Ixchel Pharma, LLC v. Biogen, Inc.

930 F.3d 1031
CourtCourt of Appeals for the Ninth Circuit
DecidedJuly 16, 2019
Docket18-15258
StatusPublished
Cited by8 cases

This text of 930 F.3d 1031 (Ixchel Pharma, LLC v. Biogen, Inc.) is published on Counsel Stack Legal Research, covering Court of Appeals for the Ninth Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Ixchel Pharma, LLC v. Biogen, Inc., 930 F.3d 1031 (9th Cir. 2019).

Opinion

FOR PUBLICATION

UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT

IXCHEL PHARMA, LLC, No. 18-15258 Plaintiff-Appellant, D.C. No. v. 2:17-cv-00715-WBS-EFB

BIOGEN, INC., ORDER CERTIFYING Defendant-Appellee. QUESTIONS TO THE CALIFORNIA SUPREME COURT

Appeal from the United States District Court for the Eastern District of California William B. Shubb, District Judge, Presiding

Argued and Submitted May 15, 2019 San Francisco, California

Filed July 16, 2019

Before: J. Clifford Wallace, Sandra S. Ikuta, and Morgan Christen, Circuit Judges. 2 IXCHEL PHARMA V. BIOGEN

SUMMARY*

California Law/Business Torts

The panel certified to the California Supreme Court the following questions:

Does section 16600 of the California Business and Professions Code void a contract by which a business is restrained from engaging in a lawful trade or business with another business?

Is a plaintiff required to plead an independently wrongful act in order to state a claim for intentional interference with a contract that can be terminated by a party at any time, or does that requirement apply only to at-will employment contracts?

* This summary constitutes no part of the opinion of the court. It has been prepared by court staff for the convenience of the reader. IXCHEL PHARMA V. BIOGEN 3

ORDER

We ask the California Supreme Court to resolve two open questions of state law. First, we need guidance in determining whether section 16600 of the California Business and Professions Code applies only to contracts between employers and employees, or also applies to contracts between two businesses. Second, the California Supreme Court has held that a plaintiff must plead an independently wrongful act in order to state a claim for intentional interference with an at-will employment contract. We need guidance, however, in determining whether this requirement applies to contracts outside of the employment context, as two California Courts of Appeal districts have suggested that it does not. Accordingly, we certify the following questions:

Does section 16600 of the California Business and Professions Code void a contract by which a business is restrained from engaging in a lawful trade or business with another business?

Is a plaintiff required to plead an independently wrongful act in order to state a claim for intentional interference with a contract that can be terminated by a party at any time, or does that requirement apply only to at-will employment contracts?

Our phrasing of the questions should not restrict the Court’s consideration of the issues involved. The Court may rephrase the questions as it sees fit in order to address the contentions of the parties. If the Court agrees to decide these questions, we agree to accept its decision. We recognize that 4 IXCHEL PHARMA V. BIOGEN

the Court has a substantial caseload, but we submit these questions in the interests of comity and because of their significance for business torts in California.

I

Ixchel Pharma is a biotechnology company that develops small-molecule drugs for the treatment of mitochondrial disease. Ixchel has been working on the development of an experimental therapeutic drug to treat Friedreich’s ataxia, a rare neurological disease. The active pharmaceutical ingredient in Ixchel’s drug is dimethyl fumarate.

To further its efforts to develop and commercialize a new dimethyl fumarate drug, Ixchel entered into a Collaboration Agreement with Forward Pharma in January 2016. Forward is a biotechnology company based in Denmark that is in the business of developing drugs containing dimethyl fumarate for the treatment of neurological disease.

The Collaboration Agreement included the following terms. Ixchel and Forward would work together to develop the new dimethyl fumarate drug. Forward would assess the feasibility of conducting clinical trials for the new drug. If Forward determined that clinical trials were feasible, Forward would be responsible for carrying out the trials and paying for their costs under the terms of the Collaboration Agreement. Ixchel would provide assistance with the clinical trials. If the clinical trials were successful and resulted in FDA approval for the new drug, the parties agreed that Forward would be responsible for managing the manufacturing and commercialization of the drug with Ixchel’s assistance. Ixchel would be entitled to receive a percentage royalty on the sales of the approved product. IXCHEL PHARMA V. BIOGEN 5

Forward could terminate the Collaboration Agreement by written notice, which would become effective sixty days after notice was received.

In late 2016, Forward began negotiations with Biogen, another pharmaceutical company, in an effort to settle a longstanding intellectual property dispute. Ixchel alleges that Forward gave Biogen a copy of the Collaboration Agreement without Ixchel’s consent. According to Ixchel, Biogen determined that Ixchel’s development work on the new dimethyl fumarate drug would pose a threat to Biogen’s sales of its own dimethyl fumarate drug designed to treat multiple sclerosis. Biogen therefore asked Forward to cut off all ties with Ixchel as part of the settlement.

In January 2017, Forward and Biogen executed an agreement (the Forward-Biogen Agreement) in which Biogen agreed to pay Forward $1.25 billion and Forward agreed to stop working with Ixchel to develop a dimethyl fumarate drug. Section 2.13 of the Forward-Biogen Agreement provides:

Ixchel. Each of the Additional Parties1 and [Forward] shall, and shall cause each of its respective controlled Affiliates to, terminate any and all existing, and not enter into any

1 The “Additional Parties” are defined as Aditech Pharma AG, NB FP Investment General Partner ApS, NB FP Investment SLP ApS, and Tech Growth Invest ApS. None of these entities is a party to this appeal. 6 IXCHEL PHARMA V. BIOGEN

new, Contracts2 or obligations to Ixchel Pharma LLC, Dr. Gino Cortopassi [Ixchel’s CEO] and/or any other Person, to the extent related to the development by any of the Additional Parties, [Forward] or any of their respective controlled Affiliates of any pharmaceutical product having dimethyl fumarate as an [active pharmaceutical ingredient] for the treatment of a human for any indication, including Friedreich’s ataxia.

Pursuant to this provision, Forward notified Ixchel that it was terminating the Collaboration Agreement and ceasing all work with Ixchel on the development of the new dimethyl fumarate drug, including work relating to the planned clinical trials.

Ixchel filed suit in district court against Biogen, asserting (1) tortious interference with contract; (2) intentional and/or negligent interference with prospective economic advantage; and (3) violations of California’s unfair competition law (UCL), which prohibits “any unlawful, unfair or fraudulent business act or practice,” Cal. Bus. & Prof. Code § 17200.3

The district court dismissed Ixchel’s complaint under Rule 12(b)(6) of the Federal Rules of Civil Procedure. It

2 “Contract” is defined as “any contract, agreement, deed, lease or similar instrument, and any legally binding obligation, commitment, arrangement or understanding, whether written or oral.” 3 Ixchel also brought antitrust claims under the Sherman Act and California Cartwright Act but did not appeal the district court’s dismissal of these claims for lack of antitrust standing. IXCHEL PHARMA V. BIOGEN 7

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930 F.3d 1031, Counsel Stack Legal Research, https://law.counselstack.com/opinion/ixchel-pharma-llc-v-biogen-inc-ca9-2019.