- Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · Jun 8, 2026 · PGR2025-00004 · APJ Susan L C Mitchell · PGR · Final written decision
Claims 1–4, 7–19, and 22 are unpatentable under § 112(a) for lack of written description and enablement, and under § 103 as obvious.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“1. Petitioner’s Position Petitioner asserts that the “terms used in the claims are either” slip op. at 12
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“7. Analysis We find the preponderance of the evidence supports a finding that the” slip op. at 59
- 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 70
Patent outcomesUS 12,018,298 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 12,018,298 - Dr. Falk Pharma GmbH v. Ellodi Pharmaceuticals, L.P.Adverse judgmentPTAB · Jun 3, 2026 · PGR2025-00086 · APJ Tawen Chang · PGR · Adverse judgment
The Board granted Patent Owner’s request for adverse judgment and terminated the PGR as to claims 1–34 after Patent Owner disclaimed all challenged claims.
RulingsAdverse judgment- Adverse judgmentAdverse judgmentGranted
“A party may request judgment against itself at any time during a proceeding,” including by “[d]isclaimer of the involved application or patent” or “[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)(1)–(b)(2). Accordingly, we grant Patent Owner’s Request for Adverse Judgment and terminate the proceeding. slip op. at 2
NonePatents in suitUS 12,290,598 - Sun Pharmaceutical Industries, Inc. v. Biofrontera Inc.Institution deniedPTAB · May 26, 2026 · PGR2026-00021 · APJ John A Squires · PGR · Director review
The Director denied Sun Pharmaceutical Industries’ PGR petition because it failed to show that it had identified all real parties in interest.
RulingsDirector review decision- PTAB / AIA Trials › Real party in interest / privityInstitution denied rpiDecided for patent owner
“As I previously explained, RPIs are not limited to entities that are actually funding and controlling the proceeding, but include entities that have the ability to control the proceeding. See Tianma Microelectronics (Director Mar. 18, 2026) (precedential) (“With its identification of RPIs in dispute, it is Petitioner’s burden to bring forth evidence or arguments demonstrating that it had named all RPIs—and that none were foreign governments or entities a foreign government had the ability to control.”); see also Worlds Inc. v. Bungie, Inc., 903 F.3d 1237, 1244–45 (Fed. Cir. 2018) (remanding to the Board to further consider RPI where the patent owner identified an unnamed party with the “opportunity to control” the proceeding). Petitioner has not provided sufficient evidence that SPI Ltd., the corporate parent and 100% owner of SPI Inc., does not have the ability to control the proceeding. Rather, Petitioner’s declaration evidence is focused on whether SPI Inc. is actually funding or controlling the proceeding. See Ex. 1021 ¶ 4 (“SPI Inc. is an indirect wholly-owned subsidiary of Sun Pharmaceutical Industries, Ltd.”). On this record, Petitioner fails to carry its burden to establish that it has identified all RPIs.” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied
“(Director Mar. 18, 2026) (precedential) (“With its identification of RPIs in dispute, it is Petitioner’s burden to bring forth evidence or arguments demonstrating that it had named all RPIs—and that none were foreign governments or entities a foreign government had the ability to control.”); see also Worlds Inc. v. Bungie, Inc., 903 F.3d 1237, 1244–45 (Fed. Cir. 2018) (remanding to the Board to further consider RPI where the patent owner identified an unnamed party with the “opportunity to control” the proceeding). Petitioner has not provided sufficient evidence that SPI Ltd., the corporate parent and 100% owner of SPI Inc., does not have the ability to control the proceeding. Rather, Petitioner’s declaration evidence is focused on whether SPI Inc. is actually funding or controlling the proceeding. See Ex. 1021 ¶ 4 (“SPI Inc. is an indirect wholly-owned subsidiary of Sun Pharmaceutical Industries, Ltd.”). On this record, Petitioner fails to carry its burden to establish that it has identified all RPIs.” slip op. at 3
Discretionary denialPatents in suitUS 12,280,146 - Pgr2026-00012InstitutedPTAB · May 19, 2026 · PGR2026-00012 · PGR · Institution
Institution of PGR2026-00012 was granted because the petitioner showed the required likelihood of prevailing on at least one challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“merits, the petitioner has shown a reasonable likelihood of prevailing with respect to at least one of the claims challenged in the petition, or that it is more likely than not that at least one of the claims challenged in the petition is unpatentable, as appropriate, and no other non-discretionary considerations warrant denial of institution. Accordingly, institution of inter partes review and post-grant review is granted in the following proceedings:” slip op. at 2
NonePatents in suitUS 12,221,196 - Pgr2026-00021Institution deniedPTAB · May 19, 2026 · PGR2026-00021 · APJ John A Squires · PGR · Director review
The Director denied institution in PGR2026-00021 after discretionary review; the notice does not identify challenged claims or a specific discretionary ground.
RulingsDirector review decision- Director reviewDirector review, deniedDenied
“Before JOHN A. SQUIRES, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office. NOTICE Pursuant to 35 U.S.C. §§ 314(a) and 324(a), after review of discretionary and non-merits considerations, institution of inter partes review and post-grant review is denied in the following proceedings: IPR2026-00200 IPR2026-00202 IPR2026-00223 IPR2026-00201 IPR2026-00221 PGR2026-000211 Pursuant to 35 U.S.C. §§ 314(a) and 324(a), after review of” slip op. at 1
Discretionary denialPatents in suitUS 12,280,146 - Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · May 18, 2026 · PGR2025-00006 · APJ Cynthia M Hardman · PGR · Final written decision
Claims 1–4 and 8–13 are unpatentable under §112(a) for lack of written description and enablement, and under §103 as obvious over the ’429 patent and Chao.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the understanding of a person of ordinary skill in the art (sometimes referred to 3 US 7,767,429 B2, issued Aug. 3, 2010 (the “’429 patent”) (Ex. 1005). 4 Chao et al., Structure of Human Hyaluronidase-1, a Hyaluronan Hydrolyzing Enzyme Involved in Tumor Growth and Angiogenesis, 46 BIOCHEMISTRY 6911–20 (2007) (Ex. 1006). 5 Patent Owner withdrew the Declaration of Dr. Triggs-Raine. PO Resp. 10 n.6. herein as “POSA”) as of the effective filing date of the challenged claims. Petitioner contends that one of ordinary skill in the art would have had an undergraduate degree, a Ph.D., and post-doctoral experience in scientific fields relevant to study of protein structure and function (e.g., chemistry, biochemistry, biology, biophysics). From training and experience, the person would have been familiar with factors influencing protein structure, folding and activity, production of modified proteins using recombinant DNA techniques, and use of biological assays to characterize protein function, as well with techniques used to analyze protein structure (i.e., sequence searching and alignments, protein modeling software, etc.). Pet. 16.” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“5. Evidence and Analysis “The construction of claims is simply a way of elaborating the normally terse claim language in order to understand and explain, but not to change, the scope of the claims.” Embrex, Inc. v. Serv. Eng’g Corp., 216 F.3d 1343, 1347 (Fed. Cir. 2000). We first turn to the intrinsic evidence because “the specification is always highly relevant to the claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term.” Phillips v. AWH Corp., 415 F.3d 1303, 1314 (Fed. Cir. 2005) (en banc). “[T]he specification may reveal a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess. In such cases, the inventor’s lexicography governs.” Id. at 1316. [T]he definition in the patent documents controls the claim interpretation. . . . Any other rule would be unfair to competitors who must be able to rely on the patent documents themselves, without consideration of expert opinion that then does not even exist, in ascertaining the scope of a patentee’s right to exclude. Southwall Tech., Inc. v. Cardinal IG Co., 54 F.3d 1570, 1578 (Fed. Cir. 1995). a) Intrinsic evidence Our analysis begins with the claims and Specification of the ’262 patent. Claim 1 recites a “modified PH20 polypeptide” that also requires the polypeptide sequence is 95% identical to one of the 35 recited SEQ ID NOs and with at least one of seven amino acids at position 317 of the reference sequence. The ’262 patent states “PH20 refers to a type of hyaluronidase that occurs in sperm and is neutral-active.”7 Ex. 1001, 45:45– 46; cf. id. at 68:33–37. The ’262 patent further explains that “[r]eference to PH20 includes precursor PH20 polypeptides and mature PH20 polypeptides (such as those in which a signal sequence has been removed), truncated forms thereof that have activity, and includes allelic variants and species variants, variants encoded by splice variants, and other variants.” Id. at 45:62–67. The ’262 patent states that “PH20 polypeptides also include those that contain chemical or posttranslational modifications and those that do not contain chemical or posttranslational modifications.” Id. at 46:4–7.” slip op. at 15
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“four species tested, and particularly in a primate model that is physiologically more similar to humans, shows that a POSA would not have understood even unmodified PH20 polypeptides to provide a contraceptive effect in humans and most other species. The data Patent Owner relies upon at most shows an immunocontraceptive effect for unmodified PH20 polypeptides limited to guinea pigs. It does not evidence that a POSA would have understood that the recited modified polypeptides would provide such an effect or otherwise be useful in a contraceptive vaccine. Accordingly, even if the term “modified PH20 polypeptides” were interpreted to include inactive polypeptides that can serve as antigens to provide a contraceptive effect, the preponderance of the evidence does not show that a POSA would have understood the inventors to be in possession of the full scope of the recited polypeptides capable of such use. 7. Analysis We find the preponderance of the evidence supports a finding that the claims fail to comply with the written description requirement. “Every patent must describe an invention. It is part of the quid pro quo of a patent.” Ariad, 598 F.3d at 1345. In determining compliance with the written description requirement for nucleic acid genus claims, the Federal Circuit has identified two extremes. In Capon, claims relying on known nucleotide sequences with known functions were found to satisfy the written description requirement. Capon v. Eshhar, 418 F.3d 1349, 1358 (Fed. Cir. 2005). At the other end, Juno found that for broad claims to a nucleic acid encoding a chimeric T cell receptor with a functional requirement to bind a target, “the written description ‘must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.’” Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337 (Fed. Cir. 2021) (quoting Ariad, 598 F.3d at 1349). As explained above, claim 1 requires modified PH20 polypeptides with some hyaluronidase activity. See supra Section II.B. Based on this claim interpretation, we find the evidence in this case closer to Juno than Capon, and that the ’262 patent does not disclose sufficient structural features in the PH20 sequences associated with hyaluronidase or” slip op. at 57
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable
“6. Analysis Petitioner has the burden to identify how the specification allegedly fails to enable the claims. We address the Wands factors and the parties’ respective arguments and evidence. a) Breadth of Claims and Nature of the Invention Dr. Park states, regarding the breadth of claim 1, that he “calculated the number of distinct polypeptides that exist that meet the specified criteria.” Ex. 1004 ¶ 173. Dr. Park’s table is reproduced below: Dr. Park’s table shows that the “number of distinct peptides is extremely large by all accounts, ranging from 1049 to 1066.” Id. Dr. Hecht agrees, stating the “sequence identity language causes the claims to encompass an immense number of distinct PH20 polypeptides.” Ex. 1003 ¶ 120. To illustrate how large a number like 1066 is, Dr. Hecht states that an “aggregate weight of the smallest set containing one molecule of each of the PH20 mutants would be . . . = 1.37 x 1027 kg. The weight of the Earth is ‘only’ ~ 5.97 x 1024 kg.” Id. ¶ 123. That is, Dr. Hecht states that a complete set of one single molecule of protein that comprises all possible mutations in PH20 as recited in claim 1 would weigh about one thousand times more than the entire mass of planet Earth. See id. In deposition, Dr. Hecht stated “my sense was that the ’262 patent lists a minuscule and highly biased sample of what would be within that fence, in the sense that it only lists single amino acid substitutions while at the same time it’s attempting to claim things that have 20 or more substitutions.” Ex. 2076, 203:6‒12. When asked if a sequence “gives you enough information to tell whether that amino acid sequence is 95 percent identical to SEQ ID NO. 3”, Dr. Hecht answered “Yes, but that’s all it tells you. It doesn’t tell you anything about active, precipitated, aggregated, folded. It doesn’t tell you anything.” Id. at 204:11‒19.” slip op. at 70
Patent outcomesUS 12,152,262 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 12,152,262 - Pgr2025-00087Institution deniedPTAB · May 15, 2026 · PGR2025-00087 · APJ John A Squires · PGR · Director review
The Director denied institution of post-grant review in PGR2025-00087 after reviewing discretionary and non-merits considerations.
RulingsDirector review decision- Director reviewDirector review, deniedDenied
“NOTICE Pursuant to 35 U.S.C. §§ 314(a) and 324(a), after review of discretionary and non-merits considerations, institution of post-grant review is denied in the following proceedings: PGR2025-00087 Pursuant to 35 U.S.C. §§ 314(a) and 324(a), after review of” slip op. at 1
Discretionary denialPatents in suitUS 12,371,685 - Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · May 12, 2026 · PGR2025-00003 · APJ Jeffrey N Fredman · PGR · Final written decision
Claims 1–4 and 8–21 are unpatentable for lack of written description and enablement; obviousness over the ’429 patent and Chao was not shown.
RulingsFinal written decision- Skill levelSkill level board ownOther
“VII. LEVEL OF ORDINARY SKILL IN THE ART We consider the grounds of unpatentability in view of the” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“term “modified PH20 polypeptide” in the ’600 patent supports the understanding that some type of activity is required for a polypeptide to be a “modified PH20 polypeptide”, and that the enzymatic activity of hyaluronidase is the most frequently identified activity recited in the definitions section of the ’600 patent. Id. at 48:38–53, 50:9‒17, 51:15‒18, 52:41–47, 55:9–23, 63:37–44, 64:14–19. In contrast, the discussion regarding the potential use of “modified PH20 polypeptides that are inactive” as antigens in contraception vaccines appears only in a non-definitional section of the ’600 patent. Id. at 75:56–58, 72:60–62. Accordingly, it does not modify the definition’s explicit requirement that the claimed “modified PH20 polypeptide” exhibit hyaluronidase activity. Id. at 48:38–53.” slip op. at 19
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“been able to use the data in the Specification to make reasonable predictions about the effect of multiple modifications on hyaluronidase activity, we view this testimony to at most describe a research plan (i.e., a “tool to engage in further modification”14) 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) 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. For these reasons, we find that a preponderance of the evidence of record better supports a finding that in the 2011–12 timeframe, it would have been unpredictable to identify which multiple mutants retained hyaluronidase activity, even with the single substitution data provided by the ’600 patent.” slip op. at 51
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable
“8. Conclusion We find that the balance of evidence supports a finding of undue” slip op. at 101
Patent outcomesUS 11,952,600 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 11,952,600 - Therabody, Inc. v. Hyperice IP Subco, LLCNo claims unpatentablePTAB · May 11, 2026 · PGR2025-00013 · APJ Alyssa A Finamore · PGR · Final written decision
Claims 1–16 and 18 were not shown unpatentable because the asserted prior art did not establish the claimed quick-connect system during reciprocation, and Clark was not analogous art.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“A. Level of Ordinary Skill in the Art The level of ordinary skill in the art is “a prism or lens” through which we view the prior art and the claimed invention. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). The prior art may reflect the level of ordinary skill in the art. Id.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“During oral argument, Petitioner confirmed it would not object to the Board adopting the construction that Petitioner proposes in the district court litigation. JUDGE MARSCHALL: I think the Petitioner wouldn’t object if we adopted the construction that Petitioner proposed in the district court, especially the “designed to” construction, correct? MR. BERG: No. We wouldn’t object to that. And we think that our Petition is on all fours with that construction. Tr. 81:12–16. As Petitioner does not object to adopting its construction from the district court litigation, we construe claim element 1[e] in accordance with Petitioner’s construction from the district court litigation.” slip op. at 11
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateNot shown unpatentable
“The invention, a reciprocating massage device, is in a predictable field, namely the electro-mechanical arts. Also, there is no evidence that the recited quick-connect system is complex, even considering Patent Owner’s alleged understanding of it. Rather, Dr. Pratt testifies that many different types of connectors, whether they require alignment or not, were known. Ex. 1002 ¶¶ 54–58. Given the predictability of the electro-mechanical arts and lack of complexity of the recited quick-connect system, a low level of detail is required to satisfy the written description requirement. See RAI Strategic Holdings, Inc. v. Philip Morris Prods. S.A., 92 F.4th 1085, 1090 (Fed. Cir. 2024) (“Given the predictability of electro-mechanical inventions such as the one at issue here, and the lack of complexity of the particular claim limitation at issue—i.e., reciting the length of a heating member—‘a lower level of detail is required to satisfy the written description requirement than for unpredictable arts.’” (quoting Hologic, Inc. v. Smith & Nephew, Inc., 884 F.3d 1357, 1361 (Fed. Cir. 2018)). In view of the low level of detail required to satisfy the written description requirement, Petitioner has not persuaded us that the Specification’s example of a quick-connect system configured to secure the massaging head as the piston reciprocates fails to provide sufficient written description support for the “quick-connect system” recited in independent claims 1 and 18.” slip op. at 14
- Disclosure Requirements (§112) › Definiteness (Nautilus)DefiniteNot shown unpatentable
“Contrary to Petitioner’s assertion, the Specification provides guidance as to what amount of deviation from a perfect cylinder is still “substantially cylindrical.” The Specification describes: Quick-connect system 600 includes a piston 602 that has a hollow-end bore 608 for receiving the shaft 621 of a massaging head 620. Located within the bore 608 of piston 602 is a cylindrical seat 604. Cylindrical seat 604 retains a magnet 606. Magnet 606 is illustrated with its north pole located flush with the seat and facing toward the opening in bore 608. Massaging head 620 includes a shaft 621 having a cylindrical pocket 622 at the distal end. Located within the cylindrical pocket 622 is a magnet 624. Magnet 624 is positioned so that its south pole is located at the distal end of shaft 621. Accordingly, when the shaft 621 of massaging head 620 is slid into opening in bore 608, the magnets 606 and 624 are attracted to one another and magnetically hold massaging head 620 firmly in place. Ex. 1001, 6:57–7:3. In view of the description of quick-connect system 600, the Specification sets forth a standard for ascertaining whether the bore and the seat located within the bore are “substantially cylindrical.” To wit, the bore and the seat within the bore are “substantially cylindrical” when the massaging head and magnet are respectively received therein so that the magnet in the seat and the magnet in the pocket of the massaging head can magnetically hold the massaging head firmly in place. Furthermore, Dr. Pratt testifies that “[m]agnetic connectors comprise a magnet on at least one of the two objects to be joined. These types of connectors are ubiquitous even today for driving threaded fasteners.” Ex. 1002 ¶ 56. Dr. Pratt also testifies that a POSITA would understand how to take into account certain variances, like runout. Ex. 2033, 25:3–17. Dr. Pratt’s testimony shows that magnetic connectors are well known and that a POSITA would be able to determine whether the bore and the seat within the bore were “substantially cylindrical” for a secure connection of the massaging head. In view of the foregoing, Petitioner has not persuaded us that the claim term “substantially cylindrical” recited in claims 13–16 fails to inform, with reasonable certainty, the shapes of the bore and the structure within the bore. Petitioner has not proven, by a preponderance of the evidence, that any of claims 13–16 are unpatentable under 35 U.S.C. § 112(b) as indefinite.” slip op. at 19
Patent outcomesUS 11,938,082 not shown unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham · NautilusPatents in suitUS 11,938,082 - Pgr2026-00013InstitutedPTAB · May 6, 2026 · PGR2026-00013 · PGR · Institution
The Board granted institution of PGR2026-00013 after finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“merits, the petitioner has shown a reasonable likelihood of prevailing with respect to at least one of the claims challenged in the petition, or that it is more likely than not that at least one of the claims challenged in the petition is unpatentable, as appropriate, and no other non-discretionary considerations warrant denial of institution. Accordingly, institution of inter partes review or post-grant review is granted in the following proceedings:” slip op. at 2
NonePatents in suitUS 12,233,106
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.