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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Pending - Other Pending
JANSSEN PHARMACEUTICALS, INC.
JANSSEN PHARMACEUTICA NV
JANSSEN RESEARCH & DEVELOPMENT, L.L.C.
MYLAN LABORATORIES LIMITED
MYLAN PHARMACEUTICALS INC.
MYLAN INSTITUTIONAL LLC
KEITH J. MILLER
Attorney at ROBINSON MILLER LLC
110 Edison Place, Suite 302
Newark, NJ 07102
Exhibit A to Complaint
Civil Cover Sheet
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)Read MoreRead Less
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