- 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 - PTAB · Jul 15, 2022 · PGR2021-00030 · APJ Sheridan K Snedden · PGR · Rehearing
Patent Owner’s rehearing request was granted, and institution was denied for all challenged claims based on changed circumstances in the parallel district court proceeding under Fintiv.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“Having considered the parties’ positions and evidence of record, summarized above, we agree with Patent Owner that a rehearing of our prior institution decision is appropriate due to the changed circumstances of: (1) the statutory disclaimer of claims 6–8 of the ’039 patent, (2) Patent Owner’s request for adverse judgment of related proceeding PGR2021-00042, and (3) the additional investment in the parallel proceeding by the district court and the parties, including the completion of a jury trial that resulted in a jury verdict not finding invalidity of the challenged claims. We further agree with Patent Owner that “[c]ontinuing with this proceeding would result in duplicative efforts and potentially conflicting results between the district court and the Board.” Reh’g Req. 9. It is the combination of these changed circumstances, rather than any one of them individually, that compels the result we reach.” slip op. at 7
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivInstitution denied
“In considering the parties’ positions and the evidence of record, we note that we have been instructed not to exercise discretion to deny a petition when “the information presented at the institution stage presents a compelling unpatentability challenge.” Guidance Memo 4–5. We previously described “Petitioner’s argument that the claims lack enablement” as presenting “strong merits.” Paper 17, 3. Despite that determination, we believe the record as it stands currently does not “present[] a compelling unpatentability challenge” on the lack-of-enablement issue. Guidance Memo 4–5. The district court already has substantially completed its review of the enablement issue, and a jury has determined that the claims do not lack enablement. Given this new information, we cannot conclude that Petitioner’s enablement case is compelling.” slip op. at 6
- Adverse judgmentOther
Discretionary denialPatents in suitUS 10,808,039 - Daiichi Sankyo, Inc. / Astrazeneca Pharmaceuticals, LP v. Seagen Inc.Institution deniedPTAB · Jun 24, 2021 · PGR2021-00042 · APJ Sheridan K Snedden · PGR · Institution
The Board denied institution of PGR on claims 6–8 under § 324(a), finding that the Fintiv factors favored discretionary denial despite potential merit in the enablement challenge.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied
“parties. We recognize that many legitimate reasons may lead a party not to file a motion to stay a parallel proceeding prior to the Board’s institution decision, including because such a motion may be viewed as premature. Be that as it may, our precedential guidance instructs us to consider whether the court has granted a stay of the parallel proceeding, or whether evidence exists that a stay may be granted upon institution. Fintiv Order at 5–6. As it stands, the record lacks sufficient evidence to suggest that a stay has been granted, or may be granted in the future. It is a judge who determines whether to grant a stay based on the facts of each specific case as presented in the briefs by the parties. We decline to infer, based on actions taken in different cases with different facts, how the district court judge would rule should a stay be requested in the Texas Litigation. For these reasons, we determine that the facts underlying this factor are neutral.” slip op. at 14
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied
“35 U.S.C. § 324(c); 37 C.F.R. § 42.4(a). The standard is set forth in § 324(a), which provides that a post-grant review shall not be instituted unless “the Director determines that the information presented in the petition filed under section 321, if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.”” slip op. at 2
Discretionary denialPatents in suitUS 10,808,039 - Daiichi Sankyo, Inc. / Astrazeneca Pharmaceuticals, LP v. Seagen Inc.Institution deniedPTAB · Jun 24, 2021 · PGR2021-00030 · APJ Sheridan K Snedden · PGR · Institution
The Board denied institution of post-grant review for claims 1–5, 9, and 10 under § 324(a), finding the Fintiv factors favored discretionary denial.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivInstitution denied
“Additionally, the Board’s precedential Fintiv Order identifies several factors to be considered when analyzing issues related to the Director’s discretion to deny institution, with the goal of balancing efficiency, fairness, and patent quality. See Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 at 5‒6 (PTAB Mar. 20, 2020) (precedential) (“the Fintiv Order”). These factors include: 1) whether a stay exists or is likely to be granted if a” slip op. at 10
Discretionary denialPatents in suitUS 10,808,039 - Ethicon, Inc. v. Board Of Regents, The University Of Texas SystemInstitution deniedPTAB · Jun 10, 2020 · IPR2019-00406 · APJ Avelyn M Ross · IPR · Institution
The Board denied institution of IPR on all challenged claims, exercising § 314(a) discretion because the parallel district court case was advanced, overlapping, and likely to conclude first.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivInstitution denied
“waive a jury demand, a trial “will happen sooner if it is scheduled as a bench trial than it will as a jury trial.” Id. at 14:20–24. According to the Court, the parties should expect trial to occur within a year. See id. at 17:21–23 (“What I’m telling you is that you will get reached in sooner than a year, in all likelihood.”). Both parties withdrew their request for a jury demand. See Ex. 3006. Were we to institute inter partes review, a final written decision in this proceeding would issue in June 2021—leaving a year before resolution of this proceeding. Given the Western District of Texas’ emphasis that the parallel litigation should proceed as if still set for June 22, 2020, and its expectation of holding a bench trial within a year, this factor weighs strongly in favor of discretionary denial in this case.” slip op. at 10
Discretionary denialPatents in suitUS 6,596,296 - Edwards Lifesciences Corp. / Edwards Lifesciences LLC v. Evalve, Inc.Institution deniedPTAB · Mar 19, 2020 · IPR2019-01546 · APJ Susan L C Mitchell · IPR · Institution
The Board denied institution on all challenged claims under § 314(a), citing the advanced district court litigation, substantial overlap, and the trial scheduled well before a final Board decision.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivInstitution denied
“First, trial is set to conclude well before a final decision would be due in this proceeding. Here, the district court has scheduled a five-day jury trial to begin on May 6, 2020. Ex. 3001, November 21, 2019, minute order. The Court’s comments in the docket reflect an intent to preserve this trial date. Id. at docket entry 333 (considering Patent Owner’s motion to amend the complaint to be withdrawn because it would require a substantial of extension of the trial date). Also, it appears from the district court’s docket that extensive pre-trial briefing by the parties, including motions to exclude or strike expert testimony, is well underway. See Ex. 3001, docket entries 352–359. The parties are also seeking partial summary judgment on various issues in view of the upcoming trial. Id. at docket entries 340–351. Accordingly, we expect that the jury trial in the district court proceeding would conclude more than ten months before a final decision would be due. See Prelim. Resp. 9; 35 U.S.C. § 316(a)(11); 37 C.F.R. § 42.100; NHK, IPR2018-00752, Paper 8, 19–20 (exercising discretion to deny institution where trial was set to occur six months before the Board’s expected final decision). Second, there is substantial overlap between the arguments raised in the district court litigation and those raised in the Petition. Petitioner relies predominantly on the same prior art – Kuehn, Tremulis, Roth, and Skelton – in both proceedings to challenge patentability and articulates substantially the same arguments as to why the combination of the teachings of these references renders obvious claims 1, 4, 6, 10, 11, 14, 16, 1720, 22, 33, and 34 of the ’388 patent. Compare Pet. 30–79 (argument with respect to Grounds 1 and 2), with Ex. 2063, 193–238 and Ex. 2013 (redline comparison of arguments from the Petition and arguments in the invalidity contentions filed in the district court litigation). In addition, the claim constructions requested in this proceeding overlap with those addressed in the district court proceeding and would be decided under the same claim construction standard.9 Pet. 22–28; Ex. 2061, 2–3, 11–13; Ex. 2062, 2. Third, both the parties and the district court have already directed substantial time and energy toward resolving the district court litigation. 9 The claim construction standard to be employed in an inter partes review recently changed from broadest reasonable interpretation to “the same claim construction standard used by Article III federal courts . . . which follow According to Patent Owner, as of the filing of its Preliminary Response, the parties had “produced over 2 million pages of documents and . . . taken around 50 depositions.” Prelim. Resp. 8. Similarly, as already discussed, the district court has been asked to decide a motion of a temporary restraining order (Ex. 3001, docket entry 63), a motion for a preliminary injunction (id. at docket entries 164, 165, and 166),10 and claim construction (id. at docket entry 297). The District Court held lengthy hearings regarding the preliminary injunction motion and claim construction that involve many of the issues presented here. Id. at docket entry 122 (minute order giving the parties 3 hours each to present arguments regarding the preliminary injunction motion); id.at docket entry 219 (minute order allocating 3 hours to be split between the parties for a Markman hearing). The district court has also been asked to rule on numerous discovery disputes. Id. at docket entries 26, 66, 74, 75, 184, 265, and 305, and at March 22, 2019 minute order. Given how far advanced the litigation is, the continued indication that trial will proceed as scheduled, and the substantial work involving many of the same issues presented here already accomplished by the district court and the parties, institution of an inter partes review here cannot be considered to be an efficient or effective alternative to the litigation.” slip op. at 10
Discretionary denialcites PhillipsPatents in suitUS 7,736,388
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.