In Momenta Pharmaceuticals, Inc. et al. v. Amphastar Pharmaceuticals, Inc. et al., No. 11-cv-11681 (D. Mass. 2018), the District Court of Massachusetts found that Momenta waived by implication the right to enforce its patent by failing to disclose the patent application while participating in a USP advisory panel.
The USP advisory panel chose USP <207> as the official test to determine whether enoxaparin products conform to the structure dictated in the USP monograph. The court found that regardless of Momenta’s opposition to USP <207>, it had a duty to disclose to the USP that its application potentially covered USP <207>. Because the court found that Momenta breached this duty, the court also found that Momenta had waived the right to enforce its patent with respect to methods that comply with USP <207>. However, the court found that Momenta had not waived its right to enforce the patent with respect to methods that do not comply with USP <207>.