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Galderma Laboratories et. al. v. Perrigo Israel Pharmaceuticals et. al.

Galderma Laboratories et. al. v. Perrigo Israel Pharmaceuticals et. al.

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Published by PriorSmart
Official Complaint for Patent Infringement in Civil Action No. 3:13-cv-03930-N: Galderma Laboratories, L.P. et. al. v. Perrigo Israel Pharmaceuticals Ltd. et. al. Filed in U.S. District Court for the Northern District of Texas, the Hon. David C Godbey presiding. See http://news.priorsmart.com/-l9de for more info.
Official Complaint for Patent Infringement in Civil Action No. 3:13-cv-03930-N: Galderma Laboratories, L.P. et. al. v. Perrigo Israel Pharmaceuticals Ltd. et. al. Filed in U.S. District Court for the Northern District of Texas, the Hon. David C Godbey presiding. See http://news.priorsmart.com/-l9de for more info.

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Published by: PriorSmart on Sep 27, 2013
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IN THE UNITED STATES DISTRICT COURTFOR THE NORTHERN DISTRICT OF TEXASDALLAS DIVISIONGALDERMA LABORATORIES, L.P.,GALDERMA S.A., andGALDERMA RESEARCH &DEVELOPMENT, S.N.C.,Plaintiffs,v.PERRIGO ISRAELPHARMACEUTICALS LTD. andPERRIGO COMPANY,Defendants.§§§§§§§§§§§§§§ CIVIL ACTION NO. ______________COMPLAINT FOR PATENT INFRINGEMENT
Plaintiffs GALDERMA LABORATORIES, L.P., GALDERMA S.A., and GALDERMARESEARCH & DEVELOPMENT, S.N.C. file this Complaint for Patent Infringement againstDefendants PERRIGO ISRAEL PHARMACEUTICALS LTD. and PERRIGO COMPANY and state:
PARTIES
1.
 
Galderma Laboratories, L.P. (“Galderma L.P.”) is a Texas limited partnershipwith its principal place of business at 14501 North Freeway, Fort Worth, Texas 76177.Galderma L.P. is the beneficial holder of rights to market Epiduo
®
(adapalene and benzoyl peroxide) Gel, 0.1% / 2.5% (“Epiduo
®
Gel”) under FDA approval of New Drug Application No.022320, approved December 8, 2008. Galderma L.P. has the exclusive right from GaldermaR&D to distribute Epiduo
®
Gel in the United States. Epiduo
®
Gel is a topical gel prescriptiondrug that combines a retinoid (adapalene) and an antimicrobial (benzoyl peroxide) for thetreatment of acne vulgaris (severe acne) in people who are at least 12 years old.
 
22.
 
Galderma S.A. is a Swiss company with its principal place of business at World Trade Center, Avenue de Gratta-Paille 1, Case Postale 552, 1000 Lausanne 30 Grey,Switzerland. Galderma S.A. is involved in the research, development, marketing, and sale of  pharmaceutical products.3.
 
Galderma Research & Development, S.N.C. (“Galderma R&D”) is a Frenchcorporation with its principal place of business at 2400 Route Des Colles, Les Templiers, Biot,France 06410. Galderma R&D is the current owner of U.S. Patent No. 7,820,186 (the “’186Patent”), U.S. Patent No. 7,964,202 (the “’202 Patent”), U.S. Patent No. 8,071,644 (the “’644Patent”), U.S. Patent No. 8,080,537 (the “’537 Patent”), U.S. Patent No. 8,105,618 (the “’618Patent”), U.S. Patent No. 8,129,362 (the “’362 Patent”), U.S. Patent No. 8,241,649 (the “’649Patent”), and U.S. Patent No. 8,445,543 (the “’543 Patent”) (collectively the “’186, ’202, ’644,’537, ’618, ’362, ’649, and ’543 Patents” or “patents in suit”). A copy of the ’186 Patent isattached as Exhibit A. A copy of the ’202 Patent is attached as Exhibit B. A copy of the ’644Patent is attached as Exhibit C. A copy of the ’537 Patent is attached as Exhibit D. A copy of the ’618 Patent is attached as Exhibit E. A copy of the ’362 Patent is attached as Exhibit F. Acopy of the ’649 Patent is attached as Exhibit G. A copy of the ’543 Patent is attached as ExhibitH.4.
 
Perrigo Israel Pharmaceuticals, Ltd. (“Perrigo Israel”) is an Israeli corporationwith its principal place of business at 29 Lehi Street, Bnei Brak 51200, Israel. On informationand belief, Perrigo Israel is a wholly-owned subsidiary of Perrigo Company and is under thedirection, control, and/or influence of Perrigo Company, both generally and with respect to theconduct alleged in this Complaint. Perrigo Israel develops, manufactures, markets, and 
 
3distributes generic pharmaceutical products for sale in the State of Texas and throughout theUnited States in concert with its parent company Perrigo Company and related companies.5.
 
Perrigo Company is a Michigan corporation with its principal place of business at515 Eastern Avenue, Allegan, Michigan 49010. Perrigo Company is a generic pharmaceuticalcompany that develops, manufactures, markets, and distributes generic pharmaceutical productsfor sale in the State of Texas and throughout the United States.6.
 
Upon information and belief, Perrigo Company is the United States marketing and sales agent for Perrigo Israel, wherein, following FDA approval of an ANDA, Perrigo Israelmanufactures and supplies the approved generic drug products to Perrigo Company, which thenmarkets and sells those products throughout the United States, including in this judicial district.
NATURE OF THE ACTION
7.
 
This is a complaint for patent infringement of the ’186, ’202, ’644, ’537, ’618,’362, ’649, and ’543 Patents. This action relates to ANDA No. 205033 (the “ANDA”) submitted in the name of Perrigo Israel to the U.S. Food and Drug Administration (“FDA”) by its U.S.agent, Perrigo Company, for approval to make, market, and import a generic version of Galderma’s Epiduo
®
Gel product, which constitutes an act of infringement under the United States Patent Laws, 35 U.S.C. § 100,
et seq.
, including 35 U.S.C. § 271(e)(2).
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JURISDICTION AND VENUE
8.
 
This Court has jurisdiction over the subject matter of the claims asserted pursuantto 28 U.S.C. §§ 1331 and 1338(a). Venue in this Court is proper under 28 U.S.C. §§ 1391 and 1400(b).
1
 
Perrigo Israel and Perrigo Company are sometimes referred to herein collectively as “Perrigo.”
 

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