Trials@uspto.gov
`571-272-7822
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`Paper No. 87
`Entered: December 12, 2018
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`v.
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner.
`
`_______________
`Case IPR2017-01528
`Patent 7,713,930 B2
`________________
`
`Before ERICA A. FRANKLIN, ROBERT A. POLLOCK, and
`MICHELLE N. ANKENBRAND, Administrative Patent Judges.
`ANKENBRAND, Administrative Patent Judge.
`
`
`FINAL WRITTEN DECISION
`
`Finding Claims 1–20 Unpatentable
`35 U.S.C. § 318(a); 37 C.F.R. § 42.73
`Denying-in-part and Dismissing-in-part as Moot Patent Owner’s Motion to Strike
`37 C.F.R. §§ 42.5(a), 42.20(a)
`Dismissing Petitioner’s Motion to Exclude and Denying-in-part and
`Dismissing-in-part as Moot Patent Owner’s Motion to Exclude
`37 C.F.R. § 42.64(c)
`Denying Petitioner’s First Motion to Seal, Granting Petitioner’s Second Motion to
`Seal, and Granting Patent Owner’s Motions to Seal
`37 C.F.R. § 42.54
`
`

`

`IPR2017-01528
`Patent 7,713,930 B2
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`I.
`INTRODUCTION
`This is a Final Written Decision in an inter partes review challenging the
`patentability of claims 1–20 (collectively, the “challenged claims”) of U.S. Patent
`No. 7,713,930 B2 (Ex. 1002, “the ’930 patent”). We have jurisdiction under
`35 U.S.C. § 6. For the reasons that follow, we determine that Petitioner
`demonstrates, by a preponderance of the evidence, that the challenged claims are
`unpatentable.
`
`A. Procedural History
`Mylan Pharmaceuticals, Inc. (“Petitioner”) filed a Petition (Paper 2, “Pet.”)
`requesting an inter partes review under 35 U.S.C. § 311. Petitioner supported its
`Petition with the testimony of Samuel H. Yalkowsky, Ph.D. (Ex. 1003). On
`December 13, 2017, we instituted trial to determine whether:
`1. Claims 1–20 of the ’930 patent are unpatentable under 35 U.S.C. § 103 as
`obvious over the combination of Lantus Label1 and Lougheed2;
`2. Claims 1–18 and 20 of the ’930 patent are unpatentable under 35 U.S.C.
`§ 103 as obvious over the combination of Lantus Label and FASS3;
`
`
`1 Physicians’ Desk Reference, Lantus entry 709–713 (55th ed. 2001) (Ex. 1004).
`We refer in this decision to the corrected version of Exhibit 1004.
`2 W.D. Lougheed et al., Physical Stability of Insulin Formulations, 32 DIABETES
`424–432 (1983) (Ex. 1006).
`3 Farmaceutiska Specialiteter I Sverige (“FASS”), Summary of Product
`Characteristics Entry for Insuman Infusat (2000) (certified English translation
`provided as Ex. 1007A; original Swedish version provided as Ex. 1007).
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`3. Claims 1–18 and 20 of the ’930 patent are unpatentable under 35 U.S.C.
`§ 103 as obvious over the combination of Lantus Label and Grau4;
`4. Claim 19 of the ’930 patent is unpatentable over the combination of
`Lantus Label, FASS or Grau, and Lougheed;
`5. Claims 1–20 of the ’930 patent are unpatentable under 35 U.S.C. § 103 as
`obvious over the combination of Owens5 and Lougheed;
`6. Claims 1–18 and 20 of the ’930 patent are unpatentable under 35 U.S.C.
`§ 103 as obvious over the combination of Owens and FASS;
`7. Claims 1–18 and 20 of the ’930 patent are unpatentable under 35 U.S.C.
`§ 103 as obvious over the combination of Owens and Grau; and
`8. Claim 19 of the ’930 patent is unpatentable over the combination of
`Owens, FASS or Grau, and Lougheed.
`Paper 12 (“Institution Decision” or “Inst. Dec.”).
`Following institution, Sanofi-Aventis Deutschland GmbH (“Patent Owner”)
`filed a Response (Paper 26, “Resp.”) and supporting declarations from Bernhardt
`Trout, Ph.D. (Ex. 2006) and Laurence C. Baker, Ph.D. (Ex. 2039). Petitioner filed
`a Reply (Paper 41, “Reply”) and supporting declarations from Dr. Yalkowsky
`(Ex. 1181), Robert S. Langer, Sc.D. (Ex. 1111), Deforest McDuff, Ph.D.
`(Ex. 1169), and William C. Biggs, M.D. (Ex. 1174).
`During an interlocutory teleconference on July 17, 2018, we authorized
`Patent Owner to file a motion to strike certain arguments Petitioner made in the
`
`4 Ulrich Grau & Christopher D. Saudek, Stable Insulin Preparation for Implanted
`Insulin Pumps – Laboratory & Animal Trials, 36 DIABETES 1453–59 (1987)
`(Ex. 1008).
`5 David R. Owens et al., Pharmacokinetics of 125I-Labeled Insulin Glargine (HOE
`901) in Healthy Men – Comparison with NPH insulin and the influence of different
`subcutaneous injection sites, 23 DIABETES CARE 813–819 (2000) (Ex. 1005).
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`Reply. See Ex. 2055, 43:3–20 (Transcript of July 17, 2018 teleconference). We
`also authorized Patent Owner to file a sur-reply as to certain, but not all, arguments
`in Petitioner’s Reply. Id. at 42:13–43:2. Subsequently, Patent Owner filed a Sur-
`reply (Paper 44) and a Motion to Strike (Paper 45, “Mot. to Strike”). Petitioner
`filed an opposition to Patent Owner’s Motion to Strike (Paper 50, “Mot. to Strike
`Opp.”).
`Petitioner and Patent Owner also filed several motions to seal certain briefs
`and exhibits. Paper 43 (Patent Owner’s Supplemental Motion to Seal), Paper 76
`(Patent Owner’s Motion to Seal), Paper 84 (Petitioner’s Motion to Seal), Paper 86
`(Petitioner’s Motion to Seal and for Entry of Proposed Protective Order). Both
`parties also filed motions to exclude, which have been fully briefed. See Papers
`55, 62, 69 (briefing related to Petitioner’s Motion to Exclude); Papers 59, 65, 68
`(briefing related to Patent Owner’s Motion to Exclude). Patent Owner also filed
`Observations on the Cross-Examination Testimony of Petitioner’s Reply
`Declarants, and Petitioner responded. Papers 58, 66. The record further includes a
`transcript of the final oral hearing conducted on September 27, 2018. Paper 75
`(“Tr.”).
`After the final oral hearing, we authorized Patent Owner to file a second sur-
`reply and additional evidence, and we authorized Petitioner to file a sur-sur-reply.
`Paper 75. Subsequently, Patent Owner filed the Sur-reply (Papers 77 (confidential
`version), 78 (public version)), and Petitioner filed the Sur-sur-reply (Papers 83
`(confidential version), 85 (public version)).
`
`B. Related Matters
`The parties identify the following pending litigation involving the ’930
`patent: Sanofi-Aventis U.S. LLC v. Merck Sharp & Dohme Corp., C.A. No. 1:16-
`cv-00812-RGA (D. Del.); Sanofi-Aventis U.S. LLC v. Merck Sharp & Dohme
`
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`Corp., C.A. No. 2:17-cv-05914 (D.N.J.); Sanofi- Aventis U.S. LLC v. Mylan N.V.,
`C.A. No. 2:17-cv-09105-SRC (D.N.J); and Sanofi- Aventis U.S. LLC v. Mylan
`N.V., C.A. No. 1:17-cv-00181-IMK (D.W.V.). Paper 6, 2; Paper 13, 1–2. The
`parties also identify the following concluded litigation involving the ’930 patent:
`Sanofi-Aventis U.S. LLC v. Eli Lilly & Co., C.A. No. 1:14-cv-00113-RGA
`(D. Del.); Sanofi-Aventis U.S. LLC v. Eli Lilly & Co., C.A. No. 1:14-cv-00884-
`RGA (D. Del.). Paper 6, 2; Paper 13, 1.
`And the parties identify as related Case IPR2017-01526— an inter partes
`review involving U.S. Patent No. 7,476,652 (Ex. 1001), which issued from a parent
`application to the application that issued as the ’930 patent. Paper 6, 2; Paper 13,
`2. Concurrent with this decision, we issue a Final Written Decision in Case
`IPR2017-01526.
`
`C. The ’930 Patent (Ex. 1002)
`The ’930 patent, titled “Acidic Insulin Preparations Having Improved
`Stability,” issued on May 11, 2010. Ex. 1002, (45), (54). The ’930 patent relates
`to a pharmaceutical formulation comprising a modified insulin—insulin glargine
`(Gly(A21)-Arg(B31)-Arg(B32)-human insulin); at least one surfactant; at least one
`preservative; and optionally an isotonicizing agent, buffers or other excipients,
`wherein the formulation has a pH in the acidic range. See, e.g., Ex. 1002, Abstract,
`1:15–23, 11:49–56. The formulation is used to treat diabetes, and is “particularly
`suitable for preparations in which a high stability to thermal and/or
`physicomechanical stress is necessary.” Id. at 1:19–22. According to the
`specification, insulin glargine was a known modified insulin with a prolonged
`duration of action injected once daily as an acidic, clear solution that “precipitates
`on account of its solution properties in the physiological pH range of the
`subcutaneous tissue as a stable hexamer associate.” Id. at 2:56–61.
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`The specification explains that, at acidic pH, insulins exhibit decreased
`stability and increased susceptibility to aggregation in response to thermal and
`physicomechanical stress, resulting in turbidity and precipitation (i.e., particle
`formation). Id. at 3:7–11. Such stresses can arise during use or shaking of the
`insulin solution. Id. at 5:43–67. Also contributing to aggregation are hydrophobic
`surfaces with which the insulin solution comes into contact during storage and
`administration, including those on glass storage vessels, solution/air boundary
`layers, sealing cap stopper materials, and siliconized insulin syringes. Id. at 3:13–
`22.
`
`According to the specification, the applicants “surprisingly [] found” that
`adding surfactants to the insulin solution or formulation “can greatly increase the
`stability of acidic insulin preparations,” thereby producing insulin solutions with
`“superior stability to hydrophobic aggregation nuclei for several months [u]nder
`temperature stress.” Id. at 3:45–49; see id. at 5:29–11:47 (examples showing that
`adding the surfactant polysorbate 20 or polysorbate 80 to an insulin glargine
`formulation stabilizes the formulation in use and during physicomechanical
`stressing).
`
`D. Illustrative Claim
`We instituted an inter partes review of claims 1–20 of the ’930 patent, of
`which claim 1 is independent. Claim 1 is illustrative of the claimed subject matter
`and recites:
`1. A pharmaceutical formulation comprising Gly(A21), Arg(B31),
`Arg(B32)-human insulin;
`at least one chemical entity chosen from esters and ethers of
`polyhydric alcohols;
`at least one preservative; and
`water,
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`wherein the pharmaceutical formulation has a pH in the acidic range
`from 1 to 6.8.
`Ex. 1002, 11:49–56.
`
`II. EVIDENTIARY MOTIONS
`Patent Owner filed a motion to strike various arguments and evidence.
`Petitioner and Patent Owner also filed motions to exclude certain evidence. We
`first address Patent Owner’s motion to strike and then turn to the parties’ motions
`to exclude.
`
` Patent Owner’s Motion to Strike
`Patent Owner requests to strike what it contends are two new arguments that
`Petitioner makes based on Lantus Label: (1) that Lantus Label’s teaching of
`different storage requirements for different product sizes would have indicated an
`aggregation problem and provided a reason to modify the Lantus Label
`formulation; and (2) that Lantus Label sometimes refers to insulin glargine as
`“insulin,” which would have suggested that it “‘behaved similar to other insulins.’”
`Mot. to Strike 1–2. Patent Owner also seeks to strike paragraphs 100 and 120–26
`of Dr. Langer’s declaration (Ex. 1111), as well as paragraphs 8 and 20–22 of
`Dr. Yalkowsky’s reply declaration (Ex. 1181). Id. at 1. According to Patent
`Owner, the arguments and testimony are outside the scope of a proper reply.
`Petitioner opposes. Mot. to Strike Opp. 1–2.6
`
`
`6 Patent Owner filed a sur-reply addressing Petitioner’s argument about the
`different storage requirements for different Lantus product sizes and additional
`evidence supporting its sur-reply. Paper 77; Exs. 2060–2069. And Petitioner filed
`a sur-sur-reply in response to Patent Owner’s sur-reply on this issue. Paper 83.
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`We do not rely on the arguments or evidence that Patent Owner seeks to
`strike in making our ultimate determination on the patentability of the challenged
`claims. Thus, we dismiss Patent Owner’s request as moot.
`Patent Owner next argues that we should strike what it contends are new
`arguments and evidence (Ex. 1111 ¶¶ 147, 159, 161) based on new insulin
`references. Mot. to Strike 2–3. Specifically, Patent Owner directs us to
`Petitioner’s argument that an ordinarily skilled artisan would have reasonably
`expected success because “at least 20 prior art references allegedly show
`surfactants tried with proteins, and at least 12 references allegedly show surfactants
`with insulin (not glargine).” Id. at 3. Patent Owner contends that this argument
`and supporting evidence amounts to “a do-over” “with new references presented
`through a new expert.” Id. Petitioner opposes, arguing that the Petition provides
`evidence that the claimed surfactants were commonly used in protein formulations
`and provides one example for insulin. Mot. to Strike Opp. 2. Petitioner further
`asserts that the argument and evidence are properly submitted in reply because
`they directly respond to Patent Owner’s argument that an ordinarily skilled artisan
`would not have reasonably expected success because of “alleged unpredictable
`effects that surfactants ‘could’ have or that ‘were possible.’” Id. at 3 (citing Resp.
`48–52).
`We agree with Petitioner that its argument and evidence is within the proper
`scope of a reply. The argument does not raise a new theory of unpatentability or
`provide new references in support of Petitioner’s prima facie obviousness case.
`Rather, we find that the formulations discussed in the Reply and Dr. Langer’s
`declaration support the initial arguments raised in the Petition and directly respond
`to Patent Owner’s arguments about reasonable expectation of success and further
`serve to “document the knowledge that skilled artisans would bring to bear in
`
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`reading the prior art identified as producing obviousness.” Anacor Pharm., Inc. v.
`Iancu, 889 F.3d 1372, 1380–81 (Fed. Cir. 2018); see Ariosa Diagnostics v.
`Verinata Health, Inc., 805 F.3d 1359, 1365 (Fed. Cir. 2015); Belden Inc. v. Berk-
`Tek LLC, 804 F.3d 1064, 1078–80 (Fed. Cir. 2015) (explaining that the Board may
`rely on new evidence submitted with a reply because that evidence was responsive
`to the arguments in patent owner’s response). Accordingly, we deny Patent
`Owner’s request to strike Petitioner’s argument and Dr. Langer’s testimony about
`additional insulin formulations.
`Patent Owner next requests that we strike Petitioner’s reply argument and
`evidence (Ex. 1111 ¶¶ 127–145; Ex. 1133; Ex. 1174) about “‘public’ knowledge,”
`arguing that Petitioner presents a new theory based on documents about a recall,
`and hearsay evidence from a new fact witness about a Lantus vial that became
`turbid in a hot car. Mot. to Strike 4–5. Patent Owner also argues that Petitioner
`improperly relies on Patent Owner’s confidential internal documents to support the
`obviousness challenge. Id. According to Patent Owner, Petitioner’s argument is
`not responsive to anything in the Response. Id. at 5. Petitioner opposes, arguing
`that it has not presented any new theory. Mot. to Strike Opp. 4–5.
`We do not rely on the arguments or evidence that Patent Owner seeks to
`strike in making our ultimate determination on the patentability of the challenged
`claims. Thus, we dismiss Patent Owner’s request as moot.
`Finally, Patent Owner requests that we strike the Reply and Dr. Langer’s
`declaration in their entirety. Mot. to Strike 5–7. Patent Owner argues that
`“Petitioner is attempting a complete re-do of its Petition, contrary to the letter and
`spirit of the IPR framework.” Id. at 6. Patent Owner further argues that
`Dr. Langer’s declaration is “an 87-page declaration from a new expert who . . .
`offers alleged support for a number of new theories and presents almost 60 new
`
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`exhibits.” Id. at 5. Petitioner opposes, arguing that both its Reply and Dr.
`Langer’s declaration are proper. Mot. to Strike Opp. 5–7.
`We do not agree with Patent Owner that Petitioner’s Reply and Dr. Langer’s
`declaration are improper. Rather, we find that the Reply and Dr. Langer’s
`declaration support the initial arguments raised in the Petition, are in fair response
`to the arguments Patent Owner raises in the Response, and also fairly respond to
`Dr. Trout’s testimony. Belden Inc., 804 F.3d at 1078. Further, Patent Owner has
`been granted, and indeed, filed two sur-replies addressing arguments made in
`Petitioner’s Reply and Petitioner’s supporting evidence. Papers 44, 77.
`Accordingly, we deny Petitioner’s request to strike the Reply and Dr. Langer’s
`declaration in their entirety.
`In sum, we deny-in-part and dismiss-in-part as moot Patent Owner’s Motion
`to Strike.
`
`E. Motions to Exclude
`Petitioner and Patent Owner each filed a motion to exclude. We address
`Petitioner’s motion first and then turn to Patent Owner’s motion.
`
`1. Petitioner’s Motion to Exclude
`Petitioner moves to exclude Exhibits 2042–2045 and Exhibits 2051–2052.
`Paper 55 (“Pet. Mot. to Exclude”). Exhibits 2042–2045 are certain documents
`Dr. Baker relied upon to support his opinions regarding the commercial success of
`the Lantus Product. Pet. Mot. to Exclude, 1–2. Exhibit 2051 is an Order from the
`related Delaware litigation, and Exhibit 2052 is a compilation of excerpts from the
`trial transcript in that same litigation. Id. at 2–4. Petitioner moves to exclude
`Exhibits 2042–2045 as irrelevant and prejudicial under Federal Rules of Evidence
`(“FRE”) 402 and 403, and as improper summaries under FRE 1006. Id. at 1–2.
`Petitioner moves to exclude Exhibits 2051–2052 as irrelevant and prejudicial under
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`FRE 402 and 403, and further moves to exclude Exhibit 2052 as an improper
`summary under FRE 1006. Id. at 2–3. Patent Owner opposes. Paper 62.
`We do not rely on any of Exhibits 2042–2045 or Exhibits 2051–2052 in
`making our ultimate determination on the patentability of the challenged claims.
`Accordingly, we need not decide Petitioner’s Motion to Exclude those exhibits,
`and we dismiss the motion as moot.
`
`2. Patent Owner’s Motion to Exclude
`Patent Owner moves to exclude the following exhibits, or portions thereof:
`Exhibits 1144–1161; Exhibit 1111; Exhibit 1169 ¶¶ 13–14, 40–49; Exhibit 1174;
`Exhibit 1181 ¶¶ 15–16, 18–24, 26, 28, 30–36, 38–51, 53–56; Exhibit 1114; and
`Exhibits 1057–1058. Paper 59 (“Patent Owner Mot. to Exclude”). Patent Owner
`notes that the exhibits fall into several categories: (a) documents and testimony
`related to Patent Owner’s confidential information; (b) testimony from witnesses
`that Patent Owner alleges lack the scientific, technical, or other specialized
`knowledge required under Federal Rule of Evidence 702; (c) testimony that is not
`cited in the Petition or Reply; and (d) evidence that Patent Owner alleges is
`inadmissible hearsay. Id. We address each category below.
`
`a. Documents and testimony related to Patent Owner’s confidential
`information
`Patent Owner moves to exclude Exhibits 1144–1161 and Dr. Langer’s
`declaration (Ex. 1111) in its entirety. Patent Owner Mot. to Exclude 5–10. Patent
`Owner argues that we should exclude Exhibits 1144–1161 under FRE 402 and 403
`because confidential information is irrelevant to the knowledge of an ordinarily
`skilled artisan. Id. at 5–7. Patent Owner argues that we should exclude
`Dr. Langer’s declaration under FRE 702 because his opinions regarding
`obviousness are compromised by his reliance on Patent Owner’s confidential
`
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`documents. Id. at 7–10. Although Patent Owner seeks to exclude Dr. Langer’s
`declaration in its entirety, Patent Owner identifies only certain paragraphs of the
`declaration as containing or relying upon the confidential information. See id. at
`7–8 (identifying paragraphs 117–126, 130–145, 148, 149, 163–165, 168–172, and
`177 of Dr. Langer’s declaration). Petitioner opposes, arguing that it does not offer
`the exhibits as prior art, but rather, to refute Patent Owner’s argument that an
`ordinarily skilled artisan would not have viewed the prior art the way the Petition
`proposes. Paper 65, 1–2. Petitioner contends that such evidence is relevant to the
`credibility of Patent Owner’s positions and Dr. Trout’s testimony. Id. at 2.
`We deny Patent Owner’s request to exclude the entirety of Dr. Langer’s
`declaration because Patent Owner’s arguments go to the weight we should accord
`Dr. Langer’s testimony and Dr. Langer’s credibility, not the declaration’s
`admissibility. See, e.g., Liberty Mutual Ins. Co. v. Progressive Casualty Ins. Co.,
`Case CBM2012-00002, slip op. at 70 (Paper 66) (PTAB Jan. 23, 2014) (“[T]he
`Board, sitting as a non-jury tribunal, is well-positioned to determine and assign
`appropriate weight to the evidence presented in this trial, without resorting to
`formal exclusion that might later be held reversible error.”). Further, although
`Patent Owner moves to exclude Dr. Langer’s declaration under FRE 702, Patent
`Owner’s motion does not discuss why the declaration is inadmissible under that
`rule.
`
`As to Exhibits 1144–1161 and paragraphs 117–26, 130–45, 148, 149, 163–
`65, 168–72, and 177 of Dr. Langer’s declaration, we do not rely on any of that
`evidence in making our ultimate determination on the patentability of the
`challenged claims. Accordingly, we need not decide Patent Owner’s motion as to
`those exhibits and paragraphs, and we dismiss that portion of Patent Owner’s
`motion as moot.
`
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`b. Testimony from witnesses that allegedly lack the knowledge required under
`Federal Rule of Evidence 702
`Patent Owner moves to exclude paragraphs 40–43 of Dr. McDuff’s
`declaration (Ex. 1169) and the entirety of Dr. Biggs’ declaration (Ex. 1174),
`arguing that the testimony lacks the scientific, technical, or other specialized
`knowledge that FRE 702 requires. Patent Owner Mot. to Exclude 10–13.
`Petitioner opposes. Paper 65, 5–6.
`We do not rely on Dr. Biggs’ declaration or any of paragraphs 40–43 of
`Dr. McDuff’s declaration in making our ultimate determination on the patentability
`of the challenged claims. Accordingly, we need not decide Patent Owner’s motion
`as to those exhibits and paragraphs, and we dismiss that portion of Patent Owner’s
`motion as moot.
`
`c. Testimony not cited in the Petition or Reply
`Patent Owner moves to exclude portions of Dr. Langer’s, Dr. McDuff’s,
`Dr. Biggs’ declarations, as well as portions of Dr. Yalkowsky’s reply declaration
`and Exhibit 1114 as irrelevant under FRE 403 because Petitioner did not cite that
`evidence in its Petition or Reply. Patent Owner Mot. to Exclude 14. Petitioner
`opposes. Paper 65, 8–9.
`As to Exhibit 1114, we do not rely on that evidence in making our ultimate
`determination of the patentability of the challenged claims. Accordingly, we need
`not decide Patent Owner’s motion as to that exhibits, and we dismiss that portion
`of Patent Owner’s motion as moot.
`Turning to the expert declarations, although Patent Owner cites SK
`Innovation Co., Ltd. v. Celgard, LLC, Case IPR2014-00679, slip op. at 49 (Paper
`58) (PTAB Sept. 25, 2015) as supporting exclusion of certain information, we do
`not agree. First, we note that SK Innovation is not precedential and, therefore, not
`
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`binding. Moreover, in SK Innovation, the Board excluded exhibits—not portions
`thereof—that a party did not cite during the course of the proceeding. Here,
`Petitioner cites to and relies upon each declaration exhibit its Reply. Accordingly,
`we deny Patent Owner’s motion as to those declarations.
`
`d. Allegedly inadmissible hearsay evidence
`Patent Owner moves to exclude paragraphs 20–22 and 25–30 of Dr. Biggs’
`declaration (Ex. 1174) and Exhibits 1057–1058 under FRE 802 as containing
`inadmissible hearsay. Patent Owner Mot. to Exclude 13, 15. Petitioner opposes.
`Paper 65, 7–8, 10.
` We do not rely on paragraphs 20–22 and 25–30 Dr. Biggs’ declaration or
`Exhibits 1057–1058 in making our ultimate determination on the patentability of
`the challenged claims. Accordingly, we need not decide Patent Owner’s motion as
`to those paragraphs and exhibits, and we dismiss that portion of Patent Owner’s
`motion as moot.
` In sum, we deny-in-part and dismiss-in-part as moot Patent Owner’s
`Motion to Exclude.
`
`III. DISCUSSION OF UNPATENTABILITY CHALLENGES
`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 the facts supporting its challenge by a preponderance of the
`evidence. 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d). Below, we explain how
`Petitioner has met its burden with respect to the challenged claims.
`
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`A. Principles of Law
`Obviousness is a question of law based on underlying determinations of fact.
`Graham v. John Deer Co., 383 U.S. 1, 17 (1966); Richardson-Vicks, Inc. v.
`Upjohn Co., 122 F.3d 1476, 1479. The underlying factual determinations include:
`(1) the scope and content of the prior art; (2) any differences between the claimed
`subject matter and the prior art; (3) the level of skill in the art; and (4) objective
`evidence of nonobviousness, i.e., secondary considerations. See Graham, 383 U.S.
`at 17–18. Subsumed within the Graham factors are the requirements that all claim
`limitations be found in the prior art references and that the skilled artisan would
`have had a reasonable expectation of success in combining the prior art references
`to achieve the claimed invention. Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1361
`(Fed. Cir. 2007). “Obviousness does not require absolute predictability of success
`. . . all that is required is a reasonable expectation of success.” In re O’Farrell, 853
`F.2d 894, 903–4 (Fed. Cir. 1988).
`Moreover, “[t]he combination of familiar elements according to known
`methods is likely to be obvious when it does no more than yield predictable
`results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “If a person of
`ordinary skill can implement a predictable variation, § 103 likely bars its
`patentability.” Id. at 417.
`
`B. Level of Ordinary Skill in the Art
`We consider each asserted ground of unpatentability in view of the
`understanding of a person of ordinary skill in the art. Petitioner contends that, as
`of June 2002, a person of ordinary skill in the art would have had “an M.S. or
`Ph.D. or equivalent in pharmacology, pharmaceutical sciences, or a closely related
`field; or an M.D. with practical academic or industrial experience in peptide
`injection formulations or stabilizing agents for such formulations.” Pet. 13 (citing
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`Dr. Yalkowsky’s testimony, Ex. 1003 ¶¶ 31–34). As an example, Petitioner notes
`and Dr. Yalkowsky testifies, that a person of ordinary skill in the art would have
`had experience in surfactants that are commonly used in peptide injection
`formulations and an understanding of the factors that contribute to the molecule’s
`instability. Id.; Ex. 1003 ¶ 33. Petitioner further contends that an ordinary artisan
`may have “consulted with one or more team members of experienced professionals
`to develop an insulin formulation resistant to the well-known aggregation
`propensities of insulin molecules.” Pet. 13; see Ex. 1003 ¶ 34.
`Patent Owner does not offer a separate description for one of ordinary skill
`in the art. Nevertheless, Patent Owner disputes some aspects of Petitioner’s
`description of the level of ordinary skill in the art. Resp. 18–20. Specifically,
`Patent Owner contends that Petitioner: (1) describes the field of invention
`improperly; (2) asserts that the skilled artisan would have been more than
`ordinarily creative by consulting other team members; and (3) incorrectly suggests
`that a person of ordinary skill in the art “would have been aware of or expected
`that the original LANTUS glargine formulation would be prone to aggregation
`under normal use conditions.” Id.
`The parties’ disputes about the person of ordinary skill in the art appear to be
`directed to an issue at the heart of this case—what an ordinarily skilled artisan
`would have expected as to aggregation of insulin glargine. We need not—and do
`not—decide that issue as part of determining the level of ordinary skill in the art.
`We find that a person of ordinary skill in the art would have possessed an M.S., a
`Ph.D., or equivalent in pharmacology, pharmaceutical sciences, or a closely related
`field; or an M.D. with practical academic or industrial experience in peptide
`injection formulations or stabilizing agents for such formulations. We further find
`that a person of ordinary skill in the art would have understood instabilities that
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`affect proteins in formulation, and that proteins may aggregate. See Ex. 1003 ¶ 33;
`Ex. 2006 ¶ 34. This description is consistent with the level of ordinary skill in the
`art at the time of the invention as reflected in the prior art in this proceeding. See
`Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art, itself,
`can reflect the appropriate level of ordinary skill in art).
`Further, based on Petitioner’s and Patent Owner’s experts’ statements of
`qualifications and curriculum vitae, we find that Dr. Yalkowsky, Dr. Langer, and
`Dr. Trout7 are qualified to opine from the perspective of a person of ordinary skill
`in the art at the time of the invention. See Ex. 1003, Ex. A (Dr. Yalkowsky’s
`curriculum vitae); Ex. 1111A (Dr. Langer’s curriculum vitae); Ex. 2007
`(Dr. Trout’s curriculum vitae).
`
`C. Claim Construction
` The Board interprets claims in an unexpired patent using the “broadest
`reasonable construction in light of the specification of the patent.” 37 C.F.R.
`§ 42.100(b) (2016)8; Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46
`
`
`7 The parties do not offer their additional witnesses as persons of ordinary skill in
`the art. Petitioner offers Dr. Biggs as a fact witness. Tr. 25:11–26:5. And
`Petitioner and Patent Owner offer Dr. McDuff and Dr. Baker, respectively, not as
`persons of ordinary skill in the art, but as economic experts to opine on the
`commercial success of Patent Owner’s reformulated Lantus product. See Ex. 1169
`¶¶ 1–5, 7 (detailing Dr. McDuff’s qualifications scope of work); Ex. 2039 ¶¶ 1–5,
`8 (detailing Dr. Baker’s qualifications and assignment).
`8 The Office recently changed the claim construction standard applicable to an
`inter partes review. See Changes to the Claim Construction Standard for
`Interpreting Claims in Trial Proceedings Before the Patent Trial and Appeal Board,
`83 Fed. Reg. 51,340 (Oct. 11, 2018). The rule changing the claim construction
`standard, however, does not apply to this proceeding because Petitioner filed its
`Petition before the effective date of the final rule, i.e., November 13, 2018. Id. at
`51,340 (rule effective date and applicability date), 51,344 (explaining how the
`Office will implement the rule).
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`(2016). Under that standard, claim terms are given their ordinary and customary
`meaning in view of the specification, as would be understood by one of ordinary
`skill in the art at the time of the invention. In re Translogic Tech., Inc., 504 F.3d
`1249, 1257 (Fed. Cir. 2007). Any special definitions for claim terms must be set
`forth with reasonable clarity, deliberateness, and precision. In re Paulsen, 30 F.3d
`1475, 1480 (Fed. Cir. 1994).
`We determined in the Institution Decision that no claim term required
`express construction based on the record developed at that stage of the proceeding.
`Inst. Dec. 10–11. Neither party contests our decision not to expressly construe
`claim terms. See Resp. 18; see generally Reply. On the full record before us, we
`can determine the patentability of the challenged claims without expressly
`construing any claim term. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200
`F.3d 795, 803 (Fed. Cir. 1999) (“only those terms need be construed that