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Allergan, Inc. v. Taro Pharmaceutical Industries Ltd.

United States District Court, D. Delaware

April 25, 2018

ALLERGAN, INC., Plaintiff,
v.
TARO PHARMACEUTICAL INDUSTRIES LTD. and TARO PHARMACEUTICALS, INC., Defendants.

          MEMORANDUM ORDER

          Sherry R. Fallon United States Magisirate Judge

         At Wilmington this 25th day of April, 2018, the court having considered the parties' letter submissions regarding plaintiff Allergan, Inc.'s ("Allergan") request for documents relating to the generic 5% dapsone formulation of defendants Taro Pharmaceutical Industries Ltd. and Taro Pharmaceuticals, Inc. (together, "Taro") in the above-captioned matter (D.I. 69; D.I. 70), IT IS HEREBY ORDERED THAT Allergan's narrowed request for documents[1] is GRANTED for the reasons set forth below.

         1. Background.

         Allergan brought this civil action for patent infringement under the Hatch-Waxman Act on June 1, 2017, alleging a cause of action for infringement of United States Patent No. 9, 517, 219 ("the '219 patent"), which is entitled "Topical Dapsone and Dapsone/Adapalene Compositions and Methods for Use Thereof." (D.I. 1 at ¶ 18) The '219 . patent encompasses the approved use of Allergan's Aczone® Gel, 7.5%, which contains dapsone as its active pharmaceutical ingredient ("API") and was approved for marketing by the Food and Drug Administration ("FDA") in Allergan's New Drug Application ("NDA") No. 207154. (Id. at¶¶l7, l9)

         2. Taro submitted Abbreviated New Drug Application ("ANDA") No. 210191 to the FDA, seeking approval to market a generic version of Allergan's 7.5% Aczone® Gel prior to the expiration of the '219 patent. (D.I. 1 at ¶ 20) Allergan represents that Taro's generic 7.5% product contains the same API at the same concentrations, and uses a multi-component polymeric viscosity builder ("PVB"). (D.I. 69 at 1) According to Allergan, the court must ultimately determine whether Taro's inclusion of Carbopol 980 as an ingredient in the PVB of its 7.5% ANDA product is equivalent to the inclusion of acrylamide/sodium acryloyldimethyl taurate copolymer ("A/SA") in the PVB composition claimed in the '219 patent. (D.I. 70 at 1)

         3. Taro previously developed a generic version of Allergan's earlier 5% dapsone formulation, which used Carbopol 980 as the exclusive PVB. (D.I. 69, Ex. A) By way of its motion to compel, Allergan seeks the production of portions of Taro's 5% ANDA, as well as laboratory notebooks relating to the development of Taro's 5% ANDA product. (D.I. 69 at 2 n.6) Allergan asserts that information relating to Taro's use of Carbopol 980 in products other than the 7.5% ANDA product is relevant to Allergan's claim of infringement pursuant to the doctrine of equivalents.

4. Legal standard. Pursuant to Rule 26,
Parties may obtain discovery regarding any nonprivileged matter that is relevant to any party's claim or defense and proportional to the needs of the case, considering the importance of the issues at stake in the action, the amount in controversy, the parties' relative access to relevant information, the parties' resources, the importance of the discovery in resolving the issues, and whether the burden or expense of the proposed discovery outweighs its likely benefit. Information within this scope of discovery need not be admissible in evidence to be discoverable.

Fed. R. Civ. P. 26(b)(1). A party may move for an order compelling discovery pursuant to Rule 37. Generally, a party moving to compel discovery bears the burden of demonstrating the relevance of the requested information. See Del. Display Grp. LLC v. Lenovo Grp. Ltd., C.A. Nos. 13-2108-RGA, 13-2109-RGA, 13-2122-RGA, 2016 WL 720977, at *2 (D. Del. Feb. 23, 2016) (citing Lnventio AG v. ThyssenKrupp Elevator Am. Corp., 662 F.Supp.2d 375, 381 (D. Del. 2009)). However, "[t]he parties and the court have a collective responsibility to consider the proportionality of all discovery and consider it in resolving discovery disputes." Fed.R.Civ.P. 26 advisory committee's note to 2015 amendment.

         5. Analysis.

         Allergan's request for production of portions of Taro's 5% AND A and associated laboratory notebooks is granted. The requested discovery is relevant to the litigation because Taro's 5% product and its 7.5% product have the same API and nearly identical inactive ingredients. In similar circumstances, discovery regarding a related AND A product has been deemed relevant by the court:

[T]he more similar or related that a product is to the ANDA product (particularly if the ingredients are used as viscosity-increasing agents), the more relevant the requested information about that product becomes to [the plaintiffs] infringement claims. Similarly, to the extent that document requests can be limited to certain narrow categories of [the defendant's] products, the burden on [the defendant] to search for responsive documents is reduced.

Medicis Pharm. Corp. v. Actavis Mid Atl. LLC, 282 F.R.D. 395, 398 (D. Del. 2012) (ordering production of documents that "relate to or discuss the substitution or interchangeability of the ingredients as viscosity-increasing agents (i.e., the manner in which the ingredients are utilized in the ANDA product).").

         6. Taro alleges that Allergan does not need Taro's development documents regarding the 5% product because Allergan's 5% product is identical to Taro's generic version, and information is available from other sources regarding the state of the prior art at the time of the invention. However, Taro's 5% AND A and ...


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