Purepac Pharmaceutical Co. v. Friedman

Under an amended section of the Food and Drug Administration’s (FDA) regulations, a first generic-drug applicant is entitled to a 180-day exclusivity marketing period if the applicant submits with its abbreviated new drug application (ANDA) a certification that the patent is invalid or will not be infringed by the manufacture, use, or sale of the drug (known as paragraph IV certification). In a paragraph IV certification, the generic applicant must give notice to the patent owner and holder of the approved application for the patented drug, and the FDA must approve the ANDA effective immediately, unless the applicant is sued within 45 days. The exclusivity period begins to run from the earlier of either (1) the commercial marketing of the applicant’s generic drug or (2) the date of a favorable decision of a court in which the applicant has been sued for patent infringement. A previous version of the regulation, which was held invalid, required that the first applicant has successfully defended against a suit for patent infringement. Interim guidance provided by the FDA indicated that an applicant would be entitled to the exclusivity period even if the applicant had not been sued and that the FDA would expect first applicants to begin marketing their generic drugs promptly upon approval. Purepac Pharmaceutical Company (Purepac) (plaintiff), the manufacturer of generic drug ticlopidine hydrochloride, brought action challenging the amended regulation and the FDA’s withholding of final approval for Purepac’s generic ticlopidine pending the expiration of the first ticlopidine applicant’s exclusivity period. At the time of Purepac’s lawsuit, Tropharm had a prior application for generic ticlopidine that was pending final FDA approval. Purepac specifically alleged that Tropham’s generic ticlopidine was not entitled to the exclusivity period because Tropham had not been sued for patent infringement, which Purepac alleged remained a triggering condition for the exclusivity period in the amended regulation. Purepac argued that without a lawsuit requirement, if a first applicant is never sued for patent infringement and never commercially markets its generic drug, the 180 days would never run, and all later generic applicants would be barred from bringing their generic drugs to market. While the action was pending, the FDA published an interim rule eliminating the successful-defense requirement. The district court denied Purepac’s motion for a preliminary injunction, and Purepac appealed.