Case 1:22-cv-00035-JPB Document 53 Filed 07/12/22 Page 1 of 8 PageID #: 326
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`Clarksburg
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`ASTRAZENECA AB and ASTRAZENECA
`PHARMACEUTICALS LP,
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`Plaintiffs,
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`v.
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`MYLAN PHARMACEUTICALS, INC. and
`KINDEVA DRUG DELIVERY L.P.,
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`Defendants.
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`CIVIL ACTION NO. I :22-CV-35
`Judge Bailey
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`MEMORANDUM OPINION AND ORDER DENYING
`DEFENDANTS’ MOTION TO DISMISS
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`Before the Court is Defendants’ Motion to Dismiss [Doc. 29], filed June 1, 2022.
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`In
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`this patent
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`infringement action brought by AstraZeneca AB and AstraZeneca
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`Pharmaceuticals LP (collectively, “Plaintiffs”), Mylan Pharmaceuticals, Inc. and Kindeva
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`Drug Delivery L.P. (collectively, “Defendants”) move for the dismissal of Count
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`I of
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`Plaintiffs’ Complaint for failure to state a claim under Rule 1 2(b)(6). For the reasons that
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`follow, the Court DENIES the Motion.
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`I.BACKGROUND
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`On April 26, 2022, Plaintiffs filed its Complaint. See [Doc. 1].
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`In the Complaint,
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`Plaintiffs allege patent infringement arising under the patent laws of the United States, 35
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`U.S.C. § I etseq., and in particular under35 U.S.C. §271(e). More specifically, Plaintiffs
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`allege two counts: (1) Infringement of the ‘558 Patent and (2) Declaratory Judgment of
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`Infringement of the ‘558 Patent. See [Id. at 11—14].
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`1
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`Plaintiffs seek injunctive relief precluding infringement, attorneys’ fees, and any
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`other relief the Court deems just and proper.
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`A.
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`The Patent-in-Suit
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`The ‘558 patent, entitled “Composition for Inhalation,” was issued by the United
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`States Patent and Trademark Office (“the USPTO”) on April 26, 2022, to AstraZeneca AB,
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`upon assignment from the inventors Nayna Govind and Maria Marlow. The ‘558 patent is
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`directed to pharmaceutical
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`formulations,
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`including Symbicort®,
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`in which the active
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`ingredients budesonide and formoterol are suspended in a liquid hydrofluoroalkane
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`propellant (“HFA 227”) with the excipients polyvinyl pyrrolidone (“PVP”) and polyethylene
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`glycol (“PEG”).
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`The ‘558 patent is related through continuation applications to AstraZeneca’s U.S.
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`Patent Nos. 7,759,328 (“the ‘328 patent”), 8,143,239 (“the ‘239 patent”), 8,575,137 (“the
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`‘137 patent”), and 10,166,247 (“the ‘247 patent”). Like the ‘558 patent, all four patents are
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`directed to formulations of budesonide and formoterol with HFA 227, PVP, and PEG, and
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`all share the same specification. The parties in the above-styled case have held two trials1
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`on these patents, both under the Hatch-Waxman Act.
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`1 The first trial involved the ‘328, ‘239, and ‘137 patents. Defendant Mylan stipulated
`to infringement and the trial was limited to validity. Senior District Judge Keeley entered
`judgment of no invalidity as to each asserted claim, rejecting Mylan’s sole defense of
`obviousness. See AstraZeneca AB v. Mylan Pharm. Inc., 522 F.Supp.3d 200 (N.D.
`W.Va. Mar. 2, 2021) (Keeley, S.J.). The Federal Circuit affirmed the judgment of no
`invalidity but disagreed with the district court’s claim construction of “0.001%” PVP and
`vacated the judgment of infringement. See AstraZeneca AB v. Mylan Pharm. Inc. 19
`F.4th 1325 (Fed. Cir. 2021).
`The second trial
`involved the ‘247 patent. Defendant Mylan stipulated to
`infringement, and the trial on Defendant Mylan’s validity case concluded on June 22, 2022.
`A decision following the second trial
`is pending. See Civil Action No. 1:1 8-CV-1 93 (N.D.
`W.Va.) (Keeley, S.J.).
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`2
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`The claims asserted in the above-styled case parrot the claims at issue in the first
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`trial—the validity of which was confirmed by this Court and the Court of Appeals—except that
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`the limitation of “0.001% PVP” that was the subject of the Federal Circuit’s ruling is
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`replaced in the ‘558 patent by a concentration range of “about 0.0005 to about 0.05% PVP.
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`As to the second trial, Defendant Mylan’s invalidity argument was directed at the
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`‘247 patent claims’ requirement that the compositions be “stable”—a requirement that is not
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`included in any claims of the ‘558 patent.
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`B.
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`Defendants ANDA No. 211699
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`On June 26, 2018, Defendants submitted ANDA No. 211699 (“Mylan’s ANDA”) to
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`the FDA, seeking approval to market inhalation aerosal products with budesonide and
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`formoterol fumarate dihydrate in two strengths (160/4.5 pg and 80/4.5 pg). Mylan’s ANDA
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`products are generic versions of Plaintiffs’ Symbicort® products. Defendants proposed
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`ANDA generic product contains the same formulation as Symbicort® but with a slightly
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`different amount of PVP. The FDA granted final approval to Mylan’s ANDA on March 15,
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`2022.
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`Il.DEFENDANTS’ MOTION TO DISMISS
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`On June 1, 2022, Defendants’ filed a Motion to Dismiss moving this Court to dismiss
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`Count I of Plaintiffs’ Complaint for failure to state a claim under Rule 12(b)(6).
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`In support
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`of the Motion, Defendants’ argue that because the ‘558 patent was not even in existence
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`during the time in which Mylan’s ANDA was awaiting FDA approval, the provisions of the
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`Hatch-Waxman Act do not apply and no relief can be afforded to Plaintiffs under the Act.
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`3
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`Moreover, Defendants state that Plaintiffs’ claim that the submission of Mylan’s
`ANDA infringed the ‘558 patent under 35 U.S.C. § 271(e)(2)(A) “cannot be” because
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`Mylan’s ANDA “was already approved before the ‘558 patent issued, mooting the need to
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`amend its ANDA to include a Paragraph IV certification to the ‘558 patent, which was not
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`even listed in the Orange Book until May 20, 2022 - three weeks after AstraZeneca filed
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`this suit.” See [Doc. 30 at 101.
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`Relying on Ferring B.V. v. Actavis, Inc., 2016 WL 3027446 (D. N.J. May 26,
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`2016)2, Defendants assert that courts “have quickly winnowed out such claims before.”
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`See [Id.].
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`In Ferring, the defendant filed its ANDA in July 2010, and the FDA approved it
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`in December 2012. See Ferring, 2016 WL 3027446, at *1. The plaintiffs’ patent did not
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`issue until June 2015. See Id. at *4 The court found that plaintiffs could not bring a §
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`271 (e)(2)(A) claim on the facts alleged and dismissed the claim. See Id. at *5
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`In this
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`case, Defendants argue that like in Ferring, a § 271 (e)(2)(A) claim must be based upon
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`a patent that has already been issued at the time the infringing ANDA is filed.
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`A.
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`Plaintiffs’ Opposition to Defendants’ Motion to Dismiss
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`In opposition, Plaintiffs’ state that
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`Mylan can seek dismissal of AstraZeneca’s claim for infringement under
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`§ 271(e) and the related relief only by advancing multiple legal propositions
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`unsupported by precedent or the statutory text. Mylan’s argument distills to
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`2 Defendants also rely on Celgene Corp. v. Mylan Pharm. Inc., 17 F.4th 1111
`(Fed. Cir. 2021), Vanda Pharm. Inc. v. West-Ward Pharm. Int’l Ltd. 887 F.3d 1117 (Fed.
`Cir. 2018), and Valeant Pharm. N. Am. LLC v. Mylan Pharm. Inc., 978 F.3d 1374
`(Fed.Cir. 2020) to reinforce the rationale of Ferring. See [Doc. 30 at 11—1 21.
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`4
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`a complaint about timing: according to Mylan, no § 271(e) claim may lie
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`where the filing and approval of an ANDA both precede the issuance of the
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`infringed patent. But Mylan points to no such temporal restriction in the
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`statute, and Federal Circuit precedent has rejected similar efforts to insert
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`one.
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`[Doc. 45 at 12—13]. Plaintiffs advance three arguments in opposition of dismissal. First,
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`Plaintiffs argue that a § 271(e)(2) claim does not require ANDA filing or a Paragraph IV
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`Certification before patent issuance. See [Id. at 13—15]. Second, Plaintiffs argue that FDA
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`approval does not bar assertion of claims under § 271(e)(2). See [Id. at 16—21]. Third,
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`Plaintiffs argue that this Court possesses the authority to award relief even absent
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`§ 271(e). See [Id. at 21—22].
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`Plaintiffs rely heavily on Research Foundation v. Mylan Pharm. Inc., 2012 WL
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`1901267 (D. Del. May 25, 2012)
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`(Stark, J.).
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`In Research Foundation, a case
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`indistinguishable from the above-styled case, Judge Stark addressed a scenario where the
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`patent did not issue until after FDA approval. The patent was issued on July 6, 2010, just
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`five days aftertheANDA approval on July 1,2010. See Research Foundation, 2012 WL
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`1901267, at *5 Judge Stark squarely addressed the issue presented in the above-styled
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`case: whether relief under § 271(e)(4) was available for a patent
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`issuing after FDA
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`approval. After addressing and considering the Federal Circuit’s precedent, Judge Stark
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`upheld the § 271(e) claim and ordered a reset of the approval date under § 271(e)(4)
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`based on the patent issuing after the ANDA filing and approval. See id. at *4 *7; see also
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`Inre OmeprazolePatentLitig., 536 F.3d 1361,1367—68 (Fed. Cir. 2008) (“If the FDA has
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`already approved the ANDA, the district court’s order would alter the effective date of the
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`application, thereby converting a final approval into a tentative approval.”).
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`III. STANDARD OF REVIEW
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`A complaint must be dismissed if it does not allege “enough facts to state a claim
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`to relief that is plausible on its face.” Bell AtI. Corp. v. Twombly, 550 U.s. 544, 570
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`(2007); see also Giarratano v. Johnson, 521 F.3d 298, 302 (4th Cir. 2008) (applying the
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`Twombly standard and emphasizing the necessity of plausibility). When reviewing a
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`motion to dismiss pursuant to Rule I 2(b)(6) of the Federal Rules of Civil Procedure, the
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`Court must assume all of the allegations to be true, must resolve all doubts and inferences
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`in favor of the plaintiff, and must view the allegations in a light most favorable to the
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`plaintiff. Edwards v. City of Goldsboro, 178 F.3d 231, 243—44 (4th Cir. 1999).
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`When rendering its decision,
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`the Court should consider only the allegations
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`contained in the Complaint, the exhibits to the Complaint, matters of public record, and
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`other similar materials that are subject to judicial notice. Anheuser-Busch, Inc. v.
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`Schmoke, 63 F.3d 1305, 1312 (4th Cir. 1995).
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`In Twombly, the Supreme Court, noted
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`that “a plaintiff’s obligation to provide the ‘grounds’ of his ‘entitle[ment] to relief’ requires
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`more than labels and conclusions, and a formulaic recitation of the elements of a cause
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`of action will not do. .
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`.
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`.“ Twombly, 550 U.S. at 555, 570 (upholding the dismissal of a
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`complaint where the plaintiffs did not “nudge[]their claims across the line from conceivable
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`to plausible.”).
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`“[M]atters outside of the pleadings are generally not considered in ruling on a Rule
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`12 Motion.” Williams v. Branker, 462 F. App’x 348, 352 (4th Cir. 2012).
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`“Ordinarily, a
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`court may not consider any documents that are outside of the Complaint, or not expressly
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`incorporated therein, unless the motion is converted into one for summary judgment.”
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`Witthohn v. Fed. Ins. Co., 164 F. App’x 395, 396 (4th Cir. 2006). However, the Court may
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`rely on extrinsic evidence if the documents are central
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`to a plaintiff’s claim or are
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`sufficiently referred to in the Complaint.
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`Id. at 396—97.
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`IV.THE HATCH-WAXMAN ACT
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`The Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No.
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`98-417, 98 Stat. 1585 (otherwise known as the “Hatch-Waxman Act”), seeks to encourage
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`“pioneering research and development of new drugs,” as well as the “production of
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`low-cost, generic copies of those drugs.” Eli Lilly & Co. v. Teva. Pharm. USA, Inc., 557
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`F.3d 1346, 1348 (Fed. Cir. 2009). To that end, a manufacturer may obtain FDA approval
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`to market a generic drug by making a certification regarding patents listed in the FDA’s
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`Approved Drug Products with Therapeutic Equivalence Evaluations (“the Orange Book”)
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`as covering the NDA drug, and certifying that those patents are “invalid or will not be
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`infringed by the manufacture, use, or sale of the new generic drug for which the ANDA is
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`submitted” (“paragraph IV certification”). Id. (citing 21 U.S.C. § 355(j)(2)(A)(vii)(IV)). Upon
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`receiving a paragraph IV certification, a patentee may sue the applicant for patent
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`infringement within 45 days, thus delaying FDA approval of the ANDA.
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`Id.
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`(citing 21
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`U.S.C. § 355(j)(5)(B)(iii)).
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`In this case, where Plaintiffs have sued Defendants under the Hatch-Waxman Act
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`for infringement of the patent-in-suit, the Court is tasked with deciding whether Mylan’s
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`ANDA product infringes upon the ‘558 patent.
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`V. DISCUSSION
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`At the motion to dismiss stage under Rule 12(b)(6), this Court finds that Plaintiffs’
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`Complaint alleges enough facts to state a claim to relief that is plausible on its face for
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`infringement under § 271 (e)(2) by “identify[ing} the ANDA and alleg[ing] that the proposed
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`ANDA products will
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`infringe.” Celgene Corp. v. Sun Pharma Gloval FZE, 2020 WL
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`1921700, at *3 (D. N.J. Apr. 6, 2020). The allegations contained in Plaintiffs’ Complaint
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`go well beyond plausibility. Thus, this Court concludes that Plaintiffs have sufficiently pled
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`infringement on one or more claims of the ‘558 patent.
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`IV.CONCLUSION
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`For the foregoing reasons,
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`the Court DENIES Defendants’ Motion to Dismiss
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`[Doc. 29].
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`It is so ORDERED.
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`The Clerk is directed to transmit copies of this Order to all counsel of record herein.
`DATED: July 1 Z1~o22.
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`~U
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`NITED STATES DISTRICT JUDGE
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`8
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