Case Studies



Securing global patent protection for FDA-approved and late-stage clinical products 

L&A represents several leading biotechnology and biopharmaceutical companies in designing and prosecuting worldwide patent portfolios covering clinically-approved and late-stage biologic products. These matters typically require consideration of life cycle management patenting strategies, protection of new indications, off-label use, formulations, production and manufacturing improvements, dosage and therapeutic regimen, patient selection, and follow-on product strategy. Strategies for extending patent protection such as patent term extension and preparation for an eventual generic challenge are also carefully considered. L&A representation routinely involves representing our clients’ portfolios on due diligence review by, and negotiations with, development partners.


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