Schiff Hardin won an appeal for our client, Fresenius Kabi USA LLC, in a patent-infringement suit filed by Hospira Inc., showing a formulation patent claim is invalid and helping generics further develop the “inherent obviousness” case law. The ground-breaking victory follows failed efforts of prior litigants and two law firms who had challenged the same claim.
Hospira, a subsidiary of Pfizer Inc., filed suit in November 2017 after Fresenius requested regulatory approval to sell a generic version of the drug Precedex. Our team argued that two patents covering the dexmedetomidine premix formulation were obvious in light of prior art, and Judge Rebecca R. Pallmeyer of the U.S. District Court for the Northern District of Illinois agreed, invalidating both patents. Hospira then appealed the decision as to one claim from one patent.
The Federal Circuit rejected all arguments Hospira offered to try to overturn Judge Pallmeyer’s decision. The patent appellate court agreed that the evidence the district court relied upon was properly considered because testing data showed the claimed stability limitation was an inherent property, and that the proper legal standard was used because inherency can be proven using confidential information. The published opinion also clarified the procedural and substantive approach district courts should use in the future when evaluating whether a claim limitation is an inherent property of an otherwise obvious product or process.
Imron Aly, Intellectual Property Practice Group co-leader said, "I am proud to be a part of the team that could help build the law on inherent obviousness, both at trial and on appeal."
The attorney team also included Kevin M. Nelson, Joel M. Wallace, and Ahmed M.T. Riaz.
For more coverage on this client win, click below.
Law360 (Subscription required)
Generics Bulletin (Subscription required)
BioWorld (Subscription required)