• Amneal Pharmaceuticals, LLC v. Purdue Pharma L.P., The P.F. Laboratories, Inc., And Purdue Pharmaceuticals L.P.All claims unpatentable
  PTAB · Jan 17, 2018 · IPR2016-01413 · APJ Christopher G Paulraj · IPR · Final written decision

  Claims 1–13 and 16–19 are unpatentable as obvious over Royce, McGinity, Hoffmeister, Joshi, and PDR.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “DISCUSSION A. Level of Skill in the Art Petitioner contends that a person of ordinary skill in the art for the ’976 patent would have “a degree in one or more fields of medicine, chemical engineering, chemistry, pharmaceutical science, polymer 1 Royce, U.S. Patent 5,273,758, issued Dec. 28, 1993 (Ex. 1022) (“Royce”). 2 McGinity et al, WO 97/49384, published Dec. 31, 1997 (Ex. 1024) (“McGinity”). 3 Hoffmeister et al., U.S. Patent 4,070,494, issued Jan. 24, 1978 (Ex. 1010) (“Hoffmeister”). 4 Joshi et al., Pub. No. US 2002/0187192 A1, published Dec. 12, 2002 (Ex. 1014) (“Joshi”). 5 OxyContin entry in Physicians’ Desk Reference, 2569–74 (53d ed., 1999) (Ex. 1016)(“PDR”). chemistry, pharmaceutics, pharmaceutical technology, pharmacokinetics, and/or pharmacology, and/or a number of years of industry training or experience in one or more of those fields.” Pet. 16 (citing Ex. 1007 ¶¶ 31– 34). Patent Owner agrees with Petitioner’s proposed level of skill in the art. PO Resp. 27. We, therefore, apply that skill level in our analysis, with the understanding that the level of skill of art in this proceeding is also reflected in the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 7

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

    “We find Petitioner’s proposed construction to be more persuasive based on the ’376 patent specification. In particular, the specification defines “unsuitable for injection” “to mean that one would have substantial difficulty injecting the dosage form (e.g., due to pain upon administration or difficulty pushing the dosage form through a syringe) due to the viscosity imparted on the dosage form, thereby reducing the potential for abuse of the opioid analgesic from the dosage form.” Id. at 3:15–20. Additionally, in an example concerning the formation of a gel at different concentrations, the specification characterizes certain solutions as “THICK (10 cP to 60 cP): Although a syringe can be filled with this solution, it was hard to do.” Id. at 32:8–24, Table 3. Thus, the specification teaches that a viscosity of at least 10cp is difficult to pull into a syringe or administer parenterally (via injection). Patent Owner does not address these teachings of the specification. We, therefore, determine that the broadest reasonable interpretation of “unsuitable for parenteral administration” and “unsuitable to pull into an insulin syringe” encompasses a gelling agent that imparts a viscosity of at least 10 cp.” slip op. at 9

  • PTAB / AIA Trials › §315(e) estoppelEstoppel appliesDecided for petitioner

    “Under the doctrine of issue preclusion, also called collateral estoppel, a judgment on the merits in a first suit precludes relitigation in a second [proceeding] of issues actually litigated and determined in the first suit.” In re Freeman, 30 F.3d 1459, 1465 (Fed. Cir. 1994) (citing Lawlor v. National Screen Serv. Corp., 349 U.S. 322, 326 (1955)). The Federal Circuit has articulated a four-factor test in determining whether collateral estoppel attaches: “(1) the identity of the issues in a prior proceeding; (2) the issues were actually litigated; (3) the determination of the issues was necessary to the resulting judgment; and (4) the party defending against preclusion had a full and fair opportunity to litigate the issues.” Levi Strauss & Co. v. Abercrombie & Fitch Trading Co., 719 F.3d 1367, 1371 (Fed. Cir. 2013). Collateral estoppel can attach in proceedings before the Office for identical issues that were addressed with respect to a different patent during prior slip op. at 16

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateDecided for petitioner

    “Although the statements above encompass “mixtures” of HPMC and PEO among a myriad of other possibilities for the gelling agent, we find no basis to conclude that the inventors of the ’376 patent were in possession of the specifically claimed formulation from such a broad disclosure.10 The Federal Circuit has held that such “laundry list” disclosures are insufficient to satisfy the written description requirement when there is no further guidance (“blazemarks”) provided about which species or combination of species included as part of the list may be selected to arrive at the claimed 9 The April 25th draft application is heavily redacted and we thus cannot discern what other materials were specifically contemplated as “thickening” agents by that time. See Ex. 2091, 5. Given the nature and amount of the redactions and Patent Owner’s assertion that the draft application ultimately led to the filing of the ’534 provisional with the broad disclosure set forth above, we find it reasonable to conclude that additional materials were included in the draft application. Moreover, the draft application was forwarded as part of an email from Patent Owner’s attorney, which “[e]nclosed the latest draft of the tamper resistant application.” Ex. 2091. As such, there is no evidence to suggest that the list of thickening agents included as part of the draft application originated from the inventors as opposed to patent counsel. 10 We recognize that the same broad disclosure with a “laundry list” of possible gelling agents is found in the specification of the ’376 patent. See Ex. 1001, 6:46–62. We, however, do not address the issue of written description support for any of the subsequently filed applications. invention. See Fujikawa v. Wattanasin, 93 F.3d 1559, 1571 (Fed. Cir. 1996). Not having specifically named or mentioned the combination in any manner, “one is left to select[] from the myriads of possibilities encompassed by the broad disclosure, with no guide indicating or directing that this particular selection should be made rather than any of the many others which could also be made.” In re Ruschig, 379 F.2d 990, 995 (CCPA 1967); see also Los Angeles Biomedical Research Inst. at Harbor-UCLA Med. Ctr. v. Eli Lilly & Co., 849 F.3d 1049, 1057 (Fed. Cir. 2017) (“To satisfy the written description requirement, the disclosure in each application must ‘reasonably convey[ ]’ to those skilled in the art that as of the claimed priority date the inventor was in possession of the later claimed subject matter.”) (citing Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991)). Other evidence of record further supports our conclusion that the inventors of the ’376 patent had not conceived of or reduced to practice the claimed formulation prior to Joshi’s August 30, 2001, filing date. In his declaration, inventor Benjamin Oshlack attests that Patent Owner’s laboratory scientists focused on “testing the syringeability of various concentration solutions of pectin, sodium alginate, and sodium acrylate, as well as combinations of pectin and sodium alginate” between January 4 and 17, 2001. Ex. 2081 ¶ 22. Additionally, Mr. Oshlack attests that the scientists had evaluated “xanthan gum, carrageenan, and locust bean gum (and combinations thereof) as gelling agents, between April 5 and 12, 2001.” Id. ¶ 23. None of the laboratory notebook excerpts proffered by Patent Owner mention a combination of HPMC and PEO as gelling agents to be used in an oxycodone formulation. Exs. 2087–2090. Consistent with the testing actually done, the working examples set forth in the ’534 provisional (as well as in the ’376 patent) focus on xantham gum, pectin, microcrystalline cellulose, and hydroxyethlcellulose as the gelling agents. See Ex. 1026, 44– 49 (Examples 1–5). We find, therefore, that the inventors did not particularly consider either PEO or HPMC, let alone both PEO and HPMC in combination, when evaluating possible gelling agents for an abuse-deterrent formulation of oxycodone. Accordingly, because we find that the ’376 patent is not entitled to a” slip op. at 22

  Patent outcomesUS 9,034,376 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR
  Patents in suitUS 9,034,376
• Amerigen Pharmaceuticals Limited / Argentum Pharmaceuticals LLC v. Janssen Oncology, Inc.All claims unpatentable
  PTAB · Jan 17, 2018 · IPR2016-01317 · APJ Kristina M Kalan · IPR · Final written decision

  Claims 1–20 are unpatentable as obvious over Gerber and O’Donnell; claims 1–4 and 6–11 are also unpatentable as obvious over Gerber and Barrie.

  RulingsFinal written decision

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

    “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). Only those terms which are in controversy need to be construed, and only to the extent necessary to resolve the controversy. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 6

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We adopt Petitioner’s contention that a person of ordinary skill in the art would be a physician specializing in urology or oncology, or holding a Ph.D. in pharmacology, biochemistry or a related discipline. Additional experience could substitute for the advanced degree. To the extent necessary, one of skill in the art may collaborate with one or more other persons of skill in the art for one or more aspects with which the other person may have expertise, experience and/or knowledge that was obtained through his or her education, industrial or academic experiences. For example, one of skill may consult with an enzymologist and/or molecular biologist and thus may rely on the opinions of such specialists in evaluating the claims. Pet. 7 (citations omitted). Patent Owner does not appear to dispute Petitioner’s definition in its Patent Owner Response. See generally PO Resp. The level of ordinary skill in the art in this case is further demonstrated by” slip op. at 9

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “Regarding the interpretation of O’Donnell’s Synacthen test, we do not agree with Patent Owner that the results “lack any significance.” See PO Resp. 20. We are persuaded that one of ordinary skill in the art would understand the results of this test to be an indicator that something was amiss with the O’Donnell Study C patients’ cortisol levels following administration of abiraterone acetate. Results of the Synacthen test led O’Donnell to conclude that further studies were needed to determine whether glucocorticoid replacement would be necessary. Ex. 1003, 2323. We understand Patent Owner’s position that the “Synacthen test results in O’Donnell do not give a complete picture of a patient’s glucocorticoid production.” PO Resp. 21. We, however, do not perceive that a complete picture of a patient’s glucocorticoid production is required for one of ordinary skill in the art to be motivated to explore whether glucocorticoid replacement therapy was necessary. Petitioner’s experts opine that O’Donnell’s results for the Study C patients were “unquestionably abnormal” and implied that abiraterone acetate could result in chronic cortisol deficiency “for which glucocorticoid replacement therapy could be required.” Reply 6– 7 (citing Ex. 1093, 22, 68; Ex. 1023, 1245). We credit this testimony as supporting Petitioner’s argument that one of ordinary skill in the art, upon reviewing O’Donnell’s Synacthen test results and statement regarding impact on adrenal reserve, would not conclude that they lack any significance; rather, they would conclude that they are significant enough to merit further investigation of administration of abiraterone acetate with glucocorticoids.” slip op. at 19

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

    “aware of the differences and the similarities in the mechanisms and, nevertheless, would have compared and analogized between the two. See, e.g., Tr. 14:20–15:5; Ex. 1003, 2318, Figure 1; Ex. 1188, 168:22–169:23. Both O’Donnell and Barrie refer to ketoconazole in their discussions of abiraterone acetate, indicating that teachings regarding ketoconazole administration were a starting point for exploration of abiraterone acetate administration. Ex. 1003, 2318; Ex. 1005, Table 1. For example, O’Donnell, after evaluating ketoconazole as an agent, turns to an evaluation of abiraterone acetate as a more selective CYP17 inhibitor, i.e., as an improvement on ketoconazole. Ex. 1003, 2318. After presenting the results from its studies, O’Donnell discusses that, in the clinical use of ketoconazole, “it is common practice to administer supplementary hydrocortisone” and that, therefore, “further studies with abiraterone acetate will be required to ascertain if concomitant therapy with glucocorticoid is required on a continuous basis, at times of physiological stress, if patients become symptomatic or indeed at all.” Id. at 2323. This statement represents the proposition that one of ordinary skill in the art would use the example of ketoconazole’s clinical use to take the next investigative steps with abiraterone acetate. We have not been presented with evidence that dissuades us from taking this statement at face value. Patent Owner’s expert testified that ketoconazole, as “an inhibitor of steroid biosynthesis that had been used at that point,” was a basis for comparison: “When you write scientific papers, you always like to make comparisons with what is known and explain why your results are different or the same or what the caveats are. And I think that’s setting up . . . to understand what comes next, why they did this experiment.” Ex. 1188, 169:15–23. Thus, we are persuaded that one of ordinary skill in the art would understand that both ketoconazole and abiraterone are CYP17 inhibitors, albeit with different mechanisms. With this knowledge, and given the teachings of the prior art on administration of ketoconazole and administration of abiraterone acetate, we find that one of ordinary skill in the art would look to the administration of ketoconazole for guidance on how to administer abiraterone acetate.” slip op. at 17

  Patent outcomesUS 8,822,438 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,822,438
• Wockhardt Bio AG v. Janssen Oncology, Inc.All claims unpatentable
  PTAB · Jan 17, 2018 · IPR2016-01582 · APJ Kristina M Kalan · IPR · Final written decision

  Claims 1–20 are unpatentable as obvious over Gerber, O’Donnell, and Sartor because the combination would have provided a reasonable expectation of success.

  RulingsFinal written decision

  • Prior constructionPrior construction adoptedDecided for patent owner

    “treatment,” and “therapeutically effective amount of prednisone.” Pet. 20– 21. Petitioner notes that these claim terms have already been construed in IPR2016-00286,1 Paper 14, and states that it analyzes the claims under those constructions for the purpose of this proceeding. Id. In our Decision on Institution, we applied our claim constructions of “treat,” “treating,” “treatment,” and “therapeutically effective amount of prednisone,” as set forth in IPR2016-00286, to the present case. Dec. 5–7; IPR2016-00286, Paper 14, 5–7. Thus, we construed those terms as follows: 1 IPR2016-00286 is an earlier-filed case involving the ’438 patent, the same grounds, and the same Patent Owner. Claim term(s) Construction “treat,” “treating,” and include the eradication, removal, “treatment” modification, management or control of a tumor or primary, regional, or metastatic cancer cells or tissue and the minimization or delay of the spread of cancer Ex. 1001, 3:46–50 “therapeutically effective an amount of prednisone effective for amount of prednisone” treating prostate cancer Patent Owner states: “Neither party has disputed the Board’s slip op. at 6

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We adopt Petitioner’s contention that a person of ordinary skill in the art would be a treating clinician specializing in oncology, typically holding an M.D. degree, with at least five years of experience specializing in medical oncology. Alternatively, a POSA would have an M.D., with at least five years of experience specializing in urology and at least two years of clinical experience. A POSA would have also typically worked as part of a multi-disciplinary team and drawn upon not only his or her own skills, but also taken advantage of certain specialized skills of others in the team, to solve a given problem. Pet. 3–4 (citations omitted). Patent Owner does not appear to dispute Petitioner’s definition in its Patent Owner Response. See generally PO Resp. The level of ordinary skill in the art in this case is further demonstrated by the prior art asserted in the Petition. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). D. Overview of the Prior Art” slip op. at 9

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

    “Based on the information presented during trial, we understand that ketoconazole and abiraterone acetate do not have identical mechanisms. See, e.g., Ex. 1005, 2318, Figure 1. As noted by both Petitioner and Patent Owner, however, abiraterone acetate and ketoconazole are both CYP17 inhibitors. Pet. 11–13; PO Resp. 13–15. Although Patent Owner urges us to focus on the differences in the mechanisms of operation of ketoconazole and abiraterone acetate (PO Resp. 13–15), we look not only at the differences, but also at the similarities. The evidence demonstrates that one of ordinary skill would have been aware of the differences and the similarities in the mechanisms, and nevertheless would have compared and analogized between the two. Ex. 1005, 2318, Figure 1; Ex. 1002 ¶ 67. O’Donnell refers to ketoconazole in its discussion of abiraterone acetate, indicating that teachings regarding ketoconazole administration were a starting point for exploration of abiraterone acetate administration. Ex. 1005, 2318. O’Donnell, after evaluating ketoconazole as an agent, turns to an evaluation of abiraterone acetate as a more selective CYP17 inhibitor, i.e., as an improvement on ketoconazole. Ex. 1005, 2318. After presenting the results from its studies, O’Donnell discusses that, in the clinical use of ketoconazole, “it is common practice to administer supplementary hydrocortisone” and that, therefore, “further studies with abiraterone acetate will be required to ascertain if concomitant therapy with glucocorticoid is required on a continuous basis, at times of physiological stress, if patients become symptomatic or indeed at all.” Id. at 2323. This statement represents the proposition that one of ordinary skill in the art would use the example of ketoconazole’s clinical use to take the next investigative steps with abiraterone acetate. We have not been presented with evidence that dissuades us from taking this statement at face value. Thus, we are persuaded that one of ordinary skill in the art would understand that both ketoconazole and abiraterone are CYP17 inhibitors, albeit with different mechanisms. With this knowledge, and given the teachings of the prior art on administration of ketoconazole and administration of abiraterone acetate, we find that one of ordinary skill in the art would look to the administration of ketoconazole for guidance on how to administer abiraterone acetate.” slip op. at 16

  • Obviousness (§103) › Objective indicia / secondary considerations › Unexpected resultsObjective indicia no nexusDecided for petitioner

    “Regarding Patent Owner’s comparison of abiraterone acetate monotherapy with abiraterone acetate/dexamethasone therapy, we agree with Petitioner that “to the extent that [Patent Owner] tries to draw any conclusion between studies that involve a combination with dexamethasone, we respectfully submit that there’s no nexus there” in that “[d]examethasone is not what’s claimed and there’s no nexus to the claims.” Tr. 19:17–20, 20:2– 3. Although dexamethasone and prednisone are both glucocorticoids, Patent Owner does not point us to satisfactory evidence as to why the ordinary artisan would consider dexamethasone and prednisone to be interchangeable for the purpose of comparing results. Cf. Ex. 2038 ¶ 240 (stating that a person of ordinary skill would “understand the dexamethasone extension study results to be due to a class effect of glucocorticoids” without further citation). Because the claims cover prednisone, and not any other glucocorticoid, the results of the combination of dexamethasone with abiraterone acetate are of limited use, as we are not informed of the similarities or differences of the mechanism of action of those glucocorticoids or how the mechanism leads to the asserted unexpected results. Moreover, to the extent the table purportedly compares the abiraterone acetate monotherapy to abiraterone acetate administered with prednisone, the table compares the abiraterone acetate monotherapy administered in clinical trial COU-AA-001 with the abiraterone acetate administered with prednisone in clinical trial COU-AA-002, without explaining or accounting for the differences between the two trials. Tr. 20:10–19. We determine that there is insufficient evidence that the alleged unpredictable and unexpected results of abiraterone acetate and prednisone are objective indicia of nonobviousness of the challenged claims. Patent Owner does not sufficiently tie the allegedly unpredictable and unexpected result to the administration of abiraterone acetate and prednisone as claimed. Thus, we determine this consideration does not weigh in favor of the patentability of the challenged claims.” slip op. at 36

  Patent outcomesUS 8,822,438 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,822,438
• Mylan Pharmaceuticals Inc. / Actavis Laboratories FL, Inc. et al. v. Janssen Oncology, Inc.All claims unpatentable
  PTAB · Jan 17, 2018 · IPR2017-00853 · APJ Kristina M Kalan · IPR · Final written decision

  Claims 1–20 are unpatentable as obvious over Gerber and O’Donnell; claims 1–4 and 6–11 are also unpatentable as obvious over Gerber and Barrie.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We adopt Petitioner’s contention that a person of ordinary skill in the art would be a physician specializing in urology, endocrinology, or oncology, or a person holding a Ph.D. in pharmacology, biochemistry or a related discipline, such as pharmaceutical science. Additional experience could substitute for the advanced degree. To the extent necessary, one of skill in the art may collaborate with one or more other persons of skill in the art for one or more aspects with which the other person may have expertise, experience and/or knowledge that was obtained through his or her education, industrial or academic experiences. For example, one of skill may consult with an endocrinologist, oncologist, or medical biochemist and thus may rely on the opinions of such specialists in evaluating the claims. Pet. 7 (citations omitted). Patent Owner does not appear to dispute Petitioner’s definition in its Patent Owner Response. See generally PO Resp. The level of ordinary skill in the art in this case is further demonstrated by the prior art asserted in the Petition. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 10

  • ExcludeMotion to exclude, deniedMixed

    “responded (Paper 76) and to which Patent Owner filed a Reply (Paper 80). The party moving to exclude evidence bears the burden of proof to establish that it is entitled to the relief requested, e.g., that the material sought to be excluded is inadmissible under the Federal Rules of Evidence. See 37 C.F.R. §§ 42.20(c), 42.62(a). Patent Owner seeks to exclude Exhibits 1002 ¶ 30; 1017; 1017 [B-1]; 1028; 1040; 1041; 1046–51; 1053–55; 1057; 1064–66; 1088; 1089; 1091 ¶¶ 17–29, 31; 1092–95; 1097, ¶¶ 11–16, 95; 1100, 1102, 1103; 1104 ¶¶ 5–9, 11–13, 88–90, 92–95, and 119–22; 1117; 1125; and 1139. Paper 69, 10. Patent Owner seeks to exclude these exhibits as (a) expert declarations and exhibits that Patent Owner alleges are outside of the scope of the prior art permitted by 35 U.S.C. § 311(b); (b) sections of Petitioner’s declarations that are not cited in the briefs, and therefore irrelevant and prejudicial; and (c) exhibits that lack authenticity or violate the hearsay rule. Id. at 1.” slip op. at 44

  • Prior constructionPrior construction not adoptedDecided for petitioner

    “treatment” and “treating” by the district court in a companion litigation. Ex. 2004. The district court, after a lengthy analysis, construed the disputed terms as follows: “Treatment/treating means the eradication, removal, modification, management or control of a tumor or primary, regional, or metastatic cancer cells or tissue and the minimization or delay of the spread of cancer.” Id. at 30. The district court read out of the definition the term “includes.” Id. Although we are not bound by the district court’s reasoning and claim constructions in related proceedings, we do not disregard the determinations of a court interpreting the same claim term in a related patent in a concurrent proceeding. Power Integrations, Inc. v. Lee, 797 F.3d 1318, 1326–27 (Fed. Cir. 2015) (“The fact that the board is not generally bound by a previous judicial interpretation of a disputed claim term does not mean, however, that it has no obligation to acknowledge that interpretation or to assess whether it is consistent with the broadest reasonable construction of the term.”). Thus, although we acknowledge and have considered the district court’s interpretation, we retain our broadest reasonable construction of the terms “treat,” “treatment,” and “treating.” We see no reason to modify our claim construction positions in light of the record developed at trial, and we maintain our claim constructions from the Decision on Institution for the purposes of this Decision. No other claim terms have been presented to us for construction following institution of trial, and we determine that no other claim terms require express construction. B. Principles of Law slip op. at 8

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

    “Based on the information presented during trial, we understand that ketoconazole and abiraterone acetate do not have identical mechanisms. See, e.g., Ex. 2038 ¶¶ 25–39, Figs. 4, 5). As noted by both Petitioner and Patent Owner, however, abiraterone acetate and ketoconazole are both steroid synthesis inhibitors, particularly, CYP17 inhibitors. Pet. 26; PO Resp. 13– 15; Reply 2, 5, 9. Both parties appear to agree that, based on their respective mechanisms of action, administration of ketoconazole would inhibit production of cortisol, and administration of abiraterone acetate inhibits one of the pathways of cortisol production. Pet. 5, 26; Tr. 12:18–19; PO Resp. 14, Figs. 1, 2; Ex. 1003, 2318; Ex. 1023, 3, Fig. 1. Patent Owner takes the position that abiraterone acetate “allows some cortisol to be made.” Tr. 31:27–29. Although Patent Owner urges us to focus on the differences in the mechanisms of ketoconazole and abiraterone acetate, we look not only at the differences, but also at the similarities. The evidence demonstrates that one of ordinary skill would have been aware of the differences and the similarities in the mechanisms and, nevertheless, would have compared and analogized between the two. See, e.g., Ex. 1003, 2318, Figure 1; Reply 6 (citing Ex. 1104 ¶¶ 14–31; Ex. 1097 ¶¶ 44–49). Both O’Donnell and Barrie refer to ketoconazole in their discussions of abiraterone acetate, indicating that teachings regarding ketoconazole administration were a starting point for exploration of abiraterone acetate administration. Ex. 1003, 2318; Ex. 1005, Table 1. O’Donnell, after evaluating ketoconazole as an agent, turns to an evaluation of abiraterone acetate as a more selective CYP17 inhibitor, i.e., as an improvement on ketoconazole. Ex. 1003, 2318. After presenting the results from its studies, O’Donnell discusses that, in the clinical use of ketoconazole, “it is common practice to administer supplementary hydrocortisone” and that, therefore, “further studies with abiraterone acetate will be required to ascertain if concomitant therapy with glucocorticoid is required on a continuous basis, at times of physiological stress, if patients become symptomatic or indeed at all.” Id. at 2323. This statement represents the proposition that one of ordinary skill in the art would use the example of ketoconazole’s clinical use to take the next investigative steps with abiraterone acetate. We have not been presented with evidence that dissuades us from taking this statement at face value. Thus, we are persuaded that one of ordinary skill in the art would understand that both ketoconazole and abiraterone are CYP17 inhibitors, albeit with different mechanisms. With this knowledge, and given the teachings of the prior art on administration of ketoconazole and administration of abiraterone acetate, we find that one of ordinary skill in the art would look to the administration of ketoconazole for guidance on how to administer abiraterone acetate.” slip op. at 18

  Patent outcomesUS 8,822,438 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,822,438
• Mylan Pharmaceuticals Inc. / Actavis Laboratories FL, Inc. et al. v. Janssen Oncology, Inc.All claims unpatentable
  PTAB · Jan 17, 2018 · IPR2016-01332 · APJ Kristina M Kalan · IPR · Final written decision

  Claims 1–20 are unpatentable as obvious over Gerber and O’Donnell; claims 1–4 and 6–11 are also unpatentable as obvious over Gerber and Barrie.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We adopt Petitioner’s contention that a person of ordinary skill in the art would be a physician specializing in urology, endocrinology, or oncology, or a person holding a Ph.D. in pharmacology, biochemistry or a related discipline, such as pharmaceutical science. Additional experience could substitute for the advanced degree. To the extent necessary, one of skill in the art may collaborate with one or more other persons of skill in the art for one or more aspects with which the other person may have expertise, experience and/or knowledge that was obtained through his or her education, industrial or academic experiences. For example, one of skill may consult with an endocrinologist, oncologist, or medical biochemist and thus may rely on the opinions of such specialists in evaluating the claims. Pet. 7 (citations omitted). Patent Owner does not appear to dispute Petitioner’s definition in its Patent Owner Response. See generally PO Resp. The level of ordinary skill in the art in this case is further demonstrated by the prior art asserted in the Petition. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 10

  • Prior constructionPrior construction adoptedDecided for petitioner

    “Patent Owner also submitted a claim construction of the terms “treatment” and “treating” by the district court in a companion litigation. Ex. 2004. The district court, after a lengthy analysis, construed the disputed terms as follows: “Treatment/treating means the eradication, removal, modification, management or control of a tumor or primary, regional, or metastatic cancer cells or tissue and the minimization or delay of the spread of cancer.” Id. at 30. The district court read out of the definition the term “includes.” Id. Although we are not bound by the district court’s reasoning and claim constructions in related proceedings, we do not disregard the determinations of a court interpreting the same claim term in a related patent in a concurrent proceeding. Power Integrations, Inc. v. Lee, 797 F.3d 1318, 1326–27 (Fed. Cir. 2015) (“The fact that the board is not generally bound by a previous judicial interpretation of a disputed claim term does not mean, however, that it has no obligation to acknowledge that interpretation or to assess whether it is consistent with the broadest reasonable construction of the term.”). Thus, although we acknowledge and have considered the district court’s interpretation, we retain our broadest reasonable construction of the terms “treat,” “treatment,” and “treating.” We see no reason to modify our claim construction positions in light of the record developed at trial, and we maintain our claim constructions from the Decision on Institution for the purposes of this Decision. No other claim terms have been presented to us for construction following institution of trial, and we determine that no other claim terms require express construction. B. Principles of Law” slip op. at 8

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

    “results from its studies, O’Donnell discusses that, in the clinical use of ketoconazole, “it is common practice to administer supplementary hydrocortisone” and that, therefore, “further studies with abiraterone acetate will be required to ascertain if concomitant therapy with glucocorticoid is required on a continuous basis, at times of physiological stress, if patients become symptomatic or indeed at all.” Id. at 2323. This statement represents the proposition that one of ordinary skill in the art would use the example of ketoconazole’s clinical use to take the next investigative steps with abiraterone acetate. We have not been presented with evidence that dissuades us from taking this statement at face value. Thus, we are persuaded that one of ordinary skill in the art would understand that both ketoconazole and abiraterone are CYP17 inhibitors, albeit with different mechanisms. With this knowledge, and given the teachings of the prior art on administration of ketoconazole and administration of abiraterone acetate, we find that one of ordinary skill in the art would look to the administration of ketoconazole for guidance on how to administer abiraterone acetate.” slip op. at 19

  • Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner

    “The teachings of the references do not rise to the level of teaching away from Petitioner’s proposed combination—they do not criticize, discredit, or otherwise discourage the solution claimed. In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004) (explaining “[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed”). Rather, as Petitioner argues, the prior art encourages exploration of such a combination. Pet. 38–42. Thus, we find that the prior art does not teach away from administration of prednisone to mCRPC patients.” slip op. at 32

  Patent outcomesUS 8,822,438 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,822,438
• Luye Pharma Group Ltd. / Luye Pharma(Usa) Ltd. et al. v. Alkermes Pharma Ireland Ltd.No claims unpatentable
  PTAB · Nov 28, 2017 · IPR2016-01096 · APJ Lora M Green · IPR · Final written decision

  Claims 1–13 and 17–23 were not shown unpatentable because Petitioner did not prove the claimed viscosity was necessarily present in either obviousness combination.

  RulingsFinal written decision

  • BurdenNot shown unpatentable

    “In that regard, we note that Petitioner must “meet a high standard in order to rely on inherency to establish the existence of a claim limitation in the prior art in an obviousness analysis—the limitation at issue necessarily must be present, or the natural result of the combination of elements explicitly disclosed by the prior art.” PAR Pharm., Inc., 773 F.3d at 1195‒ 96.” slip op. at 17

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

    “In the Institution Decision, we determined that none of the terms in the challenged claims require express construction at that time. Dec. Inst. 6 (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (noting that only claim terms which are in controversy need to be construed, and then only to the extent necessary to resolve the controversy)); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017). Petitioner offers explicit constructions of several claim terms (Pet. 19‒22), as did Patent Owner in its Preliminary Response (Prelim. Resp. 9‒12). In its full Response, Patent Owner states that there is no need to expressly construe any of the claim terms. PO Resp. 13‒14. On the present record, we agree with Patent Owner and determine that none of the claim terms require explicit construction for purposes of this Decision.” slip op. at 7

  • Skill levelOther

    “We conclude that, for practical purposes, there is little difference between Petitioner’s and Patent Owner’s definitions of the ordinary artisan. Thus, our analysis would be the same under either Petitioner’s or Patent Owner’s definition. In addition, the level of ordinary skill in the art in this case is reflected by the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8

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

    “Patent Owner argues also that objective indicia of non-obviousness, such as unexpected results and commercial success support the patentability of the challenged claims. PO Resp. 59‒61. As we conclude that the preponderance of evidence of record does not support Petitioner’s obviousness challenge, we need not address Patent Owner’s evidence of secondary indicia.” slip op. at 29

  Patent outcomesUS 6,667,061 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,667,061
• Amneal Pharmaceuticals, LLC v. Purdue Pharma L.P., The P.F. Laboratories, Inc., And Purdue Pharmaceuticals L.P.All claims unpatentable
  PTAB · Nov 8, 2017 · IPR2016-01027 · APJ Christopher G Paulraj · IPR · Final written decision

  Claim 1 is unpatentable as obvious over McGinity, Joshi, and Palermo.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “DISCUSSION A. Level of Skill in the Art Petitioner contends that a person of ordinary skill in the art for the ’976 patent would have “a degree in one or more fields of medicine, chemical engineering, chemistry, pharmaceutical science, polymer chemistry, pharmaceutics, pharmaceutical technology, pharmacokinetics, and/or pharmacology, and/or a number of years of industry training or experience in one or more of those fields.” Pet. 24 (citing Ex.1009 ¶ 17). Patent Owner agrees with Petitioner’s proposed level of skill in the art. PO Resp. 26. We, therefore, apply that skill level in our analysis, with the understanding that the level of skill is also reflected in the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 9

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

    “The Specification teaches the following: The term “sustained release” is defined for purposes of the present invention as the release of the opioid analgesic from the oral dosage form at such a rate that blood (e.g., plasma) concentrations (levels) are maintained within the therapeutic range but below toxic levels over an extended period of time, e.g., from about 12 to about 24 hours as compared to an immediate release product. Preferably the sustained release is sufficient to provide a twice-a-day or a once-a-day formulation. Ex. 1001, 4:56–64. The use of “e.g.” in the above definition for “sustained release” plainly indicates that a 12 to about 24 hour time period is exemplary. Thus, we decline to limit the claim term as Patent Owner would have us do. Rather, we construe “extended release” as “release of the opioid analgesic from the oral dosage form at a rate such that blood (e.g., plasma) concentrations (levels) are maintained within the therapeutic range but below toxic levels over a period of time longer than that of an immediate release of the opioid analgesic.”” slip op. at 11

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner

    “We are unpersuaded by Patent Owner’s arguments. Claim 1 is drawn to a dosage form—a composition. Patent Owner does not point out how the recitation of “abuse deterrent” in the preamble modifies the structurally complete dosage form recited in the body of claim 1. See Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (“[A] preamble is not limiting ‘where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention.’”) (quoting Rowe v. Dror, 112 F.3d 473, 478 (Fed.Cir.1997)). We conclude, therefore, that the term “abuse deterrent” is a goal of the invention, that is, it is merely a statement of intended use that is not entitled to patentable weight.” slip op. at 13

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

    “iv. “core matrix” The parties agree that the broadest reasonable construction of “core matrix” is “a blended mixture having: (a) PEO having a molecular weight of from about 300,000 to about 5,000,000 daltons, (b) magnesium stearate, and (c) oxycodone or a pharmaceutically acceptable salt of oxycodone.” Ex. 3001. We adopt that agreed-upon construction for purposes of this Decision. v.” slip op. at 14

  Patent outcomesUS 9,060,976 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR
  Patents in suitUS 9,060,976
• Topgolf International, Inc. v. Amit AgarwalRehearing denied
  PTAB · Sep 5, 2017 · IPR2017-00928 · APJ Lora M Green · IPR · Rehearing

  The Board denied Patent Owner’s rehearing request and left in place institution of inter partes review of claims 1 and 6 based on the reasonable likelihood of obviousness over Bertoncino and Foley.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “decision for an abuse of discretion. See 37 C.F.R. § 42.71(c). An abuse of discretion occurs if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. See Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000). “The burden of showing that a decision should be modified lies with the party challenging the decision.” Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). In its request for rehearing, the dissatisfied party must, in relevant part, “specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” 37 C.F.R. § 42.71(d); Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,768. We address Petitioner’s arguments with these principles in mind.” slip op. at 2

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

    “most end located at the forward portion of the target green ha[s] an elevation that is significantly lower than at its rearmost end.” We note that the term “significantly lower” is a relative term, and Patent Owner does not offer a construction of that term.1 Nor does Patent Owner point us to anything in the prosecution history as providing a construction for that term. In addition, we note further that the Specification of the ’389 patent also does not define the relative term “significantly lower.” The Specification of the ’389 patent, however, teaches that each target green includes a target flag and a receptacle hole that is located near the front section of the green. Ex. 1001, 4:29‒32. According to the Specification of the ’389 patent, the target green is sloped downhill and has the general shape of a concave surface so that the receptacle hole is at the lowest portion of the green. Id. at 4:32‒35. Figure 4C of the ’389 patent is reproduced below: 1 We acknowledge that the ’389 patent expired as of September 2012, and we are, thus, guided by the principle that the words of a claim “are generally given their ordinary and customary meaning” as understood by a person of ordinary skill in the art in question at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc) (internal citation omitted). But, “[i]n determining the meaning of the disputed claim limitation, we look principally to the intrinsic evidence of record, examining the claim language itself, the written description, and the prosecution history, if in evidence.” DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 469 F.3d 1005, 1014 (Fed. Cir. 2006) (citing Phillips, 415 F.3d at 1312–17). Figure 4C shows a cross-sectional view of a target green. Id. at 3:28‒29. As taught by the ’389 patent, “[t]arget green 30 would appear to the golfer at the teeing area to have a sudden drop off near the front portion of the green, and then a gradual slope upwardly toward the back of the green.” Id. at 4:37‒40. Thus, at best, the Specification of the ’389 patent appears to support a construction of the claim limitation of a target green profile whose “forward most end located at the forward portion of the target green ha[s] an elevation that is significantly lower than at its rearmost end” as a green that has a sudden drop off near the front portion of the green and then a gradual slope upward toward the back of the green.” slip op. at 10

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

    “established sufficiently a reasonable likelihood that the challenged claims were rendered obvious by the combination of Bertoncino and Foley. Dec. 22. In particular, as to the limitation that the target green has a profile whose “forward most end located at the forward portion of the target green ha[s] an elevation that is significantly lower than at its rearmost end,” for purposes of institution, we determined: that Petitioner has shown a reasonable likelihood that this claim limitation is rendered obvious by Bertoncino. In particular, Figure 5 of Bertoncino clearly shows that the front ends of the target green on the driving range are substantially lower than the back ends. Ex. 1004, Fig. 5. In addition, we determine that to the extent they are not, Petitioner has reasonably demonstrated that Bertoncino makes such a green obvious by teaching that the ability to see the lie of the ball is dependent on the ability to visually follow the path of the ball (id. at 1:26‒ 29), as well as teaching a “sloped driving range” (id. at 4:12‒ 13; see also id. at 5:37‒39 (“Each target . . . preferably comprises a surface generally sloped towards the tee stands area)). Id. at 19.” slip op. at 3

  • BurdenDecided for petitioner

    “Pet. 49. Figure 5 of Bertoncino, as addressed above, is a schematic perspective of a sloped driving range of Bertoncino. Petitioner also relied on its version of Figure 4 of Bertoncino, which was altered in line with the teaching of that reference that the target green may have only the inner section 22 (Ex. 1004, 6:61–65), and including the slope of the driving range shown in Figure 5 of Bertoncino, reproduced below: Pet. 49 (citing Ex. 1003 ¶ 92). Figure 4 of Bertoncino is a cross-sectional view of the sloped circular target of Figure 3. Ex. 1004, 4:8‒9. That is supported by Petitioner’s expert, Mr. Robbins, who declares that “[a] person of skill in the art would interpret Bertoncino to disclose a range with a plurality of target greens, each of which is composed of a single section with the slope profile of inner section 22” as depicted above. Ex. 1003 ¶ 92. Thus, as we concluded in the Decision on Institution (Dec. 17‒18), Petitioner in its Petition has established reasonably that Bertoncino teaches a target green having a profile wherein the “profile’s forward most end located at the forward portion of the target green having an elevation that is significantly lower than at its rearmost end.” That is, Petitioner has established reasonably for purposes of institution that the target green of Bertoncino meets the “significantly lower” limitation as construed above, as it has as a green that has a sudden drop off near the front portion of the green due to the concave shape of the target green and then a gradual slope upward toward the back of the green. See Ex. 1004, 6:3‒11, 12:6‒12, Figure 4.” slip op. at 12

  Claim constructioncites Phillips
  Patents in suitUS 5,370,389
• Generico, LLC / Flat Line Capital LLC et al. v. Dr. Falk Pharma GmbHAll claims unpatentable
  PTAB · May 19, 2017 · IPR2016-00297 · APJ Elizabeth M Roesel · IPR · Final written decision

  Claims 1 and 16 are unpatentable as obvious over the Sept. 2007 Press Release, Endonurse, and Davis-1985 in view of either Marakhouski or Brunner.

  RulingsFinal written decision

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner

    “is an express definition for the term “remission.” In the Specification, the term, “DAI score,” is expressly defined in the following passage: Ulcerative colitis disease activity was assessed using a modified Sutherland Disease Activity Index1 (DAI), which is a sum of four subscores based on stool frequency, rectal bleeding, mucosal appearance on endoscopy, and physician’s rating of disease activity. Each subscore can range from 0 to 3, for a total possible DAI score of 12. Ex. 1001, 17:7–12.4 When the express definitions for “remission” and “DAI score” are read together, the claim 1 phrase “remission is defined as a DAI” slip op. at 9

  • Skill levelSkill level board ownOther

    “The ’688 patent relates to a method for administering granulated mesalamine to treat ulcerative colitis. The claimed method is the result of pharmacokinetic studies and clinical studies conducted by the inventors. Ex. 2036 ¶¶ 7, 10–12, 19, 21 (inventor declaration describing pharmacokinetic and clinical studies); Exs. 2029, 2045, 2048–2050 (reports and protocol for pharmacokinetic and clinical studies). Most of the written description of the ’688 patent relates to these studies. Ex. 1001, 6:27–35, 6:43–7:25, 16:1–45, 17:1–35, 21:17–33:64, Figs. 1–3 (clinical studies); id. at 7:26–31, 14:5–15:67, 16:47–67, 17:38–21:15 (pharmacokinetic, in vitro, and animal studies). According to Dr. Johnson’s testimony, neither of the inventors is a medical doctor, and neither has experience treating patients. Ex. 1067, 16:23–17:8, 22:19–23:3. Co-inventor William Forbes has a doctorate in pharmacy (“Pharm.D.”) and was Vice President of Research and Development for Salix at the relevant time. Ex. 1012, 1; Ex. 1067, 24:14– 25:17. Co-inventor Lorin Johnson5 has a Ph.D. in molecular biology and” slip op. at 12

  • Expert testimonyPetitioner expert creditedDecided for patent owner
  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable

  Patent outcomesUS 8,865,688 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,865,688
• Steadymed Ltd. v. United Therapeutics CorporationAll claims unpatentable
  PTAB · Mar 31, 2017 · IPR2016-00006 · APJ Jacqueline T Harlow · IPR · Final written decision

  Claims 1–22 are unpatentable under § 102(b) and § 103(a), based on the Board’s anticipation and obviousness grounds.

  RulingsFinal written decision

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

    “proposed construction (PO Resp. 17). Indeed, if any conclusion can be drawn from the specification excerpts highlighted by UTC, it is that the claim term “product” is defined solely by the recited claim limitations. See Ex. 1001, 5:45–46 (referring to the purportedly improved impurity of the “product of the process according to the present invention.”).” slip op. at 14

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

    “2. Discussion Each of the challenged claims, including independent claims 1 and 9,” slip op. at 24

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

    “below, we are persuaded by SteadyMed’s showing that an ordinarily skilled artisan, at the time of invention of the ’393 patent, would have had reason to combine, and a reasonable expectation of success in combining, Moriarty and Phares. “[T]he skilled artisan need not be motivated to combine [the prior art] for the same reason contemplated by [the inventor].” In re Kahn, 441 F.3d 977, 990 (Fed. Cir. 2006). In this regard, we note that in addition to teaching that intermediate purification is unnecessary to the production of treprostinil diethanolamine salt by the disclosed process (Ex. 1005, 40–42), Phares explicitly describes the Moriarty process in disclosing the production of (-)-treprostinil, the enantiomer of (+)-treprostinil (id. at 42). Ex. 1009 ¶¶ 50, 77–78. Accordingly, we are persuaded that an ordinarily skilled artisan would have modified the process of Moriarty to incorporate the step of adding and dissolving diethanolamine to treprostinil as taught by Phares (Ex. 1005, 24) to eliminate the requirement for intermediate purification, thus, improving synthetic efficiency and reducing cost.” slip op. at 47

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

    “minimize all impurities in all pharmaceuticals to the extent possible, such a general agency preference for improved purity is insufficient to establish a long-felt but unmet need for improved treprostinil, in particular. See Tex. Instruments v. Int’l Trade Comm’n, 988 F.2d 1165, 1178 (Fed. Cir. 1993) (“[L]ong-felt need is analyzed as of the date of an articulated identified problem and evidence of efforts to solve that problem.”). Indeed, adherence to UTC’s position would dictate a conclusion of nonobvious for any pharmaceutical product exhibiting any improvement in purity over prior art versions of that same product.” slip op. at 61

  Patent outcomesUS 8,497,393 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,497,393

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.