• Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.No claims unpatentable
  PTAB · Nov 18, 2020 · PGR2019-00048 · APJ David Cotta · PGR · Final written decision

  Claims 1–13 were not shown unpatentable because the prior art did not establish a reasonable expectation that doses above 300 mg/day of mifepristone could be safely co-administered with a strong CYP3A inhibitor.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “The definition of a POSA that best incorporates both experience with drug-drug interaction and experience treating patients is Petitioner’s proposed multidisciplinary team. Patent Owner does not object to defining the POSA as part of a multidisciplinary team, so long as that team includes a person with experience treating Cushing’s syndrome, which, as discussed above, is appropriate. Tr. 38. Accordingly, we define the POSA as: a multidisciplinary team that includes researchers and clinicians in the field and is able to draw upon not only the individual skills of each team member, but also the specialized skills of others to solve a given problem. The 6 Claim 5 and its dependents are directed to “[a] method of treating symptoms associated with elevated cortisol levels.” Cushing’s syndrome is “caused by excess levels of cortisol.” Ex. 1001, 1:31–33. Accordingly, claim 5 relates to Cushing’s syndrome even if it does not specifically recite that the patient has Cushing’s syndrome. All of the other claims expressly recite Cushing’s syndrome. researchers and clinicians would have an M.D., a Pharm. D., and/or a Ph.D. in pharmacology or a related discipline. The clinician would have at least four years of experience treating patients with Cushing’s syndrome using mifepristone and/or CYP3A inhibitors. The researcher would have at least four years of experience studying drug-drug interactions involving CYP3A inhibitors.” slip op. at 8

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner

    “Further, if we were to consider Petitioner’s new argument, we would find that the claims do require safety, as entirely consistent with what both parties unmistakably understood, as evidenced by their patentability arguments throughout the proceeding (until Petitioner’s new argument in its Reply). In this regard, we note that the preambles in the independent claims at issue, i.e., in claims 1, 5, and 10, are necessarily limiting and we consider the scope of the challenged claims as a whole, including preambles, in our patentability analysis. The preamble in claim 1, for example, recites a “method of treating Cushing’s syndrome in a patient who is taking an original once-daily dose of 1200 mg or 900 mg per day of mifepristone.” Ex. 1001, 68:2–16. Claims 5 and 10 contain similar language relating to a patient taking an “original once-daily dose” of 1200 mg or 900 mg per day of mifepristone, although claim 5 is directed to a “method of treating symptoms associated with elevated cortisol levels,” and claim 10 is directed” slip op. at 19

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

    “In addition, when considering the recited methods of treatment (or controlling hyperglycemia) in a patient in the context of the specification, we interpret the recited methods to require administration of drugs in a manner that is safe for a patient. The summary section in the specification of the ’214 patent, for example, states that: concomitant administration of a CYP3A inhibitor such as ketoconazole and a GRM such as mifepristone is believed to be safe for the subject, and to provide the therapeutic benefits of both drugs to the subject, and may allow the reduction in the amount of a GRM, or of a CYP3A inhibitor, administered to the subject; such reduction may reduce the risk of toxic effects of the CYP3A inhibitor concomitantly administered with the GRM. Ex. 1001, 3:50–58 (emphasis added); see id. at 4:4–21. That disclosure, along with many other statements in the specification, clarify that safety and efficiency are important aspects of the recited methods, especially in relation to toxic effects that might preclude treatment in patients. See also id. at 13:1–3 (stating “Applicant discloses herein methods for the safe concomitant administration of both a glucocorticoid receptor modulator (GRM) and steroidogenesis inhibitor to a subject.”), 13:10–23 (same).” slip op. at 20

  • Strike new argumentNew argument disregardedDecided for patent owner

    “Our regulations require the Petition to identify “[h]ow the challenged claim is to be construed” and “[h]ow the construed claim is unpatentable.” 37 C.F.R. § 42.104(b)(3),(4). A reply is not an opportunity to start anew, to fill in gaps or to remedy omissions in a petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1357 (2018) (explaining that “petitioner’s contentions [in a petition] ... define the scope of the litigation all the way from institution through to conclusion.”); see also Patent Trial and Appeal Board Consolidated Trial Practice Guide 73 (Nov. 2019), https://www.uspto.gov/sites/default/files/documents/tpgnov.pdf. We therefore decline to consider Petitioner’s belatedly presented new argument in its Reply that the claims do not require safety. See Acceleration Bay, LLC v. Activision Blizzard Inc., 908 F.3d 765, 775 (Fed. Cir. 2018) (concluding that the Board did not abuse its discretion in refusing to consider portions of a reply declaration “rais[ing] a new obviousness argument for [a claim] limitation that could have been made in the petition” but was not); Intelligent Bio-Sys., 821 F.3d at 1369–70 (concluding that the Board did not abuse its discretion in refusing to consider reply brief arguments advocating a “new theory” of unpatentability under 37 C.F.R. § 42.23(b)). Even if we were to consider Petitioner’s new argument regarding claim construction, we would not find it persuasive because Petitioner’s obviousness rationale incorporates an expectation of safety. Irrespective of whether the claims require safety, Petitioner cannot carry its burden to establish that the claimed methods would have been obviousness without establishing that – as posited in the Petition – the POSA would have expected co-administration to be safe.” slip op. at 18

  Patent outcomesUS 10,195,214 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips
  Patents in suitUS 10,195,214
• 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
• Coalition For Affordable Drugs (Adroca) LLC v. Acorda Therapeutics, Inc.No claims unpatentable
  PTAB · Mar 9, 2017 · IPR2015-01853 · APJ Susan L C Mitchell · IPR · Final written decision

  Claims 1–52 of the ’703, claims 1–3, 5–8, and 10–41 of the ’826, claims 1–8 of the ’685, and claims 1–40 of the ’437 were not shown unpatentable under § 103.

  RulingsFinal written decision

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

    “Petitioner asserts constructions for the following claim terms, “less than 15 milligrams,” “release profile,” “matrix,” “improving walking,” and “initiating treatment.” Pet. 18–19. Patent Owner contends that Petitioner has failed to provide an explanation as to why the identified claim terms require construction and why the Board should depart from the plain and ordinary meaning of the terms. Prelim. Resp. 17, n.4. In the Institution Decision, we agreed with Patent Owner and determined that it was unnecessary to construe explicitly the claim terms for purposes of the Institution Decision. See Dec. Instit. 6 (citing Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). We also determine here that we need not construe expressly any claim term in order to issue a Final Written Decision regarding the patentability of the challenged claims.” slip op. at 7

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “1. Level of Skill Petitioner’s declarants, Drs. Pleasure and Polli, testify that a person of ordinary skill in connection with the ’703 patent would have had an M.D. or Ph.D. in neuroscience or a related field with an understanding of pharmacokinetics and at least some experience in providing drug therapy to MS patients. Ex. 1023 ¶ 16, Ex. 1044 ¶ 13. Additionally, Drs. Pleasure and Polli testify that a person of ordinary skill in the art would have had access to a person having an advanced degree in pharmaceutics or pharmaceutical formulation, specifically oral sustained release formulations, or at least five years of experience in formulating sustained oral release drug products and may work as part of a multi-disciplinary team. Ex. 1023 ¶¶ 16–17; Ex. 1044 ¶¶ 13–14. Patent Owner does not dispute this recitation of the level of ordinary skill in the art. See Ex. 2042 ¶ 68 n.5. We adopt the level of ordinary skill in the art identified by Drs. Pleasure and Polli as it is consistent with the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (stating level of ordinary skill in the art may be reflected by the prior art of record); In re GPAC Inc., 14 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978).” slip op. at 14

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner

    “In order for claims of the ’703 patent to be entitled to benefit of the filing date of the Provisional, the Provisional must provide written description support for those claims. See 35 U.S.C. § 120. To satisfy the written description requirement of 35 U.S.C. § 112, first paragraph, and provide support for the challenged claims of the ’703 patent under 35 U.S.C. § 120, the Provisional must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See In re Wertheim, 541 F.2d 257, 261, 262 (CCPA 1976); Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563– 64 (Fed. Cir. 1991). The primary consideration in determining whether appropriate written description support exists “is factual and depends on the nature of the invention and the amount of knowledge imparted to those skilled in the art by the disclosure.” Union Oil Co. of Cal. v. Atlantic Richfield Co., 208 F.3d 989, 996 (Fed. Cir. 2000).” slip op. at 27

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner

    “We are persuaded by Dr. Hayes’ testimony as confirmed by testimony from Drs. Pleasure and Polli, and conclude that the Provisional supports the CavSS ranges in claims 14–15 and 35–36. Dr. Hayes offers credible 34 testimony concerning how one of skill in the art would interpret Table 7 of the Provisional, which depicts essentially the same data as Table 3 of Hayes. See Ex. 2041 ¶ 17. Dr. Hayes interpretation of the data in Table 7 is supported by testimony from Drs. Pleasure and Polli that about two thirds of the measured data fall within one standard deviation and approximately 95 percent of measured values are within two standard deviations from the mean. Id. at 20–22 (citing deposition testimony from Drs. Pleasure and Polli confirming such an understanding). We agree with Dr. Hayes that “[i]n light of the fact that a POSA would immediately recognize that Table 7 of the ’894 Provisional (Ex. 1007-00045) shows possession of measured data beyond even two standard deviations from its reported mean values, a more complete view of the information reported in Table 7 would consider data dispersed beyond two standard deviations from the mean” to encompass a CavSS range from 3.7–37.8 ng/ml. Ex. 2041 ¶ 23. We are not persuaded by Dr. Fairweather’s testimony that Table 7 supports a CavSS of only 15.1 ng/ml to 26.5 ng.ml. See Ex. 1066 ¶ 21. Dr. Fairweather was asked if he could identify where “range” is defined as plus or minus one standard deviation, and he replied that he could not identify where he found such a definition, Ex. 2176, 44:13–22, but Dr. Fairweather confirmed such a definition is not how he would define “range” in his usual practice, Id. at 92:20–93:21. See also id. at 108:5–11 (conceding there may not be any document that defines “range” as one 35 standard deviation from the mean). When asked whether he could justify the range that he provided for CavSS in his declaration, Dr. Fairweather stated that he could not. Id. at 104:25–105:2. He testified that he conceded the smallest range so as to avoid a discussion of what’s the proper definition for range. Id. at 104:16–20. Dr. Fairweather stated twice that he was not a person of skill in the art and would not be able to answer what assumptions such a person would make when reviewing Table 7 of the Provisional. Id. 136:16–23, 138:14–139:7. Finally, Dr. Fairweather also testified that he could not rule out whether the CavSS data for the 10 mg b.i.d. dose described in Table 7 of the Provisional had a range of at least 15 to 35 ng/ml. Id. at 90:9–92:19. In light of these statements, we do not credit Dr. Fairweather’s testimony.” slip op. at 34

  Patent outcomesUS 8,007,826 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 8,007,826
• Coalition For Affordable Drugs (Adroca) LLC v. Acorda Therapeutics, Inc.No claims unpatentable
  PTAB · Mar 9, 2017 · IPR2015-01850 · APJ Susan L C Mitchell · IPR · Final written decision

  Claims 1–52 of the ’703 patent were not shown unpatentable because S-1 was not prior art under § 102(a) or (b), defeating each instituted § 103 ground.

  RulingsFinal written decision

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

    “Petitioner asserts constructions for the following claim terms, “less than 15 milligrams,” “release profile,” “matrix,” “improving walking,” and “initiating treatment.” Pet. 18–19. Patent Owner contends that Petitioner has failed to provide an explanation as to why the identified claim terms require construction and why the Board should depart from the plain and ordinary meaning of the terms. Prelim. Resp. 17, n.4. In the Institution Decision, we agreed with Patent Owner and determined that it was unnecessary to construe explicitly the claim terms for purposes of the Institution Decision. See Dec. Instit. 6 (citing Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). We also determine here that we need not construe expressly any claim term in order to issue a Final Written Decision regarding the patentability of the challenged claims.” slip op. at 7

  • Skill levelSkill level petitioner adoptedDecided for patent owner

    “1. Level of Skill Petitioner’s declarants, Drs. Pleasure and Polli, testify that a person of ordinary skill in connection with the ’703 patent would have had an M.D. or Ph.D. in neuroscience or a related field with an understanding of pharmacokinetics and at least some experience in providing drug therapy to MS patients. Ex. 1023 ¶ 16, Ex. 1044 ¶ 13. Additionally, Drs. Pleasure and Polli testify that a person of ordinary skill in the art would have had access to a person having an advanced degree in pharmaceutics or pharmaceutical formulation, specifically oral sustained release formulations, or at least five years of experience in formulating sustained oral release drug products and may work as part of a multi-disciplinary team. Ex. 1023 ¶¶ 16–17; Ex. 1044 ¶¶ 13–14. Patent Owner does not dispute this recitation of the level of ordinary skill in the art. See Ex. 2042 ¶ 68 n.5. We adopt the level of ordinary skill in the art identified by Drs. Pleasure and Polli as it is consistent with the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (stating level of ordinary skill in the art may be reflected by the prior art of record); In re GPAC Inc., 14” slip op. at 14

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner

    “In order for claims of the ’703 patent to be entitled to benefit of the filing date of the Provisional, the Provisional must provide written description support for those claims. See 35 U.S.C. § 120. To satisfy the written description requirement of 35 U.S.C. § 112, first paragraph, and provide support for the challenged claims of the ’703 patent under 35 U.S.C. § 120, the Provisional must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See In re Wertheim, 541 F.2d 257, 261, 262 (CCPA 1976); Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563– 64 (Fed. Cir. 1991). The primary consideration in determining whether appropriate written description support exists “is factual and depends on the nature of the invention and the amount of knowledge imparted to those skilled in the art by the disclosure.” Union Oil Co. of Cal. v. Atlantic Richfield Co., 208 F.3d 989, 996 (Fed. Cir. 2000).” slip op. at 27

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner

    “Because the Provisional provides written description support for the challenged claims, S-1 potentially qualifies as prior art only under 35 U.S.C. § 102(a), but not § 102(b), because the S-1 publication date of September 26, 2003 is less than one year before the filing date of the Provisional of April 9, 2004. As discussed in more detail below, however, Patent Owner has provided evidence that S-1 is not prior art to the claims of the ’703 patent under § 102(a) either because the pertinent portions of the S-1 are the original work of inventors Drs. Blight and Cohen. See 35 U.S.C. § 102(a); Katz, 687 F.2d at 454 (stating “one’s own work is not prior art under sec. 102(a) even though it has been disclosed to the public in a manner or form which otherwise would fall under [sec.] 102(a)”).” slip op. at 37

  Patent outcomesUS 8,440,703 not shown unpatentable
  Claim construction§ 102 anticipation§ 112 disclosurecites KSR · Graham
  Patents in suitUS 8,440,703
• Coalition For Affordable Drugs (Adroca) LLC v. Acorda Therapeutics, Inc.No claims unpatentable
  PTAB · Mar 9, 2017 · IPR2015-01858 · APJ Susan L C Mitchell · IPR · Final written decision

  Claims 1–40 of the ’437 patent were not shown unpatentable under § 103 because S-1 was not prior art under § 102(a) or (b).

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedOther

    “1. Level of Skill Petitioner’s declarants, Drs. Pleasure and Polli, testify that a person of ordinary skill in connection with the ’703 patent would have had an M.D. or Ph.D. in neuroscience or a related field with an understanding of pharmacokinetics and at least some experience in providing drug therapy to MS patients. Ex. 1023 ¶ 16, Ex. 1044 ¶ 13. Additionally, Drs. Pleasure and Polli testify that a person of ordinary skill in the art would have had access to a person having an advanced degree in pharmaceutics or pharmaceutical formulation, specifically oral sustained release formulations, or at least five years of experience in formulating sustained oral release drug products and may work as part of a multi-disciplinary team. Ex. 1023 ¶¶ 16–17; Ex. 1044 ¶¶ 13–14. Patent Owner does not dispute this recitation of the level of ordinary skill in the art. See Ex. 2042 ¶ 68 n.5. We adopt the level of ordinary skill in the art identified by Drs. Pleasure and Polli as it is consistent with the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (stating level of ordinary skill in the art may be reflected by the prior art of record); In re GPAC Inc.,” slip op. at 14

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

    “Petitioner asserts constructions for the following claim terms, “less than 15 milligrams,” “release profile,” “matrix,” “improving walking,” and “initiating treatment.” Pet. 18–19. Patent Owner contends that Petitioner has failed to provide an explanation as to why the identified claim terms require construction and why the Board should depart from the plain and ordinary meaning of the terms. Prelim. Resp. 17, n.4. In the Institution Decision, we agreed with Patent Owner and determined that it was unnecessary to construe explicitly the claim terms for purposes of the Institution Decision. See Dec. Instit. 6 (citing Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). We also determine here that we need not construe expressly any claim term in order to issue a Final Written Decision regarding the patentability of the challenged claims.” slip op. at 7

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner

    “We agree with Patent Owner that the Provisional provides adequate written description support for the challenged claims of the ’703 patent. We agree with Drs. Lublin and Peck and credit their testimony that one of skill in art reading the Study Design schematic for Example 11 would have understood that a patient in the 10 mg b.i.d. arm of the study would have received 10 mg b.i.d. throughout the two-week upward titration period. As 10 mg b.i.d. is the lowest dose except for placebo, we find that it necessarily 30 follows that those patients in the 10 mg b.i.d. arm of the study do not need upward titration to the treatment dose because they start and finish at the lower 10 mg dose.” slip op. at 30

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artNot shown unpatentable

    “Although the burden of persuasion for unpatentability never shifts from Petitioner during the trial, the burden of production may shift. See Dynamic Drinkware, 800 F.2d at 1379. Petitioner adequately met its burden of production by presenting S-1 as prior art that on its face lists authors that differ from the inventors of the patents at issue. See Ex. 1003, 92. Patent Owner has responded with ample and persuasive evidence, however, that Drs. Blight and Cohen are the sole source of the disclosure of S-1. Thus, Patent Owner satisfies any burden of production to refute Petitioner’s case that S-1 is prior art under 35 U.S.C. § 102(a). See supra. Petitioner’s response to Patent Owner’s evidence does not persuade us that the portions of S-1 upon which they rely are not solely attributable to Drs. Blight and Cohen. Specifically, Petitioner offers evidence from the S-1 of a statement that the MS-F202 clinical trial was designed “after extensive consultation with a panel of expert MS neurologists and with the FDA,” arguing that statement indicates that Drs. Blight and Cohen may not be the sole authors 41 of the protocol for this clinical trial. Reply 2. Petitioner further argues that Drs. Blight and Cohen’s deposition testimony supports its contention that Drs. Blight and Cohen may not be the sole authors of the protocol for this clinical trial because they could not recall the details of that consultation. Id. at 3 (citing Ex. 1064, 64:18–65:14; Ex. 1063, 76:20–77:20, 80:9–81:14, 110:13–111:2). Petitioner also takes issue with another statement in S-1 indicating that in early 2002, Drs. Blight and Cohen drafted descriptions of the MS-F201 and MS-F202, although version 1.0 of the MS-F202 protocol is dated October 2002. Id. at 2 (citing Paper 28, 16; Ex. 2050, 6). Finally, Petitioner points to publications discussing MS-F201 and MS-F202 where Drs. Blight and Cohen are not consistently named as authors and other authors, such as Drs. Goodman and Katz, are listed. Id. at 3–4. We find that Petitioner’s evidence that allegedly casts doubt on the authorship of the relevant portions of S-1 is not sufficient to overcome the ample, unequivocal evidence presented by Patent Owner that supports our finding that the relevant portions of S-1 are the original work of Drs. Blight and Cohen alone. See In re Katz, 687 F.2d at 455. Both Drs. Cohen and Blight state that they alone are the inventors and sole originators of the work in S-1 upon which Petitioner relies. See Exs. 2044, 2045. Five other declarants, intimately involved in the development of S-1, two of which now work for entities other than Acorda, substantiate this testimony. See Exs. 2046–2048, 2052, 2056. Relying on statements that may, on their face,” slip op. at 41

  Patent outcomesUS 8,354,437 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 8,354,437
• Coalition For Affordable Drugs (Adroca) LLC v. Acorda Therapeutics, Inc.No claims unpatentable
  PTAB · Mar 9, 2017 · IPR2015-01857 · APJ Susan L C Mitchell · IPR · Final written decision

  Claims 1–8 of the ’685 patent were not shown unpatentable because S-1 was not prior art, alone or with Hayes or Juarez.

  RulingsFinal written decision

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner

    “filing date of the Provisional, the Provisional must provide written description support for those claims. See 35 U.S.C. § 120. To satisfy the written description requirement of 35 U.S.C. § 112, first paragraph, and provide support for the challenged claims of the ’703 patent under 35 U.S.C. § 120, the Provisional must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See In re Wertheim, 541 F.2d 257, 261, 262 (CCPA 1976); Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563– 64 (Fed. Cir. 1991). The primary consideration in determining whether appropriate written description support exists “is factual and depends on the nature of the invention and the amount of knowledge imparted to those skilled in the art by the disclosure.” Union Oil Co. of Cal. v. Atlantic Richfield Co., 208 F.3d 989, 996 (Fed. Cir. 2000).” slip op. at 27

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedReference not prior artDecided for patent owner

    “Because the Provisional provides written description support for the challenged claims, S-1 potentially qualifies as prior art only under 35 U.S.C. § 102(a), but not § 102(b), because the S-1 publication date of September 26, 2003 is less than one year before the filing date of the Provisional of April 9, 2004. As discussed in more detail below, however, Patent Owner has provided evidence that S-1 is not prior art to the claims of the ’703 patent under § 102(a) either because the pertinent portions of the S-1 are the original work of inventors Drs. Blight and Cohen. See 35 U.S.C. § 102(a); Katz, 687 F.2d at 454 (stating “one’s own work is not prior art under sec. 102(a) even though it has been disclosed to the public in a manner or form which otherwise would fall under [sec.] 102(a)”).” slip op. at 37

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Applicant-admitted prior artReference not prior artDecided for patent owner

    “We find that Petitioner’s evidence that allegedly casts doubt on the authorship of the relevant portions of S-1 is not sufficient to overcome the ample, unequivocal evidence presented by Patent Owner that supports our finding that the relevant portions of S-1 are the original work of Drs. Blight and Cohen alone. See In re Katz, 687 F.2d at 455. Both Drs. Cohen and Blight state that they alone are the inventors and sole originators of the work in S-1 upon which Petitioner relies. See Exs. 2044, 2045. Five other declarants, intimately involved in the development of S-1, two of which now work for entities other than Acorda, substantiate this testimony. See Exs. 2046–2048, 2052, 2056. Relying on statements that may, on their face, 42 indicate that others may have been involved without any evidence that others were, in fact, originators of the work in question or inventors is simply not enough to carry Petitioner’s burden to show that the S-1 is prior art under 35 U.S.C. § 102(a). For the reasons discussed above, we determine that S-1 does not qualify as prior art to the claims of the ’703 patent under 35 U.S.C. § 102(a) or (b). Thus, all of Petitioner’s challenges to the patentability of the claims of the ’703 patent, which depend on S-1 alone or in combination with Hayes or Juarez, fail. Petitioner, therefore, has not carried its burden to prove unpatentability of claims 1–52 of the ’703 patent by a preponderance of the evidence.9” slip op. at 42

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

    “For the reasons discussed above, we determine that S-1 does not qualify as prior art to the claims of the ’703 patent under 35 U.S.C. § 102(a) or (b). Thus, all of Petitioner’s challenges to the patentability of the claims of the ’703 patent, which depend on S-1 alone or in combination with Hayes or Juarez, fail. Petitioner, therefore, has not carried its burden to prove unpatentability of claims 1–52 of the ’703 patent by a preponderance of the evidence.9 D. IPR2015-01853; IPR2015-01857; and IPR2015-01858 Petitioner’s patentability challenges to the claims of U.S. Patent No. 8,354,437 B2 (“the ’437 patent”), U.S. Patent No. 8,007,826 B2 (“the ’826 patent”), and U.S. Patent No. 8,354,437 B2 (“the ’437 patent”), at issue in IPR2015-01853, IPR2015-01857, and IPR2015-01858, respectively, essentially raise the same issues presented in the patentability challenge to the claims of the ’703 patent in IPR2015-01850. Therefore, we chose to 9 Because we find that S-1 is not prior art under 35 U.S.C. § 102(a), we need not reach whether S-1 is a printed publication.” slip op. at 43

  Patent outcomesUS 8,663,685 not shown unpatentable
  § 102 anticipation§ 112 disclosurecites KSR · Graham
  Patents in suitUS 8,663,685
• Coalition For Affordable Drugs Vii LLC v. Pozen Inc.No claims unpatentable
  PTAB · Feb 21, 2017 · IPR2015-01718 · APJ Toni R Scheiner · IPR · Final written decision

  Claims 1–16 were not shown unpatentable over Plachetka, Graham, and Goldstein or Plachetka alone because the claimed comparative ulcer reduction was an unexpected difference in kind.

  RulingsFinal written decision

  • BurdenNot shown unpatentable

    “Based on the evidence developed at trial, we find that Petitioner has shown that it would have been expected that the method of the challenged claims would be effective in reducing the risk of gastric ulcers in patients taking both LDA and a non-aspirin NSAID. But Petitioner has not established that that the claimed method would have been expected to be more effective in patients taking LDA than in patients not taking LDA, especially in light of evidence of record establishing that patients taking both LDA and a non-aspirin NSAID would be at increased risk for developing gastric ulcers relative to patients taking NSAID alone. We find that this surprising result—the opposite of what the ordinary artisan would have expected—represents a difference in kind, rather than degree. Accordingly, we conclude that Petitioner has not demonstrated by a preponderance of the evidence that the subject matter of claims 1–16 would have been obvious over Plachetka, Graham, and Goldstein.” slip op. at 27

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “Pet. 17–18 (citing Ex. 1003 ¶ 83). Paragraph 83 of Dr. Shargel’s Declaration is virtually identical to the Petition. Neither Petitioner nor Dr. Shargel identifies the basis for these purported results in the Petition, or in the cited portion of the Declaration, much less the basis for the conclusion that an ordinary artisan “would have understood that a combination of lansoprazole and naproxen was more effective at reducing the incidence of the NSAID-associated ulcers in patients taking LDA than in patients not taking LDA.” Pet. 18 (citing Ex. 1003 ¶ 83). As we stated in the Decision 20 of Institution, “[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”— accordingly, we are not persuaded by these conclusory and unsupported statements by Petitioner or Dr. Shargel. Dec. 15 (quoting 37 C.F.R. § 42.65(a)).” slip op. at 20

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

    “Nevertheless, the issue presented by Petitioner’s rationale is not whether the cited art would have suggested administering LDA to a patient already taking Plachetka’s unit dosage form. Rather, the salient issue is whether the art would have suggested that a patient already taking LDA in 13 addition to a non-aspirin NSAID—which Goldstein teaches was known to increase the incidence of gastric ulcers—would have benefited by taking the non-aspirin NSAID in the form of Plachetka’s coordinated unit dose form containing an acid inhibitor in addition to the NSAID. Having considered Petitioner’s and Patent Owner’s arguments and observations with respect to this aspect of the challenged claims, as well as evidence of record establishing that administering an acid inhibitor to a patient taking both LDA and a non-aspirin NSAID was known to reduce the incidence of NSAID-associated gastric ulcers, we determine that Petitioner has demonstrated that an ordinary artisan would have had a reason to administer Plachetka’s coordinated unit dosage forms to patients in need of NSAID therapy and at risk of developing gastric ulcers—including those patients also taking low dose aspirin—in order to reduce the incidence of gastric ulcers.” slip op. at 13

  • Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia outweighedDecided for patent owner

    “Based on the evidence developed at trial, we find that Petitioner has shown that it would have been expected that the method of the challenged claims would be effective in reducing the risk of gastric ulcers in patients taking both LDA and a non-aspirin NSAID. But Petitioner has not established that that the claimed method would have been expected to be more effective in patients taking LDA than in patients not taking LDA, especially in light of evidence of record establishing that patients taking both LDA and a non-aspirin NSAID would be at increased risk for developing gastric ulcers relative to patients taking NSAID alone. We find that this surprising result—the opposite of what the ordinary artisan would have expected—represents a difference in kind, rather than degree. Accordingly, we conclude that Petitioner has not demonstrated by a preponderance of the evidence that the subject matter of claims 1–16 would have been obvious over Plachetka, Graham, and Goldstein.” slip op. at 27

  Patent outcomesUS 8,945,621 not shown unpatentable
  § 103 obviousnesscites Graham
  Patents in suitUS 8,945,621

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.