Case 2:21-cv-01816 Document 1 Filed 02/26/21 Page 1 of 64 Page ID #:1
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`
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`Jerry A. Crandall (CSB No. 250192)
`jac@crandalltech.com
`CRANDALL TECHNOLOGIES LLC
`1590 Heavenly View Trail
`Reno, NV 89523
`Telephone: 775.525.8777
`Facsimile: 775.501.5157
`
`Attorney for Plaintiff
`CRANDALL TECHNOLOGIES LLC
`
`
`
`UNITED STATES DISTRICT COURT
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`CENTRAL DISTRICT OF CALIFORNIA
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`WESTERN DIVISION
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`Case No. 2:21-cv-01816
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`COMPLAINT FOR:
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`PATENT INFRINGEMENT
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`DEMAND FOR JURY TRIAL
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`CRANDALL TECHNOLOGIES LLC,
`a Nevada limited liability company,
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`Plaintiff,
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`vs.
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`AMGEN INC.,
`a Delaware corporation,
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`Defendant.
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`COMPLAINT FOR:
`PATENT INFRINGEMENT
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`Case No. 2:21-cv-01816
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`

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`Case 2:21-cv-01816 Document 1 Filed 02/26/21 Page 2 of 64 Page ID #:2
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`
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`TABLE OF CONTENTS
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`NATURE OF THE ACTION …………………………………………………… 1
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`THE PARTIES ………………………………………………………………….. 1
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`JURISDICTION ………………….……………………………………………... 1
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`VENUE ………………….………………………………………………………. 4
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`PATENT PILOT PROGRAM ELIGIBILITY ………………………………….. 5
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`PLAINTIFF‟S ASSERTIONS AND STATEMENT OF THE CLAIM ………... 5
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`I.
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`Letters Patent and Standing …………………………………………… 5
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`II. Notice of Letters Patent Provided to Defendant ……………………… 7
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`III. Activities and Instrumentalities ………………………………………. 9
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`IV. COUNT I (Direct Infringement under 35 U.S.C. § 271(a)) ………….. 24
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`A. Claim 6 ………………….……………………………………… 27
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`B.
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`C.
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`Claim 7 ………………….……………………………………… 34
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`Claim 8 ………………….……………………………………… 34
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`D. Claim 9 ………………….……………………………………… 35
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`E.
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`F.
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`Claim 10 ………………….……………………………………. 36
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`Claim 11 ………………….……………………………………. 37
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`G. Claim 12 ……………….………………………………………. 45
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`H. Claim 13 ……………….………………………………………. 45
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`I.
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`J.
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`Claim 15 ……………….………………………………………. 46
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`Claim 17 ……………….………………………………………. 49
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`K. Claim 18 ……………….………………………………………. 50
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`L.
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`Claim 19 ……………….………………………………………. 51
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`M. Claim 20 ……………….………………………………………. 53
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`V. COUNT II (Contributory Infringement under 35 U.S.C. § 271(c)) …... 54
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`VI. Additional Information ………….……………………………………. 57
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`VII. Remedies ………….…………………………………………………... 58
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`DEMAND FOR JUDGMENT; PRAYER FOR RELIEF ………………………. 59
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`COMPLAINT FOR
`PATENT INFRINGEMENT
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`Case 2:21-cv-01816 Document 1 Filed 02/26/21 Page 3 of 64 Page ID #:3
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`DEMAND FOR JURY TRIAL …..…………………………………………….. 60
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`COMPLAINT FOR
`PATENT INFRINGEMENT
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`ii
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`Case 2:21-cv-01816 Document 1 Filed 02/26/21 Page 4 of 64 Page ID #:4
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`1.
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`Plaintiff Crandall Technologies LLC (hereinafter referred to as
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`“Plaintiff”), for its Complaint for Patent Infringement against Defendant Amgen
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`Inc. (hereinafter referred to as “Defendant”), alleges as follows:
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`NATURE OF THE ACTION
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`2.
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`This is a civil action for patent infringement under the patent laws of
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`the United States, 35 U.S.C. § 1, et seq.
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`3.
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`Defendant has infringed and continues to infringe, and has contributed
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`to and continues to contribute to infringement of, one or more claims of U.S.
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`Patent No. 10,254,077 B2.1
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`4.
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`Plaintiff is the legal owner by assignment of U.S. Patent No.
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`10,254,077 B2, which was duly and legally issued by the United States
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`Patent and Trademark Office (USPTO).
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`5.
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`Plaintiff seeks injunctive relief and monetary damages.
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`THE PARTIES
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`6.
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`Plaintiff is a limited liability company organized under the laws of the
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`State of Nevada and having its principal place of business at 1590 Heavenly View
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`Trail, Reno, Nevada 89523.
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`7.
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`Defendant is a corporation incorporated under the laws of the State of
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`Delaware and having its principal place of business at One Amgen Center Drive,
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`Thousand Oaks, California 91320-1799.
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`JURISDICTION
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`8.
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`The action arises under 28 U.S.C. §§ 1331 and 1338(a), as herein
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`more fully appears, and the Court therefore has jurisdiction over this action.
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`9.
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`Defendant has its Corporate Headquarters located at One Amgen
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`Center Drive, Thousand Oaks, California 91320-1799. Defendant‟s office located
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`1 The specific claim language from these Letters Patent that is quoted in this
`Complaint is presented in both bold and italic font in the applicable paragraphs
`herein so that the quoted claim language is easily identifiable in such paragraphs.
`COMPLAINT FOR:
`1
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`PATENT INFRINGEMENT
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`Case No. 2:21-cv-01816
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`Case 2:21-cv-01816 Document 1 Filed 02/26/21 Page 5 of 64 Page ID #:5
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`at this address is a regular and established place of business within the forum.
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`10. Defendant is listed with the Office of the California Secretary of State
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`as an entity that is currently doing business in the State of California, and the
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`Office of the California Secretary of State has assigned Defendant the following
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`business entity number: C1579467. A current Office of the California Secretary of
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`State business listing for Defendant is attached herein as “Exhibit A”. This
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`business listing lists the physical address of Defendant as One Amgen Center
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`Drive, Thousand Oaks, CA 91320. See Exhibit A at page 2.
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`11. On February 18, 1987, Defendant filed a Statement and Designation
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`by Foreign Corporation form with the Office of the California Secretary of State; a
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`true and correct copy of this form is attached herein as “Exhibit B”. The filing of
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`this form on February 18, 1987, constituted a “REGISTRATION” by Defendant
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`with the Office of the California Secretary of State. See Exhibit A at page 3. This
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`form states that (i) the principal office of Defendant in the State of California as
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`well as (ii) the principal executive office of Defendant were located at the same
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`physical address in the City of Thousand Oaks in the State of California at the time
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`of this filing. See Exhibit B at page 2.
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`12. On January 19, 2021, Defendant filed a Statement of Information with
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`the Office of the California Secretary of State; a true and correct copy of this
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`Statement of Information is attached herein as “Exhibit C”. This Statement of
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`Information states that the principal executive office of Defendant is located in the
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`City of Thousand Oaks in the State of California. See Exhibit C at page 2. This
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`physical address is listed as One Amgen Center Drive, Thousand Oaks, CA 91320.
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`See Exhibit C at page 2. This Statement of Information also indicates that the
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`address of Defendant‟s corporate Chief Executive Officer, corporate Secretary and
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`corporate Chief Financial Officer is this same physical address.
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`13. Defendant maintains its company website at the following address:
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`https://www.amgen.com/. A screenshot of a webpage from Defendant‟s website
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`that lists the physical address of Defendant‟s Corporate Headquarters is attached
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`COMPLAINT FOR:
`PATENT INFRINGEMENT
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`2
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`Case No. 2:21-cv-01816
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`Case 2:21-cv-01816 Document 1 Filed 02/26/21 Page 6 of 64 Page ID #:6
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`herein as “Exhibit D”.2 This webpage lists the following physical address as the
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`location of Defendant‟s “Corporate Headquarters”: One Amgen Center Drive,
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`Thousand Oaks, CA 91320-1799. See Exhibit D at page 2. Defendant‟s office
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`located at One Amgen Center Drive, Thousand Oaks, CA 91320-1799 serves as
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`Defendant‟s Corporate Headquarters and is a regular and established place of
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`business within the forum.
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`14. The Statement of Information that Defendant filed on January 19,
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`2021, with the Office of the California Secretary of State lists Defendant‟s agent
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`for service of process as being “CORPORATION SERVICE COMPANY WHICH
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`WILL DO BUSINESS IN CALIFORNIA AS CSC - LAWYERS
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`INCORPORATING SERVICE (C1592199)”. Exhibit C at page 3. The Office of
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`the California Secretary of State currently lists this same agent as being
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`Defendant‟s current agent for service of process in the State of California. See
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`Exhibit A at page 2.
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`15. This same agent (referred to in the immediately preceding paragraph
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`as CORPORATION SERVICE COMPANY WHICH WILL DO BUSINESS IN
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`CALIFORNIA AS CSC - LAWYERS INCORPORATING SERVICE
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`(C1592199)) filed a 1505 Certificate with the Office of the California Secretary of
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`State on January 7, 2020; a true and correct copy of this 1505 Certificate is
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`attached herein as “Exhibit E”. This is the most recent 1505 Certificate that has
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`been filed by this agent with the Office of the California Secretary of State. This
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`1505 Certificate lists the following address as being the complete street address in
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`California of the office where any entity that named said agent as its agent for
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`service of process may be served with process: 2710 Gateway Oaks Drive, Suite
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`150N, Sacramento, CA 95833. See Exhibit E at page 2. Upon information and
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`belief, this address is a correct address upon which Defendant may be served with
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`process within the State of California.
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`16. As herein more fully appears, Defendant is a corporate entity
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`2 This webpage may be accessed at https://www.amgen.com/contact-us/.
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`COMPLAINT FOR:
`PATENT INFRINGEMENT
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`3
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`Case No. 2:21-cv-01816
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`Case 2:21-cv-01816 Document 1 Filed 02/26/21 Page 7 of 64 Page ID #:7
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`currently doing business in the State of California and having a regular and
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`established place of business within the forum, Defendant purposefully engaged in
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`activities that were directed at the forum, the action arises out of or relate to those
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`activities, and the assertion of personal jurisdiction in the forum comports with
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`traditional notions of fair play and substantial justice. For at least this rationale,
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`the Court has jurisdiction over Defendant in this action.
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`VENUE
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`17. Plaintiff realleges and incorporates by reference the allegations
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`contained in the previous paragraphs of this Complaint as though fully set forth
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`herein. Plaintiff also hereby explicitly incorporates by reference all exhibits filed
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`with this Complaint as though such exhibits were presented herein.
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`18. As previously indicated, Defendant has a regular and established place
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`of business within the forum, wherein such place of business is Defendant‟s
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`corporate headquarters. Additionally, and as herein more fully appears, Defendant
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`has committed acts of infringement, and those acts of infringement have been and
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`continue to be directed at the forum. For at least this rationale, venue is proper in
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`this Court under 28 U.S.C. § 1391(b)(2), (c)(2) and 1400(b).
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`19. Upon information and belief, a number of individuals who are current
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`employees of Defendant, and who have knowledge pertaining to the infringing
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`instrumentality (including, but not limited to, technical aspects, potential uses, and
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`sales information associated with said instrumentality) currently work or reside
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`within the forum, such as a number of those employees who currently work in
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`Defendant‟s Corporate Headquarters located in the City of Thousand Oaks in the
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`State of California. For at least this additional rationale, venue is proper in this
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`Court.
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`20. Upon information and belief, and as herein more fully appears, a
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`number of individuals involved in the advertising, testing and use of the infringing
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`instrumentality currently work or reside within the forum. For at least this
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`COMPLAINT FOR:
`PATENT INFRINGEMENT
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`4
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`Case No. 2:21-cv-01816
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`Case 2:21-cv-01816 Document 1 Filed 02/26/21 Page 8 of 64 Page ID #:8
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`additional rationale, venue is proper in this Court.
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`21. This lawsuit has initially arisen in Ventura County in the State of
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`California, which is the county in which a substantial part of the events or
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`omissions which give rise to the claim occurred or in which a substantial part of
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`the property that is the subject of the action is situated. Additionally, and as herein
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`more fully appears, upon information and belief, a substantial number of witnesses
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`having knowledge pertaining to the allegedly infringing instrumentality currently
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`work or reside within the forum. Moreover, as previously indicated, Defendant has
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`a regular and established place of business located within this District, including
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`Defendant‟s Corporate Headquarters.
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` This District is therefore the most
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`convenient forum for this action.
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`PATENT PILOT PROGRAM ELIGIBILITY
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`22. This lawsuit is eligible for transfer to the Patent Pilot Program in
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`which this Court currently participates. See General Order No. 19-10, section I.2.
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`It is noted, however, that various terms of the asserted patent claims require
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`construction in this action. As such, Plaintiff hereby demands that a claim
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`construction hearing be held by the Court for the asserted patent claims, in
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`accordance with Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996).
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`PLAINTIFF’S ASSERTIONS AND STATEMENT OF THE CLAIM
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`I.
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`Letters Patent and Standing
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`23. On July 12, 2011, U.S. Patent Application No. 13/181,467
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`(hereinafter “the Parent Patent Application”) was filed with the United States
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`Patent and Trademark Office (USPTO). The Parent Patent Application was
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`published by the USPTO on January 17, 2013, as U.S. Patent Application
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`Publication No. 2013/0016449 A1. A true and copy of this published version of
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`the Parent Patent Application is attached herein as “Exhibit F”. This publication
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`names Jerry Alan Crandall as the sole inventor for the Parent Patent Application.
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`See Exhibit F at page 2.
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`COMPLAINT FOR:
`PATENT INFRINGEMENT
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`5
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`Case No. 2:21-cv-01816
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`Case 2:21-cv-01816 Document 1 Filed 02/26/21 Page 9 of 64 Page ID #:9
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`24. On October 25, 2016, Jerry Alan Crandall assigned all right, title and
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`interest in the subject matter of the Parent Patent Application to Plaintiff. Jerry
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`Alan Crandall was and remained the owner of this subject matter until assigning
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`said subject matter to Plaintiff on October 25, 2016. A true and correct copy of the
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`formal Assignment is attached herein as “Exhibit G”.
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`25. On November 17, 2016, the USPTO issued a Filing Receipt for U.S.
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`Patent Application No. 15/346,710
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`(hereinafter “the Divisional Patent
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`Application”), which was filed with the USPTO on November 8, 2016 (after the
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`aforementioned Assignment had been executed). A true and correct copy of this
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`Filing Receipt is attached herein as “Exhibit H”. The Filing Receipt lists Jerry
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`Alan Crandall as the sole inventor for the Divisional Patent Application. See
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`Exhibit H at page 2. The Filing Receipt also lists Plaintiff as both the Applicant
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`and the Assignee of the Divisional Patent Application. See Exhibit H at page 2.
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`The Filing Receipt also identifies the Divisional Patent Application as being a
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`divisional application (“DIV”) of the Parent Patent Application. See Exhibit H at
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`page 2.
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`26. On November 10, 2016, Plaintiff recorded a copy of the formal
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`Assignment (see Exhibit G at page 2) of the subject matter of the Divisional Patent
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`Application with the Assignment Recordation Branch of the Public Records
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`Division of the USPTO. A true and correct copy of the Patent Assignment Cover
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`Sheet issued by the USPTO on November 10, 2016, is attached herein as “Exhibit
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`I”. A true and correct copy of the Notice of Recordation of Assignment Document
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`issued by the USPTO on November 10, 2016, is attached herein as “Exhibit J”.
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`27. On April 9, 2019, the USPTO issued U.S. Patent No. 10,254,077 B2
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`(the Divisional Patent) to Plaintiff. A true and copy of the Divisional Patent is
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`attached herein as “Exhibit K”. The Divisional Patent lists Jerry Alan Crandall as
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`the sole inventor for the Divisional Patent. See Exhibit K at page 2. The
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`Divisional Patent also lists Plaintiff as both the Applicant and the Assignee for the
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`COMPLAINT FOR:
`PATENT INFRINGEMENT
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`6
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`Case No. 2:21-cv-01816
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`Case 2:21-cv-01816 Document 1 Filed 02/26/21 Page 10 of 64 Page ID #:10
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`Divisional Patent. See Exhibit K at page 2.
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`28. Since being assigned the subject matter at issue in the Divisional
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`Patent on October 25, 2016, Plaintiff has been and still is the owner of this subject
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`matter. Additionally, since being issued the Divisional Patent by the USPTO on
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`April 9, 2019, Plaintiff has been and still is the owner of this subject matter. As
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`such, Plaintiff currently has standing to assert the Divisional Patent within the
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`forum. The Divisional Patent is the patent-in-suit in this action.
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`II. Notice of Letters Patent Provided to Defendant
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`29. As herein more fully appears, Plaintiff provided Defendant with actual
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`notice of the Divisional Patent prior to the initiation of this lawsuit.
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`30. A declaration executed on February 26, 2021, by the undersigned
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`attorney of record for Plaintiff is being filed with this Complaint. Such declaration
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`shall be referred to herein as “Decl. of Crandall”.
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`31. On February 8, 2021, Plaintiff sent, via a Secure Courier service
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`provider known as FedEx, an envelope containing a true and correct copy of the
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`Divisional Patent along with a letter (dated February 8, 2021) to Defendant‟s office
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`located at 1 Amgen Center Drive, Thousand Oaks, California 91320. See Decl. of
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`Crandall at ¶2. A true and correct copy of this letter dated February 8, 2021, is
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`attached herein as “Exhibit L”. A true and copy of the Divisional Patent is
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`attached herein as Exhibit K, as discussed above.
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`32. A true and correct copy of a printed receipt for the aforementioned
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`FedEx deposit of February 8, 2021, is attached herein as “Exhibit M”. This printed
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`receipt indicates that the deposit was made on February 8, 2021. See Exhibit M at
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`page 2. Moreover, true and correct copies of digital photographs of this envelope,
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`after such envelope had been labeled with the applicable FedEx shipping
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`information, are attached herein as “Exhibit N”. Both the printed receipt and this
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`envelope indicate that the envelope was to be shipped to “AMGEN INC” at “1
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`AMGEN CENTER DR” in the city of “THOUSAND OAKS”, in the State of
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`COMPLAINT FOR:
`PATENT INFRINGEMENT
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`7
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`Case No. 2:21-cv-01816
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`

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`Case 2:21-cv-01816 Document 1 Filed 02/26/21 Page 11 of 64 Page ID #:11
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`California. See Exhibit M at page 2 and Exhibit N at pages 2-3. Furthermore, both
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`the printed receipt and this envelope list a FedEx tracking number of
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`783521790748. See Exhibit M at page 2 and Exhibit N at pages 2-3. See also
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`Decl. of Crandall at ¶2.
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`33. Tracking
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`information published online by FedEx
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`for
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`the
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`aforementioned envelope is attached herein as “Exhibit O”. A copy of a delivery
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`confirmation from FedEx for this envelope is attached herein as “Exhibit P”. Both
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`the FedEx tracking information and the FedEx delivery confirmation confirm that
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`the envelope was delivered to its destination in “THOUSAND OAKS, CA” on
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`February 9, 2021, where the delivery was signed for on behalf of Defendant by an
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`individual referred to as “A.ARTHUR”. Exhibit O at page 2 and Exhibit P at page
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`2. As such, Defendant had actual notice of the Divisional Patent at least as early as
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`February 9, 2021. Moreover, the aforementioned individual referred to as
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`A.ARTHUR is an individual who was working on behalf of Defendant in the
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`subject forum on February 9, 2021, and who has knowledge of both (1)
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`Defendant‟s ability to receive correspondence at its corporate headquarters in the
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`City of Thousand Oaks in the State of California and (2) the aforementioned
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`delivery of this envelope to Defendant within the subject forum on February 9,
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`2021.
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`34. On February 12, 2021, Plaintiff e-mailed a true and correct copy of
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`the Divisional Patent, along with a copy of the aforementioned letter of February 8,
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`2021, to Defendant at the following e-mail address: tmops@amgen.com. See Decl.
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`of Crandall at ¶3. A true and correct copy of this e-mail is attached herein as
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`“Exhibit Q”. This e-mail included two attachments: a true and correct copy of the
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`aforementioned letter of February 8, 2021 (attached herein as Exhibit L) and a true
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`and correct copy of the Divisional Patent (attached herein as Exhibit K). This e-
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`mail and its two attachments were successfully delivered to Defendant at this e-
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`mail address (tmops@amgen.com). See Decl. of Crandall at ¶3. Moreover, and as
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`COMPLAINT FOR:
`PATENT INFRINGEMENT
`
`
`
`8
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`Case No. 2:21-cv-01816
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`

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`Case 2:21-cv-01816 Document 1 Filed 02/26/21 Page 12 of 64 Page ID #:12
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`herein more fully appears, this e-mail address is a valid e-mail address for
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`Defendant.
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`35.
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`In addition to the foregoing, Plaintiff has listed the United States
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`patent number (U.S. Patent No. 10,254,077 B2) of the Divisional Patent on its
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`company website since February 5, 2020. See Decl. of Crandall at ¶4. Also, this
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`listed patent number is itself an Internet hyperlink, which has been embedded
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`within Plaintiff‟s website since February 5, 2020, that will redirect a web browser
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`to a webpage from the USPTO website that includes an electronic (and word-
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`searchable) version of the Divisional Patent that has been published by the
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`USPTO, wherein such electronic version includes a listing of the issued patent
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`claims for the Divisional Patent. See Decl. of Crandall at ¶5. Moreover, this
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`USPTO web page includes a hyperlink that will redirect a web browser to a
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`USPTO portal where true and correct copies of pages from the Divisional Patent
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`can be viewed (one page at a time), including each of the patent drawings for the
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`Divisional Patent. See Decl. of Crandall at ¶5.
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`36. Furthermore, since February 5, 2020, an additional Internet hyperlink
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`has been embedded in Plaintiff‟s website, wherein this additional Internet
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`hyperlink is located to the left of the aforementioned patent number of the
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`Divisional Patent. See Decl. of Crandall at ¶6. Selecting such Internet hyperlink
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`will cause a web browser to launch a true and correct copy (in PDF format) of the
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`Divisional Patent. See Decl. of Crandall at ¶6.
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`III. Activities and Instrumentalities
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`37. Defendant advertises, offers for sale and sells a medication referred to
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`as Repatha® (hereinafter “Repatha”) within the United States. Screenshots of a
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`webpage from which Defendant advertises Repatha are attached herein as “Exhibit
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`R”.3 “Repatha® is an injectable prescription medicine used … in adults with
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`3 This webpage was accessed at https://www.repatha.com/.
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`COMPLAINT FOR:
`PATENT INFRINGEMENT
`
`
`
`9
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`Case No. 2:21-cv-01816
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`

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`Case 2:21-cv-01816 Document 1 Filed 02/26/21 Page 13 of 64 Page ID #:13
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`cardiovascular disease to reduce the risk of heart attack, stroke, and certain types of
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`heart surgery” and “to reduce low-density lipoprotein (LDL) or bad cholesterol.”
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`Exhibit R at page 2 (emphasis in original omitted). Additionally, it is noted that
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`this webpage specifically states, “This site is intended for U.S. residents only.”
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`Exhibit R at page 9. Defendant currently advertises Repatha within the subject
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`forum. See Exhibit R at page 9 (“© 2020 Amgen Inc., Thousand Oaks, CA 91320.
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`All rights reserved. 02/20”).
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`38. An online news article dated October 24, 2018, about Defendant‟s
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`pricing of Repatha is attached herein as “Exhibit S”.4 A press release dated
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`October 24, 2018, about Defendant‟s pricing of Repatha is attached herein as
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`“Exhibit T”.5 Another press release dated October 24, 2019, about Defendant‟s
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`pricing of Repatha is attached herein as “Exhibit U”.6 Notably, Defendant
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`publishes various financial information pertaining to its products on its investor
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`website located at https://investors.amgen.com. Moreover, one of Defendant‟s
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`advertisements for Repatha is attached herein as “Exhibit V”. Repatha was
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`initially “launched in 2015 at [a] list price[] of more than $14,000 a year.” Exhibit
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`S at page 5. On October 24, 2018, Defendant announced that it was making
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`Repatha available at a reduced list price of $5,850 per year. See Exhibit S at page
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`3 and Exhibit T at page 2. The online news article dated October 24, 2018, reports
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`that a representative of Defendant stated, “The new $5,850 price is in line with the
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`4 This online news article was accessed at https://www.reuters.com/article/us-
`amgen-cholesterol-price/amgen-cuts-price-of-cholesterol-drug-repatha-by-60-
`percent-idUSKCN1MY2SX.
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`5 This press release was accessed at https://investors.amgen.com/news-
`releases/news-release-details/amgen-makes-repathar-evolocumab-available-us-60-
`percent-reduced.
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`6 This press release was accessed at https://investors.amgen.com/news-
`releases/news-release-details/amgen-make-repathar-evolocumab-available-
`exclusively-its-lower.
`
`COMPLAINT FOR:
`PATENT INFRINGEMENT
`
`
`
`10
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`Case No. 2:21-cv-01816
`
`

`

`Case 2:21-cv-01816 Document 1 Filed 02/26/21 Page 14 of 64 Page ID #:14
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`current net price Amgen gets after discounts and rebates to pharmacy benefit
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`managers (PBMs) and health insurers”. Exhibit S at page 6. This reduced list
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`price of $5,850 per year was a “60 percent reduction from [Repatha‟s] original list
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`price”. Exhibit T at page 2. $5,850 is a 60 percent price reduction from a
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`calculated amount of $14,625. As such, starting in 2015, Defendant originally
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`offered for sale and sold doses of Repatha, within the United States, for an
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`aggregated amount of approximately $14,625 per year for each patient. However,
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`on October 24, 2019, Defendant announced that effective Dec. 31, 2019, Repatha
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`would be distributed exclusively at the 60 percent lower list price of $5,850 per
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`year and would no longer be available at its original list price. See Exhibit U at
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`page 2. Thus, as early as October 24, 2018, but no later than December 31, 2019,
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`Defendant was offering for sale and selling doses of Repatha, within the United
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`States, for an aggregated amount of $5,850 per year for each patient. Defendant
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`advertises that this aggregated amount of $5,850 per year for each patient equates
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`to $450 for each dose of Repatha, and that this pricing is applicable to Repatha
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`sales within the United States. See Exhibit V at page 2.
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`39. Defendant also makes Repatha. A safety data sheet for Repatha is
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`attached herein as “Exhibit W”. This safety data sheet was issued in February of
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`2020. See Exhibit W at pages 2-9 (“Date Issued 19-Feb-2020”). Additionally, this
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`data sheet identifies the manufacturer of Repatha as being “Amgen Inc.” Exhibit
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`W at page 2. This safety data sheet also indicates that Repatha is Defendant‟s
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`product name for the medication “Evolocumab”, which is also known as “anti-
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`PCSK9 monoclonal antibody” and “AMG 145”. Exhibit W at page 2. Notably,
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`this safety data sheet further lists Defendant‟s office in the subject forum as being
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`the physical address of the manufacturer of Repatha. See Exhibit W at page 2.
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`40. Additionally, Defendant makes, uses and advertises the Pushtronex®
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`System (hereinafter
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`the “Pushtronex System”) within
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`the United States.
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`Screenshots of a webpage from which Defendant advertises the Pushtronex System
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`COMPLAINT FOR:
`PATENT INFRINGEMENT
`
`
`
`11
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`Case No. 2:21-cv-01816
`
`

`

`Case 2:21-cv-01816 Document 1 Filed 02/26/21 Page 15 of 64 Page ID #:15
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`are attached herein as “Exhibit X”.7 The Pushtronex System is an injection
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`delivery system for Repatha. See Exhibit X at pages 2-3 (describing the
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`Pushtronex System as an injection option for Repatha). This webpage also
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`specifically states, “This site is intended for U.S. residents only.” Exhibit X at
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`page 22. Defendant currently advertises the Pushtronex System within the subject
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`forum. See Exhibit X at page 22 (“© 2020 Amgen Inc., Thousand Oaks, CA
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`91320. All rights reserved. 02/20”). Moreover, instructions for using the
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`Pushtronex System, which have been published by Defendant, are attached herein
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`as “Exhibit Y”. These instructions state that the Pushtronex System is
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`“Manufactured by: Amgen Inc.”, while also listing Defendant‟s address in the City
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`of Thousand Oaks in the State of California. Exhibit Y at page 14. These
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`instructions also include the following copyright notice: “© 2015-2017, 2019
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`Amgen Inc. All rights reserved.” Exhibit Y at page 14. Moreover, these
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`instructions state that “[t]his Instructions for Use has been approved by the U.S.
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`Food and Drug Administration.” Exhibit Y at page 14.
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`41. Defendant also offers for sale and sells the Pushtronex System within
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`the United States, where the United States Food and Drug Administration (FDA)
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`has already approved the Pushtronex System. A copy of a press release dated July
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`11, 2016, announcing FDA approval of the Pushtronex System is attached herein
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`as “Exhibit Z”.8 A copy of a press release dated July 27, 2016, confirming FDA
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`approval of the Pushtronex System is attached herein as “Exhibit AA”.9 A copy of
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`
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`7 This webpage was accessed at https://www.repatha.com/how-to-start-repatha-
`injection.
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`8 This press release was accessed at https://www.amgen.com/newsroom/press-
`releases/2016/07/fda-approves-first-and-only-single-monthly-injection-for-a-
`pcsk9-inhibitor.
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`9 This press release was accessed at https://investors.amgen.com/news-
`releases/news-release-details/amgen-reports-second-quarter-2016-financial-results.
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`COMPLAINT FOR:
`PATENT INFRINGEMENT
`
`
`
`12
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`Case No. 2:21-cv-01816
`
`

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`Case 2:21-cv-01816 Document 1 Filed 02/26/21 Page 16 of 64 Page ID #:16
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`a press release dated January 7, 2019, about Defendant‟s pricing of the Pushtronex
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`System is attached herein as “Exhibit AB”.10 The FDA approved the Pushtronex
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`System in July of 2016. See Exhibit Z at page 2 and Exhibit AA at page 8. Upon
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`information and belief, Defendant began selling the Pushtronex System, within the
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`United States, in the year 2016 after the FDA approved the Pushtronex System.
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`Indeed, a search result from the USPTO‟s Trademark Electronic Search System
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`(TESS) for the registered trademark “PUSHTRONEX” (USPTO Trademark
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`Registration Number 5075206) is attached herein as “Exhibit AC”.11 This search
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`result indicates that Defendant first used, and first used in commerce, this
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`trademark within the United States on August 1, 2016. See Exhibit AC at page 2.
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`As such, upon information and belief, Defendant has bee