Judge Andrews finds patents not infringed in ANDA litigation

Following a two day bench trial in Fresenius Kabi USA, LLC v. Dr. Reddy’s Laboratories Ltd. et al., C.A. Nos. 13-925, 13-1015-RGA (D. Del. Aug. 25, 2014), Judge Richard G. Andrews found that plaintiff failed to prove that defendants’ ANDA products infringe claims 1, 16, 36, an 37 of the patents-in-suit. Defendants certified that the only differences between plaintiff’s brand drug, Diprivan, and defendants’ ANDA products are the “antimicrobial agents” (i.e., “the preservatives”). Id. at 3. Additionally, plaintiff conceded that “there is no literal infringement, but claim[ed] that Defendants ANDA products infringe under the doctrine of equivalents.” Id. While plaintiff argued that “dipropofol” was the equivalent, Judge Andrews concluded that dipropofol was not actually the preservative in defendants’ ANDA products. Id. at 6-8. To this end, Judge Andrews noted that while plaintiff “was not under an obligation to prove that the ANDA products contained dipropofol, it would have been probative of whether the identified preservatives were responsible for antimicrobial activity.” Id. at 8 n.3. Judge Andrews also concluded that dipropofol does not function in substantially the same way as edetate, the preservative appearing in the asserted claims, and thus concluded that defendants’ ANDA products do not infringe. Id. at 8-11.


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