• 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 · IPR2016-01245 · 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
• Mylan Pharmaceuticals Inc. v. Research Corporation Technologies, Inc.Institution denied
  PTAB · Oct 24, 2016 · IPR2016-01248 · APJ Jacqueline Wright Bonilla · IPR · Institution

  The Board denied institution on all challenged claims under § 325(d), because Mylan presented the same prior art and arguments it had previously presented.

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied

    “Institution of an inter partes review is subject to the Board’s discretion. See 37 C.F.R. § 42.108(b). By statute, “[i]n determining whether to institute or order a proceeding under this chapter, chapter 30, or chapter 31, the Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” 35 U.S.C. § 325(d). For the reasons discussed above, the current Petition presents the same prior art and arguments previously presented by the same Petitioner in IPR2016-01101. Accordingly, we exercise our discretion to deny institution of inter partes review in this case under 35 U.S.C. § 325(d).” slip op. at 3

  Discretionary denial
• Biodelivery Sciences International, Inc. v. Monosol RX, LLCRehearing denied
  PTAB · Sep 26, 2016 · IPR2015-00169 · APJ Francisco C Prats · IPR · Rehearing

  The Board denied BioDelivery Sciences International’s request for rehearing, leaving intact its finding that the challenged claims were not shown unpatentable over Chen and Tapolsky.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “STANDARD OF REVIEW The party requesting rehearing has the burden of showing that the decision should be modified, and “[t]he request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” 37 C.F.R. § 42.71(d). III. ANALYSIS” slip op. at 3

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

    “As we noted in our Final Decision, under the doctrine of collateral estoppel, also known as issue preclusion, a judgment on the merits in a first proceeding precludes relitigation in a second proceeding “of issues actually litigated and determined in the first [proceeding].” In re Freeman, 30 F.3d 1459, 1465 (Fed. Cir. 1994). In Freeman, the court explained that the rationale underlying issue preclusion is that “a party who has litigated an issue and lost should be bound by that decision and cannot demand that the issue be decided over again.” Id.. The court set out the requirements of the doctrine as follows: Issue preclusion is appropriate only if: (1) the issue is identical to one decided in the first action; (2) the issue was actually litigated in the first action; (3) resolution of the issue was essential to a final judgment in the first action; and (4) [the party against whom issue preclusion is asserted] had a full and fair opportunity to litigate the issue in the first action. Id. (citations omitted). As to element (3), when determining whether the issue in question in the second action was essential to the final judgment in the first action, the court advised that “statements regarding the scope of patent claims made in a former adjudication should be narrowly construed.” Id. at 1466.” slip op. at 3

  • Strike new argumentNew argument disregardedDecided for patent owner

    “Accordingly, Petitioner does not persuade us that we misapprehended or overlooked any point of fact or law, or any arguments Petitioner presented during trial, on the issue of whether the ’337 decision should be given preclusive effect. To the extent that Petitioner attempts, in its Request for Rehearing, to present for the first time a specific explanation as to why the ’337 decision meets the requirements of collateral estoppel, Petitioner does not explain why that discussion could not have been presented earlier in the proceeding, at the very least in its Reply. We, therefore, decline to consider those new contentions. In any event, Petitioner does not explain with any particularity why the ’337 decision meets the four elements of collateral estoppel. See, e.g., Req. Reh’g 12–13.” slip op. at 9

  Nonecites Phillips
  Patents in suitUS 8,765,167
• Biodelivery Sciences International, Inc. v. Monosol RX, LLCRehearing denied
  PTAB · Sep 26, 2016 · IPR2015-00165 · APJ Francisco C Prats · IPR · Rehearing

  The Board denied the petitioner’s rehearing request, leaving in place the final decision that claims 1, 4, 11, 12, 26, 27, 44, 51, 58, 65, 72, 82, and 125–127 were not shown unpatentable over Chen.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “STANDARD OF REVIEW The party requesting rehearing has the burden of showing that the decision should be modified, and “[t]he request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” 37 C.F.R. § 42.71(d). III. ANALYSIS” slip op. at 3

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

    “As we noted in our Final Decision, under the doctrine of collateral estoppel, also known as issue preclusion, a judgment on the merits in a first proceeding precludes relitigation in a second proceeding “of issues actually litigated and determined in the first [proceeding].” In re Freeman, 30 F.3d 1459, 1465 (Fed. Cir. 1994). In Freeman, the court explained that the rationale underlying issue preclusion is that “a party who has litigated an issue and lost should be bound by that decision and cannot demand that the issue be decided over again.” Id. The court set out the requirements of the doctrine as follows: Issue preclusion is appropriate only if: (1) the issue is identical to one decided in the first action; (2) the issue was actually litigated in the first action; (3) resolution of the issue was essential to a final judgment in the first action; and (4) [the party against whom issue preclusion is asserted] had a full and fair opportunity to litigate the issue in the first action. Id. (citations omitted). As to element (3), when determining whether the issue in question in the second action was essential to the final judgment in the first action, the court advised that “statements regarding the scope of patent claims made in a former adjudication should be narrowly construed.” Id. at 1466.” slip op. at 3

  • Strike new argumentNew argument disregardedDecided for patent owner

    “Accordingly, Petitioner does not persuade us that we misapprehended or overlooked any point of fact or law, or any arguments Petitioner presented during trial, on the issue of whether the ’337 decision should be given preclusive effect. To the extent that Petitioner attempts, in its Request for Rehearing, to present for the first time a specific explanation as to why the ’337 decision meets the requirements of collateral estoppel, Petitioner does not explain why that discussion could not have been presented earlier in the proceeding, at the very least in its Reply. We, therefore, decline to consider those new contentions. In any event, Petitioner does not explain with any particularity why the ’337 decision meets the four elements of collateral estoppel. See, e.g., Req. Reh’g 12–13.” slip op. at 8

  • Expert testimonyNot reached

    “Lastly, Petitioner presents arguments explaining why the testimony of Drs. Reitman and Goldberg demonstrate that the ultimate conclusion in our Final Decision was erroneous. Req. Reh’g 8–10. Petitioner, however, does not identify specifically the place in the record where it presented these particular arguments, such that we may have misapprehended or overlooked them. We, therefore, decline to consider these new arguments. IV.” slip op. at 13

  Nonecites Phillips
  Patents in suitUS 8,765,167
• Biodelivery Sciences International, Inc. v. Monosol RX, LLCRehearing denied
  PTAB · Sep 26, 2016 · IPR2015-00168 · APJ Zhenyu Yang · IPR · Rehearing

  The Board denied the petitioner’s rehearing request, leaving intact its decision that the challenged claims were not shown unpatentable over Chen and Tapolsky.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “STANDARD OF REVIEW A rehearing request for a final decision is governed by 37 C.F.R. § 42.71 (d), which requires the party requesting rehearing to “specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” III.” slip op. at 2

  • PTAB / AIA Trials › §315(e) estoppelDecided for patent owner

    “estoppel, also known as issue preclusion, a judgment on the merits in a first proceeding precludes relitigation in a second proceeding “of issues actually litigated and determined in the first [proceeding].” Final Dec. 12 (quoting In re Freeman, 30 F.3d 1459, 1465 (Fed. Cir. 1994)). Issue preclusion is appropriate only if: (1) the issue is identical to one decided in the first action; (2) the issue was actually litigated in the first action; (3) resolution of the issue was essential to a final judgment in the first action; and (4) the party against whom issue preclusion is asserted had a full and fair opportunity to litigate the issue in the first action. Id. (citing Freeman, 30 F.3d at 1465). When applying issue preclusion, “statements regarding the scope of patent claims made in a former adjudication should be narrowly construed.” Id. (citing Freeman, 30 F.3d at 1466).” slip op. at 4

  • Strike new argumentNew argument disregardedDecided for patent owner

    “To the extent that Petitioner attempts, in its Request for Rehearing, to present for the first time a specific explanation as to why the ’337 decision meets the requirements of collateral estoppel, Petitioner does not explain why that discussion could not have been presented earlier in the proceeding, at the very least in its Reply. We, therefore, decline to consider those new contentions. In any event, Petitioner does not sufficiently explain why the ’337 decision meets the four elements of collateral estoppel. See, e.g., Req. Reh’g 12–13.” slip op. at 8

  Nonecites Phillips
  Patents in suitUS 8,765,167
• 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

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.