Judge Noreika just addressed an issue that rarely comes up in D. Del.: whether a patent should be delisted from the Orange Book for non-compliance with the Hatch-Waxman listing requirements. Although the issue itself is uncommon, the decision highlights the difficulty of winning a Rule 12 motion that hinges on early-stage claim construction.
The plaintiff sued "for infringement of five patents, only one of which . . . is listed in the Orange Book." The defendants counterclaimed that the Orange Book patent "must be delisted because it claims a 'system,' not a drug product, or method of using a drug, as required by" the Hatch-Waxman Act. The defendants then moved for judgment on the pleadings on their delisting …
