Abbott Laboratories v.

CourtCourt of Appeals for the Third Circuit
DecidedMarch 11, 2024
Docket23-2412
StatusPublished

This text of Abbott Laboratories v. (Abbott Laboratories v.) is published on Counsel Stack Legal Research, covering Court of Appeals for the Third Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Abbott Laboratories v., (3d Cir. 2024).

Opinion

PRECEDENTIAL

UNITED STATES COURT OF APPEALS FOR THE THIRD CIRCUIT _______________________

No. 23-2412 _______________________

In re: ABBOTT LABORATORIES; ABBVIE INC.; ABBVIE PRODUCTS LLC; UNIMED PHARMACEUTICALS LLC; BESINS HEALTHCARE, INC., Petitioners _______________________

On Petition for a Writ of Mandamus to the United States District Court for the Eastern District of Pennsylvania District Court No. 2-19-cv-03565 District Judge: The Honorable Harvey Bartle, III __________________________

Argued November 29, 2023

Before: JORDAN, MONTGOMERY-REEVES, and SMITH, Circuit Judges

(Filed: February 22, 2024)

Paul D. Clement Erin E. Murphy Clement & Murphy 706 Duke Street Alexandria, VA 22314

Elaine J. Goldenberg Donald B. Verrilli, Jr. [ARGUED] Sarah Weiner Munger Tolles & Olson 601 Massachusetts Avenue NW Suite 500e Washington, DC 20001

Adam R. Lawton Munger Tolles & Olson 350 S Grand Avenue 50th Floor Los Angeles, CA 90071

Rohit K. Singla Munger Tolles & Olson 560 Mission Street 27th Floor San Francisco, CA 94105 Counsel for Petitioners Abbott Laboratories, AbbVie Inc., AbbVie Products LLC, and Unimed Pharmaceuticals LLC

Melinda F. Levitt Gregory E. Neppl Foley & Lardner 3000 K Street NW Suite 600 2 Washington, DC 20007 Counsel for Petitioner Besins Healthcare, Inc.

Samuel E. Bonderoff Bruce E. Gerstein Garwin Gerstein & Fisher 88 Pine Street Wall Street Plaza, 28th Floor New York, NY 10005

Russell A. Chorush [ARGUED] Heim Payne & Chorush 609 Main Street Suite 3200 Houston, TX 77002

David A. Langer Ellen T. Noteware David F. Sorensen Berger Montague 1818 Market Street Suite 3600 Philadelphia, PA 19103 Counsel for Respondents AmerisourceBergen Corp, Amerisourcebergen Drug Corp, King Drug Co. of Florence, Inc., Bellco Drug Corp., HD Smith LLC, Cardinal Health, Inc., Harvard Drug Group, McKesson Corp., J M Smith Corp., agent of D/B/A Smith Drug Co., Burlington Drug Co., Inc., North Carolina Mutual Wholesale Drug, Dakota Drug, Value Drug, FWK Holdings LLC 3 __________________________

OPINION OF THE COURT __________________________

SMITH, Circuit Judge.

I. INTRODUCTION

The underlying litigation in the matter before us sounds in patent and antitrust law. What we are presented with here, however, is a petition for mandamus relief after a district judge ruled that application of the crime-fraud exception to the attorney-client privilege justified an order compelling production of certain documents generated by in-house counsel for the patent holder. Petitioners are Abbott Laboratories, Abbvie Inc., Abbvie Products LLC, Unimed Pharmaceuticals LLC, and Besins Healthcare, Inc. 1 They contend that a writ of mandamus relief is the only means available to them to

1 Abbvie Inc.; Abbvie Products LLC; and Unimed Pharmaceuticals, LLC are collectively referred to as “Abbvie.” As explained in Petitioners’ corporate disclosure statement: “Neither Abbott Laboratories nor AbbVie Inc. has any parent corporation. Unimed Pharmaceuticals LLC is a direct, wholly owned subsidiary of AbbVie Products LLC, which is a direct, wholly owned subsidiary of AbbVie Inc. Besins Healthcare, Inc. (“BHI”) is a wholly owned subsidiary of Besins Healthcare Ireland Ltd.” Pet. at i. 4 preserve confidentiality, which should extend to documents they claim are privileged. Respondents include various drug manufacturers who argue that mandamus should not lie because Petitioners (1) have failed to show that the District Court committed a clear and indisputable abuse of discretion; (2) have another adequate remedy; and (3) will not suffer irreparable injury. Because Petitioners fail to meet the high bar set for granting a petition for writ of mandamus, we will deny their petition.

II. FACTUAL BACKGROUND

Petitioners Abbvie and BHI owned a now-expired patent (the ’894 patent), protecting AndroGel 1%, a topical drug used to treat patients with low testosterone. FTC v. AbbVie Inc., 976 F.3d 327, 341-42 (3d Cir. 2020) (“FTC II”). 2 The original patent application, which the patent examiner rejected, “claimed all penetration enhancers.” Id. at 341. It was later amended “to recite at least one of 24 penetration enhancers,” among them isopropyl myristate and isostearic acid, though not isopropyl palmitate. Id. The claimed pharmaceutical composition for the patent that ultimately

2 “AbbVie acquired Unimed’s interest in the patent as follows: in 1999, Unimed was acquired by Solvay; in 2010, Solvay was acquired by Abbott; in 2013, Abbott separated into two companies—Abbott and AbbVie—with AbbVie assuming all of Abbott’s propriet[ar]y pharmaceutical business, including its interest in Androgel.” FTC II, 976 F.3d at 341.

5 issued had been reduced to a formulation with only a single enhancer: isopropyl myristate. Id. at 342.

The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch- Waxman Act, provides a regulatory scheme for testing and approving new drugs. 21 U.S.C. § 355; FTC v. Actavis, Inc., 570 U.S. 136, 142-44 (2013); see In re Wellbutrin XL Antitrust Litig. Indirect Purchaser Class, 868 F.3d 132, 143-44 (3d Cir. 2017). The Act provides special procedures for approving brand-name and generic drugs, as well as “for identifying, and resolving, related patent disputes.” Actavis, Inc., 570 U.S. at 143. Following these procedures, drug companies Perrigo Company (“Perrigo”) and Teva Pharmaceuticals USA, Inc. (“Teva”) sought FDA approval for generic Androgel 1% formulations. FTC II, 976 F.3d at 342-43. Perrigo’s version specified a formulation using isostearic acid as its penetration enhancer, while Teva specified a formulation using isopropyl palmitate (which Petitioners later argued was equivalent to isopropyl myristate). Id. at 343. Both companies certified under 21 U.S.C. § 355(b)(2) that Petitioners’ ’894 patent was invalid or not infringed by their own formulations. Id. at 343- 44, 361. Under 21 U.S.C. § 355(j)(5)(B)(iii), Petitioners then— as owners of the ’894 patent—had “45 days to decide whether to sue.” Id. at 340.

Petitioners sued Perrigo for infringement in the District of New Jersey. Id. at 344. They then contacted Perrigo only days later to discuss settling the lawsuit, offering to pay Perrigo $500,000. Ultimately, Abbott paid Perrigo $2,000,000, with Perrigo agreeing in exchange to delay marketing its generic 1% testosterone gel until January 1, 2015, or until another version 6 entered the market, whichever occurred first. Id. Abbott also sued and settled with Teva, agreeing to license Teva to market its generic gel beginning on December 27, 2014. Id. The FDA later approved Perrigo’s and Teva’s products, which used isostearic acid and isopropyl palmitate, respectively. Id. at 345.

III. PROCEDURAL BACKGROUND

The procedural history of this and related litigation is lengthy and has begun to resemble the many heads of Hydra. On October 31, 2011, Petitioners filed a lawsuit against Perrigo (the “Perrigo Lawsuit”) through their outside counsel, Munger, Tolles & Olson, LLP (“Munger Tolles”) and Foley & Lardner LLP (“Foley Lardner”). Petitioners alleged that “the submission of [Perrigo’s new drug application] . . . constitutes infringement by Perrigo . . . of the ’894 Patent” and that “any commercial manufacture, use, sale, offer for sale, or importation of Perrigo’s Generic AndroGel® would infringe the ’894 Patent.” App. 272.

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Abbott Laboratories v., Counsel Stack Legal Research, https://law.counselstack.com/opinion/abbott-laboratories-v-ca3-2024.