On September 9, 2016, Wockhardt filed a motion to dismiss for lack of subject matter jurisdiction. Wockhardt argued that, because it had converted its Paragraph IV certification to a Paragraph III certification, it no longer sought to engage in the commercial manufacture, use or sale of its ANDA product before the expiration of AstraZeneca’s patents. Wockhartd further argued that AstraZeneca’s claims of infringement did not present a real or immediate controversy establishing subject matter jurisdiction under Article III of the Constitution. In its decision on Wockhardt’s motion to dismiss, the court explained that subject matter jurisdiction is not lost for mootness when (1) the challenged action is too short to be fully litigated prior to cessation or expiration, and (2) there is reasonable expectation that the complaining party will be subject to the same action again. See Fed. Election Comm’n v. WI Right to Life, Inc., 551 U.S. 449, 462 (2007). Here, the court found that the first criterion was met because it was unlikely that AstraZeneca could obtain complete judicial relief before a generic party converted its initial Paragraph IV certification. The court also found that there is a reasonable expectation that the same controversy between the parties would reoccur based on Wockhardt’s refusal to covenant or agree to a stipulation precluding it from re-converting its FDA submission to a Paragraph IV or attacking AstraZeneca’s patents in a subsequent inter partes review proceeding. Therefore, the court denied Wockhardt’s motion to dismiss based on the reasonable expectation that AstraZeneca will need to assert its patent rights against Wockhardt, both in federal court and before the Patent Office, in the future.
AstraZeneca AB v. Aurobindo Pharma Ltd., No. 14-664-GMS, (D. Del. Sep. 15, 2016).