Pharmaceutical Life Cycle Management: Navigating The New IP, FDA, And Antitrust Terrain

Efforts to extend the life cycle of pharmaceutical products frequently involve innovations and improvements in product design, formulation, route of administration and treatment indications. In addition, negotiation of agreements with competitors, including generic and biosimilar manufacturers, is frequently employed as part of a life cycle management strategy. However, recent changes in patent, regulatory and antitrust laws have introduced greater complexity and higher risk into these strategies.

On October 23, 2015, a distinguished panel of BakerHostetler partners led an exclusive seminar in person and online at which they discussed these and related issues and provided suggestions for developing successful life cycle management strategies. Carl W. Hittinger, Lee Rosebush, Lance Shea and Maurice Valla are all deeply knowledgeable attorneys with decades of experience in helping clients meet their pharmaceutical business objectives.

Patent-Based Exclusivity

Maurice Valla discussed several broad categories with regard to patent-based exclusivity:

Early-stage development Developmental candidate identification Clinical development Approaching approval Prior to launch and follow-on indications Active pharmaceutical ingredient characteristics and new formulations Additional protection strategies Selected highlights:

Early-stage development: Patent practitioners have historically focused on obtaining protection for therapeutic targets such as isolated DNA sequences, or for research tools used to identify compounds that interact with those isolated DNA sequences. But Valla also explained that patent practitioners now face a legal landscape in which isolated sequences are no longer patentable unless the sequence has a markedly different characteristic from its naturally occurring counterpart.

He also discussed how patent practitioners regularly sought patent protection for correlations between a therapeutic target and disease. For example, a claim might be directed to a method of treating a disease by interacting with a particular target. The current § 112 jurisprudence forecloses these types of claims unless the specification provides sufficient examples of the therapeutic compound to inform one of ordinary skill in the art. Valla suggested that such target/disease correlation claims might still be allowable when the target is well-characterized and the contemplated method of treatment is the administration of a biologic such as an antibody or an oligonucleotide. Unlike small molecule therapeutics, the prevailing view is that one of skill in the art could design an antibody or an interfering RNA to a sufficiently definite target.

Developmental candidate identification: Valla said that freedom to operate should be a consideration from the very beginning of the patenting process. He advised looking at what already exists in the patent landscape in terms of the...

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