPECIA, a 1 mg/day tablet of finasteride for the treatment

of male pattern balding. Male pattern balding is believed to be caused by

dihydrotestosterone, which is produced from testosterone by the activity of the

enzyme 5?-reductase. Finasteride blocks the activity of this enzyme.

Actavis

UK Limited (Actavis) sought to revoke the patent under which PROPECIA is sold (Actavis

UK Limited v Merck & Co., Inc. [2007] EWHC 1311 Ch). This disputed

patent claimed, in the so-called ìSwiss-typeî form, the use of low dose (0.05

to 1 mg/day) finasteride for the preparation of a medicament for oral

administration useful for the treatment of androgenic alopecia (a condition

including both male and female pattern baldness).

At

the priority date of the disputed patent, October 1993, Merck was already marketing

a product called PROSCAR, a 5 mg/day tablet of finasteride for the treatment of

a condition known as benign prostatic hyperplasia (prostate enlargement) under

an earlier patent. The specification of the earlier patent disclosed the

treatment of androgenic alopecia with finasteride, but at a much higher dosage

than claimed in the disputed patent.

Actavis'

grounds of invalidity were that the claims in the patent in suit were (1) a

method of treatment; and (2) obvious in light of the prior art and common

general knowledge. In relation to the first ground, Actavis argued that for a

ìSwiss-typeî (or second medical use) 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 v Baker Norton (2000) ENPR 230, a new dosing regimen for the

treatment of a previously disclosed disorder would not confer novelty.

Mr

Justice Warren agreed with Actavis' submission that Merck's earlier patent had

disclosed the therapeutic application, i.e. treatment of androgenic alopecia,

and that there had been no novelty in the use of finasteride as treatment for

androgenic alopecia, only in its reduced dosing regimen. The...

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