Case 2:21-cv-11261 Document 1 Filed 05/14/21 Page 1 of 30 PageID: 1
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`
`
`Charles M. Lizza
`William C. Baton
`Sarah A. Sullivan
`SAUL EWING ARNSTEIN & LEHR LLP
`One Riverfront Plaza, Suite 1520
`Newark, NJ 07102-5426
`(973) 286-6700
`clizza@saul.com
`
`Attorneys for Plaintiff
`Celgene Corporation
`
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`
`
`Plaintiff,
`
`
`Civil Action No. ________________
`
`COMPLAINT FOR
`PATENT INFRINGEMENT
`
`(Filed Electronically)
`
`
`
`CELGENE CORPORATION,
`
`
`
`v.
`
`
`
`BIOCON PHARMA LIMITED, BIOCON
`LIMITED, and BIOCON PHARMA, INC.,
`
`
`
`
`
`
`
`
`Defendants.
`
`Plaintiff Celgene Corporation (“Celgene”), by its undersigned attorneys, for its
`
`Complaint against Defendants Biocon Pharma Limited, Biocon Limited, and Biocon Pharma,
`
`Inc. (collectively, “Biocon” or “Defendants”), alleges as follows:
`
`Nature of the Action
`
`1.
`
`This is an action for patent infringement under the patent laws of the United
`
`States, 35 U.S.C. §100, et seq., arising from Biocon Pharma Limited, Biocon Limited, and
`
`Biocon Pharma, Inc.’s submission of Abbreviated New Drug Application (“ANDA”) No.
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`215759 (“Biocon’s ANDA”) to the United States Food and Drug Administration (“FDA”)
`
`seeking approval to manufacture, use, import, distribute, offer to sell, and/or sell generic versions
`
`of Celgene’s Revlimid® drug products prior to the expiration of United States Patent Nos.
`
`
`
`1
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`

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`Case 2:21-cv-11261 Document 1 Filed 05/14/21 Page 2 of 30 PageID: 2
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`
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`7,189,740 (“the ’740 patent”), 7,465,800 (“the ’800 patent”), 7,855,217 (“the ’217 patent”),
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`7,968,569 (“the ’569 patent”), 8,404,717 (“the ’717 patent”), 8,530,498 (“the ’498 patent”),
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`8,648,095 (“the ’095 patent”), 9,056,120 (“the ’120 patent”), 9,101,621 (“the ’621 patent”), and
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`9,101,622 (“the ’622 patent”) (collectively, “the patents-in-suit”), all owned by Celgene.
`
`The Parties
`
`2.
`
`Plaintiff Celgene is a biopharmaceutical company committed to improving the
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`lives of patients worldwide. Celgene focuses on, and invests heavily in, the discovery and
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`development of products for the treatment of severe and life-threatening conditions. Celgene is a
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`world leader in the treatment of many such diseases, including cancer. Celgene is a corporation
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`organized and existing under the laws of the State of Delaware, having a principal place of
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`business at 86 Morris Avenue, Summit, New Jersey 07901.
`
`3.
`
`On information and belief, Defendant Biocon Pharma Limited (“BPL”) is a
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`corporation organized and existing under the laws of India having a principal place of business at
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`20th KM, Hosur Road, Electronic City, Bangalore, 560100, Karnataka, India.
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`4.
`
`On information and belief, Defendant Biocon Limited is a corporation organized
`
`and existing under the laws of India, having a principal place of business at 20th KM, Hosur
`
`Road, Electronic City, Bangalore, 560100, Karnataka, India.
`
`5.
`
`On information and belief, Defendant Biocon Pharma, Inc. (“BPI”) is a
`
`corporation organized and existing under the laws of Delaware, having a principal place of
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`business at 485 US Highway 1 S Ste B305, Iselin, New Jersey 08830.
`
`6.
`
`7.
`
`8.
`
`On information and belief, BPI is a wholly owned subsidiary of BPL.
`
`On information and belief, BPL is a wholly owned subsidiary of Biocon Limited.
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`On information and belief, Biocon Limited is the parent company of BPL.
`
`
`
`2
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`Case 2:21-cv-11261 Document 1 Filed 05/14/21 Page 3 of 30 PageID: 3
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`
`
`The Patents-in-Suit
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`9.
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`On December 16, 2008, the United States Patent and Trademark Office
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`(“USPTO”) duly and lawfully issued the ’800 patent, entitled, “Polymorphic Forms of 3-(4-
`
`amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione,” to Celgene as assignee. A copy
`
`of the ’800 patent is attached hereto as Exhibit A.
`
`10.
`
`On December 21, 2010, the USPTO duly and lawfully issued the ’217 patent,
`
`entitled, “Polymorphic Forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-
`
`dione,” to Celgene as assignee. A copy of the ’217 patent is attached hereto as Exhibit B.
`
`11.
`
`On June 28, 2011, the USPTO duly and lawfully issued the ’569 patent, entitled,
`
`“Methods For Treatment of Multiple Myeloma Using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-
`
`yl)-piperidine-2,6-dione,” to Celgene as assignee. A copy of the ’569 patent is attached hereto as
`
`Exhibit C.
`
`12.
`
`On September 10, 2013, the USPTO duly and lawfully issued the ’498 patent,
`
`entitled, “Methods For Treating Multiple Myeloma With 3-(4-amino-1-oxo-1,3-dihydroisoindol-
`
`2-yl)piperidine-2,6-dione,” to Celgene as assignee. A copy of the ’498 patent is attached hereto
`
`as Exhibit D.
`
`13.
`
`On February 11, 2014, the USPTO duly and lawfully issued the ’095 patent,
`
`entitled, “Methods For Treating Multiple Myeloma Using 3-(4-amino-1-oxo-1,3-
`
`dihydroisoindol-2-yl)-piperidine-2,6-dione In Combination With Proteasome Inhibitor,” to
`
`Celgene as assignee. A copy of the ’095 patent is attached hereto as Exhibit E.
`
`14.
`
`On August 11, 2015, the USPTO duly and lawfully issued the ’621 patent,
`
`entitled, “Methods For Treating Multiple Myeloma With 3-(4-amino-1-oxo-1,3-dihydro-
`
`
`
`3
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`

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`
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`isoindol-2-yl)-piperidine-2,6-dione After Stem Cell Transplantation,” to Celgene as assignee. A
`
`copy of the ’621 patent is attached hereto as Exhibit F.
`
`15.
`
`On August 11, 2015, the USPTO duly and lawfully issued the ’622 patent,
`
`entitled, “Methods For Treating Newly Diagnosed Multiple Myeloma 3-(4-amino-1-oxo-1,3-
`
`dihydro-isoindol-2-yl)-piperidine-2,6-dione In Combination With Dexamethasone,” to Celgene
`
`as assignee. A copy of the ’622 patent is attached hereto as Exhibit G.
`
`16.
`
`On March 13, 2007, the USPTO duly and lawfully issued the ’740 patent,
`
`entitled, “Methods of Using 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione for
`
`the Treatment and Management of Myelodysplastic Syndromes,” to Celgene as assignee. A
`
`copy of the ’740 patent is attached hereto as Exhibit H.
`
`17.
`
`On March 26, 2013, the USPTO duly and lawfully issued the ’717 patent,
`
`entitled, “Methods of Treating Myelodysplastic Syndromes Using Lenalidomide,” to Celgene as
`
`assignee. A copy of the ’717 patent is attached hereto as Exhibit I.
`
`18.
`
`On June 16, 2015, the USPTO duly and lawfully issued the ’120 patent, entitled,
`
`“Methods of Treating Myelodysplastic Syndromes with a Combination Therapy Using
`
`Lenalidomide and Azacitidine,” to Celgene as assignee. A copy of the ’120 patent is attached
`
`hereto as Exhibit J.
`
`The Revlimid® Drug Product
`
`19.
`
`Celgene holds an approved New Drug Application (“NDA”) under Section 505(a)
`
`of the Federal Food Drug and Cosmetic Act (“FFDCA”), 21 U.S.C. § 355(a), for lenalidomide
`
`capsules (NDA No. 021880), which it sells under the trade name Revlimid®. The claims of the
`
`patents-in-suit cover, inter alia, solid forms of lenalidomide, pharmaceutical compositions
`
`
`
`4
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`

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`containing lenalidomide, and methods of use and administration of lenalidomide or
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`pharmaceutical compositions containing lenalidomide.
`
`20.
`
`Pursuant to 21 U.S.C. § 355(b)(1) and attendant FDA regulations, the patents-in-
`
`suit are listed in the FDA publication, “Approved Drug Products with Therapeutic Equivalence
`
`Evaluations” (the “Orange Book”), with respect to Revlimid®.
`
`21.
`
`The labeling for Revlimid® instructs and encourages physicians, pharmacists,
`
`other healthcare workers, and patients to administer Revlimid® for the treatment of, inter alia,
`
`adult patients with multiple myeloma (MM), in combination with dexamethasone.
`
`22.
`
`The labeling for Revlimid® instructs and encourages physicians, pharmacists,
`
`other healthcare workers, and patients to administer Revlimid® for the treatment of, inter alia,
`
`adult patients with MM, as maintenance following autologous hematopoietic stem cell
`
`transplantation (auto-HSCT).
`
`23.
`
`The labeling for Revlimid® instructs and encourages physicians, pharmacists,
`
`other healthcare workers, and patients to administer Revlimid® for the treatment of, inter alia,
`
`adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk
`
`myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without
`
`additional cytogenetic abnormalities.
`
`24.
`
`The labeling for Revlimid® instructs and encourages physicians, pharmacists,
`
`other healthcare workers, and patients to administer Revlimid® according to one or more of the
`
`methods claimed in the patents-in-suit.
`
`
`
`5
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`

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`
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`Jurisdiction and Venue
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`25.
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`This Court has jurisdiction over the subject matter of this action pursuant to 28
`
`U.S.C. §§ 1331, 1338(a), 2201, and 2202.
`
`26.
`
`This Court has personal jurisdiction over BPI by virtue of, inter alia, its
`
`systematic and continuous contacts with the State of New Jersey. On information and belief,
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`BPI maintains a regular and established, physical place of business in Iselin, New Jersey. On
`
`information and belief, BPI is registered with the State of New Jersey’s Division of Revenue and
`
`Enterprise Services as a business operating in New Jersey under Business ID No. 0450071685.
`
`On information and belief, BPI is registered with the State of New Jersey’s Department of Health
`
`as a drug manufacturer and wholesaler under Registration No. 5004931. By virtue of its physical
`
`presence in New Jersey, this Court has personal jurisdiction over BPI. On information and
`
`belief, BPI purposefully has conducted and continues to conduct business in this Judicial
`
`District.
`
`27.
`
`On information and belief, BPI is in the business of, among other things,
`
`manufacturing, marketing, importing, offering for sale, and selling pharmaceutical products,
`
`including generic drug products, throughout the United States, including in this Judicial District.
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`On information and belief, BPI also prepares and/or aids in the preparation and submission of
`
`ANDAs to the FDA, including Biocon’s ANDA.
`
`28.
`
`On information and belief, this Judicial District is a likely destination for the
`
`generic drug products described in Biocon’s ANDA.
`
`29.
`
`On information and belief, Biocon Limited has a registered agent for service of
`
`process in the State of New Jersey at 485 US Hwy 1 South, Woodbridge Corp. Plaza, Suite
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`B305, Iselin, NJ 08830.
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`
`
`6
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`30.
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`On information and belief, BPL derives substantial revenue from directly or
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`indirectly selling generic pharmaceutical products and/or active pharmaceutical ingredient(s)
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`used in generic pharmaceutical products sold throughout the United States, including in this
`
`Judicial District.
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`31.
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`On information and belief, BPI derives substantial revenue from directly or
`
`indirectly selling generic pharmaceutical products and/or active pharmaceutical ingredient(s)
`
`used in generic pharmaceutical products sold throughout the United States, including in this
`
`Judicial District.
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`32.
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`On information and belief, Biocon Limited derives substantial revenue from
`
`directly or indirectly selling generic pharmaceutical products and/or active pharmaceutical
`
`ingredient(s) used in generic pharmaceutical products sold throughout the United States,
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`including in this Judicial District.
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`33.
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`This Court has personal jurisdiction over BPL because, inter alia, it: (1) has
`
`purposefully availed itself of the privilege of doing business in New Jersey, including directly or
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`indirectly through its subsidiary, agent, and/or alter ego, BPI, a company with its principal place
`
`of business in New Jersey; and (2) maintains extensive and systematic contacts with the State of
`
`New Jersey, including through the marketing, distribution, and/or sale of generic pharmaceutical
`
`drugs in New Jersey including through, directly or indirectly, BPI.
`
`34.
`
`This Court has personal jurisdiction over Biocon Limited because, inter alia, it:
`
`(1) has purposefully availed itself of the privilege of doing business in New Jersey, including
`
`directly or indirectly through its related corporate entity, agent, and/or alter ego, BPI, a company
`
`with its principal place of business in New Jersey; and (2) maintains extensive and systematic
`
`
`
`7
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`contacts with the State of New Jersey, including through the marketing, distribution, and/or sale
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`of generic pharmaceutical drugs in New Jersey including through, directly or indirectly, BPI.
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`35.
`
`This Court also has personal jurisdiction over BPI, BPL, and Biocon Limited
`
`because, inter alia, they have committed an act of patent infringement under 35 U.S.C. §
`
`271(e)(2), including sending notice of the ANDA submission to Celgene in the State of New
`
`Jersey. On information and belief, BPL, BPI, and Biocon intend a future course of conduct that
`
`includes acts of patent infringement in New Jersey. These acts have led and will continue to lead
`
`to foreseeable harm and injury to Celgene in New Jersey and in this Judicial District.
`
`36.
`
`In the alternative, this Court has personal jurisdiction over BPL and Biocon
`
`Limited because the requirements of Federal Rule of Civil Procedure 4(k)(2) are met as
`
`(a) Celgene’s claims arise under federal law; (b) BPL and Biocon Limited are foreign defendants
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`not subject to general personal jurisdiction in the courts of any state; and (c) BPL and Biocon
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`Limited have sufficient contacts with the United States as a whole, including, but not limited to,
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`preparing and submitting ANDAs to the FDA and/or manufacturing, importing, offering to sell,
`
`and/or selling pharmaceutical products that are distributed throughout the United States, such
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`that this Court’s exercise of jurisdiction over BPL and Biocon Limited satisfies due process.
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`37.
`
`On information and belief, BPI, BPL, and Biocon Limited work in privity and/or
`
`concert either directly or indirectly through one or more of their wholly owned subsidiaries with
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`respect to the regulatory approval, manufacturing, use, importation, marketing, offer for sale,
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`sale, and distribution of generic pharmaceutical products throughout the United States, including
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`in this Judicial District.
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`38.
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`On information and belief, each of BPI, BPL, and Biocon Limited actively
`
`participated in the submission of Biocon’s ANDA. On information and belief, BPI will work in
`
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`
`8
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`privity and/or concert with BPL, Biocon Limited, and/or other related entities towards the
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`regulatory approval, manufacturing, use, importation, marketing, offer for sale, sale, and
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`distribution of generic pharmaceutical products, including Biocon’s Proposed Products,
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`throughout the United States, including in New Jersey and in this Judicial District, prior to the
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`expiration of the patents-in-suit.
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`39.
`
`On information and belief, BPI intends to benefit directly if the ANDA is
`
`approved by participating in the manufacture, importation, distribution, and/or sale of the generic
`
`drug products that are the subject of Biocon’s ANDA.
`
`40.
`
`On information and belief, BPL intends to benefit directly if the ANDA is
`
`approved by participating in the manufacture, importation, distribution, and/or sale of the generic
`
`drug products that are the subject of Biocon’s ANDA.
`
`41.
`
`On information and belief, Biocon Limited intends to benefit directly if the
`
`ANDA is approved by participating in the manufacture, importation, distribution, and/or sale of
`
`the generic drug products that are the subject of Biocon’s ANDA.
`
`42.
`
`On information and belief, BPI acts at the direction, and for the benefit, of BPL
`
`and Biocon Limited, and is controlled and/or dominated by BPL and Biocon Limited.
`
`43.
`
`On information and belief, BPI, BPL, and Biocon Limited act, operate, and/or
`
`hold themselves out to the public as a single integrated business.
`
`44.
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`Venue is proper in this Judicial District pursuant to 28 U.S.C. §§ 1391 and/or
`
`1400(b).
`
`Acts Giving Rise To This Suit
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`45.
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`Pursuant to Section 505 of the FFDCA, BPI, BPL, and Biocon Limited,
`
`collectively, submitted Biocon’s ANDA seeking approval to engage in the commercial
`
`
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`9
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`manufacture, use, sale, offer for sale, or importation into the United States of 2.5 mg, 5 mg, 10
`
`mg, 15 mg, 20 mg, and 25 mg lenalidomide capsules (“Biocon’s Proposed Products”), before the
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`patents-in-suit expire.
`
`46.
`
`On information and belief, following FDA approval of Biocon’s ANDA, BPI,
`
`BPL, and Biocon Limited will make, use, sell, or offer to sell Biocon’s Proposed Products
`
`throughout the United States, or import such generic products into the United States.
`
`47.
`
`On information and belief, in connection with the submission of Biocon’s ANDA
`
`as described above, BPI, BPL, and Biocon Limited provided written certifications to the FDA
`
`pursuant to Section 505 of the FFDCA, 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (“Biocon’s Paragraph
`
`IV Certification”), alleging that the claims of the ’740, ’800, ’217, ’569, ’717, ’498, ’095, ’120,
`
`and ’622 patents are invalid and/or will not be infringed by the activities described in Biocon’s
`
`ANDA.
`
`48.
`
`No earlier than April 1, 2021, BPI, BPL, and Biocon Limited sent a written notice
`
`of their Paragraph IV Certification to Celgene (“Biocon’s Notice Letter”). Biocon’s Notice
`
`Letter alleged that the claims of the ’740, ’800, ’217, ’569, ’717, ’498, ’095, ’120, and ’622
`
`patents are invalid, and/or will not be infringed by the activities described in Biocon’s ANDA.
`
`Biocon Notice Letter also informed Celgene that Biocon seeks approval to market Biocon’s
`
`Proposed Products before the patents-in-suit expire. Biocon specifically directed Biocon’s
`
`Notice Letter to Celgene’s headquarters in Summit, New Jersey, in this Judicial District.
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`Count I: Infringement of the ’740 Patent
`
`49.
`
`Celgene repeats and realleges the allegations of the preceding paragraphs as if
`
`fully set forth herein.
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`10
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`50.
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`BPI, BPL, and Biocon Limited’s submission of their ANDA, with the
`
`accompanying Paragraph IV Certification and notice to Celgene of same, to engage in the
`
`commercial manufacture, use, sale, offer for sale, or importation into the United States of
`
`Biocon’s Proposed Products, prior to the expiration of the ’740 patent, constitutes infringement
`
`of one or more of the claims of that patent under 35 U.S.C. § 271(e)(2)(A).
`
`51.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the ’740 patent.
`
`52.
`
`Unless enjoined by this Court, upon FDA approval of Biocon’s ANDA, BPI,
`
`BPL, and Biocon Limited will infringe one or more claims of the ’740 patent under 35 U.S.C. §
`
`271(a) by making, using, offering to sell, selling, and/or importing Biocon’s Proposed Products
`
`in the United States.
`
`53.
`
`Unless enjoined by this Court, upon FDA approval of Biocon’s ANDA, BPI,
`
`BPL, and Biocon Limited will induce infringement of one or more claims of the ’740 patent
`
`under 35 U.S.C. § 271(b) by making, using, offering to sell, selling, and/or importing Biocon’s
`
`Proposed Products in the United States. On information and belief, upon FDA approval of
`
`Biocon’s ANDA, BPI, BPL, and Biocon Limited will intentionally encourage acts of direct
`
`infringement with knowledge of the ’740 patent and knowledge that their acts are encouraging
`
`infringement.
`
`54.
`
`Unless enjoined by this Court, upon FDA approval of Biocon’s ANDA, BPI,
`
`BPL, and Biocon Limited will contributorily infringe one or more claims of the ’740 patent
`
`under 35 U.S.C. § 271(c) by making, using, offering to sell, selling, and/or importing Biocon’s
`
`Proposed Products in the United States. On information and belief, BPI, BPL, and Biocon
`
`Limited have had and continue to have knowledge that Biocon’s Proposed Products are
`
`
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`especially adapted for a use that infringes one or more claims of the ’740 patent and that there is
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`no substantial non-infringing use for Biocon’s Proposed Products.
`
`55.
`
`Celgene will be substantially and irreparably damaged and harmed if BPI, BPL,
`
`and Biocon Limited’s infringement of the ’740 patent is not enjoined.
`
`56.
`
`57.
`
`Celgene does not have an adequate remedy at law.
`
`This case is an exceptional one, and Celgene is entitled to an award of its
`
`reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`Count II: Infringement of the ’800 Patent
`
`58.
`
`Celgene repeats and realleges the allegations of the preceding paragraphs as if
`
`fully set forth herein.
`
`59.
`
`BPI, BPL, and Biocon Limited’s submission of their ANDA, with the
`
`accompanying Paragraph IV Certification and notice to Celgene of same, to engage in the
`
`commercial manufacture, use, sale, offer for sale, or importation into the United States of
`
`Biocon’s Proposed Products, prior to the expiration of the ’800 patent, constitutes infringement
`
`of one or more of the claims of that patent under 35 U.S.C. § 271(e)(2)(A).
`
`60.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the ’800 patent.
`
`61.
`
`Unless enjoined by this Court, upon FDA approval of Biocon’s ANDA, BPI,
`
`BPL, and Biocon Limited will infringe one or more claims of the ’800 patent under 35 U.S.C. §
`
`271(a) by making, using, offering to sell, selling, and/or importing Biocon’s Proposed Products
`
`in the United States.
`
`62.
`
`Unless enjoined by this Court, upon FDA approval of Biocon’s ANDA, BPI,
`
`BPL, and Biocon Limited will induce infringement of one or more claims of the ’800 patent
`
`
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`under 35 U.S.C. § 271(b) by making, using, offering to sell, selling, and/or importing Biocon’s
`
`Proposed Products in the United States. On information and belief, upon FDA approval of
`
`Biocon’s ANDA, BPI, BPL, and Biocon Limited will intentionally encourage acts of direct
`
`infringement with knowledge of the ’800 patent and knowledge that their acts are encouraging
`
`infringement.
`
`63.
`
`Unless enjoined by this Court, upon FDA approval of Biocon’s ANDA, BPI,
`
`BPL, and Biocon Limited will contributorily infringe one or more claims of the ’800 patent
`
`under 35 U.S.C. § 271(c) by making, using, offering to sell, selling, and/or importing Biocon’s
`
`Proposed Products in the United States. On information and belief, BPI, BPL, and Biocon
`
`Limited have had and continue to have knowledge that Biocon’s Proposed Products are
`
`especially adapted for a use that infringes one or more claims of the ’800 patent and that there is
`
`no substantial non-infringing use for Biocon’s Proposed Products.
`
`64.
`
`Celgene will be substantially and irreparably damaged and harmed if BPI, BPL,
`
`and Biocon Limited’s infringement of the ’800 patent is not enjoined.
`
`65.
`
`66.
`
`Celgene does not have an adequate remedy at law.
`
`This case is an exceptional one, and Celgene is entitled to an award of its
`
`reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`Count III: Infringement of the ’217 Patent
`
`67.
`
`Celgene repeats and realleges the allegations of the preceding paragraphs as if
`
`fully set forth herein.
`
`68.
`
`BPI, BPL, and Biocon Limited’s submission of their ANDA, with the
`
`accompanying Paragraph IV Certification and notice to Celgene of same, to engage in the
`
`commercial manufacture, use, sale, offer for sale, or importation into the United States of
`
`
`
`13
`
`

`

`Case 2:21-cv-11261 Document 1 Filed 05/14/21 Page 14 of 30 PageID: 14
`
`
`
`Biocon’s Proposed Products, prior to the expiration of the ’217 patent, constitutes infringement
`
`of one or more of the claims of that patent under 35 U.S.C. § 271(e)(2)(A).
`
`69.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the ’217 patent.
`
`70.
`
`Unless enjoined by this Court, upon FDA approval of Biocon’s ANDA, BPI,
`
`BPL, and Biocon Limited will infringe one or more claims of the ’217 patent under 35 U.S.C. §
`
`271(a) by making, using, offering to sell, selling, and/or importing Biocon’s Proposed Products
`
`in the United States.
`
`71.
`
`Unless enjoined by this Court, upon FDA approval of Biocon’s ANDA, BPI,
`
`BPL, and Biocon Limited will induce infringement of one or more claims of the ’217 patent
`
`under 35 U.S.C. § 271(b) by making, using, offering to sell, selling, and/or importing Biocon’s
`
`Proposed Products in the United States. On information and belief, upon FDA approval of
`
`Biocon’s ANDA, BPI, BPL, and Biocon Limited will intentionally encourage acts of direct
`
`infringement with knowledge of the ’217 patent and knowledge that their acts are encouraging
`
`infringement.
`
`72.
`
`Unless enjoined by this Court, upon FDA approval of Biocon’s ANDA, BPI,
`
`BPL, and Biocon Limited will contributorily infringe one or more claims of the ’217 patent
`
`under 35 U.S.C. § 271(c) by making, using, offering to sell, selling, and/or importing Biocon’s
`
`Proposed Products in the United States. On information and belief, BPI, BPL, and Biocon
`
`Limited have had and continue to have knowledge that Biocon’s Proposed Products are
`
`especially adapted for a use that infringes one or more claims of the ’217 patent and that there is
`
`no substantial non-infringing use for Biocon’s Proposed Products.
`
`
`
`14
`
`

`

`Case 2:21-cv-11261 Document 1 Filed 05/14/21 Page 15 of 30 PageID: 15
`
`
`
`73.
`
`Celgene will be substantially and irreparably damaged and harmed if BPI, BPL,
`
`and Biocon Limited’s infringement of the ’217 patent is not enjoined.
`
`74.
`
`75.
`
`Celgene does not have an adequate remedy at law.
`
`This case is an exceptional one, and Celgene is entitled to an award of its
`
`reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`Count IV: Infringement of the ’569 Patent
`
`76.
`
`Celgene repeats and realleges the allegations of the preceding paragraphs as if
`
`fully set forth herein.
`
`77.
`
`BPI, BPL, and Biocon Limited’s submission of their ANDA, with the
`
`accompanying Paragraph IV Certification and notice to Celgene of same, to engage in the
`
`commercial manufacture, use, sale, offer for sale, or importation into the United States of
`
`Biocon’s Proposed Products, prior to the expiration of the ’569 patent, constitutes infringement
`
`of one or more of the claims of that patent under 35 U.S.C. § 271(e)(2)(A).
`
`78.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the ’569 patent.
`
`79.
`
`Unless enjoined by this Court, upon FDA approval of Biocon’s ANDA, BPI,
`
`BPL, and Biocon Limited will infringe one or more claims of the ’569 patent under 35 U.S.C. §
`
`271(a) by making, using, offering to sell, selling, and/or importing Biocon’s Proposed Products
`
`in the United States.
`
`80.
`
`Unless enjoined by this Court, upon FDA approval of Biocon’s ANDA, BPI,
`
`BPL, and Biocon Limited will induce infringement of one or more claims of the ’569 patent
`
`under 35 U.S.C. § 271(b) by making, using, offering to sell, selling, and/or importing Biocon’s
`
`Proposed Products in the United States. On information and belief, upon FDA approval of
`
`
`
`15
`
`

`

`Case 2:21-cv-11261 Document 1 Filed 05/14/21 Page 16 of 30 PageID: 16
`
`
`
`Biocon’s ANDA, BPI, BPL, and Biocon Limited will intentionally encourage acts of direct
`
`infringement with knowledge of the ’569 patent and knowledge that their acts are encouraging
`
`infringement.
`
`81.
`
`Unless enjoined by this Court, upon FDA approval of Biocon’s ANDA, BPI,
`
`BPL, and Biocon Limited will contributorily infringe one or more claims of the ’569 patent
`
`under 35 U.S.C. § 271(c) by making, using, offering to sell, selling, and/or importing Biocon’s
`
`Proposed Products in the United States. On information and belief, BPI, BPL, and Biocon
`
`Limited have had and continue to have knowledge that Biocon’s Proposed Products are
`
`especially adapted for a use that infringes one or more claims of the ’569 patent and that there is
`
`no substantial non-infringing use for Biocon’s Proposed Products.
`
`82.
`
`Celgene will be substantially and irreparably damaged and harmed if BPI, BPL,
`
`and Biocon Limited’s infringement of the ’569 patent is not enjoined.
`
`83.
`
`84.
`
`Celgene does not have an adequate remedy at law.
`
`This case is an exceptional one, and Celgene is entitled to an award of its
`
`reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`Count V: Infringement of the ’717 Patent
`
`85.
`
`Celgene repeats and realleges the allegations of the preceding paragraphs as if
`
`fully set forth herein.
`
`86.
`
`BPI, BPL, and Biocon Limited’s submission of their ANDA, with the
`
`accompanying Paragraph IV Certification and notice to Celgene of same, to engage in the
`
`commercial manufacture, use, sale, offer for sale, or importation into the United States of
`
`Biocon’s Proposed Products, prior to the expiration of the ’717 patent, constitutes infringement
`
`of one or more of the claims of that patent under 35 U.S.C. § 271(e)(2)(A).
`
`
`
`16
`
`

`

`Case 2:21-cv-11261 Document 1 Filed 05/14/21 Page 17 of 30 PageID: 17
`
`
`
`87.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the ’717 patent.
`
`88.
`
`Unless enjoined by this Court, upon FDA approval of Biocon’s ANDA, BPI,
`
`BPL, and Biocon Limited will infringe one or more claims of the ’717 patent under 35 U.S.C. §
`
`271(a) by making, using, offering to sell, selling, and/or importing Biocon’s Proposed Products
`
`in the United States.
`
`89.
`
`Unless enjoined by this Court, upon FDA approval of Biocon’s ANDA, BPI,
`
`BPL, and Biocon Limited will induce infringement of one or more claims of the ’717 patent
`
`under 35 U.S.C. § 271(b) by making, using, offering to sell, selling, and/or importing Biocon’s
`
`Proposed Products in the United States. On information and belief, upon FDA approval of
`
`Biocon’s ANDA, BPI, BPL, and Biocon Limited will intentionally encourage acts of direct
`
`infringement with knowledge of the ’717 patent and knowledge that their acts are encouraging
`
`infringement.
`
`90.
`
`Unless enjoined by this Court, upon FDA approval of Biocon’s ANDA, BPI,
`
`BPL, and Biocon Limited will contributorily infringe one or more claims of the ’717 patent
`
`under 35 U.S.C. § 271(c) by making, using, offering to sell, selling, and/or importing Biocon’s
`
`Proposed Products in the United States. On information and belief, BPI, BPL, and Biocon
`
`Limited have had and continue to have knowledge that Biocon’s Proposed Products are
`
`especially adapted for a use that infringes one or more claims of the ’717 patent and that there is
`
`no substantial non-infringing use for Biocon’s Proposed Products.
`
`91.
`
`Celgene will be substantially and irreparably damaged and harmed if BPI, BPL,
`
`and Biocon Limited’s infringement of the ’717 patent is not enjoined.
`
`92.
`
`Celgene does not have an adequate remedy at law.
`
`
`
`17
`
`

`

`Case 2:21-cv-11261 Document 1 Filed 05/14/21 Page 18 of 30 PageID: 18
`
`
`
`93.
`
`This case is an exceptional one, and Celgene is entitled to an award of its
`
`reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`Count VI: Infringement of the ’498 Patent
`
`94.
`
`Celgene repeats and realleges the allegations of the preceding paragraphs as if
`
`fully set forth herein.
`
`95.
`
`BPI, BPL, and Biocon Limited’s submission of their ANDA, with the
`
`accompanying Paragraph IV Certification and notice to Celgene of same, to engage in the
`
`commercial manufacture, use, sale, offer for sale, or importation into the United States of
`
`Biocon’s Proposed Products, prior to the expiration of the ’498 patent, constitutes infringement
`
`of one or more of the claims of that patent under 35 U.S.C. § 271(e)(2)(A).
`
`96.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the ’498 patent.
`
`97.
`
`Unless enjoined by this Court, upon FDA approval of Biocon’s ANDA, BPI,
`
`BPL, and Biocon Limited will infringe one or more claims of the ’498 patent under 35 U.S.C. §
`
`271(a) by making, using, offering to sell, selling, and/or importing Biocon’s Proposed Products
`
`in the United States.
`
`98.
`
`Unless enjoined by this Court, upon FDA approval of Biocon’s ANDA,