- 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 - Arthrex, Inc. v. Medshape, Inc.Institution deniedPTAB · Apr 25, 2025 · IPR2025-00053 · APJ James A Tartal · IPR · Institution
The Board denied institution of IPR challenging claims 1–10, exercising § 314(a) discretion because the Fintiv factors, considered holistically, favored denial.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied discretionary otherInstitution denied
“review. 35 U.S.C. § 314(b) (2018); 37 C.F.R. § 42.4(a) (2023). An inter partes review may not be instituted “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.” 35 U.S.C. § 314(a). However, institution of inter partes review is discretionary. Upon consideration of the Petition, the Preliminary Response, the Preliminary Reply, the Preliminary Sur-reply, and the evidence of record, we exercise our discretion to deny institution of inter partes review under 35 U.S.C. § 314(a) in view of the co-pending district court litigation.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“7. Balancing the Fintiv Factors As discussed above, factors 1 and 3–5 each favor denial. Factor 2 is the only factor that favors institution because there is no trial date in the Parallel Proceeding and the evidence presented of a median time-to-trial for civil trials in that district suggests a potential trial date after the statutory deadline for a final written decision in this proceeding. However, Patent Owner also shows that discovery and any dispositive motions will be completed in the Parallel Proceeding well before the statutory deadline for a final written decision in this proceeding, which presents a risk of duplicated efforts given the unmitigated overlap in issues between proceedings. On balance, considerations concerning an uncertain trial date in the Parallel Proceeding under Factor 2 do not outweigh the more substantial reasons identified under the other Fintiv Factors. Thus, considering all of the factors holistically, we find on balance that the factors on this unique record weigh in favor of discretionary denial of the Petition. Accordingly, we exercise discretion to deny institution under 35 U.S.C. § 314(a).” slip op. at 15
Discretionary denialPatents in suitUS 7,985,222
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.