• Argentum Pharmaceuticals LLC / Mylan Pharmaceuticals Inc. et al. v. Research Corporation Technologies, Inc.No claims unpatentable
  PTAB · Mar 22, 2017 · IPR2016-01245 · APJ Francisco C Prats · IPR · Final written decision

  Claims 1–13 were not shown unpatentable because the petitioner failed to establish obviousness over the instituted combinations.

  RulingsFinal written decision

  • Strike new argumentNew argument disregardedNew argument consideredMixed

    “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

  • 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

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

    “We agree with Patent Owner (PO Resp. 38) that, given Kohn 1991’s teaching that “stringent steric and electronic requirements exist for maximal anticonvulsant activity in this class of compounds” (Ex. 1012, 2447), the expected substantial change to the conformation of the overall molecule is significant evidence that an ordinary artisan would not have been motivated to replace the methoxyamino group of compound 3l, the most potent compound taught in Kohn 1991, with a methoxymethyl group. In sum, we acknowledge Dr. Wang’s testimony, discussed above, that due to a methoxyamino group’s potential synthetic and stability issues, and uncommonness in commercial pharmaceuticals, an ordinary artisan may have had a reason to replace such a group with a more common and acceptable moiety, such as a methoxymethyl group, in chemical compounds generally. Nonetheless, as also discussed above, the evidence advanced by Patent Owner shows that, as to the specific FAA compounds of Kohn 1991, an ordinary artisan would have understood that compound 3l’s methoxyamino moiety was considered a basic C(α)-amino substituent that conferred significant activity to the compound, and replacement of that moiety with other substituents would have led to a reduction in activity. As also discussed above, Kohn 1991 teaches that “stringent steric and electronic requirements exist for maximal anticonvulsant activity in this class of compounds” (Ex. 1012, 2447), whereas an ordinary artisan would have understood that substituting a methoxymethyl group for the methoxyamino group of Kohn 1991’s compound 3l would result in a compound with a significantly different conformation and biological activity. Thus, assessing Petitioner’s evidence of a more general motivation for substituting a methoxymethyl group for the methoxyamino group of compound 3l, against Patent Owner’s evidence specifically suggesting that an ordinary artisan would not have viewed the posited substitution as being desirable, we find that the weight of the evidence significantly favors Patent Owner’s position. Overall, the evidence before us indicates that an ordinary artisan lacked motivation, as well as a reasonable expectation of success, for making the specific substitution to Kohn 1991’s compound 3l, required to arrive at lacosamide. That is, we agree with Patent Owner that Petitioner has not shown sufficiently that the prior art of record would have suggested making the specific modification to compound 3l required to yield lacosamide.” slip op. at 23

  • Obviousness (§103) › Objective indicia / secondary considerations › Long-felt need / failure of othersObjective indicia with nexusDecided for patent owner

    “this issue, we agree with Patent Owner (PO Resp. 56–58) that lacosamide satisfied a long-felt but unmet need in that lacosamide has been found to be useful for treating refractory patients for which other antiepileptic drugs were ineffective. Patent Owner’s witness on this issue, Dr. Bazil,20 testifies as follows: For many of my patients, lacosamide is a very important option, and it certainly fills a need in those patients who require a drug with the unique combination of properties as lacosamide possesses. Thus, lacosamide exhibits its biggest advantages in refractory patients. I have had numerous patients who were able to successfully control their seizures with lacosamide, but who had failed to do so previously with other antiseizure drugs. As director of Columbia’s Epilepsy Center, I have also heard many success stories from other neurologists about patients whose seizures were not controlled by other AEDs but were controlled when they switched to lacosamide. Ex. 2038 ¶ 79 (Bazil Decl.).” slip op. at 36

  Patent outcomesUS RE38,551 not shown unpatentable
  § 103 obviousnesscites KSR · Graham
• Argentum Pharmaceuticals LLC / Mylan Pharmaceuticals Inc. et al. v. Research Corporation Technologies, Inc.No claims unpatentable
  PTAB · Mar 22, 2017 · IPR2016-01101 · APJ Francisco C Prats · IPR · Final written decision

  Claims 1–13 were not shown unpatentable: the prior art did not motivate the specific modification for claims 1–9, and the challenge to claims 10–13 was insufficiently supported.

  RulingsFinal written decision

  • Strike new argumentNew argument disregardedNew argument consideredMixed

    “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

  • ExcludeMotion to exclude, deniedMixed

    “In any event, Petitioner fails to explain adequately why the declarations of Patent Owner’s President, Shaun Kirkpatrick (Ex. 2185), and Vice President and General Counsel of a licensee, Paul Petigrow (Ex. 2187), are insufficient to authenticate the letters. Although Petitioner contends that “[n]either declaration demonstrates personal knowledge of the facts necessary to establish the business-records exception” (Pet. Reply Opp. 1 (Paper 81)), Petitioner does not support that assertion with specific explanation, other than asserting that Mr. Petigrow has worked for the licensee for less than a year (see id.). Petitioner does not, however, address with any specificity the substance of any of Mr. Petigrow’s other assertions, nor does Petitioner explain why they should not be credited. As to hearsay, as Patent Owner contends (PO Opp. 5–6), under FRE 703, the proponent of an expert opinion may disclose otherwise inadmissible evidence underlying that opinion to a jury, if the court determines that the “probative value in helping the jury evaluate the opinion substantially outweighs [its] prejudicial effect.” In the present case, Patent Owner’s expert Dr. Roush relied on Exhibit 2125 (see Ex. 2036 ¶ 314 (Roush Decl.)), and another expert witness, Dr. Vellturo, relied on Exhibits 2141–2170 (see Ex. 2132 ¶¶ 41–42 (Vellturo Decl.)). As is evident from our discussion above, the probative value of reviewing the documents substantially assisted our evaluation of Patent Owner’s contentions regarding skepticism. In addition, any prejudicial effect on Petitioner is minimal because we ultimately did not find Patent Owner’s evidence of skepticism to be probative. Lastly, we are not persuaded that Patent Owner’s alleged failure to submit controverting correspondence warrants exclusion of Exhibits 2125 and 2141–2170 under either FRE 106 or the Board’s discovery rules. FRE 106, which appears to be more pertinent to a live trial, as opposed to an administrative proceeding such as this case, provides that “[w]hen a writing or recorded statement or part thereof is introduced by a party, an adverse party may require the introduction at that time of any other part or any other writing or recorded statement which ought in fairness to be considered contemporaneously with it.” Thus, rather than providing a basis for excluding evidence, FRE 106 is a vehicle for entry of additional evidence, allowing an adverse party to a proffered writing or statement (in this case Petitioner) the opportunity to require entry of any other part of the proffered writing/statement, or any” slip op. at 47

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “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

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedMixed

    “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

  Patent outcomesUS RE38,551 not shown unpatentable
  § 103 obviousnesscites KSR · Graham
• Argentum Pharmaceuticals LLC / Mylan Pharmaceuticals Inc. et al. v. Research Corporation Technologies, Inc.No claims unpatentable
  PTAB · Mar 22, 2017 · IPR2016-00204 · APJ Francisco C Prats · IPR · Final written decision

  Claims 1–13 were not shown unpatentable: the Board found no sufficient motivation or reasonable expectation of success for the proposed compound modification, and the challenge to claims 10–13 was inadequately supported.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “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 12

  • 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

  • ExcludeMotion to exclude, deniedMixed

    “In any event, Petitioner fails to explain adequately why the declarations of Patent Owner’s President, Shaun Kirkpatrick (Ex. 2185), and Vice President and General Counsel of a licensee, Paul Petigrow (Ex. 2187), are insufficient to authenticate the letters. Although Petitioner contends that “[n]either declaration demonstrates personal knowledge of the facts necessary to establish the business-records exception” (Pet. Reply Opp. 1 (Paper 81)), Petitioner does not support that assertion with specific explanation, other than asserting that Mr. Petigrow has worked for the licensee for less than a year (see id.). Petitioner does not, however, address with any specificity the substance of any of Mr. Petigrow’s other assertions, nor does Petitioner explain why they should not be credited. As to hearsay, as Patent Owner contends (PO Opp. 5–6), under FRE 703, the proponent of an expert opinion may disclose otherwise inadmissible evidence underlying that opinion to a jury, if the court determines that the “probative value in helping the jury evaluate the opinion substantially outweighs [its] prejudicial effect.” In the present case, Patent Owner’s expert Dr. Roush relied on Exhibit 2125 (see Ex. 2036 ¶ 314 (Roush Decl.)), and another expert witness, Dr. Vellturo, relied on Exhibits 2141–2170 (see Ex. 2132 ¶¶ 41–42 (Vellturo Decl.)). As is evident from our discussion above, the probative value of reviewing the documents substantially assisted our evaluation of Patent Owner’s contentions regarding skepticism. In addition, any prejudicial effect on Petitioner is minimal because we ultimately did not find Patent Owner’s evidence of skepticism to be probative. Lastly, we are not persuaded that Patent Owner’s alleged failure to submit controverting correspondence warrants exclusion of Exhibits 2125 and 2141–2170 under either FRE 106 or the Board’s discovery rules. FRE 106, which appears to be more pertinent to a live trial, as opposed to an administrative proceeding such as this case, provides that “[w]hen a writing or recorded statement or part thereof is introduced by a party, an adverse party may require the introduction at that time of any other part or any other writing or recorded statement which ought in fairness to be considered contemporaneously with it.” Thus, rather than providing a basis for excluding evidence, FRE 106 is a vehicle for entry of additional evidence, allowing an adverse party to a proffered writing or statement (in this case Petitioner) the opportunity to require entry of any other part of the proffered writing/statement, or any” slip op. at 47

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

    “Having considered the rationale and supporting evidence advanced by Petitioner alongside Patent Owner’s arguments and supporting evidence, Patent Owner persuades us that Petitioner has not shown sufficiently that the prior art of record would have suggested making the specific modification to compound 3l required to yield lacosamide. 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

  Patent outcomesUS RE38,551 not shown unpatentable
  § 103 obviousnesscites KSR · Graham
• 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. 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

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.