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Alza Et. Al. v. Osmotica Kereskedelmi Es Szolgaltato Kft

Alza Et. Al. v. Osmotica Kereskedelmi Es Szolgaltato Kft

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Alza et. al. v. Osmotica Kereskedelmi es Szolgaltato Kft
Alza et. al. v. Osmotica Kereskedelmi es Szolgaltato Kft

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Published by: PatentBlast on Jun 28, 2013
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02/28/2014

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IN THE UNITED STATES DISTRICT COURTFOR THE NORTHERN DISTRICT OF ILLINOIS
ALZA CORPORATION andJANSSEN PHARMACEUTICALS, INC.,Plaintiffs,v.OSMOTICA KERESKEDELMI ESSZOLGALTATO KFT,Defendant.))))))))))))Civil Action No. ____________ 
COMPLAINT
In this patent infringement action, Plaintiffs ALZA Corporation ("ALZA") andJanssen Pharmaceuticals, Inc. (collectively "Plaintiffs"), for their complaint against Defendant,Osmotica Kereskedelmi es Szolgaltato Kft, allege as follows:
NATURE OF THE ACTION
1.
 
This is an action for patent infringement under the patent laws of theUnited States, Title 35, United States Code, in response to the filing by the Defendant of Abbreviated New Drug Application ("ANDA") No. 20-5327 with the U.S. Food and DrugAdministration ("FDA") seeking approval to manufacture and sell a generic version of CONCERTA® prior to the expiration of U.S. Patent No. 8,163,798.
PARTIES
2.
 
Plaintiff ALZA is a Delaware corporation, having its principal place of  business at 700 Eubanks Drive, Vacaville, California 95688.3.
 
Plaintiff Janssen Pharmaceuticals, Inc. is a Pennsylvania corporation,having a place of business at 1125 Trenton-Harbourton Road, Titusville, New Jersey 08560.
 
 24.
 
On information and belief, Defendant Osmotica Kereskedelmi esSzolgaltato Kft ("Osmotica Kft") is a company organized under the laws of Hungary involved inthe development and sale of pharmaceutical products in various countries and has a place of  business at Berlini u. 47-49. III. ép. I. em, Budapest 1045, Hungary.5.
 
On information and belief, Osmotica Kft is the owner of ANDA No. 20-5327 and is the ANDA applicant.
JURISDICTION AND VENUE
6.
 
This action for patent infringement arises under 35 U.S.C. § 1
et seq.
 generally, and 35 U.S.C. §§ 271(b), 271(c), 271(e)(2) specifically.7.
 
This Court has subject matter jurisdiction over this dispute pursuant to 28U.S.C. §§ 1331, 1338(a), 2201, and 2202.8.
 
Personal jurisdiction over Defendant Osmotica Kft is proper because, oninformation and belief, Osmotica Kft is the applicant of ANDA No. 20-5327 and has designatedas its authorized agent for receipt of service of process relating to the commencement of a patentinfringement suit based on ANDA No. 20-5327 a resident of the Northern District of Illinois athis business address in the Northern District of Illinois, specifically Mr. William A. Rakoczy,
AKOCZY
M
OLINO
M
AZZOHI
S
IWIK 
LLP, 6 West Hubbard Street, Suite 500, Chicago, IL 60654.9.
 
Venue is proper in this district pursuant to 28 U.S.C. §§ 1391 and 1400(b).
GENERAL ALLEGATIONS
10.
 
On April 24, 2012, the USPTO issued U.S. Patent No. 8,163,798 ("the'798 Patent"). A true and correct copy of the '798 Patent is attached hereto as Exhibit A.11.
 
Plaintiffs own all rights, title and interest in the '798 Patent, including allrights needed to bring this action in Plaintiffs' names.12.
 
ALZA is the current assignee of the '798 Patent.
 
 313.
 
ALZA manufactures the drug covered by the FDA-approved New DrugApplication ("NDA") No. 21-121 and marketed under the registered tradename CONCERTA®,the active ingredient of which is methylphenidate hydrochloride ("CONCERTA" or "theCONCERTA drug product"), in the United States.14.
 
Janssen Pharmaceuticals, Inc. holds NDA No. 21-121 for CONCERTA.15.
 
Marketing of CONCERTA is authorized in four dosage strengths (
i.e.
, 18mg, 27 mg, 36 mg and 54 mg) by NDA No. 21-121.16.
 
CONCERTA is covered by one or more claims of the '798 Patent, whichis listed in connection with CONCERTA in the FDA's publication,
 Approved Drug Productswith Therapeutic Equivalence Evaluations
(the "Orange Book") as a patent "with respect towhich a claim of patent infringement could reasonably be asserted if a person not licensed by theowner engaged in the manufacture, use, or sale of the drug" CONCERTA.
See
21 U.S.C.§ 355(b)(1).17.
 
On information and belief, Osmotica Kft filed ANDA No. 20-5327 withthe FDA seeking approval to market a generic copy of the 54 mg dosage strength of theCONCERTA drug product (the "ANDA Product") prior to the expiration of the '798 Patent. Oninformation and belief, if ANDA No. 20-5327 is approved by the FDA, Osmotica Kft will, prior to the expiration of the '798 Patent, begin making, selling, offering for sale, marketing,distributing, and/or importing a generic copy of the 54 mg dosage strength of the CONCERTAdrug product for the treatment of ADHD, and doctors and patients will use the 54 mg dosagestrength of Osmotica Kft's generic copy of the CONCERTA drug product for the indicationsfound in the approved generic label,
i.e
., the treatment of ADHD.18.
 
Pursuant to FDA regulation 21 C.F.R. § 314.94, Osmotica Kft's genericcopy of CONCERTA must have the same dosage strength as CONCERTA and must be bioequivalent to CONCERTA.

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