Method-of-treatment (“MoT”) claims can be powerful tools for pharmaceutical companies seeking to extend market exclusivity for their products after the original composition-of-matter patents expire. However, the District of Delaware’s recent decision in Novo Nordisk v. Mylan is another reminder that the scope of method of treatment claims must be aligned with an FDA approved drug label.
Patent prosecution often involves trade-offs. To overcome prior art rejections, applicants may introduce narrowing limitations. But these limitations can later become liabilities if they don’t align with a drug’s approved use and description in the…
