Melvin Gross v. Biogen Inc.

Court of Chancery of Delaware·Decided April 14, 2021·No. C.A. No. 2020-0096-PAF·Published

Opinion

IN THE COURT OF CHANCERY OF THE STATE OF DELAWARE

)

MELVIN GROSS, )

)

Plaintiff, )

)

v. ) C.A. No. 2020-0096-PAF )

BIOGEN INC., ) a Delaware corporation, )

)

Defendant. )

)

MEMORANDUM OPINION

Date Submitted: January 11, 2021 Date Decided: April 14, 2021

Kurt M. Heyman, Gillian L. Andrews, HEYMAN ENERIO GATTUSO & HIRZEL LLP, Wilmington, Delaware; Gustavo F. Bruckner, Daryoush Behbood, POMERANTZ LLP, New York, New York; Attorneys for Plaintiff Melvin Gross.

Kevin G. Abrams, J. Peter Shindel, Jr., Eliezer Y. Feinstein, ABRAMS & BAYLISS LLP, Wilmington, Delaware; Attorneys for Defendant Biogen Inc.

FIORAVANTI, Vice Chancellor

I. INTRODUCTION Plaintiff Melvin Gross seeks an order to compel inspection of books and records of Biogen Inc. (“Biogen” or the “Company”) pursuant to Section 220 of the Delaware General Corporation Law (“DGCL”). Plaintiff aims to investigate, among other things, potential corporate wrongdoing and mismanagement arising from a federal investigation and a former employee’s allegations in a wrongful termination suit. In this post-trial Memorandum Opinion, I conclude that Plaintiff is entitled to inspect some, but not all, of the categories of books and records sought in his demand for inspection. II. FACTUAL BACKGROUND The following facts were either stipulated or proven at trial by a preponderance of the evidence.

A. The Company

Biogen is a Delaware corporation with its headquarters in Cambridge, Massachusetts.1 Biogen is a global pharmaceutical company that develops drug therapies to treat neurological and neurodegenerative diseases.2 Among the

1 Pre-Trial Stipulation and Order (“PTO”) ¶ 1.

2 Id. ¶ 2.

Company’s drug therapies are Tysabri and Zinbryta, both of which are used to treat multiple sclerosis (MS). 3 Biogen operates in a heavily regulated industry, and its governance documents recognize that risk oversight is paramount. Under Biogen’s Governance Principles, its board of directors (the “Board”) is responsible for, among other things, “[r]eviewing, approving and monitoring . . . material government and other investigations” and “[e]nsuring processes are in place for maintaining . . . compliance with law . . . .” 4 The Board has a standing Audit Committee, which oversees the Company’s compliance program with a focus on “[f]inancial, accounting, disclosure, corporate compliance, distributors, insurance, capital, credit, anti-bribery and anti-corruption matters and other risks reviewed in its oversight of the internal audit and corporate compliance functions.” 5 The Board also oversees Biogen’s compliance program, which is led by a Corporate Compliance Committee of senior officers.6 The compliance program enumerates policies and practices that “prohibit illegal remuneration in violation of federal and state anti-kickback statutes” and that provide for “appropriate . . . making of grants and charitable contributions so that such funds are not conditioned, express or implied, on any agreement to

3 JX 16; Pl.’s Pre-Trial Br. 8.

4 JX 24 at 1.

5 JX 42 at 41.

6 JX 58 at 9.

prescribe, purchase, recommend, influence or provide favorable formulary status for any Biogen product.”7 Biogen acknowledges that sales of its products “depend, to a significant extent, on the availability of and extent of adequate coverage, pricing and reimbursement from government health administration authorities, private health insurers and other organizations.” 8 For this reason, Biogen’s sales partly rely on certain charities that provide financial assistance to Medicare patients. These charities “operate[] funds that receive payments from pharmaceutical manufacturers and others, and that then use those payments, less administrative fees that [the charity] charges, to cover the drug co-pay obligations of patients, including Medicare patients.”9 Those practices, however, are subject to state and federal laws pertaining to health care fraud and abuse. Among those laws is the federal Anti- Kickback Statute, which generally prohibits a prescription drug manufacturer from directly or indirectly receiving or paying any remuneration to generate business, including the purchase or prescription of a particular drug. 10 A violation of the Anti-

7 JX 57 at 2.

8 JX 13 at 49.

9 JX 22 at Recital B.

10 42 U.S.C. § 1320a-7b(b)(2) (“Whoever knowingly and willfully offers or pays any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind to any person to induce such person—(A) to refer an individual to a person for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part under a Federal health care program, or

Kickback Statute constitutes a fraudulent claim for purposes of the federal False Claims Act. 11 B. Biogen Is Subpoenaed in Federal and State Investigations On April 21, 2016, Biogen disclosed that it had received subpoenas from state and federal authorities that were investigating Biogen’s “sales and promotional practices.”12 In the same disclosure, Biogen revealed that it had also received a document subpoena on March 4, 2016 as part of a federal investigation (the “Investigation”) into Biogen’s “relationship with non-profit organizations that provide assistance to patients taking drugs sold by Biogen.” 13 Biogen’s disclosure did not identify which agencies had issued the subpoenas. On May 27, 2016, Bloomberg reported that Biogen was among three pharmaceutical companies that had recently disclosed having received federal subpoenas for documents concerning their relationships with charities that help patients to afford their products.14 The

(B) to purchase, lease, order, or arrange for or recommend purchasing, leasing, or ordering any good, facility, service, or item for which payment may be made in whole or in part under a Federal health care program, shall be guilty of a felony and upon conviction thereof, shall be fined not more than $100,000 or imprisoned for not more than 10 years, or both.”). 11 Id. § 1320a-7b(g) (“[A] claim that includes items or services resulting from a violation of this section constitutes a false or fraudulent claim for purposes of subchapter III of chapter 37 of title 31 [the False Claims Act].”). 12 JX 2 at 31.

13 Id.

14 See JX 23 (citing Ben Elgin & Robert Langreth, Gilead Subpoenaed as Feds Probe Drugmaker-Charity Connections, Bloomberg (May 27, 2016, 5:00 AM EDT),

article reported that the other two companies—Gilead Sciences, Inc. (“Gilead”) and Jazz Pharmaceuticals plc (“Jazz”)—disclosed that their subpoenas were issued by the United States Attorney’s Office for the District of Massachusetts, which operates a health-care fraud unit.15 Following its initial disclosure about the subpoenas in 2016, Biogen regularly reported in filings with the U.S. Securities and Exchange Commission (the “SEC”) that it had received those subpoenas.16 In its Form 10-Q for the second quarter of 2020, Biogen disclosed:

We have learned that state and U.S. governmental authorities are investigating our sales and promotional practices and have received related subpoenas. We are cooperating with the investigation.

We have received subpoenas and other requests from the U.S.

government for documents and information relating to our relationship with non-profit organizations that assist patients taking drugs sold by Biogen and the government has challenged some of our contributions to these organizations. We have reached an agreement in principle with the government to resolve this matter.17

https://www.bloomberg.com/news/articles/2016-05-27/gilead-subpoenaed-as-feds-probedrugmaker -charity-connections). The trial record reflects a May 31, 2016 version of the article. JX 46. 15 Id.

16 See, e.g., JX 13 at 47 (Form 10-Q dated July 23, 2019); JX 14 at 47–48 (Form 10-Q dated October 22, 2019); JX 43 at 40 (Form 10-Q dated April 23, 2020). 17 JX 56 at 44 (emphasis added).

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Melvin Gross v. Biogen Inc., (Del. Ct. App. 2021).

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