Fresenius Kabi Amends ANDA Complaint to Name Infusion Bag Supplier

June 8, 2016 – On June 6, Fresenius Kabi (“Fresenius”) amended its complaint asserting the Orange Book-listed patents covering its ropivicaine hydrochloride product (Naropin®) against generic drug maker Mylan to include medical infusion bag manufacturer Technoflex as a defendant.

The patents-in-suit include U.S. Patent Nos. 8,118,802 and 8,162,915, directed to connectors for medical infusion bags. According to the amended complaint, Technoflex holds a Drug Master File (“DMF”) covering infringing infusion bags and connectors, and Mylan’s ANDA indicates that the infusion bags for use with the generic version of Naropin® will be produced by Technoflex pursuant to its DMF. The complaint alleges that Technoflex has acted and will act in concert with Mylan to infringe Fresenius’s medical infusion bag connector patents by virtue of its production of the infusion bags for use with the infringing ANDA product.

The case is captioned Fresenius Kabi USA, LLC et al. v. Mylan Laboratories Limited et al., Docket No. 15-cv-185-IMK in the District Court for the Northern District of West Virginia.

By: Sean C. McDonagh