Helsinn Healthcare Exhibit 2069
`Dr. Reddy's Laboratories, Ltd., et al. v. Helsinn Healthcare S.A.
`Trial PGR2016-00007
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`Page 1 of 5
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`Receipt date: 03/05/2015
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`33901830 ~ GAE}: 1628
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`IN FORMATION DISC LOSU RE
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`(Use as many sheets as necessary)
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`Application Number
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`I’:”’”9ND5"edl
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`Art Unit
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`Attorney Docket Number
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`Complete if Known
`13/901,830
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`2'33’ 24vC2°|:j3
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`244168-000007-US-9
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`NONPATENT LITERATURE DOCUMENTS
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`P|aintiff‘s Answer to the Counterclaims of Aurobindo Pharma USA Inc. and Aurobindo Pharma Ltd., dated
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`September 13, 2013 (D. Del. Case No. 13-688).
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`Plaintiffs‘ Responses to Dr. Reddy‘s Laboratories, Ltd. and Dr. Reddy‘s Laboratories, |nc.‘s Amended
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`Invalidity Contentions, dated August 19, 2013 (D. N.J. Case Nos. 11-3962 and 11-5579; consolidated)
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`(confidentiality designation redacted).
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`Plaintiffs‘ Responses to Sandoz |nc.‘s Second Amended Invalidity Contentions, dated August 19, 2013 (D.
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`N.J. Case Nos. 11-3962 and 11-5579; consolidated) (confidentiality designation and other portions
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`redacted).
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`Plaintiffs‘ Responses to Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries, Ltd.‘s First
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`Amended Invalidity Contentions, dated August 19, 2013 (D. N.J. Case Nos. 11-3962 and 11-5579;
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`consolidated) (confidentiality designation redacted).
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`Complaint for patent infringement filed by Helsinn Healthcare SA and Roche Palo Alto LLC against Dr.
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`Reddy‘s Laboratories, Ltd., Dr. Reddy‘s Laboratories, Inc., Sandoz |nc., Teva Pharmaceuticals USA, Inc.,
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`and Teva Pharmaceutical Industries, Ltd. regarding U.S. Patent No. 8,518,981 dated September 30, 2013
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`(D.N.J. Case No. (13-5815)).
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`Answer and Counterclaim of Dr. Reddy's Laboratories, Ltd. and Dr. Reddy's Laboratories, Inc. to Amended
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`Complaint for Patent Infringement regarding U.S. Patent Nos. 8,518,981, 8,598,218, and 8,598,219, dated
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`February 3, 2014 (D.N.J. Case No. 13-5815).
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`Sandoz |nc.‘s Answer, Affirmative Defenses, and Counterclaims to Amended Complaint regarding U.S.
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`Patent Nos. 8,518,981, 8,598,218, and 8,598,219, dated February 3, 2014 (D.N.J. Case No. 13-5815).
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`Defendants Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd.‘s Answer to
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`Amended Complaintfor Patent Infringement regarding U.S. Patent Nos. 8,518,981, 8,598,218, and
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`8,598,219, dated February 3, 2014 (D.N.J. Case No. 13-5815).
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`Teva Pharmaceuticals USA, Inc Paragraph IV Letter regarding U.S. Patent Nos. 8,518,981, 8,598,218, and
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`8,598,219, dated April 29, 2014 (portions redacted).
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`Mylan Institutional LLC Paragraph IV Letter regarding U.S. Patent Nos. 7,947,724, 7,947,725, 7,960,424,
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`8,518,981, 8,598,218, and 8,598,219, dated May 16, 2014 (portions redacted).
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`Bedford Laboratories division of Ben Venue Laboratories, Inc. Paragraph IV Letter regarding U.S. Patent
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`No. 8,729,094, dated May 29, 2014 (portions redacted).
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`Defendants‘ Opening Claim Construction Brief regarding U.S. Patent No. 8,598,219, dated June 19, 2014
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`(D.N.J. 11-3962, consolidated).
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`Answer, Affirmative Defenses and Counterclaims of Defendants Cipla Ltd. and Cipla USA, Inc. regarding
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`U.S. Patent Nos. 7,947,724, 7,947,725, 7,960,424, 8,518,981, 8,598,218 and 8,598,219 dated April 29,
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`2014 (D. Del. Case No. 14-427).
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`Complaint for Patent Infringement filed by Helsinn Healthcare S.A. and Roche Palo Alto LLC against Mylan
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`Inc. and Mylan Institutional LLC regarding U.S. Patent Nos. 7,947,724, 7,947,725, 7,960,424, 8,598,219,
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`and 8,729,094, dated June 4, 2014 (D. Del. Case No. 14-709).
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`G. Steele, Preformulation predictions from small amounts of compound as an aid to candidate drug
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`selection, in Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug
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`Selection to Commercial Dosage Form, Ch. 3, pp. 21-95 (Gibson ed., CRC Press 1st ed. 2001).
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`G. Steele, Preformulation as an aid to product design in early drug development, in Pharmaceutical
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`Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage
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`Form, Ch. 6, pp. 175-237 (Gibson ed., CRC Press 1st ed. 2001).
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`M. Gibson, Product optimisation, in Pharmaceutical Preformulation and Formulation: A Practical Guide from
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`Candidate Drug Selection to Commercial Dosage Form, Ch. 8, pp. 295-329 (Gibson ed., CRC Press 1st ed.
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`2001).
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`Mylan Institutional LLC Paragraph IV Letter regarding U.S. Patent No. 8,729,094, dated June 27, 2014
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`(portions redacted).
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`Ben Venue Laboratories, |nc.‘s Opening Claim Construction Brief, dated April 17, 2014 (D. Del. Case No.
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`13-688, consolidated).
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`Ben Venue Laboratories, |nc.‘s Answering Claim Construction Brief, dated July 8, 2014 (D. Del. Case No.
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`13-688, consolidated).
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`Answer, Defenses and Counterclaims of Mylan Institutional LLC regarding U.S. Patent Nos. 7,947,724,
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`7,947,725, 7,960,424, 8,598,219, and 8,729,094, dated June 26, 2014 (D. Del. Case No. 14-709).
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`Aurobindo Pharma Ltd. Paragraph IV Letter regarding U.S. Patent No. 8,729,094, dated July 25, 2014
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`(portions redacted).
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`Defendants‘ Responsive Claim Construction Brief regarding U.S. Patent No. 8,598,219, dated July 17, 2014
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`com:<7:l\) o0 IS(I)Q Em..cuQ \_/
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`A U Z F-
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`ALL REFERENCES CQNSEDEREI3 EXCEPT WHERE LENED THRQUGH.
`Page 2 of 5
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`/S.G./
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`Page 2 of 5
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`Receipt date: 03/05/2015
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`33901830 ~ GAE}: 1628
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`IN FORMATION DISC LOSU RE
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`(Use as many sheets as necessary)
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`Application Number
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`I’:”’”9ND5"edl
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`Irs
`.an7e
`nVen OI’
`Art Unit
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`Attorney Docket Number
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`Complete if Known
`13/901,830
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`2'33’ 24vC2°|:j3
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`I0rgI0
`3 erarl
`1628
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`Shjrjey V_ GEMBEH
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`244168-000007-US-9
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`NONPATENT LITERATURE DOCUMENTS
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`Cipla Ltd. Paragraph IV Letter regarding U.S. Patent No. 8,729,094, dated August 6, 2014 (portions
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`redacted).
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`2014.- Teva Pharmaceuticals USA, Inc Paragraph IV Letter regarding U.S. Patent No. 8,729,094, dated August 29, -
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`904
`Expert Report of Patrick P. DeLuca, Ph.D. with Respect to U.S. Patent No. 8,598,219, dated August 15,
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`2014 (D.N.J. 11-3962, consolidated).
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`Expert Report of David G. Frame, Pharm.D. with Respect to U.S. Patent No. 8,598,219, dated August 15,
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`2014 (D.N.J. 11-3962, consolidated) (confidentiality designation redacted).
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`Opening Expert Report of John P. Fruehauf, M.D., Ph.D. for U.S. Patent No. 8,598,219, dated August 15,
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`2014 (D.N.J. 11-3962, consolidated) (confidentiality designation and other portions redacted).
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`Opening Expert Report of Lee Kirsch, Ph.D. for U.S. Patent No. 8,598,219, dated August 15, 2014 (D.N.J.
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`11-3962, consolidated) (confidentiality designation and other portions redacted).
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`Expert Report of Maurie Markman, M.D. with Respect to U.S. Patent No. 8,598,219, dated August 15, 2014
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`(D.N.J. 11-3962, consolidated) (confidentiality designation and other portions redacted).
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`Opening Expert Report of Paul Myrdal, Ph.D. for U.S. Patent No. 8,598,219, dated August 15, 2014 (D.N.J.
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`11-3962, consolidated) (confidentiality designation and other portions redacted).
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`Second Opening Expert Report of Dr. Bert Spilker with Respect to U.S. Patent No. 8,598,219, dated August
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`15, 2014 (D.N.J. 11-3962, consolidated) (confidentiality designation and other portions redacted).
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`K. A. Connors, Introduction to Chemical Kinetics, Chemical Kinetics The Study of Reaction Rates in
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`Solution, John Wiley & Sons, Inc., 1990, Ch. 1, pp. 1-15.
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`R. G. Strickley, Parenteral formulations of small molecule therapeutics marketed in the United States
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`(1999)—Part I. PDA J. Pharm. Sci. Technol. 53:324-349 (1999).
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`Physicians‘ Desk Reference, entries for Hespan® (pp. 933-35) and Hyperstat® |.V. Diazoxide Injection (pp.
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`2848-49) (53'd ed. 1999).
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`Physicians‘ Desk Reference for Astromorph/PF® (pp. 594-95); Baxter's Atrophine Sulfate Injection (p. 858);
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`Baxter's Dobutamine Hydrochloride Injection (p. 861); Duramorph® (p. 863); Baxter's Fentanyl Citrate
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`Injection (p. 868); Baxter's Metoclopramide Injection (p. 871); Baxter's Phenylephrine Hydrochloride
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`Injection (pp. 872-73); Robinu|® (p. 873; 2940-42); Phenytoin Sodium Injection (p. 1312); and Dif|ucan® (pp.
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`2681-85) (56“‘ ed. 2002).
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`The United States Pharmacopeia (USP 26) The National Formulary (NF 21), Official from January 1, 2003,
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`entries for Atrophine Sulfate Injection (p. 192); Diazoxide Injection (p. 591); Dobutamine Hydrochloride
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`Injection (p. 652); Fentanyl Citrate Injection (p. 781); Glycopyrrolate Injection (p. 870); Lidocaine
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`Hydrochloride and Dextrose Injection (pp. 1079-80); Metoclopramide Injection (pp. 1217-18); Morphine
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`Sulfate Injection (pp. 1254-55); Phenylephrine Hydrochloride Injection (pp. 1459-60); Phenytoin Sodium
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`Injection (pp. 1471-72); Potassium Chloride for Injection (pp. 1503-04) (2002).
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`‘ HELSN0004208 (2002) (redacted).
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`‘ Full Prescribing Information for Aloxi (palonosetron HCI) Injection for Intravenous Use (2014). ‘
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`‘ Preformulation Book, Syntex Research, pp. c1—7, C149, and C1-26 (1993) (redacted). ‘
`919
`Accord Healthcare, |nc.'s Petition for Post Grant Review of U.S. Patent No. 8,598,219 dated September 2,
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`2014.
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`Exhibit 1015 to Accord Healthcare, |nc.'s Petition for Post Grant Review of U.S. Patent No. 8,598,219,
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`Declaration of Arnold J. Repta, Ph.D. dated September 2, 2014.
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`Rebuttal Expert Report of Gordon L. Amidon, Ph.D. concerning U.S. Patent No. 8,598,219, dated
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`September 15, 2014 (D.N.J. 11-3962, consolidated) (confidentiality designation and other portions
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`redacted).
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`Rebuttal Expert Report of Keith A. Candiotti, M.D. with respect to U.S. Patent No. 8,598,219, dated
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`September 15, 2014 (D.N.J. 11-3962, consolidated) (confidentiality designation and other portions
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`1 Second Rebuttal Expert Report of Carl C. Peck, M.D. dated September 15, 2014 (D.N.J. 11-3962,
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`consolidated) (confidentiality designation and other portions redacted).
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`Rebuttal Expert Report of Tanios Bekaii-Saab, M.D. with respect to U.S. Patent No. 8,598,219, dated
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`September 15, 2014 (D.N.J. 11-3962, consolidated) (confidentiality designation and other portions
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`redacted).
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`Answer and Counterclaims of Dr. Reddy's Laboratories, Ltd. and Dr. Reddy's Laboratories, Inc. to
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`Complaint for Patent Infringement regarding U.S. Patent No. U.S. Patent No. 8,729,094 dated September 5,
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`2014 (D.N.J. Case No. 14-4274).
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`ALL REFERENCES CQNSEDEREI3 EXCEPT WHERE LENEEI) THROUGH.
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`Receipt date: 03/05/2015
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`33901830 ~ GAE}: 1628
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`IN FORMATION DISC LOSU RE
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`(Use as many sheets as necessary)
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`Application Number
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`I’:”’”9ND5"edl
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`Art Unit
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`Attorney Docket Number
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`Complete if Known
`13/901,830
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`2'33’ 24vC2°|:j3
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`244168-000007-US-9
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`NONPATENT LITERATURE DOCUMENTS
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`Dr. Reddy's Laboratories, Ltd.‘s and Dr. Reddy's Laboratories, |nc.‘s Paragraph IV Letter regarding U.S.
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`Patent Nos. 8,518,981, 8,598,218, 8,598,219, and 8,729,094, dated September 19, 2014 (portions
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`redacted).
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`Dr. Reddy's Laboratories, Ltd.‘s and Dr. Reddy's Laboratories, |nc.‘s Paragraph IV Letter regarding U.S.
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`Patent Nos. 8,518,981, 8,598,218, 8,598,219, and 8,729,094, dated September 24, 2014 (portions
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`redacted).
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`R. M. Eglen and D. W. Bonhaus, “5-Hydroxytryptamine (5-HT)3 Receptors: Molecular Biology,
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`Europe,” PR Newswire, September 14, 2000.
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`G. Piraccini, et al., “A Novel Anti-Emetic Agent, Palonosetron (RS 25259-197): Evidence From Phase I
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`Trials,” Support Care Cancer, June 2001, Vol. 9, No. 4, Abstract no. P-41 and associated poster
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`presentation.
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`R. E. Leak and J. D. Woodford, “Pharmaceutical Development of Ondansetron |njection,” Eur J Cancer Clin
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`Oncol. 25(Suppl 1):S67-69 (1989).
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`Reply Expert Report of David G. Frame, Pharm. D. with respect to U.S. Patent No. 8,598,219 dated October
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`10, 2014 (D.N.J. 11-3962, consolidated) (confidentiality designations redacted).
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`Reply Expert Report of Maurie Markman, M.D. with respect to U.S. Patent No. 8,598,219 dated October 10,
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`2014 (D.N.J. 11-3962, consolidated) (confidentiality designations redacted).
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`Reply Expert Report of John P. Fruehauf, M.D., Ph.D. for U.S. Patent No. 8,598,219 dated October 10,
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`2014 (D.N.J. 11-3962, consolidated) (confidentiality designation redacted).
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`Reply Expert Report of Lee Kirsch, Ph.D. for U.S. Patent No. 8,598,219 dated October 10, 2014 (D.N.J. 11-
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`3962, consolidated) (confidentiality designation redacted).
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`Reply Expert Report of Paul Myrdal, Ph.D. for U.S. Patent No. 8,598,219 dated October 10, 2014 (D.N.J.
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`11-3962, consolidated) (confidentiality designation redacted).
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`Second Reply Expert Report of Dr. Bert Spilker regarding U.S. Patent No. 8,598,219 dated October 10,
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`2014 (D.N.J. 11-3962, consolidated) (confidentiality designations redacted).
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`Exela Pharma Sciences LLC's Paragraph IV Letter regarding U.S. Patent Nos. 7,947,724, 7,947,725,
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`7,960,424, 8,518,981, 8,598,218, 8,598,219, and 8,729,094, dated October 16, 2014 (portions redacted).
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`Final Joint Claim Construction Chart regarding U.S. Patent Nos. 7,947,724, 7,947,725, 7,960,424,
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`8,598,219, and 8,729,094 dated October 24, 2014 (D. Del. Case Nos. 13-688 and 14-709).
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`Mylan Institutional LLC's Opening Claim Construction Brief dated December 5, 2014 (D. Del. Case No. 13-
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`688, consolidated).
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`|nc.‘s Corrected Opening Claim Construction Brief dated January 27,
`Defendants Cipla Ltd. And Cipla USA,
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`2015 (D. Del. Case No. 13-688, consolidated).
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`Plaintiffs‘ Opening Claim Construction Brief dated December 5, 2014 (D. Del. Case No. 13-688,
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`consolidated).
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`Defendants Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd. Corrected Answer to
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`Complaint for Patent Infringement and Counterclaim for Declaratory Judgment regarding U.S. Patent No.
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`8,729,094 dated January 8, 2015 (D.N.J. Case No. 14-6341).
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`Termination of the Proceeding (Case No. PGR2014-00010) dated November 24, 2014.
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`Declaration of Dr. Neervalur Raghavan, Ph.D. with Exhibits 1-25, dated September 28, 2014.
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`Gavis Pharma LLC‘s Paragraph IV Letter regarding U.S. Patent Nos. 7,947,724, 7,947,725, 7,960,424,
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`8,518,981, 8,598,218, 8,598,219, and 8,729,094, dated December 31, 2014 (portions redacted).
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`Answer, Defenses, and Counterclaims of Defendants Exela Pharma Sciences, LLC, Exela Pharmsci, Inc.
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`and Exela Holdings, Inc. to Complaint regarding U.S. Patent Nos. 8,518,981 and 8,598,218 redacted
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`version dated December 29, 2014 (D. Del. Case No. 14-1444).
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`Defendant Mylan Institutional, LLC's Responsive Claim Construction Brief dated January 14, 2015 (D. Del.
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`Case No. 13-688, consolidated).
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`|nc.‘s Corrected Answering Claim Construction Brief dated January
`Defendants Cipla Ltd. and Cipla USA,
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`27, 2015 (D. Del. Case No. 13-688, consolidated).
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`ALL REFERENCES CQNSEDEREI3 EXCEPT WHERE LENED THROUGH.
`Page 4 of 5
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`/S.G./
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`Page 4 of 5
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`Receipt date: 03/05/2015
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`33901830 ~ GAE}: 1628
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`IN FORMATION DISC LOSU RE
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`(Use as many sheets as necessary)
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`Application Number
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`I’:”’”9ND5"edl
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`Irs
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`Art Unit
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`Attorney Docket Number
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`Complete if Known
`13/901,830
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`2'33’ 24vC2°|:j3
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`I0rgI0
`3 erarl
`1628
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`Shir|ey V_ GEMBEH
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`244168-000007-US-9
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`NONPATENT LITERATURE DOCUMENTS
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`Plaintiffs‘ Responsive Claim Construction Brief, redacted public version dated January 20, 2015 (D. Del.
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`Case No. 13-688, consolidated).
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`On Sale and Public Use Bars to Patentability After AIA: Minimizing the Risk of Patent lneligibility or
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`lnvalidation, Cover and Slide 74, November 7, 2013.
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`Hospira |nc.'s Paragraph IV Letter regarding U.S. Patent Nos. 7,947,724, 7,947,725, 7,960,424, 8,518,981,
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`8,598,218, 8,598,219, and 8,729,094, dated February 10, 2015 (portions redacted).
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`Par Pharmaceutical, |nc.‘s Paragraph IV Letter regarding U.S. Patent Nos. 7,947,724, 7,947,725, 7,960,424,
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`8,518,981, 8,598,218, 8,598,219, and 8,729,094, dated February 10, 2015 (portions redacted).
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`EXAMINER:
`Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through
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`citation if not in conformance and not considered.
`Include copy of this form with next communication to applicant.
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`ALL REFERENCES CQNSEEBERED EXCEPT WHERE LENEEI) THROUGH.
`Page 5 of 5
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`/S.G./
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`Page 5 of 5