`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`INNOPHARMA LICENSING, INC., INNOPHARMA LICENSING LLC,
`INNOPHARMA INC., INNOPHARMA LLC,
`MYLAN PHARMACEUTICALS INC., MYLAN INC., LUPIN LTD., and LUPIN
`PHARMACEUTICALS INC.,
`Petitioner,
`
`v .
`
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.
`Patent Owner.
`__________________
`
` Case IPR2015-00903 (Patent 8,129,431)1
`_________________
`
`Filed: April 6, 2016
`__________________
`
`Petitioner’s Response to Patent Owner’ Motion for Observation
`Regarding Cross-Examination of Reply Witnesses
`Dr. Paul A. Laskar, Ph.D. and Ivan T. Hofmann, CPA/CFF, CLP
`
`
`
`
`
`1 IPR2015-01871 has been joined with IPR2015-00903.
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`
`
`
`
`
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`Pursuant to the Scheduling Order (Papers 17 and 29), Petitioner hereby files
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`its response to Patent Owner’s Motion for Observation (Paper 61).
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`I.
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`INTRODUCTION
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`Patent Owner’s Motion for Observation mischaracterizes the testimony of Dr.
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`Laskar and Mr. Hofmann, and further includes several arguments to the merits,
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`which is an improper use of the Motion for Observation as a vehicle to make
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`arguments in sur-reply. Furthermore, those arguments to the merits, which
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`ultimately fail to contradict any of Petitioner’s positions in this proceeding, further
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`show why Patent Owner’s Motion to Exclude Dr. Laskar’s Reply Declaration and
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`associated exhibits (Paper 59 at 8-10) is without merit. Accordingly, the Board
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`should expunge or give no weight to Patent Owner’s purported observations.
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`II. RESPONSES TO OBSERVATIONS ON CROSS-EXAMINATION
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`Observation #1: Patent Owner cites a small part of Dr. Laskar’s testimony
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`to imply that Dr. Laskar lacks qualification to provide the testimony in his reply
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`
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`declaration (EX1104).
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` Dr. Laskar is plainly qualified even under Patent
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`Owner’s definition of a POSA. Indeed, Dr. Davies, Patent Owner’s own expert,
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`states a POSA would have at least a Bachelor’s degree in a field of science which
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`includes “pharmaceutical sciences or a related discipline with about three to five
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`
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`1
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`
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`years of work experience in this area, or a comparable level of education and
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`training.” EX2105, ¶ 41. Dr. Laskar also is qualified under Dr. Williams’s
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`definition of a POSA and the definition of a POSA in the Patent Owner’s Response.
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`EX2082, ¶ 41; Patent Owner’s Response, Papers 34 at 6. Petitioner provide a more
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`complete response as to Dr. Laskar’s proper qualifications for the offered opinions
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`and testimony in his Reply Declaration in the concurrently filed Petitioner’s
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`Opposition to Patent Owner’s Motion to Exclude.
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`Observation #2: Patent Owner mischaracterizes Dr. Laskar’s testimony to
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`suggest his testimony is inconsistent with his statement regarding tyloxapol’s
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`antioxidant properties. Patent Owner distorts the record by mischaracterizing Dr.
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`Laskar’s answer to Patent Owner’s vague and ambiguous questioning. EX2272,
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`69:3-4 (Petitioner objecting to the question as vague and ambiguous). Dr. Laskar
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`testimony is consistent with the teaching that tyloxapol has antioxidant properties.
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`
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` See EX1104, ¶¶ 30-31; EX1012, Tables 4
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`and 5. Dr. Laskar did not state that tyloxapol was not an antioxidant. This aspect of
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`Dr. Laskar’s testimony is clear when read in context of his Reply Declaration
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`(EX1104) and his cross-examination testimony on November 4, 2015 (EX2114),
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`2
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` See EX2272, 68:10-19; EX1104, ¶ 6;
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`EX2114, 157:25-158:3 (
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`). In Yasueda Table
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`4, formulations A and B contain tyloxapol, which has two functions (i.e., antioxidant
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`and surfactant), whereas formulation E contains BHT, which has a single function
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`as an antioxidant and thus a “traditional antioxidant.” Indeed, Dr. Laskar cited a
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`wide range of prior art references to support his statement that tyloxapol is an
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`antioxidant. EX1104, ¶¶ 6-7, 14-29.
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`Observation #3: Patent Owner improperly mischaracterizes Dr. Laskar’s
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`testimony. Patent Owner suggests that Dr. Laskar’s testimony in response to
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`“preliminary questions” that are incomplete hypotheticals vaguely directed to
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`somehow shows that the teaching
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`in the Merck Index and Remington do not apply to the ’431 patent and ’290 patent.
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`See EX2272, 29:11, 29:15. Dr. Laskar’s testimony is consistent with the teaching
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`
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`that tyloxapol has antioxidant properties and does not contradict it.
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`, EX2272, 112:16-22),
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`much like the statement in the Merck Index and Remington that tyloxapol is
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`“oxidized by metals.” EX1089, 1751; EX1106, 1415.
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`Furthermore, Patent Owner’s allegation is not a proper distinction of the
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`general teaching in the Merck Index and Remington, which provide a more
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`3
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`
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`generalized teaching that tyloxapol has antioxidant properties. EX1089, 1751;
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`EX1106, 1415; EX1080, 114:6-16; EX1104, ¶¶21-22. If tyloxapol were not an
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`antioxidant, and instead an oxidizing agent (which it is not), then it would not be
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`oxidized by oxidizing agents. Whether or not the sodium in bromfenac sodium is in
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`cation form or not has no relevance to Dr. Laskar’s analysis.
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`Observation #4: Patent Owner’s questions seeking legal conclusions
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`whether a prior art is relevant in view of the preamble of the claims is improper and
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`misleading. EX2272, 32:20, 33:6. Furthermore, Patent Owner omits other parts Dr.
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`Laskar’s testimony,
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`EX1104, ¶¶ 25-26.
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`
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`EX2272, 127:13-17;
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`Indeed, Patent Owner’s own expert’s testimony contradicts Patent’ Owner’s
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`improper legal conclusion, stating that inhalation and nasal formulations have the
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`same characteristics as ophthalmic formulations. EX1079, 20:13-21 (“I -- I study -
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`- these often involve solution formulations and suspension formulations especially
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`the one for the inhalation and nasal. So the characteristics are the same, but my
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`application at the current time is not necessarily for the eye but for the lungs and
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`nasal. So the properties of the materials I, mean, to me -- to a person of skill in the
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`art would be quite similar.”). Moreover, the ’431 patent and Ogawa similarly
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`involve nasal formulations. EX1001, 4:10-13, 11:48-51; EX1004, 4:60-62,
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`
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`4
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`
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`Example 10. Moreover, the scope of prior art is broadly defined by controlling case
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`law. See Wyers v. Master Lock Co., 616 F.3d 1231, 1238 (Fed. Cir. 2010).
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`Observation #5: Patent Owner mischaracterizes Dr. Laskar’s testimony. Dr.
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`Laskar’s testimony cited by Patent Owner does not contradict Dr. Laskar’s opinion
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`that Fu discloses a class of compounds that includes tyloxapol. As Dr. Laskar stated,
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`Fu
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`teaches
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`that
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`the “nonionic ethoxylated octylphenol surfactant
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`is an
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`octylphenoxypoly(ethyleneoxy)ethanol with a mole ratio of ethylene oxide to
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`octylphenol between 3:1 and 40:1.” EX1104, ¶ 2; EX1011, Claim 3. Dr. Williams
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`also admitted that Fu teaches a “series” of ethoxylated octylphenol surfactant.
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`EX1067, 112:7-16 (Patent Owner’s expert admitting that given these mole ratios, Fu
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`discloses a “series of [] octoxynols”). Dr. Davies also characterized tyloxapol as
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`being substituted octylphenols that has chains of polyoxyethylated groups, thus
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`falling in the family of octylphenol surfactants that are ethoxylated. EX1061, 193:7-
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`10, 193:22-194:11; see also EX1080, 56:10-57:1. Schott also stated that
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`“[t]yloxapol is essentially an oligomer of octoxynol 9” and that “[d]espite the
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`methylene bridges, it has practically the same hydrophilic-lipophilic balance as
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`octoxynol,” the mole ratio of ethylene oxide to octylphenol of tyloxapol is 9.6.
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`EX1019, 496-97. Consistent with these teachings, Dr. Laskar concluded tyloxapol
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`“falls within the series” of ethoxylated octoxynols disclosed by Fu. EX1104, ¶ 3.
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`5
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`Observation #6: As discussed with respect to Observation #5, Dr. Laskar’s
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`testimony cited by Patent Owner does not contradict Dr. Laskar’s opinion that Fu
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`discloses a class of compounds that includes tyloxapol. Dr. Laskar has noted that
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`tyloxapol is essentially an oligomer of octoxynol 9. EX1104, n. 4. As stated in
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`response to Observation #5, Dr. Laskar’s testimony cited by Patent Owner is
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`consistent with Dr. Laskar’s statement in the Reply Declaration that tyloxapol falls
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`within the class of ethoxylated octylphenols disclosed in Fu.
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`Observation #7: Patent Owner mischaracterizes Dr. Laskar’s testimony and
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`misunderstands Dr. Laskar’s opinion in his Reply Declaration. In his Reply
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`Declaration, Dr. Laskar observed that Dr. Davies stated that “bromfenac is
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`susceptible to oxidation” and that Dr. Davies stated that a POSA would expect
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`bromfenac to degrade in the presence of both polysorbate 80 and tyloxapol.
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`EX1104, ¶ 4; EX2105, ¶ 72. As Dr. Laskar stated in his Reply Declaration, Dr.
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`Laskar agreed that polysorbate 80 would cause oxidative degradation and thus a
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`POSA would have been motivated to replace polysorbate 80, but disagreed with Dr.
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`Davies that tyloxapol would cause oxidative degradation, because tyloxapol has
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`
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`antioxidant properties. EX1104, ¶ 5-8.
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` EX2272, 55:9-56:2. Dr. Laskar further stated that
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`6
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` EX2272, 56:6-19.
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`Observation #8: Patent Owner mischaracterizes Dr. Laskar’s testimony
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`relating to the general stability of the examples of Ogawa, and then misapplies it as
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`testimony relevant to whether a POSA would be motivated to replace polysorbate
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`
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`80. The two issues are separate. As to the first issue,
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` EX2114, 258:24-259:4; Petitioner’s Reply, Paper 51 at 18.
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`The fact that the formulations of Examples, 6, 7, and 8 were all generally stable does
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`
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`not change the fact that Example 6 was a good formulation.
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`As to the second issue, Dr. Laskar testified at other parts
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`The portion of Ogawa referenced by Dr. Laskar state
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`
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` EX1004, 10:53-57. Accordingly, Dr. Laskar
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`. EX2272, 60:13-19.
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`7
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` EX2114, 259:4-13.
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`Observation #9: Patent Owner’s purported observations suggest that
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`Yasueda is not relevant because it is directed to pranlukast, did not have the same
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`stability test duration, and the amount of tyloxapol was allegedly different. Patent
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`Owner’s purported observations, however, do not address the fact that the 5-
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`substituted tetrazole moiety is considered an acidic functionality. EX1003, n. 10;
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`
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`EX1046, 3168, Table 43; EX1047. It also does not address
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` EX2114, 157:7-18; EX1104, ¶ 6.
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`Observation #10: Patent Owner’s purported observations incorrectly suggest
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`that Doi’s disclosure is not relevant to tyloxapol, because tyloxapol is not
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`specifically disclosed in Doi and because the exemplary alkylphenols disclosed by
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`Doi are structurally different from tyloxapol.
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` Patent Owner’s purported
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`
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`observations, however, does not take into consideration Dr. Laskar’s statement
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` EX2272, 166:9-168:4. As Dr. Laskar
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`l,
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`testified,
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`8
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` EX2272, 168:5-17.
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`And as Dr. Laskar further testified,
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`. EX2272, 169:5-171:19. Indeed the ’431
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`patent also characterize tyloxapol as an “alkylaryl polyether alcohol type polymer.”
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`EX1001, 2:35-36. These statements by Dr. Laskar and various references are also
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`
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`consistent with Dr. Laskar’s statement that
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`EX1094, 1221:2:2-1222:1:1.
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`Observation #11: Patent Owner’s purported observation that the ’956
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`application (EX1105) and WO ’610 (EX1148) are irrelevant is based on omissions
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`of relevant testimony of Dr. Laskar. For example, Patent Owner omits Dr. Laskar’s
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`testimony to the contrary,
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`
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` EX2272, 127:13-17; EX1104, ¶¶ 25-26. Patent Owner also omits
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`Dr. Laskar’s testimony
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`
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` EX2272, 109:10-18.
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`Moreover, as discussed with respect to Observation #4, Patent Owner’s own
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`expert’s testimony contradicts Patent Owner’s position, who testified that inhalation
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`and nasal formulations have the same characteristics as ophthalmic formulations.
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`
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`9
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`
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`EX1079, 19:21-20:21. The ’431 patent and Ogawa involve nasal formulations.
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`EX1001, 4:10-13, 11:48-51; EX1004, 4:60-62, Example 10.
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`As to the amount of tyloxapol used in the ’956 patent and WO ’610, both prior
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`art do not limit the antioxidant properties of tyloxapol based on the concentration of
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`tyloxapol. EX1148, 6:25-28, 40:21-22; EX1105, ¶¶ [0032], [0248]. Furthermore,
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`the concentration of tyloxapol for treating snoring or sleep apnea is not relevant to
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`the antioxidant properties of tyloxapol. Instead, both prior art show that tyloxapol
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`has antioxidant properties, and cannot be an oxidant. EX1104, ¶¶ 23-24.
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`Observation #12: Patent Owner’s purported observations are improper,
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`because they (1) mischaracterize Dr. Laskar’s testimony and omit relevant parts of
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`Dr. Laskar’s testimony, (2) rely on hearsay statements made by Dr. Heathcock, who
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`is not a declarant in this case, and (3) are improper arguments that essentially are
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`sur-reply arguments. See also Petitioner’s Motion to Exclude, Paper 56 at 4-6.
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`Patent Owner cites to Dr. Laskar’s testimony to suggest Kennedy is not relevant
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`prior art. That is a mischaracterization Dr. Laskar’s testimony. Dr. Laskar testified
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`
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` thus making such references relevant and directly contradicting
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`Patent Owner’s purported observations. EX2272, 127:13-17. Dr. Laskar also
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`testified that
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`10
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` EX2272, 111:16-18 (emphasis
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`added). Dr. Laskar’s testimony again contradicts Patent Owner’s purported
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`observation that the antioxidant properties of tyloxapol does not apply to the present
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`situation. Dr. Laskar’s testified that
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`
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` See EX2272, 180:6-12; EX1104, ¶¶ 14-29.
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`To further mischaracterize Dr. Laskar’s testimony, Patent Owner points to the
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`hearsay statements by Dr. Heathcock from the district court litigation deposition,
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`which counsel for Patent Owner merely reads into the record. Patent Owner’s
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`purported observations are improper attempts to place hearsay testimony into the
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`record to further circumvent the Board’s denial of Patent Owner’s request for a sur-
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`reply. EX1154; see also Petitioner’s Motion to Exclude, Paper 56 at 4-6.
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`Observation #13: Patent Owner’s purported observations fail for the similar
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`reasons as in Observation #12. Patent Owner cites to Dr. Laskar’s testimony to
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`suggest Ghio is not relevant prior art, but again conveniently omit Dr. Laskar’s
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`
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`thus making such references
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`testimony where he stated
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`relevant and directly contradicting Patent Owner’s purported observations. EX2272,
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`127:13-17. Patent Owner also omits Dr. Laskar’s testimony where he indicates
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`
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`11
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`
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`180:6-12; EX1104, ¶¶ 14-29.
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`. See EX2272,
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`Observation #14: Patent Owner’s purported observation allegedly show Dr.
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`Laskar’s testimony conflicts with Dr. Laskar’s declaration regarding whether a
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`POSA would remove other components (e.g., sodium sulfite). That again is a
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`mischaracterization of Dr. Laskar’s testimony. Counsel for Patent Owner’s asked,
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`
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`
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`more specifically,
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` EX2272, 140:16-17.
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` EX1104, ¶ 33. Furthermore, Dr. Laskar’s
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`response to Patent Owner’s question w
`
`
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` is consistent with Dr. Laskar’s testimony that doing so
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`would be “a matter of routine experimentation.” EX1104, ¶ 33.
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`Observation #15: Patent Owner’s purported observation again incorrectly
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`suggests that there is no data to support the recognition in the prior art that tyloxapol
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`is an antioxidant, omitting Dr. Laskar’s testimony in this proceeding to the contrary.
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`Dr. Laskar specifically testified
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`
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`.
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`12
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`
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`EX2114, 157:13-22, 183:3-7; EX1104, ¶¶ 5-6, 30-31. Dr. Laskar’s testimony was
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`supported by experimental data indicating tyloxapol’s antioxidant properties.
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`Observation #16: Patent Owner’s purported observations does not fairly
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`characterize Dr. Laskar’s opinions. Dr. Laskar has explained that Fu provides
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`experimental data showing BAC complexes with acidic NSAIDs. EX1104, ¶¶ 35-
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`37. That is consistent with Petitioner’s position that a POSA would have known of
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`the complexation issue because several references report the issue with respect to
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`different acidic NSAIDs (which bromfenac is) and BAC, and several references
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`report the issue with respect to anions (which bromfenac is at the relevant pH) and
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`BAC. Petitioner Reply, Paper 51 at 1-2 Indeed, Dr. Williams testified that a POSA
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`would have taken such teachings in the prior art at “face value.” EX1067, 81:4.
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`Significantly, the ’431 patent expressly discusses this same issue. EX1001, 1:62-
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`2:3. Patent Owner’s own exhibit shows that bromfenac and BAC complex.
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`EX2098, 30 (“[B]romfenac sodium forms insoluble complexes due to the addition
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`of quaternary ammonium salt and becomes cloudy.”).
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`Observation #17:
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` Patent Owner’s observation mischaracterizes the
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`testimony of Mr. Hofmann. Patent Owner intimates that Mr. Hofmann’s testimony
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`contradicts the statements in his declaration, EX1150, ¶ 70. The statement in Mr.
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`Hofmann’s declaration reports the increased relative performance of Bromday over
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`Prolensa in the testing data from a Cataract Discussion Group, as opposed to each
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`
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`13
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`
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`formulation’s performance against respective vehicles. EX1150, ¶ 70; EX2226, p.
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`
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`19-20. Contrary to Patent Owner’s insinuation, Mr. Hofmann merely
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`, which does not contradict his
`
`
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`declaration or the evidence in EX2226 itself, that
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`. EX2273. 217:14–218:8; EX2226, pp. 19-20.
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`Observation #18: Patent Owner’s observation ignores the substance of the
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`testimony provided by Mr. Hofmann. Patent Owner’s proposed observation
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`ostensibly suggests that Mr. Hofmann made representations in his declaration that
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`Patent Owner’s marketing materials do not identify purported benefits of Prolensa.
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`The substance of Mr. Hofmann’s opinions was clarified during his cross-
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`
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`examination testimony in response to that suggestion:
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` EX2273, 122:2–14. Moreover, the opinions in Mr.
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`Hofmann’s declaration make clear that while Patent Owner’s declarant, Mr. Jarosz,
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`identified purported benefits deriving from the patents at issue in certain marketing
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`materials, he “fails to address that these same marketing materials and efforts focus
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`14
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`
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`on factors that I understand are not attributable to the patents at issue . . . [including]
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`the efficacy of the bromfenac molecule and once-daily dosing.” EX1150, ¶¶ 90-96.
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` Observation #19: Patent Owner’s proposed observation mischaracterizes
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`
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`
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`Mr. Hofmann’s testimony. Mr. Hofmann did not testify at 51:22-54:5
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`. Rather, Mr. Hofmann
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` EX2273, 52:15-53:3. Specifically, Mr. Hofmann’s earlier testimony
`
`
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`
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`32:9; 33:5-17; 35:22-36:21. Mr. Hofmann also testified that
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`. See, e.g., EX2273, 31:6-
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`. See, e.g., EX2273,
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`22:22-24:17; 34:8-16; 37:3-19; 44:3-45:7.
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`III. CONCLUSION
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`Patent Owner’s proposed observations should be disregarded and the Board
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`should enter a final determination of unpatentability of the challenged claims.
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`
`
`Date: April 6, 2016
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`
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`
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`RESPECTFULLY SUBMITTED,
`ALSTON & BIRD LLP
`
`
`
`/Jitendra Malik/
`Jitendra Malik, Ph.D. (Reg. No. 55823)
`
`
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`15
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`
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`CERTIFICATION OF SERVICE
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`Pursuant to 37 C.F.R. §§ 42.6(e), 42.8(b)(4) and 42.105, the undersigned
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`certifies that on the 6th day of April, 2016, a complete copy of the foregoing
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`Petitioner’s Response to Patent Owner’ Motion for Observation Regarding Cross-
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`Examination of Reply Witnesses Dr. Paul A. Laskar, Ph.D. and Ivan T. Hofmann,
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`CPA/CFF, CLP were served via email on counsel of record for the Patent Owner:
`
`
`
`Senju Pharmaceutical Co., Ltd., et al.
`
`Bryan C. Diner
`bryan.diner@finnegan.com
`
`Justin J. Hasford
`justin.hasford@finnegan.com
`
`Joshua L. Goldberg
`Joshua.goldberg@finnegan.com
`
`
`
`
`Respectfully submitted,
`
`Alston & Bird LLP
`
`By: /Jitendra Malik/
`
`Jitendra Malik, Ph.D.
`Reg. No. 55823
`Alston & Bird LLP
`4721 Emperor Blvd., Suite 400
`Durham, NC 27703-8580
`jitty.malik@alston.com
`
`Bryan Skelton, Ph.D.
`Reg. No. 50893
`Alston & Bird LLP
`4721 Emperor Blvd., Suite 400
`
`Date: April 6, 2016
`
`
`
`
`
`Durham, NC 27703-8580
`bryan.skelton@alston.com
`
`Lance Soderstrom
`Reg. No. 65405
`Alston & Bird LLP
`90 Park Avenue
`15th Floor
`New York, NY 10016-1387
`lance.soderstrom@alston.com
`
`Hidetada James Abe
`Reg. No. 61,182
`Alston & Bird LLP
`333 South Hope Street
`16th Floor
`Los Angeles, CA 90071
`james.abe@alston.com
`
`Joseph M. Janusz (Reg. No. 70396)
`ALSTON & BIRD LLP
`101 S. Tryon Street, Suite 4000
`Charlotte, NC 28205
`Telephone: 704-444-1000
`Fax: 704-444-1111
`joe.janusz@alston.com
`
`Attorneys for Petitioners InnoPharma
`Licensing, Inc., InnoPharma Licensing LLC,
`InnoPharma Inc., InnoPharma LLC, Mylan
`Pharmaceuticals Inc., and Mylan Inc.
`
`
`
`Deborah H. Yellin (Reg. No. 45,904)
`Crowell & Moring LLP
`Intellectual Property Group
`1001 Pennsylvania Avenue, N.W.
`Washington, DC 20004-2595
`Telephone No.: (202) 624-2947
`Facsimile No.: (202) 628-5116
`
`2
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`DYellin@Crowell.com
`
`Jonathan Lindsay (Reg. No. 45,810)
`Crowell & Moring LLP
`Intellectual Property Group
`3 Park Plaza, 20th Floor
`Irvine, CA 92614-8505
`Telephone No.: (949) 798-1325
`Facsimile No.: (949) 263-8414
`JLindsay@Crowell.com
`
`Shannon Lentz (Reg. No. 65,382)
`Crowell & Moring LLP
`Intellectual Property Group
`1001 Pennsylvania Ave, N.W.
`Washington, DC 20004-2595
`Telephone No.: (202)624-2897
`Facsimile No.: (202) 628-5116
`SLentz@Crowell.com
`
`Attorneys for Petitioners Lupin Ltd. and
`Lupin Pharmaceuticals, Inc.
`
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