Sailing is one of those endeavors that really make you respect the ancestors. As a kid (and indeed, a thirty-something) it seemed like a simple matter or pointing a sheet in the wind to go forward. Then you actually go on one of these crazy things and—even setting aside the knots—there's this mad calculus that goes into what turns where when that somehow makes you best off when you're perpendicular to the actual wind. Real witchcraft.
This, of course, brings us to one of my favorite areas of patent law, the safe harbor provision. For those, less familiar, Judge Barker's opinion this week in Merus N.V. v. Xencor, Inc., C.A. No. 24-913-JCB, D.I. 35 (D. Del. Sep. 30, 2025), gives a good overview.
Briefly, 35 U.S.C. § 271(e)(1) allows one to make/use/etc, a patented invention "solely for uses reasonably related to the development and submission of information under" a qualifying regulatory regime. This most often comes into play in the ANDA context where the generic manufacturer can use the otherwise patented drug to perform the necessary studies to submit their ANDA to the FDA.
The situation is somewhat more complicated in Merus. The patents there
