September 1, 2016

“Biomedicine protection strategy in the US – ‘No patent is trivial,'” Pharmafocus, September 2016

By Kisuk Lee, Principal

Biologic medicines are next generation drugs capable of treating many medical conditions that lack other treatment. New marketing approvals for biologics have risen sharply in the United States for the past few years. Approved biologics are gaining increased market share. From small molecule drug experience, all players know that a successful drug is always chased by generic manufacturers. Successful biomedicines are destined to face fierce biosimilar challenges. Therefore, for effective defence, biologics innovators must prepare in advance of a biologics license application (BLA) filing. Biologic medicines require unique market protection strategies, particularly in patent preparation. Biologic innovators need to build a robust patent portfolio to fend off generic entries.

However, traditional patenting models for small molecules are insufficient for the biomedicine sector. The structural complexity of biologics makes it impractical to draft a patent claim that covers all possible biosimilars. In addition, biologics do not have patent listing requirements like the so-called “Orange Book”. Any categories of patents can be asserted against biosimilar products.

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