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Chiesi USA, Inc. v. Sandoz Inc.

United States District Court, D. New Jersey, Camden Vicinage Division

August 21, 2014

CHIESI USA, INC., CORNERSTONE BIOPHARMA, INC., and EKR THERAPEUTICS, LLC, Plaintiffs,
v.
SANDOZ INC., SANDOZ AG, and ACS Dobfar Info SA, Defendants

Page 418

For CHIESI USA, INC., CORNERSTONE BIOPHARMA, INC., EKR THERAPEUTICS, LLC, Plaintiffs, Counter Defendants: MICHAEL R. GRIFFINGER, LEAD ATTORNEY, JAMES JUNE-HO KANG, SHEILA F. MCSHANE, GIBBONS, PC, NEWARK, NJ; LEANN MARIE CLYMER, FROMMER LAWRENCE & HAUG LLP, NEW YORK, NY.

For SANDOZ INC., Defendant, Counter Claimant: CHRISTINA LYNN SAVERIANO, ERIC I. ABRAHAM, LEAD ATTORNEYS, HILL WALLACK, LLP, PRINCETON, NJ.

Page 419

[Doc. Nos. 40, 41, 42, 47, 51, 76, 77, 78]

MEMORANDUM OPINION AND ORDER

ANN MARIE DONIO, UNITED STATES MAGISTRATE JUDGE.

In this patent infringement action, Plaintiffs Chiesi USA, Inc., Cornerstone Biopharma, Inc., and EKR Therapeutics, LLC (collectively, " Plaintiffs" ) generally allege that Defendant Sandoz Inc.'s (hereinafter, " Defendant" ) attempt to produce, market, and/or distribute a generic ready-to-use premixed nicardipine injection infringes four of Plaintiffs' patents. Presently before the Court are the parties' various submissions concerning the entry of a discovery confidentiality order (hereinafter, " DCO" ). The parties agree to the entry of a DCO, but dispute the inclusion of a patent prosecution bar.[1] For the reasons set forth herein, the Court finds that Defendant has failed to demonstrate good cause sufficient for the imposition of a

Page 420

patent prosecution bar and, therefore, denies without prejudice Defendant's informal application.

The Court's Order dated August 15, 2014 sets forth the background of this patent infringement action, and shall not be reiterated herein. (See generally Order [Doc. No. 168], Aug. 15, 2014.) Rather, with respect to the pending submissions, the Court notes that Defendant asserts that Plaintiffs' active prosecution of patent applications related to the patents-in-suit warrants the inclusion of a patent prosecution bar in any DCO entered in this action. (See Letter [Doc. No. 42], 1.) Defendant specifically asserts that the breadth of potential disclosures in this action will require Defendant to disclose non-public information concerning " the precise ingredients," the " method of manufacture," the container " composition" and " design" of Defendant's generic nicardipine product. (Id. at 5; see also Letter [Doc. No. 51].) Defendant therefore asserts that it " faces the risk that knowledge of its highly confidential information will improperly affect [the] recipient['s] advice and guidance[,]" and that Plaintiffs and/or counsel for Plaintiffs may inadvertently and/or subconsciously misuse this information in connection with (and for the benefit of) Plaintiffs' active prosecution of patents related to the patents at issue in this litigation. (Letter from Defendant regarding DCO [Doc. No. 76], 2.) Defendant therefore asserts that the DCO must include a patent prosecution bar precluding counsel involved in the discovery in this litigation from drafting new patent claims and/or amendments, in addition to drafting claim specifications and/or rendering advice " on arguments to be made to the [Patent and Trademark Office] that may likewise affect claim scope." (Id.) Defendant further asserts that the bar must " appropriate[ly]" reflect the subject matter of the patents-in-suit, by barring patent prosecution activities concerning nicardipine parenteral formulations, the storage container, and the various methods for production and use of nicardipine formulations. (Id. at 3; see also Letter from Defendant Sandoz Inc. -- Response to Plaintiffs' May 9, 2014 Submission [Doc. No. 86], 3 (asserting that Defendant's " product is a complex product with a particular active ingredient, in a certain formulation, in a certain container; [and that] the patents in suit likewise contain elements relating to each of these areas[,]" thereby creating " a grave and recognized risk of misuse" ).) For those reasons, Defendant specifically moves for the inclusion in the DCO of the following provision:[2]

Page 421

Any person that receives Attorneys' Eyes Only technical or regulatory information from another party may not, during the pendency of this action and for one year thereafter, participate in, assist in, or advise regarding the drafting of patent claims, claim amendments, and patent specifications, or regarding arguments to be made in any proceeding before the U.S. Patent and Trademark Office (or equivalent foreign agency), relating to patents or patent applications owned or controlled by the person, their employer or clients, or the receiving party concerning the subject matter of the patents in suit, i.e., pre-mixed nicardipine parenteral formulations, their containers, active ingredients, methods of manufacture and methods of treatment.

( See [Proposed] Discovery Confidentiality Order [Doc. No. 76-1], ¶ 6.)

Plaintiffs generally assert that Defendant has failed to demonstrate " 'a clearly defined, specific and serious injury'" sufficient to support the imposition of a patent prosecution bar.[3] (Letter from Michael Griffinger [Doc. No. 83], 3 (citation omitted) (emphasis in original).) Plaintiffs assert that Defendant instead predicates its assertions concerning the necessity of a patent prosecution bar upon " 'mere general allegations'" of harm, without identifying " 'specific facts'" to demonstrate an entitlement to such a bar. (Id. at 3-4.) Moreover, Plaintiffs assert that Defendant " cannot demonstrate that its requested bar reasonably reflects any 'risk'" of misuse, particularly in light of the fact that Defendant's proposed generic nicardipine product constitutes " a qualitative and quantitative copy" of Plaintiffs' brand name nicardipine product. (Id. at 4; see also Letter from Michael R. Griffinger [Doc. No. 93], 1 (" although [Defendant] admits that its generic product 'mirrors' Plaintiffs' patented drug product, it still vaguely maintains--without specifying any particular harm--that ...


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