Case 1:20-cv-00207 ECF No. 1 filed 03/09/20 PageID.1 Page 1 of 21
IN THE UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF MICHIGAN
) ) TEVA RESPIRATORY, LLC, and TEVA ) PHARMACEUTICALS USA, INC., ) ) Civil Action No. 20-00207 ) Plaintiffs, ) ) v. ) ) PERRIGO PHARMACEUTICALS CO., and ) PERRIGO COMPANY PLC, ) ) Defendants. ) ) )
COMPLAINT
Plaintiffs Teva Respiratory, LLC (“Teva Respiratory”) and Teva Pharmaceuticals USA,
Inc. (“Teva USA”) (collectively, “Plaintiffs” or “Teva”), allege against defendants Perrigo
Pharmaceuticals Co., and Perrigo Company plc (collectively, “Defendants” or “Perrigo”) as follows:
INTRODUCTION
1. This case arises from Perrigo’s deliberate and unlawful attempt to misappropriate
Teva’s federally registered trade dress for Teva’s revolutionary ProAir RespiClick® rescue respiratory inhaler and usurp and tarnish Teva’s goodwill.
2. Teva’s ProAir RespiClick® is the only albuterol rescue inhaler on the market that is “breath-activated”; it does not require any hand-breath coordination during inhalation. In other words, Teva’s ProAir RespiClick® enables users to get a rescue dose of albuterol during an asthma or COPD attack simply by breathing in. ProAir RespiClick® is a leading drug for the treatment of bronchospasm. -1- ACTIVE/102581507.4 Case 1:20-cv-00207 ECF No. 1 filed 03/09/20 PageID.2 Page 2 of 21
3. Teva’s ProAir RespiClick® design includes a white body and a distinctive red cap.
Teva has a federally registered trademark on the ProAir RespiClick® design.
4. Teva also sells an earlier-generation albuterol rescue inhaler named ProAir® HFA, both as a branded product and as an authorized generic product. ProAir® HFA is a standard metered-dose inhaler (“MDI”). MDI systems use a pressurized canister that when activated will deliver consistent and accurate doses of aerosolized medication to the user. In order to receive a rescue dose of albuterol, ProAir® HFA users must simultaneously press down on an activation button and inhale
5. Teva’s ProAir® HFA design includes a red body with a white cap. Teva has a federally registered trademark on the ProAir® HFA design.
6. Teva has consistently used red and white trade dress for its albuterol rescue inhalers, but has distinctive uses of those colors and designs as between ProAir® HFA and ProAir
RespiClick®. In particular, ProAir RespiClick® has a distinctive red cap and white body which, as detailed below, Teva emphasizes when instructing patients how to use ProAir RespiClick®.
7. On February 24, 2020, Perrigo received approval to launch a generic version of
Teva’s first-generation ProAir® HFA albuterol sulfate inhaler (“the Perrigo HFA”).
8. While ProAir® HFA is the reference product for the Perrigo HFA – meaning that the Perrigo HFA does not have the next-generation breath-activated technology of Teva’s ProAir
RespiClick® – the Perrigo HFA intentionally copies the trade dress of ProAir RespiClick®, including ProAir RespiClick®’s white body and distinctive red cap.
9. Perrigo’s infringement is doubly harmful. Not only does Perrigo copy the red and white color scheme used in all of Teva’s albuterol inhalers, Perrigo’s generic HFA rescue inhaler specifically copies the trade dress of ProAir RespiClick® including its distinctive red cap. But the
-2- ACTIVE/102581507.4
Case 1:20-cv-00207 ECF No. 1 filed 03/09/20 PageID.3 Page 3 of 21
Perrigo HFA does not incorporate the next-generation breath-activation technology of ProAir
RespiClick®. By mimicking the next-generation ProAir RespiClick®, the Perrigo HFA therefore poses particular dangers to patients who will be confused about the operation of their rescue inhaler in the midst of an asthma or COPD attack.
10. On information and belief, patients are likely to be confused in the midst of an emergency and think that they can receive albuterol from the Perrigo HFA simply by breathing in, when in reality they will not receive any medication unless they coordinate inhaling at the same time that they depress an activation button. This confusion caused by the Perrigo HFA is likely to lead to patients failing to receive rescue doses of albuterol without realizing they are not receiving the medication that they need. That in turn is likely to cause significant harm to patients. It is also likely to cause significant harm to the reputation and goodwill of Teva.
11. Perrigo’s unlawful conduct constitutes trademark infringement, unfair competition, and false and misleading advertising under the federal Lanham Act and Michigan state law.
THE PARTIES
12. Plaintiff Teva Respiratory, LLC is a Florida limited liability company with its principal place of business at 400 Interpace Parkway, Building A, Parsippany, New Jersey 07054.
13. Plaintiff Teva Pharmaceuticals USA, Inc. is a Delaware corporation with its principal place of business at 400 Interpace Parkway, Building A, Parsippany, New Jersey 07054.
14. On information and belief, defendant Perrigo Pharmaceuticals Co. is a Michigan
Corporation with its principal place of business at 515 Eastern Avenue, Allegan, Michigan 49010.
15. On information and belief, defendant Perrigo Company plc is a company organized under the laws of Ireland. On information and belief, it does not have any places of business in the United States.
-3- ACTIVE/102581507.4
Case 1:20-cv-00207 ECF No. 1 filed 03/09/20 PageID.4 Page 4 of 21
JURISDICTION AND VENUE
16. This Court has subject matter jurisdiction over the federal claims under 15 U.S.C.
§ 1121 (Lanham Act), 28 U.S.C. § 1331 (federal question), 28 U.S.C. § 1332 (diversity), and over the state law claims under 28 U.S.C. § 1367 (supplemental jurisdiction). There is complete diversity of citizenship of the parties and the amount in controversy exceeds $75,000.
17. The Court has personal jurisdiction over Perrigo Pharmaceuticals Co. because, on information and belief, Perrigo Pharmaceuticals Co. is a Michigan corporation with a principal place of business in Allegan, Michigan.
18. The Court has personal jurisdiction over Perrigo Company plc under Federal Rule of Civil Procedure 4(k)(2). Plaintiffs’ claims arise under federal law, and Perrigo Company plc is a foreign defendant not subject to general personal jurisdiction in the courts of any state; Perrigo
Company plc has sufficient contacts with the United States as a whole, including, but not limited to, by purposefully placing its infringing products in U.S. commerce.
19. Venue is proper in this District pursuant to 28 U.S.C. § 1391 because a substantial part of the events giving rise to the claim occurred in this judicial district, a substantial part of the property that is the subject of this action is situated in this judicial district, and because Defendants are subject to personal jurisdiction in this district.
BACKGROUND
I. TEVA’S PROAIR RESCUE INHALERS
20. Teva markets and sells two quick-relief, or “rescue,” respiratory inhalers in the
United States.
21. Designed to treat sudden and acute respiratory symptoms, rescue inhalers are specifically designed to deliver short-acting medications such as albuterol to a user’s lungs,
-4- ACTIVE/102581507.4
Case 1:20-cv-00207 ECF No. 1 filed 03/09/20 PageID.5 Page 5 of 21
quickly reducing inflammation and opening that user’s airways. In contrast, maintenance inhalers are designed to be used consistently even when symptoms are not present, so as to limit chronic inflammation and prevent acute flare-ups.
22. Teva uses and advertises a red and white color scheme for its albuterol rescue inhalers, but distinguishes between its two products by using different design elements. The
ProAir® HFA has a red body with a white cap, and the ProAir RespiClick® has a white body with a distinctive red cap.
23. Teva’s first rescue inhaler product was the ProAir® HFA, a standard metered-dose inhaler (“MDI”). MDI systems use a pressurized canister that when activated will deliver consistent and accurate doses of aerosolized medication to the user. Teva also produces and markets an authorized generic version of the ProAir® HFA, a device which is produced by the same production facility as, and is otherwise functionally identical to the branded version.
24. To operate an MDI, a patient is required to simultaneously press down on an activation button and inhale. If the user does not inhale at the same time the activation button is depressed, the medication will often be released into the mouth and upper throat, as opposed to the lungs, rendering the dose ineffective.
25. Teva’s next-generation rescue inhaler, ProAir RespiClick®, is the only albuterol rescue inhaler on the market that requires no hand-breath coordination during inhalation. Where a standard MDI requires a user to push down on a button and inhale simultaneously, the act of inhaling alone activates ProAir RespiClick®, consistently delivering needed medicine to the lungs.
26. The ProAir RespiClick® system does not require washing, priming, or shaking, while ProAir® HFA and other MDI products do. Priming ensures that the inhaler will deliver a correct dose of medication and requires that a user take the cap off the mouthpiece and shake the
-5- ACTIVE/102581507.4
Case 1:20-cv-00207 ECF No. 1 filed 03/09/20 PageID.6 Page 6 of 21
inhaler, then spray it away from their face to finish priming it. The priming process must be completed before the first use and again if the inhaler has not been used in more than 14 days.
27. By contrast, to operate ProAir RespiClick®, a user must only (1) open the cap; (2) inhale by breathing in deeply through their mouth; and (3) the user must close the cap after inhalation.
28. This next-generation “Open-Inhale-Close” technology – found only in ProAir
RespiClick® – provides unique benefits especially for those patients who have difficulty activating an MDI device while simultaneously inhaling, such as pediatric users, elderly users, and users with disabilities.
29. ProAir RespiClick® is indicated for patients 4 years of age and older for treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.
30. The features of ProAir RespiClick® that eliminate the need for hand-breath coordination and therefore simplify administration are particularly beneficial for patient populations that need ease of administration in emergency situations, such as children, and disabled or elderly populations. Ex. A, https://www.oindpnews.com/2016/04/fda-approves- proair-respiclick-for-pediatric-use/.
II. THE IMPORTANCE OF DISTINGUISHABLE INHALER TRADE DRESS
31. On information and belief, for users of respiratory inhalers, the design and coloring of the wide variety of available respiratory inhaler products carries significant meaning to users concerning the source and type of the inhaler. In fact, being able to easily distinguish between the different types of asthma drugs and inhalers based on the inhaler color and design may be a matter of life and death for patients.
-6- ACTIVE/102581507.4
Case 1:20-cv-00207 ECF No. 1 filed 03/09/20 PageID.7 Page 7 of 21
32. Of the inhalers on the market, each has a distinct color scheme and design that is chosen by the product manufacturer. See, e.g., https://www.urmc.rochester.edu/MediaLibraries/
URMCMedia/childrens-hospital/pulmonology/documents/AsthmaInhaler.pdf (showing chart of inhalers). On information and belief, given the substantial differences in the types of inhalers available, both in terms of short-acting versus long-acting, and in terms of the medications and propellants used, it is critical that healthcare providers, patients and their caregivers are able to quickly distinguish and navigate the landscape of existing products to ensure that they are prescribing and/or using the correct medication. Indeed, the issue of “inhaler confusion” is well known in the art and of specific concern to clinicians.
33. On information and belief, the phenomenon of “inhaler confusion” is particularly harmful where a patient’s confusion leads them to believe that they are receiving appropriate medication, but as a result of confusion and resulting misuse of an inhaler, they are not.
34. On information and belief, healthcare providers, patients, and the caregivers of patients often rely on the color schemes and designs to distinguish inhalers. Ex. B, https://asthma.net/living/the-color-of-inhalers-part-1/.
35. The ProAir RespiClick® trade dress is a red and white color scheme in which the inhaler body is white with a red cap. The ProAir RespiClick® trade dress is displayed on Teva
Respiratory’s website at http://www.proair.com/, and can be seen in the image below:
-7- ACTIVE/102581507.4
Case 1:20-cv-00207 ECF No. 1 filed 03/09/20 PageID.8 Page 8 of 21
36. Teva has expended substantial resources advertising the ProAir RespiClick® and displaying its distinctive trade dress, and as a result has built significant goodwill and secondary meaning in that brand.
37. Neither the red and white color combination of the ProAir RespiClick® nor the use of the red color on the device’s cap is functional. There are a large variety of alternative colors used in the market for other inhaler products and the association of the red and white trade dress with the ProAir RespiClick® is the result of Plaintiff’s advertising and educational efforts.
38. Critically, Teva specifically instructs patients how to use ProAir RespiClick® by referencing the red cap. The following instructions appear in the packaging of the ProAir
RespiClick® and in the instructional materials that Teva provides to healthcare providers and pharmacists concerning ProAir RespiClick®.
-8- ACTIVE/102581507.4
Case 1:20-cv-00207 ECF No. 1 filed 03/09/20 PageID.9 Page 9 of 21
39. Teva relies on the red cap to teach patients how to use ProAir RespiClick® properly, including by telling patients: “The red cap on your inhaler is used to load a dose;” and “Important: always close the red cap to reload your next dose.” (emphasis original); see also Ex. C, ProAir
RespiClick® Instructions for Use, available at https://www.accessdata.fda.gov/drugsatfda_docs/ label/2016/205636s006lbl.pdf (featuring red cap in instructions for use).
40. The ProAir RespiClick® trade dress is federally protected under trademark
Registration No. 5461616, which was registered on May 8, 2018. Ex. D.
41. For reference, the trade dress of the ProAir® HFA is the inverse of the RespiClick® system – that is, a red body with a white cap. The trade dress of the two Teva ProAir rescue inhalers is shown in the images below:
-9- ACTIVE/102581507.4
Case 1:20-cv-00207 ECF No. 1 filed 03/09/20 PageID.10 Page 10 of 21
42. On information and belief, in the category of short-acting or rescue inhalers, users and medical professionals strongly associate the ProAir RespiClick® system with having a white body with a red cap. These colors are clearly distinguished against other rescue inhalers on the market such as the Proventil HFA, which is yellow with an orange cap, and Ventolin HFA, which is blue with a dark blue cap. Ex. B.
43. On information and belief, the trade dress of ProAir RespiClick® – with its unique red cap and white body – is distinct from any other rescue inhaler on the market, and therefore distinguishes it as the only rescue inhaler that eliminates the need for hand-breath coordination.
III. PERRIGO’S UNLAWFUL ACTIONS
44. Perrigo notified Teva on or about July 3, 2013 that it had filed Abbreviated New
Drug Application (“ANDA”) No. 203760 with the FDA pursuant to 21 U.S.C. § 355(j) to obtain approval to market and sell a generic version of Teva’s ProAir® HFA. Following receipt of
Perrigo’s notice letter, Teva filed a lawsuit asserting claims of patent infringement under 35 U.S.C.
§ 271(e)(2)(A) in the United States District Court for the District of Delaware on August 16, 2013.
See Teva Branded Pharm. Prods. R&D, Inc. v. Perrigo Pharm. Co., C.A. No. 1:13-cv-01441-
GMS. Perrigo ultimately conceded infringement and the parties settled the litigation.
45. Perrigo has not been granted any license to any Teva trademark or trade dress for its respiratory inhalers, including trademarks or trade dress of either ProAir® HFA or ProAir
RespiClick®.
46. Perrigo has not been granted any license to the unique patented features of the
ProAir RespiClick® system, including its unique breath-activation technology.
47. Perrigo announced on February 25, 2020 that it had received approval from the
Food and Drug Administration for its generic version of Teva’s ProAir® HFA and that it was
-10- ACTIVE/102581507.4
Case 1:20-cv-00207 ECF No. 1 filed 03/09/20 PageID.11 Page 11 of 21
immediately launching the generic product with limited commercial quantities. Ex. E, https://www.perrigo.com/press-release/perrigo-and-catalent-announce-fda-approval-perrigos-ab- rated-generic-version-proairr (Feb. 25, 2020).
48. Perrigo’s generic version of ProAir® HFA improperly infringes and misappropriates the trade dress of ProAir RespiClick®.
49. The Perrigo HFA inhaler has a white body with a red cap, a trade dress that is identical to Teva’s federally protected trade dress for its ProAir RespiClick® system.
50. For comparison purposes, in the image depicted below, the ProAir RespiClick® is on the left and Perrigo’s generic ProAir® HFA is on the right:
51. Perrigo could have chosen from a large range of colors and color combinations for the Perrigo HFA inhaler
52. On information and belief, Perrigo’s misappropriation of Teva’s trade dress by using the exact color design of the ProAir RespiClick® system was deliberate and willful.
-11- ACTIVE/102581507.4
Case 1:20-cv-00207 ECF No. 1 filed 03/09/20 PageID.12 Page 12 of 21
53. On information and belief, given the extent to which trade dress for both ProAir®
HFA and ProAir RespiClick® was well-known amongst respiratory medical professionals and users, there can be no question that Perrigo was fully aware of the fact that an inhaler with a white body and red cap was necessarily associated with the ProAir RespiClick®.
54. Perrigo was on notice of the Teva’s rights in the trade dress of the ProAir
RespiClick® due to Teva Respiratory’s federal trademark registration with the USPTO, which has been available publicly as an application since October 1, 2015 and was registered by the USPTO on May 8, 2018. See Ex. D (Registration No. 5461616.)
55. On information and belief, by choosing the identical color scheme for their Perrigo
HFA system that is used for the ProAir RespiClick® system, Perrigo intentionally sought to benefit from the goodwill and patient benefits associated with the next-generation ProAir RespiClick®.
56. On information and belief, Perrigo’s actions are particularly dangerous because the
Perrigo HFA is likely to cause confusion among consumers, which in turn will cause harm to the public because the Perrigo HFA is does not have the next-generation breath-activation technology of the ProAir RespiClick®.
57. On information and belief, Perrigo’s actions in copying Teva’s trade dress will cause confusion as to which inhaler a patient has actually received. It is critical that patients who rely on their prescription medication are prescribed and dispensed the correct medication without risk of confusion, particularly given that a number of users of the ProAir RespiClick® system are children, disabled populations, and elderly populations who rely on the simplified functionality for administration of their medication during life-threatening situations.
-12- ACTIVE/102581507.4
Case 1:20-cv-00207 ECF No. 1 filed 03/09/20 PageID.13 Page 13 of 21
58. On information and belief, as a generic albuterol rescue inhaler, the Perrigo HFA is likely to be substituted for ProAir RespiClick® on pharmaceutical formularies, and at pharmacies, and provided to users who were prescribed ProAir RespiClick®.
59. On information and belief, the Perrigo HFA does not incorporate any of the unique features of the ProAir RespiClick® system allowing for “Open-Inhale-Close” use.
60. On information and belief, if a patient is dispensed the incorrect medical device which does not operate in the way they expect, it will cause harm to vulnerable patient populations, including children, disabled populations, and elderly populations.
61. On information and belief, the medical risks to patients who confuse the Perrigo
HFA product for the ProAir RespiClick® product are likely to be particularly severe. Those patients are likely, in an emergency situation in which they need medication from a rescue inhaler, not only fail to receive the necessary medication, but also fail to realize that they have not received their medication. As detailed in the label of the ProAir RespiClick® the device delivers albuterol via a “very fine powder that the user may or may not taste or feel.” Ex. C. Accordingly, the instructions for the ProAir RespiClick® instruct patients: “Do not take extra dose from the inhaler even if they do not taste or feel the medicine.” Id. (emphasis original). If a patient mistakes the similar looking Perrigo HFA for ProAir RespiClick® and uses the Perrigo HFA in an emergency situation as they would use ProAir RespiClick® – by simply breathing in – the Perrigo HFA will not deliver any medication, and the user will have no reason to think that is out of the ordinary, given that users often do not taste or feel the albuterol dispensed by ProAir RespiClick®.
62. On information and belief, confusion between the trade dress of ProAir
RespiClick® and the Perrigo HFA will cause consumers physical harm which in turn will tarnish the goodwill associated with the ProAir RespiClick® system.
-13- ACTIVE/102581507.4
Case 1:20-cv-00207 ECF No. 1 filed 03/09/20 PageID.14 Page 14 of 21
63. On information and belief, a patient using the Perrigo HFA system with the incorrect belief that it is the ProAir RespiClick® will come to the mistaken belief that the ProAir
RespiClick® does not function properly or is an ineffective product.
64. On information and belief, Perrigo’s unlawful actions will continue to cause irreparable harm to Teva, including without limitation, by causing confusion in the marketplace; putting at risk and harming the health and wellbeing of Teva’s patients, especially among the vulnerable patient populations of children, and disabled and elderly patients; diminishing the reputation and goodwill associated with the ProAir RespiClick® brand and its trade dress; and causing permanent loss of sales and market share of Teva.
COUNT I: FEDERAL TRADEMARK/TRADE DRESS INFRINGEMENT UNDER 15 U.S.C. § 1114(1)
65. Teva realleges and incorporates by reference the allegations in the preceding paragraphs as though fully stated herein.
66. Teva Respiratory owns the design as used on the ProAir RespiClick® system, which is registered with the United States Patent and Trademark Office (“USPTO”). See Ex. D.
67. Perrigo’s generic version of the ProAir® HFA inhaler is confusingly similar to
Teva’s ProAir RespiClick® in appearance.
68. Perrigo’s generic version of the ProAir® HFA inhaler is likely to cause confusion among consumers with Teva’s ProAir RespiClick®, or to deceive as to source, affiliation or sponsorship with Teva, in violation of the Lanham Act, 15 U.S.C. § 1114.
69. Teva has been and/or is likely to be damaged by Perrigo’s infringement in an amount to be determined at trial.
-14- ACTIVE/102581507.4
Case 1:20-cv-00207 ECF No. 1 filed 03/09/20 PageID.15 Page 15 of 21
70. Perrigo’s acts have been committed with the knowledge of Teva’s exclusive rights and goodwill in the design elements of the ProAir RespiClick®, and Perrigo’s conduct is willful, deliberate, intentional, and/or in bad faith, making this an exceptional case.
71. As a result of Perrigo’s trademark infringement, Perrigo has caused, and will continue to cause, irreparable harm to Teva and the goodwill associated with the ProAir
RespiClick®, for which Teva has no adequate remedy at law. Teva is entitled, inter alia, to preliminary and permanent injunctive relief.
COUNT II: FEDERAL UNFAIR COMPETITION UNDER 15 U.S.C. § 1125(A)
72. Teva realleges and incorporates by reference the allegations in the preceding paragraphs as though fully stated herein.
73. Teva has common law and federal trademark rights in the design of the ProAir
RespiClick®, which is uniquely associated with Teva as a source of goods and services offered in connection with the ProAir RespiClick®.
74. Perrigo’s generic version of the ProAir® HFA inhaler is confusingly similar to
Teva’s ProAir RespiClick® in appearance and constitutes unfair competition.
75. Perrigo’s generic version of the ProAir® HFA inhaler is likely to cause confusion among consumers with Teva’s ProAir RespiClick®, or to deceive as to source, affiliation or sponsorship with Teva, in violation of the Lanham Act, 15 U.S.C. § 1125(a).
76. Teva has been and/or is likely to be damaged by Perrigo’s infringement in an amount to be determined at trial.
77. Perrigo’s acts have been committed with the knowledge of Teva’s exclusive rights and goodwill in the design elements of the ProAir RespiClick®, and Perrigo’s conduct is willful, deliberate, intentional, and/or in bad faith, making this an exceptional case.
-15- ACTIVE/102581507.4
Case 1:20-cv-00207 ECF No. 1 filed 03/09/20 PageID.16 Page 16 of 21
78. As a result of Perrigo’s trademark infringement, Perrigo has caused, and will continue to cause, irreparable harm to Teva and the goodwill associated with the ProAir
RespiClick®, for which Teva has no adequate remedy at law. Teva is entitled, inter alia, to preliminary and permanent injunctive relief.
COUNT III: FEDERAL FALSE AND MISLEADING ADVERTISING UNDER 15 U.S.C. § 1125(A)(1)(B)
79. Teva realleges and incorporates by reference the allegations in the preceding paragraphs as though fully stated herein.
80. The design of Perrigo’s HFA inhaler confusingly similar to Teva’s ProAir
RespiClick® in appearance and constitutes unfair competition.
81. By adopting a design confusingly similar to Teva’s ProAir RespiClick®, Perrigo intentionally and falsely misrepresented to potential customers that the Perrigo HFA inhaler is likely to provide the same unique activation-free use as Teva’s ProAir RespiClick®, in violation of the Lanham Act, 15 U.S.C. § 1125(a).
82. Teva has been and/or is likely to be damaged by Perrigo’s false and misleading advertising in an amount to be determined at trial.
83. As a result of Perrigo’s false and misleading advertising, Perrigo has caused, and will continue to cause, irreparable harm to Teva and the goodwill associated with the ProAir
RespiClick®, for which Teva has no adequate remedy at law. Teva is entitled, inter alia, to preliminary and permanent injunctive relief.
COUNT IV: TRADEMARK/ TRADE DRESS INFRINGEMENT UNDER MICHIGAN COMMON LAW
84. Teva realleges and incorporates by reference the allegations in the preceding paragraphs as though fully stated herein.
-16- ACTIVE/102581507.4
Case 1:20-cv-00207 ECF No. 1 filed 03/09/20 PageID.17 Page 17 of 21
85. Teva Respiratory owns the design as used on the ProAir RespiClick® system, which is registered with the USPTO. See Ex. D.
86. Perrigo’s generic version of the ProAir® HFA inhaler is confusingly similar to
Teva’s ProAir RespiClick® in appearance.
87. Perrigo’s generic version of the ProAir® HFA inhaler is likely to cause confusion among consumers with Teva’s ProAir RespiClick®, or to deceive as to source, affiliation or sponsorship with Teva.
88. Teva has been and/or is likely to be damaged by Perrigo’s infringement in an amount to be determined at trial.
89. Perrigo’s acts have been committed with the knowledge of Teva’s exclusive rights and goodwill in the design elements of the ProAir RespiClick®, and Perrigo’s conduct is willful, deliberate, intentional, and/or in bad faith, making this an exceptional case.
90. As a result of Perrigo’s trademark infringement, Perrigo has caused, and will continue to cause, irreparable harm to Teva and the goodwill associated with the ProAir
RespiClick®, for which Teva has no adequate remedy at law. Teva is entitled, inter alia, to preliminary and permanent injunctive relief.
COUNT V: UNFAIR COMPETITION UNDER THE MICHIGAN CONSUMER PROTECTION ACT, § 445.903(1)(a)
91. Teva realleges and incorporates by reference the allegations in the preceding paragraphs as though fully stated herein.
92. Teva has common law and federal trademark rights in the design elements of the
ProAir RespiClick®, which are uniquely associated with Teva as a source of goods and services offered in connection with the ProAir RespiClick®.
-17- ACTIVE/102581507.4
Case 1:20-cv-00207 ECF No. 1 filed 03/09/20 PageID.18 Page 18 of 21
93. Perrigo’s generic version of the ProAir® HFA inhaler is confusingly similar to
Teva’s ProAir RespiClick® in appearance.
94. Perrigo’s generic version of the ProAir® HFA inhaler is likely to cause confusion among consumers with Teva’s ProAir RespiClick®, or to mislead consumers as to source, sponsorship, approval, or certification of goods or services, in violation of the Michigan Consumer
Protection Act, § 445.903(1)(a).
95. Teva has been and/or is likely to be damaged by Perrigo’s infringement in an amount to be determined at trial.
96. Perrigo’s acts have been committed with the knowledge of Teva’s exclusive rights and goodwill in the design elements of the ProAir RespiClick®, and Perrigo’s conduct is willful, deliberate, intentional, and/or in bad faith, making this an exceptional case.
97. As a result of Perrigo’s trademark infringement, Perrigo has caused, and will continue to cause, irreparable harm to Teva and the goodwill associated with the ProAir
RespiClick®, for which Teva has no adequate remedy at law. Teva is entitled, inter alia, to preliminary and permanent injunctive relief.
COUNT VI: FALSE AND MISLEADING ADVERTISING UNDER THE MICHIGAN CONSUMER PROTECTION ACT, § 445.903(1)(a)
98. Teva realleges and incorporates by reference the allegations in the preceding paragraphs as though fully stated herein.
99. The design of Perrigo’s HFA inhaler is confusingly similar to Teva’s ProAir
RespiClick® in appearance and constitutes unfair competition.
100. By adopting a design confusingly similar to Teva’s ProAir RespiClick®, Perrigo intentionally and falsely misrepresented to potential customers that the Perrigo HFA inhaler is
-18- ACTIVE/102581507.4
Case 1:20-cv-00207 ECF No. 1 filed 03/09/20 PageID.19 Page 19 of 21
likely to provide the same unique activation-free use as Teva’s ProAir RespiClick®, in violation of the Lanham Act, 15 U.S.C. § 1125(a).
101. Teva has been and/or is likely to be damaged by Perrigo’s false and misleading advertising in an amount to be determined at trial.
102. As a result of Perrigo’s false and misleading advertising, Perrigo has caused, and will continue to cause, irreparable harm to Teva and the goodwill associated with the ProAir
RespiClick®, for which Teva has no adequate remedy at law. Teva is entitled, inter alia, to preliminary and permanent injunctive relief.
PRAYER FOR RELIEF
WHEREFORE, Teva respectfully requests that this Court enter judgment in its favor and against Defendants on each of the above referenced claims and caused of action as follows:
A. Preliminary and permanent injunctions requiring Defendants and all those acting in
concert or participation with each of them to the full extent of Fed. R. Civ. P. 65 be
preliminarily and permanently enjoined and restrained form directly or indirectly
using, in any manner or in any medium, the ProAir RespiClick® trade dress, or
otherwise engaging in any further acts of trademark infringement or unfair
competition against Teva, or aiding, abetting, encouraging, or inducing another to
do any of the acts herein enjoined;
B. Preliminary and permanent injunctions requiring Defendants and all those acting in
concert or participation with each of them to the full extent of Fed. R. Civ. P. 65
take affirmative steps to prevent any additional confusion that may be created by
its unlawful activities, including, but not limited to, recalling from U.S. commerce
all products, packaging, labels, advertisements, promotional materials,
-19- ACTIVE/102581507.4
Case 1:20-cv-00207 ECF No. 1 filed 03/09/20 PageID.20 Page 20 of 21
publications, broadcasts, or any other media that use the ProAir RespiClick® trade
dress.
C. That Defendants file with the Court and serve on counsel for Teva within thirty (30)
days after entry of any injunction issued by the Court in this action, a sworn written
statement pursuant to 15 U.S.C. § 1116(a) setting forth in detail the manner and
form in which each of them has complied with any injunction which the Court may
enter in this action;
D. Finding that this is an exceptional case within the meaning of 15 U.S.C. § 1117;
E. Awarding actual damages and treble damages;
F. Ordering an accounting and disgorgement of Defendants’ profits;
G. Awarding punitive and exemplary damages;
H. Awarding the costs and expenses of this litigation and these proceedings to Teva;
I. Awarding reasonable attorneys’ fees and costs to Teva as provided by law;
J. Awarding pre-judgment and post-judgment interest to Teva; and
K. Granting to Teva all other relief as the Court deems just and proper.
JURY DEMAND
Pursuant to Federal Rule of Civil Procedure 38(b), Plaintiffs demand a trial by jury on all issues triable by jury.
Dated: March 9, 2020 By: /s/ Rebecca Cantor Linda Dupont Mettes OF COUNSEL: Rebecca Cantor Brooks Kushman Robert D. Carroll 1000 Town Center Todd Marabella 22nd Floor GOODWIN PROCTER LLP Southfield, MI 48075 100 Northern Avenue Tel.: 248-358-4400 Boston, MA 02210 Fax: 248-358-3351 Tel.: (617) 570-1000
-20- ACTIVE/102581507.4
Case 1:20-cv-00207 ECF No. 1 filed 03/09/20 PageID.21 Page 21 of 21
[email protected] David M. Hashmall [email protected] GOODWIN PROCTER LLP The New York Times Building Attorneys for Teva Respiratory, LLC, 620 Eighth Avenue and Teva Pharmaceuticals USA, Inc. New York, NY 10018 Tel.: (212) 813-8800
-21- ACTIVE/102581507.4