- 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 - Pgr2026-00039Institution deniedPTAB · Aug 6, 2026 · PGR2026-00039 · APJ John A Squires · PGR · Director review
The Director denied institution of PGR2026-00039 after discretionary review; the opinion explaining the denial is forthcoming.
RulingsDirector review decision- Director reviewDirector review, deniedDenied
“Before JOHN A. SQUIRES, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office. 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 12,168,036 - Pgr2026-00023Institution deniedPTAB · Aug 6, 2026 · PGR2026-00023 · APJ John A Squires · PGR · Director review
The Director denied institution of PGR2026-00023 after discretionary review; the accompanying notice states that opinions for the listed discretionary denials are forthcoming.
RulingsDirector review decision- Other 314aInstitution denied discretionary otherDenied
“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 12,370,716 - 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 - Ipr2026-00295Institution 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 - Ajinomoto Co., Inc. v. Abtis Co., Ltd.No claims unpatentablePTAB · Aug 3, 2026 · IPR2025-00283 · APJ Lilan Ren · IPR · Final written decision
The Board cancelled claim 11 and granted substitute claims 14–16, finding Petitioner had not shown those claims unpatentable on any asserted ground.
RulingsFinal written decision- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, grantedGranted
“must determine whether the motion to amend meets the statutory and regulatory requirements set forth in 35 U.S.C. § 316(d) and 37 C.F.R. § 42.121. Lectrosonics, Paper 15 at 4. In that regard, Patent Owner bears the burden of persuasion to show that: (1) the amendment proposes a reasonable number of substitute claims; (2) the amendment responds to a ground of unpatentability involved in the trial; (3) the amendment does not seek to enlarge the scope of the claims of the patent or introduce new subject matter;” slip op. at 9
- ExcludeMotion to exclude, deniedDenied
“In this case, Patent Owner’s expert “Dr. Zhou signed the second declaration, stood behind its contents, and was available for cross-examination.” Paper 35, 4. Petitioner does not dispute this statement. Paper 39, 1. Petitioner does not identify any specific undue prejudice caused by Exhibit 2008. For example, Petitioner argues that “the failure to impress upon a witness that a statement is under oath goes to the heart of its reliability as evidence” and that “as the Board has recognized, hearsay is inherently unreliable” without specifying what statement in Exhibit 2008 lacks reliability. Paper 39, 4. Because Petitioner does not provide specific evidence of undue prejudice, we find Petitioner has suffered no such undue prejudice in this case. See Liquidia, 2021 WL 4860773 at *25. We therefore deny Petitioner’s Motion to Exclude on the basis of lack of authenticity. With regard to the assertion that Exhibit 2008 is hearsay, Petitioner objects to the exhibit because the testimony is based “on other informal and unpublished documents that are hearsay under FRE 802.” Paper 29, 1. Petitioner does not specify what such “informal and unpublished documents” are. See id. Federal Rule of Evidence 703 expressly states, “[a]n expert may base an opinion on fact or data in the case that the expert has been made aware of or personally observed.” The facts or data “need not be deny Petitioner’s Motion to Exclude on the basis of hearsay.” slip op. at 50
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateNot shown unpatentable
“Petitioner’s argument is unpersuasive. Paragraph 59 of the ’503 application describes formula 8-1 but does not support Petitioner’s argument that other unknown formulas may be included in the recited modified heavy chains. Ex. 2003 ¶ 59. Petitioner’s hypothesis that the recited heavy chains may (or may not) encompass unknown formulas is also inapposite to the written description inquiry before us — that is, whether the inventor was in possession of the subject matter recited in claims 14–16 based on the disclosure including formulas 8-1, 8-2, and 8-3. See PowerOasis, 522 F.3d at 1306.” slip op. at 14
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledNot shown unpatentable
“These arguments in the Sur-Reply are unpersuasive to show a lack of enablement first and foremost because the arguments do not specifically provide evidence showing that any purported experimentation is undue. See Sur-Reply 2–8 (asserting, but without providing evidence under any specific Wands factors, that the examples and guidance in the specification do not extend to the broad scope of all antibodies); see Wands, 858 F.2d at 737. We again emphasize that the analysis of undue experimentation does not necessarily require every Wands factor to be explicitly addressed but the analysis must be based on “weighing many factual considerations” depending on the nature of the invention and underlying art. Cephalon, Inc. v. Watson Pharms., Inc., 707 F.3d 1330, 1336 (Fed. Cir. 2013). The assertion that the claim scope is broad alone does not suffice to show a lack of enablement based on the record before us. Moreover, as we note supra, Petitioner’s claim scope argument is based on the false premise that the scope of claims 14–16 is as broad as the claim term “antibody” without taking into account all other claim elements. For example, Petitioner does not disagree with Patent Owner’s statement that “[t]he ’675 Patent’s specification discloses the structural modification site, the chemistry used to modify that residue, and working examples demonstrating the modification” (Reply 2), but asserts only that “[t]he disclosure of SSFI that only binds to IgG1 Fc domains (SEQ ID NO:1) is . . . . inconsistent with the expansive scope of the claims.” Sur-Reply 5. Petitioner’s argument that the claims encompass proteins that lack a lysine reside at a 248 position improperly excludes from the claim language the “lysine residue at 248 position . . . [as] determined by the EU numbering system” that claims 14–16 require. As Dr. Zhou testifies, “each proposed lysine residue at position 248 (EU numbering) is covalently modified with a specific attachment with a terminal bio-orthogonal click-chemistry functional group. The specification describes targeted transfer of a chemical functional group to lysine 248” and when claims 14–16 are considered in their entirety, which includes all claim elements, “[a] POSA would understand the claim itself to limit the modified antibodies to those with lysine at position 248.” Ex. 2004 ¶ 48; Ex. 2008 ¶ 47. We also note that Patent Owner states “a POSA would understand that the phrase ‘one or more modified heavy chain’ encompasses antibodies within typical DAR distributions (i.e., fractional numbers) rather than requiring a distinct process for producing antibodies bearing modified heavy chains in exact integers.” Reply 2–3. Moreover, Patent Owner states that PepTalk Presentation demonstrates that “a POSA would understand antibody conjugation products to exist as mixtures rather than discrete whole number species” because PepTalk Presentation “presents DAR values as non-integer measurements, i.e. DARs of 1.8 and 1.9 reflecting such distributions.” Id. at 3 (citing Ex. 1007, 28). According to Patent Owner, “preparations having an average DAR of approximately 1.8 (commonly referred to in practice as ‘DAR2’) may reflect typical reaction distributions in which some antibodies contain two modified heavy chains while others contain fewer.” Id. at 3 (citing Ex. 2008 ¶ 46). Petitioner does not rebut these statements. See Sur-Reply 2–8. Based on the foregoing, the evidence before us does not show any” slip op. at 27
Patent outcomesUS 11,896,675 not shown unpatentable§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham · NautilusPatents in suitUS 11,896,675 - Liftwerx USA Inc. v. Liftra IP ApsInstitution deniedPTAB · Jul 28, 2026 · IPR2026-00102 · APJ John A Squires · IPR · Institution
The Board denied institution because the petition did not sufficiently explain where the prior art taught the claimed elements.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Petitioner is required to show how the construed claim is unpatentable under the asserted grounds by “specify[ing] where each element of the claim is found in the prior art patents or printed publications relied upon.” 37 C.F.R. § 42.104(b)(4). Here, Petitioner fails to specify where in the prior art each claim element is found. For example, Petitioner’s analysis based on Signore and Weaver includes a statement that each reference “discloses pressure mandrels with tap shoes,” with quotations from the references and colorized figures. See Pet. 49–51. Yet Petitioner does not explain why Signore’s “plurality of torque clamps” teach “tap shoes,” and Petitioner’s highlighting of a figure from Weaver does not elucidate which elements from Weaver that Petitioner regards as “tap shoes.” See id. As such, I find Petitioner’s showing to be insufficient for institution. “It is of the utmost importance that petitioners in the IPR proceedings adhere to the requirement that the initial petition identify ‘with particularity’ the ‘evidence that supports the grounds for the challenge to each claim.’” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 2016) (quoting 35 U.S.C. § 312(a)(3)).” slip op. at 2
- BurdenDenied
“Petitioner is required to show how the construed claim is unpatentable under the asserted grounds by “specify[ing] where each element of the claim is found in the prior art patents or printed publications relied upon.” 37 C.F.R. § 42.104(b)(4). Here, Petitioner fails to specify where in the prior art each claim element is found. For example, Petitioner’s analysis based on Signore and Weaver includes a statement that each reference “discloses pressure mandrels with tap shoes,” with quotations from the references and colorized figures. See Pet. 49–51. Yet Petitioner does not explain why Signore’s “plurality of torque clamps” teach “tap shoes,” and Petitioner’s highlighting of a figure from Weaver does not elucidate which elements from Weaver that Petitioner regards as “tap shoes.” See id. As such, I find Petitioner’s showing to be insufficient for institution. “It is of the utmost importance that petitioners in the IPR proceedings adhere to the requirement that the initial petition identify ‘with particularity’ the ‘evidence that supports the grounds for the challenge to each claim.’” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 2016) (quoting 35 U.S.C. § 312(a)(3)).” slip op. at 2
NonePatents in suitUS 12,104,578 - Ipr2026-00322Institution deniedPTAB · Jul 28, 2026 · IPR2026-00322 · APJ John A Squires · IPR · Director review
The Director denied institution of IPR2026-00322 after reviewing discretionary and non-merits considerations.
RulingsDirector review decision- Director reviewDirector review, deniedDenied
“NOTICE Pursuant to 35 U.S.C. § 314(a), after review of discretionary and non- merits considerations, institution of inter partes review is denied in the following proceedings: IPR2026-00320 IPR2026-00321 IPR2026-00322 Pursuant to 35 U.S.C. §§ 314(a) and 324(a), after review of” slip op. at 1
Discretionary denialPatents in suitUS 10,020,961 - Ipr2026-00321Institution deniedPTAB · Jul 28, 2026 · IPR2026-00321 · APJ John A Squires · IPR · Director review
The Director denied institution in IPR2026-00321 after reviewing discretionary and non-merits considerations.
RulingsDirector review decision- Director reviewDirector review, deniedDenied
“NOTICE Pursuant to 35 U.S.C. § 314(a), after review of discretionary and non- merits considerations, institution of inter partes review is denied in the following proceedings: IPR2026-00320 IPR2026-00321 IPR2026-00322 Pursuant to 35 U.S.C. §§ 314(a) and 324(a), after review of” slip op. at 1
- Other 314aInstitution denied discretionary otherInstitution denied
“NOTICE Pursuant to 35 U.S.C. § 314(a), after review of discretionary and non- merits considerations, institution of inter partes review is denied in the following proceedings: IPR2026-00320 IPR2026-00321 IPR2026-00322 Pursuant to 35 U.S.C. §§ 314(a) and 324(a), after review of” slip op. at 1
Discretionary denialPatents in suitUS 9,313,101
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.