Petitioner v. Halozyme, Inc.
Pending- Docket:
- IPR2026-00313
- Filed:
- 2026-03-23
An Inter Partes Review (IPR) was filed to challenge the validity of US patent 11041149. The patent owner is Halozyme, Inc.
Defendant
8 cases as defendant.
Halozyme Inc., also known as Halozyme Therapeutics, Inc. (NASDAQ: HALO), is a publicly traded American biotechnology company headquartered in San Diego, California. Founded in 1998, Halozyme focuses on developing and commercializing drug delivery technologies. As of December 31, 2025, the company had 423 employees and reported a trailing twelve-month revenue of $1.397 billion. Its market capitalization was approximately $8.41 billion as of May 12, 2026.
Halozyme's primary business revolves around its proprietary ENHANZE® drug delivery technology. This platform utilizes a recombinant human hyaluronidase enzyme, rHuPH20, to facilitate the subcutaneous delivery of injectable biologics that traditionally require intravenous administration. This technology aims to improve patient convenience and adherence by reducing administration time and injection volume. Halozyme licenses its ENHANZE® technology to leading pharmaceutical companies, generating significant royalty revenue from commercialized products. The company also has its own proprietary commercial products, including Hylenex® and XYOSTED®.
Halozyme's patent litigation posture indicates it is an operating company that defends its intellectual property. The company has one tracked case in our database, appearing as a defendant in "Unified Patents v. Halozyme Inc" before the Patent Trial and Appeal Board (PTAB). This suggests that Halozyme is primarily focused on developing and commercializing its technologies and defending its patents when challenged, rather than asserting them as a plaintiff.
Notable collaborations include licensing agreements for its ENHANZE® technology with major pharmaceutical and biotechnology companies such as Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, and GSK. These partnerships have led to the commercialization of numerous ENHANZE®-enabled products across various therapeutic areas, including oncology. Recent developments include collaborations with Vertex Pharmaceuticals for its Hypercon™ technology and with Oruka Therapeutics, Inc.
An Inter Partes Review (IPR) was filed to challenge the validity of US patent 11041149. The patent owner is Halozyme, Inc.
Merck Sharp & Dohme LLC filed a post-grant review petition challenging U.S. Patent No. 12,077,791. The Director denied discretionary denial and institution was granted; the proceeding remains in merits briefing with no final written decision.
Merck filed a petition for post-grant review challenging all claims 1–40 of U.S. Patent 12,091,692 B2. The PTAB instituted review on October 10, 2025, on written description, enablement, and obviousness grounds. A motion to terminate based on an alleged undisclosed real party-in-interest remains pending.
Merck Sharp & Dohme LLC petitioned for post-grant review of US 12,037,618. The PTAB instituted review on November 13, 2025, on claims 3, 4, 6, and 34-40 based on written description and enablement, with obviousness also pleaded. Patent Owner's Response was filed January 15, 2026.
Merck Sharp & Dohme LLC filed a post-grant review challenging US 12,104,185 B2. The PTAB instituted trial on October 1, 2025, and the proceeding remains pending; Halozyme statutorily disclaimed claims 5-6.
Post-grant review petition filed by Merck Sharp & Dohme LLC challenging US 12,049,652. The PTAB instituted review on October 1, 2025 on written description and enablement grounds; no final written decision was located.
Merck Sharp & Dohme LLC filed a post-grant review petition challenging claims 1-40 of US 12,054,758 B2. The Board instituted the PGR on October 16, 2025, and the trial remains ongoing with no final written decision yet.
Merck filed a post-grant review challenging claims of the '520 patent on obviousness, written description, and enablement grounds. The PTAB instituted review on written description and enablement, and later reportedly issued a Final Written Decision finding the challenged claims unpatentable while rejecting Merck's novelty challenge; Halozyme may appeal to the Federal Circuit.