Case 1:21-cv-01338-UNA Document 1 Filed 09/22/21 Page 1 of 20 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`PUMA BIOTECHNOLOGY, INC. and
`WYETH LLC,
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`Plaintiffs,
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`v.
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`ASTRAZENECA PHARMACEUTICALS
`LP, ASTRAZENECA AB, and
`ASTRAZENECA PLC,
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`Defendants.
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`C.A. No. _______________
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`DEMAND FOR JURY TRIAL
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`COMPLAINT FOR PATENT INFRINGEMENT
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`Plaintiffs Puma Biotechnology, Inc. (“Puma”) and Wyeth LLC (collectively,
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`“Plaintiffs”), by their attorneys, bring this complaint against Defendants AstraZeneca
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`Pharmaceuticals LP, AstraZeneca AB, and AstraZeneca PLC (collectively, “AstraZeneca” or
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`“Defendants”), and hereby allege as follows:
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`NATURE OF THE ACTION
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`1.
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`This is an action for patent infringement arising under the patent laws of
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`the United States, Title 35, United States Code § 100 et seq., including 35 U.S.C. § 271, for
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`infringement of United States Patent Nos. 10,603,314 (“the ’314 patent”) and 10,596,162 (“the
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`’162 patent”) (collectively, “the patents-in-suit”) directed to the treatment of non-small cell lung
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`cancer.
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`2.
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`Plaintiffs seek judgment that Defendants have infringed, and continue to
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`infringe, the patents-in-suit arising out of Defendants’ commercial manufacture, use, offer for sale,
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`sale, distribution, and/or importation of osimertinib and Tagrisso® (osimertinib) dosage forms
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`(“Tagrisso® Products”) in the United States prior to the expiration of the patents-in-suit.
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`THE PARTIES
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`3.
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`Plaintiff Puma is a corporation organized and existing under the laws of the
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`State of Delaware, having a principal place of business at 10880 Wilshire Boulevard, Suite 2150,
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`Los Angeles, California 90024. Puma is the exclusive licensee of the patents-in-suit under a
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`license agreement with Wyeth LLC (“Wyeth”).
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`4.
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`Plaintiff Wyeth is a limited liability company organized and existing under
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`the laws of the State of Delaware with offices at 235 East 42nd Street, New York, NY 10017.
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`Wyeth LLC is a wholly owned subsidiary of Pfizer, Inc. Wyeth is a co-owner of the patents-in-
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`suit.
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`5.
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`On information and belief, Defendant AstraZeneca Pharmaceuticals LP is
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`a limited partnership organized and existing under the laws of the State of Delaware, with a
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`principal place of business at 1800 Concord Pike, P.O. Box 15437, Wilmington, Delaware 19850.
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`On information and belief, AstraZeneca Pharmaceuticals LP is a wholly owned subsidiary of
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`Defendant AstraZeneca PLC, wherein the ownership is held as a partnership interest. See
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`AstraZeneca Annual Report and Form 20-F Information 2020 (“2020 Annual Report”) at 236–37,
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`available
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`at
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`https://www.astrazeneca.com/content/dam/az/Investor_Relations/annual-report-
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`2020/pdf/AstraZeneca_AR_2020.pdf.
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`6.
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`On information and belief, Defendant AstraZeneca Pharmaceuticals LP is
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`the holder of New Drug Application (“NDA”) No. 208065 for Defendants’ Tagrisso® Products,
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`including tablets of 40 mg and 80 mg dosage strength, and is a distributor of Defendants’ Tagrisso®
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`Products throughout the United States, including in the State of Delaware. See Tagrisso® Product
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`Label.
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`7.
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`On information and belief, Defendant AstraZeneca Pharmaceuticals LP is
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`in the business of, among other things, manufacturing, promoting, marketing, selling, offering for
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`sale, using, distributing, and/or importing pharmaceutical products, including the Defendants’
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`Tagrisso® Products, throughout the United States, including in this Judicial District, through its
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`own actions and through the actions of its agents.
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`8.
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`On information and belief, Defendant AstraZeneca AB is a public limited
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`liability company organized under the laws of Sweden with its principal place of business at
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`Karlebyhus, Astraallén, Södertälje, S-151 85, Sweden. On information and belief, AstraZeneca
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`AB is a wholly owned subsidiary of Defendant AstraZeneca PLC. On information and belief, the
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`President of AstraZeneca AB serves on the AstraZeneca PLC Senior Executive Team. See 2020
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`Annual Report at 106.
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`9.
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`On information and belief, Defendant AstraZeneca AB is the European
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`Marketing Authorization Holder for Defendants’ Tagrisso® Product, including tablets of 40 mg
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`and 80 mg dosage strength. On information and belief, AstraZeneca AB is in the business of,
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`among other things, manufacturing, promoting, marketing, selling, offering for sale, using, and/or
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`distributing pharmaceutical products, including the Defendants’ Tagrisso® Products, throughout
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`the world, including in Europe and in the United States, through its own actions and through the
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`actions of its agents. See Center For Drug Evaluation And Research, Application Number
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`208065Orig1s000, Chemistry Review(s), effective date March 13, 2015, at 10–13, 50–52, 136–
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`138, and 164, available at
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`
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`https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208065Orig1s000ChemR.pdf.
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`10.
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`On information and belief, Defendant AstraZeneca PLC is a public limited
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`company domiciled in the United Kingdom and having a location at 1 Francis Crick Avenue,
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`Cambridge Biomedical Campus, Cambridge CB2 0AA, United Kingdom. See 2020 Annual
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`Report at 288. On information and belief, AstraZeneca PLC, through its 100% ownership of
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`subsidiaries Defendant AstraZeneca Pharmaceuticals LP and Defendant AstraZeneca AB, derived
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`and reported substantial revenue in 2020 from the worldwide sales ($4.328 billion USD) associated
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`with Defendants’ Tagrisso® Products, and particularly sales revenue from within the United States
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`($1.566 billion USD), including in this Judicial District. See 2020 Annual Report at 87 and 187.
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`JURISDICTION AND VENUE
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`11.
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`Plaintiffs incorporate each of the preceding paragraphs 1–10 as if fully set
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`forth herein.
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`12.
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`This is a civil action for patent infringement arising under the patent laws
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`of the United States, 35 U.S.C. §§ 100 et seq., including 35 U.S.C. § 271, for infringement of the
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`asserted patents-in-suit.
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`13.
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`This Court has jurisdiction over the subject matter of this action pursuant
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`to 28 U.S.C. §§ 1331 and 1338(a).
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`14.
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`This Court has personal jurisdiction over AstraZeneca Pharmaceuticals LP
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`because AstraZeneca Pharmaceuticals LP is a corporation with a principal place of business in
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`Delaware and has at least one other regular and established place of business in Delaware.
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`15.
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`AstraZeneca Pharmaceuticals LP is also subject to personal jurisdiction in
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`Delaware because, among other things, upon information and belief, it has purposely availed itself
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`of the benefits and protections of Delaware’s laws such that it should reasonably anticipate being
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`sued in this Court. On information and belief, AstraZeneca Pharmaceuticals LP develops,
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`manufactures, imports, markets, distributes, uses, offers to sell, and/or sells, or causes others to
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`use, promote, market, offer to sell, or sell pharmaceutical products, including Tagrisso® Products,
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`throughout the United States, including in the State of Delaware related to Plaintiffs’ claims, and
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`therefore, transacts business within the State of Delaware related to Plaintiffs’ claims, and/or has
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`engaged in systematic and continuous business contacts within the State of Delaware.
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`16.
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`Upon information and belief, AstraZeneca Pharmaceuticals LP, as the
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`holder of NDA No. 208065 and distributor of Defendants’ Tagrisso® Products throughout the
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`United States, including in the State of Delaware, also derives substantial revenue from interstate
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`and/or international commerce, including substantial revenue from pharmaceutical products,
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`including Tagrisso® Products, used and/or consumed or services rendered in the State of Delaware
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`and this Judicial District and that are manufactured and/or distributed by Defendants.
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`17.
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`On information and belief, AstraZeneca Pharmaceuticals LP is one of
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`AstraZeneca PLC’s principal U.S. trading entities. See AstraZeneca Annual Report and Form 20-
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`F Information 2014 (“2014 Annual Report”) at 98, available at
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`
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`https://www.astrazeneca.com/content/dam/az/Investor_Relations/annual-reports-
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`homepage/2014-Annual-report-English.pdf.
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`18.
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`AstraZeneca Pharmaceuticals LP, in concert with AstraZeneca AB, and
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`under the direct or indirect control of AstraZeneca PLC, has committed acts of infringement and
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`continues to commit such acts in this Judicial District by developing, manufacturing, importing,
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`marketing, distributing, using, offering to sell, and/or selling pharmaceutical products, including
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`Tagrisso® Products, under its NDA No. 208065 in or into this Judicial District, prior to the
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`expiration of the patents-in-suit.
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`19.
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`AstraZeneca AB is subject to personal jurisdiction in Delaware because,
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`among other things, AstraZeneca AB purposely availed itself of the benefits and protections of
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`Delaware’s laws such that it should reasonably anticipate being sued in this Court. On information
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`and belief, AstraZeneca AB itself, develops, manufactures, imports, markets, distributes, uses,
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`offers to sell, and/or sells, or causes others to use, offer to sell, or sell pharmaceutical products,
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`including Tagrisso® Products, throughout the United States, including in the State of Delaware
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`related to Plaintiffs’ claims, and therefore, transacts business within the State of Delaware related
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`to Plaintiffs’ claims, and/or has engaged in systematic and continuous business contacts within the
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`State of Delaware. Upon information and belief, AstraZeneca AB also derives substantial revenue
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`from interstate and/or international commerce, including substantial revenue from pharmaceutical
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`products, including Tagrisso® Products, used and/or consumed or services rendered in the State of
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`Delaware and this Judicial District.
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`20.
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`On information and belief, AstraZeneca AB has consented to jurisdiction
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`in Delaware in one or more prior cases arising out of its filing of an action for patent infringement
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`under the provisions of § 271 related to the filing of Abbreviated New Drug Application
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`(“ANDA”) to the U.S. Food and Drug Administration (“FDA”) and/or it has filed counterclaims
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`in such cases. These actions include cases specifically related to enforcement actions concerning
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`ANDAs concerning generic alternatives to Tagrisso®. See, e.g., AstraZeneca AB and AstraZeneca
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`Pharmaceuticals LP v. Alembic Pharmaceuticals Limited et al., C.A. No: 20-202-RGA (D. Del.
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`Feb. 11, 2020).
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`21.
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`Additionally, this Court has personal jurisdiction over AstraZeneca AB
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`because the requirements of Federal Rule of Civil Procedure 4(k)(2)(A) are met since (a) Plaintiffs’
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`claims arise under federal law; (b) AstraZeneca AB is a foreign defendant not subject to general
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`personal jurisdiction in the courts of any state; and (c) AstraZeneca AB has sufficient contacts in
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`the United States as a whole, including, but not limited to, by participating in the preparation of
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`AstraZeneca Pharmaceuticals LP’s NDA No. 208065, including drug product manufacturing,
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`quality control testing, drug product release, and stability testing, and/or manufacturing and/or
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`selling pharmaceutical products, including Tagrisso® Products, distributed throughout the United
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`States, including in this Judicial District, such that this Court’s exercise of jurisdiction over
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`AstraZeneca AB satisfies due process.
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`22.
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`AstraZeneca PLC is subject to personal jurisdiction in Delaware because,
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`among other things, AstraZeneca PLC itself, and through its wholly owned subsidiaries
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`AstraZeneca Pharmaceuticals LP and/or AstraZeneca AB, purposely availed itself of the benefits
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`and protections of Delaware’s laws such that it should reasonably anticipate being sued in this
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`Court. On information and belief, AstraZeneca PLC itself, and through its wholly owned
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`subsidiaries AstraZeneca Pharmaceuticals LP and/or AstraZeneca AB, develops, manufactures,
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`imports, markets, distributes, uses, offers to sell, and/or sells pharmaceutical products, including
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`Tagrisso® Products, throughout the United States, including in the State of Delaware, and
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`therefore transacts business within the State of Delaware related to Plaintiffs’ claims, and/or has
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`engaged in systematic and continuous business contacts within the State of Delaware.
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`23.
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`In addition, AstraZeneca PLC is subject to personal jurisdiction in
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`Delaware because, on information and belief, it controls, either directly or indirectly, and
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`dominates AstraZeneca Pharmaceuticals LP and/or AstraZeneca AB, and therefore, the activities
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`of AstraZeneca Pharmaceuticals LP and/or AstraZeneca AB in this jurisdiction are attributed to
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`AstraZeneca PLC. See 2020 Annual Report at 236. The AstraZeneca global website presents the
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`company as a single entity and presents the AstraZeneca PLC Board as responsible for setting
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`strategy and policies and monitoring progress toward meeting annual plans of the company, further
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`indicating central control of AstraZeneca PLC over its wholly owned subsidiaries AstraZeneca
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`Pharmaceuticals LP and/or AstraZeneca AB. See, e.g., https://www.astrazeneca.com/our-
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`company/leadership.html.
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`24.
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`On information and belief, Defendants regularly do business in Delaware,
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`and their practices have involved placing pharmaceutical products, including Tagrisso® Products,
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`into the stream of commerce for distribution throughout the United States, including in Delaware.
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`On information and belief, Defendants’ pharmaceutical products, including Tagrisso® Products,
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`are used and/or consumed within and throughout the United States, including in Delaware. On
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`information and belief, Tagrisso® Products are prescribed by physicians practicing within
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`Delaware, dispensed by pharmacies located within Delaware, and used by patients in Delaware.
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`Each of these activities has a substantial effect within Delaware and constitutes infringement of
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`the patents-in-suit before their expiration.
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`25.
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`AstraZeneca PLC’s annual report states that their largest selling product in
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`2020 was Tagrisso®, of which sales revenue from the United States accounted for $1.566 billion
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`USD, which includes sales in this Judicial District.
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`26.
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`Additionally, this Court has personal jurisdiction over AstraZeneca PLC
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`because the requirements of Federal Rule of Civil Procedure 4(k)(2)(A) are met since (a) Plaintiffs’
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`claims arise under federal law; (b) AstraZeneca PLC is a foreign defendant not subject to general
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`personal jurisdiction in the courts of any state; and (c) AstraZeneca PLC itself, through its wholly
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`owned subsidiaries AstraZeneca Pharmaceuticals LP and/or AstraZeneca AB, has sufficient
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`contacts in the United States as a whole, including, but not limited to, either directly or indirectly,
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`participating in the preparation of AstraZeneca Pharmaceuticals LP’s NDA No. 208065, and/or
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`manufacturing and/or selling pharmaceutical products, including Tagrisso® Products, distributed
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`throughout the United States, including in this Judicial District, such that this Court’s exercise of
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`jurisdiction over AstraZeneca PLC satisfies due process.
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`27.
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`On information and belief, Defendants have systematic and continuous
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`contacts with Delaware; have established distribution channels for Tagrisso® Products in
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`Delaware; regularly and continuously conduct business in Delaware, including by selling
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`Tagrisso® Products in Delaware, either directly or indirectly through their subsidiaries, agents, or
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`affiliates; have purposefully availed themselves of the privilege of doing business in Delaware;
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`and derive substantial revenue from the sale of Tagrisso® Products in Delaware.
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`28.
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`Venue is proper in this Court pursuant to 28 U.S.C. §§ 1391 and 1400(b)
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`as to AstraZeneca Pharmaceuticals LP because AstraZeneca Pharmaceuticals LP resides in
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`Delaware and has a regular and established place of business in Delaware.
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`29.
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`Venue is proper in this Court as to AstraZeneca AB because AstraZeneca
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`AB is a foreign entity that may be sued in any judicial district, including in the District of Delaware.
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`28 U.S.C. § 1391(c)(3); see also 28 U.S.C. § 1400(b).
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`30.
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`Venue is proper in this Court as to AstraZeneca PLC because AstraZeneca
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`PLC is a foreign entity that may be sued in any judicial district, including in the District of
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`Delaware. 28 U.S.C. § 1391(c)(3); see also 28 U.S.C. § 1400(b).
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`FACTUAL BACKGROUND
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`31.
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`Non-Small Cell Lung Cancer (“NSCLC”) is an epithelial lung cancer and
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`the leading cause of cancer death in the United States, Japan, and Western Europe. Approximately
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`75 percent of lung cancer cases are categorized as NSCLC.
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`32.
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`In 2003, the FDA approved the compound known as gefitinib (marketed
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`under the tradename IRESSA®) for the treatment of epidermal growth factor receptor (EGFR)-
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`mediated NSCLC in the United States. Soon after, the FDA also approved the compound known
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`as erlotinib (marketed under the tradename TARCEVA®) for treating EGFR-mediated NSCLC in
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`the United States. Both gefitinib and erlotinib are small molecule EGFR Tyrosine Kinase
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`Inhibitors (“TKIs”). Unfortunately, some NSCLC patients treated with gefitinib or erlotinib later
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`were recognized as desensitized or resistant, or never initially responsive to these treatments
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`(together categorized as “gefitinib and/or erlotinib resistant NSCLC”).
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`33.
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`The inventors of the patents-in-suit determined that small molecule
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`inhibitors that irreversibly bind to the EGFR tyrosine kinase domain via a covalent bond to cysteine
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`773 of the EGFR catalytic domain in EGFR (“irreversible EGFR TKIs”) are effective in treating
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`cancers like NSCLC that are resistant to gefitinib and/or erlotinib therapy. The inventions arising
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`out of this research are described and claimed in the patents-in-suit: the ’314 patent and the ’162
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`patent.
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`34.
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`Puma is a biopharmaceutical company that focuses on the development
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`and commercialization of products for the treatment of cancer. In 2011, Puma licensed the patent
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`rights for the patents-in-suit from Pfizer and Wyeth to fully develop treatments for cancer, bring
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`approved therapies to market, and deliver them to patients in need. Puma has invested millions of
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`dollars in this endeavor.
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`35.
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`Pursuant to the licensing agreement, Puma is the holder of NDA 208051
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`for NERLYNX® (neratinib), an intracellular kinase inhibitor that irreversibly binds to EGFR,
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`human epidermal growth factor receptor 2 (“HER2”), and human epidermal growth factor receptor
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`4 (“HER4”). NERLYNX® was approved on July 17, 2017, by the FDA for use (1) as a single
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`agent for extended adjuvant treatment of adult patients with early-stage HER2-positive breast
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`cancer, to follow adjuvant trastuzumab based therapy and (2) in combination with capecitabine for
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`the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have
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`received two or more prior anti-HER2 based regimens in the metastatic setting.
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`36.
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`Additionally, Puma is currently in phase 2 clinical trials investigating the
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`use of neratinib in treating EGFR-mutant mediated lung cancers.
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`THE PATENTS-IN-SUIT
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`37.
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`The ’314 patent, titled “Method For Treating Gefitinib Resistant Cancer”
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`was duly and lawfully issued on March 31, 2020. Plaintiff Wyeth co-owns, and Plaintiffs Wyeth
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`and Puma are the exclusive licensees of, and together have all the rights to enforce, the ’314 patent.
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`The ’314 patent is the U.S. national entry of corresponding international application
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`PCT/US2006/003717, filed February 2, 2006. A true and correct copy of the ’314 patent is
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`attached hereto as Exhibit A.
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`38.
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`The patents-in-suit are assigned to Wyeth LLC and The General Hospital
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`Corporation (“GHC”).
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`39.
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`GHC is a corporation organized and existing under the laws of the State of
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`Massachusetts with its principal office at 55 Fruit Street, Boston, MA 02114. Wyeth LLC is the
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`exclusive licensee of the patents-in-suit under a license agreement with GHC. Under the license,
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`GHC transferred all substantial rights to the patents-in-suit, including the exclusive right to enforce
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`and sub-license those patents, to Wyeth LLC, and the only limited rights retained by GHC relate
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`to their retained research rights to the patents-in-suit.
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`40.
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`The ’314 patent claims methods for treating patients with NSCLC that are
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`resistant to gefitinib and/or erlotinib using an irreversible EGFR inhibitor that covalently binds to
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`cysteine 773 residue in the ligand-binding pocket of EGFR. According to the claimed method, the
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`irreversible EGFR inhibitor is administered daily and can be delivered orally. NSCLCs with a
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`T790M EGFR mutation, including those treated with Tagrisso®, are resistant to gefitinib and/or
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`erlotinib treatment.
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`41.
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`The ’162 patent, titled “Method For Treating Gefitinib Resistant Cancer”
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`was duly and lawfully issued on March 24, 2020. Plaintiff Wyeth co-owns, and Plaintiffs Wyeth
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`and Puma are the exclusive licensees of, and together have the right to enforce, the ’162 patent. A
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`true and correct copy of the ’162 patent is attached hereto as Exhibit B.
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`42.
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`The ’162 patent claims methods for treating gefitinib and/or erlotinib
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`resistant NSCLC having a T790M EGFR mutation using an irreversible EGFR inhibitor that
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`covalently binds to cysteine 773 of the catalytic domain within the EGFR T790M mutant.
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`According to the claimed method, the irreversible EGFR inhibitor is administered daily with a unit
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`dosage of 2–500 mg. NSCLCs with a T790M EGFR mutation, including those treated with
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`Tagrisso®, are resistant to gefitinib and/or erlotinib treatment.
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`TAGRISSO® PRODUCT
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`43.
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`A decade after publication of the provisional applications that led to the
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`patents-in-suit and disclosure to the public of the inventors’ contribution to the relevant field of
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`medicine, on November 13, 2015, the FDA approved Tagrisso® (osimertinib), as an irreversible
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`EGFR inhibitor. Tagrisso® was approved by the FDA under NDA No. 208065 held by Defendant
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`AstraZeneca Pharmaceuticals LP, for the indication of treating patients with metastatic EGFR
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`T790M mutation-positive NSCLC who have progressed on or after EGFR TKI therapy. A copy
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`of the current prescribing information for Tagrisso® (the “Tagrisso® Product Label”) is attached
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`hereto as Exhibit C.
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`44.
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`Since November 13, 2015, the Tagrisso® Product has been approved by the
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`FDA to treat metastatic EGFR T790M mutation-positive NSCLC, and AstraZeneca through this
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`Label knowingly and intentionally instructs end users to administer Tagrisso® Products to humans
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`to treat EGFR T790M mutation-positive NSCLC.
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`45.
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`On April 18, 2018, the FDA granted the supplemental approval of Tagrisso®
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`(osimertinib), under NDA No. 208065/S-008 held by Defendant AstraZeneca Pharmaceuticals LP,
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`and the Tagrisso® Product Label was amended to include an indication for first-line treatment of
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`patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R
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`mutations, as detected by an FDA-approved test.
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`46.
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`On December 18, 2020, the FDA granted the supplemental approval of
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`Tagrisso® (osimertinib), under NDA No. NDA 208065/S-21 held by Defendant AstraZeneca
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`Pharmaceuticals LP, and the Tagrisso® Product Label was amended to include an indication for an
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`adjuvant therapy after tumor resection in adult patients with NSCLC whose tumors have EGFR
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`exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
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`47.
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`Use of AstraZeneca’s Tagrisso® Products according to the Tagrisso®
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`Product Label infringes at least claim 1 of each of the patents-in-suit.
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`COUNT I: INFRINGEMENT OF THE ’314 PATENT
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`48.
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`Plaintiffs re-allege and incorporate by reference each of the allegations set
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`forth in Paragraphs 1–47.
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`49.
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`The use of Tagrisso® Products to treat patients according to the Tagrisso®
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`Product Label is covered by one or more claims of the ’314 patent, including at least claim 1 of
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`the ’314 patent, because claim 1 of the ’314 patent encompasses treating patients with gefitinib
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`and/or erlotinib resistant NSCLC using an irreversible EGFR TKI.
`
`50.
`
`AstraZeneca’s commercial manufacture, use, importation, marketing, sale,
`
`and/or offer for sale of the Tagrisso® Products, including tablets of 40 mg and 80 mg dosage
`
`strength, in or into the United States directly infringes, contributes to the infringement of, and/or
`
`actively induces the infringement by others of one or more claims of the ’314 patent under 35
`
`U.S.C. § 271(a)–(c).
`
`- 13 -
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`Case 1:21-cv-01338-UNA Document 1 Filed 09/22/21 Page 14 of 20 PageID #: 14
`
`51.
`
`The use of AstraZeneca’s Tagrisso® Products by pharmacies, hospitals,
`
`clinics, healthcare professionals, and other end users to treat NSCLC patients under the indications
`
`specified in the Tagrisso® Product Label directly infringes one or more claims of the ’314 patent
`
`under 35 U.S.C. § 271(a).
`
`52.
`
`On information and belief, AstraZeneca, through their own actions or
`
`through the actions of their agents, affiliates, and subsidiaries, market and/or distribute Tagrisso®
`
`Products to resellers, pharmacies, hospitals, clinics, healthcare professionals, and other end users.
`
`On information and belief, AstraZeneca knowingly and intentionally accompany the Tagrisso®
`
`Products with a product label or product insert that includes instructions for using or administering
`
`the Tagrisso® Products to treat NSCLC patients which infringes the ’314 patent. Accordingly,
`
`AstraZeneca induce resellers, pharmacies, hospitals, clinics, healthcare professionals, and other
`
`end users of the Tagrisso® Products to directly infringe the ’314 patent. On information and belief,
`
`AstraZeneca encourage acts of direct infringement with knowledge of the ’314 patent and
`
`knowledge that they are encouraging infringement thereof.
`
`53.
`
`On information and belief, AstraZeneca are actively inducing infringement
`
`of the ’314 patent. AstraZeneca’s activities are done with knowledge of the ’314 patent and
`
`specific intent to infringe that patent.
`
`54.
`
`On information and belief, prior to the ’314 patent issuing,
`
`AstraZeneca were aware of the corresponding European Patent 1 848 414 B1 (or respectively, the
`
`underlying PCT application publication WO 2006/084058), issued April 6, 2011, including the
`
`same or similar claims as the ’314 patent and having the same owner (Plaintiff Wyeth LLC) and
`
`exclusive licensee (Plaintiff Puma). Two patents that are listed in the FDA Orange Book for
`
`Tagrisso®, US 8946235 and US 9732058, recite the inventors’ WO 2006/084058 as important
`
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`

`

`Case 1:21-cv-01338-UNA Document 1 Filed 09/22/21 Page 15 of 20 PageID #: 15
`
`prior art. On information and belief, as of March 31, 2020, the date of issuance of the ’314 patent,
`
`AstraZeneca knew that a U.S. patent containing claims such as those in the ’314 patent would
`
`issue.
`
`55.
`
`On information and belief, AstraZeneca know that the Tagrisso® Products
`
`and Tagrisso® Product Label are especially made or adapted for use in infringing the ’314 patent,
`
`that the Tagrisso® Products are not staple articles or commodities of commerce, and that the
`
`Tagrisso® Products and accompanying Tagrisso® Product Label are not suitable for substantial
`
`noninfringing use. On information and belief, AstraZeneca contribute to infringement of the ’314
`
`patent.
`
`56.
`
`The foregoing actions by AstraZeneca constitute and/or will constitute
`
`direct infringement of the ’314 patent, active inducement of infringement by others of the ’314
`
`patent, and contribution to the infringement by others of the ’314 patent under 35 U.S.C. § 271(a)–
`
`(c).
`
`57.
`
`Plaintiffs have been and will continue to be damaged by AstraZeneca’s
`
`infringement of the ’314 patent. Plaintiffs are entitled to recover from AstraZeneca the damages
`
`sustained by Plaintiffs as a result of AstraZeneca’s wrongful acts, including at a minimum a
`
`reasonable royalty.
`
`58.
`
`AstraZeneca’s infringement is deliberate and willful, entitling Plaintiffs to
`
`seek enhanced damages under 35 U.S.C. § 284 and to seek attorneys’ fees and costs incurred in
`
`prosecuting this action under 35 U.S.C. § 285. AstraZeneca’s infringement of the ’314 patent is
`
`with full and complete knowledge of the ’314 patent and its applicability to the use of Tagrisso®
`
`Products without a good faith belief that the ’314 patent is invalid or not infringed.
`
`- 15 -
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`

`

`Case 1:21-cv-01338-UNA Document 1 Filed 09/22/21 Page 16 of 20 PageID #: 16
`
`59.
`
`Plaintiffs have been and will continue to be substantially and irreparably
`
`damaged by infringement of the ’314 patent. Unless AstraZeneca are enjoined from actively
`
`inducing infringement of the ’314 patent, and contributing to the infringement of the ’314 patent,
`
`Plaintiffs will suffer irreparable injury. Plaintiffs have no adequate remedy at law, and considering
`
`the balance of hardships between Plaintiffs and AstraZeneca, a remedy in equity is warranted.
`
`Further, the public interest would not be disserved by the entry of an injunction.
`
`COUNT II: INFRINGEMENT OF THE ’162 PATENT
`
`60.
`
`Plaintiffs re-allege and incorporate by reference each of the allegations set
`
`forth in Paragraphs 1–59.
`
`61.
`
`The use of Tagrisso® Products to treat patients according to the Tagrisso®
`
`Product Label is covered by one or more claims of the ’162 patent, including at least claim 1 of
`
`the ’162 patent, because claim 1 of the ’162 patent encompasses treating patients with gefitinib
`
`and/or erlotinib resistant NSCLC having a T790M mutation in EGFR using an irreversible EGFR
`
`TKI administered daily in a dosage amount of 2–500 mg.
`
`62.
`
`AstraZeneca’s commercial manufacture, use, importation, marketing, sale,
`
`and/or offer for sale of the Tagrisso® Products, including tablets of 40 mg and 80 mg dosage
`
`strength, in or into the United States directly infringes, contributes to the infringement of, and/or
`
`actively induces the infringement by others of one or more claims of the ’162 patent under 35
`
`U.S.C. § 271(a)–(c).
`
`63.
`
`The use of AstraZeneca’s Tagrisso® Products by pharmacies, hospitals,
`
`clinics, healthcare professionals, and other end users to treat NSCLC patients under the indications
`
`specified in the Tagrisso® Product Label directly infringes one or more claims of the ’162 patent
`
`under 35 U.S.C. § 271(a).
`
`- 16 -
`
`

`

`Case 1:21-cv-01338-UNA Document 1 Filed 09/22/21 Page 17 of 20 PageID #: 17
`
`64.
`
`On information and belief, prior to the ’162 patent issuing, AstraZeneca
`
`were aware of the corresponding European Patent 1 848 414 B1, issued April 6, 2011 (or
`
`respectively, the underlying PCT application publication WO 2006/084058), circumscribing the
`
`same or similar claims as the ’162 patent and having the same owner (Plaintiff Wyeth LLC) and
`
`exclusive licensee (Plaintiff Puma). Two patents that are listed in the FDA Orange Book for
`
`Tagrisso®, US 8946235 and US 9732058, recite the inventors’ WO 2006/084058 as important
`
`prior art. On information and belief, as of March 24, 2020, the date of issuance of the ’162 patent,
`
`AstraZeneca knew that a U.S. patent containing claims such as those in the ’162 patent would
`
`issue.
`
`65.
`
`On information and belief, AstraZeneca, through their own actions or
`
`through the actions of their agents, affiliates, and subsidiaries, market and/or dist