Par Pharm., Inc. v. Luitpold Pharms., Inc.

Allegations of infringement about a would-be formulation and seeking discovery about highly confidential, competitive information concerning that would-be formulation necessitated an exceptional case finding and an award of fees and costs.

July 14, 2017

GENERICally Speaking

Case Name: Par Pharm., Inc. v. Luitpold Pharms., Inc., 2017 U.S. Dist. LEXIS 62020 (D.N.J. Apr. 24 2017) (Walls, J.)

Drug Product and Patent(s)-in-Suit: Adrenalin® (adrenaline (epinephrine)); U.S. Patents Nos. 9,119,876 (“the ’876 patent”) and 9,295,657 (“the ’657 patent”)

Nature of the Case and Issue(s) Presented: In a February decision, the court granted Luitpold’s motion for judgment on the pleadings in a Hatch-Waxman matter under Fed. R. Civ. P. 12(c) because Par admitted that the drug formulation asserted in Luitpold’s operative ANDA did not infringe its patents. Luitpold moved for attorney fees pursuant to 35 U.S.C. § 285, arguing that the case was exceptional.

Why Luitpold Prevailed: The court found the case exceptional for two reasons. Firstly, it noted that although Par stated its “key question” was whether Luitpold would change its ANDA product into one that would infringe the patents-in-suit, the complaint alleged—without any factual basis—that the current ANDA product infringed. The court further concluded that even if the future patent infringement were at issue, the complaint still failed to allege that Luitpold was engaged in any specific activities to alter its drug formulation to infringe the patents-in-suit. Secondly, the court concluded that Par attempted to engage in overbroad discovery of highly confidential, competitive information. For despite Luitpold’s requirement under a local rule to turn over all new communications to and from the FDA within seven days, Par made extensive discovery requests about Luitpold’s plans.

In light of these findings, the court found the case exceptional. It ordered payment of $207,482.50 in fees and $4,580.93 in costs.

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