`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_____________________
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________
`
`APOTEX INC. AND APOTEX CORP.
`Petitioners
`
`v.
`
`CELGENE CORPORATION
`Patent Owner
`_____________________
`
`Case IPR2018-00685
`Patent 8,741,929 B2
`Issued: June 3, 2014
`
`Title: METHODS OF USING 3-(4-AMINO-1-OXO-1,3-DIHYDRO-
`ISOINDOL-2-YL)-PIPERIDINE-2,6-DIONE
`FOR TREATMENT OF MANTLE CELL LYMPHOMAS
`
`
`
`_____________________
`
`PETITIONERS’ REQUEST FOR REHEARING
`
`Case No. IPR2018-00685
`_____________________
`
`
`
`
`
`
`
`
`
`TABLE OF CONTENTS
`
`
`
`I.
`
`INTRODUCTION ............................................................................................. 1
`
`II. LEGAL STANDARD ........................................................................................ 2
`
`III. ARGUMENT ..................................................................................................... 3
`
`A. The Board Erred in Denying Institution Pursuant to § 325(d),
`Overlooking or Disregarding that Drach Discloses Substantially
`More Than the References Substantively Before the Examiner ............... 3
`
`1. Unlike the References Substantively Considered By the
`Examiner, Drach Discloses the Clinical Use of Lenalidomide
`For Treating Cancers Similar to MCL ............................................ 4
`
`2. The Board Erred in Disregarding Its Own Finding that Drach
`Was “Stronger Evidence” than the References Before the
`Examiner ............................................................................................. 6
`
`B. The Board Misapprehended the Teachings of Querfeld in Finding that
`Querfeld Was Cumulative of Zeldis ............................................................. 7
`
`C. The Board Abused Its Discretion By Not Instituting a Trial, as
`Numerous Disputed Issues of Material Fact Exist Concerning
`Unexpected Results ........................................................................................ 8
`
`IV. CONCLUSION ................................................................................................12
`
`
`
`i
`
`
`
`
`CASES
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Belden Inc. v. Berk-Tek LLC,
`805 F.3d 1064 (Fed. Cir. 2015) ............................................................................ 7
`
`Star Fruits S.N.C. v. United States,
`393 F.3d 1277 (Fed. Cir. 2005) ............................................................................ 3
`
`AGENCY PROCEEDINGS
`
`Merial Ltd. v. VIRBAC,
`IPR2014-01279, Paper No. 18 (Apr. 15, 2015) ................................................ 6, 7
`
`Yamaha Golf Car Co. v. Club Car, LLC,
`IPR2017-02141-2-3-4, 2018 WL 3198594 (Jun. 26, 2018) ........................... 3, 12
`
`STATUTES
`
`35 U.S.C. § 325(d) ............................................................................................passim
`
`CODE OF FEDERAL REGULATIONS
`
`37 C.F.R. § 42.71(c) ................................................................................................... 3
`
`37 C.F.R. § 42.71(d) .............................................................................................. 1, 2
`
`37 C.F.R. § 42.108(c) ........................................................................................... 9, 12
`
`
`
`
`
`
`
`
`
`
`
`Pursuant to 37 C.F.R. § 42.71(d), Apotex Inc. and Apotex Corp.
`
`(“Petitioners”) submit this Request for Rehearing of the Board’s Decision Denying
`
`Institution of Inter Partes Review of U.S. Patent No. 8,741,929 (Paper No. 8)
`
`(“Decision”).
`
`I.
`
`INTRODUCTION
`
`The Board should grant rehearing of its Decision not to institute based on
`
`three crucial errors in its analysis.
`
`First, with respect to Grounds 1 and 2, the Board overlooked or disregarded
`
`that the Drach reference, a review article synthesizing relevant prior art for mantle
`
`cell lymphoma (“MCL”) treatment, discloses substantially more than what was
`
`substantively considered by the Examiner. Specifically, the Board determined that
`
`Drach, which discloses the clinical use of lenalidomide and was not substantively
`
`considered by the Examiner, was cumulative of references the Examiner
`
`considered that focused only on the use of thalidomide to treat MCL. The Board
`
`also disregarded its own finding that Drach was “stronger evidence” than the
`
`thalidomide references because Drach disclosed that lenalidomide was “a new
`
`treatment paradigm” for MCL. Drach’s unique teachings were lynchpins of
`
`Petitioners’ argument and the declaration of Petitioners’ expert, Dr. Thirman, with
`
`respect to reasonable expectation of success and of lack unexpected results.
`
`
`
`
`
`
`
`
`
`
`Second, with respect to Ground 2, the Board misapprehended that the
`
`Querfeld reference, which was not considered during prosecution, was cumulative
`
`of the Zeldis reference, despite Querfeld disclosing a Phase II lenalidomide clinical
`
`study not disclosed by Zeldis. Querfeld’s additional teachings are relevant to the
`
`issues of reasonable expectation of success and lack of unexpected results, and
`
`were relied upon by Dr. Thirman and Petitioners.
`
`Lastly, the Board should have instituted trial in light of numerous disputed
`
`issues of material fact present here. Indeed, Dr. Thirman squarely disagreed with
`
`the declaration of Dr. Zhang, which was submitted by Patent Owner during
`
`prosecution, on the issue of unexpected results. Likewise, Dr. Thirman disagreed
`
`with many factual assertions of Patent Owner in its Preliminary Response
`
`regarding reasonable expectation of success and unexpected results. Such factual
`
`disputes should have been viewed in a light most favorable to the Petitioner and
`
`should ultimately be resolved at trial.
`
`II.
`
`LEGAL STANDARD
`
`Requests for rehearing are governed by 37 C.F.R. § 42.71(d), which
`
`provides in pertinent part that a party’s “request must specifically identify all
`
`matters the party believes the Board misapprehended or overlooked, and the place
`
`where each matter was previously addressed in a motion, an opposition, or a
`
`reply.” Id. When rehearing a decision on petition, a panel reviews the decision for
`
`
`
`2
`
`
`
`
`
`
`an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion occurs if the
`
`Board’s original decision misinterprets the law, finds a fact not supported by
`
`substantial evidence, or makes “an unreasonable judgment in weighing relevant
`
`factors.” Yamaha Golf Car Co. v. Club Car, LLC, IPR2017-02141-2-3-4, 2018
`
`WL 3198594, at *1 (Jun. 26, 2018) (citing Star Fruits S.N.C. v. United States, 393
`
`F.3d 1277, 1281 (Fed. Cir. 2005)).
`
`III. ARGUMENT
`
`A. The Board Erred in Denying Institution Pursuant to § 325(d),
`Overlooking or Disregarding that Drach Discloses Substantially
`More Than the References Substantively Before the Examiner
`
`The Board denied institution of Ground 1 (Drach in view of Zeldis) and
`
`Ground 2 (Drach in view of Zeldis and Querfeld) on the basis of being cumulative
`
`of the combination of art that was before the Examiner (Zeldis in view of Damaj,
`
`Wilson and Kaufmann). Decision at 26 (citing 35 U.S.C. § 325(d)). With respect
`
`to Drach specifically, the Board reasoned that Drach was substantially the same
`
`prior art as Damaj, Wilson and Kaufmann and was “no more informative as to
`
`expected results” than those references. Decision at 23, 25-26. The Board erred in
`
`making those determinations for two reasons: (1) it overlooked two key disclosures
`
`in Drach regarding the clinical use of lenalidomide for cancers related to MCL and
`
`(2) it disregarded its own finding that Drach was “stronger evidence” than
`
`
`
`3
`
`
`
`
`
`
`references substantively considered by the Examiner and then inexplicably found
`
`Drach cumulative anyway.
`
`1.
`
`Unlike the References Substantively Considered By the
`Examiner, Drach Discloses the Clinical Use of Lenalidomide
`For Treating Cancers Similar to MCL
`
`As an initial matter, the Board overlooked the fact that Drach provides key
`
`disclosures of the clinical use of lenalidomide for cancers similar to MCL that are
`
`nowhere present in the publications before the Examiner. Unlike those
`
`publications, Drach is a review article that synthesized many pieces of pertinent
`
`prior art, including art relating to various clinical applications of lenalidomide.
`
`Drach provides two particularly relevant disclosures that are highly relevant to
`
`both reasonable expectation of success and lack of unexpected results:
`
` Lenalidomide was successful in treating multiple myeloma (a B-Cell
`
`cancer like MCL). Pet. 10, 16 and 19; Ex. 1002 ¶ 68.
`
` Lenalidomide was the subject of various clinical trials including those
`
`related to lymphoma (MCL is a lymphoma). Pet. 11, 16 and 19; Ex.
`
`1002 ¶ 68.
`
`By contrast, the publications before the Examiner make no reference to
`
`lenalidomide whatsoever, much less the clinical application of that drug. That is
`
`because those publications only disclose the clinical use of thalidomide for MCL.
`
`And while the Board referenced Drach’s clinical application disclosures in its
`
`Overview of the Asserted Prior Art, Decision at 11, it failed to address them in any
`
`
`
`4
`
`
`
`
`
`
`way whatsoever when conducting its analysis under § 325(d), even though those
`
`disclosures were never considered by the Examiner. Decision at 22-26.
`
`It is significant to note that in his declaration, Dr. Thirman relied heavily
`
`upon those key disclosures with respect to reasonable expectation of success and
`
`lack of unexpected results. For example, in his analysis that the claims at issue
`
`would have been obvious based on Drach in view of Zeldis, Dr. Thirman cites to
`
`Drach and states that “it was additionally known that lenalidomide was successful
`
`in treating MM [multiple myeloma] and was undergoing clinical trials for
`
`lymphomas, both of which are relevant to MCL.” Ex. 1002 ¶ 68 (part of Section
`
`VII.A.a). Dr. Thirman further relied on this particular disclosure in support of his
`
`opinion that alleged unexpected results during prosecution were entirely expected.
`
`Ex. 1002 ¶ 109 (“The clinical results achieved by lenalidomide in relapsed,
`
`refractory or relapsed and refractory mantle cell lymphoma patients were not
`
`unexpected in light of the prior art at the relevant time, for the reasons discussed
`
`above in Section VII.A.a (which I incorporate here by reference).”).
`
`Likewise, Petitioners made arguments related to reasonable expectation of
`
`success and lack of unexpected results based on Drach’s disclosure of lenalidomide
`
`use in MM treatment and clinical trials for lymphomas. Pet. at 10, 16, 19, 28-29.
`
`For these reasons, the Board overlooked two of Drach’s key teachings in
`
`finding that reference cumulative of Damaj, Wilson and Kaufmann, and the Board
`
`
`
`5
`
`
`
`
`
`
`therefore abused its discretion in denying institution of Grounds 1 and 2 under
`
`§ 325(d). Merial Ltd. v. VIRBAC, IPR2014-01279, Paper No. 18 at 8 (Apr. 15,
`
`2015) (recognizing that “misapprehend[ing] or overlook[ing] a significant fact
`
`[establishes] the necessary abuse of discretion required by Rule 42.71(c)”).
`
`2.
`
`The Board Erred in Disregarding Its Own Finding that
`Drach Was “Stronger Evidence” than the References
`Before the Examiner
`
`Moreover, the Board erred in disregarding its own finding that Drach was
`
`not cumulative relative to the references before the Examiner. Drach discloses a
`
`crucial teaching concerning the use lenalidomide to treat MCL, namely that
`
`“thalidomide and its analogs (e.g., lenalidomide) are therefore important agents for
`
`the new treatment paradigm of targeting both the tumor cell and its
`
`microenvironment (mainly by interference with tumor-stromal interactions) [i.e.
`
`MCL].” Ex. 1003 at 10.
`
`Acknowledging this passage, the Board found that Drach suggested the use
`
`of lenalidomide for MCL treatment and that “Drach – given its particular focus on
`
`treating mantle cell lymphoma – is stronger evidence than Damaj, Wilson and
`
`Kaufmann that one of ordinary skill in the art would have had a reason to treat
`
`MCL patients with lenalidomide.” Decision at 25; see also id. at 23. Those
`
`findings explicitly acknowledge that Drach discloses more than the references
`
`
`
`6
`
`
`
`
`
`
`substantively before the Examiner and therefore is not cumulative of them. And
`
`again, Damaj, Wilson and Kaufmann do not even mention lenalidomide.
`
`Not surprisingly, this key disclosure was relied upon by Petitioners and Dr.
`
`Thirman in support of their arguments regarding reasonable expectation of success
`
`and lack of unexpected results. Pet. at 18-19, 28-29; Ex. 1002 ¶¶ 68, 81-82, 109-
`
`110.
`
`In view of the foregoing, the Board plainly disregarded its own finding that
`
`Drach is not cumulative of Damaj, Wilson and Kaufmann, and for this additional
`
`reason it abused its discretion in denying institution of Grounds 1 and 2 under
`
`§ 325(d). Merial, IPR2014-01279, Paper No. 18 at 8; cf. Belden Inc. v. Berk-Tek
`
`LLC, 805 F.3d 1064, 1076 (Fed. Cir. 2015) (reversing Board’s conclusion of non-
`
`obviousness in IPR because Board disregarded its own finding regarding a
`
`teaching of the prior art reference).
`
`B.
`
`The Board Misapprehended the Teachings of Querfeld in Finding
`that Querfeld Was Cumulative of Zeldis
`
`The Board denied institution of Ground 2 (Drach in view of Zeldis and
`
`Querfeld) in part based on its finding that Querfeld was cumulative of Zeldis.
`
`Decision at 26 (citing 35 U.S.C. § 325(d)). But that finding misapprehended the
`
`teachings of Querfeld. While both Zeldis and Querfeld disclose 25 mg of
`
`lenalidomide daily for 21 days with 7 days rest in 28-day cycles (i.e. the same
`
`dosage and regimens disclosed in Claims 4 and 20), Querfeld additionally
`
`7
`
`
`
`
`
`
`
`
`discloses the use of such dosing regimens in patients being treated for cutaneous T-
`
`Cell lymphoma during a Phase II clinical trial. Decision at 11; Ex. 1004 ¶ 229;
`
`Ex. 1005 at 2. This distinction is crucial, because the clinical application of
`
`lenalidomide in a Phase II clinical study provides further evidence of reasonable
`
`expectation of success for a POSITA that lenalidomide could be used in the
`
`claimed dosages and regimens for treatment of MCL. This distinction also
`
`undercuts allegations of unexpected results. Significantly, Querfeld was relied
`
`upon by Petitioners and by Dr. Thirman for at least that purpose. Pet. 27-28; Ex.
`
`1002 ¶¶ 105-107.
`
`For these reasons, the Board misapprehended the teachings of Querfeld in
`
`finding that reference cumulative of Zeldis, and the Board thus abused its
`
`discretion in denying institution of Ground 2 under § 325(d).
`
`C. The Board Abused Its Discretion By Not Instituting a Trial, as
`Numerous Disputed Issues of Material Fact Exist Concerning
`Unexpected Results
`
`Lastly, the Board abused its discretion in not instituting a trial given the
`
`numerous disputed issues of material fact relating to the issue of unexpected results
`
`and the closely related issue of reasonable expectation of success. These disputed
`
`factual issues arise in two contexts: (1) Dr. Thirman’s disagreement with the
`
`Zhang declaration submitted by Patent Owner during prosecution and (2) Dr.
`
`Thirman’s disagreement with Patent Owner’s positions set forth in its Preliminary
`
`
`
`8
`
`
`
`
`
`
`Response. At this early stage, those facts should have been viewed in a light most
`
`favorable to the petitioner. 37 C.F.R. § 42.108(c). Instead, the Board did not
`
`address these factual disputes and unfairly deprived Petitioners of a trial.
`
`Turning first to the Zhang declaration, that declaration stated that MCL
`
`patients treated with lenalidomide showed a 28% overall response rate. Ex. 1008
`
`¶ 6. The Examiner concluded that this purported evidence of unexpected results
`
`was sufficient to overcome the evidence of obviousness. Ex. 2007 at 81-82. Dr.
`
`Thirman vigorously disagreed with the Zhang declaration. Ex. 1002 ¶¶ 108-110.
`
`With minimal analysis, the Board dismissed Dr. Thirman’s declaration, finding
`
`that nothing in Drach added anything over Damaj, Wilson, and Kaufmann with
`
`respect to unexpected results, and determined that Dr. Thirman simply disagreed
`
`with the Examiner’s view of the 28% response rate on the obviousness inquiry.
`
`Decision at 25. Notably, the Board failed to meaningfully address many of the
`
`factual issues that Dr. Thirman raised in response to the Zhang Declaration, Ex.
`
`1002 ¶¶ 108-110, which are summarized in Paragraph 109 of his declaration:
`
`109. The clinical results achieved by lenalidomide in relapsed, refractory, or
`
`relapsed and refractory mantle cell lymphoma patients were not unexpected
`
`in light of the prior art at the relevant time, for the reasons discussed above
`
`in Section VII.A.a (which I incorporate here by reference). The prior art
`
`teaches, at least, the following: (1) thalidomide was being used to treat
`
`relapsed and/or refractory MCL (Drach), (2) thalidomide had undesirable
`
`
`
`9
`
`
`
`
`
`
`side effects (Drach), (3) lenalidomide was a less toxic, more potent,
`
`structurally similar analogue of thalidomide being suggested for MCL
`
`treatment (Drach and Zeldis), and (4) lenalidomide could be used for MCL
`
`treatment in the dosages, dosage forms and cycling regimen claimed by the
`
`challenged claims of the ’929 patent (Zeldis, Querfeld, Celgene Press
`
`Release). See also supra Sections VI.A, VI.B, VII.A.
`
`
`
`The Board abused its discretion in not viewing these factual issues in a light most
`
`favorable to petitioner, and any factual disputes arising therefrom should be
`
`addressed at trial.
`
`At the same time, the Board apparently agreed with Patent Owner’s
`
`arguments, unsupported by any expert declaration, on the issue of unexpected
`
`results.1 Focusing on what transpired during prosecution, the Board again failed to
`
`meaningfully addressing the factual issues raised by Dr. Thirman’s declaration,
`
`which squarely opposed those raised by Patent Owner’s Preliminary Response.
`
`The table below summarizes exemplary disputed facts relating to unexpected
`
`results/reasonable expectation of success:
`
`
`
`1 Unlike Petitioners’ arguments in its Petition, which were fully supported
`by Dr. Thirman’s expert declaration, Patent Owner submitted an essentially naked
`Preliminary Response, with only one portion of that submission relying on Zhang’s
`declaration presented during prosecution.
`
`10
`
`
`
`
`
`
`
`
`
`Petitioner
`A POSITA would have reasonably
`
`Patent Owner
`A POSITA would not have reasonably
`
`expected lenalidomide to treat MCL
`
`expected that lenalidomide could
`
`based on what was known about
`
`effectively treat MCL based on
`
`thalidomide’s clinical use to treat MCL.
`
`thalidomide because its use for MCL
`
`See e.g. Pet. 18-19; Ex. 1002 ¶ 65.
`
`was too limited. POPR 24-26.
`
`Structural similarity between
`
`“[M]ere structural similarity between
`
`thalidomide and lenalidomide would
`
`thalidomide and lenalidomide would not
`
`have provided a reasonable expectation
`
`have given a POSA any expectation that
`
`of success. Pet. 19; Ex. 1002 ¶¶ 65, 69.
`
`these two compounds would have
`
`substantially similar effects in any given
`
`patient population in vivo.” POPR 28.
`
`A POSITA would have reasonably
`
`Areas of increased potency of
`
`expected lenalidomide to treat MCL,
`
`lenalidomide were not necessarily
`
`inter alia, based on its increased
`
`relevant to MCL. POPR 32.
`
`potency over thalidomide. Pet. 20-21;
`
`Ex. 1002 ¶¶ 71, 75, 76.
`
`A POSITA would have reasonably
`
`Because of the unique nature of MCL, a
`
`expected success in treating MCL based
`
`POSITA could not have expected that a
`
`on disclosure of lenalidomide’s use for
`
`treatment option that worked for one
`
`cancers related to MCL. Pet. 19-21; Ex.
`
`disease state would work for MCL.
`
`1002 ¶¶ 78, 88.
`
`POPR 37.
`
`
`
`11
`
`
`
`
`
`
`
`Petitioner
`Drach explicitly taught that
`
`Patent Owner
`Drach does not suggest, let alone
`
`lenalidomide was an important agent for
`
`disclose, that lenalidomide could be
`
`the new treatment paradigm of MCL at
`
`used to treat MCL. POPR 9.
`
`the time, which would provide a
`
`POSITA a reasonable expectation of
`
`success. Pet. 18; Ex. 1002 ¶ 68.
`
`
`
`Again, the Board abused its discretion in not viewing these factual issues in
`
`a light most favorable to Petitioner, and any factual disputes arising therefrom
`
`should be addressed at trial. Yamaha Golf Car Co. v. Club Car, LLC, IPR2017-
`
`02141-2-3-4, Paper 21, 2018 WL 3198594, at *2 (Jun. 26, 2018) (granting
`
`Petitioner’s request for rehearing because Board initially resolved disputed issue of
`
`material fact in favor of Patent Owner, contrary to 37 C.F.R. § 42.108(c)).
`
`In view of the foregoing, the Board abused its discretion in not instituting a
`
`trial given the numerous disputed issues of material fact relating to the issue of
`
`unexpected results and the closely related issue of reasonable expectation of
`
`success.
`
`IV. CONCLUSION
`
`In view of the foregoing, Petitioners respectfully request that the Board
`
`reverse its denial of institution with respect to Grounds 1 and 2.
`
`
`
`
`
`12
`
`
`
`
`
`
`Date: October 29, 2018
`
`
`
`
`
`
`By: /John Josef Molenda/
`
`John Josef Molenda
`Registration No. 47,804
`Steptoe & Johnson LLP
`1114 Avenue of the Americas
`New York, NY 10036
`Telephone: 212-506-3900
`Facsimile: 212-506-3950
`
`
`
`13
`
`
`
`CERTIFICATE OF SERVICE
`
`
`
`
`The undersigned hereby certifies that a copy of the foregoing
`
`PETITIONERS’ REQUEST FOR REHEARING was served on October 29, 2018
`
`by filing this document through the Patent Trial and Appeal Board End to End
`
`system as well as by delivering a copy via electronic email to the attorneys of
`
`record for the Patent Owner’s as follows:
`
`
`F. Dominic Cerrito
`nickcerrito@quinnemanuel.com
`
`Andrew S. Chalson
`andrewchalson@quinnemanuel.com
`
`Frank C. Calvosa
`frankcalvosa@quinnemanuel.com
`
`Daniel C. Wiesner
`danielwiesner@quinnemanuel.com
`
`
`
`
`J. Patrick Elsevier
`pelsevier@celgene.com
`
`Christopher J. Harnett
`charnett@jonesday.com
`
`Anthony M. Insogna
`aminsogna@jonesday.com
`
`
`
`
`
`
`
`
`
`Date: October 29, 2018
`
`
`
`
`
`
`
`
`
`
`
`By: /John Josef Molenda/
`
`John Josef Molenda
`Registration No. 47,804
`Steptoe & Johnson LLP
`1114 Avenue of the Americas
`New York, NY 10036
`Telephone: 212-506-3900
`Facsimile: 212-506-3950
`
`Lead Counsel for Petitioners
`
`
`
`
`
`
`
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