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Rhodes Pharmaceuticals L.P. v. Indivior Inc.

United States District Court, D. Delaware

January 8, 2018

RHODES PHARMACEUTICALS L.P. Plaintiff,
v.
INDIVIOR, INC. Defendant.

          MEMORANDUM OPINION

          GOLDBERG, J.

         This case involves a patent dispute between manufacturers of opioid addiction substitution therapy drugs. Plaintiff Rhodes Pharmaceuticals, L.P. (“Rhodes”) has sued Defendant Indivior, Inc. (“Indivior”) alleging patent infringement in connection with Defendant's sale of Suboxone Sublingual Film. Specifically, Plaintiff brings claims for direct infringement, indirect infringement, contributory infringement, and willful infringement. Defendant moves to dismiss the case for failure to state a claim under Federal Rule of Civil Procedure 12(b)(6). For the following reasons, the Motion will be granted in part and denied in part.

         I. FACTUAL BACKGROUND [1]

         On June 21, 2016, the United States Patent and Trademark Office (“USPTO”) issued United States Patent No. 9, 370, 512 (the “512 Patent”)-entitled “Buprenorphine-Wafer for Drug Substitution Therapy”-to Plaintiff Rhodes. (Compl. ¶ 9.) Independent claim 1 of the ‘512 patent contains the following eight distinct elements:

         A method of opioid substitution therapy for treating opioid addiction, the method comprising contacting the sublingual mucosa of a patient in need thereof with a sublingual film dosage form comprising:

A method of opioid substitution therapy for treating opioid addiction, the method

comprising contacting the sublingual mucosa of a patient in need thereof with a sublingual film dosage form comprising:

a) approximately 0.1 mg to approximately 16 mg buprenorphine, or an equivalent amount of a pharmaceutically acceptable salt thereof;

b) naloxone or a pharmaceutically acceptable salt thereof; and

c) at least one non-gelatin polymeric film-forming material in which the buprenorphine or the equivalent amount of the pharmaceutically acceptable salt thereof, are dissolved or homogeneously dispersed;

the buprenorphine or the equivalent amount of the pharmaceutically acceptable salt thereof and the naloxone or the pharmaceutically acceptable salt thereof being present in the sublingual film dosage form in a weight ration of from 1:1 to 10:1;

such that within less than 5 minutes after contacting the sublingual mucosa of the patient with the sublingual film dosage form, the buprenorphine or thepharmaceutically acceptable salt thereof and approximately substantially all of the naloxone or the pharmaceutically acceptable salt thereof contact the sublingual mucosa,

And wherein said contacting achieves (i) an average buprenorphine AUC0-48from approximately 10 to approximately 15 (hrs*ng)/ml when the sublingual film dosage form includes 4 mg buprenorphine or an equivalent amount of a pharmaceutically acceptable salt thereof; (ii) an average buprenorphine AUC0-48 from approximately 15 to approximately 25 (hrs*ng)/ml when the sublingual film dosage form includes 8 mg buprenorphine or an equivalent amount of a pharmaceutically acceptable salt thereof or (iii) an average buprenorphine AUC0-48 from approximately 25 to approximately 40 (hrs*ng)/ml when the sublingual film dosage form includes 16 mg buprenorphine or an equivalent amount of a pharmaceutically acceptable salt thereof.

(Compl., Ex. A.) Independent claim 19 contains at least seven distinct elements:

A method of opioid substitution therapy for treating opioid addiction, the method comprising

Contacting the sublingual mucosa of a patient in need thereof with a sublingual film dosage form comprising:

a) an amount of buprenorphine, or an equivalent amount of a pharmaceutically acceptable salt thereof, sufficient to provide an average buprenorphine Cmax of less than 40 (hrs*ng)/ml;

b) naloxone or a pharmaceutically acceptable salt thereof; and

c) at least one non-gelatin polymeric film-forming material in which the burprenorphine or the equivalent amount of the pharmaceutically acceptable salt thereof and the naloxone or the pharmaceutically acceptable salt thereof, are dissolved or homogeneously dispersed;

the buprenorphine or the equivalent amount of the pharmaceutically acceptable salt thereof and the naloxone or the pharmaceutically acceptable salt thereof being present in the sublingual film dosage form in a weight ration of from 1:1 to 10:1;

Such that within less than 5 minutes after contacting the sublingual mucosa of the patient with the sublingual film dosage form, the buprenorphine or the pharmaceutically acceptable salt thereof and approximately substantially all of the naloxone or the pharmaceutically acceptable salt thereof contact the sublingual mucosa.

(Id.)

         Defendant Indivior is the holder of a New Drug Application (“NDA”) No. 22-410 for SUBOXONE® (buprenorphine and naloxone) Sublingual Film (“Suboxone Sublingual Film”). The FDA approved NDA No. 22-410, on August 30, 2010, for the treatment of opioid dependence. Since its approval, Defendant has sold and continues to sell Suboxone Sublingual Film in the United States. In connection with those sales, Defendant provides information and instructions to healthcare professionals and/or patients regarding its Suboxone Sublingual Film, including Prescribing Information and Medication Guides (“Prescribing Information”). (Id. ¶¶ 10-13.) The Prescribing Information provides, in pertinent part:

• “SUBOXONE sublingual film is indicated for treatment of opioid dependence and should be used as part of a complete treatment plan to including counseling and psychosocial support.” (Id ¶ 14.)
• “Sublingual Administration: Place one film under the tongue, close to the base on the left or right side, and allow to completely dissolve.” (Id ¶ 15.)
• Suboxone Sublingual Film “contains polyethylene oxide, hydroxypropl methylcellulose, maltitol, acesulfame potassium, lime flavor, citric acid, sodium citrate, FD&C yellow #6, and white ink.” (Id ¶ 16.)
• Suboxone Sublingual Film comes in four dosage strengths: “Sublingual film: 2 mg buprenorphine with 0.5 mg naloxone, 4 mg buprenorphine with 1 mg naloxone, 8 mg buprenorphine with 2 mg naloxone and 12 mg buprenorphine with 3 mg naloxone.” (Id. ¶ 17.)

         On December 23, 2016, Plaintiff initiated this litigation alleging that the use or administration of any of the four aforementioned dosage strengths of Defendant's Suboxone Sublingual Film by healthcare professionals and/or patients for treating opioid addiction has and continues to directly infringe on one or more claims of the ‘512 patent under 35 U.S.C. § 271(a), including, at minimum, independent claims 1 and 19.

         On May 9, 2017, Defendant filed a Motion to Dismiss pursuant to Federal Rule of Civil Procedure 12(b)(6). Plaintiff responded on May 23, 2017 and Defendant filed a Reply Brief on May 30, 2017.

         II. STANDARD OF REVIEW

         Under Federal Rule of Civil Procedure 12(b)(6), a defendant bears the burden of demonstrating that the plaintiff has not stated a claim upon which relief can be granted. Fed.R.Civ.P. 12(b)(6); see also Hedges v. United States, 404 F.3d 744, 750 (3d Cir. 2005). The United States Supreme Court has recognized that “a plaintiffs obligation to provide the ‘grounds' of his ‘entitle[ment] to relief requires more than labels and conclusions.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007) (quotations omitted). “[T]hreadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice” and “only a complaint that states a plausible claim for relief survives a motion to dismiss.” Ashcroft v. Iqbal 556 U.S. 662, 678 (2009). “A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Id A complaint does not show an entitlement to relief when the well-pleaded facts do not permit the court to infer more than the mere possibility of misconduct. Id

         The United States Court of Appeals for the Third Circuit has detailed a three-step process to determine whether a complaint meets the pleadings standard. Bistrian v. Levi, 696 F.3d 352 (3d Cir. 2014). First, the court outlines the elements a plaintiff must plead to state a claim for relief. Id. at 365. Next, the court must “peel away those allegations that are no more than conclusions and thus not entitled to the assumption of truth.” Id. Finally, the court “look[s] for well-pled factual allegations, assume[s] their veracity, and then ‘determine[s] whether they plausibly give rise to an entitlement to relief.'” Id. (quoting Iqbal, 556 U.S. at 679). The last step is “a context-specific task that requires the reviewing court to draw on its judicial experience and common sense.” Id. (quoting Iqbal, 556 U.S. at 679).

         Although claims of direct infringement were previously governed by Federal Rule of Civil Procedure 84 and the Appendix of Forms, those rules were abrogated effective December 1, 2015. Raindance Techs., Inc. v. 10x Genomics, Inc., No. 15-150, 2016 WL 927143, at *2 (D. Del. Mar. 4, 2016). It is now well established that both direct and indirect infringement claims are subject to the Twombly/Iqbal standard. IP Commc'n Solutions, LLC v. Viber Media (USA) Inc., No. 16-134, ...


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