IP Litigation Team Secures Brand-Side Bench Trial Victory for Par Sterile Products’ Drug Adrenalin®

Latham recently secured an important bench trial victory for Par Sterile Products, LLC an indirect subsidiary of Endo International plc that makes specialty injectable drug products. The District of Delaware held that two Par patents were valid and infringed by Defendant Hospira, Inc.’s (Hospira) proposed generic version of Par’s Adrenalin® brand epinephrine injection drug product. Hospira (now Pfizer Injectables) filed an abbreviated new drug application (ANDA) seeking to sell a generic version of Adrenalin® and is now enjoined from making or selling its generic until the patents expire in 2035. 

Epinephrine is used to treat allergic reactions such as anaphylaxis. Though an earlier version of Adrenalin® had been sold for more than 100 years without FDA approval, Par scientists redeveloped the drug to have potency, purity, and stability that comport with modern pharmaceutical standards, and obtained the two suit patents as a result of their work. The patents-in-suit solved long-standing stability problems associated with epinephrine, and provided an extended shelf life.  

Par sued Hospira for infringement, and Latham successfully opposed Hospira’s motion to dismiss the case and Hospira’s request for leave to file summary judgment. The case proceeded to trial before Judge Joseph F. Bataillon, a Nebraska district court judge sitting by designation in Delaware. Latham presented Par’s infringement and validity case at trial, to show that Hospira’s generic product infringed and that the patents-in-suit were not invalid.  

In a 40-page written opinion, the Court found that Hospira’s proposed generic product infringed all of the asserted claims of Par’s patents. The Court also rejected Hospira’s invalidity defense, holding that Hospira failed to prove by clear and convincing evidence that the asserted claims of the patents-in-suit are invalid.

The Latham team was led by partners Daniel Brown, Kenneth Schuler, and Jennifer Koh, with associates Tom Watson, Kamilah Alexander, Alex Grabowski, Yi Sun, and Brett Frazer.