Tawfilis v. Allergan, Inc.

157 F. Supp. 3d 853, 2015 U.S. Dist. LEXIS 174848, 2015 WL 9701165
CourtDistrict Court, C.D. California
DecidedOctober 20, 2015
DocketCASE NO. SACV 15-307-JLS (JCGx)
StatusPublished

This text of 157 F. Supp. 3d 853 (Tawfilis v. Allergan, Inc.) is published on Counsel Stack Legal Research, covering District Court, C.D. California primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

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Tawfilis v. Allergan, Inc., 157 F. Supp. 3d 853, 2015 U.S. Dist. LEXIS 174848, 2015 WL 9701165 (C.D. Cal. 2015).

Opinion

ORDER DENYING DEFENDANT’S MOTION TO DISMISS (Doc. 32)

Honorable Josephine L. Staton, United States District Judge

I. INTRODUCTION

Before the Court is Defendant Allergan, Inc.’s Motion to Dismiss. (Mot., Doc. 32.) Plaintiffs Adel Tawfilis, DDS d/b/a Carmel Valley Center for Oral and Maxillofacial Surgeiy and Hamid A. Towhidian, M.D. filed an Opposition, and Allergan replied. (Opp’n, Doc, 39; Reply, Doc. 40.) Having considered the parties’ briefing, heard oral [856]*856argument, and taken the matter under submission, the Court DENIES Allergan’s Motion.

II. BACKGROUND1

This antitrust case arises out of an allegedly anticompetitive exclusive licensing agreement between Defendant Allergan, Inc. and Allergan’s Korean-based competitor Medytox, Inc.. (First Amended Complaint, “FAC” ¶ 1, Doc. 28.) Defendant Allergan, Inc. is a U.S.-based multinational pharmaceutical company and the producer of Botox, an injectable neuromodulator most notably used for the treatment, of facial wrinkles. (Id. ¶4.) Plaintiff Adel Tawfilis is a dentist, oral and maxillofacial surgeon, and the principal of the Carmel Valley Center for Oral and Maxillofacial Surgery. (Id. ¶ 2.) Plaintiff Hamid A. To-whidian, M.D. is a cosmetic surgeon and the head of Total Cosmetix. (Id. ¶3.) Plaintiffs allege that they “both purchased Botox directly from Allergan during the Class Period for use in cosmetic procedures they perform routinely within their respective practices.” (Id. ¶ 1.)

Plaintiffs bring -this antitrust action against Allergan on behalf of a putative class of “direct purchasers within the United States of [Allergan]’s Botox neuromo-dulator product for cosmetic use during the Class Period.” (Id. ¶ 1.) Plaintiffs define the relevant antitrust product market as “the market for injectable neurotoxins for cosmetic use,” and the relevant antitrust geographic market as the United States. (Id. ¶¶ 16, 17.) The Class- Period is defined as “thé period between September 25, 2013[,' and] such date as the Court enters an Order certifying any Count of th[e FAC] as a class action.” (Id. ¶ 67.)

Injectable neurotoxin products like Bo-tox are derived from the “acutely lethal” botulinum toxin. (Id. ¶¶ 9 — 10.) Because ■of the high lethal effect of the botulinum toxin, manufacturing facilities that produce injectable neuromodulators for sale in the United States, even when located outside of the United States, are subject to heavy regulation and control. (Id. ¶21.) Further, until recently, all injectable neurotox-ins for cosmetic use have contained the protein human albumin. (Id. ¶ 13.) The Food and Drug Administration (“FDA”) mandates that the human albumin found in any injectable neurotoxin for sale in the United States must come from FDA-approved blood establishments. (Id.) Thus, foreign neurotoxin manufacturers whose products rely on human albumin obtained outside of the United States are unable to obtain FDA approval for the sale of those products within the United States. (Id.)

Allergan’s Botox is the overwhelming leader in the United States market for injectable neurotoxins for cosmetic use, with a market share of at least -85%. (Id. ¶ 18.)' Because of the high barriers, to entry and extensive government regulation and control, only two other products, Dys-port and Ximeon, compete with Botox in the United States. (Id. ¶ 20.) Plaintiffs allege, however, that Dysport’s and Xi-meon’s small presences in the United States are “insufficient to pose meaningful price-constraining competition to Aller-gan’s Botox.” (Id.) Thus, Plaintiffs claim that “Botox’s high market share, coupled with the significant barriers to entry into the relevant antitrust market, mean that Allergan possesses monopoly market power in this relevant antitrust market and has the ability, which is has exercised, to raise prices or reduce output.” (Id. ¶ 19.)

Medytox is a Korean company that, like Allergan, manufactures and distributes an [857]*857injectable neurotoxin for cosmetic use. (Id. ¶ 24.) Medytox sells its primary product, Meditoxin,2 in approximately 40 countries throughout Asia, Eastern Europe, and Latin America. (Id. ¶¶ 24-25.) Me-dytox, however, does not sell Meditoxin within the United States. (Id. ¶ 26.) Nonetheless, Plaintiffs allege that Medytox posed a real and significant threat to Aller-gan’s dominance of the United States market. (Id. ¶ 27.)

Plaintiffs allege that “Medytox undertook considerable investment and preparation” to facilitate entry into the United States-and other European countries. (Id. ¶26.) According to the FAC, Medytox understood that, due to FDA regulations, it could not enter the United States market if its injectable neurotoxin products contained Korean-based albumin. - (Id.) Thus, “Medytox reformulated a bio-better version of its product that was manufactured without using animal-derived fermentation medium or human albumin — a significant advance in the industry, as it represented the only and first neurotoxin that did not require the presence' of albumin.” (Id.) Plaintiffs further assert that, because Medytox’s’' albumin-free product does not need to be freeze-dried in a high vacuum for storage in order to be preserved like other competing neurotoxins that contain albumin, this new product has the clinical advantage of helping Plaintiffs and other direct purchasers reduce the risk of bacterial infection during treatment. (Id. ¶ 32.)

According to the FAC, “in Korea, where Botox is also sold but faces competition from, inter alia, Medytox’s rival injectable neurotoxin for cosmetic applications, Botox has only approximately 35 percent share of the Korean market and lags behind Medy-tox’s near 40 percent or greater share of the Korean market.” (Id. ¶ 27.) Plaintiffs allege that Medytox has had such success in Korea because Medytox’s products are priced 30 to 50 percent lower than Aller-gan’s Botox. (Id. ¶¶ 29-30.) In mid-2013, Medytox received regulatory approval in Korea for its “reformulated albumin-free botulinum toxin-based neurotoxin,” and began marketing it under the brand name Innotox. (Id. ¶26.) According to the FAC, “[t]he approval of Medytox’s [Inno-tox in Korea] meant that entry into' the U.S. market was now in reach.” (Id. ¶ 32.) Further, Plaintiffs allege that “Medytox was planning on building a new manufacturing plant starting the first quarter of 2012 to be completed during the first quarter of 2013 in order to supply Innotox for sales abroad, including planned sales to the U,S'. and Europe.” (Id. ¶ 570 On July 27, 2010, Medytox filed a U.S. Patent Application for the invention embodied in In-notox. (Id. ¶ 33.) On December 31, 2013, Medytox’s patent covering the invention embodied in Innotox was issued by the United States Patent Office.3 (Id.) Plaintiffs also allege that Medytox implemented and invested in clinical trials for Innotóx in Australia. (Id. ¶ 26.)

Plaintiffs claim that Innotox “could have been approved for sale in the U.S. in less than two years following its obtaining regulatory approval abroad in mid-2013.” .(Id, ¶ 65.) According to the FAC, “the pathway to obtain FDA approval [in the United States] to market and sell botulinum-toxin based injectable neuromodulators like Bo-tox and Medytox’s .Innotox for cosmetic use is far less onerous and time-consuming than the regulatory approval process and timeline that involve the nonclinical and clinical tests required for drugs and biolog-[858]*858ics that treat or cure human disease.” (Id.

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157 F. Supp. 3d 853, 2015 U.S. Dist. LEXIS 174848, 2015 WL 9701165, Counsel Stack Legal Research, https://law.counselstack.com/opinion/tawfilis-v-allergan-inc-cacd-2015.