I
`
`EuropaLsches
`Patentamt
`
`European
`Patent Office
`
`Office europeen
`dee b,eve4s
`
`Submission n opposition proceedings
`made following summons to attend oral proceedings
`
`Date:/
`
`—
`
`T. Alfaro J
`
`Representative:
`JA1’rp LIP
`811
`9) Tummill Street
`Union Greater London RI M %IJ
`Utited Klngdctn
`
`Phona 4442)30778600
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`
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`
`- representing the proprietor(s):
`
`Proprietorlrepresentative’s reference
`
`UPL Limited
`
`C426430EP
`
`The information given below Ls pertaining b the following patent ii opposition proceedings:
`
`Patent r
`
`Application No
`
`EP3073826
`
`EP148655.1
`
`Date of mention of the grant n the European Patent Bulletin (4sf.
`97(3), NI. 99(1) EPG)
`
`30 October2019
`
`Title of the invention
`
`Proprietor of the paletit
`
`Requests:
`
`. See attached written submissions
`
`Documents attached
`
`Description of document
`
`Auxiliary request h opposition
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`Auxiliary request ii opposition
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`Auxiliary request ii opposition
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`Auxiliary request h opposition -
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`C42643(EP
`Page 1 of 17
`
`A METHOD FCR CONTROWNG SOYBEAN RUST
`
`UPL Limited
`
`Original file name
`
`(clean) Jul 2023
`APP - FRI
`G426430EP,PDF
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`APP -AR2 (clean) Jul 2023
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`APP -AR3 (dean) Jul 2023
`C426430EP.PDF
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`APP -AR4 (clean) Jul 2023
`C426430EP,PDF
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`Assigned file name
`
`AIJXREQ-1,PDF
`
`AUXREO-2.PDF
`
`AUXREQ-3.PDF
`
`AtJXREQ-4.PDF
`
`SYNGENTA EXHIBIT 1034
`Syngenta v. UPL, PGR2023-00017
`
`

`

`5 Auxiliary request n opposilion
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`23 Any annexes (other Than dtalion) to rn opposition
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`Pay annexes (other Than citation) to a, opposition
`letter - Annex
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`24
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`rp,,irt
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`liethod of payment
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`APP -ARS (dean) Jul 2023
`C426430EP. PDE
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`C426430EP.PDF
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`APP -AR? (dean) Jd 2023
`C426430EP.PDF
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`APP -AR8 (dean) Ji 2023
`C42643OERPDF
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`APP -AR9 (dean) JU 2023
`C426430ERPD1
`APP - ARIO (dean) Ji 2023
`C426430EPPDF
`APP - P511 (dean) JLA 2023
`C426430EP.PDF
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`APP - PSI
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`(tracked) JtA 2023
`0426430EP.PDE
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`APP - P52 (tracked) JtA 2023
`C426430EP.PDE
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`APP -AR3 (tracked) JLA 2023
`C426430EPPDE
`APP -AR4 (tracked) Jii 2023
`C426430EPPDF
`APP - ABS (tracked) JiJ 2023
`C426-43OERPDF
`APP -ARE (Packed) JtA 2023
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`APP - AR? (tracked) Ji4 2023
`C426430EPPDE
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`C426430EP.PDF
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`APP - PBS (trackec) Jti 2023
`C4264301P POE
`APP - ARID (Packed) Jul 2023
`C426430EP.PDF
`APP - P511 (Iracked) Jul 2023
`C42643OERPDF
`Wntlen submissions 17 Jr1 2023
`C426-430EP PDF
`ANNEX July 2023 C426430EPPDF
`
`NrI speohed
`
`Cufte’cy
`
`aIR
`
`AUXREQ-5PDF
`
`AUXREQ-6PDF
`
`AUXREQ-7PDF
`
`AUXREQ-8PDF
`
`AIJXREQ-9.PDF
`
`AUXREQ-1D. FOE
`
`AUXREQ-1l.PDF
`
`AUXREQ-12.PDE
`
`AUXREQ-13. FOE
`
`AUXRE0-14.PDF
`
`AUXREQ-15. POF
`
`AUXREQ-16 POE
`
`AUXREQ-1TPDF
`
`AUXREQ-1 & P01
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`AUXREO-19 FIX
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`AtJXREO-2ft FIX
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`AUXREO-21.PDF
`
`AUXREQ-22. P01
`
`OTHER-IPDF
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`OTHER-2.PDF
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`Race:
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`Signed by
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`Assodalion
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`C426430EP
`Page 2 of 17
`
`SYNGENTA EXHIBIT 1034
`Syngenta v. UPL, PGR2023-00017
`
`

`

`Representative name:
`
`Capacity:
`
`R C SitWi
`
`(Representalive)
`
`C426430EP
`Page 3 of 17
`
`SYNGENTA EXHIBIT 1034
`Syngenta v. UPL, PGR2023-00017
`
`

`

`C426430EP
`Written submissions July 2023
`ANNEX
`
`ANNEX
`
`Additional experimental evidence
`
`D58, D59 and D69 describe experiments which test the presence of synergy, using the
`Colby formula, for a variety of compositions according to the claims having different
`ratios ol active ingredients. These are briefly summarised below.
`
`Combination
`
`(i) mancozeb,
`trifloxystrobin,
`prothioconazole
`(ii) mancozeb,
`, picoxystrobin,
`tebuconazole
`(Hi) mancozeb,
`picoxystrobin,
`cyproconazole
`
`(iv) mancozeb,
`azoxystrobin,
`cyproconazole
`
`Mancozeb
`(gil-la)
`1125
`1125
`1125
`1125
`1125
`998
`1125
`
`Strobilurin Conazole
`(gil-la)
`(gil-ia)
`60
`70
`60
`70
`60
`70
`60
`100
`60
`100
`84
`68
`60
`24
`
`1125
`
`1125
`1125
`1125
`1125
`
`36
`
`36
`60
`60
`60
`
`60
`
`60
`24
`24
`24
`
`Reference
`
`row 12
`
`row no. 2
`D58, para. 21,
`rows 10, 20, 27
`D59 table,
`D69 p3, 5
`D59 table,
`D69 p3
`(row B of table)
`D69 p10-li
`row no. 3,
`D58, para. 21,
`14
`D59 table,
`29
`D69p3, 5
`D58, para.21,
`row no. 5, 13
`rows 6, 16
`D59 table,
`D69 p3
`
`rows 4, 14, 22,
`
`Thus, synergy for differing absolute quantities and ratios of components has already
`been demonstrated for combinations (H) and (Hi), as defined in claim L
`
`The following is a summary of additional experiments performed by UPL Brazil to assess
`the efficacy of combinations as defined in claim las the ratio of the active ingredients
`therein is varied from that utilised in the examples given in the application as originally
`filed. The combinations concerned are three of the four recited in claim 1:
`
`(i)
`trifloxystrobin and prothioconazole;
`inancozeb,
`(ii) mancozeb, picoxystrobin and tebuconazole; and
`(iv) mancozeb, azoxystrobin and cyproconazole.
`
`These ratios are summarised in the table below, and the details of each of experiments
`In each case,
`it is
`i-S (all performed on soybean plants) are provided hereafter.
`confirmed that the ternary combination shows synergistic control of soybean rust.
`
`Combination
`
`(i) mancozeb,
`trifloxystrobin
`and
`p roth ioco n a zo le
`
`Mancozeb
`(9/Ha)
`1050
`1300
`
`Strobilurin Conazole
`(9/Ha)
`(g/Ha)
`70
`
`101
`
`Experiment
`number, below
`1
`2
`
`Page 4 of 17
`
`SYNGENTA EXHIBIT 1034
`Syngenta v. UPL, PGR2023-000l 7
`
`1
`
`

`

`C426430EP
`Written submissions July 2023
`ANNEX
`
`(U) moncozeb,
`picoxystrobin
`and
`tebuconazole
`(iv) mancozeb,
`azoxystrobin
`and
`cyproconazole
`
`900
`900
`1000
`1835
`1194
`1350
`
`48
`60
`67
`275
`94
`60
`
`80
`75
`83
`480
`53
`60
`
`3
`4
`5
`6
`7
`8
`
`Synergy of the ternary combination in all the following experiments is assessed in all
`cases using the standard Colby formula:
`
`l:xpected control (F) =A + B + C-
`
`(AB+AC+Bcj
`:100
`
`+
`
`ABC
`10000
`
`Experiment I
`
`This tesi was carried out in Lucas do Rio Verde - MT in field conditions in the 2020/21
`harvest. The culture variety was Monsoy 8372 IPRO. A spacing between lines of 0.45 m
`was used. To enable comparison, a variety of different sprays were used; each spray
`was applied to a test patch in the field,
`in accordance with the following protocol.
`
`Location
`Coordinates
`Company
`Cultivar
`Sowing date
`Spray volume (L/ha)
`Condition
`Replications
`Replication
`Plants/replication
`Sprays
`BBCH stage at first spray
`Date of first spray
`BBCH stage at second spray
`Date of second spray
`BBCH stage at third spray
`Date of third spray
`Phokopsora pachyrhizi
`inoculation
`Statistical analyses
`
`Lucas do Rio Verde - MT
`S -12,99914 W -55, 9702222
`UPL Brasil
`Monsoy 8372 IPRO
`12-12-2020
`150
`Field
`4
`1 plot of 3 mx 6 m = 18m2
`NA
`3
`40
`28-01-2021
`54
`11-02-2021
`68
`25-02-2021
`
`Natural occurrence
`
`Duncan 5°/s
`
`Page 5 of 17
`
`SYNGENTA EXHIBIT 1034
`Syngenta v. UPL, PGR2023-00017
`
`2
`
`

`

`C426430EP
`Written submissions July 2023
`ANNEX
`
`The eight different sprays used were
`ester of soybean oil.
`
`follows. The “methyl soya” element is a methyl
`
`Spray
`no.
`
`Product
`
`Formulation
`type
`
`Active ingredient
`
`Cone.
`(gIL)
`
`Dose
`(g/Ha)
`
`1
`2
`2
`3
`3
`4
`4
`S
`5
`5
`6
`6
`6
`7
`7
`7
`8
`8
`8
`8
`
`Control
`Flint
`Strides
`UPL 2030 FP
`Strides
`Unizeb Gold
`Strides
`Flint
`UPL 2030 FP
`Strides
`Flint
`Unizeb Gold
`Strides
`UPL 2030 EP
`Unizeb Gold
`Strides
`Flint
`UPL 2030 FP
`Unizeb Gold
`Strides
`
`WG
`EC
`3:
`EC
`WG
`EC
`WG
`3:
`
`WG
`WG
`EC
`3:
`WG
`EC
`WG
`3:
`WG
`EC
`
`N/A
`Trifloxystrobin
`500
`Methyl soya
`720
`Prothioconazole
`480
`Methyl soya
`720
`Mancozeb
`750
`Methyl soya
`720
`Trifloxystrobin
`500
`Prothioconazole
`480
`Methyl soya
`720
`Trifloxystrobin
`500
`Mancozeb
`750
`Methyl soya
`720
`Prothioconazole
`480
`Mancozeb
`750
`Methyl soya — 720
`Trifloxystrobin
`500
`Prothioconazole
`480
`Mancozeb
`750
`Methyl soya
`720
`
`70
`270
`
`270
`1050
`270
`70
`
`270
`70
`1050
`270
`
`1050
`270
`70
`
`1050
`270
`
`Thus, spray 8 contained a ternary combination (i).
`
`The percentage severity of Phukopsero pochyrrhizi was observed at 28-DAC (that is, 28
`days after the third application, also called application “C”) and the results are tabled
`below.
`
`Spray ttive ingredient
`rn
`
`Severity
`(%)
`
`Control
`
`Expected
`
`Conclusion
`
`observed
`
`Colby
`
`e3)
`
`Control(%)
`
`I
`2
`3
`4
`5
`
`Untreated
`Trifloxystrobin
`Prothioconazole
`Mancozeb
`Trifloxystrobin +
`
`Proth i oco nazo le
`
`60.0
`44.9
`34.4
`556
`30.5
`
`0.0
`25.2
`42,6
`40.6
`49.3
`
`-
`
`-
`
`-
`
`-
`
`57.)
`
`Antagonism
`
`Page 6 of 17
`
`SYNGENTA EXHIBIT 1034
`Syngenta v. UPL, PGR2023-00017
`
`3
`
`

`

`C426430EP
`Written submissions July 2023
`ANNEX
`
`6
`
`7
`
`8
`
`Trifloxystrobin +
`
`27.5
`
`54.3
`
`55.6
`
`Antagonism
`
`Mancozeb
`
`Prothioconazol
`
`e +Mancozeb
`
`25.4
`
`57.7
`
`66.0
`
`Antagonism
`
`Trifloxystrobin +
`
`14.1
`
`76.5
`
`74.6
`
`Synergy
`
`Prothioconazole +
`
`Mancozeh
`
`Experiment 2
`
`This test was performed at ARDS - ltuverava - SP in
`a vegetable house in 2021. The
`variety of the crop was 64H0133 IPRO. Two plants per pot were used, each pot with 5
`liters of soil capacity. The first spray (application ‘A’) was carried out in the
`development stage of the HARVEST 60 (Ri) BBCH. The incidence of the disease was
`measured before the first spray, spray A, and 14 days after the second spray (14 DAB).
`To enable comparison,
`a variety of different sprays were used; each spray was applied
`in accordance with the following protocol.
`
`Location
`Coordinates
`Company
`Cultivar
`Sowing date
`Spray volume (L/ha)
`Condition
`Replications
`Replication
`Plants/replication
`Sprays
`BBCH stage at first spray
`Date of first spray
`BBCH state at second spray
`Date of second spray
`Phakopsora pachyrh/zi
`inoculation
`Statistical analyses
`
`Ituverava - Sao Paulo
`S -20,3243611 W -47,8088333
`UPL Brasil
`64H0133 IPRO
`27-04-2021
`150
`Greenhouse
`6
`1 pot of 5 L with 2 plants
`2
`2
`60
`2i062021
`67
`05-07-2021
`
`25-06-2021
`
`Duncan ‘/n
`
`The eight different sprays used were as follows.
`
`Page 7 of 17
`
`SYNGENTA EXHIBIT 1034
`Syngenta v. UPL, PGR2023-00017
`
`4
`
`

`

`C426430EP
`Written submissions July 2023
`ANNEX
`
`Spray
`no.
`1
`
`2
`2
`3
`3
`4
`4
`5
`5
`5
`6
`6
`6
`7
`7
`7
`8
`8
`8
`8
`
`Product
`
`Control
`(untreated)
`Flint
`StrEdes
`UPL 2030 FP
`Strides
`Unizeb Gold
`Strides
`Flint
`UPL 2030 [P
`Strides
`Flint
`Unizeb Gold
`Strides
`UPL 2030 FP
`Unizeb Gold
`Strides
`Flint
`UPL 2030 FP
`Unizeb Gold
`Strides
`
`Formulation Active
`type
`ingredients
`
`Cone. (gIL) Dose
`(g/Ha)
`
`WG
`EC
`T
`EC
`WG
`EC
`WG
`a:
`EC
`WG
`WG
`EC
`a:
`WG
`EC
`WG
`a:
`WG
`EC
`
`Trifloxystrobin
`Methyl soya
`Prothioconazole
`Methyl soya
`Mancozeb
`Methyl soya
`Trifloxystrobin
`Prothioconazole
`Methyl soya
`Trifloxystrobin
`Mancozeb
`Methyl soya
`Prothioconazole
`Mancozeb
`Methyl soya
`Trifloxystrobin
`Prothioconazole
`Mancozeb
`Methyl soya
`
`500
`720
`480
`720
`750
`720
`500
`480
`720
`500
`750
`720
`480
`750
`720
`500
`480
`750
`720
`
`83
`270
`101
`270
`1300
`270
`83
`101
`270
`83
`1300
`270
`101
`1300
`270
`83
`101
`1300
`270
`
`Thus, spray 8 contained a ternary combination (i).
`
`The percentage severity of Phokopsera pachyrrhizi was observed at 14-DAB (that is, 14
`days after the second application, also called application “B’) and the results are
`tabled below.
`
`Spray
`no.
`
`Active
`ingredients
`
`Disease
`Incidence
`
`p<O,O5 Observed
`control
`
`Conclusion
`
`Colby
`(Expected
`control)
`
`I
`2
`3
`4
`5
`
`6
`
`7
`
`Control
`Trifloxystrobin
`Prothioconazole
`Mancozeb
`Trifloxystrobin +
`Proth i oco nazole
`Trifloxystrobin +
`Mancozeb
`Prothioconazole
`+ Mancozeb
`
`68.8
`66.7
`60.4
`66.7
`62.5
`
`68.8
`
`58.3
`
`1
`
`0.0
`3.0
`2.
`3.0
`9.!
`
`0.0
`
`15.2
`
`a
`a
`a
`a
`a
`
`a
`
`a
`
`5
`
`4.8
`
`6.0
`
`14.8
`
`Antagonistic
`
`Antagonistic
`
`Synergistic
`
`Page 8 of 17
`
`SYNGENTA EXHIBIT 1034
`Syngenta v. UPL, PGR2023-00017
`
`

`

`C42541EP
`Written submissions July 2023
`
`S
`
`Trifloxystrobin +
`Prothioconazole
`÷ Mancozeb
`
`Experiment 3
`
`56.3
`
`a
`
`18.2
`
`17A
`
`Synergistic
`
`The test was performed at PE - ltuverava -
`on plants with a sowing date of 15
`December 2020. The soybean variety of 1.01 4779 FtC was used for these experiments.
`The trial was conducted in field conditions. A spray volume of 150 L/ha was maintained
`in all cases. A first spray (A) was performed at growth stage
`J-l (R2). Two
`!B!! and C”) were carried out and evaluation of
`subsequent sprays (referred to
`disease incidence was carried out 14 days and 21 days after the last spray (C).
`
`A consistent row spacing of 0.50 m was maintained. The plot size was 18m2-
`
`5 spray compositions were utilised,
`
`follows.
`
`Spray no. Active ingredients Dose (g/Ha)
`
`1
`2
`3
`4
`5
`5
`5
`
`Untreated control
`Picoxystrobin
`Tebuconazole
`Mancozeb
`Picoxystrobin
`Tebuconazole
`Mancozeb
`
`N/A
`48
`
`900
`48
`
`900
`
`Thus, spray 5 contained a ternary combination (ii).
`
`In view of the severity of soybean rust at 14 and 21 days after spray C, ai area under
`disease progress curve (AUDPC) was calculated. The expected Colby control was
`calculated both in connection with the severity of disease at 14-DAC, and in connection
`with the AUDPC, The results are shown in the table below.
`
`Spray Active
`
`14 DC results
`
`No.
`
`ingredient
`
`Severity Observed
`f%)
`
`control
`
`1
`
`2
`
`3
`
`4
`
`Untreated
`
`100.0
`
`Picoxystrobin
`
`Tebuconazole
`
`Mancozeb
`
`82.5
`
`90.0
`
`77.5
`
`c7)
`0.0
`
`18.5
`
`10.0
`
`22.5
`
`Expected MD Observed
`
`Colby
`
`Control
`
`(Colby)
`
`control
`
`(Expected
`
`Control)
`
`1750.0
`
`1347.5
`
`1417.5
`
`838.5
`
`00
`
`23.0
`
`19(0
`
`49.5
`
`-
`
`-
`
`-
`
`6
`
`Page 9 of 17
`
`SYNGENTA EXHIBIT 1034
`Syngenta v. UPL, PGR2023-00017
`
`

`

`C426430EP
`Written submissions July 2023
`ANNEX
`
`5
`
`Picoxystrobin,
`
`32.5
`
`67.5
`
`42.5
`
`446.3
`
`74.5
`
`68.5
`
`Tebuconazole
`
`+Mancozeb
`
`By either calculation,
`the observed control achieved by spray no. 5 exceeded the Colby
`expected control,
`indicating the existence of a synergistuc effect.
`
`Experiment 4
`
`The test was perlormed at PROS - Ituverava - S on plants with a sowing date of 27th
`June. The soybean variety of NA 5909 PG was used for these experiments. The trial was
`conducted in greenhouse conditions. A spray volume of 150 L/ha v•sas maintained in all
`cases. A first spray (A) was performed at growth stage 16 BBCF-l and disease incidence
`(percentage of leaves with symptoms) before the spray and 7 days after spray was
`noted. The Tukeys test at 9/oof probability was used for all statistical analysis.
`
`A consistent row spacing of 0.20 m was maintained with a plant density of 2 plants per
`pot. A sowing fertilizer dose at 500 kg/ha of formula 04.14.08 (NPK) was initially
`applied at the moment of sowing, putting the fertilizer below the seeds’ positions in
`mixture with the soil. Plot size was 1 pot.
`
`The eight different sprays used were
`
`follows.
`
`Spray Product
`no.
`1
`2
`
`Control
`Unizeb
`Gold
`Strides
`Oranis
`Strides
`Tebufort
`Strides
`Unizeb
`Gold
`Dranis
`Strides
`Unizeb
`Gold
`Tebufort
`Strides
`Dranis
`Tebufort
`Strides
`
`2
`3
`3
`4
`4
`S
`
`5
`S
`6
`
`6
`6
`7
`7
`7
`
`Cone. (gIL)
`
`Formulation Active
`ingredients
`type
`
`Dose
`(g/Ha)
`
`Mancozeb
`
`Methyl soya
`Picoxystrobin
`Methyl soya
`Tehuconazole
`Methyl soya
`Mancozeb
`
`Picoxystrobin
`Methyl soya
`Mancozeb
`
`Tebuconazole
`Methyl soya
`Picoxystrobin
`Tebuconazole
`Methyl soya
`
`900
`
`270
`60
`270
`75
`270
`900
`
`60
`270
`900
`
`75
`270
`60
`75
`270
`
`750
`
`720
`250
`720
`200
`720
`750
`
`250
`720
`750
`
`200
`720
`250
`200
`720
`
`WG
`
`EC
`
`EC
`EC
`EC
`WG
`
`EC
`WG
`
`EC
`EC
`32
`WG
`EC
`
`7
`
`Page 10 of 17
`
`SYNGENTA EXHIBIT 1034
`Syngenta v. UPL, PGR2023-00017
`
`

`

`C426430EP
`Written submissions July 2023
`ANNEX
`
`8
`
`8
`8
`8
`
`Unizeb
`Gold
`Oranis
`Tehufort
`[ Strides
`
`750
`
`250
`200
`720
`
`WG
`
`32
`EC
`EC
`
`Mancozeb
`
`Picoxystrobin
`Tebuconazole
`Methyl soya
`
`900
`
`60
`75
`270
`
`Thus, spray 8 contained a ternary combination (ii).
`
`The percentage severity of Phakopsera pachyrrhizi was observed at 7-DAA (that is, 7
`days after the first application, also called application “A’) and the results are
`tabulated below. The initial disease incidence, at application A, was 0 in all cases.
`
`Spray Active
`ingredient(s)
`no.
`
`Disease
`incidence
`(%)
`
`Observed
`(%)
`control
`
`Colby
`(Expected
`control)
`
`Conclusion
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`35,4
`
`2], 1
`
`29,2
`
`Untreated
`Check
`Unizeb Gold
`Strides
`Oranis
`Strides
`Tebufort
`Strides
`Unizeb Gold , 35,4
`Oranis
`Strides
`Unizeb Gold
`Tehufort
`Strides
`Oranis
`Tebufort
`Strides
`Unizeb Gold
`Oranis
`Tebufort
`
`31,3
`
`35,4
`
`22,9
`
`0,0
`
`0,0
`
`18,8
`
`12,5
`
`0,0
`
`6,2
`
`0,0
`
`18,8
`
`12,5
`
`Antagonistic
`
`Antagonistic
`
`28,9
`
`Antagonistic
`
`31,2
`
`28,9
`
`Synergistic
`
`Strides
`
`Experiment 5
`
`The test was performed at ARDS - Ituverava - 54’ on plants with a sowing date of 27th
`June. The soybean crop variety was NA 5909 RG for these experiments. The trial was
`conducted in greenhouse conditions.
`A spray volume of 150 L/ha was maintained in all
`cases. A row spacing of 0.5 m was used. A sowing fertiliser was applied at 500 Kg/Ha.
`
`Page 11 of 17
`
`SYNGENTA EXHIBIT 1034
`Syngenta v. UPL, PGR2023-00017
`
`8
`
`

`

`C426430EP
`Written submissions July 2023
`ANNEX
`
`A first spray (A) was performed at growth stage 16 BBCR (V6) on 7 August. Disease
`incidence was measured before spray and at 35 days after spray (“35-DAN) was noted
`according to the following diagrammatic scale:
`
`or/b
`
`1.0%
`
`5.O0/o
`
`10°/n
`
`jth.
`
`4O/
`
`ES,’0
`
`700/
`
`64%
`
`The eight different sprays used were as follows.
`
`Spray Product
`no.
`1
`
`Control
`(untreated)
`Unizeb
`Gold
`Strides
`Oranis
`Strides
`Tebufort
`Strides
`Unizeb
`Gold
`Oranis
`Strides
`Unizeb
`Gold
`Tebufort
`Strides
`
`2
`
`2
`3
`3
`4
`4
`5
`
`5
`5
`6
`
`6
`6
`
`Cone. (gIL)
`
`Formulation Active
`type
`ingredients
`
`Dose
`(g/Ha)
`
`Mancozeb
`
`Methyl soya
`Picoxystrobin
`Methyl soya
`Tebuconazole
`Methyl soya
`Mancozeb
`
`Picoxystrobbi
`Methyl soya
`Mancozeb
`
`Tebuconazole
`Methyl soya
`
`1000
`
`270
`66.66
`270
`83.33
`270
`1000
`
`66.66
`270
`1000
`
`83.3
`270
`
`750
`
`720
`250
`720
`200
`720
`750
`
`250
`720
`750
`
`200
`720
`
`WG
`
`EC
`a:
`
`EC
`EC
`WG
`
`SC
`
`WG
`
`9
`
`Page 12 of 17
`
`SYNGENTA EXHIBIT 1034
`Syngenta v. UPL, PGR2023-00017
`
`

`

`C426430EP
`submissions July 2023
`Written
`ANNEX
`
`7
`7
`7
`8
`
`8
`8
`S
`
`Oranis
`Tebufort
`Strides
`Unizeb
`Gold
`Oranis
`Tebufort
`Strides
`
`250
`200
`720
`750
`
`250
`200
`720
`
`3
`WG
`EC
`WG
`
`EC
`EC
`
`Picoxystrobin
`Tebuconazole
`Methyl soya
`Mancozeb
`
`Picoxystrobin
`Tebuconazole
`Methyl soya
`
`66.66
`83.33
`270
`1000
`
`66.66
`83.33
`270
`
`The percentage severity of Phakopsera pachyrrhizi was observed at 35-DAA (that is, 35
`days after the first apphcation, also called application “A”) and the results are
`tabulated below,
`
`Spray No,
`
`Product
`
`I
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`S
`
`Untreated check
`Unizeb Gold
`Strides
`Oranis
`Strides
`Tebufort
`Strides
`Unizeb gold
`Oranis
`Strides
`Unizeb gold
`Tebufort
`Strides
`Oranis
`Tebufort
`Strides
`Unizeb gold
`Oranis
`tebufort
`Strides
`
`Percentage
`Disease
`incidence
`93.8
`81.3
`
`70.8
`
`79.2
`
`64.6
`
`72.9
`
`68.8
`
`43.8
`
`Percentage Colby
`Control
`predicted
`Control
`
`cd4
`
`0.0
`13.3
`
`24.4
`
`15.6
`
`31. 1
`
`22.2
`
`26.7
`
`53.3
`
`-
`
`-
`
`-
`
`34.5
`(Antagonistic)
`
`26.8
`(Antagonistic)
`
`36.2
`(Antagonistic)
`
`44.7
`(Synergistc)
`
`Experiment 6
`
`Ii this test, a randomized block design of experiments was carried out for five differing
`spray compositions with 4 replications each- A plot size of 5 X 4 sq m. was maintained.
`The crop variety selected for the experiments was soybean JS 9305. The soil type was
`black sandy loam. To apply sprays, an irrigation sprinkler was used with backpack
`knapsack electrical sprayer with a hollow cone nozzle. The amount of water volume
`used was 500 L/ha.
`
`Page 13 of 17
`
`SYNGENTA EXHIBIT 1034
`Syngenta v. UPL, PGR2023-00017
`
`10
`
`

`

`C426430EP
`Written submissions July 2023
`ANNEX
`
`Two treatments were applied. The first treatment was applied at the onset of disease
`symptoms. The application dates were 8th September and 20th September respectively.
`The disease evaluated was Asian soybean rust.
`
`Incidence of soybean rust disease was assessed after the second treatment, according
`to the following scale.
`
`Disease
`Scale
`Rating
`0
`1
`3
`
`5
`
`7
`
`9
`
`Disease
`Severity
`
`Description
`
`--
`
`-
`
`l%
`1.1
`1k
`10.1 -
`ak
`25.1 -
`Fk
`50.1 0/
`of
`Above
`
`No lesions/spots
`leaf area covered with lesions/spots
`leaf area covered with lesions/spots, no spots on stem
`
`leaf area covered with lesions/spots, no defoliation;
`little damage
`leaf area covered with lesions/spots; some leaves
`drop; death of few plants; damage conspicuous
`lesions/spots very
`More than 5Tk area covered,
`common on all parts, defoliation common; death of
`plants common; damage more than S/o.
`
`The above scale is exemplified by leaves with the following appearance:
`
`4
`
`1’.
`
`-U’.
`
`‘E:;Lyfr
`
`-S.
`
`; A
`
`I
`
`.
`
`‘
`
`,;
`—-t’
`
`M
`
`with the leaves epresenting,
`
`left to right,
`
`rating 0,
`
`1, 3, 5, 9 and 9.
`
`Having assessed leaves using this scale,
`calculated as follows;
`
`the percentage disease index (“P01”) was
`
`PD/r
`
`Sum of all numerical disease rat/rigs x 100
`Total rio. of leaves observed x max. disease grade
`
`The five spray compositions, and the percentage disease control achieved by each,
`were as follows
`
`Page 14 of 17
`
`SYNGENTA EXHIBIT 1034
`Syngenta v. UPL, PGR2023-00017
`
`11
`
`‘,-‘
`

`

`Spray no. Active ingredients Dose (g/Ha) Mean percentage
`disease control
`(PDC)
`96.9
`
`C426430EP
`Written submissions July 2023
`ANNEX
`
`T-1
`T-1
`11
`T-2
`T-3
`T-4
`T-5
`
`Mancozeb
`Picoxystrobin
`Tebuconazole
`Mancozeb
`Picoxystrobin
`Tebuconazole
`Untreated control
`
`1835
`275
`480
`1835
`275
`480
`N/A
`
`72.9
`72.2
`34.7
`0.0
`
`The expected control was calculated as follows, using the usual ternary Colby formula:
`
`Expected control (E1 =A * B + C-
`
`(AB+AC-i-Bç)
`
`*
`
`ABC
`10000
`
`Inserting the values from the table above,
`
`this calculation becomes:
`
`B = 72.9 ± 72.2 -I- 34.7 -
`
`((72.9 * 72.2) + (72.9
`34.7) + (72.2 * 34.7))
`.1011
`
`+
`
`72.9 * 72.2 * 34.7
`10000
`
`leading to an expected control percentage of 95.2. The observed control of 96.9
`exceeds this value, confirming that the ternary combination shows a synergistic effect.
`
`Experiment 7
`
`The test was performed in field conditions at ARDS - Ituverava - SP. The soybean
`cultivar ADV 4681 IPRO was used for these experiments. A consistent row spacing of 0.5
`m was maintained. A sowing fertilizer dose at 500 kg/ha was initially applied at the
`moment of sawing. A first spray (A) was performed at growth stage BBCH 60. Three
`subsequent sprays (referred to as “B”, “C and “D”) were carried out and evaluation of
`disease incidence was carried out 14 days after the last spray (D). Each spray was
`applied to a test patch in the field,
`in accordance with the following protocol.
`
`Loration
`Coordinates
`Company
`Cultivar
`Sowing date
`Spray volume (L/ha)
`Condition
`Replications
`Replication
`Plants/replication
`Sprays
`
`Ituverava - Sao Paulo
`S 20’ 19’ 42” W 47’ 48’ 45”
`UPL Brasil
`ADV 4681 IPRO
`06-12-2020
`150
`Field
`4
`1 plot of 3 mx 6 m
`NA
`4
`
`18m2
`
`Page 15 of 17
`
`SYNGENTA EXHIBIT 1034
`Syngenta v. UPL, PGR2023-00017
`
`12
`
`

`

`C426430EP
`Written submissions July 2023
`ANNEX
`
`BBCH stage at first spray
`Date of first spray
`BBCH stage at second spray
`Date of second spray
`BBCH stage at third spray
`Date of third spray
`BBCH stage at fourth spray
`Date of fourth spray
`Phakopsora pachyrhizi
`inoculation
`
`60
`27-01-2021
`65
`10-02-2021
`70
`24-02-2021
`75
`09-03-2021
`
`Natural occurrence
`
`Five different spray compositions were applied. The first was a control, containing no
`active ingredient. Sprays 2-4 contained individual active components azoxystrobin,
`cyproconazole, and mancozeb. Spray 5 contained a ternary combination (iv). These
`compositions
`together with the evaluation of disease incidence and efficacy of control
`at 14-DAD, are tabulated below.
`
`Dose(g/Ha) Disease
`
`Observed
`
`Expected
`
`Conclusion
`
`Spray
`
`Active
`
`no.
`
`ingredient
`
`control
`
`Incidence
`r4
`
`Colby
`
`Control
`f34)
`
`-
`
`-
`
`-
`
`-
`
`35.2
`
`Synergistic
`
`1
`
`2
`
`3
`
`4
`
`5
`
`Untreated
`
`Azoxystrobin
`
`-
`
`94
`
`Cyproconazole 9
`
`Mancozeb
`
`1194
`
`100.0
`
`97.5
`
`95.0
`
`70.0
`
`Azoxystrobin +
`
`94 + 9 + 32.5
`
`0.0
`
`2.5
`
`5.0
`
`30.0
`
`67.5
`
`1194
`
`Cyproconazole
`
`J_______________
`
`Experiment S
`
`This test was carried out at ltaara - Rio Grande do Sul. The crop variety was BMX Ativa.
`Pot trials in greenhouse conditions were carried out (1 pot of 5 L with 2 plants, 4
`replicates). A single application was carried out at BBCH stage 17 of crop development.
`The sowing date was 15 July 2023 and the spray date was 1 September 2021. As
`elsewhere, the target pest was Phakopsora pachyrrhizi.
`Jnoculation with Phakopsora
`pachyrrhizi was performed on 2 September 2021.
`
`The percentage incidence of Phakopsora pachyrrhizi was observed at 35 days after the
`last spray (35 DAA).
`
`Page 16 of 17
`
`SYNGENTA EXHIBIT 1034
`Syngenta v. UPL, PGR2023-00017
`
`13
`
`

`

`C426430EP
`Written submissions July 2023
`ANNEX
`
`Five different spray compositions were applied. The first was a control, containing no
`active ingredient. Sprays 2-4 contained individual active components azoxystrobin,
`cyproconazole, and mancozeb. Spray S contained a ternary combination (iv). These
`compositions, together with the evaluation of disease incidence and efficacy of control
`at 35-DAA, are tabulated below.
`
`Disease
`
`Observed
`
`Expected
`
`Conclusion
`
`control
`
`Colby
`
`Y0)
`
`0.0
`
`43.4
`
`44.7
`
`77.2
`
`954
`
`Control
`
`3)
`
`-
`
`-
`
`-
`
`-
`
`929
`
`Synergistic
`
`Spray
`
`Active
`
`no.
`
`ingredient
`
`Dose
`
`(g/Ha)
`
`Incidence
`)
`
`1
`
`2
`
`3
`
`4
`
`5
`
`Untreated
`
`Azoxystrobin
`
`Cyproconazole
`
`-
`
`60
`
`60
`
`Mancozeb
`
`1350
`
`Azoxystrobin ÷ 60 + 60
`
`Cyproconazole
`
`+ 1350
`
`+ Mancozeb
`
`39.8
`
`22.5
`
`22
`
`9.1
`
`1.8
`
`Summaiy
`
`It is clear from the above, and the data already on file, that the ratio of active
`to (iv) can be varied while maintaining a synergistic
`ingredients in combinations (i)
`efficacy in the treatment of soybean rust.
`
`Page 17 of 17
`
`SYNGENTA EXHIBIT 1034
`Syngenta v. UPL, PGR2023-00017
`
`14
`
`