Monday, April 19, 2010

First-to-File ANDA Applicant's Loss of 180-Day Market Exclusivity Does Not Justify Stay of Litigation

Defendant ANDA applicant's motion to stay pending the resolution of the ANDA was denied. Defendant sought a stay because the drug subject to the ANDA was covered by multiple patents, some of which received a Paragraph III certification, meaning the ANDA would not be approved by the FDA until those patents expired four years in the future. As a result, defendants' hoped-for success in the instant litigation would trigger the 75-day window during which defendant would have to begin marketing its drug. Defendants' failure to do so -- a likely event given that the patents subject to the Paragraph III certification would not expire for four more years -- would forfeit the 180-day period of market exclusivity defendants would otherwise enjoy by virtue of being the first to file an ANDA for the patented drug. "Admittedly, 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. Rather than wait until they could fully take advantage of their position as first filer, however, Defendants sought to prematurely reserve their place at the front of the line, and now seek an order from this Court that allows them to preserve that position. This is not the type of hardship or balance of inequities that can appropriately convince this Court to issue a stay in the present proceedings."

Millennium Pharmaceuticals Inc. et al v. Teva Parenteral Medicines Inc. et al., 1-10-cv-00137 (DED April 14, 2010, Memorandum & Order) (Joyner, J.)

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