In a recent ANDA case involving valganciclovir hydrochloride 450 mg tablets, Judge Sleet construed the term “compound 2-(2-amino-l ,6-dihydro-6-oxo-purin-9-yl)methoxy-3-hydroxy-lpropanyl-L-valinate hydrochloride in crystalline form” to mean “valganciclovir hydrochloride in a physical form having molecules arranged in a regularly repeating three dimensional pattern.”
Roche Palo Alto LLC v. Endo Pharmaceuticals, Inc., C.A. No. 10-261-GMS (D. Del. Aug. 11, 2011)