In a significant legal development, the US Court of Appeals for the Federal Circuit has affirmed a district court’s ruling that safety and efficacy do not influence the validity of a method of treatment patent. As reported by law firm McDermott Will & Emery, this judgment took place in the dispute between United Therapeutics Corporation and Liquidia Technologies, Inc.
The Federal Circuit Court further endorsed the district court’s determination that certain claims of the product-by-process patent were invalid, despite the process by which they were manufactured. This noteworthy decision came from the observation that the claimed product was previously known or found in the prior art.
These decisions jointly emphasize the factor of novelty in product-by-process patents, steering clear of the product’s safety and efficacy rate. The ruling exhibits a marked shift in judicial consideration, separating the method of treatment from concerns related to a product’s safety and effectiveness.
However, the ramifications of this decision in the broader patent landscape remain to be seen. Practitioners must monitor the developments closely that could potentially influence how method of treatment patents are viewed, as well as the drafting of product-by-process patents.