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.