• Celltrion, Inc. / Pfizer, Inc. v. Biogen, Inc. And Genentech, Inc.No claims unpatentable
  PTAB · Feb 21, 2018 · IPR2016-01614 · APJ Erica A Franklin · IPR · Final written decision

  Claims 1–3, 5–7, and 9–11 were not shown unpatentable under § 103 because the Rituxan Label was not established as prior art and the remaining references did not teach all claimed limitations.

  RulingsFinal written decision

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

    “In the Petition, Petitioners assert that no terms of the challenged claims require construction. Pet. 22. However, Petitioners note that a person of skill in the art would have understood that “rituximab,” recited in claim 1, is “a CD20 antibody that binds to the CD20 antigen on human B lymphocytes.” Pet. 22–23. Indeed, claims 5 and 9 recite “an antibody that binds to the CD20 antigen on human B lymphocytes” and explain that “the CD20 antibody is rituximab.” Id. at 23. In the Institution Decision, we agreed with Petitioners that no claim terms required construction for purposes of that decision. Dec. 5 (citing See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (only terms which are in controversy need to be construed, and only to the extent necessary to resolve the controversy)). The parties do not assert otherwise in the Patent Owner Response or in Petitioners’ Reply. Accordingly, because the parties identify no controversy as to the scope of any claim terms, we conclude that, for the purpose of this Final Written Decision, no claim term requires express construction.” slip op. at 7

  • Skill levelSkill level board ownOther

    “The proposed definitions asserted by Petitioners and Patent Owner suggest that the level of skill in the art is considerably high. Petitioners’ definition is more limiting than Patent Owner’s definition in that it requires, for example, the person of ordinary skill in the art to have more years of experience in treating RA patients and an understanding of “all of the available and proposed methods of treating RA and other auto-immune disorders … and how they work to treat such disorders.” Pet. 24. Based on the record as a whole, we determine that a person of ordinary skill in the art is not so limited. The invention and the cited references are directed to standard and proposed methods of treating RA and not all “other auto-immune disorders.” In terms of years of experience, we recognize rheumatology as a specialized area of medicine, wherein acquiring at least three years of experience would be sufficiently significant. Accordingly, we find that the record as a whole supports defining the level of ordinary skill in the art as: a practicing rheumatologist with a medical degree (M.D. or equivalent) and: (i) at least three years of experience treating RA patients; (ii) an understanding of the immunology and the pathophysiology of RA; and (iii) an understanding of the available and proposed methods of treating RA, including relevant clinical trials for such treatment. We also note that the applied prior art 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 9

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedNot shown unpatentable

    “under 35 U.S.C. § 102(b). Even assuming that Exhibit 1056 authenticates Exhibit 1055 and establishes that the reference was online on January 23, 1998, our determination whether Exhibit 1055 was publicly accessible prior to the critical date requires further inquiry. That is, we must determine whether Petitioners made a satisfactory showing that the reference was “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., 511 F.3d at 1194. For example, the Federal Circuit has explained “evidence that a query of a search engine before the critical date, using any combination of search words, would have led to the [reference] appearing in the search results” is probative of public accessibility. Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1350 (Fed. Cir. 2016). In this regard, Petitioners assert only that “Genentech’s website was organized such that the label could be easily located. Therefore the label was broadly disseminated and publicly accessible before May 1998 to anyone with a browser and an Internet connection.” Pet. 18 n.2. That assertion is not further explained or accompanied by citation to any evidence supporting Petitioners’ contention about Genentech’s website. Nor have Petitioners offered evidence indicating that persons interested and ordinarily skilled in treating rheumatoid arthritis would have identified and visited Genentech’s website before the critical date, and in doing so, would have searched for rituximab drug information, a product newly manufactured and indicated for the treatment of non-Hodgkin’s lymphoma. Ex. 1055, 3.” slip op. at 18

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

    “Petitioners do not rely on Edwards, O’Dell, or Kalden as teaching or suggesting “administering more than one intravenous dose of a therapeutically effective amount of” rituximab. See Pet. 34–35. Claims 2, 6, and 10 depend from claims 1, 5, and 9, respectively, and recite specific ranges for the dosage of rituximab. Ex. 1001, 30:1–3, 18–20, 35–37. Petitioners do not rely on Edwards, O’Dell, or Kalden as teaching or suggesting that limitation. Pet. 40–41. Claims 3, 7, and 11 also depend from claims 1, 5, and 9, respectively, and recite methods further comprising administering a glucocorticosteroid. Ex. 1001, 30:4–5, 21–22, 38–39. Petitioners do not rely on Edwards, O’Dell, or Kalden as teaching or suggesting that limitation. Pet. 41. In the Reply, Petitioners assert that “the dose of Rituxan that was approved by FDA to treat NHL, and [the] proposition that steroids effectively treat hypersensitivity reactions . . . were common knowledge in 1999 (Boers2 at ¶¶ 23–24).” Reply 24. This assertion is inadequate to supply the claim limitations not asserted to be taught or suggested by the combined prior art. Significantly, Petitioners have not shown that its assertion in the Reply was presented in the Petition. Further, the referenced testimony of Dr. Boers relates only to the use of glucocorticosteroids and not to the dose of Rituxan. Ex. 1064 ¶¶ 23–24. Moreover, Dr. Boers’ opinions relating to the use of glucocorticosteroids is unaccompanied by citation to any evidence. Id. Thus, those opinions are not entitled to persuasive weight.” slip op. at 22

  Patent outcomesUS 7,820,161 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Graham
  Patents in suitUS 7,820,161
• Argentum Pharmaceuticals LLC / Mylan Pharmaceuticals Inc. et al. v. Research Corporation Technologies, Inc.No claims unpatentable
  PTAB · Mar 22, 2017 · IPR2016-01242 · APJ Francisco C Prats · IPR · Final written decision

  Claims 1–13 were not shown unpatentable: Petitioner failed to establish obviousness of claims 1–9 over Kohn 1991 and Silverman, or claims 10–13 over those references and the ’729 patent.

  RulingsFinal written decision

  • BurdenNot shown unpatentable

    “In an inter partes review instituted under this chapter, the petitioner shall have the burden of proving a proposition of unpatentability by a preponderance of the evidence.” 35 U.S.C. § 316(e). Based on the record developed in this proceeding, we conclude that Petitioner has not established by a preponderance of the evidence that claims 1–9 of the ’551 patent are unpatentable for obviousness over Kohn 1991 and Silverman, nor has Petitioner established by a preponderance of the evidence that claims 10–13 of the ’551 patent are unpatentable for obviousness over Kohn 1991, Silverman, and the ’729 patent. slip op. at 4

  • Strike new argumentNew argument disregardedDecided for patent owner

    “As provided in 37 C.F.R. § 42.23(b), a “reply may only respond to arguments raised in the corresponding opposition or patent owner response.” Thus, “a reply that raises a new issue or belatedly presents evidence will not be considered and may be returned. The Board will not attempt to sort proper from improper portions of the reply.” Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,767 (Aug. 14, 2012). One indication that a new issue has been raised in a reply is where a petitioner submits “new evidence necessary to make out a prima facie case” of unpatentability of an original claim. Id.; see also Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369–70 (Fed. Cir. 2016) (Board did not err or abuse its discretion in declining to consider new contentions and evidence in reply advanced to supplement unpatentability rationale presented in petition).” slip op. at 5

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedMixed

    “Petitioner relies on the uncorroborated testimony of its expert, Dr. Wang, as support for its contention that compound 3l’s methoxyamino group is an uncommon moiety among commercial pharmaceuticals that presents potential synthetic and stability issues, and also for its contention that the posited substitute, a methoxymethyl group, is a more common and acceptable moiety for pharmaceutically active compounds. See Pet. 44–45; see also Ex. 1002 ¶¶ 106, 107 (Wang Decl.) (citing no documentary support). As stated in 37 C.F.R. § 42.65(a), “[e]xpert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.” We, nonetheless, acknowledge Dr. Wang’s education and experience (Ex. 1002 ¶¶ 6–10, Appendix A), and note that Patent Owner does not dispute specifically the accuracy of Dr. Wang’s assertions in this regard. We thus acknowledge that, as a general principle in the art of medicinal chemistry, an ordinary artisan seeking to develop a commercial pharmaceutical compound ordinarily would have considered the substitution of a methoxyamino group with another more common and acceptable moiety, particularly because of any potential synthetic and stability issues associated with the methoxyamino group in the compound. Petitioner, however, does not identify a specific reason as to why that substitution would have been considered desirable for any of the prior art anticonvulsant compounds taught by Kohn 1991, let alone compound 3l identified as the lead compound.” slip op. at 18

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “1. Level of Ordinary Skill in the Art Petitioner contends that the relevant art is medicinal chemistry. Pet 12. As to the level of ordinary skill in that art as of March 15, 1996 (the earliest possible priority date of the ’551 patent), Petitioner contends as follows: [A] POSA [person of ordinary skill in the art] would have a Ph.D. in organic or medicinal chemistry and at least a few years of experience in medicinal chemistry, including in the development of potential drug candidates. Ex. 1002, ¶ 13 [Wang Decl.]. The POSA would also include a person having a Bachelor’s or Master’s degree (organic chemistry or medicinal chemistry) if such a person had more years of experience in medicinal chemistry and the development of potential drug candidates. Id. With experience in drug development, the POSA would have an appreciation of the diseases and ailments a particular drug candidate is intended to treat, but would not necessarily be a medical doctor or clinician. The POSA would know how to evaluate the physical and biological properties of chemical compounds and would be able to conduct, or otherwise have access to resources that could conduct, in vitro and in vivo evaluations of biological and toxicity properties of chemical compounds. Id. Pet. 12. Patent Owner does not controvert Petitioner’s characterization of the relevant art, or the level of ordinary skill in that art, nor does Patent Owner advance a specific assertion of its own as to the level of ordinary skill. See, generally, PO Resp. Accordingly, when evaluating the parties’ contentions regarding the scope and content of the prior art, and the differences between the prior art and the challenged claims, we take into consideration Petitioner’s assertions regarding the level of ordinary skill. We also consider that the cited references provide evidence as to the level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 11

  Patent outcomesUS RE38,551 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
• Lupin Ltd. / Lupin Pharmaceuticals Inc. et al. v. Senju Pharmaceutical Co., Ltd.No claims unpatentable
  PTAB · Sep 12, 2016 · IPR2015-01105 · APJ Erica A Franklin · IPR · Final written decision

  Petitioners failed to prove claims 1–27 unpatentable as obvious over Sallmann and Ogawa, because unexpected properties, industry praise, and commercial success outweighed the obviousness showing.

  RulingsFinal written decision

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

    “We agree with Petitioners. Only those claim terms that are in controversy need to be construed, and only to the extent necessary to resolve the controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). Patent Owner has not identified any controversy as to the scope of the claim terms for which it seeks construction. Nor does Patent Owner explain specifically why adopting the district court’s construction of the identified terms is necessary to resolve an issue in this proceeding. Accordingly, we decline to adopt the district court’s claim construction. Rather, because the parties identify no controversy as to the scope of any claim terms, we conclude that, for the purposes of this decision, no claim term requires express construction.” slip op. at 8

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “Petitioners assert that a person of ordinary skill in the art “would generally be a pharmaceutical scientist involved in the research and development of pharmaceuticals, and would have a Ph.D. and several years of experience in the field.” Pet. 6. Patent Owner asserts, more broadly, that a person of ordinary skill in the art would have at least a bachelor’s degree in a field such as chemistry, pharmaceutical chemistry or a related discipline with 3–5 years of work experience. PO Resp. 7 (citing Ex. 2082 ¶¶ 47–48 (Williams Decl.)). Based on the record as a whole, we find that Patent Owner’s description more appropriately encompasses the broad education that the person of ordinary skill in the relevant art may possess. Thus, we adopt that description. We note, however, that neither party asserts specifically that the ultimate conclusion of obviousness turns on adoption of a particular level of ordinary skill.” slip op. at 9

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner

    “Given these prior art teachings, Petitioners persuade us that an ordinary artisan would have recognized that tyloxapol and polysorbate 80 were interchangeably useful as non-ionic surfactants in acidic NSAID-containing ophthalmic aqueous solutions, and, therefore, absent persuasive objective evidence to the contrary, that is enough to support the proposed substitution, even in the absence of an express suggestion to do so. In re Mayne, 104 F.3d 1339, 1340 (Fed. Cir. 1997); In re Fout, 675 F.2d 297, 301 (CCPA 1982); In re Siebentritt, 372 F.2d 566, 568 (CCPA 1967)). As to the stability requirements in claims 1, 7, and 13, the ’813 patent discloses that the tyloxapol range effective to stabilize a bromfenac-containing solution is between about 0.01 and 0.5 w/v %. Ex. 1003, 5:19– 25. Both the tyloxapol concentration described in Sallmann (0.1 w/v %) and the polysorbate 80 concentration described in Ogawa (0.15 w/v %), fall within the stabilizing range set out in the ’813 patent. Therefore, in addition to having a reason to substitute the tyloxapol recited in claims 1, 7, and 13 of the ’813 patent for the polysorbate 80 in Ogawa’s Example 6, an ordinary artisan also had a reason to include the tyloxapol at a concentration encompassed by each of those claims.” slip op. at 15

  • Obviousness (§103) › Objective indicia / secondary considerations › Unexpected resultsObjective indicia outweighedDecided for patent owner

    “In sum, in light of the discussed comparisons, the advantageous properties inhering to tyloxapol-containing bromfenac formulations, and the supporting testimony of Patent Owner’s witnesses, we find that Patent Owner has advanced evidence sufficient to support its contentions that the compositions recited in claims 1, 7, and 13 of the ’813 patent exhibit unexpected properties.” slip op. at 26

  Patent outcomesUS 8,871,813 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,871,813
• Lupin Ltd. / Lupin Pharmaceuticals Inc. et al. v. Senju Pharmaceutical Co., Ltd.No claims unpatentable
  PTAB · Sep 12, 2016 · IPR2015-01100 · APJ Erica A Franklin · IPR · Final written decision

  Claims 1–30 were not shown unpatentable over Sallmann and Ogawa under § 103 because the unexpected properties and other objective evidence outweighed the showing of obviousness.

  RulingsFinal written decision

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

    “We agree with Petitioners. Only those claim terms that are in controversy need to be construed, and only to the extent necessary to resolve the controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). Patent Owner has not identified any controversy as to the scope of the claim terms for which it seeks construction. Nor does Patent Owner explain specifically why adopting the district court’s construction of the identified terms is necessary to resolve an issue in this proceeding. Accordingly, we decline to adopt the district court’s claim construction. Rather, because the parties identify no controversy as to the scope of any claim terms, we conclude that, for the purposes of this decision, no claim term requires express construction.” slip op. at 9

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “Petitioners assert that a person of ordinary skill in the art “would generally be a pharmaceutical scientist involved in the research and development of pharmaceuticals, and would have a Ph.D. and several years of experience in the field.” Pet. 6. Patent Owner asserts, more broadly, that a person of ordinary skill in the art would have at least a bachelor’s degree in a field such as chemistry, pharmaceutical chemistry or a related discipline with 3–5 years of work experience. PO Resp. 7 (citing Ex. 2082 ¶¶ 47–48 (Williams Decl.)). Based on the record as a whole, we find that Patent Owner’s description more appropriately encompasses the broad education that the person of ordinary skill in the relevant art may possess. Thus, we adopt that description. We note, however, that neither party asserts specifically that the ultimate conclusion of obviousness turns on adoption of a particular level of ordinary skill.” slip op. at 9

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner

    “Given these prior art teachings, Petitioners persuade us that an ordinary artisan would have recognized that tyloxapol and polysorbate 80 were interchangeably useful as non-ionic surfactants in acidic NSAID-containing ophthalmic aqueous solutions, and, therefore, absent persuasive objective evidence to the contrary, that is enough to support the proposed substitution, even in the absence of an express suggestion to do so. In re Mayne, 104 F.3d 1339, 1340 (Fed. Cir. 1997); In re Fout, 675 F.2d 297, 301 (CCPA 1982); In re Siebentritt, 372 F.2d 566, 568 (CCPA 1967)). As to the stability requirements in claims 1, 11, and 19, the ’606 patent discloses that the tyloxapol range effective to stabilize a bromfenac-containing solution is between about 0.01 and 0.5 w/v %. Ex. 1004, 5:19– 25. Both the tyloxapol concentration described in Sallmann (0.1 w/v %) and the polysorbate 80 concentration described in Ogawa (0.15 w/v %), fall within the stabilizing range set out in the ’606 patent. Therefore, in addition to having a reason to substitute the tyloxapol recited in claims 1, 11, and 19 of the ’606 patent for the polysorbate 80 in Ogawa’s Example 6, an ordinary artisan also had a reason to include the tyloxapol at a concentration encompassed by each of those claims.” slip op. at 16

  • Strike new argumentNew argument disregardedDecided for patent owner

    “However, as noted above, Petitioners sought in their Reply to supplement the original obviousness rationale over Sallmann and Ogawa in the Petition by advancing new evidence supporting “further motivation” for including tyloxapol in bromfenac formulations. See, e.g., Reply 8–9. Accordingly, Patent Owner persuades us that the evidence allegedly supporting Petitioners’ assertions of “further motivation” is impermissibly raised for the first time in the Reply. See 37 C.F.R. § 42.23(b) (“A reply may only respond to arguments raised in the corresponding opposition or patent owner response.”); see also Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821 F.3d at 1369–70 (Board did not err or abuse its discretion in declining to consider new contentions and evidence in Reply advanced to supplement unpatentability rationale presented in Petition). We, therefore, accord no weight to ¶¶ 31–33, 37, 38, and footnote 5 of Dr. Lawrence’s Reply Declaration, or to Exhibits 1096–1098, 1100–1102, 1107–1109, 1172, and 1173, to the extent that evidence is discussed in the Reply and relates to the new rationale of unpatentability. Patent Owner’s motion to exclude that evidence, therefore, is dismissed as being rendered moot.” slip op. at 47

  Patent outcomesUS 8,927,606 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,927,606
• Lupin Ltd. / Lupin Pharmaceuticals Inc. et al. v. Senju Pharmaceutical Co., Ltd.No claims unpatentable
  PTAB · Sep 12, 2016 · IPR2016-00090 · APJ Erica A Franklin · IPR · Final written decision

  Claims 1–27 were not shown unpatentable under § 103 over Sallmann and Ogawa because unexpected properties, industry praise, and commercial success outweighed the obviousness showing.

  RulingsFinal written decision

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

    “We agree with Petitioners. Only those claim terms that are in controversy need to be construed, and only to the extent necessary to resolve the controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). Patent Owner has not identified any controversy as to the scope of the claim terms for which it seeks construction. Nor does Patent Owner explain specifically why adopting the district court’s construction of the identified terms is necessary to resolve an issue in this proceeding. Accordingly, we decline to adopt the district court’s claim construction. Rather, because the parties identify no controversy as to the scope of any claim terms, we conclude that, for the purposes of this decision, no claim term requires express construction.” slip op. at 8

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “Petitioners assert that a person of ordinary skill in the art “would generally be a pharmaceutical scientist involved in the research and development of pharmaceuticals, and would have a Ph.D. and several years of experience in the field.” Pet. 6. Patent Owner asserts, more broadly, that a person of ordinary skill in the art would have at least a bachelor’s degree in a field such as chemistry, pharmaceutical chemistry or a related discipline with 3–5 years of work experience. PO Resp. 7 (citing Ex. 2082 ¶¶ 47–48 (Williams Decl.)). Based on the record as a whole, we find that Patent Owner’s description more appropriately encompasses the broad education that the person of ordinary skill in the relevant art may possess. Thus, we adopt that description. We note, however, that neither party asserts specifically that the ultimate conclusion of obviousness turns on adoption of a particular level of ordinary skill.” slip op. at 9

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner

    “Given these prior art teachings, Petitioners persuade us that an ordinary artisan would have recognized that tyloxapol and polysorbate 80 were interchangeably useful as non-ionic surfactants in acidic NSAID-containing ophthalmic aqueous solutions, and, therefore, absent persuasive objective evidence to the contrary, that is enough to support the proposed substitution, even in the absence of an express suggestion to do so. In re Mayne, 104 F.3d 1339, 1340 (Fed. Cir. 1997); In re Fout, 675 F.2d 297, 301 (CCPA 1982); In re Siebentritt, 372 F.2d 566, 568 (CCPA 1967)).” slip op. at 15

  • Obviousness (§103) › Objective indicia / secondary considerations › Unexpected resultsObjective indicia outweighedDecided for patent owner

    “and compositions encompassed by claims 1, 7, and 13 of the ’813 patent show that including tyloxapol in bromfenac-containing aqueous solutions unexpectedly inhibits bromfenac degradation. PO Resp. 36–45. Having reviewed Patent Owner’s evidence and arguments regarding unexpected results, in light of Petitioners’ responsive evidence and arguments on that issue, we agree with Patent Owner that the evidence of record supports a finding that the claimed compositions exhibit properties that an ordinary artisan would not have expected.” slip op. at 20

  Patent outcomesUS 8,871,813 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,871,813
• Lupin Ltd. / Lupin Pharmaceuticals Inc. et al. v. Senju Pharmaceutical Co., Ltd.No claims unpatentable
  PTAB · Sep 12, 2016 · IPR2016-00091 · APJ Erica A Franklin · IPR · Final written decision

  Claims 1–30 were not shown unpatentable under § 103 over Sallmann and Ogawa; unexpected properties and objective evidence outweighed the showing of obviousness.

  RulingsFinal written decision

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

    “On February 25, 2016, we instituted an inter partes review in IPR2016-00091 and granted the motion for joinder with IPR2015-01100, adding InnoPharma Licensing, Inc., InnoPharma Licensing LLC, InnoPharma Inc., InnoPharma LLC, Mylan Pharmaceuticals, and Mylan Inc. to the Lupin petitioner (collectively “Petitioners”). Paper 22. Petitioners filed a Reply to the Patent Owner Response. Paper 35 (Public), Paper 37 (Parties and Board Only), (collectively, “Reply”).” slip op. at 2

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

    “We agree with Petitioners. Only those claim terms that are in controversy need to be construed, and only to the extent necessary to resolve the controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). Patent Owner has not identified any controversy as to the scope of the claim terms for which it seeks construction. Nor does Patent Owner explain specifically why adopting the district court’s construction of the identified terms is necessary to resolve an issue in this proceeding. Accordingly, we decline to adopt the district court’s claim construction. Rather, because the parties identify no controversy as to the scope of any claim terms, we conclude that, for the purposes of this decision, no claim term requires express construction.” slip op. at 9

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “development of pharmaceuticals, and would have a Ph.D. and several years of experience in the field.” Pet. 6. Patent Owner asserts, more broadly, that a person of ordinary skill in the art would have at least a bachelor’s degree in a field such as chemistry, pharmaceutical chemistry or a related discipline with 3–5 years of work experience. PO Resp. 7 (citing Ex. 2082 ¶¶ 47–48 (Williams Decl.)). Based on the record as a whole, we find that Patent Owner’s description more appropriately encompasses the broad education that the person of ordinary skill in the relevant art may possess. Thus, we adopt that description. We note, however, that neither party asserts specifically that the ultimate conclusion of obviousness turns on adoption of a particular level of ordinary skill.” slip op. at 10

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for patent owner

    “Given these prior art teachings, Petitioners persuade us that an ordinary artisan would have recognized that tyloxapol and polysorbate 80 were interchangeably useful as non-ionic surfactants in acidic NSAID-containing ophthalmic aqueous solutions, and, therefore, absent persuasive objective evidence to the contrary, that is enough to support the proposed substitution, even in the absence of an express suggestion to do so. In re Mayne, 104 F.3d 1339, 1340 (Fed. Cir. 1997); In re Fout, 675 F.2d 297, 301 (CCPA 1982); In re Siebentritt, 372 F.2d 566, 568 (CCPA 1967)). As to the stability requirements in claims 1, 11, and 19, the ’606 patent discloses that the tyloxapol range effective to stabilize a bromfenac-containing solution is between about 0.01 and 0.5 w/v %. Ex. 1004, 5:19– 25. Both the tyloxapol concentration described in Sallmann (0.1 w/v %) and the polysorbate 80 concentration described in Ogawa (0.15 w/v %), fall within the stabilizing range set out in the ’606 patent. Therefore, in addition to having a reason to substitute the tyloxapol recited in claims 1, 11, and 19 of the ’606 patent for the polysorbate 80 in Ogawa’s Example 6, an ordinary artisan also had a reason to include the tyloxapol at a concentration encompassed by each of those claims.” slip op. at 16

  Patent outcomesUS 8,927,606 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,927,606
• Lupin Ltd. / Lupin Pharmaceuticals Inc. v. Senju Pharmaceutical Co., Ltd.No claims unpatentable
  PTAB · Sep 12, 2016 · IPR2015-01099 · APJ Francisco C Prats · IPR · Final written decision

  Claims 1–30 were not shown unpatentable because unexpected properties, industry praise, and commercial success outweighed the obviousness showing over Sallmann and Ogawa.

  RulingsFinal written decision

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

    “acknowledge that, under Microsoft v. Proxyconn, claim construction in inter partes reviews must not be unreasonably broad or inconsistent with the specification of the patent under consideration. 789 F.3d at 1298. In general, however, only those claim terms that are in controversy need to be construed, and only to the extent necessary to resolve the controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). In the instant case, Patent Owner does not identify any controversy as to the scope of the claim terms for which it seeks construction. Nor does Patent Owner explain specifically why adoption of the district court’s construction of the identified terms is necessary to resolve any of the issues critical to this proceeding. Accordingly, we decline to adopt the district court’s claim construction. Rather, because the parties identify no controversy as to the scope of any claim terms, we conclude that, for the purposes of this decision, no claim term requires express construction.” slip op. at 8

  • Skill levelSkill level board ownOther

    “As to the level of ordinary skill in this art, the parties’ expert witnesses advance somewhat different opinions. See Pet. 6 (citing Ex. 1005 ¶ 40 (Lawrence Decl.4)); see also PO Resp. 7 (citing Ex. 2082 ¶¶ 45–46 (Williams Decl.5)). Nonetheless, neither party asserts specifically that the ultimate conclusion of obviousness turns on adoption of a particular level of ordinary skill. In any event, both experts generally agree that an ordinarily skilled artisan at the critical time would have had at least a bachelor’s degree in a field such as chemistry, pharmaceutical chemistry, or a related discipline, with 3–5 years of work experience, and potentially a Ph.D., depending on the extent of formal education and practical experience. See id. When evaluating the parties’ contentions regarding the scope and content of the prior art, and the differences between the prior art and the challenged claims, we take into consideration both parties’ assertions regarding the level of ordinary skill. We also consider that the cited references provide evidence as to the level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 9

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner

    “Given these prior art teachings, Petitioner persuades us that an ordinary artisan would have recognized that tyloxapol and polysorbate 80 were interchangeably useful as non-ionic surfactants in acidic NSAID-containing ophthalmic aqueous solutions, and, absent persuasive objective evidence to the contrary, that is enough to support the proposed substitution, even in the absence of an express suggestion to do so. In re Mayne, 104 F.3d 1339, 1340 (Fed. Cir. 1997); In re Fout, 675 F.2d 297, 301 (CCPA 1982); In re Siebentritt, 372 F.2d 566, 568 (CCPA 1967)). As to the stability requirements in claims 1, 8, and 14, the ’290 patent discloses that the tyloxapol range effective to stabilize a bromfenac-containing solution is between about 0.01 and 0.5 w/v %. Ex. 1001, 5:37– 38. Both the tyloxapol concentration described in Sallmann (0.1 w/v %) and the polysorbate 80 concentration described in Ogawa (0.1 w/v %), discussed above, fall within the stabilizing range set out in the ’290 patent. Therefore, in addition to having a reason to substitute the tyloxapol recited in claims 1, 8, and 14 of the ’290 patent for the polysorbate 80 in Ogawa’s Example 6, an ordinary artisan also had a reason to include the tyloxapol at a concentration encompassed by claims 1, 8, and 14. Patent Owner’s arguments do not convince us to the contrary.” slip op. at 14

  • Obviousness (§103) › Objective indicia / secondary considerations › Unexpected resultsObjective indicia outweighedDecided for patent owner

    “In sum, in light of the discussed comparisons, the advantageous properties inhering to tyloxapol-containing bromfenac formulations, and the supporting testimony of Patent Owner’s witnesses, we find that Patent Owner has advanced evidence sufficient to support its contentions that the compositions recited in claims 1, 8, and 14 of the ’290 patent exhibit unexpected properties.” slip op. at 24

  Patent outcomesUS 8,669,290 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,669,290
• Lupin Ltd. / Lupin Pharmaceuticals Inc. et al. v. Senju Pharmaceutical Co., Ltd.No claims unpatentable
  PTAB · Sep 12, 2016 · IPR2016-00089 · APJ Francisco C Prats · IPR · Final written decision

  Claims 1–30 were not shown unpatentable because the unexpected properties and commercial success of the claimed formulations outweighed the obviousness showing over Sallmann and Ogawa.

  RulingsFinal written decision

  • BurdenNot shown unpatentable

    “ordinary artisan would have recognized that tyloxapol and polysorbate 80 were interchangeably useful as non-ionic surfactants in acidic NSAID-containing ophthalmic aqueous solutions, and, absent persuasive objective evidence to the contrary, that is enough to support the proposed substitution, even in the absence of an express suggestion to do so. In re Mayne, 104 F.3d 1339, 1340 (Fed. Cir. 1997); In re Fout, 675 F.2d 297, 301 (CCPA 1982); In re Siebentritt, 372 F.2d 566, 568 (CCPA 1967)).” slip op. at 14

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

    “acknowledge that, under Microsoft v. Proxyconn, claim construction in inter partes reviews must not be unreasonably broad or inconsistent with the specification of the patent under consideration. 789 F.3d at 1298. In general, however, only those claim terms that are in controversy need to be construed, and only to the extent necessary to resolve the controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). In the instant case, Patent Owner does not identify any controversy as to the scope of the claim terms for which it seeks construction. Nor does Patent Owner explain specifically why adoption of the district court’s construction of the identified terms is necessary to resolve any of the issues critical to this proceeding. Accordingly, we decline to adopt the district court’s claim construction. Rather, because the parties identify no controversy as to the scope of any claim terms, we conclude that, for the purposes of this decision, no claim term requires express construction.” slip op. at 8

  • Skill levelOther

    “witnesses advance somewhat different opinions. See Pet. 6–7 (citing Ex. 1005 ¶ 40 (Lawrence Decl.));5 see also PO Resp. 7 (citing Ex. 2082 ¶¶ 44– 45 (Williams Decl.)).6 Nonetheless, neither party asserts specifically that the ultimate conclusion of obviousness turns on adoption of a particular level of ordinary skill. In any event, both experts generally agree that an ordinarily skilled artisan at the critical time would have had at least a bachelor’s degree in a field such as chemistry, pharmaceutical chemistry, or a related discipline, with 3–5 years of work experience, and potentially a Ph.D., depending on 5 Declaration of M. Jayne Lawrence, Ph.D., dated April 21, 2015 (Ex. 1005). 6 Declaration of Robert O. Williams III, Ph.D., dated February 22, 2016 (Ex 2082). the extent of formal education and practical experience. See id. When evaluating the parties’ contentions regarding the scope and content of the prior art, and the differences between the prior art and the challenged claims, we take into consideration both parties’ assertions regarding the level of ordinary skill. We also consider that the cited references provide evidence as to the level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 9

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner

    “contention that an ordinary artisan would have considered Sallmann’s tyloxapol and Ogawa’s polysorbate 80 to be interchangeably useful in aqueous ophthalmic solutions. Pet. 38 (citing Ex. 1005 ¶¶ 334–336). Given her qualifications, experience, and explanation, we credit her testimony on this issue. See Ex. 1005 ¶¶ 3–15. Dr. Lawrence’s testimony in this regard, moreover, is supported by the Yasueda and Desai references cited in Dr. Lawrence’s Declaration.” slip op. at 13

  Patent outcomesUS 8,754,131 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,754,131
• Lupin Ltd. / Lupin Pharmaceuticals Inc. et al. v. Senju Pharmaceutical Co., Ltd.No claims unpatentable
  PTAB · Sep 12, 2016 · IPR2015-01097 · APJ Francisco C Prats · IPR · Final written decision

  Claims 1–30 were not shown unpatentable over Sallmann and Ogawa under § 103 because unexpected properties, industry praise, and commercial success outweighed the obviousness showing.

  RulingsFinal written decision

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

    “acknowledge that, under Microsoft v. Proxyconn, claim construction in inter partes reviews must not be unreasonably broad or inconsistent with the specification of the patent under consideration. 789 F.3d at 1298. In general, however, only those claim terms that are in controversy need to be construed, and only to the extent necessary to resolve the controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). In the instant case, Patent Owner does not identify any controversy as to the scope of the claim terms for which it seeks construction. Nor does Patent Owner explain specifically why adoption of the district court’s construction of the identified terms is necessary to resolve any of the issues critical to this proceeding. Accordingly, we decline to adopt the district court’s claim construction. Rather, because the parties identify no controversy as to the scope of any claim terms, we conclude that, for the purposes of this decision, no claim term requires express construction.” slip op. at 8

  • Skill levelOther

    “As to the level of ordinary skill in this art, the parties’ expert witnesses advance somewhat different opinions. See Pet. 6–7 (citing Ex. 1005 ¶ 40 (Lawrence Decl.));5 see also PO Resp. 7 (citing Ex. 2082 ¶¶ 44– 45 (Williams Decl.)).6 Nonetheless, neither party asserts specifically that the ultimate conclusion of obviousness turns on adoption of a particular level of ordinary skill. In any event, both experts generally agree that an ordinarily skilled artisan at the critical time would have had at least a bachelor’s degree in a field such as chemistry, pharmaceutical chemistry, or a related discipline, with 3–5 years of work experience, and potentially a Ph.D., depending on 5 Declaration of M. Jayne Lawrence, Ph.D., dated April 21, 2015 (Ex. 1005). 6 Declaration of Robert O. Williams III, Ph.D., dated February 22, 2016 (Ex 2082). the extent of formal education and practical experience. See id. When evaluating the parties’ contentions regarding the scope and content of the prior art, and the differences between the prior art and the challenged claims, we take into consideration both parties’ assertions regarding the level of ordinary skill. We also consider that the cited references provide evidence as to the level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 9

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
  • Obviousness (§103) › Objective indicia / secondary considerations › Unexpected resultsObjective indicia with nexusDecided for patent owner

  Patent outcomesUS 8,754,131 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,754,131
• Biodelivery Sciences International, Inc. v. Monosol RX, LLCNo claims unpatentable
  PTAB · Mar 24, 2016 · IPR2015-00165 · APJ Francisco C Prats · IPR · Final written decision

  Claims 1, 4, 11, 12, 26, 27, 44, 51, 58, 65, 72, 82, and 125–127 were not shown unpatentable over Chen because the evidence did not establish the claimed active-component uniformity.

  RulingsFinal written decision

  • BurdenNot shown unpatentable

    “In an inter partes review instituted under this chapter, the petitioner shall have the burden of proving a proposition of unpatentability by a preponderance of the evidence.” 35 U.S.C. § 316(e). We conclude that Petitioner has not proved by a preponderance of the evidence that claims 1, 4, 11, 12, 26, 27, 44, 51, 58, 65, 72, 82, and 125–127, of the ’167 patent are unpatentable for anticipation under 35 U.S.C. § 102(b) by Chen. slip op. at 3

  • PTAB / AIA Trials › §315(e) estoppelEstoppel does not applyDecided for patent owner

    “We find that the instant inter partes review under the AIA offers a significant procedural opportunity to the parties that was not available in the prior inter partes reexamination proceeding of the ’588 patent cited by Petitioner. Specifically, inter partes reexamination proceedings are conducted essentially by the same procedure as routine examination of patent applications. 37 C.F.R. § 1.937(b). Although normal examination procedure allows for submission of evidence in affidavit form (37 C.F.R. §§ 1.131, 1.132), the rules for inter partes reexaminations do not provide for cross-examination of those affiants. See 37 C.F.R. §§ 1.902–1.997. In contrast, in the instant proceeding, witnesses presenting direct testimony by affidavit are subject to cross-examination via deposition. 37 C.F.R. § 42.53. Indeed, as discussed herein below, the testimony on cross-examination of one of Petitioner’s witnesses uncovered facts significant to our evaluation of the issue of anticipation, resulting in a determination on that issue different from the prior ’588 reexamination appeal decision cited by Petitioner. Thus, the availability of cross-examination of witnesses in this inter partes review under the AIA is a significant procedural opportunity for Patent Owner that is not present in the prior inter partes reexamination proceeding, and that procedural distinction indeed yields a result different from that in the prior inter partes reexamination. In addition, we also find that the instant situation does not meet the requirements for applying issue preclusion, because resolution of the issue in this case was not essential to the final judgment in the ’588 decision. As to that requirement, in Freeman the court noted that “statements regarding the scope of patent claims made in a former adjudication should be narrowly construed.” In re Freeman, 30 F.3d at 1466. With that in mind, we note again that the limitation at issue in claim 1 of the ’167 patent states that the “substantially uniform distribution is measured by substantially equally sized individual unit doses which do not vary by more than 10% of said desired amount of said active component.” Ex. 1001, 41:19–22. In the prior ’588 decision, because Patent Owner had not argued any claims separately, the Board resolved the issue of whether Chen met the uniformity requirement based on claim 1 of the ’588 patent. Ex. 1027, 12 (the ’588 decision).5 In contrast to the language at issue here, claim 1 of the ’588 patent, as amended, required only “substantially uniform content of therapeutic active composition per unit of film.” Ex. 1027, 4. Thus, the ’588 decision did not resolve the issue of whether Chen met the 5 In citing to the ’588 decision we cite to the original page numbers of the decision, not the pages numbers entered by Petitioner as part Exhibit 1027. substantial uniformity requirement based on the claim language at issue in this proceeding. We acknowledge the statement in the ’588 decision that, as to claim 3 of the ’588 patent, the “weight deviation” described in Example 1 of Chen “is well within the less than 10% variation of active content per film unit requirement of claim 3” of the ’588 patent. Ex. 1027, 19. As noted immediately above, however, the ’588 decision resolved the uniformity issue based on claim 1 of the ’588 patent, not on claim 3, which depends from claim 1.” slip op. at 14

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownOther

    “drying process,” claim 1 expressly recites that the controlled drying process, which produces the film, rapidly forms a viscoelastic matrix to lock-in the active component in place within the matrix to maintain the above-discussed substantially uniform distribution. Ex. 1001, 41:13–16. Accordingly, contrary to Petitioner’s contentions (see Pet. 10–11), we conclude that claim 1 does limit the conditions of the “controlled drying process.” As noted above, moreover, the ’167 patent discusses the advantages of the controlled drying process, including the faster drying times. Ex. 1001, 6:61–7:1. According to the Specification, “[d]esirably, the drying of the film will occur within about ten minutes or fewer, or more desirably within about five minutes or fewer.” Id. at 7:1–3. It further discloses that the initial film setting period, “during which a solid, visco-elastic structure is formed . . . can take place within the first few minutes, e.g. about the first 0.5 to about 4.0 minutes of the drying process.” Id. at 24:52–56. Thus, contrary to Petitioner’s contention, the ’167 patent does provide a standard for the term “rapidly” as recited in claim 1. Especially given the express language in the claims, we conclude that the claims encompass a film having a structure which would result from a controlled drying process which forms a viscoelastic matrix within a few minutes of the drying process to lock-in the active component within the matrix, the film having a substantially uniform distribution of the active component, measured by substantially equally sized individual unit doses which do not vary by more than 10% of the desired amount of the active component.” slip op. at 7

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable

    “Because visual inspection is not the measure of uniformity recited in claim 1 of the ’167 patent, Petitioner does not persuade us that it is reasonable to construe the uniformity limitation at issue in claim 1 as being met by a visual evaluation, based on the ’292 patent’s disclosure that substantial uniformity (as opposed to the claimed uniformity of distribution with a variation of no more than 10%) can be verified visually. We acknowledge that the passage cited above in column 20 of the ’292 patent describes actual testing of the amount of active component as an “alternative” method of verifying substantial uniformity. Ex. 1035, 20:62. Petitioner does not persuade us, however, that it is reasonable to construe the measure of uniformity in claim 1 of the ’167 patent, which requires a determination of the amount of active component in equal size dosage units, as being met by a method (simple visual inspection) which no evidence has shown is capable of quantifying the active component amount.” slip op. at 19

  Patent outcomesUS 8,765,167 not shown unpatentable
  Claim construction§ 102 anticipationcites Phillips
  Patents in suitUS 8,765,167

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.