- Eli Lilly And Company v. Teva Pharmaceuticals International GmbHNo claims unpatentablePTAB · Mar 31, 2020 · IPR2018-01711 · APJ James A Worth · IPR · Final written decision
The Board held claims 1–18 of the ’907 patent not unpatentable over Olesen, Tan, and Queen under §103, finding Lilly had not met its burden.
RulingsFinal written decision- Skill levelSkill level board ownOther
“appreciable difference in the parties’ respective definitions of a person of ordinary skill in the art. Inst. Dec. 8. Accordingly, we determined for purposes of our Institution Decision that a person of ordinary skill in the art” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther
“2. “effective amount” The term “effective amount” is recited in all of the independent” slip op. at 18
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“Reply. In fact, Petitioner argues that “[t]he prior art expressly recognized the downside of treating migraine patients with CGRP inhibitors having a short half-life,” citing to a report that CGRP8-37 (a peptide fragment of CGRP) “‘proved ineffective in migraine treatment’ due to ‘its low potency and short half-life.’” Pet. 31 (citing Ex. 1031, 323; Ex. 1014 ¶ 124) (emphasis by Petitioner). Accordingly, we find that Petitioner has not sufficiently established that a POSA would have been motivated to humanize an anti-CGRP antibody fragment.” slip op. at 93
- ExcludeMotion to exclude, grantedMotion to exclude, deniedGranted in part
“the cross-examination of Dr. Ferrari as beyond the scope of Dr. Ferrari’s direct testimony. Mot. Excl. 9. Upon review of the Ferrari Declaration, Exhibit 2268, we agree that questions on cyclic AMP were beyond the scope of the Ferrari Declaration. Accordingly, we grant this aspect of the motion.” slip op. at 159
Patent outcomesUS 9,884,907 not shown unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,884,907 - Eli Lilly And Company v. Teva Pharmaceuticals International GmbHNo claims unpatentablePTAB · Mar 31, 2020 · IPR2018-01710 · APJ Richard J Smith · IPR · Final written decision
The Board found that Lilly did not prove claims 1, 3, 4, 8–17, 19, 20, and 24–31 of the ’045 patent, or claims 1–18 of the ’907 and ’908 patents, unpatentable over Olesen, Tan, and …
RulingsFinal written decision- Skill levelSkill level board ownDecided for patent owner
“appreciable difference in the parties’ respective definitions of a person of ordinary skill in the art. Inst. Dec. 8. Accordingly, we determined for purposes of our Institution Decision that a person of ordinary skill in the art” slip op. at 13
- ExcludeMotion to exclude, grantedMotion to exclude, deniedGranted in part
“conclusion based on underlying factual findings. Nobel Biocare Servs. AG v. Instradent USA, Inc., 903 F.3d 1365, 1375 (Fed. Cir. 2018) (citing Jazz Pharm., Inc. v. Amneal Pharm., LLC, 895 F.3d 1347, 1356 (Fed. Cir. 2018)). The underlying factual findings include whether the reference was publicly accessible. Id. (citing In re NTP, Inc., 654 F.3d 1279, 1296 (Fed. Cir. 2011)). In an inter partes review, the petitioner bears the burden of establishing by a preponderance of the evidence that a particular document is a printed publication. Id. (citing Medtronic Inc. v. Barry, 891 F.3d 1368, 1380 (Fed. Cir. 2018)); see also In re Wyer, 655 F.2d 221, 227 (CCPA 1981) (a party asserting a reference as a prior art printed publication should provide sufficient proof of accessibility).” slip op. at 152
- Strike new argumentNew argument consideredDenied
“(Ex. 2239), and also the opportunity to submit a Sur-reply (Paper 43). Therefore, we determine that Patent Owner has failed to meet its burden to show that the arguments and evidence should be stricken. See 37 C.F.R. § 42.20; Genzyme Therapeutic Prods. L.P. v. Biomarin Pharm Inc., 825 F.3d 1360, 1367 (Fed. Cir. 2016); see also Anacor Pharms., Inc. v. Iancu, 889 F.3d 1372, 1380–81 (Fed. Cir. 2018) (reply may document the knowledge that skilled artisans would bring to bear in reading the prior art identified as producing obviousness). Accordingly, this aspect of the motion is denied.” slip op. at 163
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundReasonable expectation not foundNot shown unpatentable
“Reply. In fact, Petitioner argues that “[t]he prior art expressly recognized the downside of treating migraine patients with CGRP inhibitors having a short half-life,” citing to a report that CGRP8-37 (a peptide fragment of CGRP) “‘proved ineffective in migraine treatment’ due to ‘its low potency and short half-life.’” Pet. 31 (citing Ex. 1031, 323; Ex. 1014 ¶ 124) (emphasis by Petitioner). Accordingly, we find that Petitioner has not sufficiently established that a POSA would have been motivated to humanize an anti-CGRP antibody fragment.” slip op. at 93
Patent outcomesUS 8,586,045 not shown unpatentable§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,586,045 - Eli Lilly And Company v. Teva Pharmaceuticals International GmbHNo claims unpatentablePTAB · Mar 31, 2020 · IPR2018-01712 · APJ James A Worth · IPR · Final written decision
The Board held claims 1–18 of the ’908 patent not unpatentable because Lilly failed to prove the Olesen, Tan, and Queen obviousness ground by a preponderance of the evidence.
RulingsFinal written decision- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“Reply. In fact, Petitioner argues that “[t]he prior art expressly recognized the downside of treating migraine patients with CGRP inhibitors having a short half-life,” citing to a report that CGRP8-37 (a peptide fragment of CGRP) “‘proved ineffective in migraine treatment’ due to ‘its low potency and short half-life.’” Pet. 31 (citing Ex. 1031, 323; Ex. 1014 ¶ 124) (emphasis by Petitioner). Accordingly, we find that Petitioner has not sufficiently established that a POSA would have been motivated to humanize an anti-CGRP antibody fragment.” slip op. at 93
- ExcludeMotion to exclude, grantedMotion to exclude, deniedGranted in part
“form, not relevant, vague, mischaracterized the witnesses’ prior testimony, called for a legal conclusion, lacked clarity, or contained compound questions. Mot. Excl. 7–12. We consider Patent Owner’s arguments in this regard to address issues of weight rather than admissibility, and we deny these aspects of the motion. See Corning Inc. v. DSM IP Assets B.V., IPR2013-00053, Paper 66 at 19 (PTAB May 1, 2014) (sitting as a non-jury tribunal, the Board may assign appropriate weight to evidence presented) (citing Donnelly Garment Co. v. NLRB, 123 F.2d 215, 224 (8th Cir. 1941)).” slip op. at 158
- Strike new argumentNew argument consideredDenied
“(Ex. 2239), and also the opportunity to submit a Sur-reply (Paper 43). Therefore, we determine that Patent Owner has failed to meet its burden to show that the arguments and evidence should be stricken. See 37 C.F.R. § 42.20; Genzyme Therapeutic Prods. L.P. v. Biomarin Pharm Inc., 825 F.3d 1360, 1367 (Fed. Cir. 2016); see also Anacor Pharms., Inc. v. Iancu, 889 F.3d 1372, 1380–81 (Fed. Cir. 2018) (reply may document the knowledge that skilled artisans would bring to bear in reading the prior art identified as producing obviousness). Accordingly, this aspect of the motion is denied.” slip op. at 163
Patent outcomesUS 9,884,908 not shown unpatentable§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,884,908 - PTAB · Jun 19, 2019 · IPR2018-01159 · APJ Bart A Gerstenblith · IPR · Rehearing
The Board denied West’s rehearing request, leaving institution denied because the petition did not show a reasonable likelihood of prevailing on the challenged claims.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“In a request for rehearing, we do not review the merits of the Institution Decision de novo. Instead, we consider whether Petitioner has met its burden of showing that a matter has been misapprehended or overlooked. 37 C.F.R. § 42.71(d) (“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.”). We conclude that Petitioner has not met this burden in its Request for Rehearing.” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Initially, we remind Petitioner that we did not find that one of ordinary skill in the art would not have been motivated to modify Carrel in view of David-Hegerich. See Dec. on Inst. 17–22. Rather, we found that Petitioner did not demonstrate a reasonable likelihood of showing that one of ordinary skill in the art would have modified Carrel as proposed by Petitioner. See id.” slip op. at 3
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“Initially, we remind Petitioner that we did not find that one of ordinary skill in the art would not have been motivated to modify Carrel in view of David-Hegerich. See Dec. on Inst. 17–22. Rather, we found that Petitioner did not demonstrate a reasonable likelihood of showing that one of ordinary skill in the art would have modified Carrel as proposed by Petitioner. See id.” slip op. at 3
§ 103 obviousnessPatents in suitUS 9,586,011 - Initiative For Medicines, Access & Knowledge (I-Mak), Inc. v. Gilead Pharmasset LLCInstitution deniedPTAB · Jun 13, 2018 · IPR2018-00103 · APJ Lora M Green · IPR · Institution
The Board denied institution for claims 1–19 because the Petition did not show a reasonable likelihood that any challenged claim was anticipated by Klecker or Sommadossi, or obvious over Sommadossi and Klecker.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Institution of an inter partes review is authorized by statute when “the information presented in the petition . . . and any response . . . 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.” 35 U.S.C. § 314; see 37 C.F.R. §§ 42.4. Upon considering the Petition and the Preliminary Response, we determine that Petitioner has not demonstrated a reasonable likelihood that it would prevail in showing the unpatentability of any of the challenged claims. Accordingly, we decline to institute an inter partes review for any challenged claim of the ’572 patent.” slip op. at 2
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“reasonable likelihood that claim 1 is anticipated by Klecker. To anticipate a reference must expressly or inherently disclose “within the four corners of the document not only all of the limitations claimed but also all of the limitations arranged or combined in the same way as recited in the claim.” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (2008). Moreover, “anticipation is not proven by ‘multiple, distinct teachings that the artisan might somehow combine to achieve the claimed invention.’” Microsoft Corp. v. Biscotti, Inc., 878 F.3d 1052, 1069 (Fed. Cir. 2017) (internal citation omitted). “[A] disclosed genus may anticipate a claimed species when the genus is so small that one of ordinary skill in the art would ‘at once envisage each member of this limited class.’” Wasica Fin. GmbH v. Continental Auto. Sys., Inc., 853 F.3d 1272, 1285 (Fed. Cir. 2017) (quoting AbbVie Inc. v. Mathilda & Terence Kennedy Inst. of Rheumatology Tr., 764 F.3d 1366, 1379 (Fed. Cir. 2014)). In this case, we agree with Patent Owner that Petitioner is improperly using claim 1 as a roadmap to cherry pick teachings of the Klecker reference to arrive at compounds encompassed by the genus of that claim. For example, we acknowledge that Klecker teaches that a fluorine may be placed below the ring at the 2' position of the sugar ring. Ex. 1005, 19:25‒26. Petitioner does not point us to any teaching of Klecker, however, that teaches a compound that has both a methyl group and a fluorine at the 2' position of the sugar ring, regardless of whether the fluorine is in the up position or the down position. That is, although the broad genus of compounds disclosed by Klecker encompasses such compounds, Petitioner does not point us to any teaching, other than the broad disclosure of the genus, wherein “W, X, Y, [and] Z” may be “H, hydroxy, halogen, alkyl (C1- C6), alkoxy (C1-C6)a label containing moiety or a label” (Ex. 1005, 15:3‒5), that would direct the ordinary artisan to choose X and W such that one of X and W is methyl and the other is fluorine, much less pointing to support of X as fluorine and W as methyl.” slip op. at 11
- Expert testimonyPetitioner expert discountedDecided for patent owner
“Petitioner relies on the Declaration of Dr. Fortunak in asserting that because Klecker teaches the X position may be substituted with fluorine and teaches that W can be an alkyl (C1 – C6), the ordinary artisan would understand from “general knowledge and common sense that methyl is a preferred lower alkyl in that group.” Pet. 34 (citing Ex. 1002 ¶ 92). Dr. Fortunak, however, merely repeats the statement in the Petition without citing any evidentiary support. See Ex. 1002 ¶ 92; see also id. ¶¶ 93‒95 (discussing choosing other substituents in the structure of Klecker). Conclusory statements by an expert “that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.” 37 C.F.R. § 42.65(a). Furthermore, Petitioner’s conclusory statements (Pet. 34‒35) that because C is the first substituent identified for J, and H and OH are the first two substituents identified for Y and Z and, thus, the ordinary artisan would immediately envisage a compound where J is C, Y is H, and Z is OH, do not sufficiently persuade us that the ordinary artisan would immediately envisage their implementation to arrive at compounds that fall within the genus of claim 1.” slip op. at 12
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable
“To the extent that Petitioner (Pet. 51‒52) is invoking inherency in arguing that the express teaching of Sommadossi that R7 may be chloro, 6 Britton et al., U.S. Patent 5,420,266, issued May 30, 1995 (Ex. 1011). bromo and iodo, is also an express teaching that R7 may be fluoro, we disagree that the use of fluoro as the R7 group is inherent in the teachings of Sommadossi. “Inherency . . . 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), quoting In re Oelrich, 666 F.2d 578, 581 (CCPA 1981). Even though the ordinary artisan may have understood that fluoro is also a halogen and may be substituted for chloro, bromo, or iodo, the fact remains that Sommadossi taught the use of, inter alia, chloro, bromo, or iodo at the R7 position, specifically, rather than a halogen element, generally. Ex. 1006, 13:24‒27. Petitioner’s argument (Pet. 52) that “Sommadossi taught that R6 could be ‘chloro, bromo, fluoro, [or] iodo,’” is actually counter to Petitioner’s assertions. That is, that statement demonstrates that Sommadossi knew that “fluoro” could be included in the list of halogens. Moreover, Sommadossi defined the term “halo” as “chloro, bromo, iodo, and fluoro.” Ex. 1006, 52:31. Thus, to avoid inadvertently excluding a halogen, Sommadossi could have used the term “halo” in listing the possible substituents for the R7 group, but chose not to do so. Accordingly, we determine that Petitioner has not sufficiently established that Sommadossi anticipates the compounds of claim 1. Because, as discussed above in our analysis of the anticipation ground over Klecker, all of the claims require the compound of that claim, or a particular compound that falls within the genus of claim 1, Petitioner has also not sufficiently demonstrated that any of the challenged claims are anticipated by Sommadossi. Accordingly, we decline to institute trial as to any of the challenged claims on the basis that the claim is anticipated by Sommadossi.” slip op. at 17
§ 102 anticipation§ 103 obviousnessPatents in suitUS 7,429,572 - Guardant Health, Inc. v. Foundation Medicine, Inc.Rehearing deniedPTAB · Nov 8, 2017 · IPR2017-01170 · APJ Richard J Smith · IPR · Rehearing
The Board denied Patent Owner’s rehearing request, leaving instituted review of claims 65, 66, 72, 73, 75–77, and 80–85 based on its reasonable-likelihood determination.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“DISCUSSION When rehearing a decision on petition, the Board reviews the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion occurs when a “decision was based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.” PPG Indus. Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed. Cir. 1988) (citations omitted). A request for rehearing “must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed.” 37 C.F.R. § 42.71(d).” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for petitioner
“According to the ’830 patent, the term “bait” is defined as including “a nucleic acid molecule . . . which can hybridize to (e.g., be complementary to), and thereby allow capture of a target nucleic acid.” Ex. 1001, 28:47–50. Patent Owner acknowledges that “both primers and baits hybridize to a complementary portion of the target nucleic acid.” Req. Reh’g. 3 (citing Prelim. Resp. 30). However, Patent Owner does not explain or otherwise persuasively address why the subject nucleic acids in Shah are not included within that definition of “bait.” We did not overlook Patent Owner’s explanation of why, in its view, “primers” are not “baits.” Rather, at this stage of the proceeding, we found such explanation unpersuasive as we stated in the Decision. Dec. 13. (stating “we are not persuaded that the definition of the term ‘bait,’ as set forth in the ’830 patent, does not include primers”). Moreover, because we did not overlook Patent Owner’s explanation, we find no basis to reconsider the disclosures of Shah.” slip op. at 4
- Obviousness (§103) › Motivation to combine / reasonable expectation of successDecided for petitioner
“We did not overlook and/or misapprehend Patent Owner’s argument. We expressly addressed that argument with respect to bait sets (i) and (ii) by stating that “we find that choosing bait sets that select somatic mutations that appear at a frequency of about 5% or less and at a frequency of about 10% or higher is taught or suggested by the combined teachings of Levin and Shah.” Dec. 17 (emphasis added); see also Dec. 20 (“Having considered the arguments and evidence, we are persuaded at this stage of the proceeding that Petitioner has sufficiently shown that the limitations of claim 65 are taught or suggested by, or would have been obvious in view of, the combined teachings of Levin and Shah.”). Moreover, contrary to Patent Owner’s argument, the fact that the Decision may not recite the words “used together” does not indicate that we overlooked and/or misapprehended Patent Owner’s argument. See Novartis AG v. Torrent Pharms. Ltd., 853 F.3d 1316, 1328 (Fed. Cir. 2017) (stating “this court has said on multiple occasions that failure to explicitly discuss every issue or every piece of evidence does not alone establish that the tribunal did not consider it”) (citing cases).” slip op. at 5
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Decided for petitioner
“We did not overlook and/or misapprehend Patent Owner’s argument; rather, we considered it and found it unpersuasive. See Dec. 13 (stating “on this record, we find that Levin’s disclosure of multiple baits would include multiple bait sets”). In particular, we found that Levin teaches the use of multiple bait sets, not one bait set as argued by Patent Owner. See id. Furthermore, Patent Owner’s argument that all of the baits in Levin were “designed in precisely the same way” was based on Levin’s statement that “[b]aits were designed in a tiling fashion with minimal overlap to span the entire protein-coding region of each transcript.” See Prelim. Resp. 28 (citing Ex. 1010, 2). However, that statement suggests the design of multiple different baits that would include multiple different bait sets.” slip op. at 6
Claim construction§ 103 obviousnessPatents in suitUS 9,340,830
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.