While a judges decide cases, it is really the lawyers who run it – their pace and interactions with the court. Sometimes, lawyers can frustrate judges to their wit’s end.

The case seemed so normal until…

A PIV case started in September 2018 over Belbuca®(buprenorphine) Buccal Film and three of its patents. Innocent enough, it worked its way through the Delaware District Court before Judge Colm Connolly. Judge Connolly started serving as a federal judge one month before the case was filed. Likely his first PIV case, little did Judge Connolly suspect that this case would linger on for 8 years.

After trial, in December 2021, the Court issued its ruling. The ruling itself is really not important to this story, but the fact that the Court of Appeals remanded the case back to Delaware one year later is. The Court of Appeals sent the case back to Delaware for some more technical analysis.

Then nothing happened. Silence.

Obstreperous, huh?

Normally, when the Court of Appeals sends a case back to a District Court, the lawyers for both sides immediately confer with each other, let the Court know they are defining the issues, and decide on how to proceed and re-hear the issues at hand. But not here.

After a period of complete silence for two and a half years, in July 2025, patent holder Biodelivery Services asked the Court to Enforce the Judgment from 2023 and prevent Alvogen from launching its product before the patents expire.

In denying this request, Judge Connolly (now promoted to Chief Judge after the lengthy passage of time) had apparently had enough of the constant fighting between the lawyers involved stating, “This case in general,…was marred by the obstreperous* behavior by both sides to a degree I have rarely experienced as a judge. Frustrated (and exhausted) by the case…”

The Court went on to highlight how the parties had drafted the Final Judgment, agreed to it, only to have Alvogen not agree to it. The Final Judgment prevented Alvogen from launching a product before the patents expire. Moreover, the Biodelivery Motion included a Motion to Disqualify one of the attorneys (but more on that in the next Blog Post.)

Meanwhile…

During the two and a half years of silence, Alvogen undertook a strategy to rework the product and file a second ANDA with FDA. After doing so, Biodelivery filed a second PIV case at the same time it asked the Court to Enforce the Judgment, essentially contending that the second ANDA was really the same as the first and is more of a supplement than a new stand-alone ANDA.

The second PIV case and Motion really got under the skin of Judge Connolly. The Court pointed out that these two things were really a waste of judicial time. Instead, the Court noted that Biodelivery could have filed a Motion for Contempt against Alvogen for disobeying the Final Judgment and could have simply demonstrated its two ANDA’s are essentially the same.

For now, the lawyers are still hacking away at the new case in front of Judge Connolly who appears to be unhappy with them, to say the least. Best of luck….

*Obstreperous – I had to look this one up, but Webster’s defines it as “stubbornly defiant,” “resisting control or restraint often with a show of noisy disobedience.”