The US International Trade Commission has agreed to look into a patent dispute between Amgen and Roche over the latter’s plans to sell CERA, a drug for renal anaemia, in the USA.
At issue in the case, according to the ITC, is whether Roche’s decision to seek marketing approval of CERA in the USA contravenes patents held by Amgen on recombinant human erythropoietin, the red blood cell stimulating factor that lies at the heart of both CERA and Amgen’s Epogen (epoetin alfa) and Aranesp (darbepoetin alfa) products, which had combined sales of $5.7 billion last year.
The ITC said it intended to rule on the Amgen’s request for a permanent exclusion order on CERA within 45 days of starting the probe. Roche said it planned to ask a US judge to dismiss the investigation, on the grounds that CERA has not yet been approved for sale in the USA.
CERA is a long-acting erythropoietin product that is considered to be one of the biggest hopes in Roche's near-term pipeline, and analysts have suggested the new product could make 1.3 billion Swiss francs ($1bn) in 2010 outside the USA alone, and more if it gets access to the US market and a follow-up indication in chemotherapy-associated anaemia.
It is a successor to the Swiss company’s NeoRecormon (epoetin beta) product, which is currently its second-biggest product with sales of 2.3 billion Swiss francs last year.