Serono Joins US Interferon Litigation

Ares-Serono's US subsidiary, Serono Laboratories, has filed suit againstBerlex Laboratories in a bid to invalidate the latter's patent for recombinant interferon beta, the active principle in Berlex' Betaseron treatment for multiple sclerosis.

Serono is seeking to invalidate Berlex' US patent, No 5,376,567 (also known as the McCormick patent), which covers the expression of interferons in Chinese hamster ovary cells. Serono is seeking to establish that its own interferon beta-1a product, Rebif, which is nearing the market, does not infringe the patent. Rebif has been granted orphan drug status in the USA for the treatment of secondary progressive MS.

A similar action concerning the McCormick patent has been filed by Biogen, which manufactures the only other approved interferon beta product for MS, Avonex. Biogen filed its suit in May last year, and this was followed by a counter-suit in July, in which Berlex maintained that Biogen was in violation of its patent and that the Food and Drug Administration had violated orphan drug legislation in allowing Avonex to come to market. This counter-suit was later dismissed (Marketletter October 14, 1996).