- MSN Laboratories Private Ltd. / MSN Pharmaceuticals Inc. v. Bausch Health Ireland LimitedNo claims unpatentablePTAB · Jan 27, 2026 · IPR2023-00016 · APJ Michael A Valek · IPR · Remand
On remand, the Board held claims 1–6 not shown unpatentable because unexpected results outweighed the prima facie obviousness case, and granted Patent Owner’s motion to exclude.
RulingsRemand decision- RemandOther
“the Court of Appeals for the Federal Circuit (“Federal Circuit”)See Paper 83 (“CAFC Decision”). The Federal Circuit did not disturb our determination that Petitioner “established a prima facie case of obviousness.” See CAFC Dec. 6–8. However, it took issue with the unexpected results analysis in the Decision, explaining that “without more explanation from the Board as to its determination that the experiments [offered by Patent Owner to show unexpected results] compared the challenged claims to the closest prior art, we cannot reach a judgment on MSN’s challenges to the Board’s holding of non-obviousness.” Id. at 14. Accordingly, the Federal Circuit vacated the Decision and remanded the case for further consideration of the unexpected results evidence. Id.” slip op. at 2
- Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner
“We agree with Patent Owner and credit Dr. Davies’s testimony (Ex. 2024 ¶¶ 210–215) that a POSA would not have expected the Glu3 substitution to produce such a result. Indeed, the premise for Petitioner’s “conservative substitution” rationale is that the Glu3 substitution would have been expected to produce an analog having similar properties to human uroguanylin. See, e.g., Pet. 1, 36 (stating that a POSA “would have expected this particular conservative substitution to retain excellent receptor-activating activity”); Reply 3 (urging that the reason to modify a known compound may be an expectation that the new compound will have “similar properties to the old”) (internal quotations omitted). Patent Owner’s HPLC data, however, demonstrate a difference in kind between the data for SP-304 (a single HPLC peak) and uroguanylin (two distinct peaks corresponding to the active and inactive topoisomer) after incubation under the same conditions. As Dr. Davies explains, “topoisomers exist as a mixture of compounds with different[] spatial conformations” that are “continuously interconverting between spatial conformations” with “varying degrees of interconversion stability.” See Ex. 2024 ¶¶ 51–56. Thus, Patent Owner’s data show that the Glu3 substitution results in a peptide that is demonstrably more stable against interconversion than the parent, unmodified peptide.” slip op. at 35
- Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia with nexusObjective indicia outweighedDecided for patent owner
“We find Patent Owner’s evidence persuasive to show that the Glu3 substitution results in an unexpected improvement in interconversion stability. As explained above, RP-HPLC was a known technique for separating the topoisomers of human uroguanylin. Ex. 2010, 230–231; Ex. 2011, 27–28; Ex. 2020, 223; Ex. 2028, TRUL00018269; see also Ex. 1063 ¶¶ 37, 40 (Petitioner’s expert confirming same). It was also known that one of human uroguanylin’s topoisomers was biologically active, whereas the other, i.e., what we and the parties refer to as the “inactive” topoisomer, had significantly less or no activity at the same concentration. Ex. 2011, 31 (“compound I shows significant activity in the cGMP producing assay, whereas compound II is practically inactive”); see also Ex. 2010, 238–239 (Fig. 8) (showing the “A isomer” had a potency “with a minimal concentration between 10-7and 10-8 M,” but that the B isomer “had virtually no effect on cGMP level at 10-6 M”); Ex. 2074, 48 (compound II “showed maximal 10% of the activity of compound I at 10-6 M”). The chromatograph for uroguanylin in Patent Owner’s data is consistent with these teachings, showing two peaks representing the active and inactive topoisomers. Compare Ex. 2028, TRUL00018269 (Fig. 1) with Ex. 2011, 28 (Fig. 2). The chromatograph for SP-304 shows a markedly different result, i.e., a “single peak,” which was confirmed “using the cGMP T84 cell assay” to represent “the fully active conformer of SP-304.” Ex. 2028, TRUL00018269; Ex. 2024 ¶¶ 208–209. We agree with Patent Owner and credit Dr. Davies’s testimony (Ex. 2024 ¶¶ 210–215) that a POSA would not have expected the Glu3 substitution to produce such a result. Indeed, the premise for Petitioner’s “conservative substitution” rationale is that the Glu3 substitution would have been expected to produce an analog having similar properties to human uroguanylin. See, e.g., Pet. 1, 36 (stating that a POSA “would have expected this particular conservative substitution to retain excellent receptor-activating activity”); Reply 3 (urging that the reason to modify a known compound may be an expectation that the new compound will have “similar properties to the old”) (internal quotations omitted). Patent Owner’s HPLC data, however, demonstrate a difference in kind between the data for SP-304 (a single HPLC peak) and uroguanylin (two distinct peaks corresponding to the active and inactive topoisomer) after incubation under the same conditions. As Dr. Davies explains, “topoisomers exist as a mixture of compounds with different[] spatial conformations” that are “continuously interconverting between spatial conformations” with “varying degrees of interconversion stability.” See Ex. 2024 ¶¶ 51–56. Thus, Patent Owner’s data show that the Glu3 substitution results in a peptide that is demonstrably more stable against interconversion than the parent, unmodified peptide.” slip op. at 34
- ExcludeMotion to exclude, grantedGranted
“motion. The American Peptide letter contains out of court statements from a third party submitted by the EPO opponent. The statements in the letter were not made under oath, nor is there evidence that Patent Owner was ever able to question the author of that letter or anyone else with personal knowledge of the statements therein. Petitioner argues that the American Peptide letter is evidence “to doubt that the ‘singular peak’ for uroguanylin in Liu represents the active topoisomer of uroguanylin” because it evidences that American Peptide “provided its customers with the ‘B’ (i.e., inactive) form of uroguanylin at the time.” Pet. Remand Resp. 25. That is, Petitioner relies on the American Peptide letter for the truth of the matters asserted therein. Such use plainly implicates the rule against hearsay and falls squarely within our prior reasoning for excluding the Currie submission portion of Exhibit 1067. We incorporate that analysis herein. See Dec. 61–72. Petitioner asserts that the American Peptide letter is admissible under the residual hearsay exception in FRE 807. MTE Opp. 3–5. We disagree. The American Peptide letter was submitted by the EPO opponent specifically for the purpose of opposing a foreign counterpart to the ’786 patent. We see no reason to distinguish it from the other materials previously excluded as hearsay in the Currie submission. Petitioner’s assertion that it contains sufficient guarantees of trustworthiness because it was “provided by a neutral third-party” (American Peptide) and “an individual having first- hand knowledge, [American Peptide Company’s] VP of sales and marketing” is speculation. See id. at 3–4. Based on the record before us, Patent Owner has never been afforded an opportunity to examine anyone regarding the statements in this letter or even confirm that it is, in fact, a letter from the American Peptide Company. The mere fact that it was submitted in a foreign patent proceeding does not make it any more trustworthy than any other untested assertion offered by an adverse party in a legal proceeding.” slip op. at 58
Patent outcomesUS 7,041,786 not shown unpatentable§ 103 obviousnessPatents in suitUS 7,041,786 - MSN Laboratories Private Ltd. / MSN Pharmaceuticals Inc. v. Bausch Health Ireland LimitedNo claims unpatentablePTAB · Jan 27, 2026 · IPR2022-00722 · APJ Michael A Valek · IPR · Remand
Claims 1–6 were not shown unpatentable because the unexpected results from the Glu3 substitution outweighed the prima facie obviousness showing; Patent Owner’s motion to exclude was granted.
RulingsRemand decision- RemandOther
“More specifically, the Federal Circuit identified “three reasons” why “the Board’s determination that the[se] experiments compared the claimed invention with the closest prior art lack[ed] adequate explanation” and instructed us to address these issues on remand. See CAFC Dec. 11–13. First, the Court stated we “should determine, based on the evidence put forward by the parties, whether plecanatide exhibits topoisomerism and whether the testing of the challenged claims should encompass both the active and inactive forms.” Id. at 12.3 Second, the Court instructed us to reconsider what the closest prior art compound is in view of Patent Owner’s “contention that highly pure A-form uroguanylin could be maintained as a lyophilized powder,” noting that “[i]f it is true . . . that uroguanylin can be maintained and therefore tested in its active A form as a lyophilized powder, that would support that the experiments [which were conducted in solution] did not use the closest prior art.” Id. Third, the Court observed that the Decision did not sufficiently address “whether the experiments submitted by [Patent Owner] actually used” the closest prior art and instructed the Board “to reevaluate the experimental evidence consistent” with the determinations noted above. Id. at 12–13.” slip op. at 3
- Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia outweighedDecided for patent owner
“In sum, we find that there is a sufficient nexus between Patent Owner’s results and the challenged claims and that those results are reasonably commensurate with the same. Accordingly, for all of reasons explained above, the unexpected results Patent Owner relies upon are probative of non-obviousness. E. Conclusion for Ground 1 Weighing the record as a whole in view of the findings and analysis above as well as our findings and analysis relating to Petitioner’s prima facie showing in the Decision, we conclude that Petitioner has not met its burden to show that claim 1 would have been obvious over Currie and Li. The evidence suggesting that it would have been obvious to make the Glu3 substitution because it is a conservative substitution (see Dec. 20–38 (§ III.E.ii)) is substantially outweighed by Patent Owner’s comparatively strong evidence demonstrating unexpected results relating to improved interconversion stability, potency, and binding affinity from the Glu3 substitution. See Millennium Pharms., Inc. v. Sandoz Inc., 862 F.3d 1356, 1368 (Fed. Cir. 2017) (“Evidence of objective indicia [such as unexpected results] ‘can be the most probative evidence of nonobviousness in the record,’ and . . . enable[s] ‘the court to avert the trap of hindsight.’”) (quoting Leo Pharm. Prods., Ltd. v. Rea, 726 F.3d 1346, 1358 (Fed. Cir. 2013). Indeed, the interconversion and potency categories of Patent Owner’s unexpected results showing are particularly strong such that even without the additional results in Liu, we would still reach the same ultimate conclusion on obviousness. Accordingly, Petitioner has not shown by a preponderance of the evidence that claim 1 is unpatentable.” slip op. at 56
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for patent owner
“same combination of Currie and Li for the limitations of claim 1 and the similar limitations recited in the other independent claims. In the Decision, we found that, based on the teachings in those references, an ordinarily-skilled artisan would have been motivated both to select human uroguanylin as a lead compound and modify its sequence by making a conservative Glu3 substitution for uroguanylin’s Asp3. Dec. 15–37. We did not, however, credit Petitioner’s other purported rationales for that modification. Id. at 34–37. Those findings were not disturbed on appeal. See CAFC Dec. 6–8 (rejecting 9 The Leahy-Smith America Invents Act, Pub. L. No. 112–29, 125 Stat. 284 (2011) (“AIA”), included revisions to 35 U.S.C. § 103 that became effective after the filing of the application that led to the ’786 patent. Therefore, we apply the pre-AIA version of 35 U.S.C. § 103. 10 U.S. Pat. 5,489,670, issued Feb. 6, 1996 (Ex. 1005) (“Currie”). 11 Z. Li et al., Purification, cDNA Sequence, and Tissue Distribution of Rat Uroguanylin, 68 Regulatory Peptides 45–56 (1997) (Ex. 1006) (“Li”). 12 R. Narayani et al., Polymer-coated Gelatin Capsules as Oral Delivery Devices and their Gastrointestinal Tract Behavior in Humans, 7 J. Biomater. Sci. Polymer Edn. 39–48 (1995) (Ex. 1007) (“Narayani”). 13 M. Campieri et al., Oral Budesonide is as Effective as Oral Prednisolone in Active Crohn’s Disease, 41 Gut 209–214 (1997) (Ex. 1008) (“Campieri”). 14 U.S. Pat. 5,359,030, issued Oct. 25, 1994 (Ex. 1009) (“Ekwuribe”). Patent Owner’s alternative arguments for affirmance). We incorporate by reference the portions of the Decision addressing Petitioner’s prima facie showing herein. See Dec. 8–37 (§§ III.A–D and E.i–ii). We consider the findings and explanation therein to the extent it bears on our analysis below.” slip op. at 10
- ExcludeMotion to exclude, grantedGranted
“motion. The American Peptide letter contains out of court statements from a third party submitted by the EPO opponent. The statements in the letter were not made under oath, nor is there evidence that Patent Owner was ever able to question the author of that letter or anyone else with personal knowledge of the statements therein. Petitioner argues that the American Peptide letter is evidence “to doubt that the ‘singular peak’ for uroguanylin in Liu represents the active topoisomer of uroguanylin” because it evidences that American Peptide “provided its customers with the ‘B’ (i.e., inactive) form of uroguanylin at the time.” Pet. Remand Resp. 25. That is, Petitioner relies on the American Peptide letter for the truth of the matters asserted therein. Such use plainly implicates the rule against hearsay and falls squarely within our prior reasoning for excluding the Currie submission portion of Exhibit 1067. We incorporate that analysis herein. See Dec. 61–72. Petitioner asserts that the American Peptide letter is admissible under the residual hearsay exception in FRE 807. MTE Opp. 3–5. We disagree. The American Peptide letter was submitted by the EPO opponent specifically for the purpose of opposing a foreign counterpart to the ’786 patent. We see no reason to distinguish it from the other materials previously excluded as hearsay in the Currie submission. Petitioner’s assertion that it contains sufficient guarantees of trustworthiness because it was “provided by a neutral third-party” (American Peptide) and “an individual having first- hand knowledge, [American Peptide Company’s] VP of sales and marketing” is speculation. See id. at 3–4. Based on the record before us, Patent Owner has never been afforded an opportunity to examine anyone regarding the statements in this letter or even confirm that it is, in fact, a letter from the American Peptide Company. The mere fact that it was submitted in a foreign patent proceeding does not make it any more trustworthy than any other untested assertion offered by an adverse party in a legal proceeding. For these reasons, we grant Patent Owner’s motion to exclude page 86 of Exhibit 1067.” slip op. at 58
Patent outcomesUS 7,041,786 not shown unpatentableClaim construction§ 103 obviousnessPatents in suitUS 7,041,786 - Dr. Falk Pharma GmbH v. Ellodi Pharmaceuticals, L.P.Adverse judgmentPTAB · Jan 26, 2026 · IPR2025-00055 · APJ Zhenyu Yang · IPR · Adverse judgment
The Board granted Patent Owner’s motion, entered adverse judgment against Patent Owner on claims 1–42 after statutory disclaimer, and terminated the proceeding.
RulingsAdverse judgment- Adverse judgmentAdverse judgmentGranted
“A party may request judgment against itself at any time during a proceeding. 37 C.F.R. § 42.73(b). Under the Rules, actions construed as a request for entry of adverse judgment include “[c]ancellation or disclaimer of a claim such that the party has no remaining claim in the trial.” 37 C.F.R. § 42.73(b)(2). Here, Patent Owner has disclaimed, under 37 C.F.R. § 1.321, claims 1–42 of the ’407 patent, which constitute all challenged claims involved in this trial. See Ex. 2031. We thus construe the statutory disclaimer as a request for entry of adverse judgment. Having reviewed the statutory disclaimer, we determine that adverse judgment against Patent Owner with respect to claims 1–42 of the ’407 patent is appropriate.” slip op. at 2
NonePatents in suitUS 9,486,407 - Dr. Falk Pharma GmbH v. Ellodi Pharmaceuticals, L.P.Adverse judgmentPTAB · Jan 23, 2026 · IPR2025-00054 · APJ John G New · IPR · Adverse judgment
The Board granted Patent Owner’s unopposed motion and entered adverse judgment against Patent Owner as to claims 1–16 after statutory disclaimer.
RulingsAdverse judgment- Adverse judgmentAdverse judgmentGranted
“A party may request judgment against itself at any time during a proceeding. Actions construed to be a request for adverse judgment include … [d]isclaimer of the involved application or patent.” 37 C.F.R. § 42.73(b)(1). We find that good cause exists to grant Patent Owner’s unopposed request for adverse judgment and to terminate this proceeding. Consequently, we grant Patent Owner’s Motion to Terminate and Request for Adverse Judgment. slip op. at 2
NonePatents in suitUS 11,246,828 - Dr. Falk Pharma GmbH v. Ellodi Pharmaceuticals, L.P.Adverse judgmentPTAB · Jan 23, 2026 · IPR2025-00052 · APJ John G New · IPR · Adverse judgment
The Board granted Patent Owner’s unopposed motion and entered adverse judgment against Patent Owner as to claims 1–17 following statutory disclaimer of all claims.
RulingsAdverse judgment- Adverse judgmentAdverse judgmentGranted
“A party may request judgment against itself at any time during a proceeding. Actions construed to be a request for adverse judgment include … [d]isclaimer of the involved application or patent.” 37 C.F.R. § 42.73(b)(1). We find that good cause exists to grant Patent Owner’s unopposed request for adverse judgment and to terminate this proceeding. Consequently, we grant Patent Owner’s Motion to Terminate and Request for Adverse Judgment. slip op. at 2
NonePatents in suitUS 10,632,069 - Dr. Falk Pharma GmbH v. Ellodi Pharmaceuticals, L.P.Adverse judgmentPTAB · Jan 23, 2026 · IPR2025-00056 · APJ Ryan H Flax · IPR · Adverse judgment
The Board entered adverse judgment against Patent Owner on claims 1–30 after it statutorily disclaimed all claims, and terminated the IPR.
RulingsAdverse judgment- Adverse judgmentAdverse judgmentGranted
“A party may request judgment against itself at any time during a proceeding. Actions construed to be a request for adverse judgment include . . . [d]isclaimer of the involved application or patent.” 37 C.F.R. § 42.73(b)(1). We find good cause exists to grant Patent Owner’s unopposed request for adverse judgement and to terminate this proceeding. Thus, we grant Patent Owner’s Motion to Terminate and Request for Adverse Judgment. slip op. at 2
NonePatents in suitUS 11,260,061 - Ipr2025-01180InstitutedPTAB · Jan 16, 2026 · IPR2025-01180 · APJ John A Squires · IPR · Director review
The Director granted institution of IPR2025-01180 after finding a reasonable likelihood of prevailing on at least one challenged claim and no other non-discretionary reason to deny institution.
RulingsDirector review decision- Director reviewDirector review, grantedGranted
“Pursuant to 35 U.S.C. § 314(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, and no other non-discretionary considerations warrant denial of institution. Accordingly, institution of inter partes review is granted in the following proceedings:” slip op. at 3
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Pursuant to 35 U.S.C. § 314(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, and no other non-discretionary considerations warrant denial of institution. Accordingly, institution of inter partes review is granted in the following proceedings:” slip op. at 3
NonePatents in suitUS 11,864,641 - Boe Technology Group Co., Ltd. v. Optronic Sciences LLCAdverse judgmentPTAB · Jan 12, 2026 · IPR2024-01134 · APJ Thu A Dang · IPR · Adverse judgment
The Board denied Patent Owner’s termination request and granted adverse judgment after it disclaimed the entire patent, leaving no claims in the trial.
RulingsAdverse judgment- Adverse judgmentAdverse judgmentGranted
“C.F.R. § 42.73(b), a party may request judgment against itself at any time during a proceeding. “Actions construed to be a request for adverse judgment include: . . . [c]ancellation or disclaimer of a claim such that the party has no remaining claim in the trial.” 37 C.F.R. § 42.73(b)(2). “The application of the [adverse judgment] rule on its face does not turn on the patentee’s characterization of its own request.” Arthrex, Inc. v. Smith & Nephew, Inc., 880 F.3d 1345, 1349 (Fed. Cir. 2018). In this case, Patent Owner’s disclaimer of the entire term of the ’733 patent leaves no claims remaining in the trial. Although Patent Owner argues that entry of adverse judgment “has negative effects that would discourage Patent Owner from making efforts to streamline the issues” (PO Sur-reply 1–2), we deem such argument not a persuasive reason as to why we should not apply § 42.73(b)(2), or why termination is more appropriate. Therefore, pursuant to 37 C.F.R. § 42.73(b)(2), we construe Patent Owner’s disclaimer as a request for adverse judgment, which we grant.” slip op. at 3
NonePatents in suitUS 9,406,733 - Boe Technology Group Co., Ltd. v. Optronic Sciences LLCAdverse judgmentPTAB · Jan 12, 2026 · IPR2024-01315 · APJ Kevin W Cherry · IPR · Adverse judgment
The Board denied Patent Owner’s termination request and entered adverse judgment after Patent Owner disclaimed all challenged claims, leaving no claims in the trial.
RulingsAdverse judgment- Adverse judgmentAdverse judgmentGranted
“C.F.R. § 42.73(b), a party may request judgment against itself at any time during a proceeding. “Actions construed to be a request for adverse judgment include: . . . [c]ancellation or disclaimer of a claim such that the party has no remaining claim in the trial.” 37 C.F.R. § 42.73(b)(2). “The application of the [adverse judgment] rule on its face does not turn on the patentee’s characterization of its own request.” Arthrex, Inc. v. Smith & Nephew, Inc., 880 F.3d 1345, 1349 (Fed. Cir. 2018). In this case, Patent Owner’s disclaimer of claims 1 and 3 of the ’477 patent leaves no claims remaining in the trial. Although Patent Owner argues that entry of adverse judgment “has negative effects that would discourage Patent Owner from making efforts to streamline the issues” (PO Sur-reply 1–2), we deem such argument not a persuasive reason as to why we should not apply § 42.73(b)(2), or why termination is more appropriate. Therefore, pursuant to 37 C.F.R. § 42.73(b)(2), we construe Patent Owner’s disclaimer as a request for adverse judgment, which we grant.” slip op. at 3
NonePatents in suitUS 8,158,477 - Mylan Pharmaceuticals Inc. / Teva Pharmaceuticals USA, Inc. et al. v. Bayer Pharma AktiengesellschaftAdverse judgmentPTAB · Jan 12, 2026 · IPR2022-01513 · APJ Ryan H Flax · IPR · Adverse judgment
The Board granted Petitioners’ withdrawal and entered adverse judgment against them on remanded claims 5–8; claims 1–4 remained affirmed as unpatentable.
RulingsAdverse judgment- Adverse judgmentAdverse judgmentGranted
“A party may request judgment against itself at any time during a proceeding. Actions construed to be a request for adverse judgment include: . . . [a]bandonment of the contest.” 37 C.F.R. §42.73(b)(4). We find good cause exists to grant Petitioners’ request to withdraw from the proceedings, which is a request for adverse judgement (with respect to challenged claims 5–8). slip op. at 3
NonePatents in suitUS 10,828,310
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.