Perez v. Progenics Pharmaceuticals, Inc.

965 F. Supp. 2d 353, 2013 CCH OSHD 33,313, 2013 WL 3835199, 2013 U.S. Dist. LEXIS 104298
CourtDistrict Court, S.D. New York
DecidedJuly 24, 2013
DocketCase No. 10-CV-8278 (KMK)
StatusPublished
Cited by6 cases

This text of 965 F. Supp. 2d 353 (Perez v. Progenics Pharmaceuticals, Inc.) is published on Counsel Stack Legal Research, covering District Court, S.D. New York primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Perez v. Progenics Pharmaceuticals, Inc., 965 F. Supp. 2d 353, 2013 CCH OSHD 33,313, 2013 WL 3835199, 2013 U.S. Dist. LEXIS 104298 (S.D.N.Y. 2013).

Opinion

OPINION AND ORDER

KENNETH M. KARAS, District Judge.

Plaintiff Julio Perez, proceeding pro se, brings this action against Defendant Pro-genies Pharmaceuticals, Inc. (“Progenies”), alleging that Defendant violated the Sarbanes-Oxley Act of 2002 (“Sarbanes-Oxley”), 18 U.S.C. § 1514A, by terminating Plaintiffs employment in retaliation for a memorandum he wrote regarding a press release about a pharmaceutical drug. Defendant now moves for summary judgment. For the reasons stated herein, Defendant’s Motion is denied.

I. Background

A. Factual Background

1. The Parties

The following facts are drawn from the Parties’ submissions and are undisputed except as otherwise indicated. Progenies is a biotechnology company located in Tarrytown, New York and has been publicly traded on the NASDAQ stock exchange since 1997. (Def.’s Rule 56.1(a) Statement (“Def. 56.1”) ¶¶ 1-2; PL’s Rule 56.1(a) Statement (“Pl. 56.1”) ¶¶ 1-2; Decl. of Jonathan Stoler Ex. K (“Maddon Dep.”) 13.)1 Plaintiff, who has a Ph.D. and a master’s degree in organic chemistry, worked for approximately eleven years as a chemist at two pharmaceutical companies prior to his employment at Progenies. (Def. 56.1 ¶¶ 3-4; PL 56.1 ¶¶ 3-4; Decl. of Jonathan Stoler Ex. C (“Perez Dep.”) 40-43, 64-67; id. Ex. M (“Pl. Resume”).) In May 2004, Progenies hired Plaintiff as a Senior Manager of Pharmaceutical Chemistry, a position he held during his entire employment with Progenies. (Def. 56.1 ¶ 5; PL 56.1 ¶ 5; Perez Dep. 70 — 73.) On May 3, 2004, Plaintiff signed an Employee Patent Assignment and Confidentiality Agreement, which required Plaintiff “to preserve in confidence, and not to use, to publish, or to otherwise disclose ..., either during or ' subsequent to [Plaintiffs] employment, without the written permission of Progenies, all confidential proprietary rights or [356]*356any knowledge, ... or any other confidential information of Progenies, its customers, or others from whom Progenies has received information under obligations of confidence.” (Def. 56.1 ¶¶6-7; PL 56.1 ¶¶ 6-7; Decl. of Jonathan Stoler Ex. L (“Confidentiality Agreement”) ¶ 3; Perez Dep. 78.)

£ Relistor Development and Clinical Trials

While employed at Progenies, Plaintiffs primary responsibility was to support development of Relistor, a pharmaceutical drug designed to treat patients suffering from postoperative bowel dysfunction or opioid-induced constipation. (Def. 56.1 ¶¶ 8-9; PL 56.1 ¶¶ 8-9; Perez Dep. 73, 84-9; Decl. of Bruce Schneider (“Schneider Decl.”) ¶ 4.) Specifically, Plaintiffs responsibilities. included working on Relistor’s oral, subcutaneous, and intravenous formulations to “figur[e] out ways that the oral form of Relistor could be better absorbed by the human body,” working on supply of the active pharmaceutical ingredient (methylnaltrexon) in Relistor, and supporting activities related to clinical trials — although Plaintiff himself did not perform the clinical trials. (Def. 56.1 ¶¶ 10-11; Pl. 56.1 ¶¶ 10-11; Perez Dep. 75, 85-88.) The Parties agree that Plaintiff had no responsibility for the marketing and commercialization of Relistor; that Plaintiff did not hold any sales, marketing, or public relations positions; and that Plaintiff did not perform any job duties in those areas. (Def. 56.1 ¶¶ 11-12; PL 56.1 ¶¶ 11-12; Perez Dep. 53.)

In December 2005, Progenies and another pharmaceutical company, Wyeth Pharmaceuticals Division (“Wyeth”), entered into a License and Co-Development Agreement (the “Progenics-Wyeth Agreement”) to co-develop and jointly commercialize Relistor. (Def. 56.1 ¶¶ 13-14; Pl. 56.1 ¶¶ 13-14; Decl. of Jonathan Stoler Ex. N (“Progenics-Wyeth Agreement”); Schneider Decl. ¶ 5.) The ProgenicsWyeth Agreement established three joint committees composed of members from both Progenies and Wyeth: a Joint Steering Committee (“JSC”), a Joint Development Committee (“JDC”), and a Joint Commercialization Committee (“JCC”). (Progenics-Wyeth Agreement § 3.2-3.4.) The JSC was to be responsible “for the overall strategic and operational direction of the Parties’ collaboration under th[e] Agreement”; the JDC was tasked with “overseeing, coordinating and expediting the Development of the Compound and the Products”; and the JCC was to “facilitate the exchange of information between the Parties regarding the Commercialization of the Products.”2 (Id.; Def. 56.1 ¶¶ 15-17; PL 56.1 ¶¶ 15-17.) Pursuant to the Progenics-Wyeth Agreement, .the companies also agreed to a Joint Development Plan to “govern all aspects of Development of the Products worldwide,” which the JSC endorsed on or around May 11, 20063 (Def. 56.1¶¶ 19-20; Pl. 56.1¶¶ 19-20; Progenics-Wyeth Agreement § 4.1; Decl. of Jonathan Stoler Ex. O (the “Development Plan”); Schneider Decl. ¶ 8.)

The Development Plan included draft Target Product Profiles (the “TPP”), “representing] the technical and commercial targets.” (Development Plan 7.) According to Defendant, the TPP was merely a “wish list” and a “marketing concept in[357]*357tended to help assess the commercial viability of a drug and its performance against competitive products.” (Def. 56.1 ¶¶ 21-22; Maddon Dep. 56-57 (stating that TPP is “a phrase that describes the marketing” and is “generally established by commercial people”); see also Decl. of Jonathan Stoler Ex. E (“Boyd Dep.”) 40; id. Ex. J (“Lukacsko Dep.”) 70, 74-75, 344, 358-59, 361; id. Ex. D (“Wong Dep”) 153-54; Schneider Decl. ¶ 9.) According to Plaintiff, the TPP was more significant than a wish list: It “specifies the labeling concepts that are the goals of the drug development program [and] documents the specific studies intended to support the labeling concepts.” (PI. 56.1 ¶ 21; Decl. of Julio Perez Ex. 9 (“FDA TPP Guidance”) 2 (also noting that “[t]he ideal version of what the sponsor would like to claim in labeling guides the design, conduct, and analysis of clinical trials to maximize the efficiency of the development program” (emphasis in original)); see also Perez Dep. 62-63 (listing commercial viability as only one of several factors in a drug’s TPP); Boyd Dep. 40 (explaining that a TPP includes “cost of goods, clinical endpoints, commercial viability, things like that”).)

In order to gain FDA approval for public sales of oral Reslistor, Progenies and Wyeth were required to conduct several phases of clinical trials demonstrating its safety and efficacy. (Def. 56.1 ¶ 28; Pl. 56.1 1128; Boyd Dep. 17; Decl. of Jonathan Stoler Ex. G (“Baker Dep.”) 46-49; Wong Dep. 119.) Each clinical trial phase had written protocols with primary and secondary endpoints. (Def. 56.1 ¶ 29; Pl. 56.1 ¶ 29; Wong Dep. 120, 132-33; Lukacsko Dep. 89-90; Boyd Dep. 99.) From October 2007 until April 2008, the companies conducted a Phase 2 clinical trial on a tablet formulation of oral Relistor (the “2201 Study”).4 (Def. 56.1 ¶¶ 40-41; Pl. 56.1 ¶¶ 40-41; Decl. of Jonathan Stoler Ex. T (“2201 Study Final Report”) 1; Schneider Decl.

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Bluebook (online)
965 F. Supp. 2d 353, 2013 CCH OSHD 33,313, 2013 WL 3835199, 2013 U.S. Dist. LEXIS 104298, Counsel Stack Legal Research, https://law.counselstack.com/opinion/perez-v-progenics-pharmaceuticals-inc-nysd-2013.