Case 1:15-cv—OOO13-IMK Document 4 Filed 01/28/15 Page 1 of 1 PageID #: 168
`
`A0 l20(Rcv.08/10)
`
`T0:
`
`Mail Stop 3
`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. § lll6 you are hereby advised that a court action has been
`filed in the u.s. District Court
`for the Northern District of West Virginia
`on the following
`D Trademarks or M Patents.
`( E] the patent action involves 35 U.S.C. § 562.):
` DOCKET NO.
`
`DATE FILED
`U.S. DISTRICT COURT
`
`1:15 cv 13
`
`PLAINTIFF
`
`
`
`for the Northern District of West Virini
`DEFENDANT
`
`7
`
`Mylan Pharmaceuticals, lnc.
`
`
`Pfizer Inc.
`
`UCB Pharma GMBH
`
`1/27/2015
`
`
`
`
`
`
`
`
`U I ‘ _Wv
`
`
`
`HOLDER OF PATENT OR TRADEASDQURQ WV 25301
`
`
`
`
`
`D
`
`
`
`
`
`DATE INCLUDED
`
`In the above-—entitled case, the following patent(s)/ trademark(s) have been included:
`INCLUDED BY
`
`PATENT OR
`TRADEMARK NO‘
`
`El Amendment
`DATE OF PATENT
`OR TRADEMARK
`
`[:] Answer
`
`I:I Cross Bill
`
`D Other Pleading
`
`HOLDER OF PATENT OR TRADEMARK
`
`——
`——
`——
`——
`
`In the above—entitled case, the following decision has been rendered orjudgement issued:
`DECISION/JUDGEMENT
`
`
`
`
`
`t’
`
`
`Copy l—Upon initiation ofaction, mail this copy to Dirirfjor Copy3———Upon termination ofaction, mail this copy to Director
`
`Copy 2——Upon filing document adding patent(s), mail th' copy to Director Copy 4———Case file copy
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1002 — Page 1
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 1
`
`

`
`Case 1:15-cv-00079-UNA Document 4 Filed 01/23/15 Page 1 of 1 PagelD #: 171
`A0 120 Rev. 08/10
`
`
`T0:
`
`Mail Stop 8
`Director of the U.S. Patent and Trademark Office
`
`REPORT ON THE
`FILING OR DETERMINATION OF AN
`
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`ACTION REGARDING A PATENT OR
`TRADEMARK
`
`In Compliance with 35 U.S.C. § 290 and/or 15 U.S.C. § I I 16 you are hereby advised that a court action has been
`
`filed in the U.S. District Court
`
`for the District of Delaware
`
`on the following
`
`El Trademarks or
`
`EZlPatents.
`
`( El the patent action involves 35 U.S.C. § 292.):
`
`
`
`DEFENDANT
`
`PFIZER INC. and UCB PHARMA GMBH
`
`
`
`MYLAN PHARMACEUTICALS INC.
`
`
`
`
`
`
`
`[:1 Other Pleading
`
`E] Answer
`
`|:I Cross Bill
`
`HOLDER OF PATENT OR TRADEMARK
`
`In the above—entitled case, the following patent(s)/ trademark(s) have been included:
`DATE INCLUDED
`INCLUDED BY
`
`
`E] Amendment
`DATE OF PATENT
`OR TRADEMARK
`
`
`
`
`
`
`
`PATENT OR
`TRADEMARK NO.
`
`
`
`In the above—entitled case, the following decision has been rendered or judgement issued:
`DECISION/JUDGEMENT
`
`
`
`CLERK
`
`(BY) DEPUTY CLERK
`
`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 patent(s), mail this copy to Director Copy 4——Case file copy
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit ‘I002 — Page 2
`
`
`
`DOCKET NO.
`
`PLAINTIFF
`
`DATE FILED
`1/23/2015
`
`U.S. DISTRICT COURT
`for the District of Delaware
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 2
`
`

`
`f
`
`Case 1:13-cv—01158-GMS Document 18 Filed 09/02/14 Page 1 of 3 PagelD #: 280
`
`Case 1:13-cv—01158-GMS Document 4 Filed 06/28/13 Page 1 of 1 PagelD #: 168
`
`A0 llll Rm’ Uililll
`
`
`
`T0:
`
`Mail Stop 8
`Director of the U.S. Patent and Trndemnrlc Office
`P.O. Box 1450
`Alexandria, VA 223|3-I 450
`
`REPORT ON THE
`FILING OR DETERMINATION OF AN
`ACTION REGARDING A PATENT OR
`TRADEMARK
`
`In Compliance with 35 U.S.C. § 290 and/or l5 U.S.C. § ll 16 you are hereby advised that a court action has been
`filed in the U.S. District Court
`for the District of Delaware
`on the following
`S Trademarks or
`[1 Patents. _( D the patent action involves 35 U.S.C. § 292.):
`DATE FILED
`U.S. DISTRICT COURT
`6/21/2013
`for the District of Delaware
`
`PLAINTIFF
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`PFIZER INC. and UCB PHARMA GMBH
`
`DEFENDANT
`
`
`
`lMPAX LABORATORIES, INC.
`
`
`
`
`
`5 8.338,478 82
`
`
`
`"W"
`
`12/25/2012
`
`UCB Pharma GmbH
`
`
`
`DATE INCLUDED
`
`In the abov&—antitlcd unse, the following patent(s)/ trudcmarlqs) have been included:
`INCLUDED BY
`
`l’A'lT-INT OR
`TRADEMARK No‘
`
`[1 Amendment
`DATE OF PATENT
`OR TRADEMARK
`
`[:1 Answer
`
`D Cross Bill
`
`D Other l‘leading
`
`HOLDER OF PATENT OR TRADEMARK
`
`
`
`
`
`
`N_ King Street. Unit 13
`
`CLERK - n ' -_
`United States District Court
`
`Copy |—Upon initlatlol of action. mail this copy to Director Copy 3—llpon termiutiun of action. mail this copy to Director
`Copy 2——Upon filing document adding patcnt(s), mail lhls copy to Director Copy 4——CIse file copy
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit ‘I002 — Page y
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 3
`
`

`
`Case 1:13-cv—O1158-GMS Document 18 Filed 09/02/14 Page 2 of 3 PagelD #: 281
`
`Case 1:13-cv-01158-GMS Document 16 Filed 08/19/14 Page 1 of 2 PagelD #: 276
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`) ) ) )
`
`) C.A. No. 13- I 1 I0 (GMS)
`CONSOLIDATED
`)
`
`PFIZER INC. and UCB PHARMA GMBH,
`
`Plaintiffs,
`
`v.
`
`) ) )
`
`) )
`
`)
`
`% C.A. No. l3-I158 (GMS)
`
`)
`
`) )
`
`)
`
`ALKEM LABORATORIES LTD., et aI.,
`
`Defendants.
`
`PFIZER INC. and UCB PHARMA GMBH,
`
`Plaintiffs,
`
`V
`
`IMPAX LABORATORIES, INC.,
`
`Defendant.
`
`STIPULATION AND ORDER OF DISMISSAL
`
`WHEREAS, Plaintiffs Pfizer Inc. and UCB Pharma GmbH (collectively,
`
`“Plaintiffs”) filed this action against Defendant Impax Laboratories, Inc. (“Impax”) in
`
`connection with Impax’s submission of Abbreviated New Drug Application Number (“ANDA”)
`
`No. 20-4904 to the Food and Drug Administration, which included certifications pursuant to 21
`
`U.S.C. §355(j)(2)(A)(vii)(IV) (“Paragraph IV”) with respect to United States Patent Nos.
`
`7,384,980 (the “‘980 patent”), 7,855,230 (the “‘230 patent”), 7,985,772 (the “‘772 patent”),
`
`8,338,478 (the “‘478 patent”), and 6,858,650 (the “‘650 patent”) (collectively, the “patents in
`
`suit”); and
`
`WHEREAS, Impax has asserted counterclaims against the patents in suit;
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit ‘I002 — Page 4
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 4
`
`

`
`Case 1:13-cv-01158-GMS Document 18 Filed 09/02/14 Page 3 of 3 PagelD #: 282
`
`Case 1:13-cv-01158-GMS Document 16 Filed 08/19/14 Page 2 of 2 PagelD #: 277
`
`IT IS HEREBY STIPULATED by Plaintiffs and Impax pursuant to Federal Rule
`
`of Civil Procedure 4l(a)(1)(A)(ii) and 4l(c), subject to approval of the Court, that all claims and
`
`counterclaims between Plaintiffs and Impax are dismissed without prejudice;
`
`IT IS HEREBY FURTHER STIPULATED by Plaintiffs and Impax, subject to
`
`approval of the Court, that this Stipulation and Order shall not act as an adjudication on the
`
`merits and that each party is responsible for its own costs and fees.
`
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`
`MORRIS JAMES LLP
`
`/5/9440933" 9‘/0791’(.‘1
`
`Jack 3. Blllmfiflfcld (#1014)
`M3|')’€”€fl Nofcika (#3203)
`I201 North Market SWCCI
`P-0- BOX 1347
`Wilmington, DE 19399
`I302) 558-9200
`_yblumenfeld@mnat.com
`mnoreika@mnat.com
`
`Attomeysfor Pfizer Inc. and UCB Pharma
`GmbH
`
`/s/ 9‘/(my ‘B. Matterer
`
`
`Richard K. Herrmann (#405)
`Mary B. Matterer (#2696)
`500 Delaware Avenue, Suite 1500
`Wilmington, DE 19801
`rherrmann@morrisjames.c0m
`mmatterer@morrisjames.com
`(302) 888-6800
`
`Artorneysfor Impax Laboratories, Inc.
`
`so ORDERED this '1 (Eda, ofAugu t 20 4.
`
`
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit ‘I002 — Page _
`
`
`
`————..__—:...............—.——-——--—-——-—-—-—-—-—~v«-.—--.._...__.__.____.._-.__-._.1......,
`
`
`
`
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 5
`
`

`
`Case 1:13-cv—O2022—GMS Document 11 Filed 02/03/14 Page 1 of 1 Page|D #: 327
`A0120 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
`District Of Delaware
`on the following
`
`Ij Trademarks or
`
`lZPatents.
`
`( [:I the patent action involves 35 U.S.C. § 292.):
`
`DOCKET NO.
`
`C.A. N0. 13-2022-GMS
`PLAINTIFF
`PFIZER INC. and UCB PHARMA GMBH
`
`
`
`DATE FILED
`12/11/2013
`
`
`
`U.S. DISTRICT COURT
`
`DEFENDANT
` APOTEX INC.
`
`District of Delaware
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`DATE IN U
`gig/E&lP4
`
`In the above—entitled case, the following patent(s)/ trademark(s) have been included:
`INCLUDED BY
`
`El Amendment
`
`M Answer
`
`I] Cross Bill
`
`[I Other Pleading
`
`1 7,807,715 B2
`
`10/5/2010
`
`UCB Pharma GmbH
`
`2 8,088,398 B2
`
`1/3/2012
`
`UCB Pharma GmbH
`
`3 8,501,723 B2
`
`8/6/2013
`
`UCB Pharma GmbH
`
`
`
`
`
`
`
`
`
`
`
`
`
`——
`——
`
`
`
`
`
`In the above——entitled case, the following decision has been rendered or judgement issued:
`DECISION/IUDGEMENT
`
` (BY) DEPUTY 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 patent(s), mail this copy to Director Copy 4—Case file copy
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1002 — Page 6
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 6
`
`

`
`Case 1:13—cv—02021—UNA Document 4 Filed 12/11/13 Page 1 of 1 PageID #: 169
`
`A0 12:» (Rev. 08/10)
`
`TO:
`
`Mail Stop 8
`Director of the US. Patent and Trademark Office
`P.0. Box 1450
`Alexandria, VA 22313-1450
`
`TRADEMARK
`
`REPORT ON THE
`
`FILING OR DETERMINATION OF AN
`ACTION REGARDING A PATENT OR
`
`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 Delaware
`on the following
`CI Trademarks or M Patents.
`( E! the pgient action involves 35 U.S.C. § 292.):
`I
`I
`DOCKET NO.
`DATE FILED
`us. DISTRICT COURT I
`12/11/201
`for the District of Delaware
`
`I
`
`DEFENDANT
`PLAINTIFF
`HETERO USA INC. and HETERO LABS LIMITED
`PFIZER INC. and UCB PHARMA GMBH
`
`
`
`2/22/2005
`
`6/10/2008
`
`12/21/2010
`
`7/26/2011
`
`12/25/2012
`
`UCB Pharma GmbH
`
`UCB Pharma GmbH
`
`UCB Pharma GmbH
`
`UCB Pharma GmbH
`
`UCB Pharma GmbH
`
`In the above—entitled case, the following patent(s)/ trademark(s) have been included:
` INCLUDED BY
`
`E] Ame
`%ARTTER“3\I:DI;3’,$‘i1,,:’,"£
`
`dmcnt
`
`1 6,858,650 B1
`
`2 7,384,980 B2
`
`3 7.855230 B2
`
`4 7,985,772 B2
`
`5 8,338,478 B2
`
`DATE INCLUDED
`
`TR}$ga‘j;rR?<RNO
`
`1
`
`
`
`
`
`_
`
`I] Answer
`W
`
`[:1 Cross Bill
`
`[] Other Pleading
`
`HOLDER or PATENT OR TRADEMARK
`
`
`
`DECISION/JUDGEMENT
`
`(BY) DEPUTY CLERK
`
`Copy 1-—Upon initiation of action, mail this copy to Director Copy 3——Upon termination ofnction, mail this copy to Director
`Copy 2—Upon filing document adding patent(s), mail this copy to Director Copy 4-——Case file copy
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1002 — Page 7
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 7
`
`

`
`Case 1:13-cv—O2022—UNA Document 4 Filed 12/11/13 Page 1 of 1 PagelD #: 168
`
`A0 1.7.1.1 ( Rev. 03/10'
`
`
`
`
`REPORT ON THE
`To
`Mail Stop 8
`'
`Director of the U.S. Patent and Trademark Office
`FILING OR DETERMINATION OF AN
`P.O. Box 1450
`ACTION REGARDING A PATENT OR
`Alexandria, VA 22313-1450
`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 Delaware
`on the following
`E] Trademarks or
`I] Patents.
`( U the patent action involves 35 U.S.C. § 292.):
`
`DATE FILED
`U.S. DISTRICT OURT
`I
`O
`
`
`12/11/2013
`7
`for the District of Delaware
`DEFENDANT
`
`
`
`
`
`PLAINTIFF
`APOTEX INC.
`PFIZER INC. and UCB PHARMA GMBH
`
`
`
`I I
`I
`I
`HOLDER OF PATENT on TRADEMARK p
`
`
`
`
`
`PATENT OR
`TRADEMARKN0.
`
`
`DATE or PATENT
`OR TRADEMRK
`
`UCB Pharma GmbH
`6/10/2008
`2 7,384,980 B2
`3 7,855,230 B2 @ UCBPharmaGmbH
`4 7.985,772 B2 UCB PharmaGmbH
`5 8,338,478 B2 UCB Pharma GmbH
`
`
`
`
`
`
`
`
`
`
`
`
`In the above——entitled case, the following paient(s)/ tradcma1'k(s) have been included:
`
`
`DECISION/JUDEMENT
`
`(BY) DEPUTY CLERK
`
`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 patent(s), mail this copy to Director Copy 4-—-Case file copy
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1002 — Page 8
`
`
`
`
`
`
`
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 8
`
`

`
`ame:n mm1mmtm:mmim:mmmi¥mnwnMmmmmm
`
`A0 121 (6/90)
`
`
`
`COMMISSIONER OF PATENTS AND TRADEMARKS
`(USPT0)
`P-0- 30* 1450
`Alexandria, VA 22313-1450
`
`REPORT ON THE
`FILING OF DETERMINATION OF AN ACTION OR APPEAL
`REGARDING A COPYRIGHT
`
`
`
`In compliance with the Act of July 19, 1952 (66 Stat. 814; 35 U.S.C. 290) you are hereby advised
`that a court action has been filed on the following patent(s) in the U.S. District Court:
`
`DOCKET
`l3—cV-4628
`
`PLAINTIFF
`Pfizer Inc. et al
`
`FILED
`6/24/2013
`
`UNITED STATES DISTRICT COURT,
`NORTHERN DISTRICT OF ILLINOIS, EASTERN
`
`DEFENDANT
`Alkem Laboratories, LTD
`
`PATENT NO.
`
`DATE OF PATENT
`
`PATENTEE
`
`6,858,650 B1
`
`7,384,980 B2
`
`‘ 7,855,230 B2
`
`Claus Meese
`
`Claus Meese, Bengt Sparf
`
`Claus Meese, Bengt Sparf
`
`DIVISION
`
`7,985,772 B2
`Claus Meese, Bengt Sparf
`8,338,478 B2 Claus Meese, Bengt Sparf
`
`In the above-entitled case, the following patent(s) have been included:
`
`
`
`DATE INCLUDED
`
`INCLUDED BY
`[
`] Amendment
`
`[
`
`]Answer
`
`[
`
`]Cross Bill
`
`[
`
`]0ther Pleading
`
`
`
`
`In the above-entitled case, the following decision has been rendered or judgment issued:
`
`DECISION/JUDGMENT
`
`
`
`
`
`CLERK
`Thomas G. Bruton
`
`(BY) DEPUTY CLERK
`K. Johnson
`
`DATE
`6/25/2013
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit ‘I002 — Page 9
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 9
`
`

`
`Case 1:13-cv-01110-GMS Document 8 Filed 07/15/13 Page 1 of 1 PagelD #: 271
`A0 120 (Rev. 08/10
`
`
`
`T0:
`
`Mail Stop 3
`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 l5 U.S.C. § 1116 you are hereby advised that a court action has been
`
`filed in the U.S. District Court
`
`of Delaware
`
`on the following
`
`I] Trademarks or
`
`[ZPatents.
`
`( E} the patent action involves 35 U.S.C. § 292.):
`
`
`
`DOCKET NO.
`13—1110—GMS
`PLAINTIFF
`
`DATE FILED
`6/21/2013
`
`U.S. DISTRICT COURT
`
`DEFENDANT
`
`of Delaware
`
`
`
`Pfizer Inc. and UCB Pharma GmbH
`
`Alkem Laboratories Ltd.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`DATE INCLUDED
`7/15/2013
`PATENT OR
`TRADEMARK NO.
`
`In the above—entitled case, the following patent(s)/ trademark(s) have been included:
`INCLUDED BY
`
`D Amendment
`DATE OF PATENT
`OR TRADEMARK
`
`M Answer
`
`El Cross Bill
`
`C] Other Pleading
`
`HOLDER OF PATENT OR TRADEMARK
`
`1 US 7,807,715 B2
`
`10/5/2010
`
`UCB PHarma GmbH
`
`2 US 8,088,398 B2
`
`1/3/2012
`
`UCB PHarma GmbH
`
`
`
`
`——
`
`——
`
`
`-—
`
`
`
`In the above—entitled case, the following decision has been rendered or judgement issued:
`DECISION/IUDGEMENT
`
`CLERK
`
`
`
`(BY) DEPUTY CLERK
`
`
`
`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 patent(s), mail this copy to Director Copy -1—Case file copy
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1002 — Page 10
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 10
`
`

`
`Case 1:13—cv—O1155—UNA Document 4 Filed 06/28/13 Page 1 of 1 PagelD #: 168
`
`A0120 Rcv 03Il(i)
`
` To
`
`'
`
`Mail Stop 8
`Director of the U.S. Patent and Trademark Office
`PO. 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. § lll6 you are hereby advised that a court action has been
`filed in the U.S. District Court
`for the District of Delaware
`on the following
`
`E] Trademarks or
`
`lZPatents.
`
`[ El lhe patent action involves 35 U.S.C. § 292.):
`
`DOCKET NO.
`
`PLAINTIFF
`
`DATE FILED
`6/21/2013
`
`U.S. DISTRICT COURT
`for the District of Delaware
`
`DF.F’ENDAN'[‘
`
`ACCORD HEALTHCARE |NC., USA
`
`PFIZER INC. and UCB PHARMA GMBH
`
`in the above—cntit1ed case, the following patent[s)/ trademark(s) have been included:
`
`DATE INCLUDED
`
`INCLUDED BY
`
`PATENT OR
`TRADEMARK NO.
`
`lj Amendment
`DATE OF PATENT
`OR TRADEMARK
`
`_—
`
`U Answer
`
`B Cross Bill
`
`C] Other Pleading
`.
`. .
`HOLDER OF PATENT OR lR.ADl:lv‘lARK
`
`
`
`
`
`In the above—~entitled case, the following decision has been rendered orjudgement issued;
`DECISION/JUDGEMENT
`
`
`
`(DY) DEPUTY CLERK
`
`Copy 1——Upon initiation ofnction, mail this copy to Director Copy 3—Upon termination of action, mail this copy to Director
`Copy 2-——Upon filing document adding patc.nI(s), mail this copy to Director Copy 4~—-Case file copy
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit ‘I002 — Page 11
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 11
`
`

`
`Case 1:13—cv-01156—UNA Document 4 Filed 06/28/13 Page 1 of 1 Page|D #: 169
`
`A0 l20(l{«.:v 08/10
`
`TO:
`
`'
`
`Mail Stop 8
`Director of the US. Patent and Trademark Office
`PO. 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 01 Delaware
`on the following
`I] Trademarks or
`IZPatents.
`[:1 the patent action involves 35 U.S.C. §_2‘)2.):
`
`(
`
`DOCKET NO.
`
`PLAINTIFF
`
`DATE FILED
`6/21/2013
`
`PFIZER INC. and UCB PHARMA GMBH
`
`
`
`U.S. DISTRICT COURT
`for the District of Delaware
`
`DEFENDANT
`
`AMERlGEN PHARMACEUTICALS, INC. and
`AMERIGEN PHARMACEUTICALS LTD.
`
`
`
`
`
`
`
`
`PATENT OR
`
`DATE. OF PATENT
`
`1 6.858.650 B1
`
`2/22/2005
`
`UCB Pharma GmbH
`
`2 7384.980 B2
`
`6/10/2008
`
`UCB Pharma GmbH
`
`3 7,855,230 B2
`
`12/21/2010
`
`UCB Pharma GmbH
`
`4 7.985,772 B2
`
`7/26/2011
`
`UCB Pharma GmbH
`
`5 6,338,478 B2
`
`
`
`12/25/2012
`
`UCB Pharma GmbH
`
`In the above-—cntitlt-d case, the following patent(s)/ traden1ar'x(s) have heen included:
`
`
`
`El Cross Bill
`
`D Other Pleading
`
`1:] Amendment
`
`El Answer
`
`DATE INCLUDED
`
`INCLUDED BY
`
`TR::.IlA3‘rIl7nIl-T’/IiAlIl(T){RN0
`
`HOLDER OF PATENT OR 'l‘RADEMAR.K
`
`l 2— —
`
`in the above-«entitled case, the following decision has been rendered or judgement issued:
`
`
`
`DECISION/JUDGEMENT
`
`
`(B Y) DEPUTY CLERK
`
`Copy 1.----Upon initiation ofaclion. mail this copy to Director Copy 3—Upon termination of action, mail this copy to Director
`Copy 2-Upon filing document adding patent(s), mail this copy to Director Copy 4-Case file copy
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1002 — Page 12
`
`
`
`
`
`
`
`
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 12
`
`

`
`Case 1:13-cv-01158-UNA Document 4 Filed 06/28/13 Page 1 of 1 PagelD #: 168
`
`AD I20 I Rev 08! II]
`
`To
`'
`
`Mail Stop 8
`Director of the US. Patent and Trademark Office
`P.0. 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 zmdlor 15 USC. § 1116 you are hereby advised that a court action has been
`filed in the U.S. District Court
`for the District of Delaware
`on the following
`
`D Trademarks or
`
`E Patents.
`
`( D the patent action involves 35 U.S.C. § 292.):
`
`
`
`DOCKET NO.
`
`PLAINTIFF
`
`
`
`HOLDER or mm on TRADEMARK
`
`
`
`
`
`
`In the above—-~entitlcd case, the following patent(s)/ tradr:mark(s) have been included:
`
`
`
`D Answer
`
`B Cross Bill
`
`D Other Pleading
`
`HOLDER OF PATENT OR TRADT.MARK
`
`
`
`DATE INCLUDED
`
`INCLUDED BY
`
`PATENT OR
`TRADEMARK N0‘
`
`[:1 Amendment
`DATE OF PATENT
`OR TRADEMARK
`
`
`—— — I
`
`n the abovc—cntiLled case, the following decision has been rendered orjudgement issued:
`
`DECISION/JUDGEMENT
`
`(BY) DEPUTY CLERK
`
`Copy l———Upon initiation ofaction, 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
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit ‘I002 — Page 13
`
`DATE FILED
`6/21/2013
`
`U.S. DISTRICT COURT
`for the District of Delaware
`
`
`
`DEFENDANT
`
`
`IMPAX LABORATORIES, INC.
`
`PFIZER INC. and UCB PHARMA GMBH
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 13
`
`

`
`Case 1:13-cv-O1153—UNA Document 4 Filed 06/28/13 Page 1 of 1 PagelD #: 169
`
`A0 120 Rev. 08/10
`
`T0:
`
`Mail Stop 3
`Director of the U.S. Patent and Trademark Office
`P.0. 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. § ll 16 you are hereby advised that a court action has been
`filed in the U.S. District Comt
`for the District of Delaware
`on the following
`
`El Trademarks or
`
`lZPatents.
`
`(
`
`[:3 the patent action involves 35 U.S.C. § 292.):
`
`DOCKET NO.
`
`PLAINTIFF
`
`DATE FILED
`6/28/2013
`
`U.S. DISTRICT COURT
`for the District of Delaware
`
`DEFENDANT
`
`PFIZER INC. and UCB PHARMA GMBH
`
`
`
`
`LUPlN LTD.
`
`
`
`
`
`
`
`
`
`
`
`
`HOLDER OF PATENT OR TRADEMARK
`vcBPharmaGmbH
`UcBPharmaGmbH
`U<=BPharmaGmbH
`UCBPharmaGmbH
`U<=BPharmaGmbH
`
`
`
`In the above—entit1ed case, the following patent(s)/ trademark(s) have been included:
`
`
`
`DATE INCLUDED
`
`INCLUDED BY
`
`PATENT OR
`TRADEMARK NO.
`
`
`El Amendment
`DATE OF PATENT
`OR TRADEMARK
`
`l___I Answer
`
`[I Cross Bill
`
`I:l Other Pleading
`
`HOLDER OF PATENT OR TRADEMARK
`
`In the above—entitled case, the following decision has been rendered or judgement issued:
`DECISION/JUDGEMENT
`
`
`
`Copy l—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 patent(s), mail this copy to Director Copy 4—Case file copy
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit ‘I002 — Page 14
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 14
`
`

`
`Case 1:13-cv-01157-UNA Document 4 Filed 06/28/13 Page 1 of 1 Page|D #: 168
`
`A0 Ill) ‘Rev (HMO)
`
`TRADEMARK
`
`To
`'
`
`Mail Stop 8
`Director of the U.S. Patent and Trademark Office
`P.0. Box 1450
`Alexandria, VA 22313-1450
`
`REPORT ON THE
`FILING OR DETERMINATION OF AN
`ACTION REGARDING A PATENT OR
`
`in Compliance with 35 U.S.C. § 290 and/or 15 U.S.C. § 1116 you are hemby advised that :1 court action has been
`filed in the U.S. District Court
`for the District of Delaware
`on the following
`
`I] Trademarks or M Patents. TI] the patent action involves 35 U.S.C. § 292.):
`.S. DISTRICT COURT
`
`U_ exzwzms
`DEFENDANT
`
`DOCKET NO.
`
`DATE FILED
`
`PLAINTIFF
`
`
`
`
`
`for the District of Delaware
`
`
`
`
`
`PFIZER INC. and UCB PHARMA GMBH
`
`AM NEAL PHARMACEUTICALS, LLC
`
`
`
`
`
`
`
`
`
`
`in the above-—enfilied case, the following paIen1(s)z' trademurk(s) have been included:
`
`DATE INCLUDED
`
`INCLUDED BY
`
`PATENT OR
`TRADEMARK Na
`
`D Amendment
`DATE OF PATENT
`OR TRADEMARK
`
`El Answer
`
`[I Cross Bill
`
`D Other Pleading
`
`HOLDER OF PATENT OR TRADEMARK
`
`
`
`————
`
`
`
`In the above—~cntitled case, lhe following decision has been rendered orjudgcment issued:
`DECISION/JUDGEMENT
`
` (BY) D'E.I’U'I'Y CLERK
`
`Copy 1—Upon initiation of action. mail this copy to Director Copy 3--Upon termination ofaction, mail this copy to Director
`Copy 2—Upon filing document adding patcnt(s). mail this copy to Director Copy 4——Casc file copy
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit ‘I002 — Page 15
`
`
`
`
`
`
`
`
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 15
`
`

`
`Case 1:13—cv—01111-UNA Document 4 Filed 06/21/13 Page 1 of 1 PageID #: 169
`
`AG 120 (Rev 0811(1)
`To
`'
`
`Mail stop 3
`Director of the U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`TRADEMARK
`
`REPORT ON THE
`FILING OR DETERMINATION OF AN
`ACTION REGARDING A PATENT OR
`
`In Compliance with 35 U.S.C. § 290 and/or l5 U.S.C. § 1116 you are hereby advised that a court action has been
`filed in the US. District Court
`for the District of Delaware
`on the following
`I:l Trademarks or
`[Z Patents. patent actionWi‘n\/olVves7T5 U.8.C. § 292.):
`
`W
`
`DATE FILED
`6/21/2013
`
`U.S. DISTRI CT COURT
`for the District of Delaware
`
`DEFENDANT
`
`
`
`
`
`
`
`
`
`DOCKET NO.
`
`PLAINTIFF
`
`PFIZER INC. and UCB PHARMA GMBH
`
`SANDOZ INC.
`
`
`
`PATENT OR
`
`DATE OF PATENT
`
`
`
`I
`
`
`
`2/22/2005
`
`6/10/2008
`
`UCB Pharma GmbH
`
`UCB Pharma GmbH
`
`12/21/2010
`
`UCB Pharma GmbH
`
`7/26/2011
`
`UCB Pharma GmbH
`
`1 6,858,650 B1
`
`2 7,384,980 B2
`
`3 7,855,230 B2
`
`4 7,985,772 B2
`
`
`
`UCB Pharma GmbH
`
`5 8,338,478 B2
`
`
`
`12/25/2012
`
`
`
`In the above———cntitled case, the following patent(s)/ trademark(s) have been included:
`
`DATE INCLUDED
`
`INCLUDED BY
`
`PATENT OR
`TRADEMARK NO‘
`
`[:1 Amendment
`DATE OF PATENT
`OR TRADEMARK
`
`I] Answer
`
`[:I Cross Bill
`
`C] Other Pleading
`
`.
`HOLDER OF PATENT OR TRADEMARK
`
`DECISION/JUDGEMENT
`
`(BY) DEPUTY CLERK
`
`Copy l——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 patent(s), mail this copy to Director Copy 4——Case file copy
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1002 — Page 16
`
`
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 16
`
`

`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`Commissioner for Patents
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`www.uspto.gov
`
`Gregg Benson
`Pfizer Inc.
`Patent Department
`Eastern Point Road
`
`Dear Mr. Benson:
`
`In Re: Patent Term Extension
`Application for
`U.S. Patent No. 6,858,650
`
`lY\"J 95‘
`
`‘°"l
`
`Muir
`
`A certificate under 35 U.S.C. § 156 is enclosed extending the term of U.S. Patent
`No. 6,858,650 for a period of 1,149 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 *95S-0117 need to be submitted on form FDA-3542
`which may be downloaded from FDA's Electronic Forms Download Website:
`http://www.fda.gov/opacorn/morechoices/fdaforms/default.html
`(http://www.fda. gov/opacorn/morechoices/fdaforrns/FDA-3 542 .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.
`
`. Ceféa
`
`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: TOVIAZ® (fesoteridine
`fumarate)
`Docket No.: FDA-2009-E-0079
`
`Attention: Beverly Friedman
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit ‘I002 — Page 17
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 17
`
`

`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`(12)
`
`I CERTIFICATE EXTENDING PATENT TERM.
`UNDER 35 U.S.C. § 156
`
`(68) PATENT NO.
`
`(45)
`
`ISSUED
`
`(75)
`
`INVENTOR
`
`(73) PATENT OWNER
`
`(95) PRODUCT
`
`:
`
`:
`
`:
`
`:
`
`:
`
`6,858,650
`
`February 22, 2005
`
`Claus Meese
`
`UCB Pharma GmbH
`
`TOVIAZ® (fesoteridine fumarate)
`
`‘ 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.
`
`'
`
`6,858,650 based upon the regulatory review of the product TOVIAZ® (fesoteridine
`
`fumarate) 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)
`
`1,149 days
`
`from May 11, 2019, 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.
`
`
`
`I have caused the seal of the United States Patent and
`
`Trademark Office to be affixed this 23rd day of August 2012.
`
`OM si kw
`
`David J. Kappos
`Under Secretary of Commerce for Intellectual Property and
`Director of the United States Patent and Trademark Office
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit ‘I002 — Page 18
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 18
`
`

`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`Commissioner for Patents
`United States Patent and Trademark Office
`Alexandria,
`www.uspto,gov
`
`Gregg Benson
`Pfizer Inc.
`Patent Department
`Eastern Point Road
`Groton, CT 06340
`
`In Re: Patent Term Extension
`Application for
`U.S. Patent No. 6,858,650
`
`NOTICE OF FINAL DETERMINATION
`
`A determination has been made that U.S. Patent No. 6,858,650, claims of which cover the human
`drug product TOVIAZ® (fesoteridine fumarate), is eligible for patent term extension under 35
`U.S.C. § 156. The period of extension has been determined to be 1,149 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.l36(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 1,149 days.
`i
`
`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
`April 6, 2010 (75 Fed. Reg, 17414). Under 35 U.S.C. § l56(c):
`
`Period of Extension
`
`=
`=
`=
`
`RRP - PGRRP - DD - ‘/2 (TP - PGTP)‘
`2,395 - 1,047 - 0 - ‘/2 (1,445-1,047)
`1149 days (3.1 years)
`
`Since the regulatory review period began April 13,2002, before the patent issued (February 22,
`2005), only that portion of the regulatory review period occurring after the date the patent issued
`has been considered in the above determination of the length of the extension period 35 U.S.C. §
`156(c). (From April 13, 2002, to and including February 22, 2005, is 1047 days; this period is
`subtracted from the number of days occurring in the testing phase according to the FDA
`determination of the length of the regulatory review period.) 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
`
`' 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 date 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 ‘/2 (TP - PGTP).
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit ‘I002 — Page 19
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 19
`
`

`
`U.S. Patent No. 6,858,650
`
`.
`
`Page 2
`
`period of extension determined above.
`
`Upon issuance of the certificate of extension, the following information will be published in the
`Official Gazette:
`'
`
`U.S. Patent No.2
`
`6,858,650
`
`Granted:
`
`February 22, 2005
`
`Original Expiration Datez:
`
`May 11, 2019
`
`Applicant:
`
`Claus Meese
`
`Owner of Record:
`
`UCB Pharma GmbH
`
`Title:
`
`Stable Salts of Novel Derivatives of 3,3-
`Diphenylpropylamines
`
`Product Trade Name:
`
`TOVIAZ® (fesoteridine fumarate)
`
`Term Extended:
`
`.
`
`1,149 days
`
`Expiration Date of Extension:
`
`July 3, 2022
`
`Any correspondence with respect to this matter should be addressed as follows:
`
`By mail:
`
`Mail Stop Hatch-Waxman PTE
`Commissioner for Patents
`
`By FAX:
`
`(571) 273-7755
`
`P.O. Box 1450
`
`Alexandria, VA 22313-1450.
`
`2Subject to the provisions of35 U.S.C. § 41(b).
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit ‘I002 — Page 20
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 20
`
`

`
`US. Patent No. 6,858,650
`
`Page 3
`
`Telephone inquiries related to this determination should be directed to the undersigned at (571)
`272-7755.
`'
`I’
`
` Mary C. Til
`
`.
`Senior Legal Advisor
`Office of Patent Legal Administration
`Office of the Associate Commissioner
`
`for Patent Examination Policy
`
`cc:
`
`RE: TOVIAZ® (fesoteridine
`Office of Regulatory Policy
`fumarate)
`Food and.Drug Administration
`10903 New Hampshire Ave., Bldg. 51, Rm. 6222 Docket No.: FDA-2009-E—0O79
`Silver Spring, MD 20993-0002
`'
`
`Attention: Beverly Friedman
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit ‘I002 — Page 21
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 21
`
`

`
`§‘,»v* ““"’°'~'~¢,,4 Department of Health and Human Services
`
`.
`
`. Public Health Service
`
`Food and Drug Administratio