This case was last updated from U.S. District Courts on 12/13/2021 at 10:08:35 (UTC).

JANSSEN PHARMACEUTICALS, INC. et al v. MYLAN LABORATORIES LIMITED et al

Case Summary

On October 14, 2021, Janssen Pharmaceuticals, Inc. (“JPI”), Janssen Pharmaceutica NV (“JPN”), and Janssen Research & Development, LLC (“JRD”), (collectively “Plaintiffs” or “Janssen”), represented by Keith J. Miller of Robinson Miller LLC, filed an intellectual property lawsuit against Mylan Laboratories Limited (“MLL”), Mylan Pharmaceuticals, Inc. (“MPI”), and Mylan Institutional LLC (“MIL”) (collectively “Defendants” or “Mylan”), seeking declaratory relief, injunctive relief with damages, and other relief for the alleged infringement of the United States Patent owned by Plaintiffs. This case was filed in the United States District Court in the District of New Jersey. 

Plaintiffs filed this complaint for the alleged infringement of United States Patent No. 10,143,693 (the “’693 Patent”) entitled “Dosing Regimen For Missed Doses For Long-Acting Injectable Paliperidone Ester” owned by Plaintiff.

In the complaint, Plaintiffs alleged that, “An actual controversy exists between the parties as to whether Mylan’s proposed sale of its generic paliperidone palmitate extended-release suspension products (273 mg/0.875 mL and 410 mg/1.315 mL) infringe at least one claim, including claim 1, of the ’693 Patent”  and “By letter dated September 8, 2021 (“Mylan Notice Letter”), MLL notified Plaintiffs that it had submitted ANDA No. 216228 to the FDA under § 505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(j)).” 

Plaintiffs further alleged that, “ANDA No. 216228 specifically seeks FDA approval to market generic versions of JPI’s Invega Trinza® brand paliperidone palmitate extended-release injectable suspension products in the 273 mg/0.875 mL and 410 mg/1.315 mL strengths prior to the expiration of the ’693 Patent” and “ANDA No. 216228 includes a Paragraph IV Certification that the claims of the ’693 Patent are invalid, unenforceable, and/or not infringed.” The Plaintiff also alleged that, “The Mylan Notice Letter purports to include a Notice of Certification for ANDA No. 216228 under 37 C.F.R. § 314.95(c)(6) as to the ’693 Patent. The Mylan Notice Letter did not include a detailed statement of allegations of non-infringement as to at least one claim of the ’693 Patent.”

Plaintiffs also alleged that, “Mylan has actual knowledge of the ’693 Patent, as shown by the Mylan Notice Letter” and “On information and belief, Mylan’s proposed generic versions of JPI’s Invega Trinza® brand product (273 mg/0.875 mL and 410 mg/1.315 mL), if approved and marketed, will infringe, either literally or under the doctrine of equivalents, at least one claim, including at least claim 1 of the ’693 Patent, under at least one of 35 U.S.C. § 271(a), (b), and/or (c).”

There is one claim of relief laid down by Plaintiffs for the alleged infringement of the ’693 Patent. 

In the prayer for relief, Plaintiff requested the court for declaratory relief and injunctive relief along with damages if Mylan engages in the commercial manufacture, use, offer for sale, sale, and/or importation into the United States of the proposed generic versions of JPI’s Invega Trinza® brand product (273 mg/0.875 mL and 410 mg/1.315 mL) identified in the complaint prior to the expiration of the ’693 Patent. Plaintiffs also requested for costs, expenses, and disbursements in this action, including reasonable attorneys’ fees, and any other relief the court deems just and proper.

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Case Details Parties Documents Dockets

 

Case Details

  • Case Number:

    3:21-CV-18609

  • Filing Date:

    10/14/2021

  • Case Status:

    Pending - Other Pending

  • Case Type:

    Intellectual Property - Patent

Judge Details

Presiding Judge

Zahid N. Quraishi

Referral Judge

Lois H. Goodman

 

Party Details

Plaintiffs and Counter Defendants

JANSSEN PHARMACEUTICALS, INC.

JANSSEN PHARMACEUTICA NV

JANSSEN RESEARCH & DEVELOPMENT, L.L.C.

Defendant and Counter Claimant

MYLAN LABORATORIES LIMITED

Attorney/Law Firm Details

Plaintiff and Counter Defendant Attorney

KEITH J. MILLER

Attorney at ROBINSON MILLER LLC

110 Edison Place, Suite 302

Newark, NJ 07102

Defendant and Counter Claimant Attorneys

JEFFREY S. SOOS

Attorney at SAIBER LLC

One Gateway Center, 10Th Floor

Newark, NJ 07102-5311

KATHERINE ANN ESCANLAR

Attorney at SAIBER LLC

18 Columbia Turnpike, Suite 200

Florham Park, NJ 07932

ARNOLD B. CALMANN

Attorney at SAIBER LLC

18 Columbia Turnpike, Suite 200

Florham Park, NJ 07932

 

Court Documents

11 #9

Text of Proposed Order

11 #8

Declaration of Joyce L. Nadipuram, Esq.

11 #7

Declaration of Aron Fischer, Esq.

11 #6

Declaration of Barbara Lynn Mullin, Esq.

11 #5

Declaration of Andrew D. Cohen, Esq.

11 #4

Declaration of A. Robert Quirk, Esq.

11 #3

Declaration of J. Jay Cho, Esq.

11 #2

Declaration of Lachlan Campbell-Verduyn, Esq.

11 #1

Declaration of Keith J. Miller, Esq.

11 #11

Main Document

#10

(#10) ANSWER to Counterclaim by JANSSEN PHARMACEUTICA NV, JANSSEN PHARMACEUTICALS, INC., JANSSEN RESEARCH & DEVELOPMENT, L.L.C..(MILLER, KEITH) (Entered: 11/18/2021)

#9

(#9) NOTICE of Appearance by KATHERINE ANN ESCANLAR on behalf of MYLAN LABORATORIES LIMITED (ESCANLAR, KATHERINE) (Entered: 11/05/2021)

#8

(#8) NOTICE of Appearance by JEFFREY S. SOOS on behalf of MYLAN LABORATORIES LIMITED (SOOS, JEFFREY) (Entered: 11/05/2021)

#7

(#7) Corporate Disclosure Statement by MYLAN LABORATORIES LIMITED. (CALMANN, ARNOLD) (Entered: 11/05/2021)

6 #1

Certificate of Service

6 #6

Main Document

#5

(#5) STIPULATION AND ORDER of Dismissal without prejudice as to Defendants MYLAN INSTITUTIONAL LLC and MYLAN PHARMACEUTICALS INC. Signed by Judge Zahid N. Quraishi on 10/18/2021. (jem) (Entered: 10/18/2021)

4 #4

Main Document

16 More Documents Available
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Docket Entries

  • 12/02/2021
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  • Docket(#11) Letter from Keith J. Miller, Esq. to Hon. Lois H. Goodman, U.S.M.J. enclosing application for the pro hac vice admissions of Lachlan Campbell-Verduyn, Esq., J. Jay Cho, Esq., A. Robert Quirk, Esq., Andrew D. Cohen, Esq., Barbara Lynn Mullin, Esq., Aron Fischer, Esq., and Joyce L. Nadipuram, Esq.. (Attachments: #1 Declaration of Keith J. Miller, Esq., #2 Declaration of Lachlan Campbell-Verduyn, Esq., #3 Declaration of J. Jay Cho, Esq., #4 Declaration of A. Robert Quirk, Esq., #5 Declaration of Andrew D. Cohen, Esq., #6 Declaration of Barbara Lynn Mullin, Esq., #7 Declaration of Aron Fischer, Esq., #8 Declaration of Joyce L. Nadipuram, Esq., #9 Text of Proposed Order)(MILLER, KEITH) (Entered: 12/02/2021)

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  • 11/18/2021
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  • Docket(#10) ANSWER to Counterclaim by JANSSEN PHARMACEUTICA NV, JANSSEN PHARMACEUTICALS, INC., JANSSEN RESEARCH & DEVELOPMENT, L.L.C..(MILLER, KEITH) (Entered: 11/18/2021)

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  • 11/05/2021
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  • Docket(#9) NOTICE of Appearance by KATHERINE ANN ESCANLAR on behalf of MYLAN LABORATORIES LIMITED (ESCANLAR, KATHERINE) (Entered: 11/05/2021)

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  • 11/05/2021
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  • Docket(#8) NOTICE of Appearance by JEFFREY S. SOOS on behalf of MYLAN LABORATORIES LIMITED (SOOS, JEFFREY) (Entered: 11/05/2021)

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  • 11/05/2021
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  • Docket(#7) Corporate Disclosure Statement by MYLAN LABORATORIES LIMITED. (CALMANN, ARNOLD) (Entered: 11/05/2021)

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  • 11/05/2021
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  • Docket(#6) ANSWER to Complaint , Separate Defenses, and, COUNTERCLAIM against JANSSEN PHARMACEUTICA NV, JANSSEN PHARMACEUTICALS, INC., JANSSEN RESEARCH & DEVELOPMENT, L.L.C. by MYLAN LABORATORIES LIMITED. (Attachments: #1 Certificate of Service)(CALMANN, ARNOLD) (Entered: 11/05/2021)

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  • 10/18/2021
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  • Docket(#5) STIPULATION AND ORDER of Dismissal without prejudice as to Defendants MYLAN INSTITUTIONAL LLC and MYLAN PHARMACEUTICALS INC. Signed by Judge Zahid N. Quraishi on 10/18/2021. (jem) (Entered: 10/18/2021)

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  • 10/15/2021
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  • Docket(#4) Letter from Keith J. Miller, Esq. to Hon. Zahid N. Quraishi, U.S.D.J. re proposed Stipulation and Order Dismissing Certain Defendants. (Attachments: #1 Text of Proposed Order)(MILLER, KEITH) (Entered: 10/15/2021)

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  • 10/15/2021
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  • Docket(#3) AO120 Patent Form filed. (jal) (Entered: 10/15/2021)

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  • 10/15/2021
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  • Docket(#2) SUMMONS ISSUED as to MYLAN INSTITUTIONAL LLC, MYLAN LABORATORIES LIMITED, MYLAN PHARMACEUTICALS INC.. Attached is the official court Summons, please fill out Defendant and Plaintiffs attorney information and serve. (jal) (Entered: 10/15/2021)

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  • 10/15/2021
  • DocketJudge Zahid N. Quraishi and Magistrate Judge Lois H. Goodman added. (jal) (Entered: 10/15/2021)

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  • 10/14/2021
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  • Docket(#1) COMPLAINT against MYLAN INSTITUTIONAL LLC, MYLAN LABORATORIES LIMITED, MYLAN PHARMACEUTICALS INC. ( Filing and Admin fee $ 402 receipt number ANJDC-12894700) , Related Case Selected, filed by JANSSEN PHARMACEUTICALS, INC., JANSSEN RESEARCH & DEVELOPMENT, L.L.C., JANSSEN PHARMACEUTICA NV. (Attachments: #1 Exhibit A to Complaint, #2 Civil Cover Sheet)(MILLER, KEITH) (Entered: 10/14/2021)

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