UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________________________________
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________________________________
`
`
`
`COALITION FOR AFFORDABLE DRUGS VIII, LLC,
`Petitioner,
`
`v.
`
`THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA,
`Patent Owner.
`
`Case IPR2015-01836
`Patent 7,832,268 B2
`
`
`
`PATENT OWNER’S REPLY IN SUPPORT OF MOTION TO AMEND
`UNDER 37 C.F.R. § 42.121
`
`
`
`
`
`
`____________________________________________
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________________________________
`
`
`
`COALITION FOR AFFORDABLE DRUGS VIII, LLC,
`Petitioner,
`
`v.
`
`THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA,
`Patent Owner.
`
`Case IPR2015-01836
`Patent 7,832,268 B2
`
`
`
`PATENT OWNER’S REPLY IN SUPPORT OF MOTION TO AMEND
`UNDER 37 C.F.R. § 42.121
`
`
`
`
`
`
`
`U.S. Patent 7,832,268 B2
`
`TABLE OF CONTENTS
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`Case IPR2015-01836
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`Patent Owner’s Reply in Support of Motion to Amend
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`Page
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`2.
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`I. INTRODUCTION .............................................................................................. 1
`II. THE PROPOSED SUBSTITUTE CLAIMS ARE PATENTABLE ............. 3
`A.
`The Claims are Patentable Over Petitioner’s 6-Way
`Combination ......................................................................................... 3
`1.
`No Motivation to Use Lomitapide Over Other MTP
`Inhibitors ..................................................................................... 3
`No Motivation to Use the Claimed Titration Method to
`Address Side Effects ................................................................... 4
`No Reasonable Expectation of Success that an Increasing
`Dosing Regimen Would Address the Dose-Dependent
`Side Effects Associated with Lomitapide ................................... 7
`The Claims are Patentable Over the IPR Combination .................. 9
`B.
`C. Objective Indicia Support Patentability ......................................... 10
`D.
`There is No Meaningful Dispute Regarding Claim
`Construction ....................................................................................... 11
`The Claims are Entitled to a January 2004 Invention Date .......... 12
`E.
`III. CONCLUSION ................................................................................................. 12
`
`3.
`
`i
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`U.S. Patent 7,932,268 B2
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`I.
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`INTRODUCTION
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`Case IPR2015-01836
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`Patent Owner’s Reply in Support of Motion to Amend
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`The only disputed issue is whether the proposed substitute claims are
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`patentable. Petitioner has failed to demonstrate that they are not.1 Petitioner’s new
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`6-way combination of alleged obviousness references—devoid of any human
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`pharmacokinetic (“PK”) or pharmacodynamic (“PD”) data about lomitapide—fails
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`to teach or suggest every limitation of the substitute claims, let alone provide any
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`motivation to treat humans with lomitapide in the first place—a compound that
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`failed in the clinic due to toxicities and was abandoned by the company that
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`discovered it. Even assuming that a skilled person would be motivated to develop
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`a treatment regimen in humans with lomitapide—notwithstanding its known
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`toxicities—nothing in the prior art provided a motivation to use the claimed
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`titration regimen. Further, a skilled artisan would not have had a reasonable
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`expectation of success given the “dose-dependent” nature of the hepatic side
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`effects associated with lomitapide (i.e., worsened as the dose increased).
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`First, the prior art contains no information regarding the dose effect of
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`lomitapide in humans. No human PK data. No human PD data. No human data at
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`1 Congress has made clear that Petitioner “shall have” the burden on any
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`“proposition of unpatentability” in this proceeding—regardless of whether the
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`proposition pertains to an issued or a substitute claim. 35 U.S.C. § 316(e). In any
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`event, Patent Owner has demonstrated that the claims are patentable.
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`1
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`Case IPR2015-01836
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`Patent Owner’s Reply in Support of Motion to Amend
`all. Indeed, all a skilled artisan in 2004 would know about lomitapide’s effect in
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`humans was that it reduced cholesterol, but had been deemed too dangerous for
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`further investigation because of dose-dependent hepatic side effects. Petitioner
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`cites but fails to explain how a single two-week rabbit study disclosed in a paper
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`(“Wetterau”) that pre-dated the withdrawal of lomitapide from the clinic would
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`motivate a person of ordinary skill in the art (“POSA”) to resume clinical study of
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`lomitapide, foregoing other known MTP inhibitors that had not been withdrawn.
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`Wetterau itself could not provide the motivation—the reference makes no mention
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`of side effects with lomitapide, let alone how to dose lomitapide effectively in
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`humans without causing them. A POSA would know that the animal study in
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`Wetterau—written by scientists at BMS—would contain far less information about
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`the safety and efficacy of lomitapide in humans than the clinical trials that led to
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`BMS’s decision to discontinue the drug.
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`Second, nothing in the prior art suggested that the liver toxicities associated
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`with lomitapide—known to increase with larger doses and to accumulate over
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`time—could be mitigated by administering two-fold increasing doses of the drug
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`over three intervals as short as a week. Nothing in the generic titration references
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`upon which Petitioner relies, suggests that administering a drug with known
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`toxicity in rapidly escalating doses would be safe, let alone mitigate toxicity.
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`In short, Petitioner’s obviousness claim impermissibly relies upon selective
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`2
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`Patent Owner’s Reply in Support of Motion to Amend
`reading and the use of hindsight—as exemplified by the need to stitch together six
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`different references (half of which do not even refer to lomitapide).
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`II. THE PROPOSED SUBSTITUTE CLAIMS ARE PATENTABLE
`A. The Claims are Patentable Over Petitioner’s 6-Way Combination
`1. No Motivation to Use Lomitapide Over Other MTP Inhibitors
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`By 2004, it was well known in the art that Bristol-Myers Squibb (“BMS”)
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`discontinued further development of lomitapide after Phase II trials because of
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`hepatotoxicity issues. (Ex. 2011; Ex. 1015 at 6.) Wetterau, a pre-clinical rabbit
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`study that pre-dates BMS’s decision to withdraw lomitapide from the clinic, would
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`not have sufficiently motivated a POSA to revive study of the drug in humans.
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`Whatever motivations a POSA might have drawn from Wetterau would have been
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`dampened, if not completely extinguished, upon learning that BMS had pulled the
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`compound from the clinic because of toxicity concerns that had not been reported
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`in Wetterau (because they had yet to be observed). (Ex. 2305 at ¶¶ 12, 21-23, 38.)
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`In fact, the Wetterau authors were from BMS. (Ex. 1018 at 1.) Petitioner’s
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`suggestion that others of skill in the art would have nonetheless been motivated to
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`continue developing lomitapide based on Wetterau, when not even BMS (i.e., the
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`author of Wetterau) was motivated to do so, is classic hindsight.
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`To have been motivated to re-start investigation with lomitapide, a POSA
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`would have required human in vivo information concerning the drug, including PK
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`and PD data. (Ex. 2305 at ¶¶ 12, 21-23, 34, 38-39; Ex. 2024 at ¶¶ 80, 95, 113,
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`Patent Owner’s Reply in Support of Motion to Amend
`128.) As of 2004, however, there were no such data in the art. (Ex. 2024 at ¶
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`128.) The WHHL model disclosed in Wetterau was used primarily as a screen for
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`efficacy, (Ex. 2023 at ¶ 101; Ex. 2305 at ¶¶ 22-23; Ex. 2022 at 92:9-21), and
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`Wetterau provides no information regarding side effects observed with lomitapide.
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`(Ex. 2306 at 49:7-13.) Accordingly, Wetterau would not have rekindled a POSA’s
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`interest to renew clinical study with lomitapide.
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`2. No Motivation to Use the Claimed Titration Method to Address
`Side Effects
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`Even if a POSA were motivated to resurrect lomitapide, a POSA would not
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`be motivated to use a dose-doubling titration regimen given the compound’s
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`known dose-dependent hepatic side effects. (Ex. 2305 at ¶¶ 17, 22-26, 28-29, 39-
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`40.) Petitioner suggests (incorrectly) that no such motivation is necessary because
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`the words “forced titration” and the concept of reducing side effects are not recited
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`in the claims. (Opp. at 18-19.) Petitioner misapprehends the law.
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`The analysis of whether a POSA would have been motivated to combine
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`elements of different references does not depend on the recitations in the claims,
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`but looks to whether the references proposed to be combined were compatible with
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`each other and likely to succeed. See Broadcom Corp. v. Emulex Corp., 732 F.3d
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`1325, 1334-35 (Fed. Cir. 2013) (no obviousness where the references proposed to
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`be combined addressed “different problems” from that described in the patent).
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`Here, the specification and prior art make clear that one of the problems in the art
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`4
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`Patent Owner’s Reply in Support of Motion to Amend
`was ameliorating side effects associated with lomitapide while giving doses high
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`enough to be effective. (’268 patent, 7:10-24; Ex. 2024 at ¶¶ 94-95, 104; Ex. 2305
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`at ¶¶ 12, 17, 52-53; Ex. 1015 at 6 (“Clearly, the ability to demonstrate a readily
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`managed therapeutic index will be critical for the progression of inhibiting MTP as
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`a viable chronic lipid lowering therapy.”)). That was the problem in the art to be
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`solved. The mere fact that the claims do not require a reduction of liver toxicity
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`does not obviate the need to find a motivation for a POSA to use the principles of
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`the references proposed to be combined to devise a dosing regimen with
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`lomitapide that would achieve such a reduction. No such motivation existed.
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`First, nothing in the prior art would encourage a POSA to use the claimed
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`titration method with lomitapide. ICH-E4 is a general disclosure of various dosing
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`methods that could be used in identifying a “starting dose” when the dose-response
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`effect of a drug is unknown in humans. (Ex. 1043 at 3.) Far from motivating a
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`POSA to use a forced titration method to address dose-dependent toxicity, ICH-E4
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`discourages such a use. (Id. at 11 (warning that a forced titration design “gives
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`poor information on adverse effects” and that a “critical disadvantage” is that it
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`“cannot distinguish response to increased dose from . . . cumulative drug dosage
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`effect.”); Ex. 2305 at ¶¶ 24-26, 40.)
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`Petitioner cites to the statement in ICH-E4 that “many studies titrate the dose
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`upward for safety reasons” and that side effects of drugs “may disappear with
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`5
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`Patent Owner’s Reply in Support of Motion to Amend
`continued treatment.” (Opp. at 12-13.) Such a statement might suggest that
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`certain side effects could dissipate over time. But this does not teach or suggest
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`forcing a patient to escalate to a specified dose level in the face of known side
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`effects. (Ex. 2305 at ¶ 24-26, 40.) Indeed, the statement in ICH-E4 is non-specific
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`to increasing the dose and as Petitioner’s expert has explained, ordinarily a POSA
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`would simply “back off” the dose when side effects were observed. (Ex. 2022 at
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`155:6-156:11.) That is the opposite of what is required by the substitute claims.
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`Second, nothing in the prior art would motivate a POSA to apply a three-
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`step, dose-doubling method with intervals as short as one week. (Ex. 2305 at ¶¶
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`15-17, 22, 25, 28-31, 36, 38, 75). With respect to the number of dose levels,
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`Petitioner’s reliance on the reference in ICH-E4 to “three or more dosage levels” is
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`misplaced. (Opp. at 8, 13.) That statement relates to a “parallel, dose-response
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`study,” where patients in different dosing groups receive a fixed dose level (e.g., a
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`first group on 5 mg, a second group on 10 mg, and a third on 20 mg). (Ex. 2306 at
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`29:4-30:8.) That is different from the claimed titration method, which requires
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`increasing dose levels for the same patient.
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`With respect to dose-doubling, there is nothing in the art suggesting that
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`such a method would be appropriate for a drug like lomitapide that was known to
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`cause dose-dependent liver toxicities. (Ex. 2305 at ¶¶ 15-17, 24-26, 28-29, 40.)
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`Petitioner plucks out 2X escalation from a multitude of choices noted in Reigner,
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`6
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`but that reference expressly notes that “the severity and reversibility of toxicities”
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`should be considered when considering the dose. (Ex. 1044 at 9.) Given what was
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`known about lomitapide’s side effect profile (dose-dependent, accumulating), a
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`POSA would not have reason to pursue a 2-fold increasing dosing strategy. (Ex.
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`2305 at ¶¶ 26, 28-29, 40, 62; Ex. 2022 at 155:6-156:11; Ex. 2306 at 44:9-15.)
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`Finally, with respect to the intervals between doses, nothing in the prior art
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`suggested that intervals as short as one week would be appropriate for a drug with
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`the side-effect profile of lomitapide. Id. Indeed, ICH-E4 cautions that titration
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`should occur “gradually” to ensure patient safety. (Ex. 1043 at 9.)
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`3. No Reasonable Expectation of Success that an Increasing
`Dosing Regimen Would Address the Dose-Dependent Side
`Effects Associated with Lomitapide
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`Petitioner also provides no “plausible rational [sic] as to why the prior art
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`references would have worked together” to address lomitapide’s dose-dependent
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`side effects. Broadcom, 732 F.3d at 1335. No such rationale existed.
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`First, a POSA could not reasonably predict an appropriate human dosing
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`regimen with lomitapide—let alone the specific dose amounts required by the
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`proposed substitute claims—based on the single, two-week study in rabbits
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`disclosed in Wetterau. (Ex. 2305 at ¶¶ 22-23, 32, 36, 38-40, 47, 62; Ex. 2022 at
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`92:9-93:9 (conceding the limited predictive power of the model used in Wetterau);
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`Ex. 2021 at 112:9-113:14 (same).) Wetterau reports only a single dose in the
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`7
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`Patent Owner’s Reply in Support of Motion to Amend
`WHHL rabbit and provides scant details regarding either PK or toxicity. (Ex. 1018
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`at 2-3). Because designing a human dosing regimen would require the POSA to
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`consider both PK and PD factors, there is nothing in Wetterau to suggest that
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`rabbits would be the “most appropriate species” from which to derive a human
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`dose. (Ex. 1042 at 6-7, 11-12; Ex. 2305 at ¶ 32). A POSA would thus have had no
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`reasonable basis from which to expect that Wetterau’s 10 mg/kg rabbit dose could
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`be successfully and safely transferred to humans, let alone in a multiple-step
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`escalating dose protocol like that required by the claims. (Ex. 2305 at ¶¶ 22-23,
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`32, 36, 38-40, 47, 62). Petitioner’s attempt to extrapolate a human dose from the
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`Wetterau rabbits is classic hindsight. The FDA Guidance relied upon by
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`Petitioner—a “draft” document “not for implementation”—makes clear that it is
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`limited to determining “the maximum recommended starting dose” for “first in
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`human” studies (Ex. 1042 at 1, 3; Ex. 2305 at ¶¶ 31-32)—a completely “different
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`problem” than that confronted by those in the art. Broadcom, 732 F.3d at 1334.
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`Second, a POSA could not reasonably predict that using a dose-doubling
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`titration method with a drug known to cause dose-dependent side effects would be
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`safe and efficacious. Quite the contrary—it is counter-intuitive and unexpected.
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`(Ex. 2305 at ¶¶ 17, 24-26, 28-29, 39-40, 62; Ex. 2023 at ¶¶ 127, 154, 175; Ex.
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`2022 at 55:4-12 (an “inherent” property of dose-dependent side effects is that they
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`worsen when more of the drug is given).)
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`8
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`Patent Owner’s Reply in Support of Motion to Amend
`The Claims are Patentable Over the IPR Combination
`
`B.
`The substitute claims are patentable over Stein, Pink Sheet, and Chang.
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`First, pointing solely to Stein, Petitioner suggests that a POSA would have been
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`interested in developing “MTP inhibitors,” generally. (Opp. at 24.) But the claims
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`here are directed to lomitapide—not MTP inhibitors generally. Petitioner makes
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`no effort to explain how Stein, Pink Sheet, or Chang would provide a motivation to
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`revive clinical development with lomitapide, when there were other MTP
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`inhibitors being developed (including the implitapide drug referenced in Stein).
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`Second, Petitioner argues that the claimed method’s unexpected result of
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`reducing the hepatic fat observed in the prior art with lomitapide, (PO Br. at 22), is
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`irrelevant because it is not required by the claims. (Opp. at 18-20, 24.) Petitioner
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`misapprehends the law. While unexpected results must have a nexus to claimed
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`features, the results themselves need not be recited in the claims. See In re
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`Merchant, 575 F.2d 865, 869 (C.C.P.A. 1978) (“We are aware of no law requiring
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`that unexpected results relied upon for patentability be recited in the claims.”).
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`Third, Petitioner argues that Pink Sheet/Stein suggest the dose-doubling and
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`intervals required by the substitute claims. (Opp. at 25.) That is incorrect. Stein
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`involves seven dose escalations from 10 to 45 mg/day in 5 mg increments over 39
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`weeks. (Ex. 1014 at 38; Ex. 2305 at ¶¶ 15-16.) By comparison, it would take just
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`three weeks and three escalations to reach the same target dose under the
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`9
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`Patent Owner’s Reply in Support of Motion to Amend
`substitute claims. (PO Br. at 4.) The largest dose increase in Stein (50%) is four
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`times smaller than that required by the proposed substitute claims (200%). (Ex.
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`2305 at ¶ 15.) Given the toxicities associated with lomitapide, a POSA would not
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`be motivated to consider such an aggressive approach. (Id. at ¶ 17, 24, 27-28, 40.)
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`C. Objective Indicia Support Patentability
`Unexpected Results and Praise. The invention unexpectedly results in less
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`hepatic fat as compared to a fixed-dose method. (PO Br. at 22; Ex. 2083 at ¶¶ 15,
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`16; Ex. 2305 at ¶¶ 65-69.) Petitioner speculates that the improvement is due to Dr.
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`Rader’s use of a low-fat diet in his trial, but BMS also used a low-fat diet in the
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`trial that led to discontinuation of lomitapide. (Ex. 2078 at 2-4; Ex. 2080 at 2-3;
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`Ex. 2305 at ¶¶ 65-68.) Petitioner’s argument that alleviation of side effects is not
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`recited in the claim is irrelevant. See supra at 9.
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`Long-Felt Need. The claimed invention satisfied an unmet need for an
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`adequate treatment for HoFH, as existing treatments, including statins, were
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`ineffective in treating the condition. (PO Br. at 23; Ex. 2022 at 36:10-22, 37:13-
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`38:13; 39:16-21; Ex. 2023 at ¶¶ 79, 144.) Contrary to Petitioner’s assertion, there
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`is no requirement that the invention satisfy a need for all hypercholesterolemia.
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`See In re Glatt Air Techniques, Inc., 630 F.3d 1026, 1030 (Fed. Cir. 2011)
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`(rejecting argument that applicant “needed to submit commercial success evidence
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`from multiple embodiments for that evidence to be commensurate in scope”).
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`10
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`Patent Owner’s Reply in Support of Motion to Amend
`Failure of Others. Petitioner’s suggestion that BMS only observed toxicity
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`at doses as high as 60-70 mg/day is incorrect; the hepatotoxicity that led to
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`lomitapide’s withdrawal by BMS occurred at 25 mg/day (Ex. 1008 at [00022]; Ex.
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`2057 at 2, 4; Ex. 2083 at ¶¶ 13-17; Ex. 2305 at ¶ 71), which is squarely within the
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`substitute claims. (PO Br. at 4.) Further, Petitioner’s selective citation to the May
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`2006 Amended Technology Donation Agreement, which Petitioner’s expert admits
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`is “not prior art” (Ex. 2306 at 53:6), is misleading. The document makes clear that
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`BMS’s withdrawal was due to “significant and serious hepatotoxicities at the
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`dosages used.” (Ex. 2001 at 30; see also Ex. 2083 at ¶ 17; Ex. 2305 at ¶ 73.) The
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`subsequent reference in the document to “commercial” feasibility is not
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`inconsistent, i.e., it is not “commercially feasible” to pursue a drug that is known to
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`have “significant and serious hepatotoxicities.” (Ex. 2305 at ¶ 74.)
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`Licensing/Commercial Success. Petitioner does not dispute the fact of
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`licensing or Juxtapid’s commercial success. Instead Petitioner argues lack of
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`nexus based on the misplaced legal argument (refuted above) that the alleviation of
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`side effects is not an express limitation of the claim.
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`D. There is No Meaningful Dispute Regarding Claim Construction
`The substitute claims are readily and easily understood by a POSA. In an
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`effort to avoid a decision on the merits, Petitioner argues that Patent Owner’s
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`motion is “facially deficient” because the words “about” and “the”—which also
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`appear in the original claims—apparently require construction in the context of the
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`substitute claims. (Opp. at 1-2.) They do not. (Paper No. 7 at 7 (finding that
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`“none of the terms in the challenged claims” require claim construction).)
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`E.
`The Claims are Entitled to a January 2004 Invention Date
`Dr. Rader’s upward titration theory was conceived by December 2002 (i.e.,
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`the date of the clinical trial protocol) and reduced to practice no later than January
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`18, 2004 (i.e., when the last patient was dosed in accordance with a 3-fold increase
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`titration). “The adequacy of a reduction to practice is to be tested by what one of
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`ordinary skill in the art would conclude from the results of the tests.” Slip Track
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`Sys., Inc. v. Metal-Lite, Inc., 304 F.3d 1256, 1265 (Fed. Cir. 2002). As Dr. Rader
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`and Petitioner’s experts agree, “[i]f tolerance for lomitapide is achieved using a
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`forced-titration dosing regimen having 3-fold dose increases . . . tolerance is
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`expected for a forced-titration dosing regimen having 2-fold dose increases.” (Ex.
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`2026 at ¶ 48; see also Ex. 2306 at 6:19-7:3.) Petitioner’s argument that Dr. Rader
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`did not reduce to practice the substitute claims is based entirely on the assumption
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`that reduction to practice requires actual performance. (Ex. 2306 at 44:20-45:23.)
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`That is incorrect. Slip Track, 304 F.3d at 1267 (“Testing is not itself a requisite for
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`reduction to practice . . . .”)
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`III. CONCLUSION
`If all issued claims are deemed unpatentable, the motion should be granted.
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`Patent Owner’s Reply in Support of Motion to Amend
`Respectfully Submitted,
`GOODWIN PROCTER LLP
`
`/William G. James /
`William G. James
`(Reg. No. 55,931)
`GOODWIN PROCTER LLP
`901 New York Avenue NW
`Washington, DC 20001
`Tel: 202-346-4046
`Fax: 2022-346-4444
`wjames@goodwinprocter.com
`
`Nicholas K. Mitrokostas
`(admitted pro hac vice)
`GOODWIN PROCTER LLP
`Exchange Place
`53 State Street
`Boston, MA 02109-2881
`Tel: 617-570-1913
`Fax: 617-523-1231
`nmitrokostas@goodwinprocter.com
`
`Cynthia Lambert Hardman
`(Reg. No. 53,179)
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018-1405
`Tel: 212-459-7295
`Fax: 212-355-3333
`chardman@goodwinprocter.com
`
`
`Attorneys for Patent Owner
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`U.S. Patent 7,932,268 B2
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`Dated: October 7, 2016
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing PATENT
`OWNER’S REPLY IN SUPPORT OF MOTION TO AMEND UNDER 37
`C.F.R. § 42.121 WITH SUPPLEMENTAL EXHIBITS:
`
`2305 – SUPPLEMENTAL DECLARATION OF THOMAS A.
`BAILLIE, PH.D., D.SC
`
`2306 – TRANSCRIPT FROM THE NOVEMBER 4, 2016
`DEPOSITION OF RANDALL M. ZUSMAN, M.D.
`
`2307 – SUPPLEMENTAL MATERIALS CONSIDERED LIST FOR
`THOMAS A. BAILLIE, PH.D., D.SC.
`
`was served electronically via e-mail on October 7, 2016 on the following:
`Dr. Gregory Gonsalves
`2216 Beacon Lane
`Falls Church, Virginia 22043
`(571) 419-7252
`gonsalves@gonsalveslawfirm.com
`
`Christopher Casieri
`McNeely, Hare & War LLP
`12 Roszel Road, Suite C104
`Princeton, NJ 08540
`(609) 731-3668
`chris@miplaw.com
`
`Counsel for Petitioner Coalition
`for Affordable Drugs VIII, LLC
`
`
`
`
`
`Respectfully submitted,
`
`
`
`Dated: October 7, 2016
`
`
`
`
`
`/Russell W. Warnick /
`Russell W. Warnick
`GOODWIN PROCTER LLP
`
`
`
`
`
`
`
`i
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