- Merck Sharp And Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · Sep 25, 2026 · PGR2025-00033 · APJ Michael A Valek · PGR · Final written decision
Claims 1, 2, and 6–29 are unpatentable for lack of written description and enablement; the Board did not find them obvious over the ’429 patent and Chao.
RulingsFinal written decision- Expert testimonyPetitioner expert creditedDecided for petitioner
“structural connections and three-dimensional modeling Patent Owner’s experts attempt to make (see, e.g., Ex. 2070 ¶¶ 126–212, 297–342; Ex. 2068 ¶¶ 123–125, 245, 294–313, 318) 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 ¶¶ 111–230 (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 ’652 patent.” slip op. at 58
- 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 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Decided for petitioner
“exclude the use of modified PH20 polypeptides as contraceptives—the only other possible utility described in the ’652 patent—is unavailing. Resp. 39. First, “[t]he fact that a patent asserts that an invention achieves several objectives does not require that each of the claims be construed as limited to structures that are capable of achieving all of the objectives.” Phillips, 415 F.3d at 1327 (citing Liebel–Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 908 (Fed. Cir. 2004)). Second, unlike the definitions of “PH20” and “modified PH20 polypeptide” in the “Definitions” section of the Specification, the passages describing possible contraceptive use do not contain any characteristics suggesting they are definitional in nature. See Alnylam, 138 F.4th at 133 (enumerating “characteristics” such as the fact that the text appears in the “Definitions” section, sets the term off in quotation marks, and uses phrases like “refer to” that indicate that specification language is definitional in nature). Accordingly, the statement that “[a]lso provided are modified PH20 polypeptides that are inactive, and that can be used, for example, as antigens in contraception vaccines” (Ex. 1001, 75:56–58), does not redefine the term, nor otherwise void the definitional language in the Specification stating that a “modified PH20 polypeptide can have up to 150 amino acid replacements, so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Id. at 48:47–49 (emphasis added).” slip op. at 26
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“1352. While a POSA might be able to embark on their own research program to try to find the genus of multiply-modified PH20 polypeptides recited in the challenged claims, the four corners of the written description here do not demonstrate the inventors were in possession of such. See id. at 1356–57 (recognizing that “[p]erhaps one of ordinary skill could discover this information, but this does not alter our conclusion that the description . . . just represent a wish or arguably a plan for future research”) (internal quotation omitted).” slip op. at 68
Patent outcomesUS 12,049,652 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 12,049,652 - Biocon Biologics, Inc. / Biocon Biologics Limited v. Regeneron Pharmaceuticals, Inc.Institution deniedPTAB · Sep 24, 2026 · PGR2026-00039 · APJ John A Squires · PGR · Director review
The Director denied the petition and instituted no trial because it was filed more than nine months after the patent issued, contrary to § 321(c).
RulingsDirector review decision- PTAB / AIA Trials › §315(b) time barInstitution denied time barDenied
“I agree with Patent Owner that the Petition is barred by § 321(c). Section 321(c) provides that “[a] petition for a post-grant review may only be filed not later than the date that is 9 months after the date of the grant of the patent or of the issuance of a reissue patent (as the case may be).” Joinder is authorized under 35 U.S.C. § 325(c), which provides that “[i]f more than 1 petition for a post-grant review under this chapter is properly filed against the same patent and the Director determines that more than 1 of these petitions warrants the institution of a post-grant review under section 324, the Director may consolidate such reviews into a single post-grant review.” Notably, the statutory authorization for joinder under § 325(c) does not provide an exception to the nine-month statutory bar, as it requires any petition considered for joinder to be “properly filed,” i.e., to meet the statutory filing requirements including the nine-month filing deadline recited in § 321(c). Petitioner argues that I have broad discretion to promulgate rules and permit exceptions, such as here where institution would increase efficiency. See Reply 2–3. I agree that my institution discretion is broad. But § 325(c) provides no exception to the time period in which a petition for post-grant review may be filed.1 The board rule on which Petitioner relies cannot override a clear statutory requirement, and Petitioner does not point” slip op. at 3
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, deniedDenied
“Section 321(c) provides that “[a] petition for a post-grant review may only be filed not later than the date that is 9 months after the date of the grant of the patent or of the issuance of a reissue patent (as the case may be).” Joinder is authorized under 35 U.S.C. § 325(c), which provides that “[i]f more than 1 petition for a post-grant review under this chapter is properly filed against the same patent and the Director determines that more than 1 of these petitions warrants the institution of a post-grant review under section 324, the Director may consolidate such reviews into a single post-grant review.” Notably, the statutory authorization for joinder under § 325(c) does not provide an exception to the nine-month statutory bar, as it requires any petition considered for joinder to be “properly filed,” i.e., to meet the statutory filing requirements including the nine-month filing deadline recited in § 321(c). Petitioner argues that I have broad discretion to promulgate rules and permit exceptions, such as here where institution would increase efficiency. See Reply 2–3. I agree that my institution discretion is broad. But § 325(c) provides no exception to the time period in which a petition for post-grant review may be filed.1 The board rule on which Petitioner relies cannot override a clear statutory requirement, and Petitioner does not point 1 Although the Office continues to encourage joinder and early challenges to increase efficiency and resolve patentability challenges early in the life of the patent, these considerations must follow the statute.” slip op. at 3
Discretionary denialPatents in suitUS 12,168,036 - Pgr2026-00043InstitutedPTAB · Sep 23, 2026 · PGR2026-00043 · APJ John A Squires · PGR · Institution
The Board granted institution of PGR2026-00043 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
“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: IPR2026-00336 PGR2026-00037 PGR2026-00043 IPR2026-00363 PGR2026-00042” slip op. at 2
NonePatents in suitUS 12,543,922 - Pgr2026-00042InstitutedPTAB · Sep 23, 2026 · PGR2026-00042 · APJ John A Squires · PGR · Institution
The Director granted institution of PGR2026-00042 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
“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 12,353,917 - Pgr2026-00037InstitutedPTAB · Sep 23, 2026 · PGR2026-00037 · APJ John A Squires · PGR · Institution
The Director granted institution of PGR2026-00037 after determining the petition showed the required likelihood of prevailing and no non-discretionary consideration warranted denial.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“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 12,347,711 - Ipr2026-00363InstitutedPTAB · Sep 23, 2026 · IPR2026-00363 · APJ John A Squires · IPR · Institution
The Director granted institution of IPR2026-00363 after finding a reasonable likelihood of prevailing on at least one challenged claim and no other non-discretionary reason to deny institution.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“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 12,143,424 - Ipr2026-00336InstitutedPTAB · Sep 23, 2026 · IPR2026-00336 · APJ John A Squires · IPR · Institution
Institution of IPR2026-00336 is granted after the petitioner showed a reasonable likelihood of prevailing on at least one challenged claim and no non-discretionary consideration warranted denial.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“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 12,232,681 - Ipr2026-00351Institution deniedPTAB · Sep 23, 2026 · IPR2026-00351 · APJ John A Squires · IPR · Director review
The Director denied institution of IPR2026-00351 after determining that the petitioner failed to show a reasonable likelihood of prevailing on at least one challenged claim.
RulingsDirector review decision- Director reviewDirector review, deniedDenied
“Pursuant to 35 U.S.C. § 314(a), after review of the merits, the petitioner has failed to show a reasonable likelihood of prevailing with respect to at least one of the claims challenged in the petition. Accordingly, institution of inter partes review is denied in the following proceedings:” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Pursuant to 35 U.S.C. § 314(a), after review of the merits, the petitioner has failed to show a reasonable likelihood of prevailing with respect to at least one of the claims challenged in the petition. Accordingly, institution of inter partes review is denied in the following proceedings:” slip op. at 2
NonePatents in suitUS 11,878,049 - Pgr2026-00044InstitutedPTAB · Sep 9, 2026 · PGR2026-00044 · APJ John A Squires · PGR · Institution
The Board granted PGR2026-00044 after finding the petition 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
“Pursuant 35 U.S.C. §§ 314(a) and 324(a), after review of the 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: IPR2026-00256 IPR2026-00312 IPR2026-00327 IPR2026-00257 IPR2026-00313 IPR2026-00334 IPR2026-00258 IPR2026-00314 PGR2026-00044 IPR2026-00259” slip op. at 2
NonePatents in suitUS 12,359,506 - Ipr2026-00334InstitutedPTAB · Sep 9, 2026 · IPR2026-00334 · APJ John A Squires · IPR · Institution
The Director granted institution of IPR2026-00334 after finding a reasonable likelihood of prevailing on at least one challenged claim and no other non-discretionary reason to deny institution.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“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: IPR2026-00256 IPR2026-00312 IPR2026-00327 IPR2026-00257 IPR2026-00313 IPR2026-00334 IPR2026-00258 IPR2026-00314 PGR2026-00044 IPR2026-00259” slip op. at 2
NonePatents in suitUS 12,231,703
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.