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ARTICLE · 05 SEPTEMBER 2019

"Substantially Equivalent" Method Of Obtaining Dissolution Profile Meets Written Description Requirement

Finnegan, Henderson, Farabow, Garrett & Dunner LLP
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In Nalpropion Pharmaceuticals v. Actavis Laboratories FL, Inc., No. 2018-1221, the Court addressed whether a particular claimed dissolution profile had the requisite written description support.

United StatesIntellectual Property
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
Sydney Kestle
Sydney Kestle
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In Nalpropion Pharmaceuticals v. Actavis Laboratories FL, Inc., No. 2018-1221 (Fed. Cir. Aug. 15, 2019), the Court addressed whether a particular claimed dissolution profile had the requisite written description support when the specification described dissolution data obtained using the USP Apparatus 1 Basket Method, whereas the specifically claimed dissolution profile was obtained using the USP Apparatus Paddle 2 Method.

In this Hatch-Waxman litigation, the proposed generic manufacturer argued that a particular asserted claim from one of the Orange Book listed patents lacked written description support because (i) the claim recited a specific dissolution profile that was collected using the USP Apparatus 2 Paddle Method, but (ii) the specification disclosed several tables of dissolution profile data collected using the USP Apparatus 1 Basket Method. The district court found credible the plaintiff's expert's statement that the claimed dissolution profile and the

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