- 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 Cir. 2016) (nonprecedential).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 - Hamilton Beach Brands, Inc. v. F’Real Food, LLCRehearing deniedPTAB · Apr 25, 2018 · IPR2017-00765 · APJ Lora M Green · IPR · Rehearing
The Board denied Hamilton Beach’s rehearing request and maintained its denial of institution, citing follow-on petition concerns and its discretion under §§ 314(a) and 325(d).
RulingsRehearing decision- RehearingRehearing, deniedDenied
“STANDARD OF REVIEW When reconsidering a decision on institution, the Board reviews the decision for an abuse of discretion. See 37 C.F.R § 42.71(c). “The burden of showing that a decision should be modified lies with the party challenging the decision.” Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). In its request for rehearing, the dissatisfied party must, in relevant part, “specifically identify all matters the party believes the Board misapprehended or overlooked.” 37 C.F.R. § 42.71(d); Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,768. We address Petitioner’s arguments with those principles in mind.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for patent owner
“The Board has discretion not to institute an inter partes review. 35 U.S.C. § 314(a); Harmonic Inc. v. Avid Tech, Inc., 815 F.3d 1356, 1367 (Fed. Cir. 2016) (“the PTO is permitted, but never compelled, to institute an IPR proceeding”); see also 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board may authorize the review to proceed on all or some of the challenged claims and on all or some of the grounds of unpatentability asserted for each claim.”). When exercising that discretion, the Board may take into account whether “the same or substantially the same prior art or arguments previously were presented to the Office.” 35 U.S.C. § 325(d); see Conopco, Inc. v. The Proctor & Gamble Co., Case IPR2014-00628, slip op. 5– 10 (PTAB October 20, 2014) (Paper 21) (declining to institute because substantially the same arguments previously were presented to the Board). The issue of whether substantially the same arguments were raised previously in IPR2016-01105 arises in the present case. In addition, when determining whether to exercise our discretion not to institute a trial proceeding under 35 U.S.C. § 314(a), we seek to balance the equities between the parties, i.e., Petitioner’s desire to be heard against Patent Owner’s interest in avoiding harassment through repeated challenges. 5 Exhibit 1002 in IPR2016-01105. 6 U.S. Patent Publication No. 2002/0189460 A1, filed April 11, 2002, published December 19, 2002, to Brown et al. (“Brown”). Exhibit 1003 in IPR2016-01105. See H.R. Rep. No. 112-98, pt.1, at 48 (2011) (post-grant proceedings conducted under the AIA “are not to be used as tools for harassment or a means to prevent market entry through repeated litigation and administrative attacks on the validity of a patent. Doing so would frustrate the purpose of the section as providing quick and cost effective alternatives to litigation.”). In circumstances such as the present case, the Board considers the potential inequity of a petitioner filing serial attacks against the same claims of a patent, while benefiting from patent owner’s arguments and/or the Board’s decision in prior cases. See, e.g., Nautilus Hyosung Inc. v. Diebold, Inc., Case IPR2017-00426 slip op. at 12–16 (PTAB June 22, 2017) (Paper 17) (citing Xactware Sols., Inc. v. Eagle View Techs., Inc., Case IPR2017-00034, slip op. at 6–11 (PTAB April 13, 2017) (Paper 9); Baker Hughes Inc. v. LiquidPower Specialty Prods., Inc., Case IPR2016-01896, slip op. at 9–11 (PTAB March 31, 2017) (Paper 10); Duk San Neolux Co., Ltd. v. Idemitsu Kosan Co., Ltd., Case IPR2017-00197, slip op. at 4–11 (PTAB March 31, 2017) (Paper 10); NVIDIA Corp. v. Samsung Elec. Co., Case IPR2016-00134, slip op. at 8 (PTAB May 4, 2016) (Paper 9); Toyota Motor Corp. v. Cellport Sys., Inc., Case IPR2015- 01423, slip op. at 8 (PTAB Oct. 28, 2015) (Paper 7)); see also Conopco, Case IPR2014-00628, slip op. at 11–12. Therefore, we must balance the parties’ competing interests when determining whether to exercise our discretion and decline to institute. Id.” slip op. at 5
- PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Institution denied general plasticDecided for patent owner
“An important reason for denying institution in the instant proceeding was that Petitioner had the advantage of Patent Owner’s preliminary response in IPR2016-01105, as well as the claim construction and analysis set forth in the decision denying institution in that proceeding. That is, Petitioner had the benefit of that information in crafting the challenges set forth in the instant proceeding, and, thus, was able to address Patent Owner’s arguments made in its preliminary response in IPR2016-01105, as well as address the concerns of the Board set forth in the decision denying institution in IPR2016-01105. Consideration of these factors is consistent with the principles set forth in General Plastic Indus. Co. v. Canon Kabushiki Kaisha, Case IPR2016-01357, 15−19 (PTAB Sept. 6, 2017) (Paper 19) (“General Plastics”) (designated precedential Oct. 18, 2017) (setting forth a non-exhaustive list of factors to be considered in determining whether to institute a follow-on petition, including whether the same petitioner previously filed a petition directed to the same claims of the same patent, and whether, at the time of filing of the second petition, the petitioner already received the patent owner’s preliminary response to the first petition or received the Board’s decision on whether to institute review in the first petition). We noted further that Sato “was published nearly 30 years ago,” and Karkos issued on December 26, 2000. Dec. 11. We determined that Petitioner had not established that those references were not available to Petitioner when it filed the petition in IPR2016-01105. Id. We declined to provide a second chance merely because Petitioner’s “highly experienced searchers” did not find those references before the filing of the petition in IPR2015-01105. Id. (citing Pet. 6). That determination was another factor that informed our decision to exercise our discretion and decline to institute inter partes review in the instant proceeding. See, e.g., General Plastics at 16 (noting that other factors to be considered in granting a follow-on petition are whether at the time of filing of the first petition petitioner knew of the prior art asserted in the second petition or should have known of it, and whether the petitioner provides adequate explanation for the time elapsed between the filings of multiple petitions directed to the same claims of the same patent). Finally, we noted that we were “troubled by the implications of Petitioner’s overarching premise – that it is cost-effective and appropriate to wait for a claim construction and institution decision by the Board, and then launch a follow-on patent challenge in reliance on additional references that challenge the same patent claims already addressed by the Board.” Dec. 13 (citing Pet. 7‒8). As noted in the Decision denying institution, however, “[s]uch tactics increase the costs to Patent Owner and impose unnecessary demands on the finite resources of the Board.” Id.; see, e.g., General Plastics at 16 (noting another factor to be considered is the finite resources of the Board).” slip op. at 7
- Other 314aInstitution denied discretionary otherDecided for patent owner
“The Board has discretion not to institute an inter partes review. 35 U.S.C. § 314(a); Harmonic Inc. v. Avid Tech, Inc., 815 F.3d 1356, 1367 (Fed. Cir. 2016) (“the PTO is permitted, but never compelled, to institute an IPR proceeding”); see also 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board may authorize the review to proceed on all or some of the challenged claims and on all or some of the grounds of unpatentability asserted for each claim.”). When exercising that discretion, the Board may take into account whether “the same or substantially the same prior art or arguments previously were presented to the Office.” 35 U.S.C. § 325(d); see Conopco, Inc. v. The Proctor & Gamble Co., Case IPR2014-00628, slip op. 5– 10 (PTAB October 20, 2014) (Paper 21) (declining to institute because substantially the same arguments previously were presented to the Board). The issue of whether substantially the same arguments were raised previously in IPR2016-01105 arises in the present case. In addition, when determining whether to exercise our discretion not to institute a trial proceeding under 35 U.S.C. § 314(a), we seek to balance the equities between the parties, i.e., Petitioner’s desire to be heard against Patent Owner’s interest in avoiding harassment through repeated challenges. 5 Exhibit 1002 in IPR2016-01105. 6 U.S. Patent Publication No. 2002/0189460 A1, filed April 11, 2002, published December 19, 2002, to Brown et al. (“Brown”). Exhibit 1003 in IPR2016-01105. See H.R. Rep. No. 112-98, pt.1, at 48 (2011) (post-grant proceedings conducted under the AIA “are not to be used as tools for harassment or a means to prevent market entry through repeated litigation and administrative attacks on the validity of a patent. Doing so would frustrate the purpose of the section as providing quick and cost effective alternatives to litigation.”). In circumstances such as the present case, the Board considers the potential inequity of a petitioner filing serial attacks against the same claims of a patent, while benefiting from patent owner’s arguments and/or the Board’s decision in prior cases. See, e.g., Nautilus Hyosung Inc. v. Diebold, Inc., Case IPR2017-00426 slip op. at 12–16 (PTAB June 22, 2017) (Paper 17) (citing Xactware Sols., Inc. v. Eagle View Techs., Inc., Case IPR2017-00034, slip op. at 6–11 (PTAB April 13, 2017) (Paper 9); Baker Hughes Inc. v. LiquidPower Specialty Prods., Inc., Case IPR2016-01896, slip op. at 9–11 (PTAB March 31, 2017) (Paper 10); Duk San Neolux Co., Ltd. v. Idemitsu Kosan Co., Ltd., Case IPR2017-00197, slip op. at 4–11 (PTAB March 31, 2017) (Paper 10); NVIDIA Corp. v. Samsung Elec. Co., Case IPR2016-00134, slip op. at 8 (PTAB May 4, 2016) (Paper 9); Toyota Motor Corp. v. Cellport Sys., Inc., Case IPR2015- 01423, slip op. at 8 (PTAB Oct. 28, 2015) (Paper 7)); see also Conopco, Case IPR2014-00628, slip op. at 11–12. Therefore, we must balance the parties’ competing interests when determining whether to exercise our discretion and decline to institute. Id.” slip op. at 5
Discretionary denialPatents in suitUS 7,520,658 - Apotex Inc. / Apotex Corp. et al. v. Osi Pharmaceuticals LLCRehearing deniedPTAB · Mar 5, 2018 · IPR2016-01284 · APJ Lora M Green · IPR · Rehearing
The Board denied the Patent Owner’s rehearing request and left intact its determination that claims 44–46 and 53 are unpatentable as obvious over Schnur combined with OSI’s 10-K or Gibbs.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“STANDARD OF REVIEW When reconsidering a final written decision the Board reviews the decision to determine whether we misapprehended or overlooked a matter. See 37 C.F.R. § 42.71(d). Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000). “The burden of showing that a decision should be modified lies with the party challenging the decision.” Office Patent Trial 1 Schnur et al., U.S. Patent No. 5,747,498, issued May 5, 1998 (Ex. 1009) (“Schnur”). 2 Annual Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the Fiscal Year Ended September 30, 1998, Commission File Number 0-15190, OSI Pharmaceuticals, Inc. (Ex. 1011) (“OSI’s 10-K”). 3 J.B. Gibbs, “Anticancer Drug Targets: Growth Factors and Growth Factor Signaling,” 105 J. CLIN. INV. 9‒13 (2000) (Ex. 1010) (“Gibbs”). Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). In its request for rehearing, the dissatisfied party must, in relevant part, “specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” 37 C.F.R. § 42.71(d); Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,768. We address Patent Owner’s arguments with these principles in mind.” slip op. at 2
- Skill levelSkill level patent owner adoptedDecided for petitioner
“In declining to adopt Petitioner’s definition of skill of the ordinary artisan, we noted that the claims encompassed cancers other than non-small cell lung cancer, and, thus, found 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.” FWD 9. We did not just rely on Dr. Bunn’s testimony as to the level of skill on the ordinary artisan, however, but noted that “the level of ordinary skill in the art in this proceeding is reflected by the prior art of record.” Id. (citing Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995)). In defining the level of ordinary skill, we also stated: [D]uring 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. FWD 9.” slip op. at 5
- Expert testimonyPetitioner expert creditedDecided for petitioner
“weight in determining whether the Gibbs reference was referring to CP- 358,774 when referring to “good anti-cancer activity” and “an acceptable therapeutic index,” we cited the Gibbs reference itself, which explicitly discloses: 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. Id. at 39 (quoting Ex. 1010, 10). That is, Gibbs refers to two compounds, ZD-1839 and CP-358,774, and refers to compounds in the plural in stating that the compounds have anticancer activity. See id. Thus, we found that “the clear inference [of the Gibbs reference] is that erlotinib has anti-cancer activity against non-small cell lung cancer.” Id. In that regard, we credited the testimony of Dr. Giaccone, noting that Dr. Giaccone 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. Id.” slip op. at 8
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“In finding that Patent Owner’s evidence of long-felt need was weak, however, we noted that “[a]ll types of objective evidence of nonobviousness must be shown to have a nexus to the claimed invention.” Id. at 42‒43 (citing In re GPAC Inc., 57 F.3d 1573, 1580 (Fed. Cir. 1995) (nexus 4 Moyer et al., Induction of Apoptosis and Cell Cycle Arrest by CP-358,774, an Inhibitor of Epidermal Growth Factor Receptor Tyrosine Kinase. 57 CANCER RESEARCH 4838‒4848 (1997) (Ex. 1016) (“Moyer”). 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)). In particular, we stated that the challenged claims were not limited to the treatment of patients with non-small cell lung cancer, but included treatment of mammals, and that the challenged claims did not require a clinical effect. Id. at 43. In addition, we noted that Patent Owner acknowledged in its Response 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. Therefore, our finding that the evidence of long-felt need is weak relied primarily on a lack of nexus. Id. at 42. To the extent we relied on the testimony of Dr. Giaccone that erlotinib was only approved for treatment of subset of non-small cell lung cancer, that testimony is supported by Patent Owner’s admission that “Tarceva is currently approved for the treatment of a subset of NSCLC patients,” as well as the evidence that Patent Owner relied upon to support that statement. PO Response 12 (citing Ex. 2030, 1; Ex. 2021 ¶¶ 41, 102‒107; Ex. 2023 ¶ 7).” slip op. at 12
§ 103 obviousnessPatents in suitUS 6,900,221 - 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
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.