- 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 · 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 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 - Amerigen Pharmaceuticals Limited / Argentum Pharmaceuticals LLC v. Janssen Oncology, Inc.All claims unpatentablePTAB · Jan 17, 2018 · IPR2016-00286 · 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 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 creditedOther
“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 foundReasonable expectation foundDecided for petitioner
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner
“We find that the prior art does not discourage or teach away from administration of prednisone to mCRPC patients. 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, but rather, as Petitioner argues, encourage exploration of such a combination. 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”). Although glucocorticoids have certain risks, we are not persuaded that those risks outweigh the positive effects in seriously ill patients with limited life expectancy, such that a person of ordinary skill in the art would have been dissuaded from administering glucocorticoids to a mCRPC patient. We have sufficient evidence before us that the risks of glucocorticoid therapy were known, that the longevity of mCRPC patients was short, that glucocorticoid therapy was reasonably well tolerated in the short term, and that any long-term side effects would have been viewed by one of ordinary skill in the art in light of the same. Thus, we are persuaded that one of ordinary skill in the art would not have been dissuaded from administering abiraterone acetate with prednisone, but rather, would have been motivated to co-administer prednisone with abiraterone acetate.” slip op. at 23
Patent outcomesUS 8,822,438 unpatentable§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,822,438 - Taro Pharmaceuticals U.S.A., Inc. v. Apotex Technologies, Inc.Rehearing deniedPTAB · Jan 11, 2018 · IPR2017-01446 · APJ Jeffrey N Fredman · IPR · Rehearing
The Board denied Patent Owner’s rehearing request, finding no abuse of discretion in instituting review because the record showed a reasonable likelihood of inherent anticipation.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“ANALYSIS When rehearing a decision on institution, the Board will review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). The applicable standard for a request for rehearing is set forth in 37 C.F.R. § 42.71(d), which provides in relevant part: A party dissatisfied with a decision may file a request for rehearing, without prior authorization from the Board. The burden of showing a decision should be modified lies with the party challenging the decision. The 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. Patent Owner “submits that the evidence of record fails to show that” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“THRESHOLD – The Director may not authorize an inter partes review to be instituted unless the Director determines that the information presented in the petition filed under section 311 and any response filed under section 313 shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition. As also noted in the decision on institution, we have considered both the Petition and Patent Owner Preliminary Response, and determined that the information presented in the Petition demonstrates that there is a reasonable likelihood that Petitioner would prevail with respect to the challenged claims. Dec. 2. Therefore, we applied the correct threshold standard for instituting the inter partes review.” slip op. at 9
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency foundOther
“We agree with Patent Owner on the legal standard for inherency. As we acknowledged in our Decision, “[i]nherency . . . may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.” MEHL/Biophile Int’l. Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999).” Dec. 14. However, we remain persuaded at this stage of the proceeding on the current factual record based on Hoffbrand 1998 and the Mehta Declaration, that Petitioner established a “reasonable likelihood” that Hoffbrand 1998 necessarily disclosed treatment of patients with “an iron overload condition of the heart” with a therapeutically effective amount of deferiprone. See Dec. 16–20; 35 U.S.C. § 314(a). Patent Owner does not identify a definition of the phrase “iron overload condition of the heart” in the ’328 patent Specification that distinguishes the claimed patient population from Hoffbrand’s disclosure of “10 patients [that] had a liver iron content above 15.0 mg/g dry weight, ie, falling within the range that has been associated with cardiac disease.” Ex. 1007, 297. The reasonable understanding of Hoffbrand’s teaching of this association between liver iron content and cardiac disease is that all ten patients with the elevated iron levels also necessarily fell into the spectrum of having “an iron overload condition of the heart.” Indeed, Patent Owner’s Declarants do not rebut Hoffbrand’s teaching that liver iron content above 15.0 mg/g identifies patients with cardiac disease, and, therefore, with “an iron overload condition of the heart.” Dr. Coates simply notes that Hoffbrand 1998 reports five treated “patients suffered fatal complications. . . . Four of the five reported fatalities resulted from congestive heart failure.” Ex. 2001 ¶ 37. Cf. Pennell Decl. Ex. 2003 ¶ 37. That statement supports the position that Hoffbrand 1998 treated patients who inherently had an ultimately fatal “iron overload condition of the heart” with 75 mg of deferiprone, acknowledged by claim 15 of the ’328 patent as a therapeutically effective amount. Ex. 1007, 295; Ex. 1001, 28:33–37. We recognize that Dr. Pennell stated that “a patient with a liver iron content above 15 mg/g dry weight is at risk of developing cardiac disease not that such liver iron content definitely establishes cardiac disease.” Ex. 2003 ¶¶ 50–51, citing Exhibits 2007, 2015, and 2016. The Exhibits cited by Dr. Pennell do not identify evidence showing a single patient with a liver iron content that exceeds 15.0 mg/g but failed to display an “iron overload condition of the heart.” See Ex. 2003 ¶ 51. Exhibit 2007 states “while whole liver iron levels >15 mg/g dry weight . . . have been shown to predict patients at highest risk of cardiac death, it is not known how these variables relate to cardiac iron deposition.” Ex. 2007, 1. No specific patient data is provided in Exhibit 2007 comparing liver iron levels of particular patients with “iron overload.” See id. Similarly, Exhibits 2015 and 2016 also do not identify any patients with elevated liver iron content >15 mg/g dry weight with normal cardiac iron levels. Therefore, the evidence currently of record in Hoffbrand 1998,” slip op. at 3
- Expert testimonyPetitioner expert creditedDecided for petitioner
“Regarding the second argument, Dr. Mehta relied upon specific facts within the Olivieri Abstract 1995 itself to support the conclusion that “lower TRT values indicate cardiac disease due to iron overload. Ex. 1010 (Olivieri Abstract 1995).” Ex. 1002 ¶ 75. In particular, Olivieri Abstract 1995 states “MRI demonstrates changes consistent with reduction in cardiac iron in L1 [deferiprone]-treated pts, in who baseline T2 relaxation time (TRT of 23.9±6.4 msec (normal >32) has increased to 32.4±9.3msec.” Ex. 1010. Olivieri Abstract 1995’s identification of the value of “32” as normal for TRT levels with lower values such as “23.9±6.4” as associated with elevated cardiac iron levels that require treatment with deferiprone, provides factual support for Dr. Mehta’s conclusion that patients with these lower TRT values inherently have “an iron overload condition of the heart.” See Ex. 1002 ¶ 75.” slip op. at 6
§ 102 anticipationPatents in suitUS 7,049,328 - 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.