The Noose Tightens on Patent Protection of Biologics?

Biologics continue to increase in number, both in approved products and in products in development. Many of the biggest selling products are biologics, and in particular biologics arising from a monoclonal antibody. 21 FDA approved therapies – including eight blockbuster drugs, are monoclonal antibody based. In 2007, the US market was worth $21.9bn. (Bioportfolio, Therapeutic Monoclonal Antibody Report 2008-2023). For example, some of the biggest are Remicade® (Johnson & Johnson, Schering-Plough, Tanabe) and Enbrel® (Amgen, Wyeth) for Rheumatoid arthritis, Rituxan®, (MabThera Roche, Genentech, Biogen Idec, Chugai Pharmaceutical) for Non-Hodgkin’s lymphoma and Herceptin® (Roche, Genentech, Chugai Pharmaceutical) for Breast cancer rank 12, and Avastin® (Roche, Genentech) for Colorectal cancer, having combined worldwide sales of over $20bn in 2008. (Krishan Maggon,

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