Hatch-Waxman Actions: Who Do You (Can You) Sue?

After receipt of a so-called Paragraph IV Notice from a generic company, a patentee - the brand company? has 45 days in which to file suit to secure a 30-month stay of FDA approval of the generic's ANDA. Not much time! But who does the brand sue? The applicable statute, 35 U.S.C. 271(e)(2)(A), envisions suit against the ANDA "submitter." Yet this is complicated where multiple organizations are involved in the "submission." Can suit be instituted against those that merely "aid and abet," i.e., induce, the ANDA filing? These considerations are significant because relief under 271(e)(4) (A)-(C) is available only against named defendants. Moreover, discovery burdens and expenses are greatly reduced where generic targets are joined as defendants, especially where discovery is sought from foreign entities. Thus, it behooves the brand to join all potential parties. —Read more on Fish’s Litigation Blog