Source: https://www.scribd.com/document/90414482/Apotex-et-al-v-Paddock-Laboratories-et-al
Timestamp: 2016-10-24 05:34:55
Document Index: 163956038

Matched Legal Cases: ['§ 271', '§ 1331', '§ 1400', '§ 1391', 'Application No. 077536', 'Application No. 090096', '§271', '§271', '§ 271', '§ 283', '§ 284']

Apotex et. al. v. Paddock Laboratories et. al.
BrowseBrowseInterestsBiography & MemoirBusiness & LeadershipFiction & LiteraturePolitics & EconomyHealth & WellnessSociety & CultureHappiness & Self-HelpMystery, Thriller & CrimeHistoryYoung AdultBrowse byBooksAudiobooksComicsSheet MusicBrowse allUploadSign inJoinBooksAudiobooksComicsSheet MusicApotex et. al. v. Paddock Laboratories et. al.Uploaded by PriorSmartPatentpatentGeneric Drug150 viewsDownloadEmbedDescription: Official Complaint for Patent Infringement in Civil Action No. None: Apotex, Inc. et. al. v. Paddock Laboratories, Inc. et. al. Filed in U.S. District Court for the Southern District of Florida, no...See MoreOfficial Complaint for Patent Infringement in Civil Action No. None: Apotex, Inc. et. al. v. Paddock Laboratories, Inc. et. al. Filed in U.S. District Court for the Southern District of Florida, no judge yet assigned. See http://news.priorsmart.com/-l5Vj for more info.Copyright: Public DomainDownload as PDF, TXT or read online from ScribdFlag for inappropriate contentUNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF FLORIDAAPOTEX, INC., a Canadian corporation and APOTEX CORP., a Delaware corporation, Plaintiffs, vs. PADDOCK LABORATORIES, INC, a Delaware corporation, and PERRIGO COMPANY, a Delaware corporation, Defendant COMPLAINT Plaintiffs, Apotex Inc. and Apotex Corp. (collectively “Apotex”), sue Defendants, Paddock Laboratories, Inc. and Perrigo Company, and state: NATURE OF THE ACTION 1. This is an action for patent infringement of certain process claims arising under the Case No.: JURY TRIAL DEMANDED
Patent Laws of the United States, 35 U.S.C. §§ 271 and 281-285. Jurisdiction is based upon 28 U.S.C. §§ 1331 and 1338(a). PARTIES 2. Plaintiff, Apotex Inc., is a Canadian corporation having its principal place of business
generic medications to consumers at a lower cost than branded medications.
Plaintiff, Apotex Corp., is a Delaware corporation having its principal place of
business in Broward County, Florida. 5. Apotex Corp. is the exclusive licensed distributor of generic moexipril medication in
the United States. 6. On information and belief, Paddock Laboratories, Inc. (“Paddock”) is a Delaware
corporation having its principal place of business in Minneapolis, Minnesota. 7. On information and belief, Perrigo Company (“Perrigo”) is a Delaware corporation
having its principal place of business in Allegan, Michigan. Perrigo acquired Paddock on or about July 16, 2011. On information and belief, Paddock products will be converted to the Perrigo brand over the next several months. 8. On information and belief, Defendants develop, manufacture, test, package, market,
promote, offer to sell, sell and distribute pharmaceutical products in the United States, including this judicial district. JURISDICTION AND VENUE 9. Venue is proper under 28 U.S.C. § 1400(b) and/or 28 U.S.C. § 1391(b) and (c) 100 et
seq. because Defendants committed acts of patent infringement, a substantial part of the events giving rise to this claim occurred, and Defendants are subject to personal jurisdiction, in this judicial district. 10. This Court has personal jurisdiction over Defendants by virtue of Defendants’ offers
for sale, sales and distribution of products, including the products which are the subject of this Complaint, throughout the State of Florida and in this District. Defendants have also placed, and are continuing to place, products into the stream of commerce in this District, and it is reasonable
to expect that such products will continue to enter and be used by consumers in Florida, including in this District. GENERAL ALLEGATIONS 11. Apotex Inc. is the lawful owner by assignment of all right, title and interest in United
States Patent No. 6,767,556 (“the ‘556 Patent”) entitled “Pharmaceutical Compositions Comprising Moexipril Magnesium,” relating to, inter alia, processes for making solid pharmaceutical compositions comprising moexipril magnesium made by reacting moexipril or an acid addition salt thereof with an alkaline magnesium compound in the presence of a solvent so as to convert the moexipril or moexipril acid addition salt to moexipril magnesium. Claims 1-15 claim such processes. 12. The ‘556 Patent was duly and lawfully issued by the U.S. Patent and Trademark
Office on July 27, 2004. A true and correct copy is attached hereto as the Exhibit. 13. 14. Apotex Corp. is the exclusive licensee of the ‘556 Patent. Apotex Inc. manufactures generic moexipril tablets for Apotex Corp. by a process
described and claimed in the ‘556 Patent. 15. Apotex Corp. imports generic moexipril tablets from Apotex, Inc. Such generic
moexipril tablets are approved by the U.S. Food and Drug Administration (“FDA”) to treat hypertension when administered alone or in combination with thiazide diuretics. Apotex Corp. sells and has sold such FDA-approved moexipril tablets in and throughout the United States. 16. Defendants, directly or by and/or through their agents, manufacture, import, offer for
sale, sell, and/or use tablets made by a process that is covered by claims 1-15 of the ‘556 Patent.
Moexipril Product 17. Defendant Paddock received approval from the FDA for Abbreviated New Drug
Application No. 077536 to market and sell generic moexpril hydrochloride products (“Paddock’s Moexipril Product”) in the United States. On information and belief, Paddock products will be converted to the Perrigo brand over the next several months. According to the product label, Paddock’s Moexipril Product contains moexipril hydrochloride, magnesium oxide, and magnesium stearate. However, testing of the Paddock’s Moexipril Product demonstrates that it contains moexipril magnesium, which is an indication that Paddock’s Moexipril Product is made by a process covered by claims 1-15 of the ‘556 patent. However, Paddock’s exact process is not publicly available. After an opportunity for discovery, there is likely to be evidence that the process used to manufacture Paddock’s Moexipril Product comprises reacting moexipril or an acid addition salt thereof with an alkaline magnesium compound in the presence of a solvent so as to convert the moexipril or moexipril acid addition salt to moexipril magnesium, which process is covered by the ‘556 patent. Moexipril Combination Product 18. Defendant Paddock also received approval from the FDA for Abbreviated New Drug
Application No. 090096 to market and sell generic moexpril hydrochloride and hydrochlorothiazide products (“Paddock’s Moexipril Combination Product”) in the United States. On information and belief, Paddock products will be converted to the Perrigo brand over the next several months. According to the product label, Paddock’s Moexipril Combination Product contains moexipril hydrochloride, magnesium oxide, and magnesium stearate. 19. Apotex is presently not aware of any analytical technique that can be used to
definitively establish that Paddock’s Moexipril Combination Product was made by use of one or
more processes claimed in the ‘556 Patent. However, based on analytical studies available to it, Apotex believes that Defendants are likely practicing processes covered by the claims of the ‘556 Patent. Apotex resorts to the judicial process and the aid of discovery to determine under appropriate judicial safeguards the exact processes used by Defendants to manufacture Paddock’s Moexipril Combination Product and confirm its belief that Defendants infringe one or more claims of the ‘556 Patent. COUNT I INFRINGEMENT OF THE PROCESS CLAIMS OF U.S. PATENT NO. 6,767,556 (MOEXIPRIL PRODUCT) 20. reference. 21. Upon information and belief, which is likely to be substantiated through discovery, The allegations of paragraphs 1-19 are realleged and incorporated herein by
Defendants have infringed one or more of claims 1-15 of the ‘556 Patent by using a process covered by those claims to manufacture products, including Paddock’s Moexipril Product, and or by importing, selling and/or offering for sale the products of such process into the United States in violation of 35 U.S.C. §271 (a) and/or (g).
COUNT II INFRINGEMENT OF THE PROCESS CLAIMS OF U.S. PATENT NO. 6,767,556 (MOEXIPRIL COMBINATION PRODUCT) 22. reference. 23. Upon information and belief, which is likely to be substantiated through discovery, The allegations of paragraphs 1-19 are realleged and incorporated herein by
Defendants have infringed one or more of claims 1-15 of the ‘556 Patent by using a process covered by those claims to manufacture products, including Paddock’s Moexipril Combination
Product, and or by importing, selling and/or offering for sale the products of such process into the United States in violation of 35 U.S.C. §271 (a) and/or (g).
RELIEF REQUESTED WHEREFORE, Plaintiffs respectfully request that this Court enter judgment in their favor and against each Defendant and grant the following relief: a. A judgment and decree that the ‘556 Patent is valid and enforceable; b. A judgment and decree that each Defendant has infringed the ‘556 Patent in violation of 35 U.S.C. § 271; c. A preliminary and permanent injunction, pursuant to 35 U.S.C. § 283, enjoining each Defendant and their officers, agents, employees and all others in concert or participation with them from acts of infringement of the ‘556 Patent; d. An Order, pursuant to 35 U.S.C. § 284, awarding Plaintiffs damages adequate to compensate for Defendants’ infringement of the ‘556 Patent, in an amount to be determined at trial, but in no event less than a reasonable royalty; and e. Such other and further relief that the Court may deem just and proper. JURY DEMAND Apotex demands a trial by jury.
Respectfully submitted, /s/Matthew S. Nelles_______ MATTHEW S. NELLES Fla. Bar No. 009245 mnelles@broadandcassel.com BROAD AND CASSEL Attorneys for Plaintiffs One Financial Plaza 100 S.E. Third Ave., Suite 2700 Fort Lauderdale, FL 33394 Telephone: (954) 764-7060 Facsimile: (954) 761-8135 Co-Counsel KATTEN MUCHIN ROSENMAN LLP Robert B. Breisblatt Fla. Bar No. 145928 robert.breisblatt@kattenlaw.com Eric C. Cohen Brian J. Sodikoff Martin S. Masar III Christopher B. Ferenc 525 West Monroe Street Chicago, IL 60661-3693 Telephone: (312) 902-5480 eric.cohen@kattenlaw.com brian.sodikoff@kattenlaw.com martin.masar@kattenlaw.com christopher.ferenc@kattenlaw.com Attorneys for Defendants Apotex Corp. and Apotex Inc.
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