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May 15, 2006

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I was hoping that someone could address the issue that therapeutic antibodies (e.g. humanized, fully human, etc.) are facing during patent prosecution in the EU. Specifically, the EU is taking the stance that merely engineering the antibody is insufficient to overcome inventive step rejections. The Applicants need to show something above and beyond lower immunogenicity. Their stance is inhibiting the ability of biotechs and pharmas to obtain coverage for their therapeutic entities. Are there any prosecution strategies that are working?

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