A Blog About Intellectual Property Litigation and the District of Delaware


Trials in ANDA cases (also known as Hatch-Waxman cases) are usually very efficient matters. There is no jury, and the judges, lawyers, and witnesses that regularly try and participate in ANDA cases are well-practiced at maximizing the amount of evidence presented in each trial day (even where the issues are quite complicated and the parties numerous). So ANDA trials are often short, sometimes just a few days from start to finish.

Analog Clock
None, Ocean Ng, Unsplash

Occasionally, however, even ANDA cases are too complicated to fit into a one-week-or-less trial. For example, Judge Stark recently stated that he may allocate up to 25 hours per side in an ANDA case set to go to trial later this week, H. Lundbeck A/S v. Apotex Inc., C.A. No. 18-88-LPS:

"Based on the Court's understanding of the number and scope of the parties’ disputes – which include allegations of infringement of at least 23 claims of at least eight patents against seven sets of Defendants as well as invalidity based on at least obviousness, anticipation, and lack of adequate written description – and considering the parties’ requests for time (Plaintiffs seek 63 hours for trial and Defendants request 70) . . . , the Court will allocate between 22 and 25 hours per side, with the final amount to be determined at the [pretrial conference]."

He explained that "this is a large case even among ANDA cases over which [the Court] has presided."

The trial, which is apparently at least partially remote (the Judge's order refers to a "virtual courtroom"), is set to begin Friday, January 15. Judge Stark has set aside all or most of 10 trial days to hear the case.

Judge Stark typically allocates 10-12 hours per side for ANDA trials. However, that is not a hard and fast limit. In another case involving "two related Plaintiffs, two asserted patents, 14 asserted claims, four Defendants, four separate non-infringement defenses, and numerous invalidity defenses," he allocated 20-22 hours per side. Bristol-Myers Squib Co. v. Aurobindo Pharma USA Inc., C.A. No. 17-374-LPS (Oct. 21, 2019 Memorandum Order).

Notably, the challenges of the pandemic and/or remote proceedings do not appear to have played a significant role in the time allocation here (or at least were not part of the Judge's express analysis).

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