Trials@uspto.gov
`571.272.7822
`
`
`
`
`
`
`
`Paper No. 56
`
`Filed: March 6, 2017
`
`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 IPR2015-01835
`Patent 8,618,135 B2
`____________
`
`Before GRACE KARAFFA OBERMANN and MICHAEL P. TIERNEY,
`Vice Chief Administrative Patent Judges, LORA M.GREEN, Administrative
`Patent Judge.
`
`
`GREEN, Administrative Patent Judge.
`
`
`
`
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
`
`
`

`

`IPR2015-01835
`Patent 8,618,135 B2
`
`
`INTRODUCTION
`I.
`Coalition for Affordable Drugs VIII, LLC (“Petitioner”) filed a
`Petition requesting an inter partes review of claims 1–10 of U.S. Patent
`No. 8,618,135 B2 (Ex. 1001, “the ’135 patent”). Paper 1 (“Pet.”). The
`Trustees of the University of Pennsylvania (“Patent Owner”) filed a
`Preliminary Response to the Petition. Paper 6 (“Prelim. Resp.”). We
`determined that the information presented in the Petition and the Preliminary
`Response demonstrated that there was a reasonable likelihood that Petitioner
`would prevail in challenging claims 1–10 as unpatentable under 35 U.S.C.
`§ 103(a). Pursuant to 35 U.S.C. § 314, the Board instituted trial on March 7,
`2016, as to the challenged claims of the ’135 patent. Paper 7 (“Institution
`Decision” or “Dec. Inst.”).
`Patent Owner filed a Response (Paper 16, “PO Resp.”), as well as a
`Corrected Motion to Amend (Paper 24, “Mot. Amend”). Petitioner
`subsequently filed a redacted copy of its Reply (Paper 30), as well as an
`unredacted copy of the Reply as Board and parties only (Paper 29).
`(“Reply”). Petitioner filed also an Opposition to the Motion to Amend.
`Paper 31 (“Opp. Mot. Amend”). Patent Owner filed a Reply in Support of
`its Motion to Amend. Paper 35 (“Reply Mot. Amend”).
`In addition, Patent Owner filed a Motion to Exclude (Paper 38, “Mot.
`Exclude”), to which Petitioner filed an Opposition (Paper 44, “Opp. Mot.
`Exclude”), and Patent Owner filed a Reply (Paper 46, “Reply Mot.
`Exclude”). Patent Owner filed Observations on the Cross-Examination of
`Petitioner’s Reply Witness (Paper 39), to which Petitioner filed a Response
`(Paper 45). Petitioner filed Observations on the Cross-Examination of Dr.
`Thomas A. Baille (Paper 41), to which Patent Owner filed a Response
`
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`

`IPR2015-01835
`Patent 8,618,135 B2
`
`(Paper 43). Oral hearing was held on December 1, 2016, and a transcript of
`that hearing has been entered into the record. Paper 54 (“Tr.”).
`We have jurisdiction under 35 U.S.C. § 6. Petitioner bears the burden
`of proving unpatentability of the challenged claims, and that burden never
`shifts to Patent Owner. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc.,
`800 F.3d 1375, 1378 (Fed. Cir. 2015). To prevail, Petitioner must establish
`facts supporting its challenge by a preponderance of the evidence. See
`35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d). This Final Written Decision is
`issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73.
`Based on the record before us, we conclude that Petitioner has failed
`to demonstrate by a preponderance of the evidence that claims 1–10 of the
`’135 patent are unpatentable. Moreover, we dismiss Patent Owner’s Motion
`to Amend as moot, and dismiss Patent Owner’s Motion to Exclude in part
`and deny Patent Owner’s Motion to Exclude in part.
`Related Proceedings
`A.
`Petitioner concurrently filed a Petition for Inter Partes Review of U.S.
`Patent No. 7,932,268 (IPR2015-01836), which is a member of the same
`family as the ’135 patent. Pet. 3. The final written decision in IPR2015-
`01836 is being issued concurrently with this Decision.
`The ’135 Patent (Ex. 1001)
`B.
`The ’135 patent issued on December 31, 2013, with Daniel J. Rader as
`
`the listed inventor. Ex. 1001. It claims priority to application No.
`10/591,923, filed as application No. PCT/US2005/007435 on March 7,
`2005, which issued as Patent No. 7,932,268, as well as to Provisional
`application No. 60/550,915, filed on March 5, 2004. Id. The ’135 patent
`
`3
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`IPR2015-01835
`Patent 8,618,135 B2
`
`relates to “methods of treating a subject suffering from a disorder associated
`with hyperlipidemia and/or hypercholesterolemia.” Id. at 6:38–40.
`
`The ’135 patent teaches that “[a] large number of genetic and acquired
`diseases can result in hyperlipidemia.” Id. at 1:61–62. Primary
`hyperlipidemias include “common hypercholesterolemia, familial combined
`hyperlipidemia, familial hypercholesterolemia, remnant hyperlipidemia,
`chylomicronemia syndrome and familial hypertriglyceridemia.” Id. at 1:66–
`2:3. For example, with homozygous familial hypercholesterolemia
`(“HoFH”), total plasma cholesterol levels are over 500 mg/dl, and left
`untreated, patients develop atherosclerosis by age 20 and often do not
`survive past age 30. Id. at 3:46–53. Such patients, however, are often
`unresponsive to conventional drug therapy. Id. at 3:56–58. According to the
`’135 patent, “[a] number of treatments are currently available for lowering
`serum cholesterol and triglycerides.” Id. at 2:4‒5. The ’135 patent notes,
`however, that “each has its own drawbacks and limitations in terms of
`efficacy, side-effects and qualifying patient population.” Id. at 2:5–7. For
`example, statins may have side effects that include liver and kidney
`dysfunction. Id. at 2:31–40.
`
`The ’135 patent teaches that abetalipoproteinemia is a rare genetic
`disease that is characterized by extremely low cholesterol and triglyceride
`levels and is caused by mutations in microsomal triglyceride transport
`protein (“MTP”). Id. at 5:1–7. Thus, the ’135 patent teaches that the
`“finding that MTP is the genetic cause of [abetalipoproteinemia] . . . led to
`the concept that pharmacologic inhibition of MTP might be a successful
`strategy for reducing atherogenic lipoproteins levels in humans.” Id. at
`5:30–35. Bristol-Myers Squibb [“BMS”] developed a series of compounds,
`
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`

`IPR2015-01835
`Patent 8,618,135 B2
`
`including BMS-201038 (i.e., lomitapide), which are potent inhibitors of
`MTP. Id. at 5:47–49.
`
`According to the ’135 patent, however:
`Clinical development of BMS-201038 as a drug for large
`scale use in the treatment of hypercholesterolemia has been
`discontinued, because of significant and serious hepatotoxicities.
`For example, gastrointestinal side effects, elevation of serum
`transaminases and hepatic fat accumulation were observed,
`primarily at 25 mg/day or higher doses.
`Id. at 6:20–25. The ’135 patent notes that “[c]ombinations using MTP
`inhibitors and other cholesterol or triglyceride drugs have been previously
`disclosed . . . but suffer the same drawbacks as described above for MTP
`inhibitors.” Id. at 8:30‒34.
`
`Thus, according to the ’135 patent, the “invention is based on the
`surprising discovery that one may treat an individual who has
`hyperlipidemia and/or hypercholesterolemia with an MTP inhibitor in a
`manner that results in the individual not experiencing side-effects normally
`associated with the inhibitor, or experiencing side-effects to a lesser degree.”
`Id. at 7:11–16.
`
`The ’135 patent specifically teaches:
`In some embodiments, the MTP inhibitor is administered
`at escalating doses. In some embodiments, the escalating doses
`comprise at least a first dose level and a second dose level. In
`some embodiments, the escalating doses comprise at least a first
`dose level, a second dose level, and a third dose level. In some
`embodiments, the escalating doses further comprise a fourth dose
`level. In some embodiments, the escalating doses comprise a
`first dose level, a second dose level, a third dose level, a fourth
`dose level and a fifth dose level. In some embodiments, six,
`seven, eight, nine and ten dose levels are contemplated.
`Id. at 11:60–12:3.
`
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`

`IPR2015-01835
`Patent 8,618,135 B2
`
`The ’135 patent teaches further:
`In some embodiments, the first dose level is from about 2
`to about 13 mg/day. In some embodiments, the second dose level
`is from about 5 to about 30 mg/day. In some embodiments, the
`third dose level is from about 10 to about 50 mg/day. In some
`embodiments, the fourth dose level is from about 20 to about 60
`mg/day. In some embodiments, the fifth dose level is from about
`30 to about 75 mg/day.
`Id. at 12:45–51. In addition, other lipid modifying compounds may be used
`with the MTP inhibitor. Id. at 11:34–41.
`
`The ’135 patent teaches that in phase II studies with BMS-201038 in
`patients that suffer from primary hypercholesterolemia, “a dosage of 25 mg
`per day for 4 weeks produced clinically significant gastrointestinal (GI)
`steatorrhea, abdominal cramping and distention) and statistically significant
`hepatobiliary (elevated liver function tests and minor fatty liver) symptoms
`in some patients receiving study drug.” Id. at 18:52‒56 (Example 8). The
`’135 patent teaches that those GI-related symptoms, as well as the hepatic
`fat, appear to be due to the design of the study, specifically, the dosing
`regimen. Id. at 18:57‒59. Six patients with HoFH were given daily doses of
`BMS-201038 at 4 dosage levels (0.03, 0.1, 0.3, and 1.0 mg/kg) for four
`weeks at each dose. Id. at 19:5‒7. According to the ’135 patent, the data
`provided by the study “indicate that symptoms of steatorrhea and hepatic fat
`can be significantly reduced by initiating a low dose with a gradual up
`titration.” Id. at 19:28‒31.
`Illustrative Claim
`C.
`Petitioner challenges claims 1–10 of the ’135 patent. Claims 1, 9, and
`10 are independent. Claim 1 is illustrative of the challenged claims and is
`reproduced below:
`
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`IPR2015-01835
`Patent 8,618,135 B2
`
`
`1. A method of treating a subject suffering from
`hyperlipidemia or hypercholesterolemia, the method
`comprising administering to the subject an effective
`amount of an MTP
`inhibitor, wherein
`said
`administration comprises at least three, step-wise,
`increasing dose levels of the MTP inhibitor wherein a
`first dose level is from about 2 to about 13 mg/day, a
`second dose level is from about 5 to about 30 mg/day,
`and a third dose level is from about 10 to about 50
`mg/day, and wherein the MTP inhibitor is represented
`by:
`
`
`
`
`
`
`
`or a pharmaceutically acceptable salt thereof or the
`piperidine N-oxide thereof, and wherein each dose
`level is administered to the subject for about 1 to
`about 5 weeks.
`
`Independent claim 9 specifies that the first dose is administered for
`
`about 2 weeks, and the second and third doses are administered for about 2
`to 4 weeks. Independent claim 10 specifies that the first dose is
`administered for about 1 to 12 weeks, and the second and third doses are
`administered for about 4 weeks.
`
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`IPR2015-01835
`Patent 8,618,135 B2
`
`
`Instituted Challenges
`D.
`We instituted trial based on the following grounds of unpatentability
`(Dec. Inst. 34):
`References
`Pink Sheet1 and Chang2
`
`Basis
`§ 103(a)
`
`Claims Challenged
`1–10
`
`Stein3 and Chang
`
`§ 103(a)
`
`1–10
`
`
`Petitioner relies also on the Declaration of Randall M. Zusman, M.D.
`
`(Ex. 1002), the Supplemental Declaration of Dr. Zusman (Ex. 1049), as well
`as the Declaration of Michael Mayersohn, Ph.D. (Ex. 1003).
`Patent Owner relies on the Declarations of Frank Sacks, M.D.
`(Ex. 2023), Thomas A. Baillie, Ph.D., D.Sc. (Ex. 2024), S. David Kimball
`Ph.D. (Ex. 2025), Richard E. Gregg, M.D. (Ex. 2083), as well as the
`Declaration of Daniel J. Rader, M.D. (Ex. 2026), the inventor of the ’135
`patent.
`
`
`1 Bayer/PPD Implitapide Development Follows Zetia Model as Statin Add-
`On, 66 THE PINK SHEET 17 (February 16, 2004) (Ex. 1013) (“Pink Sheet”).
`2 George Chang, Roger B’Ruggeri & H James Harwood Jr., Microsomal
`Triglyceride Transfer Protein (MTP) Inhibitors: Discovery of Clinically
`Active Inhibitors Using High-Throughput Screening and Parallel Synthesis
`Paradigms, 5 CURRENT OP. DRUG DISCOVERY & DEV. 562–570 (2002)
`(Ex. 1015) (“Chang”).
`3 Evan Stein, CEO & President, MRL Int’l (Division of PPD), Presentation
`Given at PPD’s Analyst Day, Microsomal Triglygeride [sic] Transfer
`Protein (MTP) Inhibitor (Implitapide) Program (Feb. 5, 2004) (Ex. 1014)
`(“Stein”).
`
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`IPR2015-01835
`Patent 8,618,135 B2
`
`
`II. ANALYSIS
`Claim Construction
`A.
`In an inter partes review, claim terms in an unexpired patent are
`interpreted according to their broadest reasonable construction in light of the
`specification of the patent in which they appear. See 37 C.F.R. § 42.100(b);
`Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–45 (2016)
`(upholding the use of the broadest reasonable interpretation standard).4
`Under that standard, we presume that a claim term carries its “ordinary and
`customary meaning,” which “is the meaning that the term would have to a
`person of ordinary skill in the art in question” at the time of the invention.
`In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007), see also
`Trivascular, Inc. v. Samuels, 812 F.3d 1056, 1062 (Fed. Cir. 2016) (“Under
`a broadest reasonable interpretation, words of the claim must be given their
`plain meaning, unless such meaning is inconsistent with the specification
`and prosecution history.”). Any special definition for a claim term must be
`set forth in the specification with reasonable clarity, deliberateness, and
`precision. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994).
`“[T]he specification ‘is always highly relevant to the claim
`construction analysis. Usually it is dispositive; it is the single best guide to
`the meaning of a disputed term.’” In re Abbott Diabetes Care Inc., 696 F.3d
`1142, 1149 (Fed. Cir. 2012) (quoting Phillips v. AWH Corp., 415 F.3d 1303,
`1315 (Fed. Cir. 2005) (en banc)). The Court of Appeals for the Federal
`Circuit has cautioned, however, “[t]here is a fine line between construing the
`
`
`4 We note that Patent Owner argues that the “broadest reasonable
`interpretation” standard is “legally impermissible.” PO Resp. 7. We note
`that Patent Owner filed its Response before Cuozzo was decided by the
`United States Supreme Court.
`
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`IPR2015-01835
`Patent 8,618,135 B2
`
`claims in light of the specification and improperly importing a limitation
`from the specification into the claims.” Retractable Techs., Inc. v. Becton,
`Dickinson, and Co., 653 F.3d 1296, 1305 (Fed. Cir. 2011). Thus, “[e]ven
`when the specification describes only a single embodiment, the claims of the
`patent will not be read restrictively unless the patentee has demonstrated a
`clear intention to limit the claim scope using ‘words or expressions of
`manifest exclusion or restriction.’” Hill-Rom Services, Inc. v. Stryker Corp.,
`755 F.3d 1367, 1372 (Fed. Cir. 2014) (quoting Liebel–Flarsheim Co. v.
`Medrad, Inc., 358 F.3d 898, 906 (Fed.Cir.2004)).
`In the Institution Decision, we determined that none of the terms in
`the challenged claims required express construction at that time. Dec. Inst. 7
`(citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed.
`Cir. 1999) (noting that only claim terms which are in controversy need to be
`construed, and then only to the extent necessary to resolve the controversy)).
`In its Response, Patent Owner states that it “does not contest any of
`the specific constructions” proffered by Petitioner. PO Resp. 7. Patent
`Owner contends, however, that the ordinary artisan
`would have understood that the “method of treating a subject
`suffering from hyperlipidemia or hypercholesterolemia, the
`method comprising administering to the subject an effective
`amount of an MTP inhibitor, wherein said administration
`comprises at least three, step-wise, increasing dose levels of the
`MTP inhibitor” means that the claimed method of treating a
`human patient requires a forced dose titration regimen including,
`but not limited to, at least three, step-wise, increasing dose levels
`of lomitapide.
`Id. at 8 (citing Ex. 2023 ¶ 44). But see Tr. 30 (Counsel for Patent Owner
`stating “we’re not asking you to read in the terms forced titration. We’re not
`saying the claim requires forced titration.”).
`
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`IPR2015-01835
`Patent 8,618,135 B2
`
`Petitioner replies that that there is nothing in the claims that limits
`
`them to a forced titration method. Reply 4. We agree. All that is required
`by independent claim 1 are at least three, step-wise doses of the claimed
`MTP inhibitor at specified dosage ranges. Thus, we decline to limit the
`challenged claims to a forced dose titration method.
`Level of Ordinary Skill in the Art
`B.
`Petitioner contends:
`A person of ordinary skill in the art as relevant to this
`proceeding would have had a high level of education (graduate
`and/or post-graduate degrees) in a pertinent discipline such as
`medicine,
`medicinal
`chemistry,
`pharmacology,
`pharmacokinetics, or drug development and delivery. Such a
`person with a medical degree (M.D.) would also have 3-5 years
`of experience treating patients in the cardiovascular/cardiac
`field, which would itself provide knowledge of dose-titration;
`dose-selection as balanced against side effects in individual
`patients; and developments in the clinical field. (Zusman, ¶¶ 28-
`29, 32; Mayersohn, ¶ 26). A non-M.D. would have a similarly
`advanced education, and
`the experiences and skill sets
`appropriate to their specialty. (See Zusman, ¶¶ 30-32;
`Mayersohn, ¶ 26).
`Pet. 28‒29.
`Patent Owner responds that that the ordinary artisan “would have had
`an M.D. and several years of experience in treating patients with lipid
`disorders, including hyperlipidemia and hypercholesterolemia.” PO Resp. 9
`(quoting Ex. 2023 ¶ 40). Although acknowledging that the ordinary artisan
`“would also have had access to and worked with individuals involved in
`drug discovery and development with degrees in medicinal chemistry,
`pharmacology, or drug delivery sciences and several years of experience in
`the development of drugs for the U.S. market,” Patent Owner argues that
`Petitioner’s proposed definition adds additional qualifications “that are
`
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`IPR2015-01835
`Patent 8,618,135 B2
`
`unnecessary and erroneous,” such as, that the ordinary artisan would consult
`the Pink Sheet. Id. at 9‒10 (citing Ex. 1002 ¶ 28).
`
`Petitioner replies that, as acknowledged by Patent Owner’s expert, Dr.
`Kimball, the ordinary artisan “is a person who has the knowledge of an
`entire drug development team.” Reply 3 (quoting Ex. 1056, 19:2‒20:3).
`Such an artisan, Petitioner asserts, would attend investor presentations and
`read the Pink Sheet. Id. (citing Ex. 1002 ¶ 28).
`
`We agree with Petitioner that the ordinary artisan would not be
`limited to an M.D., but as acknowledged by Patent Owner, would have
`access to a drug discovery team. Such a team would be aware of the art and
`the work of other teams, such as that reported by Pink Sheet. Moreover, the
`level of ordinary skill in the art is reflected by the prior art of record. See
`Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC
`Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91
`(CCPA 1978).
`
`C. Obviousness over Stein and Chang
`Petitioner contends that claims 1–10 are rendered obvious by the
`combination of Stein and Chang. Pet. 46–56. Patent Owner disagrees with
`Petitioner’s contentions. PO Resp. 45–56.
`i.
`Overview of Stein (Ex. 1014)
`Stein is a slide set prepared by Evan Stein, M.D., Ph.D., for PPD, Inc..
`
`Ex. 1014, 4.5 According to Stein, the lipid lowering market is one of the
`largest therapeutic segments, of which statins are the largest component. Id.
`
`
`5 The page numbers for Stein refer to the page numbers added by Petitioner.
`We note, however, that unless otherwise noted, our reference to page
`numbers of an exhibit are to the numbering as set forth in the exhibit itself,
`and not to the page numbering added by a party.
`
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`IPR2015-01835
`Patent 8,618,135 B2
`
`at 7. Thus, according to Stein, “[n]ew therapeutic agents will be additive or
`complementary” to statins, or other existing agents. Id.
`
`Stein teaches further that there are a growing number of “statin
`adverse” patients and that 10 to 15% of high risk patients do not meet
`current goals for LDL cholesterol levels, even at maximum statin doses. Id.
`at 10. Moreover, the number of such patients continues to grow. Id.
`
`Stein notes that a number of companies, such as Bayer and BMS, have
`developed MTP inhibitors, noting further that some of the companies, such
`as BMS, discontinued their research due to class toxicities. Id. at 21. Stein
`teaches, however, that MTP inhibitors “[m]ay still have [a] role in
`[homozygous familial hypocholesteremia, heterozygous familial
`hypocholesteremia, familial combined hyperlipidemia] and
`hyperchylomicronemia,” with the challenge being to find a therapeutic
`window, that is, where efficacy is obtained without toxicity. Id. Stein
`specifically looks at the MTP inhibitor, implitapide (BAY 13-9952). Id. at
`22. Thus, Stein proposes a development plan, in which test subjects are
`started at low doses of 10 mg, and then titrated by 5 mg “based on ‘safety’
`every 5 weeks.” Id. at 37.
`ii.
`Availability of Stein as Prior Art
`Before reaching the merits of Petitioner’s obviousness grounds, we
`must determine whether Stein qualifies as prior art as a printed publication.
`It is Petitioner’s burden to prove that it is, as Petitioner bears the burden of
`proving unpatentability by a preponderance of the evidence. See 35 U.S.C.
`§ 316(e); Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir.
`2016) (“In an [inter partes review], the petitioner has the burden from the
`onset to show with particularity why the patent it challenges is
`
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`unpatentable.”); In re Wyer, 655 F.2d 221, 227 (CCPA 1981) (noting that a
`party asserting a reference as a prior art printed publication “should produce
`sufficient proof of its dissemination or that it has otherwise been available
`and accessible to persons concerned with the art to which the document
`relates”).
`The determination of whether a document is a “printed publication”
`under 35 U.S.C. § 102 “involves a case-by-case inquiry into the facts and
`circumstances surrounding the reference’s disclosure to members of the
`public.” In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004).
`“Because there are many ways in which a reference may be disseminated to
`the interested public, ‘public accessibility’ has been called the touchstone in
`determining whether a reference constitutes a ‘printed publication’ bar under
`35 U.S.C. § 102(b).” Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331,
`1348 (Fed. Cir. 2016) (citing In re Hall, 781 F.2d 897, 898–99 (Fed. Cir.
`1986)).
`“A given reference is ‘publicly accessible’ upon a satisfactory
`showing that such document has been disseminated or otherwise made
`available to the extent that persons interested and ordinarily skilled in the
`subject matter or art exercising reasonable diligence, can locate it.” SRI
`Int’l, Inc. v. Internet Sec. Sys., Inc., 511 F.3d 1186, 1194 (Fed. Cir. 2008)
`(quoting Bruckelmyer v. Ground Heaters, Inc., 445 F.3d 1374, 1378 (Fed.
`Cir. 2006)).
`Citing Klopfenstein, Petitioner contends that the presentation itself
`qualifies as a “printed publication.” Pet. 17. Specifically, Petitioner asserts
`that “a skilled artisan could have captured (or recorded), processed and
`retained the relevant material.” Id. at 17–18.
`
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`IPR2015-01835
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`
`As set forth in Klopfenstein, the factors to be considered are: (i) the
`length of time the display was exhibited; (ii) the expertise of the target
`audience; (iii) the existence (or lack thereof) of reasonable expectations that
`the material displayed would not be copied; and (iv) the simplicity or ease
`with which the material displayed could have been copied. Klopfenstein,
`380 F.3d at 1350. It is only by “considering and balancing these factors can
`we determine whether or not [a] reference was sufficiently publicly
`accessible to be a ‘printed publication.’” Id.
`Petitioner asserts that Stein was presented, as well as webcast, on
`February 5, 2004, at the Analyst Day at PPD, Inc. Pet. 16. The hyperlink
`was distributed to interested parties and “was targeted to financial analysts,
`investors, and skilled artisans interested in drug discovery and
`development.” Id. (citing Ex. 1005, 4). Moreover, it was reported in Pink
`Sheet. Id. at 16–17 (citing Ex. 1002 ¶¶ 106–110; Ex. 1003 ¶¶ 23–25).
`Petitioner asserts further that PPD had publicized its investor day for weeks
`and had provided a hyperlink for interested parties to register for the event or
`the webcast. Id. at 18 (citing Ex. 1005, 4). Petitioner argues that the skilled
`artisan would have taken great interest in the presentation. Id. (citing
`Ex. 1002 ¶¶ 20‒22).
`As to the third and fourth factors of Klopfenstein of expectation and
`ease of copying, Petitioner asserts that “[t]here is no evidence Stein or PPD
`intended to keep Stein’s presentation private; no expectation of privacy in a
`webcast presentation exists absent attempts to keep it private.” Id. at 19
`(citing Klopfenstein, 380 F.3d at 1351). Moreover, Petitioner asserts “[i]t
`would have been simple for the skilled artisan to copy the relevant
`information from the Stein presentation.” Id. In fact, Petitioner asserts
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`IPR2015-01835
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`“Pink Sheet did copy and distribute the step-wise escalating dosing
`regimen.” Id.
`Petitioner asserts further that the slides themselves, once they were
`posted online for viewing and download, constituted “a second, re-
`publication of Stein 2004.” Pet. 19. According to Petitioner, “PPD posted
`the Stein 2004 slides on a clearly marked, tabbed, and indexed page.” Id.
`(citing Ex. 1004, 4‒5).
`Citing Hall, 781 F.2d at 899, Petitioner asserts that it “need not prove
`the specific date Stein 2004 became publicly available, only that in the
`ordinary course of PPD, Inc.’s business, Stein 2004 would have been
`accessible by the critical date.” Pet. 20. Petitioner contends that a press
`release issued by PPD announcing the February 5, 2004, Analyst Day, stated
`that “it would make Stein 2004 available online ‘shortly after the call for on-
`demand replay.’” Id. (citing Ex. 1005, 4). Petitioner asserts further that
`PPD “had an established pattern and practice” in the relevant time period “of
`uploading presentations to its website for review and download within a few
`days of their delivery.” Id. at 20–21. Finally, Petitioner contends “if there
`were any doubt Stein 2004 was published before March 5, 2004, it was
`surely available for download no later than April 15, 2004, as captured by
`the Internet Archive.” Id. at 22 (citing Ex. 1004, 4‒5).
`
`In our Decision on Institution, we determined that, for purposes of
`institution, Petitioner had “reasonably demonstrated that the Stein
`presentation was available to the public no later than April 15, 2004, and
`thus qualifies as prior art under at least 35 U.S.C. § 102(a).” Dec. Inst. 30.
`
`Patent Owner argues that Petitioner has not met its burden of
`demonstrating that Stein is prior art. PO Resp. 45. First, Patent Owner
`
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`argues that Petitioner has not demonstrated by a preponderance of the
`evidence that the presentation at a PPD investor event on February 5, 2004,
`qualified as a printed publication. Id. at 45‒47.
`
`According to Patent Owner, an analysis of the factors set forth in
`Klopfenstein does not support Petitioner’s assertion that the presentation
`qualifies as a printed publication. Id. at 46. Patent Owner argues that
`Petitioner has not provided any evidence that the slides were displayed at all,
`much less for how long. Id. The fact that the slides were purportedly shown
`at an “Investor Day” suggests that the presentation would have been viewed
`by business people, and not those of ordinary skill in the art. Id. In that
`regard, Patent Owner cites the deposition testimony of Petitioner’s
`declarants, Drs. Mayersohn and Zusman, who both testified that they did not
`believe they had ever attended an investor day presentation. Id. (citing Ex.
`2021, 191:19‒21; Ex. 2022, 140:22‒141:5). As to the third and fourth
`Klopfenstein factors, Patent Owner asserts “[g]iven the brevity of the Stein
`Presentation and the fact that it purported to present an extremely dense set
`of materials in a fleeting timeframe, there would not have been an
`expectation of copying or ease of copying in real time.” Id. at 47.
`
`Petitioner responds that Patent Owner’s declarant, Dr. Kimball,
`testified that the ordinary artisan “is an entire drug development team.”
`Reply 15 (citing Ex. 1056, 19:2‒20:3). At least one of the members of such
`a team, Petitioner asserts, would have been aware of the Stein presentation
`given that PPD publicized the investor day presentation for weeks. Id. at 16
`(citing Ex. 1005, 4). Moreover, Petitioner relies on Pink Sheet as reporting
`the presentation, as well as for supporting the ease of copying, as it did in
`fact “copy and distribute Stein’s dosing regimen.” Id. (citing Ex. 1013).
`
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`We conclude that Petitioner has not met its burden of establishing that
`
`the Stein presentation itself constitutes a printed publication under
`Klopfenstein. Petitioner asserts that a hyperlink was distributed to interested
`parties and was targeted to skilled artisans interested in drug development
`and discovery, citing Exhibit 1005 to support that statement. See Pet. 16.
`
`Exhibit 10056 at page 4 is a press release advertising that PPD is to
`hold an analyst day on February 5, 2004. The press release states in full:
`PPD, Inc. (Nasdaq: PPDI) today confirmed that it will hold an
`analyst day for equity analysts and institutional investors on
`Thursday, February 5, 2004, at the Plaza Hotel in New York City
`from approximately 8:00 a.m. to 12:00 p.m. EST. Chief
`Executive Officer Dr. Fred Eshelman and other PPD senior
`management will deliver presentations regarding PPD’s business
`strategies. Executives representing some of PPD’s strategic
`partners will also be presenting their business as it relates to PPD.
`To attend the presentations, register via the investors section of
`the PPD Web site, http://www.ppdl.com. Note that space is
`limited. The event will also be Webcast live, and all interested
`parties will be able to access the Webcast through the investors
`section of the PPD Web site. The Webcast will be archived
`shortly after the call for on-demand replay.
`As a leading global provider of discovery and development
`services and products for pharmaceutical, biotechnology and
`medical device companies, PPD applies innovative technologies,
`therapeutic expertise and a commitment to quality to help clients
`maximize the return on their R&D investments. With proven
`early discovery through post-market resources, the company also
`offers unique compound partnering opportunities. PPD has more
`than 5,700 professionals in 26 countries around the world. For
`
`
`6 The page numbers for Exhibit 1005 refer to the page numbers added by
`Petitioner.
`
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`site at
`
`information on PPD, visit our Web
`more
`http://www.ppdi.com.
`Ex. 1005, 4.
`
`Notably, the press release does not mention hyperlipidemia,
`hypocholesteremia, MTP inhibitors, or any information relating to the topic
`of the presentation, other than stating that PPD is a “leading global provider
`of discovery and development services and products for pharmaceutical,
`biotechnology and medical device companies.” Id. The press release does
`not even mention Dr. Stein. Thus, there is nothing in the press release
`suggesting that the ordinary artisan in the cardiovascular/cardiac field, or
`interested in MTP inhibitors, should attend the presentation. We, therefore,
`decline to credit Dr. Mayersohn’s testimony that “[a]person of ordinary skill
`in the art interested in the development of MTP inhibitors could apparently
`have attended the meeting or accessed the presentation itself