- Wockhardt Bio AG v. Janssen Oncology, Inc.Rehearing deniedPTAB · Dec 3, 2018 · IPR2016-01582 · APJ Kristina M Kalan · IPR · Rehearing
The Board denied Patent Owner’s rehearing request, finding no overlooked or misapprehended matter in its decision holding claims 1–20 unpatentable.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. THE REQUEST FOR REHEARING In pertinent part, 37 C.F.R. § 42.71(d) states: 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. Thus, a request for rehearing is not an opportunity merely to disagree with the Board’s assessment of the arguments or weighing of the evidence, or to present new arguments or evidence.” slip op. at 2
- Strike new argumentNew argument disregardedDecided for patent owner
“Patent Owner now presents a new argument that we misapprehended the teachings of the prior art with respect to claims 4, 11, 19, and 20. Req. 12–14. Patent Owner, however, does not point out where this matter was previously raised. Because Patent Owner has not previously raised any of its arguments presented in the Request, we are not permitted to consider its arguments now. 37 C.F.R. § 42.71(d). Moreover, we did not overlook Patent Owner’s arguments regarding these claims; rather, we considered and adopted Petitioner’s arguments regarding these claims. Dec. 45; cf. Cutsforth, Inc. v. Motive Power, Inc., 636 F. App’x 575 (Fed. Cir. 2016) (nonprecedential). Patent Owner’s failure to argue specifically against these claims during trial does not permit Patent Owner to now present arguments in this regard.” slip op. at 5
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“In our Final Written Decision, in connection with our assessment of motivation to combine Sartor with Gerber and O’Donnell, we addressed the disputed portion of Dr. Godley’s testimony directly. Dec. 26 (“Fourth, Patent Owner argues that Petitioner’s expert agrees that prednisone was not known to have anti-cancer treatment effects in prostate cancer patients.”) There, we agreed with Petitioner that Dr. Godley’s interpretation of Sartor was “consistent with Petitioner’s position regarding Sartor, i.e., that prednisone has its own anti-cancer effect.” Id. (citing Ex. 1002 ¶ 116; Ex. 2162, 61:15–62:17). Patent Owner’s disagreement with our analysis is not a proper basis for a rehearing request. Regarding the Board’s consideration of Sartor’s credibility, we evaluated the evidence and testimony before us to conclude that, despite the fact that Sartor was a chart review, it is a “peer-reviewed article published in a reputable journal” and its format did not undercut its teachings. Dec. 24. Regarding the Board’s use of the word “palliative,” we disagree that such use constitutes a new theory advanced by the Board. Req. 7–8. Rather, we used the term “palliative” three times in the Final Written Decision—once to accurately quote the language used by Dr. Godley in his Declaration (Dec. 26 (citing Ex. 1002 ¶ 116)), once to accurately quote Dr. Godley’s testimony (Dec. 26–27 (citing Ex. 2162, 66:1–10, 66:17–67:1), and once in our discussion of claim construction (Dec. 33). None of these instances advances a new theory. Although we noted that Dr. Godley stated that prednisone could be prescribed for palliative treatment in reconciling that statement with our claim construction (id. at 26–27), we relied on Petitioner’s arguments in chief regarding reasons to combine Gerber, O’Donnell, and Sartor in reaching our ultimate determination of unpatentability. Id. at 11–13.” slip op. at 3
§ 103 obviousnessPatents in suitUS 8,822,438 - Amerigen Pharmaceuticals Limited / Argentum Pharmaceuticals LLC v. Janssen Oncology, Inc.Rehearing deniedPTAB · Dec 3, 2018 · IPR2016-00286 · APJ Kristina M Kalan · IPR · Rehearing
The Board denied Patent Owner’s rehearing request, leaving claims 1–20 unpatentable because the request did not show that the Board overlooked or misapprehended matters.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. THE REQUEST FOR REHEARING In pertinent part, 37 C.F.R. § 42.71(d) states: 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. Thus, a request for rehearing is not an opportunity merely to disagree with the Board’s assessment of the arguments or weighing of the evidence, or to present new arguments or evidence.” slip op. at 2
- Strike new argumentNew argument disregardedDecided for petitioner
“Patent Owner now presents a new argument that we misapprehended the teachings of the prior art with respect to claims 4, 11, 19, and 20. Req. 14–15. Patent Owner, however, does not point out where this matter was previously raised. Because Patent Owner has not previously raised any of its arguments presented in the Request, we are not permitted to consider its arguments now. 37 C.F.R. § 42.71(d). Moreover, we did not overlook Patent Owner’s arguments regarding these claims; rather, we considered and adopted Petitioner’s arguments regarding these claims. Dec. 43; cf. Cutsforth, Inc. v. Motive Power, Inc., 636 F. App’x 575 (Fed. Cir. 2016) (nonprecedential). Patent Owner’s failure to argue specifically against these claims during trial does not permit Patent Owner to now present arguments in this regard.” slip op. at 7
NonePatents in suitUS 8,822,438 - Mylan Pharmaceuticals Inc. / Actavis Laboratories FL, Inc. et al. v. Janssen Oncology, Inc.Rehearing deniedPTAB · Dec 3, 2018 · IPR2016-01332 · APJ Kristina M Kalan · IPR · Rehearing
The Board denied Patent Owner’s rehearing request, leaving claims 1–20 unpatentable under the Final Written Decision.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. THE REQUEST FOR REHEARING In pertinent part, 37 C.F.R. § 42.71(d) states: 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. Thus, a request for rehearing is not an opportunity merely to disagree with the Board’s assessment of the arguments or weighing of the evidence, or to present new arguments or evidence.” slip op. at 2
- Obviousness (§103) › Motivation to combine / reasonable expectation of successOther
“Decision, particularly noting Patent Owner’s argument that “there is no prior art evidence that ketoconazole causes mineralocorticoid excess.” Dec. 17 (citing PO Resp. 18). We also considered Petitioner’s countervailing evidence (id. at 17–18), Patent Owner’s Identification of New Arguments and Evidence in Petitioner’s Reply (Paper 65), and Petitioner’s reply to the same (Paper 74). We also noted in our Final Written Decision that Petitioner’s motivation to combine appeared to be premised on the adverse effects caused by reduced production of cortisol. Dec. 13. We also relied, in the Final Written Decision, on Dr. Garnick’s testimony that CYP17 inhibitors undesirably suppressed the production of cortisol, which is necessary for other biochemical cycles in the body, and which led to adverse side effects. Id. at 12–13 (citing Ex. 1002 ¶¶ 42, 44, 58). We also relied on Dr. Garnick’s testimony that “in light of steroid synthesis inhibitors’ known effects on the adrenal pathways,” one of ordinary skill in the art “would have been motivated to administer a glucocorticoid with administered abiraterone acetate to counteract expected endocrine disruptions.” Dec. 17 (citing Ex. 1097 ¶¶ 21–66). We expressly addressed Petitioner’s arguments and evidence, Patent Owner’s arguments and evidence, and the respective testimony on this issue, and did not overlook Patent Owner’s testimony or other testimony regarding the relationship between ketoconazole and mineralocorticoid excess. Nor are we persuaded, given our consideration and analysis of the testimony and other evidence, that we misapprehended the import of this testimony and evidence, or Petitioner’s reliance on the same for Petitioner’s arguments to support motivation to combine the reliedupon references.” slip op. at 3
- Strike new argumentNew argument disregardedDecided for petitioner
“under 35 U.S.C. § 282. Patent Owner further argues that the Board overlooked or misapprehended that evidence that skilled artisans evaluated O’Donnell and nevertheless proceeded to undertake studies based on abiraterone acetate monotherapy. Req. 13. Patent Owner, however, does not point us to where these argument were raised previously. 37 C.F.R. § 42.71(d). Therefore, Petitioners did not have an opportunity to respond to these issues. Nor did Patent Owner previously address the question of why the presumption of validity in 35 U.S.C. § 282 controls inter partes review proceedings in light of the statement in 35 U.S.C. § 316(e) that “In an inter partes review instituted under this chapter, the petitioner shall have the burden of proving a proposition of unpatentability by a preponderance of the evidence.” Accordingly, because Patent Owner does not demonstrate that these arguments were raised previously, and because we cannot be assured that Petitioner has had any opportunity to respond, we do not consider these arguments in our present order.” slip op. at 6
§ 103 obviousnessPatents in suitUS 8,822,438 - Merck Sharp & Dohme Corp. v. Pfizer Inc.Rehearing deniedPTAB · May 4, 2018 · IPR2017-02138 · APJ Jeffrey N Fredman · IPR · Rehearing
The Board denied Pfizer’s rehearing request, leaving institution of review on claims 11–15 and 20–37 unchanged because the petition made a threshold showing that Pfizer 2012 was publicly accessible.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“ServiceNow, Inc. v. Hewlett–Packard Co., Case IPR2015–00707, slip op. at 2 (PTAB August 26, 2015) (Paper 12, 2) (Crumbley, APJ, dissenting) (citations omitted). For the reasons set forth below, we determine that that Petitioner has made a threshold showing that Pfizer 2012 is a printed publication.” slip op. at 7
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“ServiceNow, Inc. v. Hewlett–Packard Co., Case IPR2015–00707, slip op. at 2 (PTAB August 26, 2015) (Paper 12, 2) (Crumbley, APJ, dissenting) (citations omitted). For the reasons set forth below, we determine that that Petitioner has made a threshold showing that Pfizer 2012 is a printed publication.” slip op. at 7
§ 102 anticipationPatents in suitUS 9,492,559 - 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
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.