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Most states have adopted a version of what is typically referred to as the “Malfunction Theory” that permits circumstantial proof of a product defect in a product liability action. The Malfunction Theory largely corresponds to the doctrine of
res ipsa loquitur in negligence cases. Generally, the concept is that if a product fails in a fashion that most likely would not have occurred if it were not defective, and reasonable alternative explanations can be ruled out, the jury is permitted to conclude that the product was defective, even absent specific proof of a defect. The Malfunction Theory is adopted at Section 3 of the
Impoyz® (clobetasol)
Case Name:
Encore Dermatology Inc. v. Glenmark Pharms. Ltd., Civ. No. 20-02509 (KM) (ESK), 2020 WL 7586958 (D.N.J. Dec. 22, 2020) (McNulty, J.)
Drug Product and Patent(s)-in-Suit: Impoyz® (clobetasol); U.S. Patent No. 9,956,231 (“the ’231 patent”)
Nature of Case and Issue(s) Presented: Encore owns the ’231 patent, which claims “[a] topical pharmaceutical composition comprising: clobetasol … wherein the composition is … propylene glycol-free.” Encore also holds an NDA for Impoyz, which uses the patented drug. Glenmark filed an ANDA seeking approval of a generic clobetasol cream. Glenmark disclosed to Encore in its Paragraph IV Notice Letter that its proposed ANDA product contained 10% propylene glycol, and therefore argued that its product did not infringe the ’231 patent. Glenmark only provided Encore with access to a limited portion of its ANDA. In turn, Encore argued it was not able to fully understand the safety of the proposed ANDA pr