An article by Jessica von Reyn “Patent Term Extension: Challenges with Defining and Claiming Approved Biologics” was published in Pharmaceutical Executive®. As biologics continue to transform modern therapeutics, securing patent term extension (PTE) for these complex products presents unique challenges—particularly in defining the product’s “active ingredient,” a key requirement for extension eligibility.
The article explores how biologics complicate the traditional PTE framework, examines examples from cell therapy technologies, and provides practical guidance on aligning patent and regulatory strategies to strengthen PTE positions for biologic innovations. Read more.
