- Amneal Pharmaceuticals, LLC v. Purdue Pharma L.P., The P.F. Laboratories, Inc., And Purdue Pharmaceuticals L.P.All claims unpatentablePTAB · Feb 8, 2018 · IPR2016-01412 · APJ Christopher G Paulraj · IPR · Final written decision
Claims 1–13 and 16–19 are unpatentable as obvious over Palermo, Joshi, and Handbook, and over Oshlack, Joshi, Handbook, and Doyon.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“’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. 15 (citing Ex.1007 ¶¶ 31– 34). Patent Owner agrees with Petitioner’s proposed level of skill in the art. PO Resp. 24 (citing Ex. 2001 ¶¶ 74–75). 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 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“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.” Ex. 1001, 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 10 cP 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 10
- PTAB / AIA Trials › §315(e) estoppelEstoppel appliesDecided for petitioner
“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 district court litigation. See In re Arunachalam, No. 2016-1607, 2017 WL 4387224, at *2–4 (Fed. Cir. Oct. 3, 2017) (“In light of Dr. Arunachalam’s previous opportunity to litigate the validity of the asserted claims of the ’500 Patent, which contain the [same] terms . . . , we see no reason to allow her to appeal the patentability of the challenged claims of the ’556 Patent, which also contain the same critical terms.”). All four factors for collateral estoppel are met here. With regard to the first factor, the issue of Joshi’s status as prior art is identical for both proceedings. The ’376 patent is part of the same chain of continuity as the ’888 patent, and both patents share the same specification and claim priority to the same non-provisional application filed August 6, 2002 and provisional application filed August 6, 2001. As such, to the extent Joshi qualifies as prior art to the ’888 patent, it would also qualify as prior art to the ’376 patent.” slip op. at 16
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateWritten description inadequateNot shown unpatentable
“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.11 The 10 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. However, 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. 11 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 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 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 Ex. 1001, 6:46–62. We, however, do not address the issue of written description support for any of the subsequently filed applications. 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 filing date earlier than August 6, 2002, we further determine that Joshi qualifies as § 102(e) prior art as of that date. Having determined that Joshi qualifies as prior art, we turn to the merits of Petitioner’s patentability challenges.” slip op. at 21
Patent outcomesUS 9,034,376 unpatentableClaim construction§ 103 obviousness§ 112 disclosurePatents in suitUS 9,034,376 - Amneal Pharmaceuticals, LLC v. Purdue Pharma L.P., The P.F. Laboratories, Inc., And Purdue Pharmaceuticals L.P.All claims unpatentablePTAB · 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 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSRPatents in suitUS 9,034,376 - Amerigen Pharmaceuticals Limited / Argentum Pharmaceuticals LLC v. Janssen Oncology, Inc.All claims unpatentablePTAB · 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 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,822,438 - Wockhardt Bio AG v. Janssen Oncology, Inc.All claims unpatentablePTAB · 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 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,822,438 - Mylan Pharmaceuticals Inc. / Actavis Laboratories FL, Inc. et al. v. Janssen Oncology, Inc.All claims unpatentablePTAB · 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 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,822,438 - PTAB · Jan 11, 2018 · IPR2016-01102 · APJ Christopher L Crumbley · IPR · Rehearing
Petitioners’ rehearing requests concerning joinder of claim 7 were dismissed as moot because claim 1 was not proven unpatentable and claim 7’s grounds depended on claim 1.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“A party dissatisfied with a decision of the Board may file a request for rehearing. 37 C.F.R. § 42.71(d). The party requesting rehearing has the burden of showing the decision should be modified, and “[t]he request must 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.” Id.” slip op. at 2
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingNot reached
“7 of the ’772 patent, which depends from claim 1 that is at issue in the instituted inter partes review IPR2016-00084. In our Decision denying joinder of claim 7, we determined that the joinder Petitions had established a reasonable likelihood of prevailing as to claim 7, based on Petitioners’ unpatentability arguments as to claim 1 made in IPR2016-00084. IPR2016- 01059, Paper 19, 10–12. Nevertheless, we declined to exercise our discretion to grant joinder. Id. at 15–18. It is of this latter determination that Petitioners request rehearing.” slip op. at 2
NonePatents in suitUS 5,665,772 - PTAB · Jan 11, 2018 · IPR2016-01059 · APJ Christopher L Crumbley · IPR · Rehearing
The Board dismissed Petitioners’ rehearing requests as moot because claim 1 was not proven unpatentable and no separate unpatentability ground was advanced for claim 7.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“A party dissatisfied with a decision of the Board may file a request for rehearing. 37 C.F.R. § 42.71(d). The party requesting rehearing has the burden of showing the decision should be modified, and “[t]he request must 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.” Id.” slip op. at 2
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingNot reached
“7 of the ’772 patent, which depends from claim 1 that is at issue in the instituted inter partes review IPR2016-00084. In our Decision denying joinder of claim 7, we determined that the joinder Petitions had established a reasonable likelihood of prevailing as to claim 7, based on Petitioners’ unpatentability arguments as to claim 1 made in IPR2016-00084. IPR2016- 01059, Paper 19, 10–12. Nevertheless, we declined to exercise our discretion to grant joinder. Id. at 15–18. It is of this latter determination that Petitioners request rehearing.” slip op. at 2
NonePatents in suitUS 5,665,772 - PTAB · Jan 11, 2018 · IPR2016-01103 · APJ Christopher L Crumbley · IPR · Rehearing
The Board dismissed Petitioners’ rehearing requests as moot because claim 1 was not proven unpatentable, leaving no basis to find dependent claim 7 separately unpatentable.
RulingsRehearing decision- RehearingRehearing, deniedOther
“A party dissatisfied with a decision of the Board may file a request for rehearing. 37 C.F.R. § 42.71(d). The party requesting rehearing has the burden of showing the decision should be modified, and “[t]he request must 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.” Id.” slip op. at 2
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingNot reached
“7 of the ’772 patent, which depends from claim 1 that is at issue in the instituted inter partes review IPR2016-00084. In our Decision denying joinder of claim 7, we determined that the joinder Petitions had established a reasonable likelihood of prevailing as to claim 7, based on Petitioners’ unpatentability arguments as to claim 1 made in IPR2016-00084. IPR2016- 01059, Paper 19, 10–12. Nevertheless, we declined to exercise our discretion to grant joinder. Id. at 15–18. It is of this latter determination that Petitioners request rehearing.” slip op. at 2
NonePatents in suitUS 5,665,772 - Par Pharmaceutical, Inc. / Breckenridge Pharmaceutical, Inc. et al. v. Novartis AGNo claims unpatentablePTAB · Jan 11, 2018 · IPR2016-00084 · APJ Christopher L Crumbley · IPR · Final written decision
Claims 1–3 and 8–10 were not proven unpatentable because the proposed obviousness analysis did not show that the choices leading to everolimus were finite, small, or easily traversed.
RulingsFinal written decision- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“The facts of the case at hand provide a stark contrast. As we have found above, while the prior art recognized rapamycin as a promising immunosuppressant, it was only one among many possible lead compounds. Furthermore, the prior art shows that chemists were pursuing a number of avenues to increase solubility, including making derivatives but also other approaches such as formulation techniques or prodrugs. And most tellingly, in contrast to Bristol-Myers Squibb where the experts agreed on the type and location of the potential substituents, here the experts diverge significantly. As discussed above, we credit the testimony of Novartis’ experts over Par’s, and find that the options of substituent and substituent position would not have been as narrow as those proposed by Par. In sum, we find that the person of ordinary skill in the art at the time the invention was made would have been faced with a large number of decision points along the lead compound analysis proposed by Par. The number of potential compounds encompassed by this decision tree is unclear, but would be far larger than the three compounds Dr. Jorgensen discusses. Only by making the “right” choice at each step would the skilled artisan arrive at everolimus, the compound of claim 10 and the basis of Par’s obviousness challenge. In light of these facts, we cannot conclude that the options faced would have been—in the words of the Federal Circuit—finite, small, or easily traversed. We, therefore, cannot conclude that the compound of claim 10, and by extension, the compounds of claims 1–3, would have been obvious to one of skill in the art as of October 1992.” slip op. at 35
- Skill levelSkill level petitioner adoptedOther
“Par contends, supported by the testimony of Dr. Jorgensen, that a person of ordinary skill in the art at the time of the invention would generally have a Ph.D. in organic chemistry or medicinal chemistry or physical chemistry or a related field, or a Masters or Bachelor degree in chemistry or a related field and at least three years’ experience in drug discovery and design. Pet. 16 (citing Ex. 1003 ¶ 45). Novartis’ experts, with insubstantial exceptions, agree with Dr. Jorgensen’s recitation. Ex. 2092 ¶ 22 (Klibanov); Ex. 2093 ¶¶ 47–48 (Roush). We adopt the level of skill recited by the parties for purposes of our analysis herein.” slip op. at 13
- Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner
“Based on our review of the entirety of the record, we cannot conclude, as Par contends, that the C40 hydroxyl group would be the obvious, optimal, or preferred location for substitutions to rapamycin. Dr. Jorgensen’s testimony to that effect is premised on his assertion that a person of ordinary skill in the art would have first narrowed the group of possible substitution positions to the C10, C28, or C40, because those are the hydroxyl groups of rapamycin. Ex. 1003 ¶ 142 (“person of ordinary skill in the art would have focused on hydroxyl groups on rapamycin as initial targets for modification.”). This statement, however, is based only on Dr. Jorgensen’s statement that the reactions of hydroxyl groups are “among the most fundamental and elementary reactions taught in beginning organic chemistry courses.” Id. Dr. Jorgensen provides no objective, documentary evidence that would indicate that starting with hydroxyl groups was an accepted rule followed by medicinal chemists in the field. To the contrary, Dr. Roush testifies that Dr. Jorgensen’s focus on rapamycin’s hydroxyl groups is inconsistent with the prior art as a whole, and provides multiple citations to the documentary evidence in the record supporting his testimony. Ex. 2093 ¶¶ 197, 206–216 (citing prior art modifications at the C9, C26, C27, C28, and C32 positions). For example, Ondeyka14 discloses demethylation of the methoxy group at rapamycin’s C29 position, while Caulfield15 discloses oxime substitutions at C32.16 We have weighed the testimony of Drs. Jorgensen and Roush on this point, and find Dr. Roush’s to be the more credible. While we agree with Par that a person of ordinary skill in the art would have considered rapamycin’s C40 position as a candidate for substitution, that site must be evaluated as one potential substitution site among many that were being modified in the field at the time of the invention.” slip op. at 24
- Obviousness (§103) › Objective indicia / secondary considerationsNot reached
“obviousness challenge. In light of these facts, we cannot conclude that the options faced would have been—in the words of the Federal Circuit—finite, small, or easily traversed. We, therefore, cannot conclude that the compound of claim 10, and by extension, the compounds of claims 1–3, would have been obvious to one of skill in the art as of October 1992. With respect to the second ground of unpatentability, pertaining to the method of treatment claims 8 and 9, Par’s obviousness arguments are premised on the conclusion that everolimus would have been obvious. See Pet. 48–51 (“claims 8 and 9 would have been obvious to a person of ordinary skill in the art in view of the art that makes the 40-O-2- hydroxyethyl-rapamycin derivative obvious”). As we conclude that everolimus has not been shown to be obvious, we reach the same conclusion as to the methods of claims 8 and 9. The addition of Hughes to the ground of unpatentability does not provide any of the teachings we found lacking from the art asserted in the first ground of unpatentability. As we have concluded that Par’s articulated lead compound analysis is insufficient to establish the obviousness of any of the challenged claims, we need not reach, and do not evaluate, the objective indicia of obviousness submitted by Novartis. PO Resp. 60–68.” slip op. at 36
Patent outcomesUS 5,665,772 not shown unpatentable§ 103 obviousnessPatents in suitUS 5,665,772 - Apotex Inc. / Apotex Corp. et al. v. Osi Pharmaceuticals LLCAll claims unpatentablePTAB · Jan 8, 2018 · IPR2016-01284 · APJ Lora M Green · IPR · Final written decision
Claims 44–46 and 53 are unpatentable under § 103(a) over Schnur combined with either OSI’s 10-K or Gibbs.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“Given that claim 44 encompasses cancers in addition to non-small cell lung cancer, we adopt Patent Owner’s statement of the level of ordinary skill in the art. Because the claim’s requirement to treat cancers in addition to non-small cell lung cancer, we find that the ordinary artisan would be a medical oncologist who would hold an M.D. degree and would have completed several years of practice in the field of oncology. Moreover, we note that the level of ordinary skill in the art in this proceeding is reflected by the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). In addition, during oral hearing, counsel for both parties opined that the outcome of the obviousness analysis would be the same under either parties’ definition of the ordinary artisan. Tr. 22:3‒8, 37:9‒11. Thus, our analysis would be the same under either Petitioner’s or Patent Owner’s definition of the ordinary artisan.” slip op. at 9
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“Gibbs, however, explicitly teaches: The EGF receptor is also the target for the development of inhibitors of the intracellular tyrosine kinase domain. ZD-1839 and CP-358,774, competitive inhibitors of ATP binding to the receptor’s active site, are currently in clinical trials (12, 13). Their mechanism of action has led to some concern about safety, given the variety and physiological significance of protein kinases and other enzymes that bind ATP. However, these compounds appear to have good anti-cancer activity in preclinical models, with an acceptable therapeutic index, particularly in patients with non-small cell lung cancer. Ex. 1010, 10 (emphasis added). As erlotinib (i.e., CP-358,774) is one of only two compounds mentioned, and as Gibbs clearly states “these compounds,” the clear inference is that erlotinib has anti-cancer activity against non-small cell lung cancer. We credit the testimony of Dr. Giaccone, who testified that the statement in Gibbs “is a pretty strong and precise statement saying, there is activity in non-small cell lung cancer patients.” Ex. 2020, 115:12‒20. In addition, Dr. Giaccone testified further that statement by Dr. Gibbs would have been based on the information he had at the time, and that as Dr. Gibbs was a reputable pharmacologist, and as the statement was made in “a peer-reviewed journal of high impact,” he would have trusted that Dr. Gibbs “was saying something very important.” Ex. 2020, 115:12‒20. Moreover, Dr. Gibbs testified: Q Dr. Gibbs, let’s go back to Exhibit 1010. So you never attempted to offer any sort of correction for this publication. Isn’t that correct? A That is correct. Q And you state in your declaration that you have written over 128 articles. Isn’t that correct? A That is correct. Q And so you have -- you would agree with me that you have experience in writing articles such as this Gibbs reference. Isn’t that correct? A That is correct. Q And of the 128 articles, have you ever asked that an article be retracted? A I have not. Q And according to your C.V., one of your areas of expertise is that you have extensive journal editorial experience. Isn’t that correct? A Yes. Ex. 1049, 29:18‒30:16 (objections omitted). Given the testimony that Dr. Gibbs was an experienced editor, and never attempted to correct or retract the Gibbs reference, we decline to afford his Declaration (Ex. 2022) much weight in this regard.” slip op. at 39
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“Patent Owner’s arguments are unavailing. That is, we find that the ordinary artisan would have combined Gibbs or OSI 10-K with Schnur and had a reasonable expectation of success of achieving the invention of challenged claims 44 and 53. In that regard, we agree with Petitioner (Pet. 26) that Schnur discloses all of the elements of claims 44 and 53, except for specifically teaching the treatment of non-small cell lung cancer. Specifically, Schnur teaches a genus of compounds that encompasses erlotinib (Ex. 1009, 1:9‒11) in which the synthesis of erlotinib is specifically disclosed (id. at 22:30‒49 (Example 20)), and erlotinib is specifically claimed (id. at 39:33 (claim 8)). In addition, Schnur discloses the treatment of hyperproliferative disorders such as cancer (id. at 1:9‒11), and specifically claims treating lung cancer with the genus of compounds (id. at 14:1‒13). Thus, as Schnur specifically discloses and claims erlotinib, and specifically discloses and claims treatment of lung cancer, we conclude that Schnur suggests the treatment of lung cancer with erlotinib. As acknowledged by Petitioner, however, Schnur does not specifically teach treatment of non-small cell lung cancer. Pet. 26.” slip op. at 25
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“We find Patent Owner’s evidence of non-obviousness to be weak as to long-felt need. All types of objective evidence of nonobviousness must be shown to have a nexus to the claimed invention. In re GPAC Inc., 57 F.3d 1573, 1580 (Fed. Cir. 1995) (nexus generally); In re Huang, 100 F.3d 135, 140 (Fed. Cir. 1996) (commercial success); Rambus Inc. v. Rea, 731 F.3d 1248, 1256 (Fed. Cir. 2013) (long-felt need). The stronger the showing of nexus, the greater the weight accorded the objective evidence of nonobviousness. See Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 306 (Fed. Cir. 1985). As we have discussed above, the claims are not limited to the treatment of human patients with non-small cell lung cancer, but are drawn to treatment of mammals. In addition, the claims do not require a clinically significant effect. See, e.g. Tr. 50:16‒17 (Counsel for Patent Owner stated that the claims do not require a “major clinical response, which is a higher standard than treatment as defined in the claims.”). As Patent Owner notes, 1,631 new drugs were tested in Phase II clinical trials for non-small cell lung cancer (PO Resp. 59 (citing Ex. 2008, 1)), and, thus, those compounds made it through preclinical trials. Patent Owner notes further that ZD-1839, which was also disclosed by Gibbs, successfully emerged from the clinic with FDA-approved indications for the treatment of non-small cell lung cancer. PO Resp. 60. Moreover, Patent Owner acknowledges that the FDA required it to change its label as it is only effective in treating approximately 10% of patients with non-small cell lung cancer. Id. at 12; Reply 19.” slip op. at 42
Patent outcomesUS 6,900,221 unpatentable§ 103 obviousnesscites KSR · GrahamPatents in suitUS 6,900,221
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.