US 9217168

I'll search for authoritative information on US 9,217,168, including any 2026 CAFC docket activity.

Let me check the litigation dockets and obtain the actual claim text.

Let me retrieve the full claim set (including asserted claim 23) and check the 2026 Delaware case and any Federal Circuit appeal.

Search notes and limits

I searched for US 9,217,168 in patent databases (Google Patents, PubChem, Justia, FreePatentsOnline, DrugPatentWatch, Espacenet) and in litigation sources (CourtListener D. Del. dockets, Big Molecule Watch, Goodwin, JD Supra, Pearce IP, HBS). I did not find any Federal Circuit 2026 docket—or any CAFC appeal at any year—naming U.S. Patent No. 9,217,168. The 2026 Federal Circuit materials my searches surfaced (Spero v. Mercedes-Benz, No. 25-1470; Contour IP v. GoPro, No. 26-2012; Dolby v. Unified Patents; Enviro Tech v. Safe Foods; TJTM v. Google) involve unrelated patents. Accordingly, I cannot confirm any appellate activity; treat "no 2026 CAFC appeal found" as a negative search result, not proof that none exists.

I also flag that "9217168" collides with unrelated identifiers elsewhere: WO 92/17168 (an October 1992 PCT publication, cited as "M0 9217168 A") and JP 9217168 A (a Japanese publication, Aug. 19, 1997). Those are not U.S. Patent 9,217,168.

Bibliographic summary — U.S. Patent No. 9,217,168 B2

Abstract (verbatim): "Polypeptide preparations having target levels of glycans, and methods of producing such polypeptide preparations using putrescine, are described."

Caveat on EP 2968549: Espacenet lists EP 2968549 A1 ("Methods of cell culture," Prentice/Tijani/Belongia) — but that appears to be a different Momenta family (application EP14769180, directed to DMSO). Do not conflate it with the '168 family (EP 2971040, from PCT/US2014/023924).

Plain-language overview of the independent claims

The patent is a cell-culture manufacturing-process patent: it claims a way of making a recombinant protein (e.g., a therapeutic antibody) in CHO-type cells by deliberately dosing the culture medium with putrescine, and then harvesting product that hits a glycan specification relative to the same process run without that putrescine level.

Claim 1 (verified verbatim in litigation papers and patent-claims databases) requires:

1. Providing a cell genetically engineered to express a recombinant protein;
2. Culturing it in medium comprising 0.1 mg/L to 10 mg/L putrescine; and
3. Harvesting a preparation that meets a target value for one or more of galactosylated glycans, high mannose glycans, and sialylated glycans,
   • where the galactosylated or sialylated target is ≥10% higher than in a preparation made without 0.1–10 mg/L putrescine, or
   • where the high-mannose target is ≥10% lower than in a preparation made without 0.1–10 mg/L putrescine.

In other words: the claim is not merely "add putrescine to a bioreactor" — it is a result-limited process claim tying a narrow putrescine concentration window to a measured, ≥10% relative glycan shift.

Claims 10, 13, and 16 are the other three independent claims. In the asserted family, Janssen characterizes the '168 patent as covering methods of targeting "galactosylated glycans, high mannose glycans, and sialylated glycans" (and, in the specification's summary section, also fucosylated glycans). Representative dependent claims show the scope:

• Claim 2 — recombinant protein is a recombinant therapeutic protein
• Claim 3 — it is a recombinant therapeutic antibody
• Claim 8 — quantitative windows: 1–95% galactosylated, 0.1–20% high mannose, 0.1–90% sialylated
• Claim 9 — reference therapeutic protein drawn from a long list (abatacept, adalimumab, bevacizumab, rituximab, trastuzumab, etc.)
• Claim 23 — the cell is a CHO (Chinese Hamster Ovary) cell (depends from any of claims 1, 10, 13, or 16)

⚠️ Uncertainty: I could verify the verbatim text of claim 1 (from the Janssen v. Amgen complaint and DrugPatentWatch) and of claims 2, 3, 7, 8, 9, and 23. I could not independently verify the verbatim wording of independent claims 10, 13, and 16; I have only the fact that they are the independent claims and that claim 10 uses the same "0.1 mg/L to 10 mg/L putrescine" culturing step. A closely related Momenta patent, US 9,487,810 ("Methods of cell culture"), has an independent claim 1 expressly directed to fucosylated glycans with the same 0.1–10 mg/L putrescine limitation and ≥10% increase threshold — I mention that as context only, not as the text of the '168 patent.

Important scope note: the specification discloses putrescine concentrations far wider than the granted claims — e.g., "about 0.01 mg/L … 40 mg/L or more," and ranges such as "about 0.1 mg/L to about 10 mg/L." The granted independent claims, however, are limited to the 0.1–10 mg/L sub-range, which is narrower than the written description.

Litigation exposure (as of the search date)

The '168 patent is a high-profile biosimilar manufacturing patent, now held by Janssen Biotech:

• Janssen Biotech, Inc. v. Amgen Inc., D. Del. No. 1:22-cv-01549 (C.A. No. 22-1549-MN) — BPCIA case over Amgen's ustekinumab biosimilar ABP 654 (STELARA®). Janssen's March 2023 preliminary-injunction motion rested on only two patents, the '168 and '858 (US 9,475,858), asserting claim 23 of the '168 patent. Janssen's expert was Dr. Matthew Croughan. (CourtListener docket 66574873, D.I. 48 — https://www.courtlistener.com/docket/66574873/48/janssen-biotech-inc-v-amgen-inc/)
• Janssen Biotech v. Alvotech — golimumab (AVT05) BPCIA complaint pleading declaratory-judgment infringement of the '168 patent. (https://www.pearceip.law/wp-content/uploads/2026/06/Janssen-v-Alvotech-Complaint-US-Golimumab.pdf)
• Janssen / Bio-Thera golimumab (BAT2506) complaint also pleads infringement of the '168 patent. (https://www.bigmoleculewatch.com/wp-content/uploads/sites/2/2026/03/Golimumab-Complaint.pdf)
• Google Patents flags two Delaware district court matters against this patent: 1:26-cv-00222 (marked "Critical," i.e., recent) and 1:22-cv-01549 — plus a "first worldwide family litigation" Darts-IP family ID 51529891.
• Third-party antitrust/overlap commentary (Stelara antitrust amended complaint, Feb. 5, 2024) describes the '168 and '858 pair as covering selection of putrescine or arginine levels to control glycans and C-terminal variants respectively. (https://www.hbsslaw.com/sites/default/files/case-downloads/stelara-antitrust/2024-02-05-amended-complaint.pdf)

Bottom line

US 9,217,168 is a Momenta-originated, now Janssen-owned process patent (filed and issued 2013/2015, expiring March 14, 2033, subject to a terminal disclaimer) claiming methods of culturing engineered cells in medium containing 0.1–10 mg/L putrescine and harvesting recombinant protein meeting a ≥10% relative shift in galactosylated/sialylated (up) or high-mannose (down) glycans versus a no-putrescine control. Its commercial significance is as a biosimilar manufacturing patent asserted against Amgen (ABP 654/ustekinumab), Alvotech (AVT05), and Bio-Thera (BAT2506).

Two explicit uncertainties: (1) I found no Federal Circuit 2026 (or earlier) appeal involving this patent — this is a negative search result, and I cannot rule out an appeal that is not indexed in the sources I could reach; (2) I could not verify the verbatim claim language of independent claims 10, 13, and 16, so the overview above fully grounds only claim 1 (and its dependents) in verified text. For an authoritative full claim set, consult the patent's own claims at https://patents.google.com/patent/US9217168/en or USPTO PatentCenter for application 13/829,333.