ITC judge rules peg-EPO covered by exemption

USA-based biotechnology firm Amgen has issued a statement regarding its ongoing legal dispute with Swiss drug major Roche, which relates to the former's belief that the latter's peg-EPO (recombinant human erythropoietin) violates several of its US patents (Marketletter May 15). Moreover, the California-headquartered company believes that Roche's product does not provide any additional clinical benefit when compared with its own Epogen (epoetin alfa) or Aranesp (darbepoetin alfa) products.

An administrative law judge of the International Trade Commission in Washington DC, has issued a summary determination that the Swiss firm's importation and use of peg-EPO in the USA to date are subject to a clinical trial exemption from patent infringement. This decision will become final within 30 days if it is not modified by the Commission.

Amgen added that the judge had made no determination with respect to the merits of its claim that Roche's future importation of the product would infringe on its patents, and that it is entitled to re-submit its complaint at a later date.