- Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · Oct 15, 2026 · PGR2025-00030 · APJ Susan L C Mitchell · PGR · Final written decision
Claims 1, 2, and 6–30 are unpatentable under §112(a) for lack of written description and lack of enablement; the §103 ground was not reached.
RulingsFinal written decision- Additional discoveryAdditional discovery, deniedDenied
“Patent Owner filed a Motion for Additional Discovery (Paper 42), Petitioner opposed the motion (Paper 44), and the Board denied the motion (Paper 47).” slip op. at 3
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther
“of the ’758 patent supports an understanding that some activity is required for a polypeptide to be a “modified PH20 polypeptide,” and it is the enzymatic activity of hyaluronidase specifically that is the most frequently identified activity recited in the Definitions section of the ’758 patent. Indeed, both the definitions of “PH20” and “modified PH20 polypeptide” require hyaluronidase activity. See Ex. 1001, 45:54–55, 50:39–41 (“PH20 refers to a type of hyaluronidase that . . . is neutral-active” and “neutral active refers to the ability . . . to enzymatically catalyze the cleavage of hyaluronic acid at neutral pH”); 48:43–46 (“A modified PH20 polypeptide can have up to 150 amino acid replacements so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.”). Similar language is used later in the definition of a “conjugate” to explain that even when the modified PH20 polypeptide is linked to another polypeptide or chemical moiety it “retains hyaluronidase activity.” Id. at 63:39–46. In contrast, the discussion regarding the potential use of “modified PH20 polypeptides that are inactive” as antigens in contraception vaccines appears only in non-definitional sections of the ’758 patent. Id. at 72:63–65, 75:60–62. Accordingly, we find that this disclosure does not modify the definition’s explicit requirement that the claimed “modified PH20 polypeptide” exhibit hyaluronidase activity. Id. at 48:38–46.” slip op. at 21
- Skill levelOther
“II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 9
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“this testimony to at most describe a research plan (i.e., a “tool to engage in further modification”16) for finding the recited polypeptides rather than demonstrating the inventors were in possession of the full scope claimed. This is particularly so given the limits of the then-available analytical tools noted above and the fact that the structural connections and three dimensional modeling Patent Owner’s experts attempt to make (see, e.g., Ex. 2070 ¶¶ 129–213; Ex. 2068 ¶¶ 123–125) do not appear in the written description itself. To the extent the experts disagree on this point, we credit the testimony of Petitioner’s experts over that of Patent Owner’s. See Ex. 1133 ¶¶ 111–251 (identifying problems with the approaches proposed by Patent Owner’s experts). For these reasons, we find that a preponderance of the evidence of record better supports a finding that in the 2011–2012 timeframe, it would have been unpredictable to identify which multiple mutants retained hyaluronidase activity, even with the single substitution data provided by the ’758 patent.” slip op. at 56
Patent outcomesUS 12,054,758 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 12,054,758 - Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · Oct 15, 2026 · PGR2025-00024 · APJ Susan L C Mitchell · PGR · Final written decision
Claims 1, 2, 6–15, and 17–30 are unpatentable under §112(a) for lack of written description and enablement; the §103 ground was not reached.
RulingsFinal written decision- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“this testimony to at most describe a research plan (i.e., a “tool to engage in further modification”16) for finding the recited polypeptides rather than demonstrating the inventors were in possession of the full scope claimed. This is particularly so given the limits of the then-available analytical tools noted above and the fact that the structural connections and three dimensional modeling Patent Owner’s experts attempt to make (see, e.g., Ex. 2070 ¶¶ 129–213; Ex. 2068 ¶¶ 123–125) do not appear in the written description itself. To the extent the experts disagree on this point, we credit the testimony of Petitioner’s experts over that of Patent Owner’s. See Ex. 1133 ¶¶ 111–250 (identifying problems with the approaches proposed by Patent Owner’s experts). For these reasons, we find that a preponderance of the evidence of record better supports a finding that in the 2011–2012 timeframe, it would have been unpredictable to identify which multiple mutants retained hyaluronidase activity, even with the single substitution data provided by the ’590 patent.” slip op. at 56
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable
“6. Analysis Petitioner has the burden to identify how the Specification allegedly” slip op. at 75
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“4. Analysis Based on the evidence of record, we agree with Patent Owner that Petitioner has not provided any persuasive reason to particularly target the leucine at position 307 of a PH20 polypeptide for modification as recited in claim 1 of the ’590 patent. It is undisputed that neither of the cited prior art references, the ’429 patent or Chao, specifically identifies or discusses position 307 of the PH20 polypeptide. See, e.g., Pet. 88‒109; PO Resp. 86‒ 93. We are not persuaded by Petitioner’s argument that multiple sequence alignments identify amino acids that are tolerated at particular positions (see Pet. 99‒109), because tolerance is not a positive reason to make a substitution. “It is not enough, even after KSR, to support a determination of obviousness that a reference includes a broad generic disclosure and a common utility to that in the claims and other prior art references—there must be some reason to select a species from the genus.” Knauf Insulation, Inc. v. Rockwool Int’l A/S, 788 F. App’x 728, 733 (Fed. Cir. 2019). Dr. Park identified 379 positions in PH20 (i.e., ~85% of the protein) with evolutionary variation, that is, where “homologous proteins have tolerated different amino acids at those positions.” Ex. 1004 ¶ 31. Dr. Park distributes the twenty standard amino acids into four categories depending on their roles in forming secondary structure such as alpha helices or beta sheets, with each category having a minimum of six members. See id. ¶ 70. Nothing in the prior art or Dr. Park’s analysis directs the ordinary artisan to position 307 itself. Although Dr. Hecht asserts that the ’429 patent suggests conservative mutations generally, Petitioner did not point us to any specific teaching or” slip op. at 126
- Additional discoveryAdditional discovery, deniedDenied
“Patent Owner filed a Motion for Additional Discovery (Paper 41), Petitioner opposed the motion (Paper 43), and the Board denied the motion (Paper 46).” slip op. at 3
Patent outcomesUS 12,060,590 unpatentable§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 12,060,590 - Snap Inc. v. You Map Inc.All claims unpatentablePTAB · May 4, 2026 · IPR2022-00568 · APJ Jason M Repko · IPR · Remand
Claims 1–20 remain unpatentable; the contingent motion to amend is denied because the proposed substitute claims would have been obvious over Feldman and Jackson in view of ordinary skill.
RulingsRemand decision- RemandDecided for patent owner
“challenge fails even if Petitioner’s summary of the references were correct because Petitioner did not present a sufficient reason to modify Feldman to include a current zoom level in its search request. FWD 56. The Federal Circuit vacated this finding specifically and contemplated that there would be a “consideration of obviousness” on remand. CAFC Dec. 10–11. That consideration requires more than determining whether any one reference teaches a current zoom level and a search, generally. See FWD 56 (quoting MTA Reply 10). Here, Petitioner’s challenge is based on modifying the Feldman-Jackson combination. So the Board must determine on remand whether the Feldman-Jackson combination in view of knowledge of a POSA meets the claim limitations at issue. We also disagree to the extent that Petitioner argues that the Board is precluded from considering additional arguments on the relevant issues on remand. The Board’s preliminary guidance on the Motion to Amend stated that Petitioner’s obviousness rationale was based on convenience and this reason was not sufficiently supported: reference lacks a sufficient explanation of why one of ordinary skill in the art would have added the zoom levels in the prior art to Feldman. See id. At most, Petitioner argues that it would be convenient to “specify the area the user desires to search for content” in this way. Id. at 14. But, on this record, Petitioner has not sufficiently explained why it would be convenient to do so in Feldman. See id. Nor has Petitioner sufficiently explained how or why the prior-art features confer this convenience. See id. MTA PG, 13. Because the Board’s conclusion turned on the lack of sufficient explanation, the briefing that followed was limited to Petitioner’s obviousness rationale. See, e.g., MTA Reply 9–12, MTA Sur-reply 1–12. Under these specific circumstances, we determine that it would be procedurally fair to fully consider the arguments on remand about whether the cited prior art teaches or suggests the limitations recited in the substitute claims. And, as discussed above, the Federal Circuit has directed the Board to consider obviousness. CAFC Dec. 10–11.” slip op. at 11
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner does not contest Petitioner’s proposed level of ordinary skill in the art. See PO Resp.; Sur-reply. Patent Owner’s expert, Dr. Shamos, and provides substantially the same expression of the level of ordinary skill in the art. Ex, 2003 ¶¶ 30–31; see FWD 6–7. In this Decision, we apply Petitioner’s proposed definition.” slip op. at 6
- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, deniedDenied
“In sum, Petitioner has shown that replacing Feldman’s radius with Badger’s zoom level meets all the limitations of the claim considered in the context of the Feldman-Jackson combination. Also, the evidence shows a motivation to modify the radius in Feldman’s search request to instead be based on the zoom-level parameter disclosed in Badger. See Intel Corp. v. PACT XPP Schweiz AG, 61 F.4th 1373, 1380–81 (Fed. Cir. 2023) (“There is a motivation to combine when a known technique ‘has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way,’ . . . using the ‘prior art elements according to their established functions.’”) (citing KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007)). substitute claim 21 is unpatentable over Feldman, Jackson, and knowledge of one of ordinary skill in the art. See Koninklijke Philips N.V. v. Google LLC, 948 F.3d 1330, 1337 (Fed. Cir. 2020) (“[U]nder 35 U.S.C. § 103, the obviousness inquiry turns not only on the prior art, but whether ‘the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious . . . to a person having ordinary skill in the art to which the claimed invention pertains.’”).” slip op. at 19
- Strike new argumentNew argument consideredDecided for patent owner
“precluded from considering additional arguments on the relevant issues on remand. The Board’s preliminary guidance on the Motion to Amend stated that Petitioner’s obviousness rationale was based on convenience and this reason was not sufficiently supported: reference lacks a sufficient explanation of why one of ordinary skill in the art would have added the zoom levels in the prior art to Feldman. See id. At most, Petitioner argues that it would be convenient to “specify the area the user desires to search for content” in this way. Id. at 14. But, on this record, Petitioner has not sufficiently explained why it would be convenient to do so in Feldman. See id. Nor has Petitioner sufficiently explained how or why the prior-art features confer this convenience. See id. MTA PG, 13. Because the Board’s conclusion turned on the lack of sufficient explanation, the briefing that followed was limited to Petitioner’s obviousness rationale. See, e.g., MTA Reply 9–12, MTA Sur-reply 1–12. Under these specific circumstances, we determine that it would be procedurally fair to fully consider the arguments on remand about whether the cited prior art teaches or suggests the limitations recited in the substitute claims. And, as discussed above, the Federal Circuit has directed the Board to consider obviousness. CAFC Dec. 10–11.” slip op. at 11
Patent outcomesUS 10,616,727 unpatentable§ 103 obviousnesscites KSRPatents in suitUS 10,616,727 - Samsung Display Co., Ltd. v. Pictiva Displays International Ltd.Some claims unpatentablePTAB · Jan 22, 2026 · IPR2024-01094 · APJ Grace Karaffa Obermann · IPR · Final written decision
Claims 1, 2, 6, and 8–14 are unpatentable as obvious over Ma; claims 3 and 4 were not shown unpatentable over Werner.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends: A person of ordinary skill in the art (“POSA”) at the time of the alleged invention of the ’223 patent would have had a university degree in chemistry and additional expertise or a second university degree in the field of electrical engineering, particularly optoelectronics, or alternatively a university degree in electrical engineering and additional expertise or a second university degree in the field of chemistry. The person of ordinary skill in the art has spent several years studying the structure and function of organic optoelectronic components, in particular OLEDs, and has detailed knowledge of the chemical structure of light-emitting organic layers and the transport of charge carriers to these layers. In this respect, the person of ordinary skill in the art works at the interface between electrical engineering/physics (charge carrier transport and light emission processes in optoelectronic components) and chemistry, in particular organic chemistry (materials and layer stack combinations suitable). Pet. 14 (citing Ex. 1003 ¶¶ 46–47). Patent Owner does not dispute Petitioner’s contention. See generally Resp. Neither party indicates that the result would change depending on the definition selected. We adopt Petitioner’s uncontested proposed definition, because it is consistent with the disclosures of the asserted prior art references. See Ex. 1005, (code 57); Ex. 1007, 8107 (abstracts of the references asserted in the patentability challenges).” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“history pertaining to the patent.” 37 C.F.R. § 42.100(b). Under that standard, claim terms generally are given their plain and ordinary meaning as would have been understood by the ordinarily skilled artisan at the time of the invention and within the context of the entire patent disclosure. See Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc). We construe claim terms only as relevant to the parties’ contentions and only to the extent necessary to resolve the issues in dispute. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999); Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017). Neither party indicates that an express construction for any claim term is necessary to resolve the disputes at hand. Pet. 15; see generally Resp. On this record, we determine that no claim term requires express construction for purposes of this Decision. In our analysis of the challenges, however, we discuss the meaning of the terms “metal complex” and “central metal atom,” which appear in claim 1 (Ex. 1001, 19:19–20) to the extent necessary to resolve Patent Owner’s contention that Petitioner fails to establish that Ma invalidates claim 1. See Resp. 53, 56–58.” slip op. at 9
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“Whether Ma qualifies as a “printed publication” involves an inquiry into the facts and circumstances surrounding the reference’s disclosure to members of the public. In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004). A reference is considered “publicly accessible” upon a satisfactory showing that the 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 (Fed. Cir. 2008); see Hulu, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper 29, 10– 11 (PTAB Dec. 20, 2019) (precedential).” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentable
“Based on the information presented, we find Petitioner has the better position. Patent Owner admits that joint vaporization means “two materials vaporize together.” Reply 21 (quoting Resp. 54). As Petitioner argues, “This is what Ma discloses.” Id. We agree with Petitioner that Ma describes a “two-component” electron transport layer having a “thickness with one value.” Id.; see Ex. 1007, 811 (reporting a “co-deposited” application of “BPhen:LiQ” that is “50 nm thick”). Ma’s disclosure, thereby, strongly “indicates that the two components were vaporized together––as opposed to creating a ‘macroscopically homogenous form’” prepared by sequentially vaporizing the individual components as Patent Owner “hypothesizes.” Reply 21 (citing Ex. 1020 ¶¶ 42–44; Ex. 2041 ¶¶ 155–157); see Resp. 54– 55; see also Ex. 1007, 811 (Ma’s description of its device fabrication, appearing in the third paragraph of the experiments section). Petitioner further advances evidence that “[p]reparing a layer that is ‘macroscopically homogeneous’ but potentially microscopically heterogeneous,” as Patent Owner postulates, “would introduce excessive variability and render the data noncomparable and unreliable, thus undermining the experiment’s purpose.” Reply 21 (citing Ex. 1020 ¶ 44); see Resp. 54–55. Patent Owner presents no counterargument or evidence that is persuasive to undercut Petitioner’s reasoning or evidence on that point. See Sur-reply 19–22. Petitioner also argues that an ordinarily skilled artisan would have recognized “that vaporizing materials together would best achieve Ma’s objective of assessing the current density using different Liq doping percentages.” Reply 22 (citing Ex. 1007, 811; Ex. 1020 ¶ 51). Here again, Petitioner’s evidence on point stands uncontested. See Sur-reply 19–22 (declining to contest that point). On this record, therefore, we agree with Petitioner that, as to the relevant disclosure in Ma, “the most natural interpretation of ‘co-deposition’ for forming a layer, particularly when there is nothing to indicate that the materials” are “vaporized sequentially,” is that the materials are co-deposited by joint vaporization. Reply 22 (citing Ex. 1020 ¶ 46–51). We further agree that, “[u]nder a preponderance standard, Ma’s disclosures are sufficient to render joint vaporization at least obvious.” Id. For the above reasons, we determine that Petitioner demonstrates by a preponderance of the evidence that Ma discloses joint vaporization as required by the challenged claims.” slip op. at 15
Patent outcomesUS 8,558,223 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 8,558,223 - Highlevel, Inc. v. Etison LLC D/B/A ClickfunnelsInstitution deniedPTAB · Jun 2, 2025 · IPR2025-00235 · APJ Jason M Repko · IPR · Institution
The Board denied institution of the IPR challenging claims 1–20 because the district court had already found the claims invalid under § 101.
RulingsInstitution decision- Other 314aInstitution denied discretionary otherDenied
“guidance on issues of first impression to the Board, guidance on Board rules and practices, and guidance on issues that may develop through analysis of recurring issues in many cases.” Patent Trial and Appeal Board, Standard Operating Procedure 2 (Revision 11).1 We see no reason to deviate from the informative decision here. The relevant facts in this case are indistinguishable from those at issue in Hulu. In that case, “Petitioner filed a motion to dismiss under Rule 12(b)(6), asserting that the claims challenged in [that] proceeding are invalid as reciting ineligible subject matter under § 101,” and “[t]he district court agreed with Petitioner and issued a decision” slip op. at 5
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied
“Because the District Court already found the claims invalid under 35 U.S.C. § 101 in the parallel litigation, we deny institution of inter partes review. See id. III. ORDER It is ORDERED that the Petition is denied, and no trial is instituted.” slip op. at 6
Discretionary denialPatents in suitUS 11,361,047 - Highlevel, Inc v. Etison LLC D/B/A ClickfunnelsInstitution deniedPTAB · Jun 2, 2025 · IPR2025-00234 · APJ Jason M Repko · IPR · Institution
The Board denied institution of the IPR challenging claims 1–20 because the district court had already found the claims invalid under § 101, making another review unnecessary.
RulingsInstitution decision- Other 314aInstitution denied discretionary otherDenied
“An informative decision provides Board norms on recurring issues, guidance on issues of first impression to the Board, guidance on Board rules and practices, and guidance on issues that may develop through analysis of recurring issues in many cases.” Patent Trial and Appeal Board, Standard Operating Procedure 2 (Revision 11).1 We see no reason to deviate from the informative decision here. The relevant facts in this case are indistinguishable from those at issue in Hulu. In that case, “Petitioner filed a motion to dismiss under Rule 12(b)(6), asserting that the claims challenged in [that] proceeding are invalid as reciting ineligible subject matter under § 101,” and “[t]he district court agreed with Petitioner and issued a decision granting Petitioner’s motion to dismiss and dismissing with prejudice Patent Owner’s infringement claim.” Hulu, IPR2024-01252, Paper 27 at 2. According to Hulu, “Because the patent claims already stand invalid, it is unnecessary to institute another proceeding to review them for patentability under other grounds.” Id. That is the case before us (Ex. 2007), and we reach the same conclusion: “the efficiency and integrity of the patent system is best served by denying institution.” Hulu, IPR2024-01252, Paper 27 at 3. slip op. at 6
Discretionary denialPatents in suitUS 10,846,357 - 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.