- CSPC Pharmaceutical Group Limited / CSPC Ouyi Pharmaceutical Co., Ltd. et al. v. Ipsen Biopharm Ltd.Some claims unpatentablePTAB · Aug 13, 2026 · IPR2025-01531 · APJ Zhenyu Yang · IPR · Final written decision
Claims 1, 3–6, and 8–14 are unpatentable as obvious; claims 2, 7, and 15 were not shown unpatentable because the prior art did not establish the claimed drug sequence.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner states that, for purposes of this proceeding, it does not dispute Petitioner’s proposed definition of a POSA. PO Resp. 8. Based on the entirety of the trial record, we adopt Petitioner’s proposed definition of a POSA’s skill level because it is consistent with the skill level reflected in the disclosures of the ’552 patent and prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art).” slip op. at 9
- Expert testimonyPatent owner expert creditedDecided for patent owner
“We decline to discount Dr. Oberstein’s opinion based on the alleged conflict of interest and bias. Dr. Oberstein testified that the consulting fees he receives from Patent Owner reflect a small fraction of his income. Ex. 1210, 402:21–403:9. We also agree with Patent Owner that an oncologist prescribing an FDA-approved regimen does not evince bias. See Sur-reply 23; see also Ex. 1206, 49 (showing NALIRIFOX is a category 1, NCCN-preferred first-line therapy for metastatic pancreatic cancer), 69 (explaining category 1 is based upon high-level evidence). Petitioner also contends that Dr. Oberstein “offers conclusory opinions,” “fails to properly apply the law, continues to look at each reference in isolation, refuses to acknowledge logical suggestions in the art, and imports new limitations into the claims.” Reply 3–4. We evaluate each piece of evidence, including Dr. Oberstein’s opinion, as it relates to our substantive patentability analysis, and accord it proper weight.” slip op. at 9
- ExcludeMotion to exclude, deniedDenied
“Petitioner, as the moving party, bears the burden of proving 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); see also Trial Practice Guide (“TPG”)15 § II.K (“A motion to exclude must explain why the evidence is not admissible.”). For the reasons explained below, we deny Petitioner’s Motion.” slip op. at 17
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“only on a ground that could be raised under section 102 or 103 and only on the basis of prior art consisting of patents or printed publications.” 35 U.S.C. § 311(b). Whether a reference qualifies as a “printed publication” involves a case-by-case inquiry into the facts and circumstances surrounding the reference’s disclosure to the public. In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004). A reference is publicly accessible upon a satisfactory showing that such document has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence can locate it. Kyocera Wireless Corp. v. ITC, 545 F.3d 1340, 1350–51 (Fed. Cir. 2008). Conroy was published on May 12, 2011. Ex. 1003, 1. Conroy refers to Conroy Protocol (Ex. 1004), stating that “[t]he protocol, including the statistical analysis plan, is available with the full text of this article at NEMJ.org.” Ex. 1003, 3. When questioned whether he has “any reason to believe that the protocol would not have been provided on NEJM.org with this text when it was published,” Dr. Oberstein testified that “if they say they provided it, then I think they probably provided it.” Ex. 1210, 165:20–166:2. 17 Alternatively, to the extent necessary, under the circumstances of this case, we waive the requirement of § 42.63(b). See 37.C.F.R. § 42.5(b). In addition, Dr. Ratain testified that “most top journals require that the protocol be submitted at the time of initial submission, and it’s always published alongside any major paper.” Ex. 2073, 42:2–5. According to Dr. Ratain, “[c]ertainly, New England Journal of Medicine does that.” Id. at 42:6–7. We credit the testimony from both Dr. Oberstein and Dr. Ratain on this issue. Accordingly, we find Exhibit 1004 was publicly accessible at the same time Conroy was published. slip op. at 28
Patent outcomesUS 11,344,552 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,344,552 - CSPC Pharmaceutical Group Limited / CSPC Ouyi Pharmaceutical Co., Ltd. et al. v. Ipsen Biopharm Ltd.Some claims unpatentablePTAB · Aug 13, 2026 · IPR2025-00505 · APJ Zhenyu Yang · IPR · Final written decision
Claims 1, 3–6, and 8–14 are unpatentable as obvious over the first § 103 combination; claims 2, 7, and 15 were not shown unpatentable because the art did not support the claimed drug sequence.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that [t]he person of ordinary skill in the art (POSA) would have been an M.D. and/or Pharm. D who would have completed training in medical oncology, particularly in the field of gastrointestinal (GI) cancers, or a Ph.D. in clinical pharmacology, pharmaceutical sciences, pharmaceutics, and/or drug delivery, also particularly in the field of GI cancers, or their equivalents, along with at least 1-2 years of post-doctoral experience. Pet. 26 (citing Ex. 1002 ¶¶ 44–46). Patent Owner states that, for purposes of this proceeding, it does not dispute Petitioner’s proposed definition of a POSA. PO Resp. 8. Based on the entirety of the trial record, we adopt Petitioner’s proposed definition of a POSA’s skill level because it is consistent with the skill level reflected in the disclosures of the ’552 patent and prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art).” slip op. at 9
- Expert testimonyPatent owner expert creditedDecided for patent owner
“We decline to discount Dr. Oberstein’s opinion based on the alleged conflict of interest and bias. Dr. Oberstein testified that the consulting fees he receives from Patent Owner reflect a small fraction of his income. Ex. 1210, 402:21–403:9. We also agree with Patent Owner that an oncologist prescribing an FDA-approved regimen does not evince bias. See Sur-reply 23; see also Ex. 1206, 49 (showing NALIRIFOX is a category 1, NCCN-preferred first-line therapy for metastatic pancreatic cancer), 69 (explaining category 1 is based upon high-level evidence). Petitioner also contends that Dr. Oberstein “offers conclusory opinions,” “fails to properly apply the law, continues to look at each reference in isolation, refuses to acknowledge logical suggestions in the art, and imports new limitations into the claims.” Reply 3–4. We evaluate each piece of evidence, including Dr. Oberstein’s opinion, as it relates to our substantive patentability analysis, and accord it proper weight.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“In the DI, the Board stated that the ordinary understanding of a claim reciting a “method of treating metastatic adenocarcinoma of the pancreas” that comprises “administering an antineoplastic therapy to the patient” in order “to treat the metastatic adenocarcinoma of the pancreas” is that the “treatment” would have more than a de minimis therapeutic benefit or efficacy for the patient being treated. DI 14. We, however, rejected the notion that the claims “would require some particular degree of clinical efficacy” because “the level of clinical efficacy is not a claim limitation.” Id.” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Not reached
“The parties, however, disagree over whether each recited dose must be the starting dose. Petitioner argues that “claim 1 requires that the method of treatment is a first-line therapy, but does not require that the claimed doses be used as a starting dose.” Paper 51, 1. In contrast, Patent Owner argues that “[t]he specification describes that the recited dose of each drug is a ‘starting’ or ‘initial’ dose.” Paper 50, 2 (citing Ex. 1001, 13:38–45, 30:5–7). For purposes of this Decision, we do not need to resolve this dispute. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (stating that claim terms need only be construed to the extent necessary to resolve the controversy). As explained below, we agree with Petitioner that, even if claim 1 recites the starting dose for each drug, Petitioner has shown, by a preponderance of the evidence, that the prior art teaches each dose and a POSA would have had a reason to start with the recited doses. See infra Section II.G.3; Paper 51, 3 n.2. Because we find that the prior art teaches or suggests the claimed subject matter even under Patent Owner’s proposed narrower claim interpretation, we need not further construe the disputed claim language.” slip op. at 16
Patent outcomesUS 11,344,552 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,344,552 - Crowdstrike, Inc. v. Gosecure, Inc.Some claims unpatentablePTAB · Aug 12, 2026 · IPR2025-00070 · APJ Neil T Powell · IPR · Final written decision
Claims 1, 3–7, and 9–21 are unpatentable as obvious; claims 2 and 8 were not shown unpatentable because the asserted art did not meet their construed limitations.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“III. ANALYSIS LEVEL OF ORDINARY SKILL A. Petitioner explains the applicable level of skill in the art as follows: As of June 24, 2010, a person of ordinary skill in the art (POSITA) would be a person having a bachelor’s degree in computer science, computer engineering, or an equivalent, as well as two years of industry experience and who would have had a working knowledge of software security analysis, and dynamic malware analysis. Additional graduate education could substitute for professional experience, or significant experience in the field could substitute for formal education. Pet. 8 (Ex. 1003 ¶¶ 30–31). Patent Owner does not dispute Petitioner’s explanation of the level of skill in the art. See Ex. 2031 ¶¶ 15–16. We adopt Petitioner’s uncontested proposed level of ordinary skill in the art, which we find consistent with the level of ordinary skill in the art reflected by the ’872 patent and the prior art of record. See Okajima v.” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“We begin with the claim language in view of the Specification, which weighs heavily against Patent Owner’s position that we should rewrite “computer system” as narrowly referring to a “computing device.” PO Resp. 24. As Petitioner notes, the ’872 patent’s Specification uses “computer system” to refer to a wide range of equipment, from a component of a computing device, to a whole computing device, to a collection of computing devices. Reply 9–10 (citing Ex. 1001, 4:5–8, 11:15–18, 16:50–55). In one example, the Specification refers to “one or more other computer systems (e.g., protected network devices 136).” Ex. 1001, 18:52–53. Thus, the Specification lists “protected network devices 136” as only an example of “other computer systems,” demonstrating that “computer systems” refers to things other than protected network devices. Although Patent Owner may be correct that this passage more than a single computing device,” we find that other disclosures in the ’872 patent do. Specifically, the Specification uses the language “distributed computer system” when referring to numerous components, including “protected network devices” and an “IDS/IPS system.” Ex. 1001, 3:26–28; Reply 10. In addition to showing that a “computer system” is not limited to a single computing device, this conveys that a “computer system” according to the ’872 patent can include an IDS/IPS.” slip op. at 14
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“Based on our review of the complete record, we find Petitioner’s arguments and evidence to be more persuasive. Patent Owner does not dispute Petitioner’s argument and evidence that capturing detailed information like Goel’s activity sources, activity targets, and association was recognized as enhancing threat analysis. Pet. 44 (citing Ex. 1003 ¶ 79); see PO Resp. 55–59; Sur-Reply 15–17. Additionally, contrary to Patent Owner’s suggestion, we find that the Petition does not propose incorporating Goel’s kernel hooks into Capalik’s system. See Pet. 41–46. Patent Owner contends that the Petition’s reference to modifying Capalik by “adding lines of code” suggests implementing the code disclosed in Goel include kernel hooks. Id. Notwithstanding Patent Owner’s assertion otherwise, this is an unpersuasive bodily incorporation argument, as the Petition never says an ordinarily skilled artisan would have used the exact lines of code from Goel in Capalik. Rather, the Petition says that an ordinarily skilled artisan would have had sufficient skill to implement straightforward code modifications to identify activity sources, targets, and associations: a [person of ordinary skill in the art] would have understood that modifying Capalik’s system (e.g., Linux-based) to additionally monitor, identify, and store each individual activity of an attack including “activity sources, activity targets, and associations” would have required straightforward modifications to programs/code instructions, which would have been well-within the skillset of a [person of ordinary skill in the art]. Pet. 46. Patent Owner argues that Petitioner does not explain how an ordinarily skilled artisan would have modified Capalik without using kernel hooks. Sur-Reply 17. But Patent Owner does not cite any evidence to counter Dr. Jakobsson’s testimony that an ordinarily skilled artisan would have had the skill to apply Goel’s general teaching of identifying sources, targets, and associations to Capalik’s system. Ex. 1003 ¶ 182. On the whole, the evidence does not support Patent Owner’s position that the combination would have required substantially increased detection risk. Moreover, even if the combination would have somewhat increased detection risk, Petitioner persuades us that an ordinarily skilled artisan still would have had reason to combine the references teachings. Patent Owner’s allegations of increased detection risk do not negate the undisputed evidence that the combination would have provided the advantage of improved threat analysis. Pet. 44 (citing Ex. 1003 ¶¶ 175–182). Ultimately, Patent Owner’s that activity logging be undetectable.” PO Resp. 56 (emphasis added) (citing Ex. 1004 ¶ 6). This exaggerates Capalik’s disclosure. Although the cited paragraph suggests that certain systems unfortunately may be detectable by some users, it does not convey that it is a requirement for the system to be categorically undetectable. See Ex. 1004 ¶ 6.8 In sum, Petitioner persuades us by a preponderance of the evidence that it would have been obvious to modify Capalik “to identify and store unauthorized activities including the activity source, activity target, and association of each activity.” Pet. 41–46; PO Resp. 55–59; Reply 20–22; Sur-Reply 15–17.” slip op. at 47
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for patent owner
“arguments and evidence, we determine that Patent Owner fails to sufficiently show a nexus between any of its objective indicia evidence and the claimed invention. See Fox Factory, Inc. v. SRAM, LLC, 944 F.3d 1366, 1373 (Fed. Cir. 2019) (“The patentee bears the burden of showing that a nexus exists”). A showing of sufficient nexus is required to establish that the evidence relied upon traces its basis to a novel element in the claim, not to something in the prior art. Institut Pasteur & Universite Pierre Et Marie Curie v. Focarino, 738 F.3d 1337, 1347 (Fed. Cir. 2013). Objective evidence that results from something that is not “both claimed and novel in the claim” lacks a nexus to the merits of the invention. In re Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011) (emphasis omitted). Thus, establishing nexus involves a showing that novel elements in the claim, not prior-art elements, account for the objective evidence of nonobviousness. Id. As discussed above, Petitioner shows that Capalik teaches all limitations of claim 1. Petitioner persuades us that none of claim 1’s elements individually nor any combination thereof is novel over Capalik’s disclosure. Accordingly, claim 1 is not novel over Capalik, which disproves Patent Owner’s assertion of nexus. PO Resp. 73–76. Moreover, even if claim 1 were novel, Patent Owner otherwise fails to show nexus for its commercial success, praise, or copying assertions. Patent Owner’s evidence does not show that Petitioner’s commercial product embodies claim 1. For example, we agree with Petitioner that Patent Owner “failed to analyze any meaningful detail regarding” how the Falcon Platform allegedly meets limitation 1(d). Reply 28–29. In particular, Patent Owner has not sufficiently addressed limitation 1(d) with the following argument: “1[D] The Falcon Platform transmitted to other computer systems” slip op. at 37
Patent outcomesUS 9,954,872 mixedClaim construction§ 103 obviousnesscites PhillipsPatents in suitUS 9,954,872 - Ipr2026-00213InstitutedPTAB · Aug 6, 2026 · IPR2026-00213 · APJ John A Squires · IPR · Institution
Institution is granted in IPR2026-00213 after the petitioner showed a reasonable likelihood of prevailing on at least one challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Pursuant to 35 U.S.C. § 314(a) and 324(a), after review of the merits, the petitioner has failed to show a reasonable likelihood of prevailing with respect to at least one of the claims challenged in the petition, or that it is more likely than not that at least one of the claims challenged in the petition is unpatentable, as appropriate. Accordingly, institution of inter partes review is denied in the following proceedings: None Pursuant to 35 U.S.C. §§ 314(a) and 324(a), after review of the merits, the petitioner has shown a reasonable likelihood of prevailing with respect to at least one of the claims challenged in the petition, or that it is more likely than not that at least one of the claims challenged in the petition is unpatentable, as appropriate, and no other non-discretionary considerations warrant denial of institution. Accordingly, institution of inter partes review and post-grant review is granted in the following proceedings:” slip op. at 2
None - Ipr2026-00214InstitutedPTAB · Aug 6, 2026 · IPR2026-00214 · APJ John A Squires · IPR · Institution
Institution is granted in IPR2026-00214 because the petitioner showed a reasonable likelihood of prevailing on at least one challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“the petitioner has shown a reasonable likelihood of prevailing with respect to at least one of the claims challenged in the petition, or that it is more likely than not that at least one of the claims challenged in the petition is unpatentable, as appropriate, and no other non-discretionary considerations warrant denial of institution. Accordingly, institution of inter partes review and post-grant review is granted in the following proceedings:” slip op. at 2
None - Ipr2026-00266InstitutedPTAB · Aug 6, 2026 · IPR2026-00266 · APJ John A Squires · IPR · Institution
Institution is granted in IPR2026-00266; the notice gives no claim-specific or ground-specific outcome.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“the petitioner has shown a reasonable likelihood of prevailing with respect to at least one of the claims challenged in the petition, or that it is more likely than not that at least one of the claims challenged in the petition is unpatentable, as appropriate, and no other non-discretionary considerations warrant denial of institution. Accordingly, institution of inter partes review and post-grant review is granted in the following proceedings: IPR2026-00213 IPR2026-00266 PGR2026-00035 IPR2026-00214” slip op. at 2
NonePatents in suitUS 10,200,654 - Ipr2026-00330Institution deniedPTAB · Aug 6, 2026 · IPR2026-00330 · APJ John A Squires · IPR · Director review
The Director denied institution of IPR2026-00330 after review of discretionary and non-merits considerations.
RulingsDirector review decision- Other 314aInstitution denied discretionary otherInstitution denied
“NOTICE Pursuant to 35 U.S.C. § 314(a) and 324(a), after review of discretionary and non-merits considerations, institution of inter partes review and post-grant review is denied in the following proceedings: IPR2026-00295 IPR2026-00297 PGR2026-00023* IPR2026-00296 PGR2026-00039* IPR2026-00330 Pursuant to 35 U.S.C. §§ 314(a), after review of discretionary” slip op. at 1
Discretionary denialPatents in suitUS 11,949,962 - Ipr2026-00297Institution deniedPTAB · Aug 6, 2026 · IPR2026-00297 · APJ John A Squires · IPR · Director review
The Director denied institution of IPR2026-00297 after review of discretionary and non-merits considerations.
RulingsDirector review decision- Director reviewDirector review, deniedDenied
“NOTICE Pursuant to 35 U.S.C. § 314(a) and 324(a), after review of discretionary and non-merits considerations, institution of inter partes review and post-grant review is denied in the following proceedings: IPR2026-00295 IPR2026-00297 PGR2026-00023* IPR2026-00296 PGR2026-00039* IPR2026-00330 Pursuant to 35 U.S.C. §§ 314(a), after review of discretionary” slip op. at 1
- Other 314aInstitution denied discretionary otherInstitution denied
“NOTICE Pursuant to 35 U.S.C. § 314(a) and 324(a), after review of discretionary and non-merits considerations, institution of inter partes review and post-grant review is denied in the following proceedings: IPR2026-00295 IPR2026-00297 PGR2026-00023* IPR2026-00296 PGR2026-00039* IPR2026-00330 Pursuant to 35 U.S.C. §§ 314(a), after review of discretionary” slip op. at 1
Discretionary denialPatents in suitUS 12,079,667 - Ipr2026-00296Institution deniedPTAB · Aug 6, 2026 · IPR2026-00296 · APJ John A Squires · IPR · Director review
The Director denied institution of IPR2026-00296 after review of discretionary and non-merits considerations.
RulingsDirector review decision- PTAB / AIA Trials › Discretionary denialInstitution denied discretionary otherInstitution denied
“NOTICE Pursuant to 35 U.S.C. § 314(a) and 324(a), after review of discretionary and non-merits considerations, institution of inter partes review and post-grant review is denied in the following proceedings: IPR2026-00295 IPR2026-00297 PGR2026-00023* IPR2026-00296 PGR2026-00039* IPR2026-00330 Pursuant to 35 U.S.C. §§ 314(a), after review of discretionary” slip op. at 1
Discretionary denialPatents in suitUS 10,810,050 - Ipr2026-00295Institution deniedPTAB · Aug 6, 2026 · IPR2026-00295 · APJ John A Squires · IPR · Director review
The Director denied institution of IPR2026-00295 after review of discretionary and non-merits considerations.
RulingsDirector review decision- Director reviewDirector review, deniedDenied
“NOTICE Pursuant to 35 U.S.C. § 314(a) and 324(a), after review of discretionary and non-merits considerations, institution of inter partes review and post-grant review is denied in the following proceedings: IPR2026-00295 IPR2026-00297 PGR2026-00023* IPR2026-00296 PGR2026-00039* IPR2026-00330 Pursuant to 35 U.S.C. §§ 314(a), after review of discretionary” slip op. at 1
- Other 314aInstitution denied discretionary otherInstitution denied
“NOTICE Pursuant to 35 U.S.C. § 314(a) and 324(a), after review of discretionary and non-merits considerations, institution of inter partes review and post-grant review is denied in the following proceedings: IPR2026-00295 IPR2026-00297 PGR2026-00023* IPR2026-00296 PGR2026-00039* IPR2026-00330 Pursuant to 35 U.S.C. §§ 314(a), after review of discretionary” slip op. at 1
Discretionary denialPatents in suitUS 11,656,915
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.