Full Press Release Details
UNITED STATES DISTRICT COURT
DISTRICT OF MASSACHUSETTS
INSULET CORPORATION,
Case No. 1 23-cv-11780
EOFLOW CO., LTD. EOFLOW, INC.
FLEX, LTD. FLEXTRONICS
CORPORATION FLEXTRONICS
MEDICAL SALES AND MARKETING,
LTD. LUIS J. MALAVE STEVEN
DIIANNI and IAN G. WELSFORD,
____________________________________
COMPLAINT FOR MISAPPROPRIATION AND INFRINGEMENT OF INTELLECTUAL PROPERTY RIGHTS AND UNFAIR COMPETITION
Plaintiff Insulet Corporation ("Insulet"), by and through its attorneys, for its Complaint against EOFlow Co., Ltd. ("EOFlow" or "EOFlow Ltd."), EOFlow, Inc. ("EOFlow Inc."), Flex, Ltd. ("Flex"), Flextronics Corporation ("Flex US"), Flextronics Medical Sales and Marketing, Ltd. ("Flex MSM"), Luis J. Malave, Steven DiIanni, and Ian G. Welsford1 alleges as follows
1.This case arises from Defendants' theft of pioneering intellectual property covering Insulet's first-of-its-kind "patch pump," a compact, wearable, waterproof, adhesive medical device that delivers insulin to people with insulin-dependent diabetes.
1 This Complaint will refer to (a) EOFlow Ltd. and EOFlow Inc. collectively as the "EOFlow Defendants" (b) Flex, Flex US, and Flex MSM collectively as the "Flex Defendants" (c) Malave, DiIanni, and Welsford collectively as the "Individual Defendants" and (d) all defendants collectively as "Defendants."
2.Approximately forty million Americans suffer from diabetes, with many-nearly eight million-requiring insulin to manage the condition. Before Insulet revolutionized insulin delivery, people who required insulin had two basic, and unsatisfying, options either self-administer insulin injections multiple times over the course of the day, or wear a multi-component, bulky pump in a satchel or clipped to clothing that delivered insulin through a long, flexible tube.
3.Insulet was founded in Massachusetts in 2000 by a father who was unsatisfied with insulin delivery options for his young son. After five years of research and development, Insulet changed the paradigm for insulin delivery when, in January 2005, the U.S. Food and Drug Administration approved the first version of Insulet's Omnipod System-the first ever adhesive, wearable, and disposable insulin patch pump. Unlike insulin pumps available at the time, Insulet's Omnipod System featured only two discreet, easy-to-use components a small, lightweight, self-adhesive, disposable insulin infusion pump component that patients could wear directly on the skin called the Omnipod or "pod" and a wireless, menu-driven, handheld component (like a personal digital assistant) called the Personal Diabetes Manager or "PDM"
4.Insulet's Omnipod System eliminated the need for the bulky pump, tubing, and separate blood glucose meter and created a new market for tubeless, wearable insulin delivery systems. Since its founding nearly a quarter century ago, Insulet has invested hundreds of millions of dollars to bring new generations of the Omnipod System to diabetes patients. Last year, FDA approved the fifth generation of Insulet's Omnipod line of products the Omnipod 5 Automated Insulin Delivery System. Insulet's Omnipod 5 and its previous generation product, the Omnipod DASH System, remain the only widely-used FDA-approved insulin patch pumps sold in the United States.
5.Insulet faced several substantial challenges in bringing the first FDA-approved patch pump to diabetes patients. It was essential that Insulet's new system deliver precise doses of insulin to patients reliably and safely. Insulet demanded that its products be easy-to-use, lightweight enough to attach to a user's skin, accurate in dose delivery, inexpensive, and precisely manufactured for quality assurance. Insulet spent significant time designing and developing software and communication protocols that enabled the Omnipod to communicate safely and effectively with the PDM. And Insulet needed to develop a way to make its Omnipod products consistently and cost-effectively. Manufacturing, especially at scale, was a particular challenge and one that Insulet spent hundreds of millions of dollars researching, testing, and refining over several years. Indeed, one of the keys to Insulet's success has been its development and implementation of robust and reliable manufacturing processes.
6.Many other companies-including some of the largest medical device companies in the world-have tried, but failed, to develop a patch pump that can be manufactured on a time-efficient, accurate, affordable, and reproducible basis. For example, Medtronic-the largest medical device company in the world-has been unable to develop a patch pump. In fact, senior
executives at Medtronic have repeatedly acknowledged publicly that manufacturing of patch pumps is extremely difficult and have attributed Medtronic's failure to develop a competitive product to Omnipod to difficulties in the manufacturing processes.
7.The EOFlow Defendants, however, claim they have done something that Medtronic and every other company but Insulet has failed to do, and in a shorter period with substantially less investment manufacture at scale a patch pump that is, in most respects, virtually indistinguishable from Insulet's Omnipod System. EOFlow Ltd. was founded in 2011, and initially focused on developing patch pumps that used a different pumping technology to deliver insulin. Early prototypes of EOFlow's product-called the EOPatch-looked nothing like Insulet's Omnipod products. But, starting around 2016, something changed. Instead of continuing to independently design and develop its own patch pump, EOFlow pivoted and launched a plan to brazenly copy Insulet's Omnipod System. EOFlow hired former Insulet senior executives and critical employees, such as Defendants Malave, DiIanni, and Welsford, to oversee the development, manufacturing, regulatory approval, and marketing of the EOPatch. EOFlow also entered into a "joint development and collaboration" contract with Insulet's primary contract manufacturer of the Omnipod products, Flex, who possessed every detail of Insulet's proprietary and confidential manufacturing processes through its own manufacturing agreement with Insulet. Through these actions, EOFlow misappropriated Insulet's trade secret product details and manufacturing processes and, moreover, copied patented components of Insulet's Omnipod products.
8.After initially having spent five years with no meaningful progress building a patch pump of its own design, in the course of just two years after contracting with Flextronics and hiring former Insulet executives with detailed knowledge of Insulet's manufacturing and
quality assurance operations, in 2018, EOFlow started advertising its completely redesigned "EOPatch" product-one that looked strikingly similar to Insulet's Omnipod product
Omnipod (left) and EOPatch (right)
9.As Insulet learned only in 2023 after it received and examined an EOPatch device, the similarities between the Omnipod and the redesigned EOPatch do not end with the exterior appearance. Other than the EOPatch actuator, which is an electro-osmotic pump instead of a shape-memory alloy wire as used by Insulet, nearly every other aspect of the EOPatch pumping mechanism is substantially identical to Insulet's Omnipod product, including but not limited to a pivoting, two-arm "walking man" hook two ratchet gear wheels each having fifty teeth and driven by the "walking man" hook a tube nut within the ratchet gear wheels a spring clutch mechanism an oval reservoir shape with a single O-ring a leadscrew driven by the tube nut and fixed to a plunger a rod on the plunger two hook switch cups spring contacts on the circuit board and ground spring contacts rotational sensors a "nail head" seal on the cannula use of a needle cap vent a piezoelectric kill break on the circuit board the particular adhesive pad weld configuration, and many others. Indeed, many of the components are entirely
interchangeable between the two products. Shown below are several illustrative examples of the similarities in physical components between Insulet's Omnipod and EOFlow's EOPatch
| Component System | Insulet's Omnipod Product | EOPatch |
| Drive system with Walking-Man Hook | ||
| Clutch Tube Nut for Drive Rod Engagement | ||
| Ratchet Gears (each with 50 teeth per wheel) | ||
| Insulin Reservoir and Plunger with Drive Rod |
| "Nail Head" Cannula Seal | ||
| Adhesive Pad Weld |
10.EOFlow's rapid development of a patch pump and the complex manufacturing processes required to produce it where others have repeatedly failed is no accident. It is based on EOFlow's wholesale theft of Insulet's intellectual property, through the use of Insulet's highly-involved former employees and Insulet's contract manufacturer, Flex.
11.For several years following its redesign, EOFlow's EOPatch was unavailable to the public and to Insulet. Although EOFlow had announced the regulatory approval of EOPatch in Korea, Europe, the UAE, and Indonesia by the end of 2022, only a few hundred patients were reportedly using EOPatch by that time, and only in Korea. On December 27, 2022, Defendant EOFlow announced plans to launch the redesigned EOPatch in the United States. On that date, EOFlow submitted to FDA a premarket submission to FDA under section 510(k) of the Federal Food, Drug, and Cosmetic Act for FDA approval for its EOPatch. Section 510(k) is an expedited approval pathway that allows medical device manufacturers to obtain FDA approval without
clinical trials and testing. Rather, EOFlow need only show that its device is "substantially equivalent" to another device already on the market-presumably, Insulet's Omnipod. FDA approval is now imminent and EOFlow is on the verge of launching an insulin patch pump that is built using Insulet's proprietary trade secrets and infringes multiple Insulet patents.
12.EOFlow's intellectual property theft has paid off handsomely so far. Not only is EOFlow on the cusp of having the EOPatch approved for sale in the United States by the FDA, but about two months ago-on May 25, 2023-Medtronic also announced its intention to acquire EOFlow for $738 million because of the EOPatch product. If it completes that acquisition, Medtronic will effectively be outsourcing the theft of intellectual property to bring to market a patch pump that it has repeatedly tried and failed to develop on its own. The disclosure of Insulet's trade secrets to Medtronic-a competitor with virtually unlimited resources-will work immediate and irreparable harm to Insulet and effectively rob all value from Insulet's trade secrets.
II.NATURE OF THE ACTION
13.This is an action for misappropriation of trade secrets in violation of the Defend Trade Secrets Act, 18 U.S.C. 1836 et seq. (DTSA) breach of contract patent infringement under 35 U.S.C. 271 false designation of origin in violation of the Lanham Act, 15 U.S.C. 1125(a) trade dress dilution and injury to business reputation under M.G.L. ch. 110H, 13 and unfair competition in violation of M.G.L. ch. 93A.
14.Plaintiff Insulet Corporation is a Delaware corporation with its principal place of business at 100 Nagog Park, Acton, MA 01720.
15.EOFlow Ltd. is a publicly traded Korean corporation with a principal place of business in Seongman-si, Korea. On information and belief, EOFlow Ltd. does and or plans to do business throughout the United States by selling the EOPatch, including in Massachusetts.
16.EOFlow Inc. is a Delaware corporation with its principal place of business at 3003 North 1st Street, #221, San Jose, California. On information and belief, as a subsidiary of EOFlow Ltd., EOFlow Inc. does and or plans to do business throughout the United States by selling the EOPatch, including in Massachusetts. Upon information and belief, EOFlow Inc. and its officers acting for an on behalf of EOFlow Inc. have participated and or facilitated EOFlow Ltd.'s efforts directed at obtaining FDA approval for EOFlow Ltd.'s EOPatch and commercializing the same in the United States. Indeed, as discussed further below, infra 74, EOFlow Ltd. has publicly acknowledged that it has used EOFlow Inc. and its officers and employees to facilitate FDA approval of the EOPatch.
17.Defendant Luis J. Malave is an individual who resides at 1712 Azul Vistan, San Marcos, CA 92078. Malave started working at Insulet in January 2002, less than two years after it was founded, and was one of Insulet's first forty employees. During his tenure at Insulet, Malave was Vice President of Research and Development from January 2002 to January 2003 Senior Vice President of Research, Development and Engineering from February 2003 to January 2007 and Chief Operating Officer from January 2007 until he left Insulet in August 2010. On information and belief, Malave was hired by EOFlow Inc. in October 2017 and served as its president until January 2022, at which time he was promoted to the role of CEO of SanPlena, LLC, a Delaware corporation established in December 2021, majority owned by EOFlow Inc.
18.Defendant Steven DiIanni is an individual who resides at 80 Market Street, Amesbury, MA 01913. DiIanni was employed by Insulet from 2002 until January 2015, where he served in several roles including Director of Mechanical Engineering, Development Engineering Manager, Senior Development Engineer, and other technical roles. Like Malave, DiIanni started working at Insulet in January 2002, less than two years after it was founded, and was one of Insulet's first forty employees. On information and belief, DiIanni has been a consultant for one or more of the EOFlow Defendants since at least June 2018.
19.Defendant Ian G. Welsford is an individual who resides at 14 Whittaker Drive, Stratham, NH 03885. Welsford was employed by Insulet from 2008 until 2010, where he served as Director of Regulatory Affairs. In 2010, Welsford transitioned from employee to consultant for Insulet and he continued to work on regulatory approval of the Eros version of Insulet's Omnipod product in the United States and Europe. Welsford was hired by EOFlow Inc. in April 2018, as Chief Technology Officer and led the preparation of EOFlow's 510(k) application for approval of the EOPatch in the United States. Welsford currently serves as the CEO of Nephria Bio, Inc., a Delaware corporation established in January 2021, majority owned by EOFlow.
20.Defendant Flex is a Singapore corporation with a principal corporate office located at 2 Changi South Lane, Singapore 486123 and a U.S. corporate headquarters located at 12455 Research Boulevard, Austin, TX 78759. On information and belief, Flex does business throughout the United States, including in Massachusetts.
21.Defendant Flex US is a Delaware corporation with a principal place of business at 6201 America Center Drive, San Jose, California 95002. On information and belief, Flex US does business throughout the United States, including in Massachusetts.
22.Defendant Flex MSM is a Mauritius corporation with a principal place of business at Level 3, Alexander House 35, Cybercity, Ebene, Mauritius. On information and belief, Flex MSM does business throughout the United States, including in Massachusetts.
23.Upon information and belief, at all times relevant to this Complaint, Flex US and Flex MSM were operating as alter egos or instrumentalities of Flex Ltd. Insulet's service agreements with Flex were signed by Flex MSM on behalf of all Flex affiliate entities, including Flex and Flex US, and Insulet's business dealings in furtherance of those agreements were not only with Flex MSM employees but with employees of Flex and or Flex US at the corporate headquarters of Flex and or Flex US in Austin, Texas, and San Jose, California.
IV.JURISDICTION AND VENUE
24.This Court has subject matter jurisdiction over Insulet's federal claims pursuant to 28 U.S.C. 1331 and supplemental jurisdiction over Insulet's state law claims pursuant to 28 U.S.C. 1367. This Court also has subject matter jurisdiction over Insulet's claims for patent and federal trade dress infringement pursuant to 28 U.S.C 1338(a).
25.This Court has personal jurisdiction over EOFlow Ltd. because, among other things, when EOFlow Ltd.'s application for FDA approval to sell the EOPatch in the United States is approved, EOFlow Ltd. will directly or indirectly market and or sell the EOPatch product within the United States, including the Commonwealth of Massachusetts. On information and belief, EOFlow Ltd. has participated and collaborated in the preparation, filing, and seeking of FDA approval of the EOPatch continues to participate and collaborate in seeking FDA approval of the EOPatch and intends to participate and collaborate in the commercial marketing, offering for sale, and sale of the EOPatch throughout the United States, including in the Commonwealth of Massachusetts. For example, EOFlow Ltd. owns at least one other proxy entity, Ferrex Therapeutics, Inc. ("Ferrex") whose business plan, based on an EOFlow press
release, is also to use the "EOFlow Patch" in the treatment of diseases other than diabetes. Ferrex lists its principal place of business as a shared office space in Cambridge, Massachusetts, and also has an office space in New Hampshire, at the same physical location as an office space used by EOFlow Inc. In corporate filings with the Massachusetts Secretary of State, Ferrex reports that its President, Treasurer, Secretary, Vice President, and Director roles are all performed by Jesse Kim. Based on publicly available information, Mr. Kim is also the "Founding CEO" of EOFlow, president of EOFlow Inc., Chairman of the Board of Directors of Nephria, and Founder CEO of SanPlena. Alternatively, if the exercise of personal jurisdiction in this Court is not held to be proper based on EOFlow Ltd.'s contacts with Massachusetts specifically, then, on information and belief, EOFlow Ltd. is not subject to jurisdiction in any state's court of general jurisdiction and therefore personal jurisdiction over EOFlow in this Court is proper pursuant to Fed. R. Civ. P. 4(k)(2).
26.This Court has personal jurisdiction over EOFlow Inc. because, on information and belief, EOFlow Inc. is EOFlow Ltd.'s proxy entity in the United States. On information and belief, EOFlow Inc. is the principal United States operating entity of EOFlow Ltd. and was incorporated to facilitate the domestic employment of, and payments to, United States citizens-including Defendants Malave, DiIanni, and Welsford-and to otherwise act as EOFlow's agent for its efforts to commercialize the EOPatch in the United States. Among other things, EOFlow Ltd. and EOFlow Inc. have common ownership, intermingle business assets, commonly refer to themselves and do business as a single entity (EOFlow), and offer the same products and services, all marketed and sold under the EOFlow brand. In addition, on information and belief, EOFlow Ltd. exercises control over EOFlow Inc. and holds out the place of business of EOFlow Inc. as the place of business of EOFlow Ltd. Further, on information and belief, EOFlow Inc. is
thinly capitalized and relies on influxes from EOFlow Ltd. to maintain operations. Further, EOFlow Inc. knowingly engaged in tortious acts primarily and substantially in the Commonwealth of Massachusetts, including by engaging Malave, DiIanni, and Welsford to commit acts of trade secret misappropriation in the Commonwealth of Massachusetts and directed at Acton, Massachusetts-based Insulet.
27.This Court has general personal jurisdiction over Defendant DiIanni because he resides in Massachusetts.
28.This Court has personal jurisdiction over Defendants Malave, DiIanni, and Welsford by virtue of their employment at Insulet, a company with its principal place of business in Massachusetts, and because Defendants Malave, DiIanni, and Welsford entered into employment and consulting agreements with Massachusetts-based Insulet to perform services on behalf of Insulet.
29.This Court also has personal jurisdiction over Defendants Malave, DiIanni, and Welsford as they purposefully availed themselves of the privilege of doing business in Massachusetts through their employment with a Massachusetts-based company and the claims alleged herein arise from and relate to those defendants' employment with that company.
30.This Court also has personal jurisdiction over Defendants Malave, DiIanni, and Welsford because, as detailed infra V.A-V.D and Count I, each performed acts of misappropriation of Insulet's trade secrets, both on their own behalf and on behalf of both EOFlow Defendants, primarily and substantially in the Commonwealth of Massachusetts, including at Insulet's former headquarters in Billerica and or Bedford, Massachusetts, which caused harm to Insulet in the Commonwealth of Massachusetts.
31.This Court has personal jurisdiction over Defendants Flex, Flex US, and Flex MSM because they entered contracts with Insulet in Massachusetts and provided goods and or performed services for Insulet in Massachusetts, and attended numerous meetings in Massachusetts for this purpose. For example, Flex MSM executed a Materials Supplier Agreement with Insulet Corporation to supply goods and perform services in Massachusetts "on behalf of itself and its worldwide affiliates," with an effective date of September 1, 2016. Defendants Flex and Flex US are and were affiliates of Flex MSM. Alternatively, if the exercise of personal jurisdiction in this Court is not held to be proper based on Flex Ltd.'s contacts with Massachusetts specifically, then, on information and belief, Flex Ltd. is not subject to jurisdiction in any state's court of general jurisdiction and therefore personal jurisdiction over Flex in this Court is proper pursuant to Fed. R. Civ. P. 4(k)(2).
32.This Court also has personal jurisdiction over Defendants Flex, Flex US, and Flex MSM because, as detailed infra V.D and Count I, each performed acts of misappropriation of Insulet's trade secrets, primarily and substantially in the Commonwealth of Massachusetts.
33.Venue is proper in this judicial District for all claims under 28 U.S.C. 1391(b)(2), 1391(b)(3), and 1391(c)(3).
V.INSULET'S INTELLECTUAL PROPERTY AND
THE DEFENDANTS' MISAPPROPRIATION AND INFRINGEMENT
A.Development of the Omnipod System and Related Manufacturing Processes
34.Insulet was founded almost a quarter century ago with the goal of developing a cost-effective, wearable, disposable, waterproof, tubeless insulin pump that can be controlled wirelessly through a handheld device containing a fully integrated blood-glucose meter. The first design of Insulet's Omnipod took over five years and more than $40 million dollars in research and development during years 2000-2005 to yield an initial, safe and reliable, FDA-
approved product, an additional six years and more than $170 million to develop its "Eros" version of the Omnipod System, and then another eight years and more than $600 million to develop its "DASH" version of the Omnipod System. The time and resources expended by Insulet is unsurprising. Insulet's Omnipod contains high-precision electromechanical components and software to accurately and safely dispense insulin in specific doses over prolonged periods. Among other things, Insulet had to design and build customized and purpose-built manufacturing machinery to assemble components into finished products in a cost-efficient and reliable manner. All aspects of this work were kept strictly confidential by Insulet.
35.In 2005, Insulet became the first company to commercially launch a tubeless insulin delivery system with a "Personalized Diabetes Manager"
36.Insulet's first revolutionary Omnipod System was lauded throughout the industry. In 2006, the Omnipod System received the Gold Industrial Excellence Award (IDEA) from the Industrial Designers Society of America. The IDEA competition is among the world's most prestigious design competitions, with awards based on excellence and innovation in the design and functionality of individual products. That same year, Insulet also received the Medical Design Excellence Award for General Hospital and Therapeutic Products from Canon Communications, LLC, and a 2006 New England Innovation Award from the Smaller Business Association of New England.
37.Insulet's Omnipod System was designed to meet all insulin needs of patients with insulin-dependent diabetes. There are generally two types of insulin delivery modes needed by people suffering from diabetes to best manage their condition basal insulin and bolus insulin. Generally speaking, basal insulin is a small amount of insulin delivered at regular, short time intervals throughout the day and night to help keep the user's glucose levels stable, and bolus insulin is a one-time, user-prompted dose delivered to address the intake of meals with carbohydrates and or to otherwise correct for high glucose readings. From its first product iteration, Insulet's Omnipod System has been engineered to deliver both basal insulin and bolus insulin.
38.By 2007, demand for Insulet's Omnipod product was exceeding Insulet's in-house manufacturing capabilities. So in late 2007, Insulet announced it had entered into a manufacturing and supply relationship with the Flex Defendants, a global medical device manufacturing company.
39.After its initial product launch, Insulet continued to innovate and improve the Omnipod System. By 2011, Insulet developed its "Eros" version of the Omnipod System, which
included significant mechanical and structural updates for improved product performance and to facilitate manufacturing processes at scale. By this time, Insulet had spent over $170 million in research and development. By 2019, Insulet developed the "DASH" version of its Omnipod System, which improved upon the Eros version by replacing the Eros PDM with a new, smartphone-based PDM running an app for pump control. By this time, Insulet had spent over $600 million in research and development, including manufacturing development costs.
40.While at Insulet, Defendants Malave and DiIanni were entrusted with details of every aspect of the research and development efforts to create the world's first insulin patch pump. As Insulet's Vice President of Research, Development and Engineering, and also as its Chief Operating Officer, Malave was intimately involved in the development, contractual engagement, and implementation of manufacturing of Insulet's Omnipod product at scale. Malave is a named inventor on 27 patents and patent applications worldwide filed by Insulet relating to non-trade secret technologies used by Insulet in its Omnipod product.
41.Similarly, as Director of Mechanical Engineering at Insulet, DiIanni was highly involved in developing manufacturing processes and resolving manufacturing issues. DiIanni was in possession of detailed technical information about Insulet's Omnipod product, including but not limited to product specifications, material compositions, coating materials, plating specifications, operational software requirements and details, product functional requirements, dimensional tolerances, drive stroke and force requirements, and other product and manufacturing details. DiIanni is a named inventor on 40 patents and patent applications worldwide filed by Insulet relating to non-trade secret technologies used by Insulet in its Omnipod product, including the patents at issue in this case U.S. Patent Nos. 11,229,741 ("the '741 Patent"), 10,420,883 ("the '883 Patent"), and 9,402,950 ("the '950 Patent").
42.As Director of Regulatory Affairs at Insulet, Welsford was responsible for managing a variety of activities concerning regulatory approvals and regulatory compliance for Insulet's Omnipod product. He also was responsible for working with management in planning, organizing and preparing regulatory documents for submission to governmental regulatory agencies worldwide. In his role, Welsford had access to every record regarding the Omnipod product and every communication between Insulet and regulatory authorities around the world. Importantly, Welsford was intimately knowledgeable about the challenges and compliance issues encountered during the product development process, and the time-consuming trial and error corrective actions taken by Insulet to address them. Examples of such challenges and issues included, but are not limited to, user interactions with the patch adhesive, effectiveness of the patch adhesive, timing and efficacy of needle deployment, safety and reliability of communications between the PDM and pump, insulin compatibility with Omnipod components, the accuracy of delivered insulin dose, occlusion susceptibility, sterilization compatibility, maintaining function with changes in pressure and altitude, and many others.
43.On behalf of Insulet, both Malave and DiIanni were intimately involved with Flex and its manufacturing development efforts for the Omnipod product. Malave was instrumental in bringing Insulet and Flex together, as Insulet's sole contract manufacturer, and in continuously working with Flex to help determine how to cost-effectively manufacture Insulet's insulin pump and work on cost bills of materials and other financial aspects of the Omnipod product. Indeed, Malave spent extended periods of time in China at Flex's plant working on technology transfer and the development of Insulet's proprietary manufacturing technologies. Similarly, during his employment at Insulet, DiIanni also spent time in China at Flex, and was intimately involved in developing manufacturing processes for Insulet's insulin pump at a Flex plant in Austin, Texas.
DiIanni spent extended periods of time at Flex for this development work, during which time he actively participated in the development and transfer of insulin pump manufacturing technologies.
B.Flex's Work for Insulet and Access to Insulet Trade Secrets
44.Insulet first entered into a "Flextronics Manufacturing Services Agreement" with Flextronics Marketing Ltd. on January 3, 2007 (including First Addendum dated October 2, 2007, the "2007 Flex Agreement"). In it, Flex Marketing agreed, inter alia, to manufacture, assemble, and test Omnipod products pursuant to Insulet's specifications (i.e., including but not limited to bill of materials, designs, schematics, assembly drawings, process documentation, test specifications, and approved vendors).
45.The 2007 Flex Agreement was superseded by a Materials Supplier Agreement between Insulet and Flex MSM dated September 1, 2016 (collectively with First Amendment to Materials Supplier Agreement dated January 1, 2018 and Second Amendment to Materials Supplier Agreement dated October 1, 2020, the "2016 Flex Agreement").
46.On information and belief, Flex MSM is the successor in interest to Flex Marketing Ltd.
47.In the 2016 Flex Agreement, Flex MSM executed the 2016 Agreement "on behalf of itself and its worldwide affiliates," with an effective date of September 1, 2016. On information and belief, Defendants Flex and Flex US are and were affiliates of Flex MSM.
48.Pursuant to the 2007 and 2016 Flex Agreements, Flex eventually became the sole contract manufacturer and supplier to Insulet of Insulet's Omnipod product. Flex remained the sole manufacturer of Omnipod for at least the five-year period prior to June 2019. Since that time, Flex continues to manufacture for Insulet, on a temporary and more limited basis, a non-insulin drug delivery pump based upon the Omnipod product. The process by which Flex
developed the manufacturing capabilities for the Omnipod product involved countless hours of investment by numerous Insulet personnel, including Defendants Malave and DiIanni, problem solving in Massachusetts and communicating resolutions with Flex, traveling the globe to various Flex plants, including to the Flex headquarters in Austin, Texas and the Flex US headquarters in San Jose, California, to facilitate technology transfer and development of precise manufacturing processes for Insulet's intricate insulin pump. As a result of this herculean effort by Insulet, Flex was able to successfully manufacture the Omnipod product to Insulet's specifications on a large scale, time efficient, accurate, and affordable basis.
49.The 2016 Flex Agreement provides that "Supplier Flex agrees that the Specifications are owned exclusively by Insulet and nothing herein shall be construed as transferring any right, title or interest of any kind or nature whatsoever to Supplier." (Section 21.b). A true and correct copy of the public 2016 Flex Agreement is attached hereto as Exhibit A ("Ex. A").
50. Section 3.a provides the definition of Specifications, and includes Drawings, specifications, test instructions, quality instructions, manufacturing instructions, assembly instructions, and bills of materials
51.At all times, Flex, its employees and contractors, and its worldwide affiliates (including Flex US and Flex MSM) have owed and continued to owe confidentiality obligations
to Insulet. Indeed, the 2016 Flex Agreement includes confidentiality provisions requiring confidential treatment of all Insulet's information shared with Flex.
52.On information and belief, Insulet was coordinating and disclosing trade secrets to personnel from Flex, Flex US, and Flex MSM, all of which were subject to contractual confidentiality obligations.
53.Insulet entered into a Transition Services Agreement with Flex MSM on June 30, 2021.
C.Insulet's Trade Secrets
54.Through nineteen years of development work and the investment of more than $600 million in research and development, Insulet developed extensive trade secrets concerning the development, design, manufacturing, and production the Omnipod, and in particular, the Eros and DASH versions of the Omnipod.
55.Insulet's trade secrets related to the development, design, manufacturing, production of the Omnipod, as relevant to this action, include at least the following, individually and in combination, (collectively, the "Insulet Trade Secrets")
detailed product drawings
quality control systems
process validation procedures
8,000 pages of detailed manufacturing specifications
the specific ordering of the manufacturing process
Insulet's suppliers for its 72 components of the Omnipod
pricing information for all components of the Omnipod
manufacturing techniques and know-how
software with complex security protocols for the operation of the Omnipod, the PDM and smartphone app, and the communications between these components
know-how concerning integration of a continuous glucose monitor (CGM) and an insulin delivery pump into a single device