Case 1:15-cv-01152-RGA-SRF Document 1 Filed 12/15/15 Page 1 of 36 PageID #: 1
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`
`
`
`
`C.A. No. __________________
`
`
`
`
`
`
`
`)))))))))))))
`
`PURDUE PHARMA L.P., PURDUE
`PHARMACEUTICALS L.P., THE P.F.
`LABORATORIES, INC., RHODES
`TECHNOLOGIES and GRÜNENTHAL
`GMBH,
`
`
`Plaintiffs,
`
`v.
`
`
`AMNEAL PHARMACEUTICALS, LLC,
`
`
`Defendant.
`
`
`COMPLAINT
`
`Plaintiffs Purdue Pharma L.P., Purdue Pharmaceuticals L.P., The P.F.
`
`Laboratories, Inc. (collectively, “Purdue”), Rhodes Technologies (“Rhodes”) and Grünenthal
`
`GmbH (“Grünenthal”) (collectively, “Plaintiffs”), for their Complaint against Defendant Amneal
`
`Pharmaceuticals, LLC (“Amneal” or “Defendant”), aver as follows:
`
`NATURE OF THE ACTION
`
`1.
`
`This is an action for patent infringement arising under the patent laws of
`
`the United States, Title 35, United States Code, for infringement of United States Patent Nos.
`
`7,674,799 (the ‘’799 patent”); 7,674,800 (the ‘’800 patent”); 7,683,072 (the ‘’072 patent”);
`
`8,114,383 (the ‘’383 patent”); 8,309,060 (the ‘’060 patent”); 8,337,888 (the ‘’888 patent”);
`
`8,808,741 (the ‘’741 patent”); 8,894,987 (the ‘’987 patent”); 8,894,988 (the ‘’988 patent”);
`
`9,060,976 (the ‘’976 patent”); 9,034,376 (the “’376 patent”); and 9,073,933 (the ‘’933 patent”)
`
`(collectively, “the patents-in-suit”). This action relates to Abbreviated New Drug Application
`
`(“ANDA”) No. 203235 as amended (“Defendant’s Amended ANDA”) submitted upon
`
`
`
`
`KASHIV1020
`IPR of Patent No. 9,492,392
`
`

`

`Case 1:15-cv-01152-RGA-SRF Document 1 Filed 12/15/15 Page 2 of 36 PageID #: 2
`
`
`information and belief in the name of Amneal to the United States Food and Drug
`
`Administration (“FDA”).
`
`2.
`
`Plaintiffs seek judgment that Defendant has infringed the ’799, ’800, ’072,
`
`’383, ’060, ’888, ’741, ’987, ’988, ’976 and ’933 patents (collectively, “the Orange Book
`
`patents”), which are listed in the FDA Approved Drug Products With Therapeutic Equivalence
`
`Evaluations (“Orange Book”) as covering Purdue’s OxyContin® (oxycodone hydrochloride)
`
`(“OxyContin®”), an extended-release pain medication. Defendant has infringed the Orange
`
`Book patents under 35 U.S.C. § 271(e)(2)(A) by filing ANDA No. 203235 as amended,
`
`submitted upon information and belief in the name of Amneal to the FDA. Defendant’s
`
`Amended ANDA seeks approval to market a generic version of Purdue’s OxyContin®, which is
`
`the subject of approved NDA No. 022272, in the 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg
`
`and 80 mg dosage strengths (“Defendant’s Amended ANDA Products”). As set forth in
`
`paragraphs 21-58, certain claims of the ’799, ’800, ’072, ’383, ’060 and ’888 patents have been
`
`found infringed but invalid in previous lawsuits. Appeals from those judgments of invalidity are
`
`pending. To conserve the resources of the Court and the parties, Plaintiffs will seek a partial stay
`
`of this action against Amneal with respect to the patents held invalid until final adjudication of
`
`the pending appeals.
`
`3.
`
`Plaintiffs also seek judgment that Defendant has infringed the ’376 patent,
`
`which is not listed in the FDA’s Orange Book, under 35 U.S.C. § 271(e)(2)(A) by filing ANDA
`
`No. 203235 as amended on Defendant’s Amended ANDA Products.
`
`4.
`
`On September 17, 2015, Purdue filed a related complaint against
`
`Defendant, C.A. No. 15-831-SLR, for patent infringement of the ’976 and ’376 patents. The
`
`previous action was filed in connection with Defendant’s ANDA, which contained a “Paragraph
`
`
`
`
`- 2 -
`
`KASHIV1020
`IPR of Patent No. 9,492,392
`
`

`

`Case 1:15-cv-01152-RGA-SRF Document 1 Filed 12/15/15 Page 3 of 36 PageID #: 3
`
`
`IV” certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) alleging that the ’976 patent, listed in
`
`the Orange Book as covering OxyContin®, is “invalid, unenforceable, and/or not infringed by
`
`the commercial manufacture, use or sale of” the drug products described in Defendant’s ANDA.
`
`THE PARTIES
`
`5.
`
`Plaintiff Purdue Pharma L.P. (“Purdue Pharma”) is a limited partnership
`
`organized and existing under the laws of the State of Delaware, having a place of business at One
`
`Stamford Forum, 201 Tresser Boulevard, Stamford, Connecticut 06901-3431. Purdue Pharma is
`
`an owner of the ’799, ’800, ’072, ’888, ’741, ’987, ’988, ’976, ’376 and ’933 patents, identified
`
`in paragraphs 21-30, and 51-64 below, and Purdue Pharma is an exclusive licensee of the ’060
`
`and ’383 patents, identified in paragraphs 31-50 below. Purdue Pharma is also the holder of
`
`approved NDA No. 022272 for OxyContin®, indicated for pain severe enough to require daily,
`
`around-the-clock, long-term opioid treatment and for which alternative treatment options are
`
`inadequate. Purdue Pharma sells OxyContin® in the United States.
`
`6.
`
`Plaintiff Purdue Pharmaceuticals L.P. (“Purdue Pharmaceuticals”) is a
`
`limited partnership organized and existing under the laws of the State of Delaware, having a
`
`place of business at 4701 Purdue Drive, Wilson, NC 27893. Purdue Pharmaceuticals is an owner
`
`of the ’799, ’800, ’072, ’888, ’976, ’376 and ’933 patents, identified in paragraphs 21-30, 51-58,
`
`and 62-64 below.
`
`7.
`
`Plaintiff The P.F. Laboratories, Inc. (“P.F. Labs”) is a corporation
`
`organized and existing under the laws of the State of New Jersey, having a place of business at
`
`One Stamford Forum, Stamford, CT 06901. P.F. Labs is an owner of the ’799, ’800, ’072, ’888,
`
`’976, ’376 and ’933 patents, identified in paragraphs 21-30, 51-58, and 62-64 below.
`
`8.
`
`Plaintiff Rhodes Technologies (“Rhodes”) is a general partnership
`
`organized and existing under the laws of the State of Delaware, having a place of business at 498
`
`
`
`
`- 3 -
`
`KASHIV1020
`IPR of Patent No. 9,492,392
`
`

`

`Case 1:15-cv-01152-RGA-SRF Document 1 Filed 12/15/15 Page 4 of 36 PageID #: 4
`
`
`Washington Street, Coventry, RI 02816. Rhodes is an owner of the ’799, ’800, ’072 and ’933
`
`patents, identified in paragraphs 21-30 and 64 below, and is involved in the manufacture of the
`
`active pharmaceutical ingredient (“API”) used in OxyContin®.
`
`9.
`
`Plaintiff Grünenthal GmbH (“Grünenthal”) is a corporation organized and
`
`existing under the laws of Germany, having an address at 52078 Aachen, Zieglerstrasse 6,
`
`Germany. Grünenthal is the owner of the ’060 and ’383 patents, identified in paragraphs 31-50
`
`below.
`
`10.
`
`On information and belief, Defendant is a limited liability company
`
`organized and existing under the laws of the State of Delaware, having a principal place of
`
`business at 400 Crossing Boulevard, 3rd floor, Bridgewater, NJ 08807.
`
`SUBJECT MATTER JURISDICTION AND VENUE
`
`11.
`
`This action arises under the patent laws of the United States, including 35
`
`U.S.C. § 271 and the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202.
`
`12.
`
`13.
`
`and 1338(a).
`
`and 1400(b).
`
`This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331
`
`Venue is proper in this Court pursuant to 28 U.S.C. §§ 1391(b), 1391(c),
`
`PERSONAL JURISDICTION
`
`14.
`
`This Court has personal jurisdiction over the Defendant by virtue of, inter
`
`alia, the fact that Amneal is a Delaware limited liability company, Defendant’s systematic and
`
`continuous contacts with Delaware, and Defendant’s contacts with Delaware in connection with
`
`the submission of its ANDA, as set forth below.
`
`
`
`
`- 4 -
`
`KASHIV1020
`IPR of Patent No. 9,492,392
`
`

`

`Case 1:15-cv-01152-RGA-SRF Document 1 Filed 12/15/15 Page 5 of 36 PageID #: 5
`
`
`15.
`
`On information and belief, Amneal is registered to conduct business
`
`within the State of Delaware and maintains as a registered agent The Corporation Trust
`
`Company, Corporation Trust Center, 1209 Orange St, Wilmington, Delaware 19801.
`
`16.
`
`On
`
`information and belief, Amneal holds current and valid
`
`“Distributor/Manufacturer CSR” and “Pharmacy-Wholesale” licenses from the Delaware Board
`
`of Pharmacy.
`
`17.
`
`On information and belief, Defendant is in the business of preparing
`
`generic pharmaceuticals that it distributes in the State of Delaware and throughout the United
`
`States.
`
`18.
`
`On information and belief, if ANDA No. 203235 as amended is approved,
`
`the Defendant’s Amended ANDA Products would, among other things, be marketed and
`
`distributed in Delaware, and/or prescribed by physicians practicing and dispensed by pharmacies
`
`located within Delaware, all of which would have a substantial effect on Delaware.
`
`19.
`
`On information and belief, Defendant has admitted to, consented to or has
`
`not contested, the jurisdiction of this Court, and/or has availed itself of the rights, benefits, and
`
`privileges of this Court by asserting counterclaims in prior District of Delaware actions, e.g.,
`
`Purdue Pharma L.P. et al. v. Amneal Pharmaceuticals LLC, C.A. No. 15-831; Forest
`
`Laboratories, LLC v. Amneal Pharmaceuticals LLC, C.A. No. 15-756; Hospira, Inc. v. Amneal
`
`Pharmaceuticals LLC, C.A. No. 15-697; Forest Laboratories, LLC v. Amneal Pharmaceuticals
`
`LLC, C.A. No. 15-430; Merck Sharpe & Dohme Corp. v. Amneal Pharmaceuticals LLC, C.A.
`
`No. 15-250; Forest Laboratories, Inc. v. Amneal Pharmaceuticals LLC, C.A. No. 14-508.
`
`20.
`
`This Court further has personal jurisdiction over Defendant by virtue of
`
`the fact that Defendant has committed, or aided, abetted, contributed to, and/or participated in the
`
`
`
`
`- 5 -
`
`KASHIV1020
`IPR of Patent No. 9,492,392
`
`

`

`Case 1:15-cv-01152-RGA-SRF Document 1 Filed 12/15/15 Page 6 of 36 PageID #: 6
`
`
`commission of, the tortious act of patent infringement that has led to foreseeable harm and injury
`
`to Plaintiffs, including Plaintiffs Purdue Pharma and Purdue Pharmaceuticals, which are limited
`
`partnerships organized and existing under the laws of the State of Delaware, and Plaintiff
`
`Rhodes, which is a general partnership organized and existing under the laws of the State of
`
`Delaware.
`
`
`
`THE PATENTS-IN-SUIT
`
`THE ’799, ’800 AND ’072 PATENTS
`
`21.
`
`Purdue and Rhodes are the lawful owners of all right, title and interest in
`
`the ’799 patent, titled “OXYCODONE HYDROCHLORIDE HAVING LESS THAN 25 PPM
`
`14-HYDROXYCODEINONE,” including the right to sue and to recover for past infringement
`
`thereof. The ’799 patent is listed in the Orange Book as covering OxyContin®, which is the
`
`subject of approved NDA No. 022272. A copy of the ’799 patent is attached hereto as Exhibit
`
`A, which was duly and legally issued on March 9, 2010, naming Robert Chapman, Lonn S.
`
`Rider, Qi Hong, Donald Kyle, and Robert Kupper as the inventors.
`
`22.
`
`Purdue and Rhodes are the lawful owners of all right, title and interest in
`
`the ’800 patent, titled “OXYCODONE HYDROCHLORIDE HAVING LESS THAN 25 PPM
`
`14-HYDROXYCODEINONE,” including the right to sue and to recover for past infringement
`
`thereof. The ’800 patent is listed in the Orange Book as covering OxyContin®, which is the
`
`subject of approved NDA No. 022272. A copy of the ’800 patent is attached hereto as Exhibit B,
`
`which was duly and legally issued on March 9, 2010, naming Robert Chapman, Lonn S. Rider,
`
`Qi Hong, Donald Kyle, and Robert Kupper as the inventors.
`
`23.
`
`Purdue and Rhodes are the lawful owners of all right, title and interest in
`
`the ’072 patent, titled “OXYCODONE HYDROCHLORIDE HAVING LESS THAN 25 PPM
`
`
`
`
`- 6 -
`
`KASHIV1020
`IPR of Patent No. 9,492,392
`
`

`

`Case 1:15-cv-01152-RGA-SRF Document 1 Filed 12/15/15 Page 7 of 36 PageID #: 7
`
`
`14-HYDROXYCODEINONE,” including the right to sue and to recover for past infringement
`
`thereof. The ’072 patent is listed in the Orange Book as covering OxyContin®, which is the
`
`subject of approved NDA No. 022272. A copy of the ’072 patent is attached hereto as Exhibit C,
`
`which was duly and legally issued on March 9, 2010, naming Robert Chapman, Lonn S. Rider,
`
`Qi Hong, Donald Kyle, and Robert Kupper as the inventors.
`
`24.
`
`The ’799, ’800 and ’072 patents have been the subject of previous District
`
`Court litigation in which certain claims were found infringed but invalid for obviousness, a
`
`judgment that is currently being appealed.
`
`25.
`
`On March 23, 2011 and June 28, 2012, Purdue and Rhodes filed suit
`
`against Teva Pharmaceuticals USA, Inc. (“Teva”) in the Southern District of New York, Civil
`
`Action Nos. 11-cv-2037-SHS and 12-cv-5083-SHS, alleging infringement of, inter alia, the
`
`’799, ’800 and ’072 patents (“the Teva case”). In response, Teva denied infringement and
`
`asserted that the claims of the ’799, ’800 and ’072 patents were invalid. A twelve-day bench
`
`trial relating, inter alia, to these patents was held in September and October 2013.
`
`26.
`
`On January 14, 2014, the Southern District of New York (Stein, J.) issued
`
`Findings of Fact and Conclusions of Law in the Teva case. The accused products were found to
`
`infringe the asserted claims of the ’799, ’800 and ’072 patents and the claims were found to
`
`satisfy the disclosure and claiming requirements of 35 U.S.C. § 112. However, the asserted
`
`claims of the ’799, ’800 and ’072 patents were also found invalid for obviousness. On January
`
`22, 2014, the Court entered Judgment holding, inter alia, that: (a) Claims 3 and 19 of the ’799
`
`patent are invalid; (b) Claims 30-34 and 76-79 of the ’800 patent are invalid; and (c) Claims 1, 4,
`
`and 5 of the ’072 patent are invalid.
`
`
`
`
`- 7 -
`
`KASHIV1020
`IPR of Patent No. 9,492,392
`
`

`

`Case 1:15-cv-01152-RGA-SRF Document 1 Filed 12/15/15 Page 8 of 36 PageID #: 8
`
`
`27.
`
`It is well established that “a judgment of invalidity will have no collateral
`
`estoppel effect if the patentee can show that it did not have a full and fair opportunity to litigate.”
`
`Pharmacia & Upjohn Co. v. Mylan Pharm., Inc., 170 F.3d 1373, 1379-80 (Fed. Cir. 1999)
`
`(citing Blonder-Tongue Labs., Inc. v. Univ. of Ill. Found., 402 U.S. 313, 332-34 (1971)). The
`
`Teva Decision does not qualify for a collateral estoppel defense under Blonder-Tongue. 402
`
`U.S. at 332-34 (stating that there is no full and fair opportunity to litigate where, for example,
`
`“the court[] wholly failed to grasp the technical subject matter and issues in suit”).
`
`28.
`
`Purdue and Rhodes did not have a full and fair opportunity to litigate the
`
`validity of the ’799, ’800 and ’072 patents before Judge Stein. See id. Therefore, to give
`
`collateral estoppel effect to Judge Stein’s holding of invalidity of claims 3 and 19 of the ’799
`
`patent, claims 30-34 and 76-79 of the ’800, and claims 1, 4, and 5 of the ’072 patent would be
`
`contrary to “justice and equity” as stated by the Supreme Court in Blonder-Tongue.
`
`29.
`
`On February 12, 2014, Plaintiffs Purdue and Rhodes filed notices of
`
`appeal of the Southern District of New York’s judgment of invalidity in the Teva case, including
`
`the judgment with respect to the claims of the ’799, ’800 and ’072 patents, to the Court of
`
`Appeals for the Federal Circuit (“the Federal Circuit”). The District Court’s judgment was
`
`amended on April 16, 2014 and July 14, 2014, and notices of appeal were filed by Purdue,
`
`Rhodes and Grünenthal on May 20, 2014 and July 23, 2014, respectively.
`
`30.
`
`The appeal was fully briefed and oral argument was held on November 3,
`
`2015.
`
`THE ’383 AND ’060 PATENTS
`
`31.
`
`Grünenthal is the lawful owner of all right, title, and interest in the ’383
`
`patent, titled “ABUSE-PROOFED DOSAGE FORM,” including the right to sue and to recover
`
`
`
`
`- 8 -
`
`KASHIV1020
`IPR of Patent No. 9,492,392
`
`

`

`Case 1:15-cv-01152-RGA-SRF Document 1 Filed 12/15/15 Page 9 of 36 PageID #: 9
`
`
`for past infringement thereof. Purdue Pharma is an exclusive licensee of the ’383 patent from
`
`Grünenthal, with the right to enforce the ’383 patent. The ’383 patent is listed in the Orange
`
`Book as covering OxyContin®, which is the subject of approved NDA No. 022272. A copy of
`
`the ’383 patent, attached hereto as Exhibit D, was duly and legally issued on February 14, 2012,
`
`naming Johannes Bartholomäus, Heinrich Kugelmann, and Elisabeth Arkenau-Marić as the
`
`inventors.
`
`32.
`
`Grünenthal is the lawful owner of all right, title, and interest in the ’060
`
`patent, titled “ABUSE-PROOFED DOSAGE FORM,” including the right to sue and to recover
`
`for past infringement thereof. Purdue Pharma is an exclusive licensee of the ’060 patent from
`
`Grünenthal, with the right to enforce the ’060 patent. The ’060 patent is listed in the Orange
`
`Book as covering OxyContin®, which is the subject of approved NDA No. 022272. A copy of
`
`the ’060 patent, attached hereto as Exhibit E, was duly and legally issued on November 13, 2012,
`
`naming Johannes Bartholomäus, Heinrich Kugelmann, and Elisabeth Arkenau-Marić as the
`
`inventors.
`
`33.
`
`The ’383 patent has been the subject of previous District Court litigation
`
`in which certain claims were found infringed but invalid for anticipation and obviousness, a
`
`judgment that is currently being appealed.
`
`34.
`
`On June 28, 2012, Purdue Pharma and Grünenthal filed suit against Teva
`
`alleging infringement of, inter alia, the ’383 patent (“the Teva ’383 case”). In response, Teva
`
`denied infringement and argued that the asserted claims of the ’383 patent were invalid. A
`
`twelve-day bench trial relating, inter alia, to the ’383 patent was held in September and October
`
`2013.
`
`
`
`
`- 9 -
`
`KASHIV1020
`IPR of Patent No. 9,492,392
`
`

`

`Case 1:15-cv-01152-RGA-SRF Document 1 Filed 12/15/15 Page 10 of 36 PageID #: 10
`
`
`35.
`
`On January 14, 2014, the Southern District of New York (Stein, J.) issued
`
`Findings of Fact and Conclusions of Law in the Teva ’383 case (“the Teva ’383 Decision”). The
`
`accused products were found to infringe the asserted claims of the ’383 patent. However, the
`
`asserted claims of the ’383 patent were found invalid for anticipation and obviousness. On
`
`January 22, 2014, the Court entered Judgment holding, inter alia, that: Claims 1, 2, 5, 7, and 8
`
`of the ’383 patent are invalid.
`
`36.
`
`It is well established that “a judgment of invalidity will have no collateral
`
`estoppel effect if the patentee can show that it did not have a full and fair opportunity to litigate.”
`
`Pharmacia & Upjohn Co. v. Mylan Pharm., Inc., 170 F.3d 1373, 1379-80 (Fed. Cir. 1999)
`
`(citing Blonder-Tongue Labs., Inc. v. Univ. of Ill. Found., 402 U.S. 313, 332-34 (1971)). The
`
`Teva ’383 Decision does not qualify for a collateral estoppel defense under Blonder-Tongue.
`
`402 U.S. at 332-34 (stating that there is no full and fair opportunity to litigate where, for
`
`example, “the court[] wholly failed to grasp the technical subject matter and issues in suit”).
`
`37.
`
`Grünenthal and Purdue Pharma did not have a full and fair opportunity to
`
`litigate the validity of the ’383 patent before Judge Stein. See id. Therefore, to give collateral
`
`estoppel effect to Judge Stein’s holding of invalidity of claims 1, 2, 5, and 7 of the ’383 patent
`
`would be contrary to “justice and equity” as stated by the Supreme Court in Blonder-Tongue.
`
`38.
`
`On February 12, 2014, Purdue Pharma and Grünenthal filed notices
`
`appealing the Southern District of New York’s Judgment of invalidity in the Teva ’383 case,
`
`including the Judgment with respect to the claims of the ’383 patent, to the Federal Circuit. The
`
`District Court’s Judgment was amended on April 16, 2014 and July 14, 2014, and Purdue
`
`Pharma and Grünenthal each filed amended notices of appeal on May 20, 2014 and July 23, 2014
`
`to account for each set of amendments to the Judgment.
`
`
`
`
`- 10 -
`
`KASHIV1020
`IPR of Patent No. 9,492,392
`
`

`

`Case 1:15-cv-01152-RGA-SRF Document 1 Filed 12/15/15 Page 11 of 36 PageID #: 11
`
`
`2015.
`
`39.
`
`40.
`
`The appeal was fully briefed and oral argument was held on November 3,
`
`Plaintiff Grünenthal filed patent infringement actions in the United States
`
`District Court for the Southern District of New York against Actavis Inc., Actavis South Atlantic
`
`LLC and other defendants alleging infringement of, inter alia, the ’383 patent by submission of
`
`ANDAs seeking approval to market generic versions of a different branded product, Opana® ER
`
`oxymorphone hydrochloride crush resistant formulation (“CRF”). Those actions are Endo
`
`Pharmaceuticals, Inc. et al. v. Amneal Pharmaceuticals, LLC et al., C.A. No. 12-cv-8115, -8060,
`
`-8317, 13-civ-435, -436 (S.D.N.Y.) (TPG) (“Endo actions”).
`
`41.
`
`Defendants filed a Motion for Partial Summary Judgment of Collateral
`
`Estoppel in the Endo actions requesting the Court to “hold invalid claims 1, 2, 5, 7, and 9 of the
`
`’383 patent” based on Judge Stein’s invalidity holding in the Teva ’383 case. C.A. No. 13-cv-
`
`436, D.I. 71 at 15. Prior to filing their opposition, Grünenthal and Endo informed Defendants
`
`that they were no longer asserting claims 1, 2, 5, and 7 of the ’383 patent, mooting Defendants’
`
`Motion with respect to those claims. E. Sommers’ letter to Defendants dated March 3, 2015.
`
`Accordingly, Grünenthal and Endo addressed only claim 9 of the ’383 patent (as well as the
`
`asserted claims of the ’060 patent) in their Opposition to Defendants’ Motion. C.A. No. 13-cv-
`
`436, D.I. 78 at 2-3, 7-11. Acknowledging the mootness of their Motion with respect to claims 1,
`
`2, 5, and 7, the Defendants’ Reply in support of their original Motion “request[ed] that the Court
`
`[] grant their motion and hold invalid [only] claim 9 of the ’383 patent.” C.A. No. 13-cv-436,
`
`D.I. 103 at 10. Nevertheless, Judge Griesa ruled that claims 1, 2, 5, and 7 were invalid on the
`
`basis of collateral estoppel (“Judge Griesa’s Collateral Estoppel Decision”). C.A. No. 13-cv-
`
`436, D.I. 117 at 4-5.
`
`
`
`
`- 11 -
`
`KASHIV1020
`IPR of Patent No. 9,492,392
`
`

`

`Case 1:15-cv-01152-RGA-SRF Document 1 Filed 12/15/15 Page 12 of 36 PageID #: 12
`
`
`42.
`
`The Court erred in concluding that collateral estoppel applied to claims 1,
`
`2, 5, and 7 for at least two reasons: (1) Defendants’ motion was mooted with respect to claims
`
`1, 2, 5, and 7 of the ’383 patent and (2) the Teva ’383 Decision does not qualify for a collateral
`
`estoppel defense under the patent validity/collateral estoppel law as articulated by the Supreme
`
`Court in Blonder-Tongue. 402 U.S. at 332-34 (stating that there is no full and fair opportunity to
`
`litigate where, for example, “the court[] wholly failed to grasp the technical subject matter and
`
`issues in suit”).
`
`43.
`
`Grünenthal did not have a full and fair opportunity to litigate the validity
`
`of the ’383 patent. See id. Therefore, to give collateral estoppel effect to the Teva ’383 Decision
`
`holding claims 1, 2, 5, and 7 of the ’383 patent invalid would be contrary to “justice and equity”
`
`as stated by the Supreme Court in Blonder-Tongue.
`
`44.
`
`Grünenthal filed notices of appeal to the Federal Circuit on September 11,
`
`2015 that includes an appeal of Judge Griesa’s Collateral Estoppel Decision.
`
`45.
`
`The ’060 patent has been the subject of previous District Court litigation
`
`in which certain claims were found infringed but invalid for obviousness, a judgment that is
`
`currently being appealed.
`
`46.
`
`In the Endo actions, Grünenthal also alleged infringement of the ’060
`
`patent by Actavis Inc., Actavis South Atlantic LLC and other defendants by submission of
`
`ANDAs seeking approval to market generic versions of branded product, Opana® ER CRF.
`
`47.
`
`The Endo actions, with respect to the ’060 patent, were tried between
`
`March 23, 2015 and April 24, 2015 before the Honorable Thomas P. Griesa. On August 14,
`
`2015, Judge Griesa issued Findings of Fact and Conclusions of Law, and on August 24, 2015,
`
`Judge Griesa entered judgment (“the Endo Decision”). The Endo Decision concluded, inter alia,
`
`
`
`
`- 12 -
`
`KASHIV1020
`IPR of Patent No. 9,492,392
`
`

`

`Case 1:15-cv-01152-RGA-SRF Document 1 Filed 12/15/15 Page 13 of 36 PageID #: 13
`
`
`that defendants in those actions infringed claims 1, 4, 9, 24-25, 27 and 29-32 of the ’060 patent.
`
`With respect to the validity of the ’060 patent, although the Endo Decision rejected defendants’
`
`invalidity defenses based on 35 U.S.C. §§ 102 and 112, the Endo Decision concluded that the
`
`above-identified claims of the ’060 patent were invalid based on obviousness.
`
`48.
`
`It is well established that “a judgment of invalidity will have no collateral
`
`estoppel effect if the patentee can show that it did not have a full and fair opportunity to litigate.”
`
`Pharmacia & Upjohn Co. v. Mylan Pharm., Inc., 170 F.3d 1373, 1379-80 (Fed. Cir. 1999)
`
`(citing Blonder-Tongue Labs., Inc. v. Univ. of Ill. Found., 402 U.S. 313, 332-34 (1971)). The
`
`Endo Decision does not qualify for a collateral estoppel defense under Blonder-Tongue. 402
`
`U.S. at 332-34 (stating that there is no full and fair opportunity to litigate where, for example,
`
`“the court[] wholly failed to grasp the technical subject matter and issues in suit”).
`
`49.
`
`Grünenthal did not have a full and fair opportunity to litigate the validity
`
`of the ’060 patent. See id. Therefore, to give collateral estoppel effect to the Endo Decision
`
`would be contrary to “justice and equity” as stated by the Supreme Court in Blonder-Tongue.
`
`50.
`
`Grünenthal filed notices of appeal from the Endo Decision to the Federal
`
`Circuit on September 11, 2015.
`
`THE ’888 PATENT
`
`51.
`
`Purdue is the lawful owner of all right, title and interest in the ’888 patent,
`
`titled “PHARMACEUTICAL FORMULATION CONTAINING GELLING AGENT,” including
`
`the right to sue and to recover for past infringement thereof. The ’888 patent is listed in the
`
`Orange Book as covering OxyContin®, which is the subject of approved NDA No. 022272. A
`
`copy of the ’888 patent is attached hereto as Exhibit F, which was duly and legally issued on
`
`
`
`
`- 13 -
`
`KASHIV1020
`IPR of Patent No. 9,492,392
`
`

`

`Case 1:15-cv-01152-RGA-SRF Document 1 Filed 12/15/15 Page 14 of 36 PageID #: 14
`
`
`December 25, 2012, naming Curtis Wright, Benjamin Oshlack, and Christopher Breder as the
`
`inventors.
`
`52.
`
`The ’888 patent has been the subject of previous District Court litigation
`
`in which certain claims were found infringed but invalid for obviousness and indefiniteness, a
`
`judgment that is currently being appealed.
`
`53.
`
`On May 17, 2013, Purdue filed suit against Amneal in the Southern
`
`District of New York, Civil Action No. 11-cv-08153-SHS alleging infringement of the ’888
`
`patent (“the Amneal I case”). In response, Amneal denied infringement and asserted that the
`
`claims of the ’888 patent were invalid. In September and October of 2013, the Court held a
`
`bench trial in the consolidated actions of Purdue Pharma L.P. et al. v. Teva Pharmaceuticals
`
`USA, Inc., Nos. 11-cv-2037 and 12-cv-5083; Purdue Pharma L.P. et al. v. IMPAX Labs., Inc.,
`
`No. 11-cv-2400; and Purdue Pharma L.P. et al. v. Sandoz Inc., Nos. 11-cv-4694 and 12-cv-5082
`
`(“the 2013 trial”). Because the evidence presented at the 2013 trial related to the claims and
`
`defenses at issue in the Amneal I case, the parties agreed to adopt the entire record as part of the
`
`factual record in the Amneal I action.
`
`54.
`
`On April 8, 2015, the Southern District of New York (Stein, J.) issued
`
`Findings of Fact and Conclusions of Law in the Amneal I case (“Amneal I Decision”). Amneal’s
`
`proposed products were found to infringe the asserted claims of the ’888 patent. However, the
`
`asserted claims of the ’888 patent were also found invalid for obviousness and, as to one asserted
`
`claim, indefiniteness. On April 9, 2015, the Court entered Judgment holding, inter alia, that: (a)
`
`Claims 5, 7, 3, and 24 of the ’888 patent are invalid; and (b) Amneal’s counterclaim for
`
`declaratory judgment for non-infringement of claims 5, 7, 3, and 24 is denied.
`
`
`
`
`- 14 -
`
`KASHIV1020
`IPR of Patent No. 9,492,392
`
`

`

`Case 1:15-cv-01152-RGA-SRF Document 1 Filed 12/15/15 Page 15 of 36 PageID #: 15
`
`
`55.
`
`It is well established that “a judgment of invalidity will have no collateral
`
`estoppel effect if the patentee can show that it did not have a full and fair opportunity to litigate.”
`
`Pharmacia & Upjohn Co. v. Mylan Pharm., Inc., 170 F.3d 1373, 1379-80 (Fed. Cir. 1999)
`
`(citing Blonder-Tongue Labs., Inc. v. Univ. of Ill. Found., 402 U.S. 313, 332-34 (1971)). The
`
`Amneal I Decision does not qualify for a collateral estoppel defense under Blonder-Tongue. 402
`
`U.S. at 332-34 (stating that there is no full and fair opportunity to litigate where, for example,
`
`“the court[] wholly failed to grasp the technical subject matter and issues in suit”).
`
`56.
`
`Purdue did not have a full and fair opportunity to litigate the validity of the
`
`’888 patent before Judge Stein. See id. Therefore, to give collateral estoppel effect to Judge
`
`Stein’s holding of invalidity of claims 5, 7, 3, and 24 of the ’888 patent would be contrary to
`
`“justice and equity” as stated by the Supreme Court in Blonder-Tongue.
`
`57.
`
`On May 8, 2015, Purdue filed a notice of appeal of the Southern District
`
`of New York’s judgment of invalidity in the Amneal I case to the Federal Circuit.
`
`58.
`
`Under a scheduling order issued by the Federal Circuit and pursuant to the
`
`Federal Rules of Appellate Procedure, Purdue’s Reply brief is due on December 23, 2015.
`
`THE ’741 PATENT
`
`59.
`
`Purdue Pharma is the lawful owner of all right, title and interest in the
`
`’741 patent, titled “TAMPER RESISTANT DOSAGE FORMS,” including the right to sue and
`
`to recover for past infringement thereof. The ’741 patent is listed in the Orange Book as
`
`covering OxyContin®, which is the subject of approved NDA No. 022272. A copy of the ’741
`
`patent is attached hereto as Exhibit G, which was duly and legally issued on August 19, 2014,
`
`naming William H. McKenna, Richard O. Mannion, Edward P. O’Donnell, and Haiyong H.
`
`Huang as the inventors.
`
`
`
`
`- 15 -
`
`KASHIV1020
`IPR of Patent No. 9,492,392
`
`

`

`Case 1:15-cv-01152-RGA-SRF Document 1 Filed 12/15/15 Page 16 of 36 PageID #: 16
`
`
`THE ’987 PATENT
`
`60.
`
`Purdue Pharma is the lawful owner of all right, title and interest in the
`
`’987 patent, titled “TAMPER RESISTANT DOSAGE FORMS,” including the right to sue and
`
`to recover for past infringement thereof. The ’987 patent is listed in the Orange Book as
`
`covering OxyContin®, which is the subject of approved NDA No. 022272. A copy of the ’987
`
`patent is attached hereto as Exhibit H, which was duly and legally issued on November 25, 2014,
`
`naming William H. McKenna, Richard O. Mannion, Edward P. O’Donnell, and Haiyong H.
`
`Huang as the inventors.
`
`THE ’988 PATENT
`
`61.
`
`Purdue Pharma is the lawful owner of all right, title and interest in the
`
`’988 patent, titled “TAMPER RESISTANT DOSAGE FORMS,” including the right to sue and
`
`to recover for past infringement thereof. The ’988 patent is listed in the Orange Book as
`
`covering OxyContin®, which is the subject of approved NDA No. 022272. A copy of the ’988
`
`patent is attached hereto as Exhibit I, which was duly and legally issued on November 25, 2014,
`
`naming William H. McKenna, Richard O. Mannion, Edward P. O’Donnell, and Haiyong H.
`
`Huang as the inventors.
`
`THE ’976 PATENT
`
`62.
`
`Purdue is the lawful owner of all right, title, and interest in the ’976 patent,
`
`titled “PHARMACEUTICAL FORMULATION CONTAINING GELLING AGENT,” including
`
`the right to sue and to recover for past infringement thereof. The ’976 patent is listed in the
`
`Orange Book as covering OxyContin®, which is the subject of approved NDA No. 022272. A
`
`copy of the ’976 patent, attached hereto as Exhibit J, was duly and legally issued on June 23,
`
`2015, naming Curtis Wright, Benjamin Oshlack, and Christopher Breder as the inventors.
`
`
`
`
`- 16 -
`
`KASHIV1020
`IPR of Patent No. 9,492,392
`
`

`

`Case 1:15-cv-01152-RGA-SRF Document 1 Filed 12/15/15 Page 17 of 36 PageID #: 17
`
`
`THE ’376 PATENT
`
`63.
`
`Purdue is the lawful owner of all right, title, and interest in the ’376 patent,
`
`titled “PHARMACEUTICAL FORMULATION CONTAINING GELLING AGENT,” including
`
`the right to sue and to recover for past infringement thereof. A copy of the ’376 patent is
`
`attached hereto as Exhibit K, which was duly and legally issued on May 19, 2015, naming Curtis
`
`Wright, Benjamin Oshlack, and Christopher Breder as the inventors.
`
`THE ’933 PATENT
`
`64.
`
`Purdue and Rhodes are the lawful owners of all right, title and interest in
`
`the ’933 patent, titled “OXYCODONE HYDROCHLORIDE HAVING LESS THAN 25 PPM
`
`14-HYDROXYCODEINONE,” including the right to sue and to recover for past infringement
`
`thereof. The ’933 patent is listed in the Orange Book as covering OxyContin®, which is the
`
`subject of appro