Andor Pharmaceuticals, LLC v. Lannett Company, Inc.

CourtSuperior Court of Delaware
DecidedApril 29, 2024
DocketN22C-06-078 EMD CCLD
StatusPublished

This text of Andor Pharmaceuticals, LLC v. Lannett Company, Inc. (Andor Pharmaceuticals, LLC v. Lannett Company, Inc.) is published on Counsel Stack Legal Research, covering Superior Court of Delaware primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Andor Pharmaceuticals, LLC v. Lannett Company, Inc., (Del. Ct. App. 2024).

Opinion

IN THE SUPERIOR COURT OF THE STATE OF DELAWARE

ANDOR PHARMACEUTICALS, LLC, ) ) Plaintiff/Counterclaim ) Defendant, ) ) C.A. No.: N22C-06-078-EMD CCLD v. ) ) LANNETT COMPANY, INC., ) ) Defendant/Counterclaim ) Plaintiff. )

Submitted: January 17, 2024 Decided: April 15, 2024 Redacted per Order dated April 29, 20241

Upon Plaintiff/Counterclaim Defendant Andor Pharmaceuticals, LLC’s Motion to Dismiss Defendant’s Counterclaim GRANTED in part DENIED in part

Jesse L. Noa, Esquire, P. Andrew Smith, Esquire, Potter Anderson & Corroon LLP, Wilmington, Delaware, Scott W. Atherton, Esquire, Terence M. Mullen, Esquire, Atherton Galardi Mullen & Reeder PLLC, West Palm Beach, Florida. Attorneys for Plaintiff/Counterclaim Defendant Andor Pharmaceuticals, LLC.

Brian E. Farnan, Esquire, Michael J. Farnan, Esquire, Farnan LLP, Wilmington, Delaware, Julia Chapman, Esquire, Stefanie A. Tubbs, Esquire, Forrest E. Lovett, Esquire, Dechert LLP, Philadelphia, Pennsylvania. Attorneys for Defendant/Counterclaim Plaintiff Lannett Company, Inc.

DAVIS, J.

I. INTRODUCTION

This civil action is a breach of contract indemnification claim assigned to the Complex

Commercial Litigation Division of the Court. Plaintiff/Counterclaim Defendant Andor

Pharmaceuticals, LLC (“Andor”) claims Defendant/Counterclaim Plaintiff Lannett Company,

1 D.I. No. 220. Inc. (“Lannett” or “LCI”) is in breach of the parties’ license agreement related to the

manufacture and sale of generic drug formulations of Concerta®, a medication used to treat

attention deficit hyperactivity disorder (“ADHD”). Lannett denies the allegations and asserts

counterclaims for reformation based on mistake, declaratory judgment based on frustration of

purpose, declaratory judgment based on substantive unconscionability, and unjust enrichment.

Presently before the Court is Andor’s Motion to Dismiss Defendant’s Counterclaims (the

“Motion”). The Court heard oral argument on the Motion on January 17, 2024. Afterwards, the

Court took the Motion under advisement.

For the reasons set forth below, the Motion is GRANTED in part, and DENIED in part.

II. RELEVANT FACTS A. PARTIES

Andor is a Delaware Limited Liability Company with a principal place of business in

Florida.2 Andor develops and licenses pharmaceutical products.3

Lannett is a Delaware corporation with its principal place of business in Pennsylvania.4

Lannett is a “provider of . . . generic pharmaceutical products.”5 Lannett was previously publicly

traded on the New York Stock Exchange (“NYSE”).6

2 Andor’s Second Amended Complaint (hereinafter “2d Am. Compl.”) ¶ 1 (D.I. No. 104). 3 Id. 4 Id. ¶ 2; Lannett’s Answer, Affirmative Defenses, and Incorporated Counterclaims to Andor's Second Amended Complaint (hereinafter “Answer”) ¶ 2 (D.I. No. 118). 5 Lannett’s Amended Answer to Plaintiff’s Amended Complaint, with Affirmative Defenses and Counterclaims (hereinafter “Countercls.”) ¶ 10 (D.I. No. 100). 6 2d Am. Compl. ¶ 2; Answer ¶ 2. Lannett was delisted in April, 2023 after it “had fallen below the NYSE’s continued listing standard requiring listed companies to maintain an average global market capitalization over a consecutive 30 trading day period of at least $15,000,000.” (NYSE to Suspend Trading Immediately in Lannett Company, Inc. (LCI) and Commence Delisting Proceedings, BUSINESS WIRE (Apr. 19, 2023), https://www.businesswire.com/news/home/20230419005997/en/).

2 B. PRODUCT DEVELOPMENT AND RELEVANT NON-PARTIES

Generic drugs contain the same active ingredient(s) as brand-name drugs and are

permitted to be sold in the United States after the original drug’s patent has expired.7

Pharmaceutical companies that sell generic drugs must first demonstrate to the U.S. Food and

Drug Administration (“FDA”) that their product is bioequivalent to the brand-name drug,

signifying that the generic drug “works in the same way and provides the same clinical benefit as

the brand-name medicine.”8 Pharmaceutical companies do this by filing an Abbreviated New

Drug Application (“ANDA”) with the FDA.9 If the FDA approves an ANDA, the FDA then

assigns the generic drug a “therapeutic equivalence” rating.10 The two ratings relevant to this

civil action are: “AB” and “BX”.

AB-rated drugs are those which “the ‘FDA considers to be therapeutically equivalent to

other pharmaceutically equivalent products’ and for which ‘actual and potential bioequivalence

problems have been resolved with . . . adequate . . . evidence supporting bioequivalence.’”11

BX-rated medications are “drug products for which actual or potential bioequivalence problems

have not been resolved by adequate evidence of bioequivalence.”12

Both AB- and BX-rated drugs are FDA-approved and may be prescribed, but only AB-

rated products can be automatically substituted by pharmacists when filling prescriptions for a

7 U.S. FOOD & DRUG ADMINISTRATION, Generic Drugs: Questions and Answers, https://www.fda.gov/drugs/frequently-asked-questions-popular-topics/generic-drugs-questions-answers (last visited Jan. 1, 2024). 8 Id. 9 Id. The application is “abbreviated” because applicants do not have to replicate certain clinical studies required for brand-name drug approval. This is also why generic medications are typically less expensive than their branded counterparts. 10 Countercls. ¶ 14. 11 2d Am. Compl. ¶ 10 (quoting U.S. FOOD & DRUG ADMINISTRATION, APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS, (43d ed. 2023), https://www.fda.gov/media/71474/download) (the “Orange Book”). 12 Id. ¶ 11.

3 brand-name product.13 BX-rated drugs must be explicitly prescribed.14 Because of the

automatic substitution allowed for AB products, these medications “gain significantly more

market share than the BX-rated product of the same drug.”15

1. Lannett’s Generic Product Development.

Methylphenidate is the active ingredient in certain medications primarily used to treat

ADHD.16 Methylphenidate is sold under several brand names, including Concerta®.17 In 2013,

Kremers Urban Development Company (“KUDCO”) received an AB-rating for its generic

version of Concerta®.18 Kremers Urban Pharmaceuticals, Inc. (“KU”) then sold Concerta® in

the United States.19 In 2014, the KU product was reclassified as BX-rated based on updated

bioequivalence criteria from the FDA.20 KU was acquired by Lannett in 2015, and Lannett

continues to distribute the BX-rated product.21

In 2016, the FDA “proposed to withdraw the approval of Lannett’s BX Product, and

proceedings relating to that proposal remain pending.”22

2. Andor’s Generic Product Development and Commercial Supply Agreement with Catalent.

Andor began to develop a generic version of Concerta® in 2015, (the “AB Product”), and

submitted an ANDA to the FDA.23 While that ANDA was pending in 2017, Andor and non-

party Catalent Pharma Solutions, LLC, (“Catalent”), a drug manufacturer, entered into a

13 Countercls. ¶¶ 15-16; Plaintiff's Motion to Dismiss Defendant's Counterclaim (hereinafter “Pl. MTD”) at 6-7 (D.I. No. 114). 14 Countercls. ¶ 16. 15 Id. ¶ 17. 16 Id. ¶ 20. 17 Id. 18 Id. ¶¶ 25-26. 19 Id. ¶ 27. 20 Id. ¶¶ 29-30. 21 Id. ¶¶ 27-28, 36. 22 Pl. MTD at 7; see also Countercls. ¶¶ 31-35. 23 Pl. MTD at 7.

4 Commercial Supply Agreement (“CSA”).24 The CSA included the following relevant

provisions:

• [REDACTED PER ORDER]25 • [REDACTED PER ORDER] o [REDACTED PER ORDER].26 o [REDACTED PER ORDER]27 • [REDACTED PER ORDER]28 • [REDACTED PER ORDER]29

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Andor Pharmaceuticals, LLC v. Lannett Company, Inc., Counsel Stack Legal Research, https://law.counselstack.com/opinion/andor-pharmaceuticals-llc-v-lannett-company-inc-delsuperct-2024.