Fresenius Kabi takes on Sagent Pharmaceuticals in patent battle

Healthcare company Fresenius Kabi has targeted Sagent Pharmaceuticals in a patent infringement lawsuit centring on generic versions of Naropin.

Naropin is Fresenius’s ropivacaine hydrochloride injection product, a local anaesthetic drug.

Filed on Wednesday, January 4 at the US District Court for the District of Delaware, the suit alleged that Sagent had infringed US patent numbers 8,118,802 and 8,162,915, owned by Fresenius.

The action stemmed from Sagent’s filing of an Abbreviated New Drug Application (ANDA) seeking approval from the US Food and Drug Administration (FDA) to sell generic versions of Naropin.

In November 2016, Sagent notified Fresenius of the ANDA and offered confidential access to it on terms and conditions in an “Offer of Confidential Access” (OCA).

Fresenius claimed that the OCA contained various terms and conditions, several of which “went above and beyond protections typically afforded in a protective order”.

Then, on December 7, 2016, Fresenius proposed revisions to the OCA, but according to the suit, despite repeated attempts to finalise the OCA, it was only finalised on December 13.

Sagent then allegedly refused to produce a complete copy of its ANDA file as part of the process.

Fresenius claimed that it has only been provided with “limited excerpts” of the ANDA, and that given the 45-day statutory deadline to file suit, it has taken legal action to obtain information “as is required” to further confirm its allegations of infringement.

The healthcare company is seeking injunctive relief, an order that any FDA approval of the ANDA is not earlier than the expiration of the patents, and an award of damages to compensate Fresenius if Sagent engages in manufacturing of the generics.

It is also seeking attorneys’ fees, costs, pre and post-judgment interest, expenses and any other relief the court deems just and proper.