US 10865400

US Patent 10865400, titled "PH20 polypeptide variants, formulations and uses thereof," was filed on August 2, 2016, and issued on December 15, 2020. The current assignee is Halozyme Inc and Halozyme Therapeutics Inc. The inventors are Ge Wei, H. Michael Shepard, Qiping Zhao, and Robert James Connor.

Abstract:
The patent describes modified PH20 hyaluronidase polypeptides, including variants that exhibit increased stability and/or increased activity. It also covers compositions, formulations, and uses of these modified polypeptides.

Independent Claims Overview:
Due to the limitations of the provided text, the specific wording of the independent claims for US10865400B2 is not available. Therefore, a plain-language overview of each independent claim cannot be provided with certainty.

Litigation Status:
The patent family is involved in ongoing litigation. A US case was filed in the New Jersey District Court (Case: 2:25-cv-03179). Additionally, there is a pending PTAB (Patent Trial and Appeal Board) case, IPR2026-00312, filed in 2026. This indicates ongoing challenges to the patent's validity. A search for direct CAFC 2026 dockets specifically mentioning US10865400 did not yield immediate results.

Known litigation involving US patent 10865400 includes the following:

1. District Court Litigation

   • Plaintiff(s): Halozyme, Inc.
   • Defendant(s): Merck Sharp & Dohme Corp. (now Merck Sharp and Dohme LLC)
   • Jurisdiction: United States District Court for the District of New Jersey
   • Case Number: 2:25-cv-03179 (ES) (JRA)
   • Filing Date: April 24, 2025
   • Outcome or Current Status: This case is pending. Halozyme, Inc. filed the action, and Merck Sharp and Dohme LLC was later substituted as the defendant. Merck Sharp and Dohme LLC was granted 60 days from May 15, 2025, to respond to the complaint.

2. PTAB Inter Partes Review (IPR)

   • Petitioner: Merck Sharp & Dohme LLC
   • Patent Owner: Halozyme Inc.
   • Jurisdiction: Patent Trial and Appeal Board (PTAB)
   • Case Number: IPR2026-00312
   • Filing Date: March 23, 2026
   • Outcome or Current Status: The case is pending.

Specific details regarding the "First worldwide family litigation filed" for US10865400, as mentioned on the Google Patents page, are not available from the provided search results. The Darts-ip links offered general information about their patent case law database but did not provide specific case numbers, parties, or outcomes for this particular patent family.

Proceedings overview

There is one active AIA trial proceeding on US Patent 10865400. This is an Inter Partes Review (IPR) that is currently pending, meaning the patent claims have not yet been challenged through a final written decision. The defensive posture for a defendant is that the patent is currently being challenged, and the outcome of this IPR could significantly impact the scope of the asserted claims.

IPR2026-00312 — Merck Sharp & Dohme LLC v. Halozyme Inc.

• Type: Inter Partes Review
• Filed: 2026-03-23
• Status: Pending. The proceeding is ongoing and has not yet reached a final decision.
• Judge panel: Information not yet publicly available in the initial stages.
• Petition grounds: Specific claims challenged, prior art cited, and statutory bases (e.g., obviousness under § 103, anticipation under § 102) are not yet publicly detailed in the provided data.
• Institution decision: Not yet issued. The deadline for the institution decision is generally six months from the filing date, which would be around September 23, 2026.
• Final Written Decision: Not issued, as the proceeding is pending.
• Settlement / termination: Not applicable at this stage.
• Appeal: Not applicable at this stage.
• Defensive value: This active IPR indicates that the validity of US10865400 is currently under scrutiny. If institution is granted, it means the petitioner has shown a reasonable likelihood of prevailing on at least one challenged claim. If claims are subsequently invalidated, any infringement theories relying on those claims would be significantly weakened or eliminated. Conversely, if institution is denied or the patent owner prevails, it could strengthen the patent's validity against similar prior art challenges.

Strategic summary

Currently, no claims of US10865400 have been CANCELED or SUSTAINED through an AIA trial proceeding. All claims remain UNTESTED by a final PTAB decision. The patent is facing a challenge, but its full impact on the claim scope is yet to be determined.

Regarding the estoppel landscape, since IPR2026-00312 is pending, no estoppel has yet attached under § 315(e)(2). If the PTAB institutes the IPR and issues a final written decision, the petitioner (Merck Sharp & Dohme LLC) and its privies would be estopped from asserting invalidity grounds that were raised or reasonably could have been raised during the IPR against the claims that reached a final decision. For other potential defendants, prior-art grounds not addressed in IPR2026-00312 would still be available for challenges, assuming they are not in privity with the petitioner.

There are no clear pattern signals from the provided data. This is the first IPR filed against the patent, and it's being brought by Merck Sharp & Dohme LLC, which is a pharmaceutical company, suggesting a potential interest in the subject matter of the patent (PH20 polypeptide variants). It is too early to determine if the patent owner will pursue PTAB appeals aggressively as no FWD has been issued.

Recommended next steps

For a defendant facing assertion of US10865400:

• Monitor IPR2026-00312: Closely track the progress of IPR2026-00312. The most immediate milestone is the institution decision, expected around 2026-09-23. The institution decision will reveal which claims, if any, the PTAB has agreed to review and on what grounds. This decision is crucial as it indicates the initial strength of the invalidity challenge.
• Review Petition: Obtain and review the full petition filed by Merck Sharp & Dohme LLC to understand the specific claims being challenged and the prior art relied upon. This will provide insights into potential weaknesses of the patent.
• Assess Impact: Depending on the outcome of the institution decision and any subsequent Final Written Decision, evaluate the impact on your potential infringement liability. If claims critical to an assertion against you are challenged or invalidated, it could significantly alter the negotiation landscape.

The USPTO Open Data Portal shows the proceeding status at: https://portal.unifiedpatents.com/ptab/case/IPR2026-00312.

Inventors

• Ge Wei
• H. Michael Shepard
• Qiping Zhao
• Robert James Connor

Employer at the time of filing: Halozyme Inc. (original assignee)
Unusual patterns: Not determinable from the provided information if inventors departed the original assignee within 12 months of filing.

Original assignee

Halozyme Inc.
Halozyme Therapeutics Inc. (Current Assignee)
Product embodying the claims: US10865400 describes "PH20 polypeptide variants, formulations and uses thereof," which are related to hyaluronidase enzymes. Halozyme Therapeutics, Inc. develops and commercializes "ENHANZE®" drug delivery technology, which utilizes a recombinant human hyaluronidase enzyme (rHuPH20) to facilitate the subcutaneous administration of co-administered therapeutics. This technology appears to embody the claims of the patent.
Primary line of business: Halozyme Therapeutics, Inc. is a biotechnology company focused on novel oncology and rare disease therapies, and also has a proprietary enzyme technology (ENHANZE®) that facilitates the delivery of injected drugs.
Current status: Operating.

Assignment timeline

• 2016-08-05 (executed) / recorded 2016-08-05 — Reel 035651/0177

  • Conveyance: Assignment of Assignors Interest
  • Assignor: CONNOR, ROBERT JAMES; WEI, GE; ZHAO, Qiping
  • Assignee: HALOZYME THERAPEUTICS, INC.
  • Correspondent: Matthew S. Blundell, PhD, Halozyme, Inc., 11388 Sorrento Valley Road, San Diego, CA 92121
  • Context: Internal reorg (transfer from individual inventors to corporate entity)

• 2016-08-05 (executed) / recorded 2016-08-05 — Reel 035651/0187

  • Conveyance: Assignment of Assignors Interest
  • Assignor: HALOZYME THERAPEUTICS, INC.
  • Assignee: HALOZYME, INC.
  • Correspondent: Matthew S. Blundell, PhD, Halozyme, Inc., 11388 Sorrento Valley Road, San Diego, CA 92121. This correspondent recurs in this chain.
  • Context: Internal reorg (transfer between related corporate entities)

• 2016-08-05 (executed) / recorded 2016-08-05 — Reel 035651/0204

  • Conveyance: Assignment of Assignors Interest
  • Assignor: SHEPARD, H. MICHAEL
  • Assignee: HALOZYME, INC.
  • Correspondent: Matthew S. Blundell, PhD, Halozyme, Inc., 11388 Sorrento Valley Road, San Diego, CA 92121. This correspondent recurs in this chain.
  • Context: Internal reorg (transfer from individual inventor to corporate entity)

Timeline diagram

timeline
    title Ownership of US 10865400
    2016 : Inventors assign to Halozyme Therapeutics
         : Halozyme Therapeutics assigns to Halozyme Inc
         : Inventor H.M. Shepard assigns to Halozyme Inc
    2020 : Patent issued to Halozyme Inc
    2025 : Litigation filed in New Jersey District
    2026 : PTAB case IPR2026-00312 filed

NPE / troll-pattern signals

1. Shell-entity transfer — not present. All transfers are between Halozyme entities or individual inventors and Halozyme entities.
2. Known asserter in the chain — not present. Halozyme Inc. and Halozyme Therapeutics, Inc. are operating companies.
3. Repeat correspondent across the chain — present. Matthew S. Blundell, PhD, of Halozyme, Inc. is listed as the correspondent for all three recorded assignments. This indicates an internal legal counsel handling assignments for the same operating company.
4. Cascading transfers — not present. While there are three assignments on the same day, they represent internal transfers from inventors to the company and between closely related corporate entities of Halozyme.
5. Pre-litigation transfer — not present. The recorded assignments occurred in 2016, and the first litigation case found for this patent was filed in 2025.
6. Bankruptcy fire-sale — not present. Halozyme Inc. is an operating company.
7. Privateering — not present. The patent remains with the original operating company.
8. Defensive aggregator (anti-NPE) — not present. The current assignee is an operating company, not a defensive aggregator.

Verdict

Operating-company assertion
The assignment records clearly show the patent has remained within the Halozyme corporate family since its inception, with all transfers being internal reorganizations. Halozyme Therapeutics, Inc. is an operating company that commercializes products directly related to the patent's claims.

USPTO Assignment Center search for US10865400: https://assignment.uspto.gov/patent/index.html?ref=advanced_search&patent_number=10865400

U.S. Patent 10,865,400, titled "PH20 polypeptide variants, formulations and uses thereof," was issued on December 15, 2020, from an application filed on August 2, 2016. The patent describes modified PH20 hyaluronidase polypeptides that exhibit increased stability and/or increased activity, as well as compositions, formulations, and uses thereof.

To identify the most relevant prior art, we need to examine the citations listed in the patent. Based on the provided information, I cannot directly access a comprehensive list of all cited prior art within US10865400B2 and their specific claims. The Google Patents link provides a "Citations" section but only lists two "APP" (application) type citations: US-3536809-A and US-3598123-A. It does not provide detailed descriptions or direct mapping to claims. To perform a thorough analysis of all patent citations and their potential anticipation of claims under 35 U.S.C. § 102, I would need access to the full patent document from the USPTO website, including its "References Cited" section and the text of each cited patent.

However, based on the abstract and description of US10865400B2, the focus is on modified PH20 hyaluronidase polypeptides with increased stability and/or activity, particularly in the presence of denaturing conditions like phenolic preservatives or elevated temperatures, or under low salt conditions. Therefore, any prior art disclosing PH20 hyaluronidase variants with improved stability or activity under similar conditions would be highly relevant.

One directly related patent family member mentioned in the search results is US9284543B2, titled "Neutral active soluble truncated PH20 polypeptides and uses thereof". This patent (US9284543B2) shares the same priority date as US10865400B2, indicating a close relationship. It focuses on soluble truncated PH20 polypeptides. While it is a family member, it also serves as relevant prior art in the broader context of PH20 modifications and uses.

Without direct access to the "References Cited" section of US10865400B2 and the full text of each cited patent within the USPTO database, a comprehensive analysis of claim anticipation is not possible.

To proceed with a full prior art analysis, the following steps would be necessary:

1. Obtain the full "References Cited" list for US10865400B2 from the USPTO Patent Public Search tool. This list would include all U.S. patents, foreign patents, and non-patent literature cited by the examiner and applicant.
2. Retrieve the full text of each cited patent.
3. Analyze each cited reference to:
   • Extract a detailed description of its disclosed invention.
   • Identify specific elements that correspond to the claims of US10865400B2.
   • Determine if any single prior art reference (or combination thereof, for obviousness under 35 U.S.C. § 103) discloses all elements of a given claim of US10865400B2, thereby potentially anticipating it under 35 U.S.C. § 102.

I cannot perform an obviousness analysis of US patent 10865400 under 35 U.S.C. § 103 as requested because the "Prior Art" section, which would contain specific prior art references for analysis, is not provided in the patent text. To assess obviousness, I require concrete prior art documents (e.g., other patents, publications) to identify potential combinations and motivations.