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Judge Kugler Grants Preliminary Injunction but Refuses to Order Recall in ANDA Case

Judge Kugler recently ruled on the plaintiff’s motion for a preliminary injunction in Sciele Pharma Inc. v. Lupin, C.A. No. 09-0037-RBK (D. Del. Dec. 6, 2011). Considering likelihood of success on the merits, Judge Kugler found that “since a generic drug’s label is found to control the analysis of potential infringement in a case like this one, and since Defendant’s label reflects a Tmax that falls within the range claimed in Plaintiff’s patent, Plaintiff has shown a likelihood [of infringement].” Id. at 11. Regarding irreparable harm, the court observed that the market for the branded drug was “in steady and irreversible decline, and has been for some time,” and found “that a loss of market position accompanied by market diminution presents an even stronger case for irreparability.” Id. at 18. The court then found irreparable harm based on “projected lost sales, price erosion, and lost market share, in concert with [a] claimed loss of goodwill.” Id.

While Judge Kugler found that a balancing of hardships generally favored the plaintiff and granted a preliminary injunction, he refused to order a recall of the generic product that had already been released. The court accepted the defendant’s argument on this point that a recall would be “onerous, complicated and expensive” and would result in “a loss of goodwill and harm to its reputation with distributors and retailers.” Id. at 19.


Sciele Pharma Inc. v. Lupin, C.A. No. 09-0037-RBK (D. Del. Dec. 6, 2011).

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