Case 2:18-cv-03632-SDW-CLW Document 31 Filed 10/23/18 Page 1 of 7 PageID: 605
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`NOT FOR PUBLICATION
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`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
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`CORCEPT THERAPEUTICS, INC.,
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` Plaintiff,
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`Civil Action No: 18-3632-SDW-CLW
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`v.
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`TEVA PHARMACEUTICALS USA, INC.,
`and TEVA PHARMACEUTICALS
`INDUSTRIES, LTD.,
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`Defendants.
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`WIGENTON, District Judge.
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`OPINION
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`October 23, 2018
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`Before this Court is Defendant Teva Pharmaceuticals USA, Inc.’s (“Teva” or “Defendant”)
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`Motion to Dismiss Plaintiff Corcept Therapeutics, Inc.’s (“Corcept” or “Plaintiff”) Amended
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`Complaint pursuant to Federal Rule of Civil Procedure 12(b)(6). Jurisdiction is proper pursuant
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`to 28 U.S.C. §§ 1331 and 1338. Venue is proper pursuant to 28 U.S.C. § 1391. This opinion is
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`issued without oral argument pursuant to Federal Rule of Civil Procedure 78. For the reasons
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`stated herein, the Motion to Dismiss is DENIED.
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`I.
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`BACKGROUND AND PROCEDURAL HISTORY
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`A.
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`Before addressing the factual and procedural history of this patent infringement case, a
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`brief review of the relevant statutory and administrative framework regarding the manufacture and
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`marketing of brand-name and generic pharmaceuticals is necessary.
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`1
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`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2004, Page 1
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`Case 2:18-cv-03632-SDW-CLW Document 31 Filed 10/23/18 Page 2 of 7 PageID: 606
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`The Hatch-Waxman Act (“the Act”), codified at 21 U.S.C. § 355 and 35 U.S.C. §§ 156,
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`271 and 282, “governs the Food and Drug Administration’s (‘FDA’) approval of new and generic
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`drugs.” Caraco Pharm. Labs., Ltd. v. Forest Labs., Inc., 527 F.3d 1278, 1282 (Fed. Cir. 2008).
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`The Act is intended to “facilitate the approval of generic drugs as soon as patents allow.” Caraco
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`Pharm. Labs., Ltd. v. Novo Nordisk A/S, 566 U.S. 399, 405 (2012); see also Astrazeneca Pharm.
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`LP v. Apotex Corp., Civ. No. 10-338, 2010 WL 5376310, at *1-3 (D. Del. Dec. 22, 2010)
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`(discussing the history and purpose of the Act). The Act requires an entity seeking to market a
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`new pharmaceutical drug to obtain approval from the FDA by submitting a New Drug Application
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`(“NDA”). 21 U.S.C. § 355(a). As part of the NDA process, applicants file “the patent number
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`and the expiration date of any patent which claims the drug for which the applicant submitted the
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`application or which claims a method of using such drug and with respect to which a claim of
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`patent infringement could reasonably be asserted . . ..” 21 U.S.C. § 355(b)(1) and (c)(2); see also
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`Purepac Pharm. Co. v. Thompson, 354 F.3d 877, 879 (D.C. Cir. 2004) (noting that NDAs “must
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`include . . . information about patents that cover or might cover the drugs”). That information is
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`published in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (“the
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`Orange Book”). Novartis Pharm. Corp. v. Actavis, Inc., Civ. No. 12-366, 2012 WL 6212619, at
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`*3 (D. Del. Dec. 5, 2012); Purepac, 354 F.3d at 880 (noting that the Orange Book is an “FDA
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`publication that includes all patent information that companies have submitted to the agency”).
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`Under the Act, companies seeking to bring a generic version of a branded prescription drug
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`can submit an Abbreviated New Drug Application (“ANDA”) to the FDA. “Like NDAs, ANDAs
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`must address patents that cover or might cover the relevant drugs. For each patent, companies can
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`satisfy this requirement by including in their ANDAs one of several ‘certifications’ that explain
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`why the FDA should approve the application despite the patent’s claim on the drug.” Purepac,
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`2
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`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2004, Page 2
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`Case 2:18-cv-03632-SDW-CLW Document 31 Filed 10/23/18 Page 3 of 7 PageID: 607
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`354 F.3d at 879 (citing 21 U.S.C. § 355(j)(2)(A)(vii)). One such certification allows the ANDA
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`applicant to assert that the branded drug patent(s) is/are invalid, unenforceable, and/or will not be
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`infringed pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (“Paragraph IV Certification”). See
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`Novartis Pharm., Corp. v. Wockhardt USA LLC, Civ. No. 12-3967, 2013 WL 5770539, at *2
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`(D.N.J. Oct. 23, 2013); see also Astrazeneca, 2010 WL 5376310 at *2 (discussing the ANDA
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`certification process). Paragraph IV Certification filers “must provide notice of their Paragraph
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`IV Certification to both the patent owner and the NDA holder,” and that notice must “set forth a
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`‘detailed statement of the factual and legal basis for the opinion of the applicant that the patent is
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`invalid or will not be infringed.’” Caraco, 527 F.3d at 1283 (citing 21 U.S.C. § 355(j)(2)(B)(iv)).
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`B.
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`Corcept is a biopharmaceutical company and the holder of NDA No. 202107 for
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`mifepristone tablets, which it sells under the trade name KORLYM®. (Dkt. No. 15 ¶¶ 2, 12.)
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`KORLYM® “is an FDA-approved medication for the treatment of hyperglycemia secondary to
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`hypercortisolism in adult patients with endogenous Cushing’s syndrome who have type 2 diabetes
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`mellitus or glucose intolerance and have failed surgery or are not candidates for surgery.” (Id. ¶
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`12.) Corcept is also the holder of patent numbers 8,921,348 (the “’348 patent”), 9,829,495 (the
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`“’495 patent”) and 9,943,526 (the “’526 patent”) (collectively, the “patents-in-suit”) and listed
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`those patents in the Orange Book with respect to KORLYM® when it applied for the KORLYM®
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`NDA.1 (Id. ¶¶ 9-13 and Ex. A, B, C.)
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`1 The ‘348 patent was issued by the United States Patent and Trademark Office (“USPTO”) on December 30, 2014,
`and is entitled “Optimizing mifepristone levels in plasma serum of patients suffering from mental disorders treatable
`with glucocorticoid receptor antagonists.” (Dkt. No. 15 ¶ 9.) The ‘495 patent was issued by the USPTO on
`November 28, 2017, and is entitled “Method for differentially diagnosing ACTH dependent Cushing’s Syndrome.”
`(Id. ¶ 10.) The ‘526 patent was issued by the USPTO on April 17, 2018, and is entitled “Optimizing Mifepristone
`Levels for Cushing’s Patients.” (Id. ¶ 11.) Copies of those patents are attached to Plaintiff’s Amended Complaint.
`(See id. Ex. A-C.)
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`3
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`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2004, Page 3
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`Case 2:18-cv-03632-SDW-CLW Document 31 Filed 10/23/18 Page 4 of 7 PageID: 608
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`Teva is a corporation “in the business of marketing, distributing, and selling
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`pharmaceutical drugs, including generic pharmaceutical drugs.” (Id. ¶¶ 3, 6.) No earlier than
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`January 2018 and May 2018, Teva sent Plaintiff letters informing Plaintiff that Teva had filed
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`ANDA No. 211436 with the FDA “seeking approval to market a generic version of Corcept’s 300
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`mg mifepristone drug product” prior to the expiration of the patents-in-suit and had provided the
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`FDA with a Paragraph IV Certification asserting that the claims of the patents-in-suit “are invalid,
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`unenforceable, and/or will not be infringed by the activities described in Teva’s ANDA.” (Id. ¶¶
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`1, 27, 31-37.)
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`On March 15, 2018, Plaintiff filed suit in this Court against Teva and its parent company,
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`Teva Pharmaceuticals Industries, Ltd. for patent infringement. (Dkt. No. 1.) Plaintiff Amended
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`its Complaint on July 6, 20182 and Defendant moved to dismiss on July 27, 2018. (Dkt. No. 15,
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`22.) Plaintiff opposed the motion on August 21, 2018, and Defendant filed its timely reply on
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`August 28, 2018. (Dkt. No. 27, 28.)
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`II.
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`LEGAL STANDARD
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`An adequate complaint must be “a short and plain statement of the claim showing that the
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`pleader is entitled to relief.” FED. R. CIV. P. 8(a)(2). This Rule “requires more than labels and
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`conclusions, and a formulaic recitation of the elements of a cause of action will not do. Factual
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`allegations must be enough to raise a right to relief above the speculative level[.]” Bell Atl. Corp.
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`v. Twombly, 550 U.S. 544, 555 (2007) (internal citations omitted); see also Phillips v. Cty. of
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`Allegheny, 515 F.3d 224, 231 (3d Cir. 2008) (stating that Rule 8 “requires a ‘showing,’ rather than
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`a blanket assertion, of an entitlement to relief”).
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`2 In its initial Complaint, Plaintiff claimed infringement of the ‘348 and ‘495 patents. (Dkt. No. 1.) The Amended
`Complaint adds a claim for infringement of the ‘526 patent. (Dkt. No. 15.)
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`4
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`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2004, Page 4
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`Case 2:18-cv-03632-SDW-CLW Document 31 Filed 10/23/18 Page 5 of 7 PageID: 609
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`In considering a Motion to Dismiss under Rule 12(b)(6), the Court must “accept all factual
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`allegations as true, construe the complaint in the light most favorable to the plaintiff, and determine
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`whether, under any reasonable reading of the complaint, the plaintiff may be entitled to relief.”
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`Phillips, 515 F.3d at 231 (external citation omitted). However, “the tenet that a court must accept
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`as true all of the allegations contained in a complaint is inapplicable to legal conclusions.
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`Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements,
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`do not suffice.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009); see also Fowler v. UPMC Shadyside,
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`578 F.3d 203 (3d Cir. 2009) (discussing the Iqbal standard). Determining whether the allegations
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`in a complaint are “plausible” is “a context-specific task that requires the reviewing court to draw
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`on its judicial experience and common sense.” Iqbal, 556 U.S. at 679. If the “well-pleaded facts
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`do not permit the court to infer more than the mere possibility of misconduct,” the complaint
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`should be dismissed for failing to “show[] that the pleader is entitled to relief” as required by Rule
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`8(a)(2). Id.
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`In conducting its analysis, the Court may only consider the contents of the complaint.
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`Although the Third Circuit has held that “a court may consider certain narrowly defined types of
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`material without converting the motion” to one for summary judgment, In re Rockefeller Ctr.
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`Props. Sec. Litig., 184 F.3d 280, 287 (3d Cir. 1999), those materials are limited to those “integral
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`to or explicitly relied upon in the complaint.” In re Burlington Coat Factory Sec. Litig., 114 F.3d
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`1410, 1426 (3d Cir. 1997) (internal citations omitted, emphasis in original); see also In re Lipitor
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`Antitrust Litig., 868 F.3d 231, 249 (3d Cir. 2017).
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`III. DISCUSSION
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`The filing of an ANDA, where “an applicant seeks approval to market a drug claimed by
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`another person’s valid patent” is an act of infringement. Astrazeneca, 2010 WL 5376310 at *1;
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`5
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`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2004, Page 5
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`Case 2:18-cv-03632-SDW-CLW Document 31 Filed 10/23/18 Page 6 of 7 PageID: 610
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`see also Caraco, 537 F.3d at 1283 (recognizing that “the mere act of filing a Paragraph IV ANDA
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`constitutes an act of patent infringement”); Mallinckrodt IP Unlimited Co. v. B. Braun Med., Inc.,
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`Civ. No. 17-365, 2018 WL 2254540, at *2 (D. Del. May 17, 2018) (denying motion to dismiss
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`where defendant made an ANDA filing with a paragraph IV certification and gave plaintiffs notice
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`of same); Shire LLC v. Mylan, Inc., Civ. No. 12-638, 2012 WL 2072665, at *2 (D.N.J. June 7,
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`2012) (noting that although “the filing of an ANDA may be often called a ‘technical’ act of
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`infringement under § 271(e)(2), it is by statute an act of infringement, nonetheless”); Celegene
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`Corp. v. KV Pharm. Co., Civ. No. 07-4819, 2008 WL 2856469, at *2 (D.N.J. July 22, 2008).
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`Plaintiff’s Amended Complaint alleges that Teva’s ANDA seeks “approval to
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`commercially market a generic version of Corcept’s 300 mg mifepristone drug product . . . prior
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`to the expiration of” the patents-in-suit. (Dkt. No. 15 ¶ 1.) The Amended Complaint further pleads
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`that Teva’s ANDA with its Paragraph IV Certification “constitutes infringement of one or more of
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`the claims,” “will induce infringement of one or more of the claims,” and will “contributorily
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`infringe one or more of the claims” of the patents-in-suit, and that the infringement would be the
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`result of both the manufacture and sale of the proposed generic and Teva’s instructions to
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`prescribers regarding dosages. (Id. ¶¶ 38-61.) “[I]n order to survive a motion to dismiss, a
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`‘patentee need only plead facts sufficient to place the alleged infringer on notice.’” Schreiber v.
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`Eli Lilly & Co., Civ. No. 5-2616, 2006 WL 782441, at *4 (E.D. Pa. Mar. 27, 2006) (quoting
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`Phonometrics, Inc. v. Hosp. Franchise Sys., Inc., 203 F.3d 790, 794 (Fed. Cir. 2000)). Here,
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`Plaintiff satisfies that standard by alleging that it is the holder of the patents-in-suit and that Teva
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`has infringed or will infringe on at least one claim in each of the patents-in-suit. As a result,
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`Defendant’s motion will be denied.3
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`3 Defendant argues that Plaintiff has not sufficiently pled infringement, relying largely on an analysis of the specifics
`of Teva’s ANDA and a comparison of the Korlym® label and the label of Teva’s proposed generic. (See Dkt. No.
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`6
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`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2004, Page 6
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`Case 2:18-cv-03632-SDW-CLW Document 31 Filed 10/23/18 Page 7 of 7 PageID: 611
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`IV. CONCLUSION
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`For the reasons set forth above, Defendant’s Motion to Dismiss is DENIED. An
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`appropriate order follows.
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`___/s/ Susan D. Wigenton_____
`SUSAN D. WIGENTON, U.S.D.J.
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`Orig:
`cc:
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`Clerk
`Cathy L. Waldor, U.S.M.J.
`Parties
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`22-1 at 11-23.) However, Plaintiff neither attached Teva’s ANDA to the Amended Complaint nor relied on it
`directly. Rather, the Amended Complaint refers to Teva’s notice letters which informed Plaintiff of the filing of the
`ANDA and the Paragraph IV Certification. (See Dkt. No. 15 ¶¶ 31-37.) Therefore, the ANDA is not “integral to or
`explicitly relied upon in the complaint,” and this Court will not consider it for the purposes of this motion. In re
`Burlington Coat Factory Sec. Litig., 114 F.3d at 1426; see also Cima Labs, Inc. v. Actavis Grp. HF, Civ. No. 07-
`893, 2007 WL 1672229, at *4 (D.N.J. June 7, 2007) (declining to consider portions of an ANDA on motion to
`dismiss); Par Pharm., Inc. v. Hospira, Inc., Civ. No. 17-944, 2018 WL 3343238, at *2 (D. Del. May 11, 2018)
`(noting that “general references to an ANDA fall short of explicit reliance, precluding consideration of the ANDA in
`a ruling on a motion to dismiss”).
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`Nor will this Court address Defendant’s argument that Plaintiff has failed to sufficiently allege infringement because
`physicians will not interpret Teva’s instructions in any way that would infringe upon the patents-in-suit. (See e.g.,
`Dkt. No. 22-1 at 20-25, Dkt. No. 28 at 1-2, 5.) Defendant presents a factual dispute that can only be properly
`resolved with expert input and claim construction. Such analysis is inappropriate on a motion to dismiss. See, e.g.,
`Novartis, 2012 WL 6212619 at *7 (discussing the components of an infringement analysis and stating that “if a
`court is required to construe the meaning of claim terms and perform an infringement analysis in order to resolve a
`motion to dismiss . . . the motion should be denied”) (collecting cases); Schreiber, 2006 WL 782441 at *4 n. 10
`(determining that “the proper time for [a court] to address claim construction is not in a motion to dismiss”) (citing
`Markman v. Westview Instruments, 517 U.S. 370 (1996)).
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`7
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`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2004, Page 7
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