Litigation

Unified Patents v. Atossa Therapeutics Inc et al.

Settlement

PGR2025-00043

Patents at issue (1)

Plaintiffs (1)

Summary

A Post-Grant Review (PGR) case filed before the PTAB by Unified Patents against the patent owners Atossa Therapeutics Inc and Krisan Biotech Co Ltd, concerning US patent 12071391, which has resulted in a settlement.

Case overview & background

Plain-language overview of the case: parties, accused product, patents at issue, and why the suit matters.

Unified Patents, a member-based organization focused on deterring frivolous patent litigation by Non-Practicing Entities (NPEs), initiated a Post-Grant Review (PGR) against U.S. Patent 12071391. The patent owners are Atossa Therapeutics Inc., a clinical-stage biopharmaceutical company specializing in innovative medicines for oncology, particularly breast cancer, and Krisan Biotech Co Ltd, a global Contract Development and Manufacturing Organization (CDMO) expert in complex drug process development and GMP production, including small molecules, peptides, and antibody-drug conjugates. As a PGR proceeding, there is no directly "accused product" in the context of infringement; instead, the validity of the patent itself is being challenged.

U.S. Patent 12071391, titled "Compositions and methods for administering endoxifen," generally relates to pharmaceutical compositions and methods for delivering endoxifen, often in the context of treating or preventing breast cancer. The case, PGR2025-00043, was filed before the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office (USPTO). The PTAB serves as an administrative forum for challenging patent validity, offering an alternative to district court litigation. PGRs are particularly significant as they permit challenges to patents on nearly all grounds of patentability under 35 U.S.C. within nine months of the patent's issuance or reissue.

This PGR is notable due to Unified Patents' active role in challenging patents, often those asserted by NPEs, to mitigate patent litigation risk for its members. The biopharmaceutical industry, where Atossa Therapeutics and Krisan Biotech operate, is characterized by substantial research and development investment and intricate intellectual property landscapes. The outcome of such validity challenges can significantly impact market strategies and product development, especially concerning breast cancer treatments. The case has concluded in a settlement, as noted in the authoritative metadata.

Key legal developments & outcome

Major rulings, motions, claim construction, settlements, and the present posture or final disposition.

I'll research the actual docket and related proceedings before drafting this section.

Key discrepancy already emerging — let me dig further before drafting.

Key Legal Developments & Disposition — PGR2025-00043 (U.S. Patent No. 12,071,391)

Threshold correction before the chronology (please read first)

Two points must be flagged before any "litigation timeline" is meaningful, because the task framing and the case metadata do not match the public record:

1. There is no patent infringement litigation in this matter. PGR2025-00043 is a purely administrative validity proceeding before the PTAB. No complaint, answer, counterclaim, Markman proceeding, summary-judgment motion, trial, verdict, JMAC/JMOL motion, fee motion, or district-court appeal exists. The party-versus-party dispute was resolved entirely within the USPTO. Every requested litigation milestone below is therefore answered as "not applicable," with the PTAB analogue identified instead.

2. The captioned petitioner appears to be wrong. The metadata provided to me — and the previously generated "Case overview" and "Plaintiff representatives" sections — identify the petitioner as Unified Patents and the respondents as Atossa Therapeutics Inc. and Krisan Biotech Co. Ltd. The public record for PGR2025-00043 shows the petitioner is Intas Pharmaceuticals Ltd., with Accord Healthcare, Inc. (a U.S. Intas subsidiary) named as a real party-in-interest and Jina Pharmaceuticals, Inc. as an identified interested party. Atossa Therapeutics, Inc. is the sole patent owner/respondent; Atossa identifies only itself as RPI. See PTACTS docket documents (institution decision and petition papers) at ptacts.uspto.gov/ptacts/public-informations/petitions/1557640; Atossa Form 8-K filed 2025-04-07 (atossatherapeutics.gcs-web.com/static-files/4230182a-b9ad-4950-a2ee-0ad173aba853).

The likely origin of the confusion: Unified Patents operates a public patent portal on which U.S. 12,071,391 is displayed with "Current Assignee: Krisan Biotech Co Ltd; Atossa Therapeutics Inc" (portal.unifiedpatents.com/patents/patent/11261151 lists the same co-assignee pairing for the family). Krisan Biotech is a co-owner of the patent family, not a respondent in this proceeding, and Unified Patents is not the petitioner. *I recommend correcting the caption to Intas Pharmaceuticals Ltd. v. Atossa Therapeutics, Inc., PGR2025-00043, and removing Unified Patents and Krisan Biotech from the party list* — or, if the client's record genuinely reflects a separate Unified Patents challenge, confirming that docket number, because no Unified Patents PGR against Atossa on the '391 patent surfaced in search.

A third, smaller correction: the prior "Plaintiff representatives" section states that the PGR2025-00043 docket "was not publicly accessible." It is publicly accessible on PTACTS, and counsel of record are identified below. That section's discussion of Unified Patents attorneys (Stroud, Rossen, Marks, Aspen, Barazesh, Fawzy) has no application to this proceeding — none appears on this docket.


Chronological developments

Pre-filing context

Date Event
2023-02-07 U.S. Patent No. 11,572,334 (the "'334 patent"), same family ("Methods for Making and Using Endoxifen"), issues to Atossa.
2023-08-18 Intas files PGR2023-00043 challenging the '334 patent (Petition, Pap. 1).
2024-01-31 PTAB institutes PGR2023-00043 (cited as Pap. 11, *33–35). Date taken from Intas's citation in the PGR2025-00043 papers; treat as reported rather than independently verified.
2024-08-27 U.S. Patent No. 12,071,391 (the "'391 patent") issues — 44 claims; claims 1 and 32 independent; directed to a composition comprising (Z)-endoxifen (≥90% by weight) and an enteric material, and methods of administering it.
2025-01-29 PTAB issues Final Written Decision in PGR2023-00043 (Pap. 37), holding all challenged claims of the '334 patent unpatentable over the Ahmad reference.
2025-01-30 Atossa announces it will not appeal the '334 FWD, citing cost and time; discloses new '151 patent issuance and continuation strategy. (globenewswire.com/news-release/2025/01/30/3018027/…)

The '334 FWD is the single most important pre-history event: it supplied Intas with a collateral-estoppel-flavored and persuasive-authority argument that the '391 patent's near-identical claims were equally unpatentable, and it framed Atossa's exposure in the new PGR.

2025 — Petition and institution

Date Event
2025-04-03 Intas files the PGR petition challenging all 44 claims of the '391 patent. Filed within the nine-month PGR window (patent issued 2024-08-27). Asserted grounds: (1) anticipation by U.S. Patent 9,333,190 (Ahmad); (2)–(7) obviousness combinations (Ahmad + Ahmad 2010/2012; Ahmad + Benameur; Ahmad + de Villiers/Gandhi; Ahmad + Stegemann/Handbook of Pharmaceutical Excipients; Ahmad + Cole; Ahmad + POSA knowledge); (8) § 112 written description/enablement as to claims 10, 12–15, 30. Petitioner also preemptively argued against § 325(d) and § 314(a) discretionary denial.
2025-04-03 On the same day, Intas files IPR2025-00799 against U.S. Patent No. 11,261,151 (the "'151 patent") — the parallel challenge.
2025-04-07 Atossa files Form 8-K disclosing both petitions and stating it "intends to vigorously contest" them.
2025-07-07 Atossa (CFO Heather Rees) executes a Stipulation of Covenant Not to Sue covering Intas, its affiliates, and Jina Pharmaceuticals — but only as to products "incorporat[ing] the salt form of (Z)-endoxifen … used for the treatment of bipolar disorder or other psychiatric disorders," and effective only if the PTAB denies institution. This was Atossa's principal § 314(a) discretionary-denial vehicle.
c. 2025-07 (mid-July) Atossa files its Patent Owner Preliminary Response arguing discretionary denial under §§ 314(a) and 325(d): compelling public-health interest; waste of Board resources given the covenant; the Office already considered the same art; and on the merits, that the '391 claims require an endoxifen-enteric composition, not merely an endoxifen composition encapsulated in an enteric coating — the distinction from the '334 claims. Exact filing date not confirmed in available sources.
2025-08-22 Board conference call; Patent Owner authorized to file a 5-page reply on discretionary denial and claim construction, due 2025-08-26; Petitioner did not oppose. (Email correspondence in PTACTS file for Pet. 1557640; Megan F. Raymond, Groombridge, Wu, Baughman & Stone LLP, for Patent Owner.)
2025-11-03 PTAB grants institution of PGR2025-00043 on all challenged claims. The same day, the Board grants institution of IPR2025-00799 on the '151 patent. Panel: APJs Christopher C. Kennedy, Jamie T. Wisz, Sheridan K. Snedden. → The discretionary-denial effort failed, and the

Plaintiff representatives

Counsel of record for the plaintiff(s): attorneys, firms, and roles (lead counsel, of counsel, local counsel).

Unified Patents, as an organization that frequently challenges patents at the PTAB, typically has in-house counsel and may also engage outside counsel depending on the complexity and specifics of a case.

Based on available information, Jonathan R.K. Stroud is a key attorney for Unified Patents.

  • Jonathan Rudolph Kominek Stroud
    • Role: Chief IP Counsel (in-house)
    • Firm: Unified Patents, LLC, Chevy Chase, MD
    • Experience Note: Stroud is frequently involved in PTAB proceedings and has been noted for his expertise in patent quality and strategies for challenging patents. He has also been counsel of record for Unified Patents in Supreme Court filings.

Other Senior Patent Counsel at Unified Patents, who may be involved in various PTAB cases, include:

  • Jordan Rossen - Senior Patent Counsel, Unified Patents.
  • Jessica Marks - Senior Patent Counsel, Unified Patents.
  • Michelle Aspen - Senior Patent Counsel, Unified Patents.
  • Ellyar Barazesh - Senior Patent Counsel, Unified Patents.
  • Ashraf Fawzy - Legal Head - SEP, Unified Patents.

The specific docket for PGR2025-00043 was not publicly accessible through the general search, but Unified Patents' internal portal lists the case as PGR2025-00043, concerning patent 12071391, and its status as a settlement. Therefore, without access to the specific docket filings, it is not possible to definitively identify which specific attorney(s) from Unified Patents or any outside counsel were formally of record for this particular PGR.

Defendant representatives

Counsel of record for the defendant(s): attorneys, firms, and roles (lead counsel, of counsel, local counsel).

I'll research counsel of record for the patent owners (Atossa Therapeutics and Krisan Biotech) in this PTAB proceeding.

Key finding: the real parties differ from the metadata. Let me dig into the docket and counsel details.

Now let me verify the party structure (Krisan Biotech) and check for related district court litigation and any counsel changes.

Counsel of Record — Patent Owner Side

Threshold correction (flagged): For this proceeding the "defendant" framing does not map cleanly onto the record. PGR2025-00043 is a PTAB post-grant review, so the defending parties are the Patent Owner / Respondent, not defendants. More importantly, the PTAB docket and PTAB Decisions materials caption the case as Intas Pharmaceuticals Ltd. (et al.) v. Atossa Therapeutics, Inc., with Alejandro Menchaca (McAndrews, Held & Malloy, Chicago) as petitioner's counsel — not Unified Patents. I could not find any PTAB filing in PGR2025-00043 in which Unified Patents appears as petitioner. Per my operating rules I defer to the case metadata for the party name, but the underlying docket contradicts it and the "Unified Patents" attribution should be treated as unverified. (ipverse case page; PTACTS correspondence)

Second, Krisan Biotech Co., Ltd. is not a named party on the PGR2025-00043 docket and no counsel appeared for it. Krisan Biotech (Taiwan) is the original assignee on the '391 patent family; it assigned its rights to Atossa Therapeutics effective January 8, 2021 (USPTO assignment reel/frame 064165/0679). Its appearance in the metadata as a "defendant" appears to derive from patent-front-page assignee data rather than from any appearance in the proceeding. (Google Patents legal events for US 12,071,391 B2)

The entirety of the defending representation is therefore Atossa Therapeutics, Inc., represented by Groombridge, Wu, Baughman & Stone LLP.


Counsel of Record for Patent Owner Atossa Therapeutics, Inc.

Attorney Role Firm / Office Note
Megan F. Raymond (Reg. No. 72,997) Lead counsel (registered practitioner) Groombridge, Wu, Baughman & Stone LLP — 801 17th St. NW, Suite 1050, Washington, DC 20006 One of the most active PTAB life-sciences practitioners; 100+ post-grant proceedings; LMG Life Sciences Post-Grant Attorney of the Year (2024); President of the PTAB Bar Association; Federal Circuit clerk (Judge Mayer).
J. Steven ("Steve") Baughman Back-up counsel Groombridge, Wu, Baughman & Stone LLP — Washington, DC Founding partner; co-counsel with Raymond on Atossa's parallel IPR2025-00799 defense; Federal Circuit and district court trial experience.
Michael F. Milea Back-up counsel Groombridge, Wu, Baughman & Stone LLP — 565 Fifth Ave., Suite 2900, New York, NY 10017 Listed on Atossa's service list in the companion Intas proceedings; PTAB/life-sciences litigation.
Jacob M. Berman Back-up counsel — pro hac vice Groombridge, Wu, Baughman & Stone LLP Admitted pro hac vice by Board order of Jan. 8, 2026 (Papers 27–29; Ex. 2027).
Han Xu Back-up counsel — pro hac vice Groombridge, Wu, Baughman & Stone LLP Admitted pro hac vice by the same Jan. 8, 2026 order (Ex. 2028).
Hayley R. LeBlanc Back-up counsel — pro hac vice Groombridge, Wu, Baughman & Stone LLP Admitted pro hac vice by the same Jan. 8, 2026 order (Ex. 2029).

Service address of record: Atossa-Intas@groombridgewu.com, with individual addresses at @groombridgewu.com. (PTACTS service list, IPR2025-00799 / PGR2025-00043; Board order granting PHV admission)


Notes, gaps, and cautions

  • No in-house counsel of record identified. The mandatory notices I could retrieve list outside counsel only; I could not confirm whether Atossa in-house attorneys (e.g., in Seattle) appear on the sealed or non-public portions of the notices. Treat the absence of an in-house name as unverified rather than as a finding.
  • Lead-counsel stability. A "Patent Owner's Supplemental Mandatory Notice" was filed Dec. 23, 2025, and a "Petitioner's Unopposed Motion to Withdraw Backup Counsel" was filed Feb. 2, 2026. The Dec. 23 filing most plausibly corresponds to the pro hac vice additions, but I could not retrieve its text, so I cannot rule out other changes to Atossa's counsel lineup. (PTAB proceeding document list)
  • Companion proceeding. The same Groombridge Wu team (Raymond, Baughman, Milea, Berman, Xu, LeBlanc) represents Atossa in IPR2025-00799 on U.S. Patent 11,261,151, which is being handled in parallel with PGR2025-00043 and shares Board correspondence — relevant because the prior section's "parallel proceedings" discussion centered only on PGR2023-00043 (the '334 patent).
  • Later-filed matter. Groombridge Wu (Raymond and Baughman) also appears for Atossa in PGR2026-00015, Atossa Therapeutics, Inc. v. Jina Pharmaceuticals, Inc., per a Feb. 18, 2026 Board correspondence — i.e., Atossa has switched to the petitioner side in a later endoxifen-family challenge. This is worth flagging because it shows the firm's role is not purely defensive.
  • Not found / not verifiable. I found no PACER district-court docket for an Intas–Atossa endoxifen infringement suit in the searches available, so I cannot confirm whether a parallel district court action exists or which firms staff it. If a district court case is the actual referent of your question, that counsel list would be separate and I have not been able to source it. Do not treat the above as a district-court appearance list.
  • Petitioner side, for completeness/conflict check: Alejandro Menchaca and Ben J. Mahon, McAndrews, Held & Malloy, Ltd., 500 W. Madison St., 34th Fl., Chicago, IL 60661 — relevant if you need to run a conflicts or comparative-staffing analysis.

Bottom line: the only counsel of record defending in PGR2025-00043 are Groombridge, Wu, Baughman & Stone LLP — Megan F. Raymond (lead), J. Steven Baughman, Michael F. Milea, Jacob M. Berman, Han Xu, and Hayley R. LeBlanc — for Atossa Therapeutics, Inc. alone. No attorney has appeared for Krisan Biotech Co., Ltd., which is not a party to the proceeding.