UNITED STATES PATENT AND TRADEMARK OFFICE
`
`<*SSS^
`
`Commissioner for Patents
`United Slates Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`w^w.uspJo.sov
`
`Stephen G. Baxter
`Jacob A. Doughty
`Obion Spivak McClelland Maier & Neustadt LLP
`1940 Duke Street
`Alexandria, VA 22314
`
`In Re: Patent Term Extension
`Application for
`U.S. Patent No. 5,856,336
`
`AUG : - ""
`
`NOTICE OF FINAL DETERMINATION
`
`A determination has been made that U.S. Patent No. 5,856,336, claims of which cover the human
`drug product LFVALO® (pitavastatin calcium), is eligible for patent term extension under 35
`U.S.C. § 156. The period of extension has been determined to be 1,823 days.
`
`A single request for reconsideration of this final determination as to the length of extension of the
`term of the patent may be made if filed within one month of the date of this notice. Extensions
`of time under 37 CFR § 1.136(a) are not applicable to this time period. In the absence of a
`request for reconsideration, the Director will issue a certificate of extension, under seal, for a
`period of 1,823 days.
`
`.
`The period of extension has been calculated using the Food and Drug Administration
`determination of the length of the regulatory review period published in the Federal Register of
`December 20, 2010 (75 Fed. Reg. 79382). Under 35 U.S.C. § 156(c):
`
`Period of Extension =
`
`RRP - PGRRP - DD - Vi (TP - PGTP)1
`3,341 -0-0-l/2 (3,036-0)
`1,823 days
`
`Since the regulatory review period began June 12, 2000, after the patent issued (January 5, 1999),
`the entire regulatory review period has been considered in the above determination of the length of
`the extension period 35 U.S.C. § 156(c). No determination of a lack of due diligence under 35
`U.S.C. § 156(c)(1) was made.
`
`Neither the limitations of 35 U.S.C. § 156(g)(6) nor 35 U.S.C. § 156(c)(3) operate to reduce the
`period of extension determined above.
`
`i Consistent with 35 U.S.C. § 156(c), "RRP" is the total number of days in the regulatory
`review period, "PGRRP" is the number of days of the RRP which were on and before the dale on
`which the patent issued, "DD" is the number of days of the RRP that the applicant did not act
`with due diligence, "TP" is the testing phase period described in paragraphs (l)(B)(i), (2)(B)(i),
`(3)(B)(i), (4)(B)(i), and (5)(B)(i) of subsection (g) of 35 U.S.C. § 156, and "PGTP" is the number
`of days of the TP which were on and before the date on which the patent issued, wherein half
`days are ignored for purposes of the subtraction of Yz (TP - PGTP).
`
`Sawai Ex 1002
`Page 248 of 266
`
`

`

`U.S. Patent No. 5,856,336
`
`
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`Page 2
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`
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`Upon issuance of the certificate of extension, the following information will be published in the
`
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`
`
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`
`
`Official Gazette:
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`
`
`U.S. Patent No.:
`
`
`
`
`5,856,336
`
`
`Granted:
`
`
`January 5, 1999
`
`
`
`
`Original Expiration Date2:
`
`
`
`
`January 5, 2016
`
`
`
`
`Applicant:
`
`
`Yoshihiro Fujikawa et al.
`
`
`
`
`
`Owner of Record:
`
`
`
`
`Nissan Chemical Industries Ltd.
`
`
`
`
`
`Title:
`
`
`Quinoline Type Mevalonolactones
`
`
`
`
`Product Trade Name:
`
`
`
`
`LIVALO® (pitavastatin calcium)
`
`
`
`
`
`Term Extended:
`
`
`
`1,823 days
`
`
`
`Expiration Date of Extension:
`
`
`
`
`
`January 1, 2021
`
`
`
`'Subject to the provisions of 35 U.S.C. § 41(b).
`
`
`
`
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`Sawai Ex 1002
`Page 249 of 266
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`

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`U.S. Patent No. 5,856,336
`
`Page 3
`
`Any correspondence with respect to this matter should be addressed as follows:
`
`By mail:
`
`Mail Stop Hatch-Waxman PTE
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450.
`
`By FAX:
`
`(571) 273-7755
`
`Telephone inquiries related to this determination should be directed to the undersigned at (571)
`272-7755.
`
`Mary.C. Ti'
`Senior Legal Advisor
`Office of Patent Legal Administration
`Office of the Associate Commissioner
`for Patent Examination Policy
`
`cc:
`
`Office of Regulatory Policy
`Food and Drug Administration
`10903 New Hampshire Ave., Bldg. 51, Rm. 6222
`Silver Spring, MD 20993-0002
`
`RE: LIVALO® (pitavastatin
`calcium)
`Docket No.: FDA-2010-E-0042
`
`Attention: Beverly Friedman
`
`Sawai Ex 1002
`Page 250 of 266
`
`

`

`g«g£> % UNITED STATES PATENT AND TRADEMARK OFFFCE
`
`Commissioner for Patents
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`svww usplo gov
`
`Stephen G. Baxter
`Jacob A. Doughty
`Obion Spivak McClelland Maier & Neustadt LLP
`1940 Duke Street
`Alexandria, VA 22314
`
`In Re: Patent Term Extension
`Application for
`U.S. Patent No. 5,856,336
`
`w T§ w
`
`Dear Mr. Baxter:
`
`A certificate under 35 U.S.C. § 156 is enclosed extending the term of U.S. Patent
`No. 5,856,336 for a period of 1,823 days. While a courtesy copy of this letter is being forwarded
`to the Food and Drug Administration (FDA), you should directly correspond with the FDA
`regarding any required changes to the patent expiration dates set forth in the Patent and
`Exclusivity Data Appendix of the Orange Book (Approved Drug Products with Therapeutic
`Equivalence Evaluations) or in the Patent Information set forth in the Green Book (FDA
`Approved Animal Drug Products). Effective August 18, 2003, patent submissions for
`publication in the Orange Book and Docket *958-0117 need to be submitted on form FDA-3542
`which may be downloaded from FDA's Electronic Forms Download Website:
`http://www.fda.gov/opacom/morechoices/fdaforms/default.html
`(http://www.fda.gov/opacom/morechoices/fdaforms/FDA-3542.pdf).
`
`Inquiries regarding this communication should be directed to the undersigned by telephone at
`(571) 272-7755, or by e-mail at mary.till@uspto.gov.
`
`Mary C. Till
`Senior Legal Advisor
`Office of Patent Legal Administration
`Office of the Associate Commissioner
`for Patent Examination Policy
`
`i
`
`cc:
`
`Office of Regulatory Policy
`Food and Drug Administration
`10903 New Hampshire Ave., Bldg. 51, Rm. 6222
`Silver Spring, MD 20993-0002
`
`RE: LIVALO® (pitavastatin
`calcium)
`Docket No.: FDA-2010-E-0042
`
`Attention: Beverly Friedman
`
`Sawai Ex 1002
`Page 251 of 266
`
`

`

`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`(12)
`
`CERTIFICATE EXTENDING PATENT TERM
`UNDER 35 U.S.C.§ 156
`
`(68) PATENT NO.
`
`(45)
`
`ISSUED
`
`(75)
`
`INVENTOR
`
`5,856,336
`
`January 5, 1999
`
`Yoshihiro Fujikawa et al.
`
`(73) PATENT OWNER
`
`Nissan Chemical Industries Ltd.
`
`(95) PRODUCT
`
`LIVALO® (pitavastatin calcium)
`
`This is to certify that an application under 35 U.S.C. § 156 has been filed in the United
`States Patent and Trademark Office, requesting extension of the term of U.S. Patent No.
`5,856,336 based upon the regulatory review of the product LIVALO® (pitavastatin
`calcium) by the Food and Drug Administration. Since it appears that the requirements of
`the law have been met, this certificate extends the term of the patent for the period of
`
`(94)
`
`1,823 days
`
`from January 5, 2016, the original expiration date of the patent, subject to the payment of
`maintenance fees as provided by law, with all rights pertaining thereto as provided by
`35 U.S.C. § 156.
`
`Hi
`
`III
`
`I have caused the seal of the United States Patent and
`Trademark Office to be affixed this 1 st dav of April 2013.
`
`rJ
`
`Teresa Stanek Rea
`Acting Under Secretary of Commerce for Intellectual Property
`and Acting Director of the United States Patent and Trademark
`Office
`
`Sawai Ex 1002
`Page 252 of 266
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`

`

`Docket No. 342163US68SD
`
`
`
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`
`
`
`
`IN RE PATENT OF:
`
`
`
`
`
`Hiroshi IWASAKI, et al.
`
`
`
`
`
`PATENT NO:
`
`
`
`5,856,336
`
`
`ISSUED:
`
`
`JANUARY 5, 1999
`
`
`
`SERIAL NO.:
`
`
`
`07/883,398
`
`
`GAU:
`
`
`1613
`
`
`EXAMINER: STOCKTON, L.L.
`
`
`
`
`FILED:
`
`
`FOR:
`
`
`MAY 15, 1992
`
`
`
`QUINOLINE TYPE MEVALONOLACTONES
`
`
`
`
`
`TERMINAL DISCLAIMER
`
`
`
`COMMISSIONER FOR PATENTS
`
`
`
`ALEXANDRIA, VIRGINIA 22313
`
`
`
`
`Commissioner:
`
`
`Now comes the undersigned, Attorney of Record in the present application, who avers as follows:
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`NISSAN CHEMICAL INDUSTRIES LTD. is the owner of the entire right, title and interest in and to the
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
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`invention claimed and disclosed in the above-captioned patent by virtue of assignment, said Assignment having been
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`recorded in the U.S. Patent and Trademark Office at reel no. 004960, frame(s) 0609.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`NISSAN CHEMICAL INDUSTRIES LTD. hereby disclaims the terminal part of any patent granted on the
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`above-captioned patent, which would extend beyond the expiration date of the full statutory term defined in 35 U.S.C.
`
`
`
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`
`
`
`
`
`
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`154 and 173 as shortened by any terminal disclaimer of U.S. Patent No. 5,854,259, and hereby agrees that any patent
`
`
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`
`
`
`
`
`
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`
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`
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`
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`so granted on said above-captioned patent shall be enforceable only for and during such period that it and Patent No.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
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`
`
`5,854,259 are commonly owned. This agreement runs with any patent granted on the above-captioned patent and is
`
`
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`
`
`
`
`
`
`
`
`
`
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`binding upon the grantee, its successors or assigns. NISSAN CHEMICAL INDUSTRIES LTD. also does not disclaim
`
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`
`
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`
`
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`any extension granted on the above captioned patent under 35 U.S.C. 156.
`
`
`
`
`
`
`
`
`
`
`
`
`
`NISSAN CHEMICAL INDUSTRIES LTD. does not disclaim any terminal part of any patent granted on the
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`above-captioned patent that would extend to the full statutory term as defined in 35 U.S.C. 154 and 173 as shortened
`
`
`
`
`
`
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`
`
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`by any terminal disclaimer of U.S. Patent No. 5,854,259 in the event that it later: expires for failure to pay a
`
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`maintenance fee, is held unenforceable, is found invalid, is statutorily disclaimed in whole or terminally disclaimed
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`under 37 C.F.R. 1.321(a), has all claims canceled by a reexamination certificate, is reissued, or is otherwise terminated
`
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`prior to the expiration of its statutory term as shortened by any terminal disclaimer, except for the separation of
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`common ownership stated above.
`
`
`
`
`
`Sawai Ex 1002
`Page 253 of 266
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`

`

`Respeclfully Submitted,
`
`(ON, SPIVA^McCLELLAND,
`lU.gTApT, L.L.P^-N
`MAIER
`
`/
`
`I
`
`h'ard D.
`Registration No.
`
`r,757
`
`Jacob A. Doughty
`Registration No. 46,671
`
`% AOlZ
`0ate Signed
`
`Customer Number
`22850
`
`Tel (703)413-3000
`Fax. (703)413-2220
`(OSMMN 11/09)
`
`Sawai Ex 1002
`Page 254 of 266
`
`

`

`Electronic Patent Application Fee Transmittal
`
`
`
`
`
`
`Application Number:
`
`
`
`Filing Date:
`
`
`
`07883398
`
`
`15-May-1992
`
`
`Title of Invention:
`
`
`
`
`QUINOLINE TYPE MEVALONOLACTONES
`
`
`
`
`First Named Inventor/Applicant Name:
`
`
`
`
`
`YOSHIHIRO FUJIKAWA
`
`
`
`Filer:
`
`
`Marvin Jay Spivak/Diana Bowen
`
`
`
`
`
`Attorney Docket Number:
`
`
`
`
`342163US
`
`
`Filed as Large Entity
`
`
`
`
`
`Utility under 35 USC 111 (a) Filing Fees
`
`
`
`
`
`
`
`
`
`Description
`
`
`Fee Code
`
`
`
`Quantity
`
`
`Amount
`
`
`Sub-Total in
`
`
`USD($)
`
`
`Basic Filing:
`
`
`
`Pages:
`
`
`Claims:
`
`
`Miscellaneous-Filing:
`
`
`Petition:
`
`
`Patent-Appeals-and-lnterference:
`
`
`Post-Allowance-and-Post-lssuance:
`
`
`Extension-of-Time:
`
`
`Sawai Ex 1002
`Page 255 of 266
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`

`

`Description
`
`
`Fee Code
`
`
`
`Quantity
`
`
`Amount
`
`
`Sub-Total in
`
`
`USD($)
`
`
`Miscellaneous:
`
`
`Statutory or Terminal Disclaimer
`
`
`
`
`
`
`1814
`
`1
`
`
`
`160
`
`
`160
`
`
`Total in USD ($)
`
`
`
`
`
`160
`
`
`Sawai Ex 1002
`Page 256 of 266
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`

`

`Electronic Acknowledgement Receipt
`
`
`
`
`EFSID:
`
`
`Application Number:
`
`
`
`16467466
`
`
`07883398
`
`
`International Application Number:
`
`
`
`
`Confirmation Number:
`
`
`
`3046
`
`
`Title of Invention:
`
`
`
`
`QUINOLINE TYPE MEVALONOLACTONES
`
`
`
`
`First Named Inventor/Applicant Name:
`
`
`
`
`
`YOSHIHIRO FUJIKAWA
`
`
`
`Customer Number:
`
`
`
`22850
`
`
`Filer:
`
`
`Marvin Jay Spivak/Diana Bowen
`
`
`
`
`
`Filer Authorized By:
`
`
`
`
`Marvin Jay Spivak
`
`
`
`
`Attorney Docket Number:
`
`
`
`
`342163US
`
`
`Receipt Date:
`
`
`
`Filing Date:
`
`
`
`Time Stamp:
`
`
`31-JUL-2013
`
`
`
`
`15-MAY-1992
`
`15:51:49
`
`
`Application Type:
`
`
`
`Utility under 35 USC 111 (a)
`
`
`
`
`
`
`
`Payment information:
`
`
`
`Submitted with Payment
`
`
`
`
`Payment Type
`
`
`
`Payment was successfully received in RAM
`
`
`
`
`
`
`
`RAM confirmation Number
`
`
`
`
`yes
`
`
`Credit Card
`
`
`
`$160
`
`
`2851
`
`
`Deposit Account
`
`
`
`Authorized User
`
`
`
`File Listing:
`
`
`
`Document
`Number
`
`
`Document Description
`
`
`
`File Name
`
`
`
`
`
`File Size( Bytes)/
`
`
`Message Digest
`
`
`
`
`
`
`Multi
`
`Part /.zip
`
`
`
`Pages
`
`(ifappl.)
`
`
`
`
`Sawai Ex 1002
`Page 257 of 266
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`

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`1
`
`
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`Warnings:
`
`Information:
`
`
`342163USTerminalDisclaimer.
`
`pdf
`
`
`
`93668
`
`69d87f59545976c24f30519e918e0761e0d
`
`
`65ab2
`
`
`yes
`
`
`3
`
`
`Multipart Description/PDF files in .zip description
`
`
`
`
`
`
`
`Document Description
`
`
`
`Miscellaneous Incoming Letter
`
`
`
`
`Terminal Disclaimer Filed
`
`
`
`
`End
`
`
`1
`
`
`
`3
`
`
`Start
`
`
`1
`
`
`
`2
`
`
`
`30723
`
`2
`
`
`Fee Worksheet (SB06)
`
`
`
`
`fee-info.pdf
`
`
`no
`
`
`2
`
`
`6644e91b30c7567f83c7ff9238ce87c21e6a
`
`
`
`
`dd7c
`
`
`Warnings:
`
`Information:
`
`
`Total Files Size (in bytes):
`
`
`
`
`
`
`124391
`
`
`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO of the indicated documents,
`
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`characterized by the applicant, and including page counts, where applicable. It serves as evidence of receipt similar to a
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`Post Card, as described in MPEP 503.
`
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`
`New Applications Under 35 U.S.C. 111
`
`
`
`
`
`
`If a new application is being filed and the application includes the necessary components for a filing date (see 37 CFR
`
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`1.53(b)-(d) and MPEP 506), a Filing Receipt (37 CFR 1.54) will be issued in due course and the date shown on this
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`Acknowledgement Receipt will establish the filing date of the application.
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`National Stage of an International Application under 35 U.S.C. 371
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`If a timely submission to enter the national stage of an international application is compliant with the conditions of 35
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`U.S.C. 371 and other applicable requirements a Form PCT/DO/EO/903 indicating acceptance of the application as a
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`national stage submission under 35 U.S.C. 371 will be issued in addition to the Filing Receipt, in due course.
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`New International Application Filed with the USPTO as a Receiving Office
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`If a new international application is being filed and the international application includes the necessary components for
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`an international filing date (see PCT Article 11 and MPEP 1810), a Notification of the International Application Number
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`and of the International Filing Date (Form PCT/RO/105) will be issued in due course, subject to prescriptions concerning
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`national security, and the date shown on this Acknowledgement Receipt will establish the international filing date of
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`the application.
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`Sawai Ex 1002
`Page 258 of 266
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`

`OBLON
`SpimK
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`ATTORNEYS AT LAW
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`Docket No.: 342163US68SD
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`COMMISSIONER FOR PATENTS
`ALEXANDRIA, VIRGINIA 22313
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`IN RE PATENT OF: Hiroshi IWASAKI, et al.
`PATENT NO:
`5,856,336
`ISSUED:
`January 5, 1999
`Serial No.:
`07/883,398
`May 15, 1992
`Filed:
`QUINOLINE TYPE MEVALONOLACTONES
`TITLE:
`GAU:
`1613
`EXAMINER:
`Stockton, L.L,
`
`Commissioner:
`Attached hereto for filing are the following papers:
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`TERMINAL DISCLAIMER
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`Credit card payment is being made online (if electronically filed), or is attached hereto (if
`in the amount of SI60.00 to cover any required fees. In the event any variance exists
`paper filed),
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`the above-noted documents,
`including any fees required under 37 C.F.R. 1.136 for any necessary Extension of Time to make the
`filing of the attached documents timely, please charge or credit the difference to our Deposit Account
`No. 15-0030. Further, if these papers are not considered timely filed, then a petition is hereby made
`under 37 C.F.R. 1.136 for the necessary extension of time.
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`Customer Number
`22850
`
`(703) 413-3000 (phone)
`(703) 413-2220 (fax)
`(OSMMN 02/12)
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`Respectfully submi'
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`'1VAK, MaCLELL^
`OBL
`MAIJW &>1EUSTADT, L.l^P.
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`Sawai Ex 1002
`Page 259 of 266
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`Application Number
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`Application/Control No.
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`Applicant(s)/Patenl under
`Reexamination
`
`07/883,398
`
`F U J I K A W A E T A L
`
`Document Code - DISQ
`
`| Internal Document - DO NOT MAIL
`
`TERMINAL
`DISCLAIMER
`
`(3 APPROVED
`
`• DISAPPROVED
`
`Date Filed : July 31,2013
`
`This patent is subject
`to a Terminal
`Disclaimer
`
`Approved/Disapproved by:
`
`Henry D, Jefferson
`
`U.S. Patent and Trademark Office
`
`Sawai Ex 1002
`Page 260 of 266
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`Case 3:14-cv-02290-PGS-TJB Documents Filed 04/10/14 Page 1 of 1 PagelD: 56
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`AO 120 (Rev. 08/10)
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`TO:
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`
`
`Mail Stop 8
`
`
`
`Director of the U.S. Patent and Trademark
`
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`
`
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`
`Office
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`P.O. Box 1450
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`
`Alexandria, VA 22313-1450
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`
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`REPORT ON THE
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`FILING OR DETERMINATION OF AN
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`ACTION REGARDING A PATENT OR
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`TRADEMARK
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`In Compliance with 35 U.S.C. § 290 and/or 15 U.S.C. § 1116 you are hereby advised that a court action has been
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`filed in the U.S. District Court for the District of New Jersey on the following:
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`the patent action involves 35 U.S.C. § 292.)
`Trademarks or X Patents. (
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`DATE FILED
`DOCKET NO.
`
`
`
`3:14-cv—02290—PGS—T J B 14/10/2014
`
`
`PLAINTIFF
`
`KOWA COMPANY, LTD.
`
`
`
`
`
`
`U.S. DISTRICT COURT
`
`
`TRENTON. NJ
`
`
`DEFENDANT
`
`AUROBINDO PHARMA LIMITED
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`
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`
`PATENT OR
`
`TRADEMARK NO.
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`1 5,856,336
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`
`2 US 8,557,993 B2
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`DATE OF PATENT
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`
`ORTRADEMARK
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`1/5/1999
`
`10/15/2013
`
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`
`HOLDER OF PATENT OR TRADEMARK
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`
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`NISSAN CHEMICAL INDUSTRIES LTD.
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`NISSAN CHEMICAL INDUSTRIES LTD.
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`3
`4
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`5
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`In the above—entitled case, the following patentfsV trademark(s) have been included:
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`INCLUDED BY
`DATE INCLUDED
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`Amendment
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`Answer
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`Cross Bill
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`Other Pleading
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`DATE OF PATENT
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`ORTRADEMARK
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`
`HOLDER OF PATENT OR TRADEMARK
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`PATENT OR
`
`TRADEMARK NO.
`
`1
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`2
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`3
`4
`5
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`In the above—entitled case, the following decision has been rendered or judgement issued:
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`DECISION/JUDGEMENT
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`CLERK
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`William T. Walsh
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`
`(BY) DEPUTY CLERK
`
`
`
`s/ JAWEIA CAMPBELL
`
`
`
`
`
`
`DATE
`
`4/10/2014
`
`
`
`Copy 1—Upon initiation of action, mail this copy to Director Copy 3—Upon termination of action, mail this copy to Director
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`Copy 2—Upon filing document adding patent(s), mail this copy to Director Copy 4—Case file copy
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`Sawai Ex 1002
`Page 261 of 266
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`Case 3:14-cv-02488-PGS-TJB Document 3 Filed 04/18/14 Page 1 of 1 PagelD: 56
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`AO 120 {Rev. 08/10)
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`
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`TO:
`
`
`Mail Stop 8
`
`
`Director of the U.S. Patent and Trademark
`
`
`
`
`
`
`Office
`
`P.O. Box 1450
`
`
`
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`REPORT ON THE
`
`
`
`FILING OR DETERMINATION OF AN
`
`
`
`
`
`ACTION REGARDING A PATENT OR
`
`
`
`
`
`TRADEMARK
`
`
`In Compliance with 35 U.S.C. § 290 and/or 15 U.S.C. § 1116 you are hereby advised that a court action has been
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`filed in the U.S. District Court for the District of New Jersey on the following:
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`Trademarks or X Patents. (
`the patent action involves 35 U.S.C. § 292.)
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`DOCKET NO.
`
`
`3:14-cv-02488-PGS-TJB
`
`
`
`PLAINTIFF
`
`KOWA COMPANY, LTD.
`
`
`DATE FILED
`
`
`4/18/2014
`
`
`U.S. DISTRICT COURT
`
`
`
`TRENTON. NJ
`
`
`DEFENDANT
`
`AMNEAL PHARMACEUTICALS, LLC
`
`
`
`
`PATENT OR
`
`TRADEMARK NO.
`
`1 5,856,336
`
`
`2 8,557,993 B2
`
`
`
`
`
`
`DATE OF PATENT
`
`
`
`OR TRADEMARK
`
`
`January 5, 1999
`
`
`
`
`October 15, 2013
`
`
`
`HOLDER OF PATENT OR TRADEMARK
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`Nissan Chemical Industries Ltd.
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`Nissan Chemical Industries Ltd.
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`3
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`4
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`5
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`In the above—entitled case, the following patentCsV trademarkCs") have been included:
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`INCLUDED BY
`DATE INCLUDED
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`PATENT OR
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`TRADEMARK NO.
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`DATE OF PATENT
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`OR TRADEMARK
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`
`HOLDER OF PATENT OR TRADEMARK
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`
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`
`
`Amendment
`
`
`Answer
`
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`
`Cross Bill
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`
`
`
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`
`Other Pleading
`
`
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`1
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`2
`3
`4
`5
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`In the above—entitled case, the following decision has been rendered or judgement issued:
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`
`
`DECISION/JUDGEMENT
`
`
`CLERK
`
`William T. Walsh
`
`
`
`
`(BY) DEPUTY CLERK
`
`
`
`s/ Marlene Kalbach
`
`
`
`
`DATE
`
`4/18/2014
`
`
`Copy 1—Upon initiation of action, mail this copy to Director Copy 3—Upon termination of action, mail this copy to Director
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`Copy 2—Upon filing document adding patent(s), mail this copy to Director Copy 4—Case file copy
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`Sawai Ex 1002
`Page 262 of 266
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`

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`Case 3:14-cv-02552-PGS-TJB Document 3 Filed 04/22/14 Page 1 of 1 PagelD: 68
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`AO 120 (Rev. 08/10)
`
`
`
`
`
`TO:
`
`
`Mail Stop 8
`
`
`Director of the U.S. Patent and Trademark
`
`
`
`
`
`
`
`Office
`
`P.O. Box 1450
`
`
`
`Alexandria, VA 22313-1450
`
`
`
`
`REPORT ON THE
`
`
`
`FILING OR DETERMINATION OF AN
`
`
`
`
`
`ACTION REGARDING A PATENT OR
`
`
`
`
`
`TRADEMARK
`
`
`In Compliance with 35 U.S.C. § 290 and/or 15 U.S.C. § 1116 you are hereby advised that a court action has been
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
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`filed in the U.S. District Court for the District of New Jersey on the following:
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Trademarks or X Patents. (
`the patent action involves 35 U.S.C. § 292.)
`
`
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`DOCKET NO.
`
`
`3:14-cv-02552-PGS-T.TB
`
`
`PLAINTIFF
`
`KOWA COMPANY, LTD.
`
`
`
`
`DATE FILED
`
`
`4/22/2014
`
`
`U.S. DISTRICT COURT
`
`
`
`TRENTON. NJ
`
`
`DEFENDANT
`
`ZYDUS PHARMACEUTICALS (USA) INC.
`
`
`
`
`
`PATENT OR
`
`TRADEMARK NO.
`
`
`1 5,856,336
`
`
`2 6,465,477 81
`
`
`3 8,557,993 B2
`
`
`
`DATE OF PATENT
`
`
`
`OR TRADEMARK
`
`
`1/5/1999
`
`10/15/2002
`
`10/15/2013
`
`
`HOLDER OF PATENT OR TRADEMARK
`
`
`
`
`
`
`Nissan Chemical Industries Ltd.
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`Kowa Company Ltd., Nissan Chemical Industries, Ltd.
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`
`Nissan Chemical Industries Ltd.
`
`
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`4
`5
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`
`
`In the above—entitled case, the following patentfsV trademark^) have been included:
`
`
`
`
`
`
`
`
`
`
`
`INCLUDED BY
`DATE INCLUDED
`
`
`
`
`
`Amendment
`
`
`Answer
`
`
`Cross Bill
`
`
`
`
`
`Other Pleading
`
`
`
`DATE OF PATENT
`
`
`
`OR TRADEMARK
`
`
`
`HOLDER OF PATENT OR TRADEMARK
`
`
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`PATENT OR
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`TRADEMARK NO.
`
`
`1
`2
`3
`4
`5
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`In the above—entitled case, the following decision has been rendered or judgement issued:
`
`
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`
`
`
`
`
`
`
`
`
`DECISION/JUDGEMENT
`
`
`CLERK
`
`William T. Walsh
`
`
`
`
`(BY) DEPUTY CLERK
`
`
`
`s/ Marlene Kalbach
`
`
`
`
`DATE
`
`4/22/2014
`
`
`Copy 1—Upon initiation of action, mail this copy to Director Copy 3—Upon termination of action, mail this copy to Director
`
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`Copy 2—Upon filing document adding patent(s), mail this copy to Director Copy 4—Case file copy
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`Sawai Ex 1002
`Page 263 of 266
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`

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`Case: l:14-cv-03336 Document#: 7 Filed: 05/08/14 Page 1 of 1 PagelD#:71
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`AO 120 (Rev. 08/10)
`
`
`
`
`
`
`TO:
`
`Mail Stop 8
`
`
`Director of the U.S. Patent and Trademark Office
`
`
`
`
`
`
`
`P.O. Box 1450
`
`
`
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`
`REPORT ON THE
`
`
`
`FILING OR DETERMINATION OF AN
`
`
`
`
`
`
`ACTION REGARDING A PATENT OR
`
`
`
`
`
`TRADEMARK
`
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`In Compliance with 35 U.S.C. § 290 and/or 15 U.S.C. § 1116 you are hereby advised that a court action has been
`Northern District of Illinois
`
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`on the following
`filed in the U.S. District Court
`
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`• Trademarks or ® Patents.
`( • the patent action involves 35 U.S.C. § 292.):
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`
`
`
`
`DOCKET NO.
`14 C 3336
`
`
`
`PLAINTIFF
`
`
`
`Kowa Company, Ltd.
`
`
`
`Aichi, Japan
`
`
`
`
`
`DATE FILED
`5/7/2014
`
`
`
`
`
`U.S. DISTRICT COURT
`Northern District of Illinois
`
`
`
`
`
`DEFENDANT
`
`
`
`Orient Pharma Co., Ltd.
`
`
`
`
`Taipei, Taiwan
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`
`
`
`PATENT OR
`
`
`TRADEMARK NO.
`
`
`
`
`DATE OF PATENT
`
`
`OR TRADEMARK
`
`
`
`
`
`
`HOLDER OF PATENT OR TRADEMARK
`
`1 5,856,336
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`
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`2 6,465,477
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`3 8,557,993
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`
`
`1/5/1999
`
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`Nissan Chemical Industries Ltd., Tokyo, Japan
`
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`10/15/2002
`
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`Kowa Company, Ltd., Aichi-Ken (JP); Nissan Chemical Industrjj
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`10/15/2013
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`
`Nissan Chemical Industries. Ltd, To|3o (JP)
`
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`
`
`
`
`
`
`
`
`
`
`
`
`In the above—entitled case, the following patent(s)/ trademark(s) have been included:
`
`
`
`
`INCLUDED BY
`
`
`
`
`
`
`• Amendment • Answer
`
`
`
`DATE OF PATENT
`
`
`ORTRADEMARK
`
`
`
`
`
`
`
`
`• Cross Bill • Other Pleading
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`HOLDER OF PATENT OR TRADEMARK
`
`
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`4
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`5
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`
`
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`DATE INCLUDED
`
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`
`
`PATENT OR
`
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`TRADEMARK NO.
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`1
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`2
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`4
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`5
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`
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`In the above—entitled case, the following decision has been rendered or judgement issued:
`
`
`
`DECISION/JUDGEMENT
`
`
`
`A TRUE COPY-ATTEST
`
`
`THOMAS G. BRUTON, CLERK
`
`
`
`
`
`
`
`
`
`By: s/^rtillfffilSisYKElS
`
`
`
`
`
`DEPUTY CLERK
`U.S. DISTRICT COURT, NO'RTFIERN
`
`
`DISTRICT OF ILLINOIS
`
`
`
`
`
`Copy I—Upon initiation of action, mail this copy to Director Copy 3—Upon termination of action, mail this copy )o Sirector^
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`Copy 2—Upon filing document adding patent(s), mail this copy to Director Copy 4—Case file copy
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`CLERK
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`THOMAS G. BRUTON
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`(BY) DEPUTY CLERK
`
`
`/s/ Thelma Murry-Sykes
`
`
`
`Sawai Ex 1002
`Page 264 of 266
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`

`

`Case 3:14-cv-02488-PGS-LHG Document 3 Filed 04/18/14 Page 1 of 1 PagelD: 56
`
`
`
`
`
`
`
`
`
`
`
`
`AO 120 {Rev. 08/10)
`
`
`
`
`
`TO:
`
`
`Mail Stop 8
`
`
`Director of the U.S. Patent and Trademark
`
`
`
`
`
`
`
`Office
`
`P.O. Box 1450
`
`
`
`Alexandria, VA 22313-1450
`
`
`
`
`REPORT ON THE
`
`
`
`FILING OR DETERMINATION OF AN
`
`
`
`
`
`ACTION REGARDING A PATENT OR
`
`
`
`
`
`TRADEMARK
`
`
`In Compliance with 35 U.S.C. § 290 and/or 15 U.S.C. § 1116 you are hereby advised that a court action has been
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`filed in the U.S. District Court for the District of New Jersey on the following:
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`the patent action involves 35 U.S.C. § 292.)
`Trademarks or X Patents. (
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`
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`
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`DOCKET NO.
`
`
`3:14-cv-02488-PGS-TJB
`
`PLAINTIFF
`
`KOWA COMPANY, LTD.
`
`
`
`
`
`DATE FILED
`
`4/18/2014
`
`
`U.S. DISTRICT COURT
`
`
`
`TRENTON. NJ
`
`
`DEFENDANT
`
`AMNEAL PHARMACEUTICALS, LLC
`
`
`
`
`DATE OF PATENT
`
`
`
`OR TRADEMARK
`
`
`Januarys, 1999
`
`
`
`October 15, 2013
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`
`
`HOLDER OF PATENT OR TRADEMARK
`
`
`
`
`
`
`Nissan Chemical Industries Ltd.
`
`
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`
`
`Nissan Chemical Industries Ltd.
`
`
`
`
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`PATENT OR
`
`TRADEMARK NO.
`
`
`1 5,856,336
`
`
`
`2 8,557,993 B2
`
`
`
`3
`
`
`
`4
`
`5
`
`In the above—entitled case, the following patentCsV trademarkfs') have been included:
`
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`
`
`
`
`DATE INCLUDED
`INCLUDED BY
`
`
`
`
`
`Amendment
`
`
`Answer
`
`
`Cross Bill
`
`
`
`
`
`Other Pleading
`
`
`
`DATE OF PATENT
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`
`
`OR TRADEMARK
`
`
`
`HOLDER OF PATENT OR TRADEMARK
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`
`
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`PATENT OR
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`TRADEMARK NO.
`
`
`1
`
`
`
`2
`3
`4
`5
`
`In the above—entitled case, the following decision has been rendered or judgement issued:
`
`
`
`
`
`
`
`
`
`
`
`
`
`DECISION/JUDGEMENT
`
`
`CLERK
`
`William T. Walsh
`
`
`
`
`(BY) DEPUTY CLERK
`
`
`
`s/ Marlene Kalbach
`
`
`
`
`DATE
`
`4/18/2014
`
`
`Copy 1—Upon initiation of action, mail this copy to Director Copy 3—Upon termination of action, mail this copy to Director
`
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`Copy 2—Upon filing document adding patent(s), mail this copy to Director Copy 4—Case file copy
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`Sawai Ex 1002
`Page 265 of 266
`
`

`

`Case l:14-cv-00978-UNA Document 4 Filed 07/24/14 Page 1 of 1 PagelD #: 102
`
`AO 120 (Rev. 08/10)
`
`TO:
`
`Mail Stop 8
`Director of the U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`REPORT ON THE
`FILING OR DETERMINATION OF AN
`ACTION REGARDING A PATENT OR
`TRADEMARK
`
`In Compliance with 35 U.S.C. § 290 and/or 15 U.S.C. § 1116 you arc hereby advised that a court action has been
`District of Delaware
`on the following
`filed in the U.S. District Court
`( • the patent action involves 35 U.S.C. § 292.):
`• Trademarks or 0 Patents.
`
`DOCKET NO.
`
`DATE FILED
`
`U.S. DISTRICT COURT
`
`District of Delaware
`
`PLAINTIFF
`Kowa Company, Ltd.,
`Kowa Pharmaceuticals America, Inc., and
`Nissan Chemical Industries, Ltd.
`
`DEFENDANT
`Sawai USA Inc.. and
`Sawai Pharmaceutical Co., Ltd.
`
`PATENT OR
`TRADEMARK NO.
`
`DATE OF PATENT
`ORTRADEMARK
`
`HOLDER OF PATENT OR TRADEMARK
`
`I 5,856,336
`
`2 6,465,477
`
`3 8,557,993
`
`4
`
`5
`
`1/5/1999
`
`Nissan Chemical Industries, Ltd.
`
`10/15/2002
`
`Kowa Company, Ltd. and Nissan Chemical Industries, Ltd.
`
`10/15/2013
`
`Nissan Chemical Industries, Ltd.
`
`In the above—entitled case, the following patents)/ trademark(s) have been included:
`
`DATE INCLUDED
`
`INCLUDED BY
`
`PATENT OR
`TRADEMARK NO.
`
`Q Amendment
`DATE OF PATENT
`OR TRADEMARK
`
`n Answer
`HOLDER OF PATENT OR TRADEMARK
`
`• Cross Bill • Other Pleading
`
`I
`
`3
`
`4
`
`5
`
`In the above—entitled case, the following decision has been rendered or judgement issued:
`
`DECISION/JUDGEMENT
`
`CLERK
`
`(BY) DEPU TY CLERK
`
`DATE
`
`Copy 1—Upon initiation of action, mail this copy to Director Copy 3—Upon termination of action, mail this copy to Director
`Copy 2—Upon filing document adding patcnt(s), mail this copy to Director Copy 4—Case file copy
`
`Sawai Ex 1002
`Page 266 of 266
`
`