Judge Joyner: Denial of Motion to Stay highlights considerations when submitting ANDA applications

In Millenium Pharms., Inc. v. Teva Parenteral Medicines, Inc., C.A. No. 09-105 (D. Del. Apr. 13, 2010), Plaintiffs brought suit after defendants filed their Abbreviated New Drug Application (“ANDA”) for a generic version of Plaintiffs’ drug. Id. at 2. Pursuant to their ANDA, Defendants submitted a Paragraph IV certification that Plaintiffs’ patents in the corresponding New Drug Application (“NDA”) were invalid, unenforceable or would not be infringed. Id. at 3-4. Due to Defendants’ Paragraph IV certification, Plaintiffs had 45 days to bring the suit to establish validity of their patents (which they did), thereby staying Defendants ANDA for 30-months. Because Defendants were the first to file a Paragraph IV certification, they are entitled to a 180-day market exclusivity after ANDA approval, provided Defendants begin marketing their generic drug within 75 days of a final judgment that Plaintiffs’ patents are invalid, unenforceable, or not infringed. In addition to the Paragraph IV certifications, Defendants submitted Paragraph III certifications which would delay FDA certification of Defendants’ ANDA until Plaintiffs’ patents expire, in 2014. The result was that Defendants could lose their 180-day exclusivity period, even if they are successful in the litigation. Id. at 5. Therefore, Defendants subsequently sought a stay of the litigation.

Judge Joyner denied Defendants’ Motion to Stay, however, after weighing the potential hardships to both Plaintiffs and Defendants. Judge Joyner noted that “Defendants have shown that they will be harmed if a stay is not entered, as they will likely forfeit their 180-day exclusivity period. Defendants, however, have only themselves to blame for this result. . . . Although Defendants did not file this suit, they were well aware that their ANDA triggered the start of a 45-day period for Plaintiffs to defend the validity of their patents, and, in this sense, did control the timing of the present litigation.” Id. at 8. Because the harm to Defendants of denying the stay was “one of their own creation,” that harm cannot outweigh any harm to Plaintiffs if the stay is granted. Id.

Millenium Pharms., Inc. v. Teva Parenteral Medicines, Inc., C.A. No. 09-105 (D. Del. Apr. 13, 2010)

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