Switzerland based Biotechnology Company; Roche Holding AG who developed pegylated version of Erythropoietin (MIRCERA®) said on Tuesday that they agreed to conditions set by the federal judge of the United States district court of Massachusetts, overseeing a patent case brought by Amgen Inc, which could clear the way for Roche to sell its anemia drug MIRCERA® in the United States. Last year the same court ruled that Roche infringed at least four Patents of Amgen in the United States which will only begin to expire in 2013. Amgen requested a permanent injunction to prevent Roche from importing, using and selling any pegylated Erythropoietin product in the United States for the term of the four patents Roche was held to infringe. Roche then proposed royalty payments of 20% to Amgen which they rejected. Earlier this year in February the court said that they would allow MIRCERA’s US Introduction if Roche agreed to pay Amgen a royalty of 22.5% of US sales, compared to 20% Roche has initially proposed. Roche agreed to this on Tuesday and in their statement also guarantee that they wouldn’t charge higher prices than those of Amgen’s anemia treatments (EPOGEN and ARANESP).
In one of its first kind of the judgment, the court tries to overcome the monopoly of Amgen that they had over Erythropoietin for Anemia associated with Chronic Kidney diseases. Erythropoietins have a worldwide market of over $12 billion and accounts major part of Amgen’s revenue from United States. MIRCERA® however is already selling in Europe and has been approved by both European (EMEA) and US (FDA) regulatory bodies for the treatment of anemia associated with Chronic Kidney diseases. It will be interesting to see how this move of the district court in the US affects Indian companies who plan to launch Biosimilars in the United States. As many as four Indian companies, Wockhardt, Biocon, Shantha Biotech and Intas Pharma are manufacturing EPO indigenously and selling it by the names of Wepox, EryproSafe, Shanpoietin and EPOFIT respectively.
In a further interesting development Chennai patent office granted one of Roche’s product patent for MIRCERA last month. The patent IN212429 covers the product claims of MIRCERA which is required at a dosing interval of only once per month as compared to the existing products which are required more frequently.
This development Roche vs Amgen case is important and will be closely watched by the Indian companies who are planning to launch their Biogenerics in the developed markets.