• Pfizer, Inc. / Samsung Bioepis Co., Ltd. v. Genentech, Inc.Some claims unpatentable
  PTAB · Nov 29, 2018 · IPR2017-02139 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1, 2, 4, 25, 29–31, 33, 62–64, 66, 67, 69, 72, 78, 80, and 81 are unpatentable; the remaining challenged claims were not shown unpatentable.

  RulingsFinal written decision

  • PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted

    “Petitioner Samsung Bioepis Co., Ltd. (“Bioepis”) timely submitted a Petition presenting substantially the same challenges as set forth in Pfizer’s Petition along with a request for joinder to IPR2017-01488. IPR2017- 02139. Paper 1. We granted Bioepis’s Petition and associated request for joinder to this case. IPR2017-02139, Paper 11, 6–7.” slip op. at 3

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “B. Person of Ordinary Skill in the Art The parties propose similar definitions of a person of ordinary skill for the ’213 patent. See Pet. 15–16; Prelim. Resp. 18; PO Resp. 18. In our institution decision, we adopted Patent Owner’s proposal that “[a] person of ordinary skill for the ’213 patent would have had a Ph.D. or equivalent in chemistry, biochemistry, structural biology, or a closely related field, and experience with antibody structural characterization, engineering, and/or biological testing, or an M.D. with practical academic or industrial experience in antibody development.” Dec. 8. Petitioners do not contest this definition in its Reply and we find no reason to revise our earlier determination.” slip op. at 11

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner

    “variable domain,” which appears in claims 4, 33, 62, and 69, to mean “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure.” Prelim. Resp. 18–19; PO Resp. 19. Patent Owner correctly points out that this “construction comes directly from the definition provided in the ’213 patent.” Prelim. Resp. 19 (citing Ex. 1001, 11:32–38). Petitioners expressly adopt this construction in their Reply. Pet. Reply 5–6. We do not agree, however, that the claims demand a consensus of “all” human immunoglobulins in the literal sense. Indeed, Petitioners point out that “the ‘consensus’ sequence used for the patent variants was generated using the most common residue at each position identified in [Kabat 198711].” Pet. Reply 15 (citations omitted). And though Patent Owner attempts to distinguish Queen 1990 as describing “a consensus framework from many human antibodies,’ not all as in the ’213 patent,’” it presents no argument as to why we should interpret the claim in this manner. 11 Kabat et al., Sequences of Proteins of Immunological Interest: Tabulation and Analysis of Amino Acid and Nucleic Acid Sequences of Precursors, V- Regions, C-Regions, J-Chain, T-Cell Receptor for Antigen, T-Cell Surface Antigens β2-Microglobulin, Major Histocompatibility Antigens, Thy-1 Complement, C-Reactive Protein, Thymopoietin, Post-Gamma Globulin, and α2-Macroblobulin, 41–175 (4th Ed. 1987). Ex. 1052. See PO Resp. 47. Moreover, in a parallel proceeding involving the same patent, Patent Owner did not dispute that the reference to “all sequences” in the patent, “refer[s] to all known sequences and there’s no dispute . . . that was really synonymous with Kabat 1987.” See IPR2017-01374 Paper 82, Tr. 15:4–16:4; see Ex. 1202 ¶ 157; Ex. 2105 ¶¶ 24–25; Ex. 2107 ¶¶ 18–19; Ex. 1198, 56:20–61:24; Ex. 1199, 27:14–28:13, 29:25–36:2, 57:1–58:6, 115:7–17, 165:17–169:9. Indeed, in a similar parallel proceeding, counsel for Patent Owner acknowledged that the term “all human immunoglobulins” refers to “all reasonably available[,] all known at the time of the invention.” IPR2017-01373, Paper 83, 47:21–48:5. Accordingly, we adopt the parties’ proposed construction, with a clarifying modification, specifically, “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure, as set forth in Kabat 1987.”” slip op. at 13

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner

    “lacks immunogenicity compared to a non-human parent antibody upon repeated administration to a human patient.” In our institution decision, we determined that this claim language “refer[s] to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody.” Dec. 10–12. Neither party disputes this interpretation. See PO Resp. 19; Pet. Reply 5–6. Consistent with claim 63’s express comparison between the immunogenicity of the claimed humanized antibody and that of its non-human parent, the Specification states that one object of the invention is to “to provide methods for the preparation of antibodies which are less antigenic in humans than non-human antibodies but have desired antigen binding and other characteristics and activities.” Ex. 1001, 4:24–28. The Specification similarly states that embodiments within the scope of the claims have “low immunogenicity,” or are designed to “minimize the potential immunogenicity of the resulting humanized antibody in the clinic.” Id. at 52:54–58, 61:56–61. Moreover, with reference to claim 63 in particular, Patent Owner points to the ’272 application as “explain[ing] that the purpose of humanizing antibodies using its consensus sequence approach is to reduce immunogenicity versus the non-human parent antibody. (Id., 6:24–30, 84:24–30.).” Prelim. Resp. 42 (citing Ex. 2032 (File History for U.S. Patent Application No. 07/715,272 (“the ’272 application”)); see also id. at 38 (indicating that the limitation is satisfied where “[o]nly 1 out of 885 patients experienced an immunogenic response . . . which was a substantial improvement over the murine 4D5 antibody”). In light of the above, we do not alter our prior determination that “[a] humanized antibody which lacks immunogenicity compared to a non-human parent antibody upon repeated administration to a human patient,” refers to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody.” slip op. at 14

  Patent outcomesUS 6,407,213 mixed
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 6,407,213
• Incyte Corporation v. Concert Pharmaceuticals, Inc.Rehearing granted
  PTAB · Apr 9, 2018 · IPR2017-01256 · APJ Tina E Hulse · IPR · Rehearing

  The Board granted Incyte’s rehearing request and instituted review of claims 1–15 on Ground 3, finding it had applied overly restrictive standards for lead compound analysis and combining references.

  RulingsRehearing decision

  • RehearingRehearing, grantedGranted

    “The party requesting rehearing has the burden to show that the decision should be modified. Under 37 C.F.R. § 42.71(d), the request for rehearing must identify, specifically, all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply. When rehearing a decision on a petition, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may arise if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if an unreasonable judgment is made in weighing relevant factors. In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000). Having considered the Request for Rehearing, the current record, and our Decision denying institution, we are persuaded that we applied an overly restrictive standard for the lead compound analysis and for the reason to combine the cited references. See Reh’g Req. 2–12. Accordingly, we grant Petitioner’s Request for Rehearing and concurrently issue a decision granting institution on Ground 3. Paper 14.” slip op. at 3

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

    “Having considered the Request for Rehearing, the current record, and our Decision denying institution, we are persuaded that we applied an overly restrictive standard for the lead compound analysis and for the reason to combine the cited references. See Reh’g Req. 2–12. Accordingly, we grant Petitioner’s Request for Rehearing and concurrently issue a decision granting institution on Ground 3. Paper 14.” slip op. at 3

  None
  Patents in suitUS 9,249,149
• Hospira, Inc. v. Genentech, Inc.Rehearing granted
  PTAB · Oct 26, 2017 · IPR2017-00731 · APJ Zhenyu Yang · IPR · Rehearing

  The Board granted Hospira’s rehearing request and instituted review of claims 1–14 for obviousness over Baselga ’94 and Baselga ’96.

  RulingsRehearing decision

  • RehearingRehearing, grantedGranted

    “recites “in the absence of an anthracycline derivative.” In the Petition and the Preliminary Response, neither party proposed a construction for that term. Patent Owner, however, argues that “[e]ven if a person of ordinary skill would have chosen to combine an anti-ErbB2 antibody and a taxoid, there is no reason an ordinarily skilled artisan would have avoided anthracyclines as part of that treatment.” Prelim. Resp. 52 (emphasis added). In our Decision denying institution, we agreed with Patent Owner, stating that evidence of the record is “insufficient to suggest that an ordinary artisan would have avoided anthracyclines while pursuing the combination therapy with anti-ErbB2 antibody and a taxoid in a treatment regimen for humans.” Dec. 10 (emphasis added). In its Request for Rehearing, Petitioner contends that we erred in interpreting the limitation “in the absence of an anthracycline derivative” as requiring “avoidance” of an anthracycline derivative. Reh’g Req. 6. According to Petitioner, this term “is a negative limitation that is satisfied by anti-ErbB2 antibody–paclitaxel combinations that do not include an [anthracycline] derivative.” Id. at 5. After reconsidering the current record, we find Petitioner’s argument persuasive. In particular, because Baselga ’94 suggests a therapeutic composition consisting of an anti-ErbB2 antibody and paclitaxel, and does not suggest that doxorubicin must necessarily be included as part of the same treatment regimen, we are persuaded that the reference satisfies the limitation “in the absence of an anthracycline derivative.” Cf. Upsher-Smith Labs., Inc. v. Pamlab, L.L.C., 412 F.3d 1319, 1322 (Fed. Cir. 2005) (concluding the prior art anticipates a claim requiring a composition “essentially free of antioxidants,” because the prior art teaches “optional inclusion” of antioxidants, “despite no express teaching to exclude the antioxidants”).” slip op. at 17

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

    “In sum, Petitioner has presented sufficient evidence, for purposes of instituting trial, to show that in considering prior therapy received, an ordinary artisan would have been motivated to treat patients with ErbB2- overexpressing breast cancer by administering a combination of an anti- ErbB2 antibody and a taxoid, and “in the absence of an anthracycline derivative.”” slip op. at 18

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted

    “Petitioner, however, points to other evidence to show that prior art teaches an ordinary artisan to combine an anti-ErbB2 antibody with a taxoid. Specifically, Petitioner refers to Baselga ʼ94 for teaching that, in mouse xenografts, “individual treatment with either anti-HER2 4D5 or paclitaxel alone resulted in 35% growth inhibition whereas the combination ‘resulted in a major antitumor activity with 93% inhibition of growth’ without increasing toxicity.” Id. at 45 (citing Ex. 1005 at 4). Similarly, Baselga ’96, citing Baselga ’94, teaches that “[i]n preclinical studies, both in vitro and in xenografts, rhuMAb HER2 markedly potentiated the antitumor effects of several chemotherapeutic agents, including … paclitaxel without increasing their toxicity.” Id. at 44 (quoting Ex. 1004, 15). Based on these teachings, we are persuaded that an ordinary artisan would have had a reason to treat HER2-positive breast cancer patients with a combination of rhuMAb HER2 and a taxoid.” slip op. at 12

  • Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner

    “Patent Owner argues that Exhibit 2029, which states that “breast cancers that overexpress p185 [i.e., HER2] will not respond well to Taxol,” teaches away from the claimed combination therapy. Prelim. Resp. 51 (citing Ex. 2029,5 1362). We are not persuaded on this record. In an obviousness inquiry, we must analyze the prior art as a whole, and not individually. See In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004) (explaining that the question is “whether there is something in the prior art as a whole to suggest the desirability, and thus the obviousness, of making the combination”). Other evidence of record shows paclitaxel had been approved for treating breast cancer (see, e.g., Ex. 1025, 10), demonstrates synergy of paclitaxel and an anti-ErbB2 antibody in human breast cancer xenografts (see, e.g., Ex. 1005, 4; Ex. 1004, 15), and suggests clinical trials of the combination therapy (see, e.g., Ex. 1005, 4; Ex. 1004, 15). Weighing all evidence of record, we are not persuaded that prior art as a whole teaches away from combining paclitaxel and an anti-ErbB2 antibody in treating HER2-positive cancers.” slip op. at 14

  Claim construction§ 103 obviousness
  Patents in suitUS 7,846,441
• Mylan Pharmaceuticals Inc. / Mylan Laboratories Limited v. Ucb Pharma GmbHNo claims unpatentable
  PTAB · Jul 19, 2017 · IPR2016-00517 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1, 3, 4, and 6–8 were held not unpatentable because Petitioner did not prove either obviousness ground by a preponderance of the evidence.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “For the purpose of this decision, we accept Petitioner’s undisputed contention that: [a] person of ordinary skill in the art would have a Ph.D. in chemistry, medicinal chemistry, pharmacology, or a related field, and at least one year of industrial exposure to drug discovery, drug design, and synthesis. In lieu of an advanced degree, the individual may have additional years of industry experience, including, for example, in drug discovery, drug synthesis, and structure-activity work. Pet. 6 (citing Ex. 1003 ¶ 20); see Prelim. Resp. 9; PO Resp. 6. Based on our review of the ’772 patent, the types of problems and solutions described in the ’772 patent and cited prior art, we adopt Petitioner’s definition of a person of ordinary skill in the art at the time of the claimed invention. We note that the applied prior art also reflects the appropriate level of skill at the time of the claimed invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “the broadest reasonable construction in light of the specification of the patent in which they appear. See Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016) (upholding the use of the broadest reasonable interpretation standard); 37 C.F.R. § 42.100(b). Under that standard, and absent any special definitions, we give claim terms their ordinary and customary meaning, as would be understood by one of ordinary skill in the art at the time of the invention. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Only those terms which are in controversy need to be construed, and only to the extent necessary to resolve the controversy. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). Petitioner submits that the “claims in the ʼ772 patent are presumed to take on their ordinary and customary meaning based on the broadest reasonable interpretation of the claim language.” Pet. 6. Patent Owner “does not dispute Petitioner’s position that no claim terms require construction, which the Board also accepted for purposes of institution.” PO Resp. 7 (citing Pet. 6; Inst. Dec. 7). In our Decision on Institution, we determined that “for purposes of this Decision, none of the terms in the challenged claims require express construction at this time.” Inst. Dec. 7. As in the Decision on Institution, we apply the broadest reasonable interpretation standard here, and see no reason to construe explicitly any claim term. B. Principles of Law” slip op. at 8

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundReasonable expectation not foundNot shown unpatentable

    “Petitioner, however, fails to point to any evidence that 5-HMT is metabolized through the CYP2D6 pathway, or that administering 5-HMT would have resulted in the same risks of drug interaction and adverse effects that Petitioner contends are the result of administering tolterodine. See Pet. 22–24 (describing alleged problems associated with tolterodine, not 5 HMT); Ex. 1003 ¶¶ 95–100 (Dr. Patterson’s testimony regarding the drawbacks of tolterodine). Indeed, such an argument appears to undermine Petitioner’s position, discussed in Section III.D.1 supra, that one of ordinary skill in the art would have selected 5-HMT as a lead compound over tolterodine to avoid the CYP2D6 metabolic pathway, and Dr. Patterson’s testimony that the prior art collectively “indicated to a skilled drug designer interested in overactive bladder treatment that 5-HMT would avoid the issues associated with dosing [] tolterodine.” Ex. 1003 ¶ 101. Petitioner’s argument also is contradicted by Dr. Patterson’s testimony that “5-HMT is not metabolized by both CYP2D6 and CYP3A4, but only by CYP3A4.” Id. ¶ 111; see also Ex. 1010, 289 (Postlind indicating that 5-HMT is not a CYP2D6 substrate).” slip op. at 25

  • Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner

    “Following our weighing of the experts’ testimony, we find that Dr. Roush’s testimony better addresses the issue at hand and we credit that testimony over Dr. Patterson’s testimony. Dr. Patterson opines generally that the “presence of two hydroxyl groups around the left most aromatic ring (shown above in blue) would have created a product likely to have decreased oral bioavailability compared to tolterodine because of its hydrophilicity and thus lower than acceptable lipophilicity” (Ex. 1003 ¶ 112), and that it “would [have been] a matter of routine experimentation” to confirm that 5-HMT could have significantly less bioavailability than its parent, tolterodine” (Ex. 1003 ¶ 115). Dr. Patterson, however, did not perform any experiments to confirm 5-HMT’s oral bioavailability, and cites to no further evidence to support his opinions. See Ex. 2022 ¶ 92; compare Brynne (Ex.1011) discussed supra § III.C.2. Dr. Roush, on the other hand, conducts an analysis of the compound under the “Rule of 5” to determine that “5-HMT does not meet a single factor, much less two, of the rule” thus teaching the skilled artisan “away from concluding that 5-HMT had an oral absorption problem.” PO Resp. 26– 27 (citing Ex. 2022 ¶¶ 56–58, 87, 92). At oral hearing, Patent Owner restated that the analysis under the Rule of 5 indicates that 5-HMT was “not even close to being a problem . . . for all four of these properties, 5-HMT says there’s no red flags; there’s no problem,” and that “Dr. Patterson admitted in his deposition, 5-HMT does not violate the Rule of Five.” Tr. 67:35–68:3; 68:17–21; see Ex. 2020 180:14–181:14.” slip op. at 31

  Patent outcomesUS 7,985,772 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 7,985,772
• Mylan Pharmaceuticals Inc. / Mylan Laboratories Limited v. Ucb Pharma GmbHNo claims unpatentable
  PTAB · Jul 19, 2017 · IPR2016-01665 · APJ Michelle N Ankenbrand · IPR · Final written decision

  Claims 1–5 and 21–24 were not shown unpatentable under either § 103 ground because the petitioner did not establish the motivation and reasonable expectation of success needed to reach the claimed compounds.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “art. For the purpose of this decision, we accept Petitioner’s undisputed contention that: [a] person of ordinary skill in the art would have a Ph.D. in chemistry, medicinal chemistry, pharmacology, or a related field, and at least one year of industrial exposure to drug discovery, drug design, and synthesis. In lieu of an advanced degree, the individual may have additional years of industry experience, including, for example, in drug discovery, drug synthesis, and structure-activity work. Pet. 6 (citing Ex. 1003 ¶ 23); see Resp. 6. Based on our review of the ’650 patent, the types of problems and solutions described in the ’650 patent and cited prior art, we adopt Petitioner’s definition of a person of ordinary skill in the art at the time of the claimed invention. We note that the applied prior art also reflects the appropriate level of skill at the time of the claimed invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 7

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner

    “the broadest reasonable construction in light of the specification of the patent in which they appear. See Cuozzo Speed Techs., LLC v. Lee, 136 S.Ct. 2131, 2144–46 (2016) (upholding the use of the broadest reasonable interpretation standard); 37 C.F.R. § 42.100(b). Under that standard, and absent any special definitions, we give claim terms their ordinary and customary meaning, as would be understood by one of ordinary skill in the art at the time of the invention. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Only those terms which are in controversy need to be construed, and only to the extent necessary to resolve the controversy. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). Petitioner submits that the “claims in the ʼ650 patent are presumed to take on their ordinary and customary meaning based on the broadest reasonable interpretation of the claim language.” Pet. 6. Patent Owner “does not dispute Petitioner’s position that no claim terms require construction, which the Board also accepted for purposes of institution.” Resp. 7 (citing Pet. 6; Inst. Dec. 7). In our Institution Decision, we determined that “no claim term requires express construction.” Inst. Dec. 7. After reviewing the entire record developed during trial, we affirm our determination from the Institution Decision that no claim term requires express construction to resolve the parties’ dispute.” slip op. at 8

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner

    “Following our weighing of the experts’ testimony, we find that Dr. Roush’s testimony better addresses the issue at hand and we credit that testimony over Dr. Patterson’s testimony. Dr. Patterson opines generally that the “presence of two hydroxyl groups around the left most aromatic ring . . . would have created a product likely to have decreased oral bioavailability compared to tolterodine because of its hydrophilicity and thus lower than acceptable lipophilicity” (Ex. 1003 ¶ 112), and that it “would [have been] a matter of routine experimentation” to confirm that 5-HMT could have significantly less bioavailability than its parent, tolterodine” (Ex. 1003 ¶ 115). Dr. Patterson, however, did not perform any experiments to confirm 5-HMT’s oral bioavailability, and cites to no further evidence to support his opinions. See Ex. 2022 ¶ 92; compare Brynne (Ex. 1011) discussed supra § II.D.1. Dr. Roush, on the other hand, conducts an analysis of the compound under the “Rule of 5” to determine that “5-HMT does not meet a single factor, much less two, of the rule” thus teaching the skilled artisan “away from concluding that 5-HMT had an oral absorption problem.” Resp. 28–29 (citing Ex. 2022 ¶¶ 56–58, 87, 92). At oral hearing, Patent Owner restated that the analysis under the Rule of 5 indicates that 5-HMT was “not even close to being a problem . . . for all four of these properties, 5-HMT says there’s no red flags; there’s no problem,” and that “Dr. Patterson admitted in his deposition, 5-HMT does not violate the Rule of Five.” Tr. 67:35–68:3; 68:17–21; see Ex. 2020, 180:14–181:14. Regarding Petitioner’s reliance on the statement in Brynne that “[t]olterodine is tenfold more lipophilic than 5-HM[T], and consequently tolterodine penetrates membranes more rapidly,” Patent Owner does not appear to dispute the substance of that statement. Although such a statement illustrates a relative relationship between the lipophilicity of 5-HMT and tolterodine, it does not demonstrate that the lipophilicity of 5-HMT would have presented an absorption problem that would have led one of ordinary skill in the art to modify 5-HMT. Even if 5-HMT were considered by one of ordinary skill in the art to be less lipophilic than tolterodine, and thereby less rapidly absorbed, the record lacks sufficient evidence regarding the actual properties of 5-HMT for us to conclude that 5-HMT’s lipophilicity would have presented a bioavailability problem.21 For these reasons, Petitioner’s assertion that 5-HMT “may have bioavailability concerns” that would have prompted one of ordinary skill in the art to modify 5-HMT is unpersuasive. Reply 13.” slip op. at 31

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable

    “On the complete record before us, we are unpersuaded that Petitioner carries its burden of demonstrating that 5-HMT has a bioavailability problem that would have motivated one of ordinary skill in the art to modify its structure. Regarding the lipophilicity profile of 5-HMT, Petitioner does not provide, or attempt to provide, any actual (as opposed to relative) data concerning the bioavailability of 5-HMT. Cf. supra § II.D.2 (Brynne comparing lipophilicity of tolterodine to lipophilicity of 5-HMT). Although data is not required, and although we do not find that absence of data alone to be fatal to Petitioner’s position on this issue, the absence of any data concerning the actual bioavailability of 5-HMT leaves Petitioner’s argument solely supported by expert testimony. We now turn to the contradictory statements of the parties’ experts. Following our weighing of the experts’ testimony, we find that Dr. Roush’s testimony better addresses the issue at hand and we credit that testimony over Dr. Patterson’s testimony. Dr. Patterson opines generally that the “presence of two hydroxyl groups around the left most aromatic ring . . . would have created a product likely to have decreased oral bioavailability compared to tolterodine because of its hydrophilicity and thus lower than acceptable lipophilicity” (Ex. 1003 ¶ 112), and that it “would [have been] a matter of routine experimentation” to confirm that 5-HMT could have significantly less bioavailability than its parent, tolterodine” (Ex. 1003 ¶ 115). Dr. Patterson, however, did not perform any experiments to confirm 5-HMT’s oral bioavailability, and cites to no further evidence to support his opinions. See Ex. 2022 ¶ 92; compare Brynne (Ex. 1011) discussed supra § II.D.1.” slip op. at 30

  Patent outcomesUS 6,858,650 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,858,650
• Mylan Pharmaceuticals Inc. / Mylan Laboratories Limited v. Ucb Pharma GmbHNo claims unpatentable
  PTAB · Jul 19, 2017 · IPR2016-01636 · APJ Michelle N Ankenbrand · IPR · Final written decision

  Claims 1–5 and 21–24 were not shown unpatentable under either § 103 ground because the evidence did not establish a reason to make the claimed modifications with a reasonable expectation of success.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “art. For the purpose of this decision, we accept Petitioner’s undisputed contention that: [a] person of ordinary skill in the art would have a Ph.D. in chemistry, medicinal chemistry, pharmacology, or a related field, and at least one year of industrial exposure to drug discovery, drug design, and synthesis. In lieu of an advanced degree, the individual may have additional years of industry experience, including, for example, in drug discovery, drug synthesis, and structure-activity work. Pet. 6 (citing Ex. 1003 ¶ 23); see Resp. 6. Based on our review of the ’650 patent, the types of problems and solutions described in the ’650 patent and cited prior art, we adopt Petitioner’s definition of a person of ordinary skill in the art at the time of the claimed invention. We note that the applied prior art also reflects the appropriate level of skill at the time of the claimed invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 7

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “the broadest reasonable construction in light of the specification of the patent in which they appear. See Cuozzo Speed Techs., LLC v. Lee, 136 S.Ct. 2131, 2144–46 (2016) (upholding the use of the broadest reasonable interpretation standard); 37 C.F.R. § 42.100(b). Under that standard, and absent any special definitions, we give claim terms their ordinary and customary meaning, as would be understood by one of ordinary skill in the art at the time of the invention. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Only those terms which are in controversy need to be construed, and only to the extent necessary to resolve the controversy. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). Petitioner submits that the “claims in the ʼ650 patent are presumed to take on their ordinary and customary meaning based on the broadest reasonable interpretation of the claim language.” Pet. 6. Patent Owner “does not dispute Petitioner’s position that no claim terms require construction, which the Board also accepted for purposes of institution.” Resp. 7 (citing Pet. 6; Inst. Dec. 7). In our Institution Decision, we determined that “no claim term requires express construction.” Inst. Dec. 7. After reviewing the entire record developed during trial, we affirm our determination from the Institution Decision that no claim term requires express construction to resolve the parties’ dispute.” slip op. at 8

  • BurdenNot shown unpatentable

    “II. DISCUSSION 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 why Petitioner has not met its burden with respect to the challenged claims.” slip op. at 7

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundReasonable expectation not foundNot shown unpatentable

    “On the complete record before us, we are unpersuaded that Petitioner carries its burden of demonstrating that 5-HMT has a bioavailability problem that would have motivated one of ordinary skill in the art to modify its structure. Regarding the lipophilicity profile of 5-HMT, Petitioner does not provide, or attempt to provide, any actual (as opposed to relative) data concerning the bioavailability of 5-HMT. Cf. supra § II.D.2 (Brynne comparing lipophilicity of tolterodine to lipophilicity of 5-HMT). Although data is not required, and although we do not find that absence of data alone to be fatal to Petitioner’s position on this issue, the absence of any data concerning the actual bioavailability of 5-HMT leaves Petitioner’s argument solely supported by expert testimony. We now turn to the contradictory statements of the parties’ experts. Following our weighing of the experts’ testimony, we find that Dr. Roush’s testimony better addresses the issue at hand and we credit that testimony over Dr. Patterson’s testimony. Dr. Patterson opines generally that the “presence of two hydroxyl groups around the left most aromatic ring . . . would have created a product likely to have decreased oral bioavailability compared to tolterodine because of its hydrophilicity and thus lower than acceptable lipophilicity” (Ex. 1003 ¶ 112), and that it “would [have been] a matter of routine experimentation” to confirm that 5-HMT could have significantly less bioavailability than its parent, tolterodine” (Ex. 1003 ¶ 115). Dr. Patterson, however, did not perform any experiments to confirm 5-HMT’s oral bioavailability, and cites to no further evidence to support his opinions. See Ex. 2022 ¶ 92; compare Brynne (Ex. 1011) discussed supra § II.D.1.” slip op. at 30

  Patent outcomesUS 6,858,650 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,858,650
• Mylan Pharmaceuticals Inc. / Mylan Laboratories Limited et al. v. Ucb Pharma GmbHNo claims unpatentable
  PTAB · Jul 19, 2017 · IPR2016-01596 · APJ Michelle N Ankenbrand · IPR · Final written decision

  Claims 1–5 and 21–24 were not shown unpatentable under either § 103 ground because the evidence did not establish a reason to make the claimed modifications with a reasonable expectation of success.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “art. For the purpose of this decision, we accept Petitioner’s undisputed contention that: [a] person of ordinary skill in the art would have a Ph.D. in chemistry, medicinal chemistry, pharmacology, or a related field, and at least one year of industrial exposure to drug discovery, drug design, and synthesis. In lieu of an advanced degree, the individual may have additional years of industry experience, including, for example, in drug discovery, drug synthesis, and structure-activity work. Pet. 6 (citing Ex. 1003 ¶ 23); see Resp. 6. Based on our review of the ’650 patent, the types of problems and solutions described in the ’650 patent and cited prior art, we adopt Petitioner’s definition of a person of ordinary skill in the art at the time of the claimed invention. We note that the applied prior art also reflects the appropriate level of skill at the time of the claimed invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 7

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “the broadest reasonable construction in light of the specification of the patent in which they appear. See Cuozzo Speed Techs., LLC v. Lee, 136 S.Ct. 2131, 2144–46 (2016) (upholding the use of the broadest reasonable interpretation standard); 37 C.F.R. § 42.100(b). Under that standard, and absent any special definitions, we give claim terms their ordinary and customary meaning, as would be understood by one of ordinary skill in the art at the time of the invention. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Only those terms which are in controversy need to be construed, and only to the extent necessary to resolve the controversy. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). Petitioner submits that the “claims in the ʼ650 patent are presumed to take on their ordinary and customary meaning based on the broadest reasonable interpretation of the claim language.” Pet. 6. Patent Owner “does not dispute Petitioner’s position that no claim terms require construction, which the Board also accepted for purposes of institution.” Resp. 7 (citing Pet. 6; Inst. Dec. 7). In our Institution Decision, we determined that “no claim term requires express construction.” Inst. Dec. 7. After reviewing the entire record developed during trial, we affirm our determination from the Institution Decision that no claim term requires express construction to resolve the parties’ dispute.” slip op. at 8

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner

    “Following our weighing of the experts’ testimony, we find that Dr. Roush’s testimony better addresses the issue at hand and we credit that testimony over Dr. Patterson’s testimony. Dr. Patterson opines generally that the “presence of two hydroxyl groups around the left most aromatic ring . . . would have created a product likely to have decreased oral bioavailability compared to tolterodine because of its hydrophilicity and thus lower than acceptable lipophilicity” (Ex. 1003 ¶ 112), and that it “would [have been] a matter of routine experimentation” to confirm that 5-HMT could have significantly less bioavailability than its parent, tolterodine” (Ex. 1003 ¶ 115). Dr. Patterson, however, did not perform any experiments to confirm 5-HMT’s oral bioavailability, and cites to no further evidence to support his opinions. See Ex. 2022 ¶ 92; compare Brynne (Ex. 1011) discussed supra § II.D.1. Dr. Roush, on the other hand, conducts an analysis of the compound under the “Rule of 5” to determine that “5-HMT does not meet a single factor, much less two, of the rule” thus teaching the skilled artisan “away from concluding that 5-HMT had an oral absorption problem.” Resp. 28–29 (citing Ex. 2022 ¶¶ 56–58, 87, 92). At oral hearing, Patent Owner restated that the analysis under the Rule of 5 indicates that 5-HMT was “not even close to being a problem . . . for all four of these properties, 5-HMT says there’s no red flags; there’s no problem,” and that “Dr. Patterson admitted in his deposition, 5-HMT does not violate the Rule of Five.” Tr. 67:35–68:3; 68:17–21; see Ex. 2020, 180:14–181:14. Regarding Petitioner’s reliance on the statement in Brynne that “[t]olterodine is tenfold more lipophilic than 5-HM[T], and consequently tolterodine penetrates membranes more rapidly,” Patent Owner does not appear to dispute the substance of that statement. Although such a statement illustrates a relative relationship between the lipophilicity of 5-HMT and tolterodine, it does not demonstrate that the lipophilicity of 5-HMT would have presented an absorption problem that would have led one of ordinary skill in the art to modify 5-HMT. Even if 5-HMT were considered by one of ordinary skill in the art to be less lipophilic than tolterodine, and thereby less rapidly absorbed, the record lacks sufficient evidence regarding the actual properties of 5-HMT for us to conclude that 5-HMT’s lipophilicity would have presented a bioavailability problem.21 For these reasons, Petitioner’s assertion that 5-HMT “may have bioavailability concerns” that would have prompted one of ordinary skill in the art to modify 5-HMT is unpersuasive. Reply 13.” slip op. at 31

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundReasonable expectation not foundNot shown unpatentable

    “On the complete record before us, we are unpersuaded that Petitioner carries its burden of demonstrating that 5-HMT has a bioavailability problem that would have motivated one of ordinary skill in the art to modify its structure. Regarding the lipophilicity profile of 5-HMT, Petitioner does not provide, or attempt to provide, any actual (as opposed to relative) data concerning the bioavailability of 5-HMT. Cf. supra § II.D.2 (Brynne comparing lipophilicity of tolterodine to lipophilicity of 5-HMT). Although data is not required, and although we do not find that absence of data alone to be fatal to Petitioner’s position on this issue, the absence of any data concerning the actual bioavailability of 5-HMT leaves Petitioner’s argument solely supported by expert testimony. We now turn to the contradictory statements of the parties’ experts. Following our weighing of the experts’ testimony, we find that Dr. Roush’s testimony better addresses the issue at hand and we credit that testimony over Dr. Patterson’s testimony. Dr. Patterson opines generally that the “presence of two hydroxyl groups around the left most aromatic ring . . . would have created a product likely to have decreased oral bioavailability compared to tolterodine because of its hydrophilicity and thus lower than acceptable lipophilicity” (Ex. 1003 ¶ 112), and that it “would [have been] a matter of routine experimentation” to confirm that 5-HMT could have significantly less bioavailability than its parent, tolterodine” (Ex. 1003 ¶ 115). Dr. Patterson, however, did not perform any experiments to confirm 5-HMT’s oral bioavailability, and cites to no further evidence to support his opinions. See Ex. 2022 ¶ 92; compare Brynne (Ex. 1011) discussed supra § II.D.1.” slip op. at 30

  Patent outcomesUS 6,858,650 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,858,650
• Enovate Medical, LLC v. Intermetro Industries CorporationAll claims unpatentable
  PTAB · May 11, 2016 · IPR2015-00300 · APJ Jennifer S Bisk · IPR · Final written decision

  Claims 27, 28, 88, 101, and 108 are unpatentable as obvious over Dell, Sweere, and Allan, with Planar additionally applied to claim 108.

  RulingsFinal written decision

  • PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner

    “77 Fed. Reg. 48,756, 48,759 (Aug. 14, 2012) (internal citations omitted). Generally, “the ‘real party-in-interest’ [on the petitioner side] is the party that desires review of the patent. Thus, the ‘real party-in-interest’ may be the petitioner itself, and/or it may be the party or parties at whose behest the petition has been filed.” Id.” slip op. at 8

  • ExcludeMotion to exclude, grantedGranted

    “IV. MOTIONS TO EXCLUDE Petitioner filed a Motion to Exclude Exhibits 2003–2006. Paper 33. Each of Exhibits 2003–2005 is a license agreement, and Exhibit 2006 is a Declaration by Robert A. Sobie. All of this evidence was submitted by Patent Owner as objective evidence of secondary considerations. Because we do not rely on any of that evidence in a manner adverse to Petitioner, we dismiss the Motion as moot. Patent Owner filed a Motion to Exclude Exhibit 1007, which is a declaration by T.E. Schlesinger, Ph.D., which Petitioner filed with its Reply. Paper 35. Because we do not rely on Exhibit 1007 in any manner, we dismiss the Motion as moot.” slip op. at 28

  • PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Other

    “entity. It was filed without our authorization because it was filed with Patent Owner’s Opposition to Petitioner’s Motion to Exclude despite that Exhibit 202316 is not responsive to the Motion to Exclude. Paper 42 (“Opp. to Pet. Mot. to Excl.”). In fact, Patent Owner’s Opposition requests that we enter into the record “new Exhibit 2023, which was finalized subsequent to Patent Owner’s Response.” Opp. to Pet. Mot. to Excl. 1. A request for relief should not be made in an opposition brief. It should be made in a motion. 37 C.F.R. § 42.20(a) (“Relief, other than a petition requesting the institution of a trial, must be requested in the form of a motion.”). Further, a motion (and, thus, a request for relief) may be filed only if authorization has been obtained. 37 C.F.R. § 42.20(b) (“A motion will not be entered without Board authorization. Authorization may be provided in an order of general applicability or during the proceeding.”). Consequently, Exhibit 2023 shall be expunged because it was filed without our authorization. See 37 C.F.R. § 42.7.” slip op. at 29

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed

    “No limitation requires an express construction for purposes of the patentability challenge at issue here. See Pet. 6–7 (offering only one proposed construction, which was not material to the patentability challenge);8 PO Resp. 11 (“Patent Owner agrees that the claim terms involved in the [instituted Grounds] do not require construction for purposes of resolving this [inter partes review (IPR)].”).” slip op. at 7

  Patent outcomesUS 6,721,178 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,721,178
• TRW Automotive U.S. LLC v. Magna Electronics Inc.No claims unpatentable
  PTAB · Jan 15, 2016 · IPR2014-01348 · APJ Michael J Fitzpatrick · IPR · Final written decision

  The Board held claims 40, 41, 43, 44, 46–59, 61–64, 66–74, 86, 87, 89, and 90 not unpatentable because it excluded Goldbeck for lack of authentication.

  RulingsFinal written decision

  • ExcludeMotion to exclude, grantedGranted

    “Rule 901(a) states: “To satisfy the requirement of authenticating or identifying an item of evidence, the proponent must produce evidence sufficient to support a finding that the item is what the proponent claims it is.” Fed. R. Evid. 901(a). Thus, we first look to what TRW claimed Exhibit 1105 to be. In that regard, the only identifying information provided by TRW is a footnote in its Petition. See Pet. 2 n.4. The footnote offers a purported bibliographic reference for Exhibit 1105 as follows: “Goldbeck et al., ‘Lane 5 detection and tracking by video sensors,’ Intelligent Transportation Systems, 1999. Proc., 5-8 Oct. 1999, pp.74-79.; prior art under 35 U.S.C. § 102(b).” Id. Thus, TRW claimed that Exhibit 1105 was published during October 5–8 of 1999 in something called Intelligent Transportation Systems. Id. TRW did not cite or otherwise provide any evidence for this claim. Id.8” slip op. at 5

  • BurdenNot shown unpatentable

    “In its Petition, TRW offered Exhibit 1105 as an article published October 5– 8, 1999, in Intelligent Transportation Systems. Pet. 2 n.4. Magna timely objected for, among other things, lack of authentication. TRW did not serve any supplemental evidence that Exhibit 1105 is what TRW claims it is. And, in opposing the Motion to Exclude, TRW has not directed us to evidence probative of Exhibit 1105 being an article published October 5–8, 1999, in Intelligent Transportation Systems or persuaded us that Exhibit 1105 is self-authenticating for that which TRW generally claims it to be: “an IEEE publication from an IEEE periodical.” Opp. 4. Magna’s Motion to Exclude Exhibit 1105 for lack of authentication is granted. III. CONCLUSION Petitioner’s ground of unpatentability relies on Exhibit 1105 (Goldbeck). Because we exclude Exhibit 1105 from evidence, Petitioner’s ground of unpatentability necessarily fails.” slip op. at 12

  Patent outcomesUS 8,508,593 not shown unpatentable
  None
  Patents in suitUS 8,508,593
• TRW Automotive U.S. LLC v. Magna Electronics Inc.No claims unpatentable
  PTAB · Jan 6, 2016 · IPR2014-01347 · APJ Michael J Fitzpatrick · IPR · Final written decision

  The Board held claims 1–3, 6–12, 16, 18–31, 33–39, 76–80, and 82–85 not unpatentable because it excluded Goldbeck for lack of authentication, defeating both obviousness grounds.

  RulingsFinal written decision

  • ExcludeMotion to exclude, grantedGranted

    “Rule 901(a) states: “To satisfy the requirement of authenticating or identifying an item of evidence, the proponent must produce evidence sufficient to support a finding that the item is what the proponent claims it is.” Fed. R. Evid. 901(a). Thus, we first look to what TRW claimed Exhibit 1005 to be.” slip op. at 6

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityNot reached

    “Magna challenged the sufficiency of TRW’s evidence that Exhibit 1005 constitutes a prior art printed publication. See PO Resp. 48–50; see also 35 U.S.C. § 311(b) (“A petitioner in an inter partes review may request to cancel as unpatentable 1 or more claims of a patent . . . only on the basis of prior art consisting of patents or printed publications.”). TRW responded to Magna’s sufficiency of the evidence arguments by” slip op. at 4

  Patent outcomesUS 8,508,593 not shown unpatentable
  § 102 anticipation
  Patents in suitUS 8,508,593

Holdings, summaries, rulings, issues, outcomes, winners and claim constructions shown for a decision were generated by a large language model reading the opinion. They are a guide to the decision, not the decision. Confirm every one against the court's own text before relying on it. Outcomes read from the patent owner’s side. Party names are extracted from the decision and are missing on about 900 short Director denials and scans, which carry the trial number instead.