Summer 2022
International Pharmaceutical Industry
By Thomas Lee Irving; Mark J. Feldstein, Ph.D.; Adriana L. Burgy; Stacy D. Lewis
Developing a pharmaceutical product can take on the order of a decade from research (first inventing the drug) to development, and finally to FDA approval. While Patent Term Extension can restore some time lost due to the regulatory approval process, the traditional strategy of relying on patents based on the drug itself or its general method of use will necessarily start – and stop – the protection clock much earlier. This limits the potential return on investment prior to generic copyists. But, if one is creative and coordinated, additional strategies can be used to advance business growth with longer and stronger patents. In this article, Tom Irving, Mark Feldstein, Adriana Burgy and Stacy Lewis discuss creative strategies for patent claiming.
Originally printed in International Pharmaceutical Industry in the Summer 2022 issue. This article is for informational purposes, is not intended to constitute legal advice, and may be considered advertising under applicable state laws. This article is only the opinion of the authors and is not attributable to Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, or the firm’s clients.
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