Intellectual Property > IP Newsflash > Subject Matter Jurisdiction Remains in Hatch-Waxman Patent Infringement Action after ANDA Filer Changes from Paragraph IV to Paragraph III Certification
29 Sep '16

The District Court of Delaware denied defendant Wockhardt’s motion to dismiss a patent infringement action based on the reasonable inference that plaintiff AstraZeneca may need to assert its patent rights in the future. On May 23, 2014, AstraZeneca filed a patent infringement action in the District of Delaware against Wockhardt. AztraZeneca alleged that Wockhardt’s submission of an Abbreviated New Drug Application (ANDA) to the FDA with a Paragraph IV certification infringed several of AstraZeneca’s patents pursuant to 35 U.S.C § 271(e)(2). Prior to the initiation of the litigation, Wockhardt submitted an ANDA seeking the FDA’s approval to market a generic version of AstraZeneca’s ONGLYZA drug product. Wockhardt’s ANDA was submitted with a Paragraph IV certification, which means that Wockhardt asserted that AstraZeneca’s patents covering ONGLYZA were invalid or unenforceable or not infringed by Wockhardt’s ANDA product. Wockhardt sent a Notice Letter to AstraZeneca stating that Wockhardt had submitted an ANDA with a Paragraph IV certification and that it intended to engage in the commercial manufacture, use and sale of a generic version of the ONGLYZA product before the expiration of AstraZeneca’s patents. Pursuant to the Hatch-Waxman Act, AstraZeneca filed suit within 45 days of receipt of Wockhardt’s Notice Letter.

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).