Patenting “Biosimilars”
Several bills now in Congress could result in a fundamental change to patenting biologics (such as monoclonal antibodies). One bill gives the FDA authority to allow an abbreviated review for generic biologics. Major players in the information technology field (e.g. Microsoft, Google, et al) argue that existing patents on biologics are too broad-thus a need to separate patent protection from information protection-while the big pharmas, obviously, hold that strong patent protection keeps the pipeline flowing. A session at the recent BIO International Conference addressed this struggle: “Intellectual Property at the Crossroads.”
Download IP Think Tank podcast In this interview, Duncan Bucknell speaks to Gregory Glover, a panelist at the 2009 BIO International Convention, about the pending Biosimilar legislation and concerns over situations where a follow-on product might avoid patent claims but still be able to rely on innovator regulatory data.