• Par Pharmaceutical, Inc. / Amneal Pharmaceuticals, LLC v. Jazz Pharmaceuticals, Inc.All claims unpatentable
  PTAB · Jul 27, 2016 · IPR2015-01814 · APJ Brian P Murphy · IPR · Final written decision

  Claims 1–11 of the ’730 patent and claims 1–15 of the ’988 patent are unpatentable as obvious over the Advisory Committee Art, with claims 2 and 10 of the ’988 patent also obvious over that …

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We begin with the premise that a hypothetical POSA is presumed to be aware of the pertinent art in the field of endeavor at the time of the invention, and to be a person of ordinary creativity. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 407-09, 420-21 (2007). As the title, field of the invention, and background discussion in the ’730 patent make clear, the relevant field of endeavor is the distribution of sensitive prescription drugs prone to abuse or causing serious adverse reactions. Ex. 1001, Title (54), 1:4–26. Petitioner provides substantial evidence of the state of the art of such sensitive drug distribution systems as of December 17, 2001, one year before the ’730 patent priority date. Pet. 3–6: Ex. 1001, filing date (22). Xyrem is a sensitive prescription drug prone to potential abuse or diversion. Ex. 1001, 3:14–19. Prior to Xyrem, sensitive prescription drugs such as Accutane, Clozaril, and thalidomide were known to use controlled distribution systems to protect against potential side effects, abuse, and diversion. Pet. 4–5 (citing Ex. 1007 ¶¶ 21–24). Accutane, a prescription drug from the 1980s that could cause birth defects, was distributed under a program requiring i) informed consent forms completed by patient and physician, ii) patient counseling to avoid pregnancy and use of birth control, and iii) a negative blood serum test for pregnancy prior to beginning treatment. Id. at 4 (citing Ex. 1007 ¶ 21). Distribution of Clozaril, indicated for treating schizophrenia but also capable of causing a fatal blood disorder, was controlled using a national registry system and computerized database for identifying patients and physicians. Id. at 4–5 (citing Ex. 1007 ¶ 22). In 1999, the manufacturers of thalidomide developed a system that combined the computerized registry of Clozaril with the controls imposed by the Accutane distribution system. Id. at 5 (citing Ex. 1007 ¶ 24). Based on such prior art activity, we find that by December 2002 a person of ordinary skill would have known the active ingredient in Xyrem – sodium oxybate – was a sensitive drug susceptible to abuse and diversion, and such person would have known of several available techniques to control and mitigate the risks associated with Xyrem’s distribution. Id. at 3 (citing Ex. 1007 ¶ 20); Ex. 1007 ¶¶ 21–27, 47.” slip op. at 11

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionOther

    “1. “exclusive central pharmacy” and “exclusive computer database” In our Decision on Institution, we construed the term “exclusive central pharmacy” to mean “single or sole pharmacy,” and the term “exclusive computer database” to mean “single or sole computer database.” Dec. on Inst. 21. Our constructions are consistent with those proposed by Petitioner, and Patent Owner takes no position regarding Petitioner’s arguments in this regard. Pet. 10; PO Resp. 25 n.8. Based on our review of the complete record, we do not perceive any reason or evidence that now compels any deviation from these interpretations.” slip op. at 14

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

    “We are not persuaded by Patent Owner’s arguments or the testimony of Dr. DiPiro and Dr. Bergeron in support thereof. Patent Owner does not explain adequately why generating a report for a particular purpose or “ad hoc” precludes it from being a report generated periodically. See, e.g., PO Resp. 28 (citing Ex. 2046 ¶ 33 (testimony by Dr. DiPiro stating that “POSA would not consider ‘ad hoc’ reports to be ‘periodic’ because they are not generated with any regular frequency.”); Ex. 2047 ¶ 31 (testimony by Dr. Bergeron stating same). As noted above, the specification does not limit “periodic reports” to those generated with “regular frequency.” Moreover, to the extent that Figure 4B in the ’730 patent illustrates generating “ad hoc” reports, as Patent Owner contends, such disclosure supports a construction that the recited “periodic reports” include such “ad hoc” reports. Ex. 1001, 6:9–7:2; Reply 13–14 (citing Ex. 1047, 6; Ex.1048, 9 (ll. 12–19), Fig. 4 (436)). Patent Owner also points us to a Merriam-Webster’s Collegiate Dictionary definition of the term “periodic,” which defines the term as “occurring or recurring at regular intervals,” or something that is “repeated.” PO Resp. 28 (citing Ex. 2043, 3). Petitioner points us to several other dictionary definitions, which define “periodic” as also including “intermittent.” Reply 15 (citing Ex. 1049, 3 (defining “periodic” as including “occurring repeatedly from time to time”); Ex. 1050, 3 (defining “periodic” as including “[t]aking place now and then” or “INTERMITTENT”); Ex. 1051, 3 (defining “periodic” as including “[h]appening or appearing now and then” or “intermittent, occasional”). Upon considering all of the evidence before us, we are not persuaded that the plain and ordinary meaning of “periodic” in the context of the ’730 patent limits “periodic reports” to those generated only at regular intervals, as Patent Owner contends. PO Resp. 28. Rather, the term includes reports generated at regular intervals and reports generated “now and again” or “intermittently,” without any particular regularity in time between events. Thus, we construe “periodic reports” as recited in the challenged claims to refer to reports that are generated at regular intervals or intermittently, i.e., now and again, including those not generated at regular intervals.” slip op. at 17

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

    “For the reasons given above, we find Petitioner’s evidence sufficient to prove by a preponderance that Exhibits 1004–1006 were publicly accessible on the FDA’s website not later than July 1, 2001.” slip op. at 35

  Patent outcomesUS 8,457,988 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 8,457,988
• Par Pharmaceutical, Inc. / Amneal Pharmaceuticals, LLC v. Jazz Pharmaceuticals, Inc.All claims unpatentable
  PTAB · Jul 27, 2016 · IPR2015-01810 · APJ Jacqueline Wright Bonilla · IPR · Final written decision

  Claims 1–16 are unpatentable as obvious over the Advisory Committee Art under § 103(a), which the Board found publicly accessible before the patent’s priority date.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We begin with the premise that a hypothetical POSA is presumed to be aware of the pertinent art in the field of endeavor at the time of the invention, and to be a person of ordinary creativity. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 407-09, 420–21 (2007). As the title, field of the invention, and background discussion in the ’059 patent make clear, the relevant field of endeavor is the distribution of sensitive prescription drugs prone to abuse or causing serious adverse reactions. Ex. 1001, Title, 1:10– 27. Petitioner provides substantial evidence of the state of the art of such” slip op. at 10

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Other

    “[h]appening or appearing now and then” or “intermittent, occasional”). Upon considering all of the evidence before us, we are not persuaded that the plain and ordinary meaning of “periodic” in the context of the ’059 patent limits “periodic reports” to those generated only at regular intervals, as Patent Owner contends. PO Resp. 25–28. Rather, the term includes reports generated at regular intervals and reports generated “now and again” or “intermittently,” without any particular regularity in time between events. Thus, we construe “periodic reports” as recited in the challenged claims to refer to reports that are generated at regular intervals or intermittently, i.e., now and again, including those not generated at regular intervals. slip op. at 18

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

    “presentation slides, thus confirming the description of the Internet Archive file links as containing 381 pages. Compare Ex. 1003, with Ex. 1020, 8. We are persuaded that the Federal Register Notice is evidence of the FDA’s general practice under the Federal Advisory Committee Act and tends to indicate an approximate timeframe when background information and advisory committee meeting minutes, transcripts, and presentation slides are posted on the FDA’s website. Case IPR2014-00059, slip op. at 34 (PTAB Apr. 15, 2014) (Paper 9) (citing In re Hall, 781 F.2d 897, 899 (Fed. Cir. 1986)); 5 U.S.C. App 2 § 10(b) (2001) (“[T]he records, reports, transcripts, minutes, appendixes, working papers, drafts, studies, agenda, or other documents which were made available to or prepared for or by each advisory committee shall be available for public inspection.”). The Federal Register Notice states that the minutes, transcript, and slides of the Xyrem Advisory Committee Meeting are “generally posted about 3 weeks after the meeting.” Ex. 1015. The Internet Archive evidence indicates the meeting transcript, presentation slides, and meeting minutes were not posted on the FDA’s website as of June 17, 2001, less than two weeks after the meeting, but were posted no later than October 4, 2001. Ex. 1018; Ex. 1020; Ex. 1028. Thus, the Federal Register Notice is consistent with the Internet Archive evidence. Petitioner further emphasizes that Patent Owner does not contest the sufficiency of the evidence establishing the public accessibility of Exhibit 1003 on the FDA’s website as of October 4, 2001. Reply 2 n.2; Tr. 6:1–9; see PO Resp. 3–15. Thus, for the reasons given above, we find that Petitioner has established by a preponderance of the evidence that the Xyrem Advisory Committee Meeting transcript and presentation slides (Exhibit 1003) were publicly accessible on the FDA’s website not later than October 4, 2001.” slip op. at 26

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

    “patent would have been obvious over the ACA (Exhibits 1003–1006) because the ACA is a public disclosure of the proposed risk management system for Xyrem—the same system covered by the ’059 patent. Pet. 18– 39; Reply 1. Petitioner relies on the Declaration testimony of Dr. Valuck in support of its argument that a POSA would have had reason to combine the ACA documents. Id. at 18 (citing Ex. 1007). Specifically, Petitioner asserts that the Preliminary Clinical Safety Review (Ex. 1004), Briefing Booklet (Ex. 1005), and Xyrem Video and Transcript (Ex. 1006) were “all distributed together for a single meeting before the FDA seeking approval for prescription Xyrem®,” and FDA Advisory Committee Transcript and Slides (Ex. 1003) “were a public transcript of and presentation given at the meeting itself.” Id. at 18 (citing Ex. 1007 ¶ 52). In addition, according to Petitioner, all four ACA documents “clearly relate to the same restricted distribution program, which the meeting was convened to discuss,” and are “all linked from a single web page.” Id. at 18–19. We agree with Petitioner’s analysis and determine that a POSA would have had ample motivation to combine the ACA documents, which were prepared at the same time, relate to the same drug product and the same restricted distribution system, were discussed together at the same Xyrem Advisory Committee Meeting, and were made available via file links from a single FDA web page.” slip op. at 39

  Patent outcomesUS 7,895,059 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 7,895,059
• Par Pharmaceutical, Inc. / Amneal Pharmaceuticals, LLC v. Jazz Pharmaceuticals, Inc.All claims unpatentable
  PTAB · Jul 27, 2016 · IPR2015-01816 · APJ Jacqueline Wright Bonilla · IPR · Final written decision

  Claims 1–16 are unpatentable as obvious over the Advisory Committee Art under § 103(a).

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We begin with the premise that a hypothetical POSA is presumed to be aware of the pertinent art in the field of endeavor at the time of the invention, and to be a person of ordinary creativity. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 407-09, 420–21 (2007). As the title, field of the invention, and background discussion in the ’059 patent make clear, the relevant field of endeavor is the distribution of sensitive prescription drugs prone to abuse or causing serious adverse reactions. Ex. 1001, Title, 1:10– 27. Petitioner provides substantial evidence of the state of the art of such” slip op. at 10

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionOther

    “1. “exclusive central pharmacy,” “exclusive computer database” and “the central pharmacy authorizing the prescription drug to be dispensed to the patient by another pharmacy” In our Decision on Institution, we construed “exclusive central pharmacy” to mean “single or sole pharmacy,” and we construed “exclusive computer database” to mean “single or sole computer database.” Dec. on Inst. 20.” slip op. at 14

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner

    “We are not persuaded by Patent Owner’s arguments or the testimony of Dr. DiPiro and Dr. Bergeron in support thereof. Patent Owner does not explain adequately why generating a report for a particular purpose or “ad hoc” precludes it from being a report generated periodically. See, e.g., PO Resp. 28 (citing Ex. 2046 ¶ 34 (testimony by Dr. DiPiro stating that “POSA would not consider ‘ad hoc’ reports to be ‘periodic’ because they are not generated with any regular frequency.”); Ex. 2047 ¶ 32 (testimony by Dr. Bergeron stating same). As noted above, the specification does not limit “periodic reports” to those generated with “regular frequency.” Moreover, to the extent that Figure 4B in the ’059 patent illustrates generating “ad hoc” reports, as Patent Owner contends, such disclosure supports a construction that the recited “periodic reports” include such “ad hoc” reports. Ex. 1001, 6:13–7:3; Reply 13–14 (citing Ex. 1047, 6; Ex. 1048, 9:12–19, Fig. 4, 436).” slip op. at 17

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

    “presentation slides, thus confirming the description of the Internet Archive file links as containing 381 pages. Compare Ex. 1003, with Ex. 1020, 8. We are persuaded that the Federal Register Notice is evidence of the FDA’s general practice under the Federal Advisory Committee Act and tends to indicate an approximate timeframe when background information and advisory committee meeting minutes, transcripts, and presentation slides are posted on the FDA’s website. Case IPR2014-00059, slip op. at 34 (PTAB Apr. 15, 2014) (Paper 9) (citing In re Hall, 781 F.2d 897, 899 (Fed. Cir. 1986)); 5 U.S.C. App 2 § 10(b) (2001) (“[T]he records, reports, transcripts, minutes, appendixes, working papers, drafts, studies, agenda, or other documents which were made available to or prepared for or by each advisory committee shall be available for public inspection.”). The Federal Register Notice states that the minutes, transcript, and slides of the Xyrem Advisory Committee Meeting are “generally posted about 3 weeks after the meeting.” Ex. 1015. The Internet Archive evidence indicates the meeting transcript, presentation slides, and meeting minutes were not posted on the FDA’s website as of June 17, 2001, less than two weeks after the meeting, but were posted no later than October 4, 2001. Ex. 1018; Ex. 1020; Ex. 1028. Thus, the Federal Register Notice is consistent with the Internet Archive evidence. Petitioner further emphasizes that Patent Owner does not contest the sufficiency of the evidence establishing the public accessibility of Exhibit 1003 on the FDA’s website as of October 4, 2001. Reply 2 n.2; Tr. 6:1–9; see PO Resp. 3–15. Thus, for the reasons given above, we find that Petitioner has established by a preponderance of the evidence that the Xyrem Advisory Committee Meeting transcript and presentation slides (Exhibit 1003) were publicly accessible on the FDA’s website not later than October 4, 2001.” slip op. at 26

  Patent outcomesUS 7,895,059 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 7,895,059
• Par Pharmaceutical, Inc. / Amneal Pharmaceuticals, LLC v. Jazz Pharmaceuticals, Inc.All claims unpatentable
  PTAB · Jul 27, 2016 · IPR2015-01820 · APJ Jacqueline Wright Bonilla · IPR · Final written decision

  Claims 1–6 are unpatentable as obvious over the Advisory Committee Art under § 103(a), based on the Board’s finding that the references were publicly accessible and disclose or suggest the claimed limitations.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We begin with the premise that a hypothetical POSA is presumed to be aware of the pertinent art in the field of endeavor at the time of the invention, and to be a person of ordinary creativity. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 407-09, 420–21 (2007). As the title, field of the invention, and background discussion in the ’107 patent make clear, the relevant field of endeavor is the distribution of sensitive prescription drugs prone to abuse or causing serious adverse reactions. Ex. 1001, Title, 1:11– 27. Petitioner provides substantial evidence of the state of the art of such sensitive drug distribution systems as of December 17, 2001, one year before the ’107 patent priority date. Pet. 3–6; see also Ex. 1001, Related Application, 1:6–9 (indicating earliest priority date for the ’107 patent).” slip op. at 11

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Other

    “In our Decision on Institution, we construed the phrase “determining with the computer processor . . . patterns of potential prescription abuse . . . from periodic reports generated only by the central database” to mean “using the central database via the computer processor to generate periodic reports containing prescriber, patient, and/or prescription related information, which permits evaluation of potential abuse of a prescription drug.” Dec. on Inst. 22. Patent Owner indicates that it generally agrees with that construction, but proposes that the construction is incomplete in relation to the term “periodic reports.” PO Resp. 25. Patent Owner contends that “periodic reports” should be construed to mean “at regular frequencies or intervals, as opposed to intermittently or upon request.” Id. at 25–26 (citing Ex. 2046 ¶¶ 30–38; Ex. 2047 ¶¶ 28–35). In support, Patent Owner points to the specification of the ’107 patent, such as Figures 13A–C, and where the specification states “[e]ach report has an associated frequency or frequencies.” Id. at 26–27; Ex. 1001, 8:22–28. The cited portions of the specification, however, describe Figures 13A–C as “descriptions of sample reports obtained by querying a central database having fields represented in Fig. 7.” Ex. 1001, 8:22–24 (emphasis added); see also id. at 2:55–57 (also describing Figs. 13A–C as describing “sample reports”); Reply 13. Thus, we do not agree that the specification indicates that “periodic reports” as recited in the claims refers only to reports obtained at regular frequencies or intervals, even if the term includes such reports.” slip op. at 16

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

    “We are not persuaded by Patent Owner’s arguments or the testimony of Dr. DiPiro and Dr. Bergeron in support thereof. Patent Owner does not explain adequately why generating a report for a particular purpose or “ad hoc” precludes it from being a report generated periodically. See, e.g., PO Resp. 28 (citing Ex. 2046 ¶ 33 (testimony by Dr. DiPiro stating that “POSA would not consider ‘ad hoc’ reports to be ‘periodic’ because they are not generated with any regular frequency.”); Ex. 2047 ¶ 31 (testimony by Dr. Bergeron stating same). As noted above, the specification does not limit “periodic reports” to those generated with “regular frequency.” Moreover, to the extent that Figure 4B in the ’107 patent illustrates generating “ad hoc” reports, as Patent Owner contends, such disclosure supports a construction that the recited “periodic reports” include such “ad hoc” reports. Ex. 1001, 6:13–7:3; Reply 13–14 (citing Ex. 1047, 6; Ex. 1048, 9:12–19, Fig. 4, 436). Patent Owner also points us to a Merriam-Webster’s Collegiate Dictionary definition of the term “periodic,” which defines the term as “occurring or recurring at regular intervals,” or something that is “repeated.” PO Resp. 27 (quoting Ex. 2043, 3). Petitioner points us to several other dictionary definitions, which define “periodic” as also including “intermittent.” Reply 15 (citing Ex. 1049, 3 (defining “periodic” as including “occurring repeatedly from time to time”); Ex. 1050, 3 (defining “periodic” as including “[t]aking place now and then” or “INTERMITTENT”); Ex. 1051, 3 (defining “periodic” as including “[h]appening or appearing now and then” or “intermittent, occasional”). Upon considering all of the evidence before us, we are not persuaded that the plain and ordinary meaning of “periodic” in the context of the ’107 patent limits “periodic reports” to those generated only at regular intervals, as Patent Owner contends. PO Resp. 26–28. Rather, the term includes reports generated at regular intervals and reports generated “now and again” or “intermittently,” without any particular regularity in time between events. Thus, we construe “periodic reports” as recited in the challenged claims to refer to reports that are generated at regular intervals or intermittently, i.e., now and again, including those not generated at regular intervals.” slip op. at 17

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

    “Petitioner’s Internet Archive evidence indicates that a file link to “Briefing Information 3754b1.htm” was posted on the FDA’s website not later than June 17, 2001. Ex. 1018, 5. Petitioner’s Internet Archive evidence further indicates this link led to file links for Orphan Medical’s “Briefing Information” (Ex. 1005 Briefing Booklet) and Xyrem “Video Script 2/2/01” (Ex. 1006) and for the FDA’s “Safety Review” (Ex. 1004 Preliminary Clinical Safety Review), which were posted on the FDA’s website not later than July 1, 2001. Ex. 1019. We also note the URL for the FDA website address in Exhibit 1019 concludes with the code “briefing/3754b1.htm,” which matches the Briefing Information code linked in Exhibit 1018.16 Thus, the Internet Archive evidence supports Petitioner’s contention that the documents of Exhibits 1004–1006 were publicly accessible on the FDA’s website for the Xyrem Advisory Committee not later than July 1, 2001, in accordance with the Federal Advisory Committee Act. We are not persuaded by Patent Owner’s argument that Petitioner’s Internet Archive evidence is insufficient, given the totality of evidence presented in this case. PO Resp. 5–9. For example, Patent Owner submits the Second Affidavit of Christopher Butler and asserts that, if one clicks on the links shown in Exhibits 1019, the earliest archive dates for the URLs corresponding to Exhibits 1004–1006 are dated after the ’107 priority date: 16 The 3754 code is consistent with the code used for other Xyrem Advisory Committee documents, as discussed above in subsection II.C.1.b. August 30, 2003, for Exhibit 1006; September 13, 2011 for Exhibit 1005; and November 21, 2011 for Exhibit 1004. Id. at 8–9 (citing Ex. 2052, 6, 129, 483, 495, 498, and 501). As Petitioner explains, however, quoting from a Third Affidavit of Christopher Butler, the first available archive or “captured” date of a URL “does not represent the first time that the pdf was posted online at that address and it is possible that the pdf was available at this URL on an earlier date.” Reply 6–7 (citing Ex. 1058 ¶¶ 6–8). The pdf “may have been available days, weeks, months, or years prior to the date it was first captured.” Ex. 1058 ¶ 6; see also Rackspace US, Inc. v. Personalweb Techs., LLC, Case IPR2014-00059, slip op. at 35 (PTAB April 15, 2014) (Paper 9) (“[T]he mere fact that a ‘downloaded’ copy of [the prior art reference] has a date subsequent to the critical date is not sufficient to rebut Rackspace’s supporting evidence that [the reference] was posted originally on publicly accessible sites well known to those interested in the art before the critical date.”). We further note that Patent Owner’s Internet Archive evidence corroborates the fact that pdf files for each of Exhibits 1004–1006 were linked to the FDA’s website with the code “briefing/3754b1.” Ex. 2052, 5 (Ex. 1004 “Preliminary Clinical Safety Review” - “briefing/3754b1_02_section %203.pdf”), 128 (Ex. 1005 “Briefing Booklet” - “briefing/3754b1_01_1-orphan-medical.pdf ”), 482 (Ex. 1006 “Video Script 2/2/01” - “briefing/3754b1_01_2-orphan-medical%20video%20tape%20Revised%20Script.pdf”). “Briefing/3754b1” is the same code linking the “Briefing Information” to the FDA’s website as of June 17, 2001 (Ex. 1018, 5) and July 1, 2001 (Ex. 1019). As in” slip op. at 33

  Patent outcomesUS 7,765,107 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 7,765,107
• Par Pharmaceutical, Inc. / Amneal Pharmaceuticals, LLC v. Jazz Pharmaceuticals, Inc.All claims unpatentable
  PTAB · Jul 27, 2016 · IPR2015-01815 · APJ Jacqueline Wright Bonilla · IPR · Final written decision

  Claims 1–8 are unpatentable as obvious over the Advisory Committee Art because it disclosed or suggested the claimed distribution controls and a skilled artisan would have combined the references.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We begin with the premise that a hypothetical POSA is presumed to be aware of the pertinent art in the field of endeavor at the time of the invention, and to be a person of ordinary creativity. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 407-09, 420-21 (2007). As the title, field of the invention, and background discussion in the ’106 patent make clear, the relevant field of endeavor is the distribution of sensitive prescription drugs prone to abuse or causing serious adverse reactions. Ex. 1001, Title, 1:11– 27. Petitioner provides substantial evidence of the state of the art of such sensitive drug distribution systems as of December 17, 2001, one year before the ’106 patent priority date. Pet. 3–6; see also Ex. 1001, Related U.S. Application Data, 1:6–9 (indicating earliest priority date for the ’106 patent).” slip op. at 11

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionOther

    “1. “exclusive central computer system” and “exclusive computer database” In our Decision on Institution, we construed the term “exclusive central computer system” to mean “single or sole computer system,” and the term “exclusive computer database” to mean “single or sole computer database.” Dec. on Inst. 20–21. Our constructions are consistent with those proposed by Petitioner, and Patent Owner takes no position regarding Petitioner’s arguments in this regard. Pet. 9; PO Resp. 25 n.8. Based on our review of the complete record, we do not perceive any reason or evidence that now compels any deviation from these interpretations.” slip op. at 15

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner

    “We are not persuaded by Patent Owner’s arguments or the testimony of Dr. DiPiro and Dr. Bergeron in support thereof. Patent Owner does not explain adequately why generating a report for a particular purpose or “ad hoc” precludes it from being a report generated periodically. See, e.g., PO Resp. 28 (citing Ex. 2046 ¶ 33 (testimony by Dr. DiPiro stating that “POSA would not consider ‘ad hoc’ reports to be ‘periodic’ because they are not generated with any regular frequency.”); Ex. 2047 ¶ 31 (testimony by Dr. Bergeron stating same). As noted above, the specification does not limit “periodic reports” to those generated with “regular frequency.” Moreover, to the extent that Figure 4B in the ’106 patent illustrates generating “ad hoc” reports, as Patent Owner contends, such disclosure supports a construction that the recited “periodic reports” include such “ad hoc” reports. Ex. 1001, 6:13–7:3; Reply 13–14 (citing Ex. 1047, 6; Ex. 1048, 9:12–19, Fig. 4, 436).” slip op. at 17

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

    “Petitioner’s circumstantial evidence. As discussed above, it is undisputed that Exhibit 1003 was available as a file link on the FDA’s website no later than October 4, 2001. It is also undisputed that Exhibits 1004–1006 were prepared and submitted to the Xyrem Advisory Committee just over one month prior to the June 6, 2001 meeting. The Safety Review (Ex. 1004) has a few redactions that tend to indicate the document was prepared for public dissemination, and the Briefing Booklet (Ex. 1005) contains the statutory legend indicating it is available for public disclosure without redaction. Reply 2–3 (citing Ex. 1057, 415). Thus, the evidence indicates Exhibits 1004–1006 were prepared, distributed to the Xyrem Advisory Committee, and available for posting to the FDA’s website 24 hours prior to the meeting, as stated in the Federal Register Notice (Ex. 1015). The Federal Register Notice even provided instructions on how to locate materials from the FDA’s website—“Click on the year 2001 and scroll down to the Peripheral and Central Nervous Systems Drugs meetings.” Reply 5 (citing Ex. 1015). As Petitioner points out, Patent Owner has not adduced evidence to indicate the FDA failed to follow the public inspection requirements of the Federal Advisory Committee Act and FDA’s own guidance document in effect at the time. Reply 2–4 (citing Ex. 1057, 2, 4, 6, 8). FDA’s guidance document states that seven business days prior to an advisory committee meeting “the sponsor package and CDER’s [Center for Drug Evaluation and Research] redacted package will be submitted . . . for posting on the FDA website.” Ex. 1057, 8 ¶ 9. The guidance document further states that 24 hours prior to the meeting “FDA will post on its website the sponsor 15 Our citations are to the internal numbering of the document, consistent with Petitioner’s citations. package and CDER’s redacted package.” Id. at ¶ 10. If for some reason the FDA is unable to post the documentation prior to a meeting, “the two packages will be made publicly available at the location of the advisory committee meeting, and the two packages will be posted on the Agency website after the meeting.” Id. The transcript of the Xyrem Advisory Committee Meeting contains internal references to the briefing material made available to the committee members and discussed at the meeting, thus tending to corroborate the availability of Exhibits 1004–1006 as of the June 6, 2001 meeting date. Reply 4 (citing Ex. 1003, 12, 179, 284, 330, 342). Petitioner’s Internet Archive evidence indicates that a file link to “Briefing Information 3754b1.htm” was posted on the FDA’s website not later than June 17, 2001. Ex. 1018, 5. Petitioner’s Internet Archive evidence further indicates this link led to file links for Orphan Medical’s “Briefing Information” (Ex. 1005 Briefing Booklet) and Xyrem “Video Script 2/2/01” (Ex. 1006) and for the FDA’s “Safety Review” (Ex. 1004 Preliminary Clinical Safety Review), which were posted on the FDA’s website not later than July 1, 2001. Ex. 1019. We also note the URL for the FDA website address in Exhibit 1019 concludes with the code “briefing/3754b1.htm,” which matches the Briefing Information code linked in Exhibit 1018.16 Thus, the Internet Archive evidence supports Petitioner’s contention that the documents of Exhibits 1004–1006 were publicly accessible on the FDA’s website for the Xyrem Advisory Committee not later than July 1, 2001, in accordance with the Federal Advisory Committee Act.” slip op. at 32

  Patent outcomesUS 7,765,106 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 7,765,106
• Par Pharmaceutical, Inc. / Amneal Pharmaceuticals, LLC v. Jazz Pharmaceuticals, Inc.All claims unpatentable
  PTAB · Jul 27, 2016 · IPR2015-01817 · APJ Brian P Murphy · IPR · Final written decision

  Claims 1–11 of the ’730 patent and claims 1–15 of the ’988 patent are unpatentable as obvious over the Advisory Committee Art, with claims 2 and 10 of the ’988 patent also obvious over that …

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “In view of the claims at issue here, we are not persuaded that the level of ordinary skill in the art is limited to the level of skill or interest of a pharmacist that dispenses FDA-approved drugs, such as one that “sits behind the counter at Walgreens.” Id. at 31:1–5. We adopt the level of ordinary skill in the art as described by Petitioner and its witness, Dr. Valuck, because it is consistent with the subject matter before us, the ’730 patent, and with prior art of record, such as Talk About Sleep (Ex.1033), Honigfeld (Ex. 1034), Elsayed (Ex. 1035), and Lilly (Ex. 1036). See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that the prior art itself can reflect the appropriate level of ordinary skill in the art).” slip op. at 12

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionTerm construed board ownOther

    “Upon considering all of the evidence before us, we are not persuaded that the plain and ordinary meaning of “periodic” in the context of the ’730 patent limits “periodic reports” to those generated only at regular intervals, as Patent Owner contends. PO Resp. 28. Rather, the term includes reports generated at regular intervals and reports generated “now and again” or “intermittently,” without any particular regularity in time between events. Thus, we construe “periodic reports” as recited in the challenged claims to refer to reports that are generated at regular intervals or intermittently, i.e., now and again, including those not generated at regular intervals.” slip op. at 18

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

    “24. Patent Owner’s attack emphasizes Petitioner’s lack of such direct evidence, but does not address persuasively the cumulative effect of Petitioner’s circumstantial evidence. As discussed above, it is undisputed that Exhibit 1003 was available as a file link on the FDA’s website no later than October 4, 2001. It is also undisputed that Exhibits 1004–1006 were prepared and submitted to the Xyrem Advisory Committee just over one month prior to the June 6, 2001, meeting. The Safety Review (Ex. 1004) has a few redactions that tend to indicate the document was prepared for public dissemination, and the Briefing Booklet (Ex. 1005) contains the statutory legend indicating it is available for public disclosure without redaction. Reply 2–3 (citing Ex. 1057, 417). Thus, the evidence indicates Exhibits 1004–1006 were prepared, distributed to the Xyrem Advisory Committee, and available for posting to the FDA’s website 24 hours prior to the meeting, as stated in the Federal Register Notice (Ex. 1015). The Federal Register Notice even provided instructions on how to locate materials from the FDA’s website – “Click on the year 2001 and scroll down to the Peripheral and Central Nervous Systems Drugs meetings.” Reply 5 (quoting Ex. 1015). As Petitioner points out, Patent Owner has not adduced evidence to indicate the FDA failed to follow the public inspection requirements of the Federal Advisory Committee Act and FDA’s own guidance document in effect at the time. Reply 2–4 (citing Ex. 1057, 2, 4, 6, 8). FDA’s guidance document states that seven business days prior to an advisory committee meeting “the sponsor package and CDER’s [Center for Drug Evaluation and Research] redacted package will be submitted . . . for posting on the FDA 17 Our citations are to the internal numbering of the document, consistent with Petitioner’s citations. website.” Ex. 1057, 8 ¶ 9. The guidance document further states that 24 hours prior to the meeting “FDA will post on its website the sponsor package and CDER’s redacted package.” Id. at 8 ¶ 10. If for some reason the FDA is unable to post the documentation prior to a meeting, “the two packages will be made publicly available at the location of the advisory committee meeting, and the two packages will be posted on the Agency website after the meeting.” Id. The transcript of the Xyrem Advisory Committee Meeting contains internal references to the briefing material made available to the committee members and discussed at the meeting, thus tending to corroborate the availability of Exhibits 1004–1006 as of the June 6, 2001, meeting date. Reply 4 (citing Ex. 1003, 12, 179, 284, 330, 342).” slip op. at 31

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

    “In addition, even assuming the Advisory Committee indicated a preference for one course of action over another, that disclosure does not dictate that a less “preferred” option is not obvious. DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed. Cir. 2009) (stating that a “reference does not teach away . . . if it merely expresses a general preference for an alternative invention but does not ‘criticize, discredit, or otherwise discourage’ investigation into the invention claimed” (quoting In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004))); Reply 24. We are not persuaded that testimony of Advisory Committee members, as cited by Patent Owner (PO Resp. 51–55 (citing Ex. 1003)), criticizes, discredits, or otherwise discourages providing educational materials regarding Xyrem before shipping the drug to a patient. We agree with Petitioner that by asking questions on this point, the Advisory Committee suggested at least some value in taking that course of action. Reply 24. Contrary to Patent Owner’s arguments, the FDA Advisory Committee expressly considered the alternative of confirming that the patient has read the Xyrem educational material prior to shipping the first prescription. The FDA reviewers specifically listed as an additional “Risk Management Recommendation[]” to the drug sponsor to include: “Obtaining the patient’s signed confirmation that he/she fully understands how GHB is to be used prior to the first prescription being mailed.” Ex. 1004, 115 (14.4); see also Ex. 1007 ¶ 71 (quoting the same passage). We are satisfied that the ACA discloses a process step to a POSA for confirming that a patient has read the Xyrem educational material prior to shipping the first dose of a potentially dangerous drug. Ex. 1007 ¶ 71. We also find the portions of the ACA identified by Petitioner and discussed by Dr. Valuck suggest, if not teach expressly, the step of confirming with a patient that educational materials were received and/or read prior to shipping Xyrem. Pet. 30 (citing (Ex. 1003, Tr., 371:10–12. 374:7–20; Ex. 1004, 115; Ex. 1007 ¶ 71). Both parties agree that the ACA teaches sending the Xyrem educational material (“Xyrem Patient Success Program”) with their first shipment of Xyrem, consistent with the “preferred” course of action noted by Patent Owner. Pet. 30 (citing Ex. 1003, 182:3–8); PO Resp. 49 (citing Ex. 1003 at 182:3–8, slide 157; Ex. 1006, 8–9 n.34–n.37, V10 at 00:05-00:40), id. at 53–55 (addressing what some Committee members indicated was “preferred”). Disclosures in the Preliminary Clinical Safety Review (Ex. 1004, 115), as discussed above, especially in view of the questions raised by the Advisory Committee, sufficiently suggest or teach as an alternative, and establish that a POSA would have had reason, to confirm with a patient that educational material had been received and/or read prior to shipping Xyrem. See, e.g., Ex. 1003, 374:7–20 (raising the idea of patients signing a form confirming that they “read the materials” “before they even get the first dose”).” slip op. at 50

  Patent outcomesUS 8,457,988 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 8,457,988
• Par Pharmaceutical, Inc. / Amneal Pharmaceuticals, LLC v. Jazz Pharmaceuticals, Inc.All claims unpatentable
  PTAB · Jul 27, 2016 · IPR2015-00554 · APJ Brian P Murphy · IPR · Final written decision

  Claims 1–11 of the ’730 patent and claims 1–15 of the ’988 patent are unpatentable as obvious over the Advisory Committee Art, with claims 2 and 10 of the ’988 patent also obvious over that …

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We begin with the premise that a hypothetical POSA is presumed to be aware of the pertinent art in the field of endeavor at the time of the invention, and to be a person of ordinary creativity. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 407-09, 420-21 (2007). As the title, field of the invention, and background discussion in the ’730 patent make clear, the relevant field of endeavor is the distribution of sensitive prescription drugs prone to abuse or causing serious adverse reactions. Ex. 1001, Title (54), 1:4–26. Petitioner provides substantial evidence of the state of the art of such sensitive drug distribution systems as of December 17, 2001, one year before the ’730 patent priority date. Pet. 3–6: Ex. 1001, filing date (22).” slip op. at 11

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther

    “Patent Owner also points us to a Merriam-Webster’s Collegiate Dictionary definition of the term “periodic,” which defines the term as “occurring or recurring at regular intervals,” or something that is “repeated.” PO Resp. 28 (citing Ex. 2043, 3). Petitioner points us to several other dictionary definitions, which define “periodic” as also including “intermittent.” Reply 15 (citing Ex. 1049, 3 (defining “periodic” as including “occurring repeatedly from time to time”); Ex. 1050, 3 (defining “periodic” as including “[t]aking place now and then” or “INTERMITTENT”); Ex. 1051, 3 (defining “periodic” as including “[h]appening or appearing now and then” or “intermittent, occasional”). Upon considering all of the evidence before us, we are not persuaded that the plain and ordinary meaning of “periodic” in the context of the ’730 patent limits “periodic reports” to those generated only at regular intervals, as Patent Owner contends. PO Resp. 28. Rather, the term includes reports generated at regular intervals and reports generated “now and again” or “intermittently,” without any particular regularity in time between events. Thus, we construe “periodic reports” as recited in the challenged claims to refer to reports that are generated at regular intervals or intermittently, i.e., now and again, including those not generated at regular intervals.” slip op. at 17

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

    “The specification of the ’730 patent indicates that “[a]n example of one prescription and enrollment form is shown at 900 in FIG. 9.” Ex. 1001, 8:4–5 (emphasis added). Thus, the enrollment form of Figure 9 describes one example of the type of information that may be information identifying a patient. The specification does not indicate, however, that “information identifying the patient,” as recited in the claims, necessarily includes each and every piece of information in the enrollment form of Figure 9. Similarly, nothing in the specification suggests that excluding one or more pieces of information in the list of a “patient’s name, social security number, date of birth, sex, and complete address information, including city, state and zip code,” as proposed by Patent Owner, means that a prescription fails to contain “information identifying the patient,” as recited in the claims. Thus, we construe “prescription requests [for GHB] containing information identifying patients” to refer to information identifying a patient, which may include the type of information presented in the enrollment form of Figure 9 and noted by Patent Owner (PO Resp. 30), but is not limited to that information nor requires all of that information.” slip op. at 19

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

    “The key inquiry is whether a reference was made “sufficiently accessible to the public interested in the art” before the critical date, here December 17, 2001. In re Cronyn, 890 F.2d 1158, 1160 (Fed. Cir. 1989). “A given reference is ‘publicly accessible’ upon a satisfactory showing that such document has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.” Bruckelmyer v. Ground Heaters, Inc., 445 F.3d 1374, 1378 (Fed. Cir. 2006). Indexing of a reference is not “a necessary condition for a reference to be publicly accessible,” but it is one among various factors that may bear on public accessibility. In re Lister, 583 F.3d 1307, 1311 (Fed. Cir. 2009). “Whether a reference is publicly accessible is determined on a case-by-case basis based on the ‘facts and circumstances surrounding the reference’s disclosure to members of the public.’” Voter Verified, Inc., v. Premier Election Solutions, Inc., 698 F.3d 1374, 1380 (Fed. Cir. 2012) (quoting In re Lister, 583 F.3d 1307, 1311 (Fed. Cir. 2009)). With these principles in mind, we consider the parties’ arguments below.” slip op. at 22

  Patent outcomesUS 7,668,730 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 7,668,730
• Par Pharmaceutical, Inc. / Amneal Pharmaceuticals, LLC v. Jazz Pharmaceuticals, Inc.All claims unpatentable
  PTAB · Jul 27, 2016 · IPR2015-00551 · APJ Brian P Murphy · IPR · Final written decision

  Claims 1–11 of the ’730 patent and claims 1–15 of the ’988 patent are unpatentable under § 103 over the Advisory Committee Art, with claims 2 and 10 of the ’988 patent also obvious over …

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We begin with the premise that a hypothetical POSA is presumed to be aware of the pertinent art in the field of endeavor at the time of the invention, and to be a person of ordinary creativity. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 407-09, 420-21 (2007). As the title, field of the invention, and background discussion in the ’730 patent make clear, the relevant field of endeavor is the distribution of sensitive prescription drugs prone to abuse or causing serious adverse reactions. Ex. 1001, Title (54), 1:4–26. Petitioner provides substantial evidence of the state of the art of such sensitive drug distribution systems as of December 17, 2001, one year before the ’730 patent priority date. Pet. 3–6: Ex. 1001, filing date (22).” slip op. at 11

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Other

    “We are not persuaded by Patent Owner’s arguments or the testimony of Dr. DiPiro and Dr. Bergeron in support thereof. Patent Owner does not explain adequately why generating a report for a particular purpose or “ad hoc” precludes it from being a report generated periodically. See, e.g., PO Resp. 28 (citing Ex. 2046 ¶ 33 (testimony by Dr. DiPiro stating that “POSA would not consider ‘ad hoc’ reports to be ‘periodic’ because they are not generated with any regular frequency.”); Ex. 2047 ¶ 31 (testimony by Dr. Bergeron stating same). As noted above, the specification does not limit “periodic reports” to those generated with “regular frequency.” Moreover, to the extent that Figure 4B in the ’730 patent illustrates generating “ad hoc” reports, as Patent Owner contends, such disclosure supports a construction that the recited “periodic reports” include such “ad hoc” reports. Ex. 1001, 6:9–7:2; Reply 13–14 (citing Ex. 1047, 6; Ex.1048, 9 (ll. 12–19), Fig. 4 (436)). Patent Owner also points us to a Merriam-Webster’s Collegiate Dictionary definition of the term “periodic,” which defines the term as “occurring or recurring at regular intervals,” or something that is “repeated.” PO Resp. 28 (citing Ex. 2043, 3). Petitioner points us to several other dictionary definitions, which define “periodic” as also including “intermittent.” Reply 15 (citing Ex. 1049, 3 (defining “periodic” as including “occurring repeatedly from time to time”); Ex. 1050, 3 (defining “periodic” as including “[t]aking place now and then” or “INTERMITTENT”); Ex. 1051, 3 (defining “periodic” as including “[h]appening or appearing now and then” or “intermittent, occasional”). Upon considering all of the evidence before us, we are not persuaded that the plain and ordinary meaning of “periodic” in the context of the ’730 patent limits “periodic reports” to those generated only at regular intervals, as Patent Owner contends. PO Resp. 28. Rather, the term includes reports generated at regular intervals and reports generated “now and again” or “intermittently,” without any particular regularity in time between events. Thus, we construe “periodic reports” as recited in the challenged claims to refer to reports that are generated at regular intervals or intermittently, i.e., now and again, including those not generated at regular intervals.” slip op. at 17

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

    “presentation slides, thus confirming the description of the Internet Archive file links (3754t) as containing 381 pages. Compare Ex. 1003, with Ex. 1020, 8. We are persuaded that the Federal Register Notice is evidence of the FDA’s general practice under the Federal Advisory Committee Act and tends to indicate an approximate timeframe when background information and advisory committee meeting minutes, transcripts, and presentation slides are posted on the FDA’s website. Case IPR2014-00059, slip op. at 34 (Apr. 15, 2014) (Paper 9) (citing In re Hall, 781 F.2d 897, 899 (Fed. Cir. 1988)); 5 U.S.C. App 2 § 10(b) (2001) (“[T]he records, reports, transcripts, minutes, appendixes, working papers, drafts, studies, agenda, or other documents which were made available to or prepared for or by each advisory committee shall be available for public inspection . . . .”). The Federal Register Notice states that the minutes, transcript, and slides of the Xyrem Advisory 13 The October 4, 2001 Internet Archive page contains a URL date code of “20011004” (Ex. 1020, 8–9). Ex. 1028 ¶ 5. Committee Meeting are “generally posted about 3 weeks after the meeting.” Ex. 1015. The Internet Archive evidence indicates the meeting transcript, presentation slides, and meeting minutes were not posted on the FDA’s website as of June 17, 2001, less than three weeks after the meeting, but were posted not later than October 4, 2001. Ex. 1018; Ex. 1020; Ex. 1028. Thus, the Federal Register Notice is consistent with the Internet Archive evidence. Petitioner further emphasizes that Patent Owner does not contest the sufficiency of the evidence establishing the public accessibility of Exhibit 1003 on the FDA’s website as of October 4, 2001. Reply 2 n.2; Tr. 6:1–9; see PO Resp. 4–14. Therefore, for the reasons given above, we find that Petitioner has established by a preponderance of the evidence that the Xyrem Advisory Committee Meeting transcript and presentation slides (Exhibit 1003) were publicly accessible on the FDA’s website not later than October 4, 2001.” slip op. at 26

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

    “We disagree with Patent Owner’s inference that members of the Advisory Committee were not POSAs, i.e., people interested in the distribution, safety, and abuse of a sensitive drug. Testimony of the Advisory Committee members cited by Patent Owner (PO Resp. 51–55 (citing Ex. 1003)) indicates that the members were interested in, and discussed at length, the distribution, safety, and abuse of Xyrem. In addition, even assuming the Advisory Committee indicated a preference for one course of action over another, that disclosure does not dictate that a less “preferred” option is not obvious. DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed. Cir. 2009) (stating that a “reference does not teach away . . . if it merely expresses a general preference for an alternative invention but does not ‘criticize, discredit, or otherwise discourage’ investigation into the invention claimed” (quoting In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004))); Reply 24. We are not persuaded that testimony of Advisory Committee members, as cited by Patent Owner (PO Resp. 51–55 (citing Ex. 1003)), criticizes, discredits, or otherwise discourages providing educational materials regarding Xyrem before shipping the drug to a patient. We agree with Petitioner that by asking questions on this point, the Advisory Committee suggested at least some value in taking that course of action. Reply 24. Contrary to Patent Owner’s arguments, the FDA Advisory Committee expressly considered the alternative of confirming that the patient has read the Xyrem educational material prior to shipping the first prescription. The FDA reviewers specifically listed as an additional “Risk Management Recommendation[]” to the drug sponsor to include: “Obtaining the patient’s signed confirmation that he/she fully understands how GHB is to be used prior to the first prescription being mailed.” Ex. 1004, 115 (14.4); see also Ex. 1007 ¶ 71 (quoting the same passage). We are satisfied that the ACA discloses a process step to a POSA for confirming that a patient has read the Xyrem educational material prior to shipping the first dose of a potentially dangerous drug. Ex. 1007 ¶ 71. We also find the portions of the ACA identified by Petitioner and discussed by Dr. Valuck suggest, if not teach expressly, the step of confirming with a patient that educational materials were received and/or read prior to shipping Xyrem. Pet. 30 (citing (Ex. 1003, Tr., 371:10–12. 374:7–20; Ex. 1004, 115; Ex. 1007 ¶ 71). Both parties agree that the ACA teaches sending the Xyrem educational material (“Xyrem Patient Success Program”) with their first shipment of Xyrem, consistent with the “preferred” course of action noted by Patent Owner. Pet. 30 (citing Ex. 1003, 182:3–8); PO Resp. 49 (citing Ex. 1003 at 182:3–8, slide 157; Ex. 1006, 8–9 n.34–n.37, V10 at 00:05-00:40), id. at 53–55 (addressing what some Committee members indicated was “preferred”). Disclosures in the Preliminary Clinical Safety Review (Ex. 1004, 115), as discussed above, especially in view of the questions raised by the Advisory Committee, sufficiently suggest or teach as an alternative, and establish that a POSA would have had reason, to confirm with a patient that educational material had been received and/or read prior to shipping Xyrem. See, e.g., Ex. 1003, 374:7–20 (raising the idea of patients signing a form confirming that they “read the materials” “before they even get the first dose”). Patent Owner does not persuade us otherwise by arguing that “the ACA discloses to a POSA that the ‘registry information’ in Ex. 1004 is not the same as the educational based ‘registry form’ discussed in Ex. 1003.” PO Resp. 52 n.17. Patent Owner’s arguments in this regard do not address the teachings in the Preliminary Clinical Safety Review (Ex. 1004, 115) discussed above, regardless of any distinction between “registry information” and a “registry form.” Nor are we persuaded otherwise by Patent Owner’s critique of Dr. Valuck’s testimony and his alleged “process” of analyzing the ACA prior art, because this testimony and argument fail to address the teachings in the Preliminary Clinical Safety Review (Ex. 1004, 115) discussed above. PO Resp. 57–58 (quoting Ex. 2044, 198:6–22). Based on the complete record before us, we find Petitioner establishes by a preponderance of the evidence that the ACA discloses a method of distributing a prescription drug that comprises “confirming with a patient that educational material has been received and/or read prior to shipping the prescription drug,” as recited in Step 1.4 of challenged claims. See also KSR, 550 U.S. at 418; In re Bell, 991 F.2d at 785.” slip op. at 50

  Patent outcomesUS 8,457,988 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 8,457,988
• Par Pharmaceutical, Inc. / Amneal Pharmaceuticals, LLC v. Jazz Pharmaceuticals, Inc.All claims unpatentable
  PTAB · Jul 27, 2016 · IPR2015-00546 · APJ Jacqueline Wright Bonilla · IPR · Final written decision

  Claims 1–8 are unpatentable as obvious over the Advisory Committee Art under § 103(a), which the Board found publicly accessible before the patent’s priority date.

  RulingsFinal written decision

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

    “The key inquiry is whether a reference was made “sufficiently accessible to the public interested in the art” before the critical date, here December 17, 2001. In re Cronyn, 890 F.2d 1158, 1160 (Fed. Cir. 1989). “A given reference is ‘publicly accessible’ upon a satisfactory showing that such document has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.” Bruckelmyer v. Ground Heaters, Inc., 445 F.3d 1374, 1378 (Fed. Cir. 2006). Indexing of a reference is not “a necessary condition for a reference to be publicly accessible,” but it is one among various factors that may bear on public accessibility. In re Lister, 583 F.3d 1307, 1312 (Fed. Cir. 2009). “Whether a reference is publicly accessible is determined on a case-by-case basis based on the ‘facts and circumstances surrounding the reference’s disclosure to members of the public.’” Voter Verified, Inc., v. Premier Election Solutions, Inc., 698 F.3d 1374, 1380 (Fed. Cir. 2012) (quoting In re Lister, 583 F.3d 1307, 1311 (Fed. Cir. 2009)). With these principles in mind, we consider the parties’ arguments below.” slip op. at 23

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We begin with the premise that a hypothetical POSA is presumed to be aware of the pertinent art in the field of endeavor at the time of the invention, and to be a person of ordinary creativity. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 407-09, 420-21 (2007). As the title, field of the invention, and background discussion in the ’106 patent make clear, the relevant field of endeavor is the distribution of sensitive prescription drugs prone to abuse or causing serious adverse reactions. Ex. 1001, Title, 1:11– 27. Petitioner provides substantial evidence of the state of the art of such sensitive drug distribution systems as of December 17, 2001, one year before the ’106 patent priority date. Pet. 3–6; see also Ex. 1001, Related U.S. Application Data, 1:6–9 (indicating earliest priority date for the ’106 patent).” slip op. at 11

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “We are not persuaded by Patent Owner’s arguments or the testimony of Dr. DiPiro and Dr. Bergeron in support thereof. Patent Owner does not explain adequately why generating a report for a particular purpose or “ad hoc” precludes it from being a report generated periodically. See, e.g., PO Resp. 28 (citing Ex. 2046 ¶ 33 (testimony by Dr. DiPiro stating that “POSA would not consider ‘ad hoc’ reports to be ‘periodic’ because they are not generated with any regular frequency.”); Ex. 2047 ¶ 31 (testimony by Dr. Bergeron stating same). As noted above, the specification does not limit “periodic reports” to those generated with “regular frequency.” Moreover, to the extent that Figure 4B in the ’106 patent illustrates generating “ad hoc” reports, as Patent Owner contends, such disclosure supports a construction that the recited “periodic reports” include such “ad hoc” reports. Ex. 1001, 6:13–7:3; Reply 13–14 (citing Ex. 1047, 6; Ex. 1048, 9:12–19, Fig. 4, 436).” slip op. at 17

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner

    “1. “exclusive central computer system” and “exclusive computer database” In our Decision on Institution, we construed the term “exclusive central computer system” to mean “single or sole computer system,” and the term “exclusive computer database” to mean “single or sole computer database.” Dec. on Inst. 20–21. Our constructions are consistent with those proposed by Petitioner, and Patent Owner takes no position regarding Petitioner’s arguments in this regard. Pet. 9; PO Resp. 25 n.8. Based on our review of the complete record, we do not perceive any reason or evidence that now compels any deviation from these interpretations.” slip op. at 15

  Patent outcomesUS 7,765,106 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 7,765,106
• Par Pharmaceutical, Inc. / Amneal Pharmaceuticals, LLC v. Jazz Pharmaceuticals, Inc.All claims unpatentable
  PTAB · Jul 27, 2016 · IPR2015-00547 · APJ Jacqueline Wright Bonilla · IPR · Final written decision

  Claims 1–6 are unpatentable as obvious over the Advisory Committee Art under 35 U.S.C. § 103(a).

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We begin with the premise that a hypothetical POSA is presumed to be aware of the pertinent art in the field of endeavor at the time of the invention, and to be a person of ordinary creativity. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 407-09, 420–21 (2007). As the title, field of the invention, and background discussion in the ’107 patent make clear, the relevant field of endeavor is the distribution of sensitive prescription drugs prone to abuse or causing serious adverse reactions. Ex. 1001, Title, 1:11– 27. Petitioner provides substantial evidence of the state of the art of such sensitive drug distribution systems as of December 17, 2001, one year before the ’107 patent priority date. Pet. 3–6; see also Ex. 1001, Related Application, 1:6–9 (indicating earliest priority date for the ’107 patent).” slip op. at 11

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionOther

    “1. “exclusive central pharmacy” In our Decision on Institution, we construed the term “exclusive central pharmacy” to mean “single or sole pharmacy.” Dec. on Inst. 20–21. Our constructions are consistent with those proposed by Petitioner, and Patent Owner takes no position regarding Petitioner’s arguments in this regard. Pet. 8; PO Resp. 24 n.8. Based on our review of the complete record, we do not perceive any reason or evidence that now compels any deviation from that interpretation.” slip op. at 14

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

    “The key inquiry is whether a reference was made “sufficiently accessible to the public interested in the art” before the critical date, here December 17, 2001. In re Cronyn, 890 F.2d 1158, 1160 (Fed. Cir. 1989). “A given reference is ‘publicly accessible’ upon a satisfactory showing that such document has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.” Bruckelmyer v. Ground Heaters, Inc., 445 F.3d 1374, 1378 (Fed. Cir. 2006). Indexing of a reference is not “a necessary condition for a reference to be publicly accessible,” but it is one among various factors that may bear on public accessibility. In re Lister, 583 F.3d 1307, 1312 (Fed. Cir. 2009). “Whether a reference is publicly accessible is determined on a case-by-case basis based on the ‘facts and circumstances surrounding the reference’s disclosure to members of the public.’” Voter Verified, Inc., v. Premier Election Solutions, Inc., 698 F.3d 1374, 1380 (Fed. Cir. 2012) (quoting In re Lister, 583 F.3d 1307, 1311 (Fed. Cir. 2009)). With these principles in mind, we consider the parties’ arguments below.” slip op. at 22

  Patent outcomesUS 7,765,107 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 7,765,107

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.