• Kite Pharma, Inc. v. Sloan Kettering Institute For Cancer ResearchNo claims unpatentable
  PTAB · Dec 16, 2016 · IPR2015-01719 · APJ Elizabeth A Lavier · IPR · Final written decision

  Claims 1–13 were not held unpatentable because Kite did not prove the asserted obviousness grounds; the Board found no persuasive rationale to combine the references.

  RulingsFinal written decision

  • Skill levelSkill level board ownOther

    “A. Level of Ordinary Skill in the Art The parties generally agree9 that one of ordinary skill in the art at the time of the invention10 would have had an advanced degree in immunology, cell biology, biochemistry, molecular biology, or a related discipline, along with knowledge and experience in the field of T cell research, including laboratory techniques. See Pet. 33–34 (citing Ex. 100811 ¶ 12); PO Resp. 9 (citing Ex. 202212 ¶ 25; Ex. 1008 ¶ 12). In light of the parties’ general agreement on this point, we adopt that description of the level of ordinary 9 However, Sloan disputes (see PO Resp. 9) Kite’s assertion that one of ordinary skill in the art would have “taken advantage of certain specialized skills” while working as part of a team (Pet. 34). As these specialties (see Pet. 34 (“[f]or example, an immunologist, a cell biologist, and a clinical oncologist”)) are in disciplines within the ambit of the relevant art of T cell research, we discern no meaningful distinction in the parties’ positions on this issue. 10 The application leading to the ’190 patent was filed on May 28, 2003. Ex. 1001, at [22].” slip op. at 8

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

    “II. CLAIM CONSTRUCTION In our decision instituting inter partes review, we determined it was not necessary to construe expressly any of the claim terms. Dec. Inst. 6. Upon consideration of the full record, express construction remains unnecessary. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (noting claim terms require construction “only to the extent necessary to resolve the controversy”). Indeed, neither the Response nor the Reply directly addresses claim construction, and the parties did not focus on claim construction issues during the oral hearing.” slip op. at 7

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

    “Central to any allegation of obviousness is that the proponent must establish that the prior art renders the invention obvious as claimed. Cf. KSR, 550 U.S. at 418 (discussing various considerations important in determining “whether there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue”). Here, Kite’s rationale (1), as presented in the Petition, does not distinguish expressly between the advantages of Krause’s CD28 sequence versus Finney’s, or explain why one of ordinary skill in the art, in developing a dual-signaling chimeric TCR to target GD2, would have been motivated to retain Krause’s 13 CD28 sequence over Finney’s when combining the two references. Accordingly, rationale (1) is deficient on its face. However, if we impute the alleged advantages of Krause’s CD28 sequence as discussed with respect to rationales (2) and (3) to rationale (1),15 then rationale (1) rises or falls with rationale (2).16” slip op. at 13

  • Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away foundDecided for patent owner

    “Although, as Kite notes, Sloan cites no prior art evidence about off- target binding concerns specifically in regard to the MYPPPY motif (see Pet. Reply 11), Sloan’s teach-away argument is nonetheless persuasive. Sloan’s argument is based on a reasonable inference from the understanding in the art at the time of the invention that (1) the MYPPPY motif of CD28’s extracellular sequence played a key role in ligand binding (as discussed above), and (2) possible ligand binding other than to the scFv, i.e., off-target binding, was a known, problematic design concern for chimeric TCRs.” slip op. at 23

  Patent outcomesUS 7,446,190 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 7,446,190
• Dr. Reddy’S Laboratories, Ltd. / Dr. Reddy’S Laboratories, Inc. v. Monosol RX, LLCInstitution denied
  PTAB · Dec 5, 2016 · IPR2016-01111 · APJ Erica A Franklin · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–3, 9, 15, 62–65, 69–73, or 75 were unpatentable over either asserted § 103 combination.

  RulingsInstitution decision

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

    “inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon considering the Petition and Preliminary Response, we determine that the Petitioner has not demonstrated a reasonable likelihood that it would prevail in showing the unpatentability of at least one of the challenged claims. Accordingly, we decline to institute an inter partes review of any challenged claim.” slip op. at 2

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner

    “Petitioner proposes a construction for one claim phrase: “dried without the loss of substantial uniformity,” appearing in independent claims 1 and 62. Pet. 15. According to Petitioner, that claim phrase should be construed broadly to mean “any method of drying.” Id. In support of that construction, Petitioner asserts only that Patent Owner’s expert witness in a co-pending litigation “testified that the claims were not limited to any particular form of drying, or any particular drying parameters.” Id. Patent Owner correctly notes that Petitioner has not explained why it has failed to account for the phrase “without the loss of substantial uniformity” in its proposed construction. Prelim. Resp. 8. Further, Patent Owner proposes that, under the broadest reasonable construction standard, the claim phrase “dried without the loss of substantial uniformity” should be given its plain meaning. Id. Based on the record, we agree.” slip op. at 6

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

    “Nor has Petitioner explained persuasively that a skilled artisan would have understood that individual doses of a pharmaceutical film cut by a rotary die can only be manufactured this way if the film does not vary more than 10%. Pet. 31–32. Petitioner’s argument and Dr. Celik’s testimony in that regard rely upon a statement in the challenged patent that “[c]urrently, as required by various world regulatory authorities, dosage forms may not vary more than 10% in the amount of active present.” Pet. 32; Ex. 1003 ¶ 101; Ex. 1001, 2:42–45. Petitioner and Dr. Celik acknowledge, however, that not all regulatory authorities require that limit. Specifically, Petitioner and Dr. Celik recognize that in the United States, “any given dose of the drug must have the same amount of active as any other dose, within a variance of 15%,” referring to the standard set by the United States Food and Drug Administration. Pet. 22; Ex. 1003 ¶ 81. Thus, at best, Petitioner’s reliance on the disclosure of the challenged patent regarding the standards set by the FDA or “various world regulatory authorities” provides a motivation for a person of skill in the art to modify the cited prior art to achieve a product film wherein the individual unit doses do not vary by more than 15%, or perhaps not more than 10%. However, even if such motivation exists, Petitioner has not shown how that the cited prior art or other knowledge in the art at the time of the invention would have informed an artisan how to reach that goal. As Patent Owner correctly asserts, “[r]ecognition of a need does not render obvious the achievement that meets that need.” Prelim. Resp. 17 (quoting Cardiac Pacemakers, Inc. v. St. Jude Med., Inc., 381 F.3d 1371, 1377 (Fed. Cir. 2004) and Abbott Labs. v. Sandoz, Inc., 544 F.3d 1341, 1352 (Fed. Cir. 2008)). Insofar as Petitioner asserts that a person of ordinary skill in the art would have needed only routine experimentation to make films within the claimed variance limitation, we are unpersuaded. Pet. 27, 34. In a somewhat cursory manner, Petitioner supports that contention by asserting that a person of skill in the art “would have understood that mixing, de-gassing, viscosity and drying are all important variables to control in order to ensure uniformity, and would have been able to make routine adjustments of these variables in Chen’s process to meet the 10% limit.” Pet. 34. Dr. Celik makes a similar statement in his declaration. Ex. 1003 ¶ 104. However, neither statement by Petitioner or Dr. Celik includes a discussion of facts allegedly supporting those assertions.” slip op. at 15

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “indicating near-maximal release, and that the final values for the drug release “are clustered within ±10% of 100.” Ex. 1003 ¶ 103. According to Dr. Çelik, “[f]rom these data, a person of ordinary skill would reasonably have concluded that the films were within the claimed 10% limit.” Id. We are unpersuaded. In particular, what is missing from Dr. Çelik’s testimony is an explanation of his data analysis. Chen’s Figure 5 is reproduced below: Ex. 1005, Fig. 5. Chen’s Figure 5 shows the release profile of four active agents from films according to Chen’s Examples 5–8. Ex. 1005, 16:27–28. Chen does not discuss the data represented in Figure 5 or otherwise provide it.2 Nor does 2 Petitioner asserts that the Board “has found on appeal in three reexaminations directed to similar subject matter that Chen discloses substantial uniformity.” Pet. 35. As discussed, infra, those decisions did not Dr. Çelik present his opinion regarding the relevant specific data points reflected in Figure 5. Rather, Dr. Çelik opines, in a conclusory fashion, that the data shows, despite the unexplained error bars in the figure and lack of specific data points provided, that “the final recorded values for the data collected . . . fall at or within ‡ 10% of 100% (i.e., 90% to 110%),” and that a person of skill in the art would, therefore, conclude that “Chen’s films had at least the claimed uniformity.” Ex. 1003, 38 n.7. Because Dr. Çelik has not provided a reliable factual basis for his opinion on this matter, those opinions are not entitled to persuasive weight. See Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48763 (Aug. 14, 2012) (a declaration expressing an opinion of an expert without disclosing underlying facts may be given no weight).” slip op. at 13

  Claim construction§ 103 obviousness
  Patents in suitUS 8,603,514
• Dr. Reddy’S Laboratories, Ltd. / Dr. Reddy’S Laboratories, Inc. v. Monosol RX, LLCInstitution denied
  PTAB · Dec 5, 2016 · IPR2016-01112 · APJ Erica A Franklin · IPR · Institution

  The Board denied institution because the Petition did not show a reasonable likelihood of establishing that any challenged claim was unpatentable over the asserted obviousness grounds.

  RulingsInstitution decision

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

    “inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon considering the Petition and Preliminary Response, we determine that the Petitioner has not demonstrated a reasonable likelihood that it would prevail in showing the unpatentability of at least one of the challenged claims. Accordingly, we decline to institute an inter partes review of any challenged claim.” slip op. at 2

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningDecided for patent owner

    “Patent Owner correctly notes that Petitioner does not rely on its proposed claim construction in the Petition. Prelim. Resp. 7. Nor does Petitioner provide any discussion supporting its position that the construction that it proposes represents the broadest reasonable construction in light of the specification of the patent, other than asserting that it is the same construction that was proffered in a district court proceeding. For purposes of this decision, we agree with Patent Owner that the plain and ordinary meaning of the phrases apply. Id. at 7. In any event, this Decision does not turn on the claim phrases for which Petitioner has proposed a construction.” slip op. at 6

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

    “particular, Petitioner has not explained adequately why a person of skill in the art at the time of the invention would have had a reason to combine the teachings of Chen and Shiraldi. As discussed, supra, Chen describes using a mixture of two or more types of the same hydrocolloid that differ only in molecular weights and Shiraldi describes selecting and blending various polymers. Petitioner has not shown that a person of skill in the art would have understood that Shiraldi teaches or suggests selecting various polymers based upon high and low molecular weights. Nor has Petitioner established that Chen’s teaching to combine two or more types of the same hydrocolloid having differing molecular weights involved selecting a mixture of high and low molecular weights in the manner claimed. Indeed, neither reference provides a teaching or an example of such a practice. The example in Chen relied upon by Petitioner includes only a low molecular weight polyethylene oxide. Pet. 32 (referring to Chen Example 11 using a polyethylene oxide having an average molecular weight of 100,000 Da). In contrast to Chen, Schiraldi preferred and exemplified only high molecular weight polyethylene, in a range well beyond that recited in the claims for that component. That is, Schiraldi describes the ethylene oxide useful for its invention as having “a relatively high molecular weight” and preferring molecular weights above 3,000,000, whereas the claims recite a molecular weight range of 600,000 to 900,000. See Ex. 1004, 4:25–31. Moreover, Petitioner has not shown that the cited prior art, alone or in combination, taught or suggested a film comprising both low and high molecular weight polyethylene oxide in the respective ranges recited by the claims, or with the specific percentage of the low molecular weight component required. The portions of Dr. Mumper’s declaration cited by Petitioner do not provide any further support for Petitioner’s position. We note that Dr. Mumper does not explain why the polyethylene oxides molecular weights limitation would have been obvious to a person of ordinary skill over the combined teachings of the prior art. Instead, Dr. Mumper opines only that the skilled artisan “would be highly motivated to vary the amounts of the low and high molecular weight polyethylene oxide to achieve the desired effects including, but not limited to drug solubility, mucoadhesion and drug release rate.” Ex. 1003 ¶ 30. That opinion does not address a skilled artisan’s motivation, ability, or reasonable expectation of successfully achieving a film comprising the specific ranges and proportion of low and high molecular weight polyethylene oxides required by the claims. See In re Fine, 837 F.2d at 1074 (a showing of obviousness must be supported by evidence, as shown by some objective teaching in the prior art or by knowledge generally available to one of ordinary skill in the art that would have led that individual to combine the relevant teachings of the references to arrive at the claimed invention).” slip op. at 10

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “The portions of Dr. Mumper’s declaration cited by Petitioner do not provide any further support for Petitioner’s position. We note that Dr. Mumper does not explain why the polyethylene oxides molecular weights limitation would have been obvious to a person of ordinary skill over the combined teachings of the prior art. Instead, Dr. Mumper opines only that the skilled artisan “would be highly motivated to vary the amounts of the low and high molecular weight polyethylene oxide to achieve the desired effects including, but not limited to drug solubility, mucoadhesion and drug release rate.” Ex. 1003 ¶ 30. That opinion does not address a skilled artisan’s motivation, ability, or reasonable expectation of successfully achieving a film comprising the specific ranges and proportion of low and high molecular weight polyethylene oxides required by the claims. See In re Fine, 837 F.2d at 1074 (a showing of obviousness must be supported by evidence, as shown by some objective teaching in the prior art or by knowledge generally available to one of ordinary skill in the art that would have led that individual to combine the relevant teachings of the references to arrive at the claimed invention).” slip op. at 11

  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosure
  Patents in suitUS 8,017,150
• Mylan Pharmaceuticals, Inc. / Amneal Pharmceuticals LLC v. Yeda Research And Development Co. Ltd.All claims unpatentable
  PTAB · Dec 2, 2016 · IPR2015-01981 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1–12 are unpatentable as obvious over Pinchasi and the 1996 FDA SBOA, and over Pinchasi and Flechter.

  RulingsFinal written decision

  • Skill levelSkill level board ownOther

    “The parties dispute the proper definition of a person of ordinary skill in the art. Petitioners contend 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 be a physician with experience in clinical pharmacology. Pet. 11. In its Preliminary Response, Patent Owner disagreed with Petitioners’ definition because it does not include experience with MS or GA, which, according to Patent Owner, are both requirements for a person of ordinary skill in the art. Prelim. Resp. 34.” slip op. at 5

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

    “In an inter partes review, the Board interprets claim terms in an unexpired patent according to the broadest reasonable construction in light of the specification of the patent in which they appear. 37 C.F.R. § 100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016). Under that standard, and absent any special definitions, we give claim terms their ordinary and customary meaning, as would be understood by one of ordinary skill in the art at the time of the invention. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Any special definitions for claim terms must be set forth with reasonable clarity, deliberateness, and precision. See In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). In our Decision to Institute, we determined that the broadest reasonable interpretation of the claims does not encompass a dosage regimen that alternates days over a period of seven days (i.e., one that administers the drug three times in one week and four times the next). Dec. Inst. 6–9. Neither Petitioners nor Patent Owner challenged this construction during trial. See generally Pet. Reply; see PO Resp. 6–7 (stating the Board correctly construed the claims). Accordingly, because nothing in the full record developed during trial persuades us to deviate from our prior construction, we adopt the construction for purposes of this Decision.5” slip op. at 6

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

    “Nevertheless, on this record, we determine that Petitioners have shown sufficiently that the 1996 SBOA constitutes prior art to the ’302 patent. As support, Petitioners offer a Declaration from Marlene S. Bobka, the president of FOI Services, Inc., which provided the 1996 SBOA to Petitioner. Ex. 1007, 1. Ms. Bobka states that FOI Services specializes in U.S. Food & Drug Administration (“FDA”) information and “maintains a private library of over 150,000 FDA documents obtained under the Freedom of Information Act.” Id. Ms. Bobka further states that FOI Services sells the documents and provided the 1996 SBOA to Petitioners on July 17, 2007. Id. Because the uncontroverted evidence shows Petitioners were able to obtain the 1996 SBOA from FOI Services on July 17, 2007, we determine that the 1996 SBOA was publicly available at least as of that date, which is before the earliest possible critical date of the ’302 patent (i.e., August 20, 2009). See Ex. 1001, [60]; see also Voter Verified, Inc. v. Premier Election Solutions Inc., 698 F.3d 1374, 1380 (Fed. Cir. 2012) (“[T]he key inquiry is whether the reference was made ‘sufficiently accessible to the public interested in the art’ before the critical date.’”) (quoting In re Cronyn, 890 F.2d 1158, 1160 (Fed. Cir. 1989)).” slip op. at 10

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

    “We also determine that an ordinary artisan would have had a reason to modify Pinchasi’s dosing regimen of 40 mg of GA every other day to 40 mg of GA three times a week. We are persuaded by Dr. Green’s testimony that an ordinary artisan would have been motivated to adopt a three times per week dosing regimen to increase patient compliance. For example, 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 ¶ 102. The desirability of less frequent injections is supported by the 1996 SBOA, which “recommend[ed] that [Teva] evaluate the necessity of daily s.c. injections as opposed to more infrequent intermittent administration of the drug.” Ex. 1004 ¶¶ 109–10; Ex. 1085 ¶ 17 (quoting Ex. 1007, 252).” slip op. at 15

  Patent outcomesUS 8,969,302 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,969,302
• 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.All claims unpatentable
  PTAB · Dec 2, 2016 · IPR2015-00643 · APJ Zhenyu Yang · IPR · Final written decision

  Claims 1–20 are unpatentable as obvious over Pinchasi and the 1996 SBOA, and over Pinchasi and Flechter.

  RulingsFinal written decision

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

    “On September 25, 2015, Amneal Pharmaceuticals LLC filed a Petition requesting an inter partes review of claims 1–20 of the ’250 patent in case IPR2015-01976. Amneal also filed a motion to join its case with this proceeding. IPR2015-01976, Paper 3. On December 28, 2015, we granted Amneal’s Petition and motion for joinder, terminated IPR2015-01976, and joined it with this case. Id., Paper 9.” 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 foundUnpatentable

  Patent outcomesUS 8,232,250 unpatentable
  § 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 · IPR2015-00643 · 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 & Development Co. Ltd.All claims unpatentable
  PTAB · Dec 2, 2016 · IPR2015-01980 · APJ Tina E Hulse · IPR · Final written decision

  Claims 1–20 are unpatentable as obvious over Pinchasi and the 1996 SBOA, and independently over Pinchasi and Flechter.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “In our Decision to Institute, we agreed with Patent Owner that a person of ordinary skill in the art should have experience with MS and GA. Dec. Inst. 5. We noted that one of Petitioners’ declarants, Dr. Ari Green, states that a person of ordinary skill in the art would have “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 Petitioners nor Patent Owner contested our definition 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, and we adopt Petitioners’ definition of a person of ordinary skill in the art, with the addition that that person would also have experience treating MS with GA.” slip op. at 6

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner

    “In our Decision to Institute, we determined that the broadest reasonable interpretation of the claims does not encompass a dosage regimen that alternates days over a period of seven days (i.e., one that administers the drug three times in one week and four times the next). Dec. Inst. 5–8. Neither Petitioners nor Patent Owner challenged this construction during trial. See generally Pet. Reply; see PO Resp. 6–7 (stating the Board correctly construed the claims). Accordingly, because nothing in the full record developed during trial persuades us to deviate from our prior construction, we adopt the construction for purposes of this Decision.5” slip op. at 7

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

    “Nevertheless, on this record, we determine that Petitioners have shown sufficiently that the 1996 SBOA constitutes prior art to the ’413 patent. As support, Petitioners offer a declaration from Marlene S. Bobka, the president of FOI Services, Inc., which provided the 1996 SBOA to Mylan Pharmaceuticals Inc. Ex. 1007, 1. Ms. Bobka states that FOI Services specializes in U.S. Food & Drug Administration (“FDA”) information and “maintains a private library of over 150,000 FDA documents obtained under the Freedom of Information Act.” Id. Ms. Bobka further states that FOI Services sells the documents and provided the 1996 SBOA to Mylan on July 17, 2007. Id. Because the uncontroverted evidence shows Mylan was able to obtain the 1996 SBOA from FOI Services on July 17, 2007, we determine that the 1996 SBOA was publicly available at least as of that date, which is before the earliest possible critical date of the ’413 patent (i.e., August 20, 2008). See Ex. 1001, [60]; see also Voter Verified, Inc. v. Premier Election Solutions, 698 F.3d 1374, 1380 (Fed. Cir. 2012) (“[T]he key inquiry is whether the reference was made ‘sufficiently accessible to the public interested in the art’ before the critical date.’”) (quoting In re Cronyn, 890 F.2d 1158, 1160 (Fed. Cir. 1989)).” slip op. at 10

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

    “We also determine that an ordinary artisan would have had a reason to modify Pinchasi’s dosing regimen of 40 mg of GA every other day to 40 mg of GA three times a week. We are persuaded by Dr. Green’s testimony that an ordinary artisan would have been motivated to adopt a three times per week dosing regimen to increase patient compliance. For example, 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 ¶ 100. The desirability of less frequent injections is supported by the 1996 SBOA, which “recommend[ed] that [Teva] evaluate the necessity of daily s.c. injections as opposed to more infrequent intermittent administration of the drug.” Ex. 1004 ¶¶ 101– 02; Ex. 1085 ¶ 17 (quoting Ex. 1007, 252).” slip op. at 15

  Patent outcomesUS 8,399,413 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,399,413
• Mylan Pharmaceuticals Inc. / Amneal Pharmaceuticals LLC v. Yeda Research & Development Co. Ltd.All claims unpatentable
  PTAB · Dec 2, 2016 · IPR2015-00644 · APJ Tina E Hulse · IPR · Final written decision

  Claims 1–20 are unpatentable as obvious over Pinchasi and the 1996 SBOA, and over Pinchasi and Flechter.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for patent owner

    “In our Decision to Institute, we agreed with Patent Owner that a person of ordinary skill in the art should have experience with MS and GA. Dec. Inst. 5. We noted that one of Petitioners’ declarants, Dr. Ari Green, states that a person of ordinary skill in the art would have “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 Petitioners nor Patent Owner contested our definition 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, and we adopt Petitioners’ definition of a person of ordinary skill in the art, with the addition that that person would also have experience treating MS with GA.” slip op. at 6

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

    “In our Decision to Institute, we determined that the broadest reasonable interpretation of the claims does not encompass a dosage regimen that alternates days over a period of seven days (i.e., one that administers the drug three times in one week and four times the next). Dec. Inst. 5–8. Neither Petitioners nor Patent Owner challenged this construction during trial. See generally Pet. Reply; see PO Resp. 6–7 (stating the Board correctly construed the claims). Accordingly, because nothing in the full record developed during trial persuades us to deviate from our prior construction, we adopt the construction for purposes of this Decision.5” slip op. at 7

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

    “Nevertheless, on this record, we determine that Petitioners have shown sufficiently that the 1996 SBOA constitutes prior art to the ’413 patent. As support, Petitioners offer a declaration from Marlene S. Bobka, the president of FOI Services, Inc., which provided the 1996 SBOA to Mylan Pharmaceuticals Inc. Ex. 1007, 1. Ms. Bobka states that FOI Services specializes in U.S. Food & Drug Administration (“FDA”) information and “maintains a private library of over 150,000 FDA documents obtained under the Freedom of Information Act.” Id. Ms. Bobka further states that FOI Services sells the documents and provided the 1996 SBOA to Mylan on July 17, 2007. Id. Because the uncontroverted evidence shows Mylan was able to obtain the 1996 SBOA from FOI Services on July 17, 2007, we determine that the 1996 SBOA was publicly available at least as of that date, which is before the earliest possible critical date of the ’413 patent (i.e., August 20, 2008). See Ex. 1001, [60]; see also Voter Verified, Inc. v. Premier Election Solutions, 698 F.3d 1374, 1380 (Fed. Cir. 2012) (“[T]he key inquiry is whether the reference was made ‘sufficiently accessible to the public interested in the art’ before the critical date.’”) (quoting In re Cronyn, 890 F.2d 1158, 1160 (Fed. Cir. 1989)).” slip op. at 10

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

    “Moreover, Pinchasi discloses administration of the 40 mg dose every other day. Ex. 1005, 9:1−11. Thus, the difference between the challenged claims and the prior art is a dosing schedule that is decreased by one day every two weeks—i.e., the difference between every other day disclosed in the prior art and the requirement of three doses per week recited in the claims. Ex. 1004 ¶ 91. In this regard, Dr. Green testifies that setting a course of treatment for the same day each week, for example on Monday, Wednesday, and Friday, is an easier dosing schedule to follow than every other day, which would occur on different days of the week throughout the month. Id. ¶ 105. In light of the evidence as a whole, we are persuaded that an ordinary artisan would have understood the benefits of less frequent injections and, therefore, would have had a reason to reduce Pinchasi’s dosing regimen to three times per week. We are also persuaded by Dr. Green’s testimony and supporting evidence that a person of ordinary skill in the art would have had a reasonable expectation of success in administering 40 mg of GA three times a week. We credit Dr. Green’s testimony that an ordinary artisan would have considered GA to be a “forgiving drug.” Ex. 1085 ¶ 19. Dr. Green testifies that it was a standard instruction for patients who miss a dose to skip the dose rather than take a double dose. Ex. 1004 ¶ 90 (citing Ex. 1062, which states, “If you miss a dose [of GA], take it as soon as you remember. If you do not remember until the following day, skip the missed dose and continue with your regular dosing schedule.”); Ex. 1085 ¶ 19 (citing Ex. 1086, which states, “If you miss a dose, take your COPAXONE® as soon as you remember. If it is nearer to the time of your next scheduled dose, skip the missed dose and resume your usual dosing schedule.”)13. Dr. Green also explains that the wide range of likely efficacious doses suggests the forgiving nature of GA. Ex. 1085 ¶¶ 20–21. Flechter and Khan 2008/Caon 2009 disclose 20 mg of GA every other day (i.e., 70 mg per week), whereas Pinchasi discloses 40 mg of GA daily (i.e., 280 mg. per week). Ex. 1008; Ex. 1010; Ex. 1011; Ex. 1005, 9:2–11. Because 40 mg three times a week (i.e., 120 mg per week) is in the middle of the range of known effective weekly doses and is close to the FDA-approved 20 mg daily regimen (i.e., 140 mg 13 We note that Patent Owner has moved to exclude Ex. 1086. We deny Patent Owner’s motion, for the reasons stated in more detail below. per week), we are persuaded by Dr. Green’s testimony that a person of ordinary skill in the art would have reasonably expected 40 mg of GA three times a week to be successful. Ex. 1085 ¶ 21.” slip op. at 17

  Patent outcomesUS 8,399,413 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,399,413
• Mylan Pharmaceuticals, Inc. / Amneal Pharmceuticals LLC v. Yeda Research And Development Co. Ltd.All claims unpatentable
  PTAB · Dec 2, 2016 · IPR2015-00830 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1–12 are held unpatentable as obvious over Pinchasi with the 1996 FDA SBOA and over Pinchasi with Flechter.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for patent owner

    “In our Decision to Institute, we agreed with Patent Owner that a person of ordinary skill in the art should have experience with MS and GA. Dec. Inst. 5. We noted that one of Petitioners’ declarants, Dr. Ari Green, states that a person of ordinary skill in the art would have “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.” Ex. 1004 ¶ 28. During trial, neither Petitioners nor Patent Owner party contested our definition 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, and we adopt Petitioners’ definition of a person of ordinary skill in the art, with the addition that that person would also have experience treating MS with GA.” slip op. at 6

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner

    “In our Decision to Institute, we determined that the broadest reasonable interpretation of the claims does not encompass a dosage regimen that alternates days over a period of seven days (i.e., one that administers the drug three times in one week and four times the next). Dec. Inst. 6–9. Neither Petitioners nor Patent Owner challenged this construction during trial. See generally Pet. Reply; see PO Resp. 6–7 (stating the Board correctly construed the claims). Accordingly, because nothing in the full record developed during trial persuades us to deviate from our prior construction, we adopt the construction for purposes of this Decision.5” slip op. at 7

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

    “shown sufficiently that the 1996 SBOA constitutes prior art to the ’302 patent. As support, Petitioners offer a Declaration from Marlene S. Bobka, the president of FOI Services, Inc., which provided the 1996 SBOA to Petitioner. Ex. 1007, 1. Ms. Bobka states that FOI Services specializes in U.S. Food & Drug Administration (“FDA”) information and “maintains a private library of over 150,000 FDA documents obtained under the Freedom of Information Act.” Id. Ms. Bobka further states that FOI Services sells the documents and provided the 1996 SBOA to Petitioners on July 17, 2007. Id. Because the uncontroverted evidence shows Petitioners were able to obtain the 1996 SBOA from FOI Services on July 17, 2007, we determine that the 1996 SBOA was publicly available at least as of that date, which is before the earliest possible critical date of the ’302 patent (i.e., August 20, 2009). See Ex. 1001, [60]; see also Voter Verified, Inc. v. Premier Election Solutions Inc., 698 F.3d 1374, 1380 (Fed. Cir. 2012) (“[T]he key inquiry is whether the reference was made ‘sufficiently accessible to the public interested in the art’ before the critical date.’”) (quoting In re Cronyn, 890 F.2d 1158, 1160 (Fed. Cir. 1989)).” slip op. at 10

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

    “We also determine that an ordinary artisan would have had a reason to modify Pinchasi’s dosing regimen of 40 mg of GA every other day to 40 mg of GA three times a week. We are persuaded by Dr. Green’s testimony that an ordinary artisan would have been motivated to adopt a three times per week dosing regimen to increase patient compliance. For example, 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 ¶ 102. The desirability of less frequent injections is supported by the 1996 SBOA, which “recommend[ed] that [Teva] evaluate the necessity of daily s.c. injections as opposed to more infrequent intermittent administration of the drug.” Ex. 1004 ¶¶ 109–10; Ex. 1085 ¶ 17 (quoting Ex. 1007, 252).” slip op. at 15

  Patent outcomesUS 8,969,302 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,969,302

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.