Antrim Pharmaceuticals LLC v. Bio-Pharm, Inc.

In action alleging that defendant breached contract to provide plaintiff with generic drug (escitalopram) where jury held for defendant, Dist. Ct. did not err in failing to give jury plaintiff’s proposed instruction regarding legal significance of plaintiff’s owning escitalopram ANDA, which plaintiff asserted entitled it to ownership of escitalopram that had been manufactured by defendant in accordance with said ANDA. FDA regulations did not support plaintiff’s assertion, since ability to manufacture and market drug listed in ANDA does not decide ownership of any product manufactured in accordance with ANDA. Also, Dist. Ct. did not err in denying plaintiff’s motion in limine to preclude defendant’s expert from testifying regarding FDA’s statutory and regulatory authority, since said testimony assisted jury in learning relationship between plaintiff and defendant in light of FDA regulations regarding generic pharmaceuticals. It also did not abuse its discretion in precluding plaintiff’s expert from testifying on industry practices, where expert had no specific knowledge regarding plaintiff’s agreement with defendant to manufacture escitalopram. Too, Dist. Ct. did not err in precluding plaintiff from presenting testimony on lost enterprise value arising out of defendant’s alleged breach of contract, where said testimony was only speculative since it was open question as to whether plaintiff would sell itself to third-party to determine any lost enterprise value.