United States District Court, C.D. California
[Copyrighted Material Omitted]
For Retrophin, Inc., a Delaware corporation, Plaintiff: Tami Kameda Sims, LEAD ATTORNEY, Katten Muchin Rosenman LLP, Los Angeles, CA; James J Calder, Jonathan Rotenberg, Mark T Ciani, PRO HAC VICE, Katten Muchin Rosenman LLP, New York, NY.
For Questcor Pharmaceuticals, Inc, a California corporation, Defendant: John F Cannon, Stradling Yocca Carlson and Rauth PC, Newport Beach, CA; Mark S Popofsky, PRO HAC VICE, Ropes & Gray LLP, Washington, DC; Rocky C Tsai, Ropes & Gray LLP, San Francisco, CA.
ORDER DENYING MOTION TO DISMISS (Doc. 21)
HONORABLE JOSEPHINE L. STATON, UNITED STATES DISTRICT JUDGE.
Before the Court is Defendant Questcor Pharmaceuticals, Inc.'s Motion to Dismiss. (Mot., Doc. 21.) Plaintiff Retrophin, Inc. opposed, and Questcor replied. (Opp'n, Doc. 25; Reply, Doc. 26.) Having considered the parties' briefing, heard oral argument, and taken the matter under submission, the Court DENIES Questcor's Motion.
When ruling on a motion to dismiss, the Court accepts as true the factual allegations in the complaint. Hemi Grp., LLC v. City of New York, 559 U.S. 1, 130 S.Ct. 983, 986-87, 175 L.Ed.2d 943 (2010). Retrophin is a biopharmaceutical company. (Compl. ¶ 11, Doc. 1.) Questcor is the sole provider in the United States of approved therapeutic preparations of adrenocorticotropic hormone (" ACTH" ), a drug used to treat certain life threatening and often fatal diseases. ( Id. ¶ 1.) Questcor's ACTH drug is sold under the brand name H.P. Acthar Gel (" Acthar" ). ( Id.)
A. Acthar and Relevant Markets
Acthar is the only long-acting ACTH therapeutic drug approved by the Food and Drug Administration for use in the United States. ( Id. ¶ 3.) It is the most effective and dominant first-line of treatment for Infantile Spasms. ( Id.) Questcor has obtained " Orphan Drug Designation" for Acthar from the FDA, giving it the exclusive right to market Acthar and its chemical equivalent for use in treating Infantile Spasms. ( Id.) Acthar is also the most commonly used treatment of last resort for patients suffering from Nephrotic Syndrome--in other words, it is used when patients do not respond to or cannot tolerate other therapies. ( Id.)
In 2001, Questcor acquired the rights to Acthar, at which time the drug was being sold for $50 a vial or less. ( Id. ¶ 2.) Since acquiring Acthar, Questcor has raised the price to $28,000 a vial. ( Id.)
Retrophin alleges that Questcor has monopoly power in the following three markets: (1) ACTH therapeutic drugs, for which Questcor " effectively has 100% of the market," ( id. ¶ ¶ 19-24, 37-39); (2) therapeutic drugs to treat Infantile Spasms, for which Questcor has " more than 50%" of the market ( id. ¶ ¶ 25-29, 40-42); and (3) last resort therapeutic drugs to treat Nephrotic Syndrome, for which no specific market share is alleged, but for which Acthar is alleged to be the " primary and dominant" treatment. ( Id. ¶ ¶ 30-34, 43-45.) Each market is geographically limited to the United States. ( Id. ¶ ¶ 24, 29, 34.) The Court refers to these three markets collectively as the " Relevant Markets."
B. Questcor's Acquisition of Rights to Synacthen
Novartis AG holds rights to Synacthen, an ACTH drug that is similar, but not chemically identical, to Acthar. ( Id. ¶ ¶ 4, 46.) Unlike Acthar, Synacthen is synthetically manufactured, and as a result Synacthen is less expensive to manufacture, is less susceptible to variation, and is produced in a more sterile environment. ( Id. ¶ 47.) Synacthen has been used for decades outside of the United States for the successful treatment of Infantile Spasms and Nephrotic Syndrome. ( Id. ¶ ¶ 4, 46, 59.) Synacthen is not sold in the United
States because it has never been submitted to the FDA for approval. ( Id. ¶ 4, 46.)
Retrophin planned to purchase rights from Novartis to manufacture and sell Synacthen in the United States, and to seek FDA approval for its use as a therapeutic. ( Id. ¶ 48.) Retrophin intended to compete in the Relevant Markets with Questcor by selling Synacthen at a fraction of the price charged by Questcor for Acthar. ( Id.) Following approximately nine months of negotiations, Retrophin and Novartis agreed on terms for Retrophin to acquire rights to Synacthen. ( Id. ¶ 49.) In anticipation of the transaction, Retrophin prepared specific plans on how to obtain regulatory approval of Synacthen, and put in place a clinical apparatus to conduct clinical trials necessary for FDA approval. ( Id. ¶ ¶ 50, 51.) Retrophin believed that the history of Synacthen's use in other countries would aid in obtaining FDA approval for the same indications. ( Id. ¶ 50.)
On June 11, 2013, the day Retrophin and Novartis were set to sign their proposed agreement, Questcor " swept in" and acquired the rights to Synacthen. ( Id. ¶ ¶ 53-54.) Retrophin alleges that Questcor's acquisition of Synacthen has preserved and entrenched Questcor's monopoly in the Relevant Markets by foreclosing or delaying Retrophin's entry into those markets. ( Id. ¶ ¶ 52, 56.)
C. Retrophin's Development of RE-034
Retrophin has also taken the " highly unusual step of trying to create from scratch a drug -- that it has designated as RE-034 -- that will match Synacthen." ( Id. ¶ 57.) " Retrophin is endeavoring to create a new formulation of the drug that will incorporate the same active pharmaceutical ingredient used in Synacthen and match Synacthen's therapeutic effects for patients suffering from Infantile Spasms and Nephrotic Syndrome." ( Id. ¶ 57.) The development of RE-034 " will take substantial time and money and will require FDA approval; " it will also require the successful completion clinical trials. ( Id. ¶ 58.) There is no guarantee that RE-034 will succeed in the clinical trials or succeed in obtaining FDA approval. ( Id.) Thus, there is no guarantee RE-034 will ever be able to enter the Relevant Markets. ( Id.) Entering the Relevant Markets through RE-034 is more difficult, risky, and time consuming than entering through Synacthen, because there are decades of clinical data from outside the United States that can be used to facilitate and speed the regulatory approval process in the United States, whereas for RE-034 " Retrophin will need to develop all of that knowledge from scratch." ( Id. ¶ ¶ 58-60.)
III. LEGAL STANDARDS
A. Rule 12(b)(6)
When evaluating a Rule 12(b)(6) motion, the Court must accept as true all allegations of material facts that are in the complaint and must construe all inferences in the light most favorable to the non-moving party. See Moyo v. Gomez, 32 F.3d 1382, 1384 (9th Cir. 1994). Rule 12(b)(6) is read in conjunction with Rule 8(a), which requires only a " short and plain statement of the claim showing that the pleader is entitled to relief." Fed.R.Civ.P. 8(a)(2). Dismissal of a complaint for failure to state a claim is not proper where a plaintiff has alleged " enough facts to state a claim to relief that is plausible on its face." Bell A. Corp. v. Twombly, 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). " A claim has facial plausibility when the plaintiff pleads factual content that ...