December 17, 2018

Case Name: Hospira, Inc. v. Fresenius Kabi USA, LLC, Civ. Nos. 16 C 651, 17 C 7903, 2018 U.S. Dist. LEXIS 212916 (N.D. Ill. Dec. 17, 2018) (Pallmeyer, J.)

Drug Product and Patent(s)-in-Suit: Precedex® Premix (dexmedetomidine); U.S. Patents Nos. 8,648,106 (“the ’106 patent”) and 9,616,049 (“the ’049 patent”)

Nature of the Case and Issue(s) Presented: Hospira owned multiple patents directed to a formulation of Precedex Premix, which is used as a sedative. Previously, Precedex was available only in a concentrated form that needed to be diluted with saline prior to administration. Hosipira’s patents, including the patents-in-suit, claimed a premixed version of Percedex, which was already diluted and ready to be administered out of the box. Fresenius Kabi sought FDA approval for an ANDA for its own premixed dexmedetomidine product. This lawsuit followed. Ultimately, Hospira dropped all claims except for infringement of claim 6 of the ’106 patent and a claim 8 of the ’049 patent. Fresenius Kabi stipulated that its proposed product would infringe those claims, but maintains its challenges to their validity. The court held a five-day bench trial on the issue of the validity and found Fresenius Kabi had established by clear and convincing evidence that both claims were invalid as obvious.

Why Fresenius Kabi Prevailed: At trial, the parties fought over one main issue—whether or not the “no more than about 2% decrease in concentration” limitation of claim 6 was disclosed by the prior art. Fresenius Kabi argued that, while not expressly disclosed, the element was inherently present in the prior art. The court agreed. Fresenius pointed to extensive stability testing and data in preparing dexmedetomidine, which showed a decrease in dexmedetomidine concentration of 2.3% necessarily occurred in preparing the product. This fell within the range the court attributed to the term “about” during claim construction, and, thus, Fresenius Kabi demonstrated that the element was inherently present.

Setting aside the “about 2%” limitation, the court found that a POSA would have had a reasonable expectation of success from combining a 4 µg/mL dexmedetomidine formulation with a Type I glass vial, sealed with a coated rubber stopper. Because the Precedex Concentrate label discloses the ingredients of the formulation and the steps for dilution, a POSA would have been reasonable to expect success in creating the pre-diluted formulation.

Finally, while Hospira presented no evidence of secondary considerations at trial, its post-trial briefs alluded to an argument concerning the failure of others. Although Hospira had offered some evidence that Fresenius Kabi expected challenges in developing a ready-to-use product, the court found that it had presented no evidence of any “failed attempts.” Thus, the failure of others to outpace Hospira in creating a ready-to-use product was more likely attributable to a legal inability to do so than an actual inability to do so. The court also acknowledged there was some evidence in the record tending to show a long-felt need for a ready-to-use product. But, again, Hospira had presented no affirmative evidence or arguments regarding secondary considerations. Therefore, under these circumstances, evidence of long-felt need did not support a finding of non-obviousness.