January 01, 2018

In January 2018, the firm secured a trial victory on behalf of Hospira, Inc. in a patent dispute over Precedex, a sedative commonly used in ICUs and surgeries.

In 2017, Partners Sara Tonnies Horton and Bradford P. Lyerla, chair of the firm’s Patent Litigation and Counseling Practice, led a team that represented Hospira, which owns the Precedex brand, in a Paragraph IV trial in the federal district court in Delaware.

Our client asserted that Amneal Pharmaceutical’s Abbreviated New Drug Application (ANDA) for a generic version of “ready-to-use” Precedex infringed on Hospira’s patents.  The ready-to-use aspect distinguishes it from the first generation of the drug, which required physicians and nurses to dilute a concentrate, leading to potential mixing errors and contamination.  By eliminating the dilution step, physicians and nurses have immediate access to the drug in a properly mixed solution with far less contamination risk.

Because of the size of the market, many generic competitors have filed ANDAs to market their own version of a ready-to-use Precedex product.

Amneal argued that the asserted patents were invalid and that its product did not infringe.  US District Judge Richard Andrews ultimately upheld the validity and found infringement, and then enjoined Amneal from infringing until the patent’s expiration.

The decision is currently on appeal to the US Court of Appeals for the Federal Circuit and should be argued later during the first quarter of 2019.

In addition to Ms. Horton and Mr. Lyerla, the Jenner & Block trial team representing Hospira included Department Counsel Yusuf Esat and former Associate Chad Ray; Partners Adam G. Unikowsky and Aaron A. Barlow, along with Associate Ren-How Harn, helped brief the appellate issues.