• Mylan Pharmaceuticals, Inc. / Amneal Pharmaceuticals LLC v. Yeda Research And Development Co. Ltd.Rehearing granted
  PTAB · Dec 2, 2016 · IPR2015-01981 · APJ Sheridan K Snedden · IPR · Rehearing

  Patent Owner’s rehearing request was granted as to the Pinchasi–Flechter combination analysis; rehearing was denied on the remaining issues, and a modified final written decision was entered.

  RulingsRehearing decision

  • RehearingRehearing, grantedRehearing, deniedGranted in part

    “found instead that the data taught that less-frequent-than-daily administration would have been more tolerable than daily administration.” Reh’g Req. 6 (citing Dec. 29). Upon review of the Decision, we agree that the analysis in the cited portion of our Decision does not conflate efficacy with tolerability. See Final Dec. 32–33. Accordingly, we grant this portion of Patent Owner’s Request for Reconsideration and retract our reliance on the efficacy data of Flechter in Section II.C.5 of the Decision as the basis for rejecting Patent Owner’s argument regarding the lack of motivation to combine Pinchasi and Flechter. We concurrently issue a modified Final Written Decision (Paper 90) to reflect this change.” slip op. at 3

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

    “As explained above, we were not persuaded that the prior art suggested decreased tolerability. Indeed, in light of the prior art references each stating that the dosage regimens were well tolerated, we were persuaded that a person of ordinary skill in the art would have had a reason to combine the cited references to reach the claimed dosing regimen with a reasonable expectation of success.” slip op. at 7

  • Obviousness (§103) › Objective indicia / secondary considerationsDecided for petitioner

    “Finally, Patent Owner asserts that the Board overlooked evidence regarding the expected decrease in tolerability in our discussion of secondary considerations. Reh’g Req. 12–13. Patent Owner also states that our “finding that Patent Owner failed to provide any evidence of improved tolerability over the Pinchasi reference (FWD at 24) is also incorrect.” Id. at 14. First, we did not state that Patent Owner failed to provide any evidence 5 Khan et al., Randomized, Prospective, Rater-Blinded, Four-Year, Pilot Study to Compare the Effect of Daily Versus Every-Other-Day Glatiramer Acetate 20 mg Subcutaneous Injections in Relapsing-Remitting Multiple Sclerosis, 14 MULTIPLE SCLEROSIS S296 (2008) (Ex. 1010) (“Khan 2008”). 6 Caon et al., Randomized, Prospective, Rater-Blinded, Four-Year, Pilot Study to Compare the Effect of Daily Versus Every-Other-Day Glatiramer Acetate 20 mg Subcutaneous Injections in RRMS, 72 NEUROLOGY A317 (Mar. 17, 2009) (Ex. 1011) (“Caon 2009”). of improved tolerability—we stated that Patent Owner provided “insufficient evidence of record showing any unexpected results between the claimed requirement of three doses per week compared to dosing every other day.” Dec. 24 (emphasis added). As explained above, we did not find Patent Owner’s characterizations of the prior art, including Cohen, persuasive.” slip op. at 7

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “We note—and agree with—Dr. Ziemssen’s testimony that a person of ordinary skill in the art “generally would not view this type of cross-study comparison between different study populations as a basis for drawing any comparative conclusions.” Ex. 2135 ¶ 87. We are therefore unpersuaded by his ad hoc comparison of Flechter’s data with that of Meiner. Id. ¶ 89. Instead, we find more credible Flechter’s conclusion that alternate-day administration of glatiramer acetate was “well tolerated, comparing favorably with the effects of daily injections of Copolymer 1 in patients with relapsing MS.” Ex. 1008, 1; see also id. at 5 (“The results of this trial suggest that alternate-day treatment with Copolymer 1 is safe, well tolerated, and probably as effective as daily Copolymer 1 in reducing relapse rate and slowing neurologic deterioration.”).” slip op. at 4

  § 103 obviousness
  Patents in suitUS 8,969,302
• Mylan Pharmaceuticals Inc. / Amneal Pharmaceuticals LLC v. Yeda Research & Development Co. Ltd.Rehearing granted
  PTAB · Dec 2, 2016 · IPR2015-00643 · APJ Zhenyu Yang · IPR · Rehearing

  The Board granted rehearing on the Pinchasi–Flechter motivation issue, denied rehearing on the remaining issues, vacated the prior Final Written Decision, and entered a modified decision concurrently.

  RulingsRehearing decision

  • RehearingRehearing, grantedRehearing, deniedGranted in part

    “§ 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.”” slip op. at 2

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

    “Patent Owner first asserts that we “misconstrued data in Flechter illustrating that alternate day dosing was as effective as daily dosing and found instead that the data taught that less-frequent-than-daily administration would have been more tolerable than daily administration.” Reh’g Req. 7 (citing Dec. 32). Upon review of the Decision, we agree. See Dec. 32–33. Accordingly, we grant this portion of Patent Owner’s Request for Reconsideration and retract our reliance on the efficacy data of Flechter in Section II.F of the Decision as the basis for rejecting Patent Owner’s argument regarding the lack of motivation to combine Pinchasi and Flechter. We concurrently issue a modified Final Written Decision (Paper 90) to reflect this change.” slip op. at 3

  • Obviousness (§103) › Objective indicia / secondary considerationsNot shown unpatentable

    “regarding the expected decrease in tolerability in our discussion of secondary considerations. Reh’g Req. 14–15. Patent Owner argues that our “finding that Patent Owner failed to provide any evidence of improved tolerability over the Pinchasi reference (FWD at 26) is also incorrect.” Id. at 14. We did not state that Patent Owner failed to provide any evidence of improved tolerability—we stated that Patent Owner provided “insufficient” slip op. at 8

  • Expert testimonyPatent owner expert discountedDecided for patent owner

    “Dr. Ziemssen, however, qualifies this comparison and explains that a person of ordinary skill in the art “generally would not view this type of cross-study comparison between different study populations as a basis for drawing any comparative conclusions.” Ex. 2135 ¶ 87. We agree. As a result, we are unpersuaded by the conclusion drawn from the ad hoc comparison of the data in Flechter with those in Meiner. This is especially so in view of Flechter’s conclusion that alternate-day administration of glatiramer acetate was “well tolerated, comparing favorably with the effects of daily injections of Copolymer 1 in patients with relapsing MS.” Ex. 1008, 1; see also id. at 5 (“The results of this trial suggest that alternateday treatment with Copolymer 1 is safe, well tolerated, and probably as effective as daily Copolymer 1 in reducing relapse rate and slowing neurologic deterioration.”).” slip op. at 4

  § 103 obviousness
  Patents in suitUS 8,232,250
• Mylan Pharmaceuticals, Inc. / Amneal Pharmaceuticals LLC v. Yeda Research And Development Co. Ltd.Rehearing granted
  PTAB · Dec 2, 2016 · IPR2015-00830 · APJ Sheridan K Snedden · IPR · Rehearing

  The Board granted rehearing on the Pinchasi–Flechter combination, retracting reliance on Flechter’s efficacy data, and denied rehearing on the remaining issues.

  RulingsRehearing decision

  • RehearingRehearing, grantedRehearing, deniedGranted in part

    “STANDARD OF REVIEW The party requesting rehearing has the burden to show that the decision should be modified. Under 37 C.F.R. § 42.71(d), the request for rehearing must identify, specifically, all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” slip op. at 2

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

    “We note—and agree with—Dr. Ziemssen’s testimony that a person of ordinary skill in the art “generally would not view this type of cross-study comparison between different study populations as a basis for drawing any comparative conclusions.” Ex. 2135 ¶ 87. We are therefore unpersuaded by his ad hoc comparison of Flechter’s data with that of Meiner. Id. ¶ 89. Instead, we find more credible Flechter’s conclusion that alternate-day administration of glatiramer acetate was “well tolerated, comparing favorably with the effects of daily injections of Copolymer 1 in patients with relapsing MS.” Ex. 1008, 1; see also id. at 5 (“The results of this trial suggest that alternate-day treatment with Copolymer 1 is safe, well tolerated, and probably as effective as daily Copolymer 1 in reducing relapse rate and slowing neurologic deterioration.”). Accordingly, we are not persuaded that a person of ordinary skill in the art considering combining a higher dose of GA with Flechter’s alternateday dosing schedule would conclude that such a regimen would likely exacerbate the frequency of injection site reactions, as Patent Owner asserts. See PO Resp. 36.” slip op. at 4

  • Expert testimonyPatent owner expert discountedDecided for petitioner

    “Flechter suggests that less frequent injections were less tolerable than daily injections reported in Meiner.3 In particular, Patent Owner points us to the Patent Owner Response, which compares the alternate-day data in Flechter with the daily administration data of Meiner. Reh’g Req. 7–8 (citing PO Resp. 35–36). Although Flechter itself did not compare the data, Patent Owner and its declarant, Dr. Tjalf Ziemssen, M.D., Ph.D., compare Flechter’s data reporting adverse events in its patients with Meiner’s data reporting adverse events in a different cohort of patients. PO Resp. 35–36; Ex. 2135 ¶ 89. From that comparison, Patent Owner argues that Flechter’s data allegedly teaches that alternate-day administration is less tolerable than daily administration. Reh’g Req. 8.” slip op. at 3

  • Obviousness (§103) › Objective indicia / secondary considerationsDecided for petitioner

    “Finally, Patent Owner asserts that the Board overlooked evidence regarding the expected decrease in tolerability in our discussion of secondary considerations. Reh’g Req. 12–13. Patent Owner also states that our “finding that Patent Owner failed to provide any evidence of improved tolerability over the Pinchasi reference (FWD at 24) is also incorrect.” Id. at 14. First, we did not state that Patent Owner failed to provide any evidence 5 Khan et al., Randomized, Prospective, Rater-Blinded, Four-Year, Pilot Study to Compare the Effect of Daily Versus Every-Other-Day Glatiramer Acetate 20 mg Subcutaneous Injections in Relapsing-Remitting Multiple Sclerosis, 14 MULTIPLE SCLEROSIS S296 (2008) (Ex. 1010) (“Khan 2008”). 6 Caon et al., Randomized, Prospective, Rater-Blinded, Four-Year, Pilot Study to Compare the Effect of Daily Versus Every-Other-Day Glatiramer Acetate 20 mg Subcutaneous Injections in RRMS, 72 NEUROLOGY A317 (Mar. 17, 2009) (Ex. 1011) (“Caon 2009”). of improved tolerability—we stated that Patent Owner provided “insufficient evidence of record showing any unexpected results between the claimed requirement of three doses per week compared to dosing every other day.” Dec. 24 (emphasis added). As explained above, we did not find Patent Owner’s characterizations of the prior art, including Cohen, persuasive.” slip op. at 7

  § 103 obviousness
  Patents in suitUS 8,969,302
• Mylan Pharmaceuticals Inc. / Amneal Pharmaceuticals LLC v. Yeda Research & Development Co. Ltd.Rehearing granted
  PTAB · Dec 2, 2016 · IPR2015-01976 · APJ Zhenyu Yang · IPR · Rehearing

  On rehearing, the Board modified its decision and held claims 1–20 unpatentable as obvious over Pinchasi with the 1996 SBOA and over Pinchasi with Flechter.

  RulingsRehearing decision

  • RehearingGranted in part

    “we entered a Final Written Decision pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. Patent Owner filed a request for rehearing of our decision. Paper 87. In a concurrently issued Order, we grant-in-part Patent Owner’s request and vacate our original decision. Paper 89. We hereby issue this modified Final Written Decision.” slip op. at 2

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “in the art. Petitioner contends that a person of ordinary skill in the art would have had (1) several years of experience in the pharmaceutical industry or in practicing medicine; (2) experience with the administration or formulation of therapeutic agents, dosing schedules and frequencies, and drug developmental study and design; and (3) a Ph.D. in pharmacology or an M.D. with experience in clinical pharmacology. Pet. 13. In its Preliminary Response, Patent Owner asserted that a skilled artisan would have had knowledge of, and experience with, both MS and GA. Prelim. Resp. 33–34. In the Decision to Institute, we agreed with Patent Owner. Dec. 9. We noted that Dr. Green, one of Petitioner’s declarants, states that a person of ordinary skill in the art would have had “direct experience administering therapeutic agents for the treatment of MS, as well as familiarity with the dosing schedules and frequencies of the different therapeutic agents available for MS treatment.” Id. (citing Ex. 1004 ¶ 27). During trial, neither party contests our findings of the level of a person of ordinary skill in the art. Upon considering the full record, we see no reason to deviate from our prior determination. Thus, we reiterate that in addition to the qualifications specified by Petitioner, a person of ordinary skill in the art would also have experience treating MS with GA.” slip op. at 8

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

    “As an initial matter, we note that, in its Preliminary Response, Patent Owner challenged the status of the 1996 SBOA as a printed publication under 35 U.S.C. § 102(b). Prelim. Resp. 47–48. In the Decision to Institute, we determined that, based on the record available then, the 1996 SBOA constitutes prior art under § 102(b). Dec. 12–13. In its Response, Patent Owner does not dispute this finding. Having considered the complete record developed at trial, we reiterate that Petitioner has presented sufficient evidence (see Ex. 1007) to show that the 1996 SBOA was publicly accessible at least by July 17, 2007, more than one year before the earliest possible priority date of the ’250 patent (i.e., August 20, 2008). See Dec. 12–13. Thus, the 1996 SBOA constitutes prior art under § 102(b).” slip op. at 9

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

    “Upon considering the evidence as a whole, we also find that an ordinary artisan would have been motivated to administer GA three times over a period of seven days to increase patient compliance. We note again that Pinchasi teaches administering 40 mg GA every other day, which equates to seven doses over two weeks. Ex. 1005, 9. Thus, the difference between the challenged claims (three doses over a period of seven days, or six doses over two weeks) and the prior art is one less injection every two weeks. Dr. Green testifies that it was a well-known principle that decreasing the frequency of injections would have a positive impact on patients to stay on course with treatment. Ex. 1004 ¶ 101. The desirability of less frequent injections is supported by the 1996 SBOA, in which the reviewer recommended that Teva evaluate the necessity of daily injections as opposed to more infrequent intermittent administration of Copaxone®. Ex. 1007, 252.” slip op. at 13

  § 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,232,250
• Mylan Pharmaceuticals Inc. / Amneal Pharmaceuticals LLC v. Yeda Research & Development Co. Ltd.Rehearing granted
  PTAB · Dec 2, 2016 · IPR2015-01976 · APJ Zhenyu Yang · IPR · Rehearing

  The Board granted rehearing on the Pinchasi–Flechter combination, denied rehearing on the remaining issues, vacated the prior final written decision, and entered a modified decision concurrently.

  RulingsRehearing decision

  • RehearingRehearing, grantedRehearing, deniedGranted in part

    “§ 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.”” slip op. at 2

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

    “person of ordinary skill in the art “generally would not view this type of cross-study comparison between different study populations as a basis for drawing any comparative conclusions.” Ex. 2135 ¶ 87. We agree. As a result, we are unpersuaded by the conclusion drawn from the ad hoc comparison of the data in Flechter with those in Meiner. This is especially so in view of Flechter’s conclusion that alternate-day administration of glatiramer acetate was “well tolerated, comparing favorably with the effects of daily injections of Copolymer 1 in patients with relapsing MS.” Ex. 1008, 1; see also id. at 5 (“The results of this trial suggest that alternateday treatment with Copolymer 1 is safe, well tolerated, and probably as effective as daily Copolymer 1 in reducing relapse rate and slowing neurologic deterioration.”). Accordingly, we are not persuaded that a person of ordinary skill in the art considering combining a higher dose of GA with the alternate-day dosing schedule in Flechter would, as Patent Owner asserts, conclude that 5 Meiner et al., Copolymer 1 in Relapsing-Remitting Multiple Sclerosis: a Multi-Centre Trial, in Frontiers in Multiple Sclerosis: Clinical Research and Therapy (Abramsky et al. eds., 1997) (Ex. 1009). such a regimen would likely exacerbate the frequency of injection site reactions. See PO Resp. 36.” slip op. at 4

  • Obviousness (§103) › Objective indicia / secondary considerationsNot shown unpatentable

    “regarding the expected decrease in tolerability in our discussion of secondary considerations. Reh’g Req. 14–15. Patent Owner argues that our “finding that Patent Owner failed to provide any evidence of improved tolerability over the Pinchasi reference (FWD at 26) is also incorrect.” Id. at 14. We did not state that Patent Owner failed to provide any evidence of improved tolerability—we stated that Patent Owner provided “insufficient 8 Khan et al., Randomized, Prospective, Rater-Blinded, Four-Year, Pilot Study to Compare the Effect of Daily Versus Every-Other-Day Glatiramer Acetate 20 mg Subcutaneous Injections in Relapsing-Remitting Multiple Sclerosis, 14 MULTIPLE SCLEROSIS S296 (2008) (Ex. 1010). 9 Caon et al., Randomized, Prospective, Rater-Blinded, Four-Year, Pilot Study to Compare the Effect of Daily Versus Every-Other-Day Glatiramer Acetate 20 mg Subcutaneous Injections in RRMS, 72 NEUROLOGY A317 (Mar. 17, 2009) (Ex. 1011). evidence of record showing any unexpected benefit between the claimed three-times-weekly as compared to the prior art every-other-day dosing.” Dec. 26 (emphasis added). Substantively, as explained above, we find Patent Owner’s characterizations of the prior art, including Cohen, unpersuasive. As a result, we were not, and remain not, persuaded that the nonobviousness of the challenged claims is supported by evidence of unexpected results.” slip op. at 8

  • Obviousness (§103) › Objective indicia / secondary considerations › Unexpected resultsDecided for petitioner

    “regarding the expected decrease in tolerability in our discussion of secondary considerations. Reh’g Req. 14–15. Patent Owner argues that our “finding that Patent Owner failed to provide any evidence of improved tolerability over the Pinchasi reference (FWD at 26) is also incorrect.” Id. at 14. We did not state that Patent Owner failed to provide any evidence of improved tolerability—we stated that Patent Owner provided “insufficient 8 Khan et al., Randomized, Prospective, Rater-Blinded, Four-Year, Pilot Study to Compare the Effect of Daily Versus Every-Other-Day Glatiramer Acetate 20 mg Subcutaneous Injections in Relapsing-Remitting Multiple Sclerosis, 14 MULTIPLE SCLEROSIS S296 (2008) (Ex. 1010). 9 Caon et al., Randomized, Prospective, Rater-Blinded, Four-Year, Pilot Study to Compare the Effect of Daily Versus Every-Other-Day Glatiramer Acetate 20 mg Subcutaneous Injections in RRMS, 72 NEUROLOGY A317 (Mar. 17, 2009) (Ex. 1011). evidence of record showing any unexpected benefit between the claimed three-times-weekly as compared to the prior art every-other-day dosing.” Dec. 26 (emphasis added). Substantively, as explained above, we find Patent Owner’s characterizations of the prior art, including Cohen, unpersuasive. As a result, we were not, and remain not, persuaded that the nonobviousness of the challenged claims is supported by evidence of unexpected results.” slip op. at 8

  § 103 obviousness
  Patents in suitUS 8,232,250
• Mylan Pharmaceuticals Inc. / Amneal Pharmaceuticals LLC v. Yeda Research & Development Co. Ltd.Rehearing granted
  PTAB · Dec 2, 2016 · IPR2015-01980 · APJ Tina E Hulse · IPR · Rehearing

  The Board granted rehearing on the Pinchasi–Flechter combination issue, denied rehearing on the remaining issues, vacated the original decision, and entered a modified final written decision.

  RulingsRehearing decision

  • RehearingRehearing, grantedRehearing, deniedGranted in part

    “STANDARD OF REVIEW The party requesting rehearing has the burden to show that the decision should be modified. Under 37 C.F.R. § 42.71(d), the request for rehearing must identify, specifically, all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” slip op. at 2

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundDecided for patent owner

    “found instead that the data taught that less-frequent-than-daily administration would have been more tolerable than daily administration.” Reh’g Req. 7 (citing Dec. 25–26). The cited pages 25–26 of our Decision address the misinterpretation of data in Flechter. Dec. 25–26. But, contrary to Patent Owner’s assertion, we do not conflate the efficacy data of Flechter with tolerability. Rather, we find that “we are not persuaded by Patent Owner’s argument that a person of ordinary skill in the art would interpret Flechter as showing that decreasing the dosing frequency would decrease the efficacy of the drug.” Dec. 25–26 (emphasis added). Although the cited portion of our Decision does not conflate efficacy with tolerability, we acknowledge that our Decision regarding the combination of Pinchasi and Flechter does. See Dec. 32–33. Accordingly, we grant Patent Owner’s request for reconsideration as to this portion of our Decision. We, therefore, do not rely on the efficacy data of Flechter in Section II.E.2 of the Final Written Decision as the basis for rejecting Patent Owner’s argument regarding the lack of motivation to combine Pinchasi and Flechter. Nevertheless, we are not persuaded by Patent Owner’s argument that Flechter suggests that less frequent injections were less tolerable than daily injections reported in Meiner.3 In particular, Patent Owner points us to the Patent Owner Response, which compares the alternate-day data in Flechter with the daily administration data of Meiner. Reh’g Req. 7–8 (citing PO Resp. 35–36). Although Flechter itself did not compare the data,” slip op. at 3

  • Expert testimonyPatent owner expert discountedPetitioner expert creditedDecided for petitioner

    “We note—and agree with—Dr. Ziemssen’s testimony that a person of ordinary skill in the art “generally would not view this type of cross-study comparison between different study populations as a basis for drawing any comparative conclusions.” Ex. 2135 ¶ 87. We are therefore unpersuaded by his ad hoc comparison of Flechter’s data with that of Meiner. Id. ¶ 89. Instead, we find more credible Flechter’s conclusion that alternate-day administration of glatiramer acetate was “well tolerated, comparing favorably with the effects of daily injections of Copolymer 1 in patients with relapsing MS.” Ex. 1008, 1; see also id. at 5 (“The results of this trial suggest that alternate-day treatment with Copolymer 1 is safe, well tolerated, and probably as effective as daily Copolymer 1 in reducing relapse rate and slowing neurologic deterioration.”).” slip op. at 4

  • Obviousness (§103) › Objective indicia / secondary considerationsDecided for petitioner

    “regarding the expected decrease in tolerability in our discussion of secondary considerations. Reh’g Req. 14–15. Patent Owner also states that our “finding that Patent Owner failed to provide any evidence of improved tolerability over the Pinchasi reference (FWD at 26–27) is also incorrect.” Id. at 14. First, we did not state that Patent Owner failed to provide any 8 Khan et al., Randomized, Prospective, Rater-Blinded, Four-Year, Pilot Study to Compare the Effect of Daily Versus Every-Other-Day Glatiramer Acetate 20 mg Subcutaneous Injections in Relapsing-Remitting Multiple Sclerosis, 14 MULTIPLE SCLEROSIS S296 (2008) (Ex. 1010) (“Khan 2008”). 9 Caon et al., Randomized, Prospective, Rater-Blinded, Four-Year, Pilot Study to Compare the Effect of Daily Versus Every-Other-Day Glatiramer Acetate 20 mg Subcutaneous Injections in RRMS, 72 NEUROLOGY A317 (Mar. 17, 2009) (Ex. 1011) (“Caon 2009”). evidence of improved tolerability—we stated that Patent Owner provided “insufficient evidence of record showing any unexpected results between the claimed requirement of three doses per week compared to dosing every other day.” Dec. 26–27 (emphasis added). As explained above, we did not find Patent Owner’s characterizations of the prior art, including Cohen, persuasive.” slip op. at 8

  § 103 obviousness
  Patents in suitUS 8,399,413
• Mylan Pharmaceuticals Inc. / Amneal Pharmaceuticals LLC v. Yeda Research & Development Co. Ltd.Rehearing granted
  PTAB · Dec 2, 2016 · IPR2015-00644 · APJ Tina E Hulse · IPR · Rehearing

  The Board granted rehearing on the Pinchasi–Flechter combination issue, denied rehearing on the remaining issues, and vacated the original final written decision.

  RulingsRehearing decision

  • RehearingRehearing, grantedRehearing, deniedGranted in part

    “STANDARD OF REVIEW The party requesting rehearing has the burden to show that the decision should be modified. Under 37 C.F.R. § 42.71(d), the request for rehearing must identify, specifically, all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” slip op. at 2

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundDecided for patent owner

    “with tolerability, we acknowledge that our Decision regarding the combination of Pinchasi and Flechter does. See Dec. 32–33. Accordingly, we grant Patent Owner’s request for reconsideration as to this portion of our Decision. We, therefore, do not rely on the efficacy data of Flechter in Section II.E.2 of the Final Written Decision as the basis for rejecting Patent Owner’s argument regarding the lack of motivation to combine Pinchasi and Flechter. Nevertheless, we are not persuaded by Patent Owner’s argument that Flechter suggests that less frequent injections were less tolerable than daily injections reported in Meiner.3 In particular, Patent Owner points us to the Patent Owner Response, which compares the alternate-day data in Flechter with the daily administration data of Meiner. Reh’g Req. 7–8 (citing PO Resp. 35–36). Although Flechter itself did not compare the data,” slip op. at 3

  • Expert testimonyPatent owner expert discountedDecided for petitioner
  • Obviousness (§103) › Objective indicia / secondary considerationsNot reached

    “regarding the expected decrease in tolerability in our discussion of secondary considerations. Reh’g Req. 14–15. Patent Owner also states that our “finding that Patent Owner failed to provide any evidence of improved tolerability over the Pinchasi reference (FWD at 26–27) is also incorrect.” Id. at 14. First, we did not state that Patent Owner failed to provide any 8 Khan et al., Randomized, Prospective, Rater-Blinded, Four-Year, Pilot Study to Compare the Effect of Daily Versus Every-Other-Day Glatiramer Acetate 20 mg Subcutaneous Injections in Relapsing-Remitting Multiple Sclerosis, 14 MULTIPLE SCLEROSIS S296 (2008) (Ex. 1010) (“Khan 2008”). 9 Caon et al., Randomized, Prospective, Rater-Blinded, Four-Year, Pilot Study to Compare the Effect of Daily Versus Every-Other-Day Glatiramer Acetate 20 mg Subcutaneous Injections in RRMS, 72 NEUROLOGY A317 (Mar. 17, 2009) (Ex. 1011) (“Caon 2009”). evidence of improved tolerability—we stated that Patent Owner provided “insufficient evidence of record showing any unexpected results between the claimed requirement of three doses per week compared to dosing every other day.” Dec. 26–27 (emphasis added). As explained above, we did not find Patent Owner’s characterizations of the prior art, including Cohen, persuasive.” slip op. at 8

  § 103 obviousness
  Patents in suitUS 8,399,413
• Geosys-Intl, Inc. v. Farmers Edge Precision Consulting Inc.Rehearing granted
  PTAB · Nov 22, 2016 · IPR2015-00711 · APJ James T Moore · IPR · Rehearing

  Rehearing was granted, and claim 25 was held unpatentable as obvious over Hauwiller, the Background of the ’867 patent, and Shibusawa.

  RulingsRehearing decision

  • RehearingRehearing, grantedGranted

    “After considering the arguments in the Request for Rehearing and reconsidering the evidence of record, we agree with Petitioner that the reasoning in our Final Decision misapprehended what is required by claim 25. Claim 25 does not require satellite imaging to create a map of soil electrical conductivity. Applying this corrected understanding of claim 25, we also now agree that Petitioner established by a preponderance of the evidence that claim 25 would have been obvious in view of Hauwiller, the Background of the ’867 patent, and Shibusawa.” slip op. at 4

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

    “Applying this corrected understanding of claim 25, we also now agree that Petitioner established by a preponderance of the evidence that claim 25 would have been obvious in view of Hauwiller, the Background of the ’867 patent, and Shibusawa. As summarized above, Petitioner presented evidence that Shibusawa discloses a map of measurements of soil electrical conductivity, and that combining Shibusawa’s teachings with Hauwiller’s system would have been obvious because electrical conductivity testing is a relatively efficient method for determining soil properties. Pet. 45–46; Ex. 1004, 20:11–16, 23:14–17; Ex. 1009 ¶ 80. As Petitioner points out, the subject matter recited in claim 25 is similar to that of claims 7 and 14, and we determined in our Final Decision that Petitioner’s contentions regarding the obviousness of those claims were persuasive. See Req. Reh’g 5; Dec. 39–40.” slip op. at 5

  § 103 obviousness
  Patents in suitUS 7,343,867
• Geosys-Intl, Inc. v. Farmers Edge Precision Consulting Inc.Rehearing granted
  PTAB · Nov 22, 2016 · IPR2015-00709 · APJ Timothy J Goodson · IPR · Rehearing

  Rehearing granted; claim 25 held unpatentable as obvious over Hauwiller, the Background of the ’912 patent, and Shibusawa.

  RulingsRehearing decision

  • RehearingRehearing, grantedGranted

    “was based on a misapprehension of what is required by claim 25. Req. Reh’g 6. Specifically, Petitioner argues that claim 25 does not require satellite imaging to create a map of soil electrical conductivity. Id. at 1. Petitioner points out that claim 25 requires that the soil electrical conductivity map is used for the calculation of the “site-specific measures of the soil nutrient existing in the field.” Id. at 2. Claim 15 requires that the map of site-specific field characteristic data generated using a satellite image of the agricultural field is used in the calculation of the map of “site-specific soil nutrient amount needed to produce at each site a maximum possible crop yield.” Ex. 1001, 12:7–12. In other words, the map of soil electrical conductivity recited in claim 25 is used in the first calculating step of claim 15, not the second calculating step that uses a map generated through satellite imaging. After considering the arguments in the Request for Rehearing and reconsidering the evidence of record, we agree with Petitioner that the reasoning in our Final Decision misapprehended what is required by claim 25. Claim 25 does not require satellite imaging to create a map of soil electrical conductivity. Applying this corrected understanding of claim 25, we also agree that Petitioner established by a preponderance of the evidence that claim 25 would have been obvious in view of Hauwiller, the Background of the ’912 patent, and Shibusawa. As summarized above, Petitioner presented evidence that Shibusawa discloses a map of measurements of soil electrical conductivity, and that combining Shibusawa’s teachings with Hauwiller’s system would have been obvious because electrical conductivity testing is a relatively efficient method for determining soil properties. Pet. 47; Ex. 1004, 20:11–16, 23:14–17; Ex. 1009 ¶ 80. As Petitioner points out, the subject matter recited in claim 25 is similar to that of claims 7 and 14, and we determined in our Final Decision that Petitioner’s contentions regarding the obviousness of those claims were persuasive. See Req. Reh’g 5–6; Dec. 34.” slip op. at 4

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableMotivation foundUnpatentable

    “reconsidering the evidence of record, we agree with Petitioner that the reasoning in our Final Decision misapprehended what is required by claim 25. Claim 25 does not require satellite imaging to create a map of soil electrical conductivity. Applying this corrected understanding of claim 25, we also agree that Petitioner established by a preponderance of the evidence that claim 25 would have been obvious in view of Hauwiller, the Background of the ’912 patent, and Shibusawa. As summarized above, Petitioner presented evidence that Shibusawa discloses a map of measurements of soil electrical conductivity, and that combining Shibusawa’s teachings with Hauwiller’s system would have been obvious because electrical conductivity testing is a relatively efficient method for determining soil properties. Pet. 47; Ex. 1004, 20:11–16, 23:14–17; Ex. 1009 ¶ 80. As Petitioner points out, the subject matter recited in claim 25 is similar to that of claims 7 and 14, and we determined in our Final Decision that Petitioner’s contentions regarding the obviousness of those claims were persuasive. See Req. Reh’g 5–6; Dec. 34.” slip op. at 4

  § 103 obviousness
  Patents in suitUS 7,171,912
• Securus Technologies, Inc. v. Global Tel*link CorporationRehearing granted
  PTAB · Sep 12, 2016 · IPR2016-00267 · APJ Kevin F Turner · IPR · Rehearing

  The Board granted rehearing only insofar as it addressed the request, but denied rehearing overall and maintained denial of institution because the petition did not show a reasonable likelihood of unpatentability.

  RulingsRehearing decision

  • RehearingRehearing, deniedGranted in part

    “public mode,” including specific citations, namely “Ex. 1005 at 16:24-31; 18:2- 8.” See Reh’g Req. 7. Those citations fall short, however, because they were not provided in the Petition. The closest citation provided by Petitioner is “Ex. 1005 at 16:54-17:3,” at page 41 of the Petition. The Board could not have overlooked a detailed explanation or analysis not presented in the Petition. A rehearing request is not a supplemental petition. The petition, itself, must identify “specific portions of the evidence that support the challenge.” 37 C.F.R. § 42.104(b)(5). “The Board may exclude or give no weight to the evidence where a party has failed to state its relevance or to identify specific portions of the evidence that support the challenge.” Id. Petitioner has the responsibility to identify and explain in the petition specific evidence that supports its arguments. We must make our determination regarding institution based on what the Petition actually presented and not what it could have reasonably contained had it been reformulated. In re 5 Magnum Oil Tools Int’l, Ltd., No. 2015-1300, 2016 WL 3974202, at *10 (Fed. Cir. July 25, 2016) (holding that the Board is not “free to adopt arguments on behalf of petitioners that could have been, but were not, raised by the petitioner during an IPR”). slip op. at 5

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

    “The Board is tasked with determining whether a petitioner would be reasonably likely to prevail in demonstrating that at least one of the challenged claims is not patentable in view of the petition filed. 35 U.S.C. § 314(a). It is the Petitioner, in its Petition, that must demonstrate whether there is a reasonable likelihood that at least one claim is unpatentable under the assert ground. See 37 C.F.R. § 42.108(c). “In an [inter partes review], the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (citing Tech. Licensing Corp. v. Videotek, Inc., 545 F.3d 1316, 1326–27 (Fed. Cir. 2008)) (discussing the burden of proof in inter partes review).” slip op. at 4

  • BurdenDecided for patent owner

    “As such, it is not clear how Petitioner could have relied solely on the public mode of Bulriss when neither the public nor the privacy modes are acknowledged in the Petition. If an understanding of the public mode of Bulriss was important in the context of Petitioner’s case against the claims of the ’816 Patent, no such import or discussion of the public mode was provided in the Petition. The Board is tasked with determining whether a petitioner would be reasonably likely to prevail in demonstrating that at least one of the challenged claims is not patentable in view of the petition filed. 35 U.S.C. § 314(a). It is the Petitioner, in its Petition, that must demonstrate whether there is a reasonable likelihood that at least one claim is unpatentable under the assert ground. See 37 C.F.R. § 42.108(c). “In an [inter partes review], the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (citing Tech. Licensing Corp. v. Videotek, Inc., 545 F.3d 1316, 1326–27 (Fed. Cir. 2008)) (discussing the burden of proof in inter partes review).” slip op. at 4

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

    “communications” limitation and its proffered motivation to combine Bulriss and Hesse. Reh’g Req. 11–14. We have previously discussed and decided these issues in the Denial of Institution Decision, and we are not persuaded of error in their consideration. Dec. 8–9, 12. As we discussed, the motivation to combine cannot come from the subject patent itself, such that even if “[t]he motivation to combine is therefore explicit in the references” (Reh’g Req. 14), it does not cure the deficiencies of the combination of Bulriss and Hesse provided in the Petition, as discussed in the rest of the Decision. Likewise, the new citations to Bulriss (Reh’g Req. 12), not found in the Petition, cannot be used to show that we misapprehended the arguments supplied in the Petition or that we used unreasonable judgment in determining that one of ordinary skill in the art would not have been motivated to provide scheduling of video visits in the context of Bulriss, in view of Hesse, for the reasons supplied by Petitioner. Dec. 12. For the foregoing reasons, Petitioner has not shown that the Board’s findings are not supported by substantial evidence, nor that the Board abused its discretion 6 in determining that Petitioner failed to demonstrate that at least one of the challenged claims of the ’816 Patent is unpatentable.” slip op. at 6

  § 103 obviousness
  Patents in suitUS 7,256,816

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.