Case 1:12-cv-08115-ALC-GWG Document 21 Filed 01/09/13 Page 1 of 3
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE SOUTHERN DISTRICT OF NEW YORK
`
`ENDO PHARMACEUTICALS INC.
`and GRÜNENTHAL GMBH,
`
`
`
`
`
`Plaintiffs,
`
`C.A. No. 12-CIV-8115-ALC-GWG
`
`v.
`
`AMNEAL PHARMACEUTICALS,
`LLC and AMNEAL
`PHARMACEUTICALS OF NEW
`YORK, LLC,
`
`
`
`
`
`Defendants.
`
`UNOPPOSED MOTION TO AMEND COMPLAINT UNDER RULE 15(a)
`
`Plaintiff Endo Pharmaceuticals Inc. (“Endo”) moves under Rule 15(a) of the Federal
`
`
`
`
`
`
`
`Rules of Civil Procedure for leave to file a Second Amended Complaint for patent infringement
`
`(attached hereto as Exhibit 1) against Defendants Amneal Pharmaceuticals, LLC and Amneal
`
`Pharmaceuticals Of New York, LLC (collectively “Defendants”). The Defendants do not oppose
`
`this Motion.
`
`Plaintiffs timely filed this Hatch-Waxman lawsuit on November 7, 2012 for infringement
`
`of U.S. Patent Nos. 7,851,482 and 8,192,722. Plaintiffs filed an Amended Complaint on
`
`November 14, 2012, asserting infringement of two additional patents, U.S. Patent Nos. 8,309,122
`
`and 8,309,060, which the United States Patent and Trademark Office (“USPTO”) issued after the
`
`original Complaint was filed. Plaintiffs now seek to file a Second Amended Complaint because
`
`the USPTO issued another patent, U.S. Patent No. 8,329,216 (“the ’216 Patent”), on December
`
`11, 2012, which Endo believes will be infringed by Defendants’ generic version of OPANA®
`
`ER.
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`- 1 -
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`ENDO - Ex. 2004
`Amneal v. Endo
`IPR2014-00360
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`

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`Case 1:12-cv-08115-ALC-GWG Document 21 Filed 01/09/13 Page 2 of 3
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`
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`Under Rule 15(a) of the Federal Rules of Civil Procedure, leave to amend a complaint
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`“shall be freely granted when justice so requires.” Fed. R. Civ. P. 15(a). The United States
`
`Supreme Court has recognized that Federal Courts should freely grant leave to amend where no
`
`“apparent or declared” reasons exist to deny the plaintiff the opportunity to test a claim on its
`
`merits. Foman v. Davis, 371 U.S. 178, 182 (1962). In the present case, Endo is expeditiously
`
`seeking to submit a Second Amended Complaint to include the newly issued ’216 Patent.
`
`Defendants do not oppose Endo’s proposed amendment. Because it is very early in this litigation
`
`― Defendants have not yet answered Plaintiffs’ Amended Complaint, no scheduling order has
`
`issued, and discovery has not yet commenced ― there has been no undue delay and Defendants
`
`will experience no prejudice if the Court grants Endo leave to amend. See Carson Optical, Inc.
`
`v. Electro-Optix, Inc., No. 09–CV–1625 (TCP), 2012 WL 6720784, *2 (E.D.N.Y. Dec. 21, 2012)
`
`(granting plaintiffs leave to amend complaint to add two new patents that issued after their
`
`original complaint was filed because discovery had not yet begun). Accordingly, Endo
`
`respectfully requests that the Court grant its Motion to Amend.
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`Case 1:12-cv-08115-ALC-GWG Document 21 Filed 01/09/13 Page 3 of 3
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`
`
`By: /s/ Joshua I. Sherman
`Joshua I. Sherman
`DECHERT LLP
`1095 Avenue of the Americas
`New York, NY 10036
`(212) 698-3500
`joshua.sherman@dechert.com
`
`
`
`Martin J. Black
`Robert D. Rhoad
`DECHERT LLP
`Cira Centre
`2929 Arch Street
`Philadelphia, PA 19104
`(215) 994-4000
`
`
`
`Ann M. Caviani Pease
`Jonathan D. Loeb
`DECHERT LLP
`2440 W. El Camino Real
`Suite 700
`Mountain View, CA 94040
`(650) 813-4800
`
`ATTORNEYS FOR PLAINTIFF
`ENDO PHARMACEUTICALS INC.
`
`Dated: January 9, 2013
`
`
`
`14784305
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`Case 1:12-cv-08115-ALC-GWG Document 21-1 Filed 01/09/13 Page 1 of 16
`Case1:12-cv—08115—ALC-GWG Document21-1
`Filed 01/09/13 Page1of16
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`EXHIBIT 1
`
`EXHIBIT 1
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`
`
`

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`Case 1:12-cv-08115-ALC-GWG Document 21-1 Filed 01/09/13 Page 2 of 16
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE SOUTHERN DISTRICT OF NEW YORK
`
`ENDO PHARMACEUTICALS INC.
`and GRÜNENTHAL GMBH,
`
`
`
`
`
`Plaintiffs,
`
`C.A. No. 12-CIV-8115-ALC-GWG
`
`v.
`
`AMNEAL PHARMACEUTICALS,
`LLC and AMNEAL
`PHARMACEUTICALS OF NEW
`YORK, LLC,
`
`
`
`
`
`Defendants.
`
`
`
`
`
`SECOND AMENDED COMPLAINT
`
`Plaintiffs Endo Pharmaceuticals Inc. (“Endo”) and Grünenthal GmbH (“Grünenthal”) for
`
`their Second Amended Complaint against Defendants Amneal Pharmaceuticals, LLC and
`
`Amneal Pharmaceuticals of New York, LLC (collectively, “Amneal”), alleges as follows:
`
`PARTIES
`
`1.
`
`Plaintiff Endo is a Delaware corporation, having its principal place of business at
`
`100 Endo Boulevard, Chadds Ford, Pennsylvania 19317. Endo is a specialty Pharmaceuticals
`
`company engaged in the research, development, sale and marketing of prescription
`
`pharmaceuticals used, among other things, to treat and manage pain. Endo markets and
`
`distributes OPANA® ER, an innovative crush-resistant opioid (alternatively referred to herein as
`
`“Opana ER CRF”).
`
`2.
`
`Plaintiff Grünenthal GmbH (“Grünenthal”) is a corporation organized and
`
`existing under the laws of Germany, having an address at 52078 Aachen, Zieglerstaβe 6, North
`
`Rhine-Westaphalia, Germany.
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`
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`

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`Case 1:12-cv-08115-ALC-GWG Document 21-1 Filed 01/09/13 Page 3 of 16
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`3.
`
`Upon information and belief, Amneal Pharmaceuticals, LLC (“Amneal
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`Pharmaceuticals”) is a limited liability company organized and existing under the laws of the
`
`State of Delaware, having a principal place of business at 440 U.S. Highway 22 East, Suite 104,
`
`Bridgewater, NJ 08897.
`
`4.
`
`Upon information and belief, Amneal Pharmaceuticals is a pharmaceutical
`
`company engaged in the research, development, production, distribution, and sale of generic
`
`pharmaceuticals throughout the United States, including sales within this judicial district.
`
`5.
`
`Upon information and belief, Amneal Pharmaceuticals of New York, LLC
`
`(“Amneal New York”) is a limited liability company organized and existing under the laws of the
`
`State of Delaware, and shares a principal place of business with Amneal Pharmaceuticals’
`
`administrative offices at 85 Adams Avenue, Hauppauge, New York 11788.
`
`6.
`
`Upon information and belief, Amneal New York is a pharmaceutical company
`
`engaged in the manufacturing for and the sale of generic prescription pharmaceutical products to
`
`Amneal Pharmaceuticals for distribution throughout the United States, including in this judicial
`
`district.
`
`NATURE OF ACTION
`
`7.
`
`This is an action for patent infringement arising under the Patent Laws of the
`
`United States, 35 U.S.C. § 100, et seq. and the Declaratory Judgment Act, 28 U.S.C. § 2201, et
`
`seq.
`
`JURISDICTION AND VENUE
`
`8.
`
`This Court has jurisdiction over the subject matter of this action pursuant to 28
`
`U.S.C. §§ 1331 and 1338(a) (patent infringement), and 28 U.S.C. §§ 2201 and 2202 (declaratory
`
`judgment).
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`Case 1:12-cv-08115-ALC-GWG Document 21-1 Filed 01/09/13 Page 4 of 16
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`9.
`
`10.
`
`Venue is proper in this district pursuant to 28 U.S.C. §§ 1391(b) and 1400(b).
`
`Upon information and belief, Amneal Pharmaceuticals conducts its North
`
`American operations in part through Amneal New York. Together, Amneal Pharmaceuticals and
`
`Amneal New York collaborate in the research, development, manufacture, testing, distribution
`
`and/or the sale of a number of pharmaceutical products manufactured and sold pursuant to
`
`approved abbreviated new drug applications within the United States and the State of New York
`
`generally and this judicial district specifically.
`
`11.
`
`This Court has personal jurisdiction over each of the Defendants by virtue of the
`
`fact that, inter alia, they have committed — or aided, abetted, planned, contributed to, or
`
`participated in the commission of — tortious conduct in the State of New York that has led to
`
`foreseeable harm and injury to Endo.
`
`12.
`
`Upon information and belief, Amneal Pharmaceuticals has submitted to FDA
`
`paperwork purporting to constitute an Abbreviated New Drug Application (“ANDA”) under
`
`§ 505(j) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 355(j) (“ANDA No. 20-4294”
`
`or “Amneal’s ANDA”), seeking approval to engage in the commercial manufacture, use, and sale
`
`of 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg oxymorphone hydrochloride extended-
`
`release tablets, (“Amneal’s ANDA Products”), as a generic version of the drug described in
`
`Endo’s sNDA 201655.
`
`13.
`
`Upon information and belief, Amneal both manufactures the Amneal ANDA
`
`Products and conducts testing necessary to validate their quality in the State of New York. On
`
`further information and belief, Amneal intends to manufacture and test Amneal’s ANDA Products
`
`produced for commercial sale in the State of New York.
`
`14.
`
`Upon information and belief, Amneal New York intends to manufacture generic
`
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`Case 1:12-cv-08115-ALC-GWG Document 21-1 Filed 01/09/13 Page 5 of 16
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`Opana ER CRF for distribution and sale in this judicial district should Amneal’s ANDA be
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`approved by FDA. Upon information and belief, Amneal Pharmaceuticals intends to distribute
`
`and sell generic Opana ER CRF in this judicial district should ANDA No. 20-4294 be approved
`
`by FDA.
`
`15.
`
`Moreover, Amneal Pharmaceuticals and Amneal New York maintain continuous
`
`and systematic contacts with the State of New York and this District.
`
`16.
`
`Upon information and belief, Amneal Pharmaceuticals and Amneal New York are
`
`registered with the New York State Department of State as corporations actively conducting
`
`business within New York and maintain a registered agent within the state.
`
`17.
`
`Upon information and belief, Amneal Pharmaceuticals currently sells significant
`
`quantities of generic drug products in the Southern District of New York. Those products
`
`include, for example, generic versions of Percocet®, Ultracet®, and Neurontin®. A list of
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`generic products manufactured and sold by Amneal Pharmaceuticals in the United States can be
`
`found at http://www.amneal.com/index.php.
`
`18.
`
`Upon information and belief, Amneal Pharmaceuticals maintains an
`
`administrative office at 85 Adams Avenue, Hauppauge, NY 11788; an oral solids manufacturing
`
`facility at 75 Adams Avenue, Hauppauge, NY 11788; an oral solids and softgels manufacturing
`
`facility at 50 Horseblock Road, Brookhaven, NY 11719; and an oral solids research and
`
`development facility at 50 Horseblock Road, Brookhaven, NY 11719.
`
`19.
`
`Upon information and belief, Amneal New York’s principal place of business is
`
`located at 85 Adams Avenue, Hauppauge, New York 11788.
`
`20.
`
`Furthermore, Amneal Pharmaceuticals has been sued as a patent infringer in this
`
`Court, asserted counterclaims in this Court, and declined to contest that this Court has personal
`
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`Case 1:12-cv-08115-ALC-GWG Document 21-1 Filed 01/09/13 Page 6 of 16
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`jurisdiction over it. See, e.g., Purdue Pharm, L.P., et al. v. Amneal Pharmaceuticals, LLC, 11-cv-
`
`08153-SHS-JLC; Pfizer Inc., et al. v. Actavis Inc., et al., 10-cv-8197-(TPG).
`
`21.
`
`Based on the facts and causes alleged herein, and for additional reasons to be
`
`developed through discovery, this Court has personal jurisdiction over the Defendants.
`
`FACTUAL BACKGROUND
`
`The Drug Approval Process
`
`22.
`
`A company seeking to market a new drug in the United States must first obtain
`
`approval from FDA, typically through the filing of a New Drug Application (“NDA”). See 21
`
`U.S.C. § 355(a). The sponsor of the NDA is required to submit information on all patents
`
`claiming the drug that is the subject of the NDA, or a method of using that drug, to FDA, and
`
`upon approval, FDA then lists such patent information in its publication, the Approved Drug
`
`Products with Therapeutic Equivalence Evaluations, which is referred to as the “Orange Book.”
`
`See 21 U.S.C. § 355(b)(1) and (c)(2).
`
`23.
`
`On the other hand, a company seeking to market a generic version of a previously
`
`approved drug is not required to submit a full NDA. Instead, it may file an ANDA. See 21
`
`U.S.C. § 355(j). The generic drug approval process is considered “abbreviated” because the
`
`generic manufacturer may piggyback on the innovator company’s data and FDA’s prior finding of
`
`safety and efficacy by demonstrating, among other things, that the generic product is
`
`bioequivalent to the previously approved drug (the “listed drug” or “branded drug”).
`
`24.
`
`In conjunction with this “abbreviated” application process, Congress has put in
`
`place a process for resolving patent disputes relating to generic drugs, under which an ANDA
`
`filer must provide certifications addressing each of the patents listed in the Orange Book for the
`
`branded drug. See 21 U.S.C. § 355(j)(2)(A)(vii); 21 C.F.R. § 314.94(a)(12). An ANDA filer may
`
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`Case 1:12-cv-08115-ALC-GWG Document 21-1 Filed 01/09/13 Page 7 of 16
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`certify, for instance, that it believes a patent is invalid or will not be infringed by the manufacture,
`
`use, or sale of the generic drug for which the ANDA is submitted. See 21 U.S.C. §
`
`355(j)(2)(A)(vii)(IV); 21 C.F.R. § 314.94(a)(12)(i)(A)(4). This is known as a “Paragraph IV
`
`Certification.”
`
`25.
`
`The sponsor of an ANDA which is accepted for review by FDA that contains a
`
`Paragraph IV Certification must provide notice (“Paragraph IV Notice”) to both the owner of the
`
`listed patents and the holder of the NDA for the referenced listed drug. The certification must
`
`include a detailed statement of the factual and legal bases for the applicant’s belief that the
`
`challenged patent is invalid or not infringed by the proposed generic product. 21 U.S.C. §
`
`355(j)(2)(B); 21 C.F.R. § 314.95.
`
`26.
`
`If the patentee or NDA holder files a patent infringement action within 45 days of
`
`receiving a Paragraph IV Notice from an ANDA filer, final approval of the ANDA is generally
`
`subject to a 30-month stay of regulatory approval. See 21 U.S.C. § 355(j)(5)(B)(iii); 21 C.F.R.
`
`§ 314.107(b)(3). The 30-month stay is important to innovator companies, such as Endo and
`
`Grünenthal, because it protects them from the severe financial harm that could otherwise ensue
`
`from FDA granting approval to a potentially infringing product without first providing an
`
`opportunity for the innovators to prove infringement and obtain an injunction prohibiting sale of
`
`the infringing product. Put another way, the innovator company is assured of a 30-month period
`
`during which it may try to enforce its intellectual property rights and resolve any patent dispute
`
`before the generic product enters the market. See 21 U.S.C. § 355(j)(5)(B)(iii).
`
`Endo’s Opana ER CRF NDA
`
`27.
`
`On December 12, 2011, FDA approved Endo’s Supplemental New Drug
`
`Application (“sNDA”) 201655, under § 505(b) of the Federal Food, Drug and Cosmetic Act, 21
`
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`Case 1:12-cv-08115-ALC-GWG Document 21-1 Filed 01/09/13 Page 8 of 16
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`U.S.C. § 355(b), for a new dosage form of Opana ER which is a crush-resistant tablet that
`
`contains oxymorphone hydrochloride for the relief of pain (hereinafter, “Opana ER CRF”).
`
`28.
`
`Opana ER CRF is distributed and sold throughout the United States for relief of
`
`moderate to severe pain in patients requiring continuous around-the-clock opioid treatment for an
`
`extended period of time.
`
`THE ENDO PATENTS
`
`29.
`
`On December 14, 2010, the PTO duly and legally issued U.S. Patent No.
`
`7,851,482 (“the ’482 Patent”), entitled “Method For Making Analgesics” to Johnson Matthey
`
`Public Limited Company (“Johnson Matthey”) as assignee. Jen-Sen Dung, Erno M. Keskeny,
`
`and James J. Mencel are named as inventors. A true and correct copy of the ’482 Patent is
`
`attached as Exhibit A.
`
`30.
`
`Endo subsequently acquired full title to the ’482 Patent, and accordingly, Endo is
`
`now the sole owner and assignee of the ’482 Patent.
`
`31.
`
`On November 13, 2012, the PTO duly and legally issued U.S. Patent No.
`
`8,309,122 (“the ’122 Patent”), entitled “Oxymorphone Controlled Release Formulations” to Endo
`
`Pharmaceuticals, Inc. as assignee. Huai-Hung Kao, Anand R. Baichwal, Troy McCall, and David
`
`Lee are named as inventors. A true and correct copy of the ’122 Patent is attached as Exhibit B.
`
`Endo is the sole owner and assignee of the ’122 Patent.
`
`32.
`
`On December 11, 2012, the PTO duly and legally issued U.S. Patent No.
`
`8,329,216 (“the ’216 Patent”), entitled “Oxymorphone Controlled Release Formulations” to Endo
`
`Pharmaceuticals, Inc. as assignee. Huai-Hung Kao, Anand R. Baichwal, Troy McCall, and David
`
`Lee are named as inventors. A true and correct copy of the ’216 Patent is attached as Exhibit C.
`
`Endo is the sole owner and assignee of the ’216 Patent.
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`Case 1:12-cv-08115-ALC-GWG Document 21-1 Filed 01/09/13 Page 9 of 16
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`33.
`
`Information regarding the Endo ’482, ’122, and ’216 Patents (the “Endo Patents”)
`
`was submitted to FDA for listing in the Orange Book. Pursuant to 21 C.F.R. § 314.53(e), FDA
`
`has listed the Endo Patents in the Orange Book with reference to NDA 201655.
`
`34.
`
`Opana ER CRF is covered by one or more claims of each of the Endo Patents.
`
`
`
`THE GRÜNENTHAL PATENTS
`
`35.
`
`On June 5, 2012, the PTO duly and legally issued U.S. Patent No. 8,192,722 (“the
`
`’722 Patent”), entitled “Abuse-Proofed Dosage Form” to Gruenenthal GmbH, also known as
`
`Grünenthal GmbH, as assignee. Elisabeth Arkenau-Marić, Johannes Bartholomäus, and Heinrich
`
`Kugelmann are named as inventors. A true and correct copy of the ’722 Patent is attached as
`
`Exhibit D.
`
`36.
`
`On November 13, 2013, the PTO duly and legally issued U.S. Patent No.
`
`8,309,060 (“the ’060 Patent”), entitled “Abuse-Proofed Dosage Form” to Gruenenthal GmbH,
`
`also known as Grünenthal GmbH, as assignee. Elisabeth Arkenau-Marić, Johannes
`
`Bartholomäus, and Heinrich Kugelmann are named as inventors. A true and correct copy of the
`
`’060 Patent is attached as Exhibit E.
`
`37.
`
`Grünenthal is the assignee and owner of the ’722 and ’060 Patents (“the
`
`Grünenthal Patents”).
`
`38.
`
`Endo has an exclusive license to the Grünenthal Patents from Grünenthal,
`
`including a right to enforce the Grünenthal Patents.
`
`39.
`
`Information regarding the Grünenthal Patents was submitted to FDA for listing in
`
`the Orange Book. Pursuant to 21 C.F.R. § 314.53(e), FDA has listed the Grünenthal Patents in
`
`the Orange Book with reference to NDA 201655.
`
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`Case 1:12-cv-08115-ALC-GWG Document 21-1 Filed 01/09/13 Page 10 of 16
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`40.
`
`Opana ER CRF is covered by one or more claims of each of the Grünenthal
`
`Patents.
`
`AMNEAL’S ANDA FILING
`
`41.
`
`Upon information and belief, some time before September 21, 2012, Amneal
`
`submitted to FDA paperwork purporting to constitute an Abbreviated New Drug Application
`
`(“ANDA”) under § 505(j) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 355(j),
`
`seeking approval to engage in the commercial manufacture, use, and sale of 5 mg, 7.5 mg, 10 mg,
`
`15 mg, 20 mg, 30 mg, and 40 mg oxymorphone hydrochloride extended-release tablets
`
`(“Amneal’s ANDA Products”), as a generic version of the products described in sNDA 201655.
`
`42.
`
`In a letter dated September 21, 2012 addressed to Endo and received on or about
`
`September 24, 2012, and in a separate letter addressed to Grünenthal dated October 10, 2012 and
`
`received by Grünenthal on or about that same day, Amneal purported to notify Plaintiffs that
`
`Amneal had submitted ANDA No. 20-4294, seeking approval to manufacture, use, or sell
`
`Amneal’s ANDA Products before the expiration of the ’482 and ’722 Patents (“Amneal Notice
`
`Letters”).
`
`43.
`
`The Amneal Notice Letters claimed that Amneal’s ANDA included a Paragraph
`
`IV Certification stating that it was Amneal’s opinion that the claims of the ’482 and ’722 Patents
`
`are invalid, unenforceable, or are not infringed by the proposed manufacture, importation, use,
`
`sale, or offer for sale of the Amneal ANDA Products.
`
`44.
`
`This action, claiming infringement of the ’482 and ’722 Patents, was commenced
`
`before the expiration of forty-five days from the date Endo and Grünenthal received the Amneal
`
`Notice Letters. The Plaintiffs’ first Amended Complaint, added two Counts, asserting
`
`infringement of the ’122 and ’060 Patents, which the United States Patent and Trademark Office
`
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`Case 1:12-cv-08115-ALC-GWG Document 21-1 Filed 01/09/13 Page 11 of 16
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`(“USPTO”) issued after Plaintiffs filed their original Complaint. This Second Amended
`
`Complaint includes one additional Count, asserting infringement of the ’216 Patent, which the
`
`USPTO issued after Plaintiffs filed their First Amended Complaint.
`
`COUNT I: INFRINGEMENT OF THE ’482 PATENT
`
`45.
`
`46.
`
`Endo incorporates each of paragraphs 1-44 above as if set forth fully herein.
`
`The submission of Amneal’s ANDA to FDA, which includes certification under §
`
`505(j)(2)(A)(vii)(IV), constitutes infringement of the ’482 Patent under 35 U.S.C. § 271(e)(2)(A).
`
`47.
`
`Amneal is seeking FDA approval to engage in the commercial manufacture, use,
`
`or sale of Amneal’s ANDA Products before the expiration of the ’482 Patent. If granted
`
`approval, Amneal intends to launch its ANDA Products before expiration of the ’482 Patent.
`
`48.
`
`Amneal’s commercial manufacture, offer for sale, or sale of its ANDA Products
`
`would infringe the ’482 Patent under 35 U.S.C. § 271(a)-(c).
`
`49.
`
`Any launch by Amneal of its ANDA Products before expiration of the ’482 Patent
`
`would cause Endo to suffer immediate and irreparable harm.
`
`50.
`
`Amneal was aware of the existence of the ’482 Patent, as demonstrated by its
`
`reference to that patent in the Amneal Notice Letters, and was aware that the filing of its
`
`Paragraph IV Certification with respect to the ’482 Patent would constitute infringement of the
`
`patent.
`
`51.
`
`52.
`
`COUNT II: INFRINGEMENT OF THE ’722 PATENT
`
`Endo incorporates each of paragraphs 1-44 above as if set forth fully herein.
`
`The submission of Amneal’s ANDA to FDA, which includes certification under §
`
`505(j)(2)(A)(vii)(IV), constitutes infringement of the ’722 Patent under 35 U.S.C. § 271(e)(2)(A).
`
`53.
`
`Amneal is seeking FDA approval to engage in the commercial manufacture, use,
`
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`Case 1:12-cv-08115-ALC-GWG Document 21-1 Filed 01/09/13 Page 12 of 16
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`or sale of its ANDA Products before the expiration of the ’722 Patent. If granted approval,
`
`Amneal intends to launch Amneal’s ANDA Products before expiration of the ’722 Patent.
`
`54.
`
`Amneal’s commercial manufacture, offer for sale, or sale of its ANDA Products
`
`would infringe the ’722 Patent under 35 U.S.C. § 271(a)-(c).
`
`55.
`
`Any launch by Amneal of its ANDA Products before expiration of the ’722 Patent
`
`would cause Endo to suffer immediate and irreparable harm.
`
`56.
`
`Amneal was aware of the existence of the ’722 Patent, as demonstrated by its
`
`reference to that patent in the Amneal Notice Letters, and was aware that the filing of its
`
`Paragraph IV Certification with respect to the ’722 Patent would constitute infringement of the
`
`patent.
`
`57.
`
`58.
`
`COUNT III: INFRINGEMENT OF THE ’122 PATENT
`
`Endo incorporates each of paragraphs 1-44 above as if set forth fully herein.
`
`The submission of Amneal’s ANDA to FDA constitutes infringement of the ’122
`
`Patent under 35 U.S.C. § 271(e)(2)(A).
`
`59.
`
`Amneal is seeking FDA approval to engage in the commercial manufacture, use,
`
`or sale of its ANDA Products before the expiration of the ’122 Patent. If granted approval,
`
`Amneal intends to launch its ANDA Products before expiration of the ’122 Patent.
`
`60.
`
`Amneal’s commercial manufacture, offer for sale, or sale of its ANDA Products
`
`would infringe the ’122 Patent under 35 U.S.C. § 271(a)-(c).
`
`61.
`
`Any launch by Amneal of its ANDA Products before expiration of the ’122 Patent
`
`would cause Endo to suffer immediate and irreparable harm.
`
`COUNT IV: INFRINGEMENT OF THE ’060 PATENT
`
`62.
`
`Plaintiffs incorporate each of paragraphs 1-44 above as if set forth fully herein.
`
`
`
`- 11 -
`
`
`
`

`
`Case 1:12-cv-08115-ALC-GWG Document 21-1 Filed 01/09/13 Page 13 of 16
`
`63.
`
`The submission of Amneal’s ANDA to FDA constitutes infringement of the ’060
`
`Patent under 35 U.S.C. § 271(e)(2)(A).
`
`64.
`
`Amneal is seeking FDA approval to engage in the commercial manufacture, use,
`
`or sale of its ANDA Products before the expiration of the ’060 Patent. If granted approval,
`
`Amneal intends to launch its ANDA Products before expiration of the ’060 Patent.
`
`65.
`
`Amneal’s commercial manufacture, offer for sale, or sale of its ANDA Products
`
`would infringe the ’060 Patent under 35 U.S.C. § 271(a)-(c).
`
`66.
`
`Any launch by Amneal of its ANDA Products before expiration of the ’060 Patent
`
`would cause Endo and Grünenthal to suffer immediate and irreparable harm.
`
`COUNT V: INFRINGEMENT OF THE ’216 PATENT
`
`Endo incorporates each of paragraphs 1-44 above as if set forth fully herein.
`
`The submission of Amneal’s ANDA to FDA constitutes infringement of the ’216
`
`67.
`
`68.
`
`Patent under 35 U.S.C. § 271(e)(2)(A).
`
`69.
`
`Amneal is seeking FDA approval to engage in the commercial manufacture, use,
`
`or sale of its ANDA Products before the expiration of the ’216 Patent. If granted approval,
`
`Amneal intends to launch its ANDA Products before expiration of the ’216 Patent.
`
`70.
`
`Amneal’s commercial manufacture, offer for sale, or sale of its ANDA Products
`
`would infringe the ’216 Patent under 35 U.S.C. § 271(a)-(c).
`
`71.
`
`Any launch by Amneal of its ANDA Products before expiration of the ’216 Patent
`
`would cause Endo to suffer immediate and irreparable harm.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiffs Endo and Grünenthal respectfully request the following relief:
`
`A.
`
`A judgment that Defendants have infringed the ’482 Patent, and a declaration that
`
`Amneal’s commercial manufacture, distribution, use, and sale of its ANDA Products would
`
`
`
`- 12 -
`
`
`
`

`
`Case 1:12-cv-08115-ALC-GWG Document 21-1 Filed 01/09/13 Page 14 of 16
`
`infringe the ’482 Patent;
`
`B.
`
`C.
`
`A declaration that the ’482 Patent is valid and enforceable;
`
`A judgment that Amneal has infringed the ’722 Patent, and a declaration that
`
`Amneal’s commercial manufacture, distribution, use, and sale of its ANDA Products would
`
`infringe the ’722 Patent;
`
`D.
`
`A declaration that the ’722 Patent is valid and enforceable;
`
`E.
`
`A judgment that Amneal has infringed the ’122 Patent, and a declaration that
`
`Amneal’s commercial manufacture, distribution, use, and sale of its ANDA Products would
`
`infringe the ’122 Patent;
`
`F.
`
`A declaration that the ’122 Patent is valid and enforceable;
`
`G.
`
`A judgment that Amneal has infringed the ’060 Patent, and a declaration that
`
`Amneal’s commercial manufacture, distribution, use, and sale of its ANDA Products would
`
`infringe the ’060 Patent;
`
`H.
`
`A declaration that the ’060 Patent is valid and enforceable;
`
`I.
`
`A judgment that Amneal has infringed the ’216 Patent, and a declaration that
`
`Amneal’s commercial manufacture, distribution, use, and sale of its ANDA Products would
`
`infringe the ’216 Patent;
`
`J.
`
`A declaration that the ’216 Patent is valid and enforceable;
`
`K.
`
`An order, pursuant to 35 U.S.C. § 271(e)(4)(A), that the effective date of any
`
`approval of Amneal’s ANDA No. 20-4324 under § 505(j) of the Federal Food, Drug and
`
`Cosmetic Act, 21 U.S.C. § 355(j), shall not be earlier than the last expiration date of the ’482,
`
`’722, ’122, ’060, and ’216 Patents, including any extensions;
`
`L.
`
`A permanent injunction, pursuant to 35 U.S.C. § 271(e)(4)(B), restraining and
`
`
`
`- 13 -
`
`
`
`

`
`Case 1:12-cv-08115-ALC-GWG Document 21-1 Filed 01/09/13 Page 15 of 16
`
`enjoining Amneal, its officers, agents, servants and employees, and those persons in active
`
`concert or participation with any of them, from infringement of the ’482, ’722, ’122, ’060, and
`
`’216 Patents for the full terms thereof, including any extensions;
`
`M.
`
`An order that damages or other monetary relief be awarded to Endo and
`
`Grünenthal if Amneal engages in the commercial manufacture, use, offer to sell, sale,
`
`distribution or importation of Amneal’s ANDA Products, or in inducing such conduct by others,
`
`prior to the expiration of the ’482, ’722, ’122, ’060, and ’216 Patents, and any additional period
`
`of exclusivity to which Plaintiffs are or become entitled, and that any such damages or monetary
`
`relief be trebled and awarded to Endo and Grünenthal with prejudgment interest;
`
`N.
`
`A declaration that this an exceptional case and an award of reasonable attorneys’
`
`fees pursuant to 35 U.S.C. § 285;
`
`O.
`
`Reasonable attorneys’ fees, filing fees, and reasonable costs of suit incurred by
`
`Endo and Grünenthal in this action; and
`
`P.
`
`Such other and further relief as the Court may deem just and proper.
`
`
`
`
`
`
`
`- 14 -
`
`
`
`

`
`ENDO PHARMACEUTICALS INC.
`Case 1:12-cv-08115-ALC-GWG Document 21-1 Filed 01/09/13 Page 16 of 16
`
`ATTORNEYS FOR PLAINTIFF
`
`Of Counsel2
`
`Basil J. Lewris
`
`Joann M. Neth
`
`Jennifer H. Roscetti
`
`FINNEGAN, HENDERSON, FARRABOW,
`GARRETT & DUNNER LLP
`
`901 New York Avenue, N.W.
`
`Washington, DC 20001
`(202) 408-4000
`bi11.1ewris@finnegan.com
`joann.neth@finnegan.com
`jennifer.roscetti@finnegan.com
`
`Anthony C. Tridico
`Avenue Louise 326, Box 37
`Brussels, Belgium B-1050
`01132 2 646 03 53
`
`anthony.tridico@finnegan.com
`
`ATTORNEYS FOR PLAINTIFF
`GRIJNENTHAL GMBH
`
`14782298
`
`Stephen D. Hoffman (SH 6089)
`WILK AUSLANDER LLP
`
`1515 Broadway, 43rd Floor
`New York, NY 10036
`(212)981-2300
`shoffman@wilkauslander.com
`
`ATTORNEYS FOR PLAINTIFF
`
`GRUNENTHAL GMBH
`
`Martin J. Black
`
`Robert D. Rhoad
`
`DECHERT LLP
`
`Cira Centre
`
`2929 Arch Street
`
`Philadelphia, PA 19104
`(215) 994-4000
`
`Ann M. Caviani Pease
`
`Jonathan D. Loeb
`
`DECHERT LLP
`
`2440 W. El Camino Real
`
`Suite 700
`
`Mountain View, CA 94040
`(650) 813-4800
`
`ATTORNEYS FOR PLAINTIFF
`
`ENDO PHARMACEUTICALS INC.
`
`-15-
`
`

`
`Case 1:12-cv-08115-ALC-GWG Document 21-2 Filed 01/09/13 Page 1 of 16
`Case1:12-cv—08115—ALC-GWG Document21-2
`Filed 01/09/13 Page1of16
`
`EXHIBIT A
`
`EXHIBIT A
`
`

`
`Case 1:12-cv-08115-ALC-GWG Document 21-2 Filed 01/09/13 Page 2 of 16
`”°“11||11|||1l|11||||llllrlllll1|l|l|ll|11l|1|||||1|l|I’|fl|1|l1||||1||
`
`US00785l482B2
`
`(12) United States Patent
`Dung et al.
`
`(10) Patent No.:
`
`(45) Date of Patent:
`
`US 7,851,482 B2
`Dec. 14, 2010
`
`(54) METHOD FOR MAKING ANALGESICS
`
`(75)
`
`Inventors: Jen-Sen Dung, Boothwyn, PA (US);
`Erno M. Keskeny, Wilmington, DE
`(US); James J. Mencel, North Wales, PA
`(US)
`
`(73) Assignee: Johnson Matthey Public Limited
`Compnay, London (GB)
`
`( * ) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. l54(b) by 646 days.
`
`(21) Appl.No.: 11/866,840
`
`(22)
`
`Filed:
`
`Oct. 3, 2007
`
`(65)
`
`(30)
`
`Prior Publication Data
`
`US 2008/0146601A1
`
`Jun. 19, 2008
`
`Foreign Application Priority Data
`
`Dec. 14, 2006
`
`(GB)
`
`............................... .. 0624880.1
`
`(51)
`
`Int. Cl.
`(2006.01)
`A61K 31/485
`(2006.01)
`C07D 489/04
`(52) U.S. Cl.
`.......................... .. 514/282; 546/45; 546/44
`(58) Field of Classification Search ............... .. 514/282;
`546/45, 44
`See application file for complete search history.
`
`(56)
`
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