A 4-day Bench Trial is currently scheduled to commence on April 25, 2022 at 8:30 AM ET in Eagle Pharmaceuticals' Case related to its BENDEKA® product. This is in the Case of: "Eagle Pharmaceuticals, Inc. v. Hospira, Inc." (Case #18-01074 in the District of Delaware). Additionally, the Pretrial Conference in this Case is currently scheduled to be held on April 14, 2022 at 3:00 PM ET.
Please note that we are currently unsure as to whether or not we will be attending this Trial; however, based on our previous experiences with Judge Connolly (the Judge assigned to this Case), we currently believe that comments made by Judge Connolly may be likely to provide some predictive power. Judge Connolly typically lets the participants know what he is thinking, but the Court is unlikely to hear Closing Arguments directly at the end of the Bench Trial. Note that this means that the Court will likely schedule separate Closing Arguments after post-Trial briefing is completed in this Case, which may be a few months following the conclusion of the Bench Trial.
This Case relates to Bendeka®, which according to Eagle's most recent Form 10-K, represents approximately 66% of Eagle's Total Revenue.
Below is a brief background on this Case:
Eagle Pharmaceuticals filed this Case against Hospira in the District of Delaware on July 19, 2018. Originally, Eagle Pharmaceuticals asserted nine Patents against Hospira's 505(b)(2) NDA No. 211530; however, on December 16, 2019, the Court issued an Order Granting Hospira's Motion to Dismiss all but U.S. Patent Number 9,572,887 (Claims 1, 3, 5, ad 8-29 are currently asserted) based on Non-Infringement. According to the Orange Book, the '887 Patent expires on March 15, 2033.
As indicated by the FDA's letter (January 19, 2019), Hospira's NDA 211530 has received Tentative Approval, and the 30-month Hatch-Waxman Stay expired on December 7, 2020. Please note that Hospira is currently unable to launch its product at-risk, because Bendeka® (as well as Treanda, which Bendeka replaced) is currently protected under Orphan Drug exclusivity that expires in December 2022.
Separate cases have been filed challenging multiple Abbreviated New Drug Applications (ANDAs) filed by multiple Parties (note that Hospira is a 505(b)(2) NDA filer not an ANDA filer). Eagle provides the following quote in its most recent Form 10-Q, which summarizes the outcome of these earlier filed suits. Eagle writes:
"On July 6, 2020, the district court entered a final judgment reflecting this decision, stating that pursuant to 35 U.S.C. § 271(e)(4)(A), the FDA shall not approve Apotex’s, Fresenius’s, Mylan’s, or Slayback’s ANDA products on a date which is earlier than January 28, 2031, and enjoining Apotex, Fresenius, Mylan, and Slayback from commercially manufacturing, using, offering to sell, or selling within the US or importing into the US, their ANDA products before that date."
Taken together, it appears to us that this upcoming Bench Trial will really determine if a new drug, which would be similar to generic Bendeka®, can enter the Market in December 2022 (when the Orphan Drug Exclusivity expires) or if such competition will be delayed until January 28, 2031.
With regards to a potential Settlement in advance of the upcoming Trial, it is worth noting that the Parties wrote the following in their Proposed Final Pretrial Order (D.E. 157):"On March 1, 2022, Plaintiffs made a settlement proposal to Hospira. Hospira is still considering that settlement offer."