Amyndas Pharm., S.A. v. Zealand Pharma A/S

• Decision Date: 02 September 2022
• Docket Number: 21-1781
• Citation: 48 F.4th 18
• Parties: AMYNDAS PHARMACEUTICALS, S.A. and Amyndas Pharmaceuticals, LLC, Plaintiffs, Appellants, v. ZEALAND PHARMA A/S and Zealand Pharma U.S., Inc., Defendants, Appellees, Alexion Pharmaceuticals, Inc., Defendant.
• Court: U.S. Court of Appeals — First Circuit

48 F.4th 18

AMYNDAS PHARMACEUTICALS, S.A. and Amyndas Pharmaceuticals, LLC, Plaintiffs, Appellants,
v.
ZEALAND PHARMA A/S and Zealand Pharma U.S., Inc., Defendants, Appellees,

Alexion Pharmaceuticals, Inc., Defendant.

No. 21-1781

United States Court of Appeals, First Circuit.

September 2, 2022

Robert E. Counihan, with whom David K. Tellekson, Jessica M. Kaempf, Deena J. Greenberg Feit, Todd R. Gregorian, Fenwick & West LLP, Russell Beck, and Beck Reed Riden LLP were on brief, for appellants.

Edwina Clarke, with whom Kevin P. Martin, Robert D. Carroll, Huiya Wu, Tiffany Mahmood, and Goodwin Procter LLP were on brief, for appellees.

Before Barron, Chief Judge, Selya and Kayatta, Circuit Judges.

SELYA, Circuit Judge.

When biotech firms engage in the entrepreneurial equivalent of musical chairs, one firm sometimes gets left out in the cold. That is essentially what happened here — and it led to the litigation described below.

The music began with serial decisions by plaintiffs Amyndas Pharmaceuticals, S.A., now known as Amyndas Pharmaceuticals Single Member P.C., and Amyndas Pharmaceuticals, LLC (collectively, Amyndas), appellants here, to consider separate joint ventures with defendants Zealand Pharma A/S (Zealand Pharma) and Alexion Pharmaceuticals, Inc. (Alexion), respectively. In the ensuing chorus of negotiations, Amyndas relied on confidential disclosure agreements (CDAs) to safeguard its trade secrets. After Amyndas shared that confidential information, though, neither of the joint ventures materialized.

Even so, the band played on. Zealand Pharma and its newly established affiliate, Zealand Pharma U.S., Inc. (Zealand US), announced a partnership with Alexion — a partnership that contemplated bringing to market a drug targeting the same part of the immune system on which Amyndas

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had been concentrating. Amyndas responded by suing for misappropriation of trade secrets and other confidential information.

The district court dismissed Amyndas's claims against Zealand Pharma on the ground that the CDA between the parties required Amyndas to litigate those claims in Denmark. See Amyndas Pharms., S.A. v. Alexion Pharm., Inc., No. 20-12254, 2021 WL 4551433, at *7 (D. Mass. June 8, 2021). It then dismissed Amyndas's claims against Zealand US for failure to state a claim because the complaint's allegations were predominately against the Zealand entities, collectively, and thus "[we]re insufficient to put [the Zealand entities] on notice as to ‘who did what to whom.’ " Id. at *2. Twenty-eight days later, Amyndas filed a motion for reconsideration or, in the alternative, for leave to amend, attaching a proposed amended complaint. The district court denied both reconsideration and leave to amend.

Amyndas appealed these rulings. Because Amyndas's claims against Alexion remained pending in the district court, the district court entered a partial final judgment under Federal Rule of Civil Procedure 54(b) to enable immediate appellate review. Following briefing and oral argument, we now uphold the entry of a partial final judgment under Rule 54(b). And having confirmed the existence of appellate jurisdiction, we affirm the dismissal of Amyndas's claims against Zealand Pharma, vacate the dismissal of Amyndas's claims against Zealand US, and remand to the district court for further proceedings consistent with this opinion.

I

We briefly rehearse the facts and travel of the case. In that account, we take as true all well-pleaded facts alleged in the proposed amended complaint, drawing all reasonable inferences in the pleader's favor. See Rodríguez- Reyes v. Molina-Rodríguez, 711 F.3d 49, 52-53 (1st Cir. 2013) ; Panther Partners Inc. v. Ikanos Commc'ns, Inc., 681 F.3d 114, 119 (2d Cir. 2012).

Amyndas consists of a Greek company and its American affiliate. It is a biotechnology firm that researches and develops therapeutics targeting a part of the immune system known as the complement system. When the complement system malfunctions, it can cause the immune system to attack healthy tissue, either causing or exacerbating a wide variety of conditions. One area of Amyndas's research deals with "complement inhibitors."

Amyndas's research has yielded compstatin — a peptide that selectively inhibits the C3 protein (which plays a role in activating the complement system). What is more, Amyndas also has developed a related peptide (AMY-101) targeting that protein for clinical use. Amyndas is the exclusive licensee of patents related to this work and has endeavored to develop therapies based on AMY-101 that target the C3 protein. It owns trade secrets and confidential information related to this work.

In March of 2015, Zealand Pharma, a Danish biotechnology firm, contacted Amyndas about a potential partnership for the development of complement-related therapeutics. Discussions ensued. The next month, the two firms entered into a CDA regarding information-sharing "for the purposes of evaluating a possible business/ services relationship between the parties and their respective Affiliates." Shortly thereafter, Amyndas started giving Zealand Pharma access to confidential information (including confidential information about AMY-101). In August of 2016, the firms signed a second CDA — with added protections — for "the evaluation or formation

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of a possible business and/or services and/or collaborative relationship."

Both CDAs contained elaborate confidentiality provisions. The confidentiality provision of the second CDA is emblematic. It stated that the recipient of confidential information:

shall (a) make no use of any of the Confidential Information disclosed by Discloser other than for the Purpose [of the evaluation or formation of a possible business and/or services and/or collaborative relationship between the parties and their respective Affiliates], (b) not disclose such Confidential Information to third parties, and (c) take all reasonable precautions to prevent disclosure of such Confidential Information to third parties.

The confidentiality provision further stated that the recipient of confidential information:

may only provide the Confidential Information of Discloser to its Representatives and its Affiliates who (a) need it for the Purpose, (b) are informed of the confidential nature of the Confidential Information, and (c) are bound by obligations of confidentiality and non-use no less restrictive than those contained herein.

The second CDA also contained an explicit guarantee that Amyndas would "own all the Developed Technology incorporating, or involving the use of, the Amyndas Base Technology."

Both CDAs included an identical "Governing Law" provision. This provision consisted of a choice-of-law clause stipulating that the CDAs would "be interpreted and governed by the laws of the country (applicable state) in which the defendant resides" and a forum-selection clause stipulating that "any dispute arising out of th[e CDA] shall be settled in the first instance by the venue of the defendant."

Following the execution of the second CDA, Amyndas shared more proprietary information with Zealand Pharma. Meanwhile, Zealand Pharma began its own research program in late 2016, also focused on complement therapeutics. It did not inform Amyndas of this initiative. Although negotiations continued, the firms ultimately decided not to collaborate. On April 26, 2017, Amyndas terminated its information-sharing relationship with Zealand Pharma.

We fast-forward to August of 2018, at which time Zealand Pharma formed Zealand US, a Delaware corporation having its principal place of business in Boston, Massachusetts. Without Amyndas's knowledge or consent, Zealand Pharma filed two European patent applications in 2018. Zealand Pharma then filed an international patent application in February of 2019, claiming priority in the two earlier patent applications and designating the United States as one jurisdiction in which patent protection would be sought.

On September 6, 2019, the international patent application was published, thus making its contents publicly available for the first time. The application purported to describe "compstatin analogues that are capable of binding to C3 protein and inhibiting complement activation." The C3 protein — which is the target of AMY-101 — has been the focus of Amyndas's research for many years. Perhaps more importantly, it was one subject of Amyndas's information-sharing with Zealand Pharma. Amyndas alleges that it shared confidential information with Zealand Pharma under the CDAs — information about various features, profiles, and characteristics of AMY-101 as well as how it could be used to make next-generation compounds.

At this juncture, it is useful to describe Alexion's role in this saga of alleged corporate

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intrigue. In 2007, Alexion — an established player in the complement therapeutics field — brought to market Soliris, a complement inhibitor that targets the C5 protein (a protein in the complement system). Soliris has been approved by the Food and Drug Administration (FDA) for four indications and — until recently — Soliris was the only FDA-approved and clinically available complement-specific therapeutic on the market. Alexion's patent on Soliris expires soon, and Alexion is facing commercial pressure to bring new complement-based drugs to market.

In January of 2018, representatives of Alexion and Amyndas met in San Francisco. Following that meeting, Alexion expressed interest in forming a partnership with Amyndas. The two companies signed a CDA limiting the use of exchanged confidential information to a singular purpose, namely, the "exploration of one or more potential business arrangements and/or potential arrangements of research, development, and commercialization of drug candidates relating to Amyndas' complement inhibitors." Alexion requested and received certain confidential information about Amyndas's complement therapeutic research, including details about Amyndas's intellectual property...