When Tools Fail: Why Real Expertise Still Matters

In theory, technology should make redactions in Hatch-Waxman litigation straightforward. In practice, it's more complicated.

In Hatch-Waxman matters, email threads between regulatory and manufacturing teams can run for years. Each week, new import forms and drug certificates are attached, old ones are swapped out, and filenames or subjects change just enough to break the logic of automated threading. Instead of one clean email chain, reviewers are left with hundreds—each a slightly different version of the same conversation, some stretching to 400 or 500 pages.

Sometimes, threading technology can’t tell the difference, so it treats each as unique. The result is duplication, bloated review sets, and thousands of pages of unnecessary redaction. In one recent matter, only a few lines in each chain were actually relevant—yet every version needed review.

That’s where real expertise steps in. At Intrepid, we have a saying – when done properly, service and expertise are synonymous. Our teams don’t just follow what the tools say to do; we understand why they fail. We also understand what this failure in technology means to the case, and more importantly, how to keep things on track and on budget even though the technology has let us down. In this recent case, we identified the “latest-in-time” version of each chain, isolated the truly responsive content, and classified the rest as duplicative. This approach compressed what would be ten hours of redaction into four minutes—without compromising defensibility.

When production of all versions is unavoidable, automation still has a role—but only when directed by informed judgment. Using targeted auto-redaction projects, we’ve processed nearly 500 documents containing over 100,000 redactions, each checked and refined by human review. Technology amplifies expertise—it doesn’t replace it.

And that expertise extends beyond efficiency. Hatch-Waxman privilege review involves a unique vocabulary—terms like “first-to-file,” “exclusivity,” and “launch date”—that standard AI models don’t understand. Our team is working directly with leading platform engineers to train systems that recognize these nuances, ensuring AI serves the case, not the other way around.

In an industry where litigation is part of getting life-saving generics to market, precision matters. When the tools falter, the difference between waste and value isn’t more automation—it’s smarter people using it. At Intrepid, that’s the work: not just running the tools, but knowing when to think beyond them.