DUKE UNIVERSITY v. AKORN, INC.

CourtDistrict Court, D. New Jersey
DecidedSeptember 16, 2019
Docket3:18-cv-14035
StatusUnknown

This text of DUKE UNIVERSITY v. AKORN, INC. (DUKE UNIVERSITY v. AKORN, INC.) is published on Counsel Stack Legal Research, covering District Court, D. New Jersey primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
DUKE UNIVERSITY v. AKORN, INC., (D.N.J. 2019).

Opinion

NOT FOR PUBLICATION

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY ____________________________________ : DUKE UNIVERSITY, ALLERGAN, INC., : And ALLERGAN SALES, LLC, : : Case No. 3:18-cv-14035-BRM-TJB Plaintiffs and : Counterclaim-Defendants, : : v. : : OPINION AKORN, INC. and HI-TECH : PHARMACAL CO., INC., : : Defendants and : Counterclaim-Plaintiffs. : ____________________________________: MARTINOTTI, DISTRICT JUDGE Before this Court is Plaintiff/Counterclaim-Defendants Duke University (“Duke”), Allergan, Inc. (“Allergan”), and Allergan Sales, LLC’s (“Allergan Sales”) (collectively, “Plaintiffs”) Motion to Dismiss Defendant/Counterclaim-Plaintiff Akorn, Inc.’s (“Akorn”) antitrust and patent misuse counterclaims and to strike the related affirmative defenses, or in the alternative, to bifurcate and stay Akorn’s counterclaims and affirmative defenses. (ECF No. 22.) Akorn filed an Opposition to Plaintiffs’ Motion to Dismiss (ECF No. 26) and Plaintiffs filed a Reply Brief to Akorn’s Opposition to its Motion to Dismiss (ECF No. 27). Having reviewed the submissions filed in connection with the motions and having declined to hold oral argument pursuant to Federal Rule of Civil Procedure 78(b), for the reasons set forth below and for good cause appearing, Plaintiffs’ Motion to Dismiss the Counterclaims and Affirmative Defenses is GRANTED and Plaintiffs’ Motion to Bifurcate and Stay the proceedings is DENIED AS MOOT. I. BACKGROUND A. Factual Background For the purposes of this Motion to Dismiss, the Court accepts the factual allegations in the Amended Complaint – or in this case, the allegations in the Counterclaim – as true and draws all

inferences in the light most favorable to the non-moving party. See Phillips v. Cty. of Allegheny, 515 F.3d 224, 228 (3d Cir. 2008). Furthermore, the Court also considers any “document integral to or explicitly relied upon in the complaint.” In re Burlington Coat Factory Secs. Litig., 114 F.3d 1410, 1426 (3d Cir. 1997) (quoting Shaw v. Dig. Equip. Corp., 82 F.3d 1194, 1220 (1st Cir. 1996)). Duke is an educational, research, and healthcare institution located in Durham, North Carolina, Allergan is a Delaware corporation with its principal place of business in Irvine, California, and Allergan Sales is a Delaware limited liability company with its principal place of business in Madison, New Jersey. (ECF No. 1 ¶¶ 1-3.) Akorn is a Louisiana corporation with its principal place of business in Lake Forest, Illinois, which also maintains a registered agent for process in Ewing, New Jersey. (Id. ¶ 4.) Hi-Tech, a wholly owned subsidiary of Akorn since 2014,

is a Delaware corporation with its principal place of business in Amityville, New York. (Id. ¶¶ 5- 6.) Allegan is the corporate parent company of Allergan Sales (collectively, “Allergan”), which is the holder of the Abbreviated New Drug Application (“ANDA”) No. 22-369 for LATISSE ® (“Latisse”). (ECF No. 1 ¶ 35.) Latisse is a bimatoprost1 ophthalmic solution, 0.03%,

1 Bimatoprost is a synthetic PGF2α analog which differs structurally from PGF2α in two respects: bimatoprost contains an ethyl amide at the C-1 position whereas PGF2α contains a carboxylic acid at the C-1 position, and the omega chain of bimatoprost is shortened by three carbons compared to PGF2α and contains a phenyl group at the C-17 position. (ECF No. 1 ¶ 28.) Unlike PGF2α, which binds to the FP receptor, bimatoprost binds only to a splice variant of the FP receptor known as the prostamide receptor. (Id. ¶ 29.) Therefore, Plaintiffs allege bimatoprost has a different which is used to treat hypotrichosis of the eyelashes by increasing their length, thickness, and darkness. (Id. ¶¶ 35-36.)2 On February 28, 2017, the United States Patent and Trademark Office (“USPTO”) issued U.S. Patent No. 9,579,270 (the “’270 Patent”), entitled “Compositions and Methods for Treating Hair Loss Using Non-Naturally Occurring Prostaglandins,” to Duke. (Id.

¶¶ 18-19.) Allergan holds an exclusive license to the ’270 Patent. (Id. ¶ 20.) Akorn, through Hi-Tech, submitted ANDA No. 203051 pursuant to § 355(j)(2)(B)(ii) of the Federal Food, Drug and Cosmetic Act (“FDCA”), and upon receiving approval, “will manufacture, sell, offer to sell, and/or import Akorn’s proposed generic bimatoprost product in the United States.” (Id. ¶ 15.) Since 2011, Allergan has brought several lawsuits against “various generic manufacturers’ submissions of . . . ANDAs under section 505(j) of the FDCA.” (Id. ¶ 42.) Relevant to this matter, Plaintiffs have brought four lawsuits – three of which Duke has joined – alleging infringement of patents covering Latisse, and specifically alleging infringement by Akorn’s ANDA No. 203051. (ECF No. 1 ¶¶ 41-50.) These lawsuits include: Allergan, Inc., et al. v. Hi-Tech Pharmacal Co.,

Inc., Case No. 1:11-cv-650, filed in the Middle District of North Carolina (“Latisse I”); Allergan, Inc. v. Apotex, Inc., et al., Case Nos. 1:12-cv-247 and 1:13-cv-16, filed in the Middle District of

pharmacological activity than PGF2α and PGF2α analogs with C-1 carboxylic acid groups. (Id. ¶ 31.)

2 The FDA approved Latisse in 2008. (ECF No. 1 ¶ 37.) Before that approval, the FDA had sanctioned only two other hair growth agents in its history, minoxidil (Rogaine®) and finasteride (Propecia®). (Id.) Both of these products are approved for growth of hair on the scalp, not eyelash hair. (Id.) Latisse “has been a commercially successful product for Allergan, resulting in net sales for Allergan of over $70 million annually since its launch in 2009.” (Id. ¶ 38.) North Carolina (“Latisse II”); and Allergan, Inc. v. Sandoz, Inc., et al., Case No. 1:14-cv-1034, filed in the Middle District of North Carolina (“Latisse III”).3 i. Latisse I On August 17, 2011, Allergan and Duke filed a complaint against Hi-Tech asserting

infringement of U.S. Patent Nos. 7,531,404 (the “’404 Patent”) and 7,388,029 (the “’029 Patent”) by Akorn’s proposed ANDA Product. (ECF No. 8 ¶ 34); Case No. 1:11-cv-650, ECF No. 1. On January 24, 2013, the United States District Court for the Middle District of North Carolina issued an opinion determining, inter alia, that Hi-Tech infringed the patents and entered judgment in favor of the plaintiffs. Case No. 1:11-cv-650, ECF No. 95. On June 10, 2014, the Federal Circuit reversed the district court’s decision, holding that the asserted claims of the ’029 and ’404 Patents were invalid as obvious and were invalid over two prior art references: PCT Application No. PCT/US98/02289 (“Johnstone”) and U.S. Patent No. 5,688,801 (the “’819 Patent”). Allergan, Inc. v. Apotex Inc., 754 F.3d 952, 966 (Fed. Cir. 2014); (ECF No. 8 ¶¶ 35-36.) Specifically, the Federal Circuit held it would have been obvious to use the family of compounds that includes bimatoprost

to treat hair loss. Allergan, 754 F.3d at 962-66. Moreover, the Federal Circuit found the ’029 Patent asserted claims that included “thousands of permutations of synthetic [prostaglandin F-2-alpha (“PGF”)] analogs,” and not just bimatoprost, which is only one such analog. Id. at 962. Plaintiffs’ request for an en banc re-hearing in Latisse I was denied. (ECF No. 8 ¶ 37.) Thereafter, the district court entered a final judgment declaring the invalidity of the asserted claims of the ’029 and ’404 Patents and non-infringement by Akorn’s Proposed ANDA Product. (Id. ¶ 38.)

3 The instant case is included as one of the four cases brought by Allergan against Akorn since 2011 and is referenced as “Latisse IV” in the parties’ briefing. ii.

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