Serono Laboratories, Inc. v. Shalala

Serono Laboratories, Inc. (Serono) (plaintiff) manufactured the Food and Drug Administration (FDA)-approved fertility drug Pergonal. In 1990, Lederle Parenterals (Lederle) submitted an abbreviated new drug application (ANDA) to the FDA for a generic version of Pergonal called Repronex. Serono filed a citizen petition with the FDA asking the FDA to withhold approval of the Repronex ANDA. Serono asserted that under federal regulations, an ANDA application could not be approved if (1) the active ingredients in the generic drug were not “the same as” the active ingredients in the listed (i.e., brand-name) drug or (2) the inactive ingredients in the generic drug were unsafe. Serono asserted that Pergonal was a menotropins drug (i.e., a product extracted from the urine of postmenopausal women) with active ingredients of follicle-stimulating hormone (FSH) and luteinizing hormone (LH). Serono claimed that the FSH in Repronex was not the same as the FSH in Pergonal because of an isoform variation caused by natural differences in the hormones’ carbohydrate chains. Serono thus asserted that Repronex was different from Pergonal and ineligible for an ANDA. Despite Serono’s objections, the FDA denied Serono’s citizen petition and approved the Repronex ANDA. The FDA’s drug-evaluation director stated that the isoform variation between the FSH in Pergonal and Repronex was not clinically significant and that ensuring a complete carbohydrate-chain match would be impossible or unfeasible. The director thus found that the isoform variation did not preclude a finding that Repronex’s active ingredients were the same as Pergonal’s provided the rest of the FSH’s relevant characteristics were the same, and the degree of batch-to-batch variation in isoforms of Repronex’s FSH was no different from the degree of variation found in Pergonal’s FSH. Serono brought an action against United States Health and Human Services Secretary Donna Shalala (defendant), seeking preliminary injunctive relief preventing FDA approval of Repronex. The district court granted Serono’s requested relief, and Shalala appealed.