- Formycon AG v. Regeneron Pharmaceuticals, Inc.Institution deniedPTAB · Jun 2, 2025 · IPR2025-00233 · APJ Michael A Valek · IPR · Institution
The Board denied institution under § 314(a) based on the Fintiv factors and denied joinder; it did not reach the merits of the asserted grounds.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivInstitution denied
“B. The Fintiv Factors and Related Guidance The Board’s precedential decision in Fintiv outlines factors that balance considerations of system efficiency, fairness, and patent quality when a patent owner raises an argument for discretionary denial due to the advanced state of a parallel proceeding, such as the MDL proceeding here. Fintiv 5–6. These factors are: 1. whether the court granted a stay or evidence exists that one may be granted if a proceeding is instituted; 2. proximity of the court’s trial date to the Board’s projected statutory deadline for a final written decision; 3. investment in the parallel proceeding by the court and the parties; 4. overlap between issues raised in the petition and in the parallel proceeding; 5. whether the petitioner and the defendant in the parallel proceeding are the same party; and 6. other circumstances that impact the Board’s exercise of discretion, including the merits. Id. “[I]n evaluating the factors, the Board takes a holistic view of whether efficiency and integrity of the system are best served by denying or instituting review.” Id. at 6.” slip op. at 10
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied
“III. DISCRETION UNDER 35 U.S.C. § 314(A) We begin by addressing Patent Owner’s arguments for discretionary denial. As explained below, we find those arguments persuasive. Thus, we exercise discretion to deny institution of the Petition under 35 U.S.C. § 314(a) without reaching the merits of Petitioner’s asserted grounds of unpatentability.” slip op. at 8
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, deniedDenied
“35 U.S.C. § 314(a) to deny institution of the Petition and deny the Joinder Motion.” slip op. at 2
Discretionary denialPatents in suitUS 11,084,865 - Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc.Institution deniedPTAB · Jun 2, 2025 · IPR2025-00176 · APJ Michael A Valek · IPR · Institution
The Board denied institution of IPR on all challenged claims under § 314(a), finding the Fintiv factors—particularly investment, overlap, and merits—weighed against review.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“raised by this overlap, but given the circumstances, it does not effectively mitigate them. First, the disputed issues for Petitioner’s ODP defense are the same or substantially similar to those for the obviousness grounds in the Petition, but the Sotera stipulation does not prevent Petitioner from litigating those issues before both the district court (as part of its ODP defense) and here in the event an IPR is instituted.19 Second, the MDL proceeding 19 ODP or nonstatutory double patenting is, as the name implies, not premised on any statute. See, e.g., Ostuka Pharm. Co., Ltd. v. Sandoz, Inc., 678 F.3d 1280, 1297 (Fed. Cir. 2012) (“Nonstatutory double patenting is a judicially created doctrine grounded in public policy.”). Accordingly, it is not a ground Petitioner reasonably could have raised in this IPR. See 35 U.S.C. § 311(b) (inter partes review may be requested “only on a ground that could be raised under section 102 or 103”). includes other biosimilar applicant defendants who are similarly motivated to try to invalidate the ’865 patent claims, but who are not subject to any Sotera stipulation. Even if we institute review on Petitioner’s grounds here, those other defendants remain free to litigate the same grounds in the consolidated MDL proceeding. For these reasons and given the particular circumstances of this case, Petitioner’s Sotera stipulation does not sufficiently mitigate the risks of duplicated efforts or inconsistent decisions by making this IPR a “true alternative” to resolution of these issues by the district court. See Motorola Solutions, Inc. v. Stellar, LLC, IPR2024-01205, Paper 19, 3–4 (PTAB Mar. 28, 2005) (determining on Director Review that a Sotera stipulation did not ensure IPR would be a “true alternative” because Petitioner’s invalidity arguments “include combinations of the prior art asserted in these proceedings with unpublished system prior art, which Petitioner’s stipulation is not likely to moot” and thus the same or similar issues would remain in the parallel proceeding); SAP America, Inc. v. Cyandia, Inc., IPR2024-01496, Paper 13, 8–9 (PTAB Apr. 7, 2025) (similar).” slip op. at 19
Discretionary denialPatents in suitUS 11,084,865 - Cipla Limited v. Gilead Sciences, Inc.Institution deniedPTAB · May 15, 2025 · IPR2025-00033 · APJ Susan L C Mitchell · IPR · Institution
The Board denied institution of IPR on claims 1–13 under § 314(a), finding the Fintiv factors favored denial and the petition did not present compelling merits.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivDenied
“We determine that this factor weighs heavily in favor of exercising discretion to deny the Petition. The trial date in the district court litigation is scheduled for October 6, 2025. See Prelim. Resp. 16 (citing Ex. 2010). This date is at least six months before our projected statutory deadline should we go forward in this case. Patent Owner points out that this trial date is nine months later than the median time to trial in the District of Delaware, and in Patent Owner’s view, the parties are on track to satisfy the current schedule. Id. at 16–17 (citing Ex. 2011).” slip op. at 9
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached
“1 Patent Owner also asserts that the Petition should be denied under 35 U.S.C. § 325(d), but we need not reach this issue because we are exercising discretion under Section 314(a) to deny the Petition. See Prelim. Resp. 2–3.” slip op. at 2
Discretionary denialPatents in suitUS 11,744,802 - Solus Advanced Materials Co, Ltd. v. SK Nexilis Co., Ltd.Institution deniedPTAB · Apr 22, 2025 · IPR2024-01460 · APJ Jon B Tornquist · IPR · Institution
The Board denied institution of review of claims 1–11 because the Fintiv factors, including the early trial date and close merits case, favored discretionary denial.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied fintivInstitution denied
“whether to institute an inter partes review. Applying the standard set forth in 35 U.S.C. § 314(a), we may not institute an inter partes review unless the information presented in the petition “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.” Institution of inter partes review, however, is discretionary. See Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1367 (Fed. Cir. 2016) (“[T]he PTO is permitted, but never compelled, to institute an IPR proceeding.”). For the reasons stated below, we exercise our discretion not to institute an inter partes review. A. Real Parties-in-Interest” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivDenied
“Board’s projected statutory deadline to issue a final written decision. Fintiv, Paper 11 at 9. “If the court’s trial date is at or around the same time as the projected statutory deadline . . . the decision whether to institute will likely implicate other factors.” Id. Conversely, “[i]f the court’s trial date is earlier than the projected statutory deadline,” this has generally weighed “in favor of exercising authority to deny institution.” Id.” slip op. at 15
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached
“Petition under 35 U.S.C. § 325(d) because the same or substantially the same art and arguments were before the Examiner during prosecution and Petitioner’s has not demonstrated that the Examiner erred in a material manner when allowing the claims. Pet. 17–18. Given our discretionary denial of the Petition in view of the Fintiv factors, we do not address Petitioner’s further arguments with respect to § 325(d).” slip op. at 32
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner applies Petitioner’s recited level of ordinary skill in the art for purposes of its Preliminary Response. Prelim. Resp. 4. Upon review of the parties’ arguments and the prior art of record, we adopt Petitioner’s unopposed definition of the ordinarily skilled artisan for purposes of this decision as it appears consistent with the disclosures of the ’090 patent and the prior art of record. C. Claim Construction” slip op. at 9
§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 10,480,090 - U.S. Venture, Inc. v. Sunoco Partners Marketing & Terminals L.P.Rehearing deniedPTAB · Dec 17, 2020 · IPR2020-00728 · APJ Brent M Dougal · IPR · Rehearing
The Board denied rehearing, leaving in place its denial of institution for claims 16–17 based on the Fintiv factors and its § 314(a) discretion.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“When rehearing a decision on institution, the Board reviews the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may arise if the decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if an unreasonable judgment is made in weighing relevant factors. Star Fruits S.N.C. v. U.S., 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000). The burdens and requirements of a request for rehearing are stated in 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. Thus, a request for rehearing is not an opportunity to present new arguments or evidence or merely to disagree with the panel’s assessment of the arguments or weighing of the evidence.” slip op. at 3
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for patent owner
“the evidence laid out an approximate time frame for when the trial would likely be held. Dec. 9 (citing Ex. 2003); see also id. at 8–9 (citing PO Resp. 35; Ex. 1026) (Discussing the Court’s Procedures and timeline for trial after the docket call). Thus, we determined that this factor favored denying institution under our analysis of the factors under Fintiv. Id. at 9.” slip op. at 4
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“Petitioner acknowledges that the proposed combination of the references relies on “us[ing] the cumulative totals of the flow rates of the unblended components in the Hoffman compensation process” (id.), however Patent Owner identifies that Hoffman appears to teach away from using the flow rates of the unblended components in its calculations because of the uncertainty in the flow rate of the blended line. Prelim. Resp. 19, 21– 22. Contrary to Petitioner’s position, it is not Patent Owner’s burden to show why “a person of ordinary skill in the art would be discouraged from measuring flow rates upstream for use in the Hoffman compensation process” (Reh. Req. 9), but rather, Petitioner bears the burden to show why a person of ordinary skill in the art would measure flow rates upstream for use in the Hoffman compensation process in view of the all of the teachings of the references (35 U.S.C. § 314(a) (Institution only authorized if “the information presented in the petition . . . 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.”)). Petitioner’s arguments do not show that we misapprehended or” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languageNot reached
“argument concerning the construction of the term “in-line blending.” Id. at 13.” slip op. at 6
Claim construction§ 103 obviousnessDiscretionary denialPatents in suitUS 9,207,686
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.