Amgen, the world’s largest biotechnology company, yesterday sought to ban the importation of Roche’s anti-anaemia product Cera into the USA, saying the drug contravenes its patent armoury. It has filed a complaint with the International Trade Commission in Washington, asking the government office to investigate the matter, and expects a decision within the next 30 days. However, an investigation will likely last months.
Amgen says that both the pegylated recombinant human erythropoietin compound, which boosts red blood cell counts in anaemia, and the manufacturing method covering it are patent protected. The company, which says it is “committed to cooperating with the ITC to protect this domestic industry [the USA] from unlawfully imported products,” is keen to protect sales of its blockbuster Epogen (epoetin alfa) and follow-up Aranesp (darbopoetin alfa), which together represented a $6 billion franchise in 2005.
Cera is Roche’s follow-up offering to NeoRecormon (epoetin beta) and is not yet approved for marketing in the USA. But its battle to reach the world’s number one pharmaceutical market has been made that much more difficult by Amgen, which last November filed its first patent infringement suit against the Swiss giant. Roche, for its part, says that Cera does not overstep Amgen’s patent armoury because its chemical structure is different.
Roche is hoping to file for US approval of Cera by the end of the year in treating anaemia associated with kidney disease but recently said it will not look for a second label in chemotherapy-related anaemia until 2009.