Litigation

Untitled case

Pending

PGR2026-00036

Filed
2026-04-02

Patents at issue (1)

Defendants (1)

Summary

A Post-Grant Review (PGR) case challenging US patent 12370153, filed on April 2, 2026, against patent owner Inforlife SA, and currently pending before the PTAB.

Case overview & background

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

This Post-Grant Review (PGR) case, PGR2026-00036, is currently pending before the Patent Trial and Appeal Board (PTAB) and was filed on April 2, 2026. The patent owner is Inforlife SA, a pharmaceutical company based in Switzerland that develops, registers, and produces ready-to-use medicines, often in plastic packaging, for markets including the USA. Inforlife SA operates as a subsidiary of the Italian chemical-pharmaceutical company, ACS Dobfar. While the specific petitioner for PGR2026-00036 is not publicly identified in the available search information, petitioners in PGRs are typically third parties seeking to challenge the validity of an issued patent.

The patent at issue is US patent 12370153. A detailed one-line technical sketch of this patent is not readily available in the provided search results; however, given Inforlife SA's business, the patent likely pertains to pharmaceutical substances, formulations, or related manufacturing processes. The PGR proceeding at the PTAB challenges the patentability of the claims within US patent 12370153 based on various grounds of invalidity under U.S. patent law, excluding the "best mode" requirement.

This case is situated within the PTAB, an administrative tribunal of the U.S. Patent and Trademark Office, which offers a streamlined, generally faster, and less costly alternative to federal court litigation for patent validity challenges. A key aspect of PTAB proceedings, particularly PGRs, is the lower burden of proof for invalidity ("more likely than not") and the adoption of the "broadest reasonable interpretation" for claim terms, which can be advantageous to petitioners. PGRs must be filed within nine months of a patent's issuance, making this a timely challenge to the patentability of US 12370153. While the specific impact of this particular PGR remains to be seen without knowledge of the petitioner or detailed patent claims, challenges to pharmaceutical patents can be notable given their potential to influence market entry for generic drugs and competitive landscapes within the industry.

Key legal developments & outcome

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

I'll research the docket and related proceedings. Note upfront: this is a PTAB post-grant review, not a district court infringement action, so I'll trace the PGR's own procedural timeline and then the parallel district court case(s) on the same patent family.

Substantive results found. Now let me pull the full institution decision, the POPR date, counsel details, and any parallel district court case on the '153 patent.

Procedural posture: this is a PTAB trial, not a district court action

A framing note before the chronology: PGR2026-00036 is an administrative trial under 35 U.S.C. §§ 321–329, so the conventional litigation milestones (complaint, answer, Markman, JMOL) do not exist. The functional equivalents in a PGR are: petition → patent owner preliminary response ("POPR") → institution decision → (if instituted) patent owner response, discovery, oral argument, final written decision. Here the case terminated at the institution stage. I use the requested categories below but map them onto PGR procedure, then separately address the district court and PTAB activity on the same patent family.

Critical correction to the case metadata and prior sections. The metadata and the existing overview describe the case as "pending." As of the current date the proceeding is closed: institution was denied on 2026-08-13, and the prior "Plaintiff representatives" section's statement that no counsel had appeared is superseded — both sides' counsel are now identified in public databases (see § 6). The metadata's filing date of 2026-04-02 also conflicts with third-party PTAB databases, which give 2026-03-25 (IPVerse/Greyb, Ex Parte AI Lab) and 2026-03-23 (Arctic Invent, likely the petition's execution/signature date). I flag this rather than silently adopt either figure; the metadata remains authoritative per operating rules, but the docket-derived date of 2026-03-25 appears more likely to be the true filing date.


1. Chronology of key developments

Date Event Source
2025 (mid-year, est.) U.S. Patent No. 12,370,153 B2 ("Ready-to-use ketamine premix formulation") issues to InfoRLife, S.A. US-12370153-B2 (Dimensions)
2026-03-23 to 2026-03-25 Par Health, Inc. files petition for post-grant review of claims 1–23 of the '153 patent (Paper 2). Two grounds: (1) anticipation under § 102(a)(1); (2) obviousness under § 103. Petition; IPVerse; Arctic Invent
~2026-06 (late June, est.) Patent Owner's Preliminary Response (Paper 5), including a statutory disclaimer of claims 1, 3–5, 13, and 18 (Ex. 2001). Only claims 2, 6–12, 14–17, and 19–23 remained at issue. Institution Decision (Paper 7) at 1–2
2026-08-13 Director denies institution. Decision issued by John A. Squires, Under Secretary of Commerce for IP and Director of the USPTO. Petitioner failed to show it was more likely than not that any challenged claim is unpatentable. Decision Denying Institution; Rothwell Figg
2026-08-13 onward Proceeding terminated as to institution; no final written decision, no estoppel. IPVerse ("Status: Institution Denied")

(The exact POPR filing date is not exposed in the public sources I could reach; § 324(a) requires the decision within six months of the petition's filing, and 2026-08-13 is consistent with a late-June/early-July 2026 POPR. I am inferring the date, not reporting it.)


2. "Initial pleadings": the petition and its invalidity theories

Par Health challenged all 23 claims of the '153 patent, which covers a sterile, ready-to-use, preservative-free ketamine premix for intravenous infusion with long-term chemical stability and shelf life. The petition rested on a narrow, single-reference theory:

  • Anticipation (§ 102(a)(1)): a data sheet for a ketamine product manufactured by Biomed Limited (New Zealand) (Ex. 1005), which Petitioner and its declarant (Ex. 1003) asserted disclosed every claim limitation. Petitioner argued the reference qualified as prior art based on the "date of revision" of June 15, 2021 appearing on its last page, and pointed to the sheet's statement that the product was first approved in New Zealand on May 5, 2011.
  • Obviousness (§ 103): Biomed combined with Remington's pharmaceutical handbook and commercial infusion-bag data sheets — SealedAir M312/M315 films and Technoflex Inerta — to supply the container/closure limitations.

Strategically, this was a single-point-of-failure petition: both grounds depended entirely on Biomed clearing the printed-publication threshold. That structural choice is what decided the case.

3. The decisive pretrial "motion of substance": the POPR and the § 102 printed-publication fight

The substantive ruling of the proceeding was on prior-art qualification under § 102(a)(1), not on anticipation or obviousness on the merits.

InfoRLife's POPR (Prelim. Resp. 16–22) argued that the June 15, 2021 date merely indicated when the document was revised and had "no bearing on whether or when the document was published, much less whether or when any alleged product described by the document became publicly available" (id. at 20). The Director agreed in full:

"I agree with Patent Owner that Petitioner has failed to show sufficiently that Biomed qualifies as a prior art printed publication." — Decision at 2

The reasoning rests on the Board's precedential decision in Hulu, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper 29 (PTAB Dec. 20, 2019), which requires the petition to "identify, with particularity, evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date," and on Jazz Pharmaceuticals, Inc. v. [Amneal Pharmaceuticals, LLC](/litigations/by-plaintiff/Amneal%20Pharmaceuticals%2C%20LLC), 895 F.3d 1347, 1356 (Fed. Cir. 2018) (petitioner bears the burden of proving printed-publication status). The Director expressly held that Hulu's guidance applies to PGRs, subject to the "more likely than not" standard of § 324(a) (citing Hulu, Paper 29, at 13 n.5). The Director's core holding: "a revision date alone does not establish that Biomed was disseminated or made publicly available."

Second, quieter ruling — the disclaimer. By disclaiming claims 1, 3–5, 13, and 18 in the POPR, InfoRLife narrowed the challenge by six claims (26% of the challenged claims) before any merits decision. Under 35 U.S.C. § 253(a) a disclaimed claim is treated as though it never existed, so those claims were removed from the controversy without any adjudication of their validity — a costless way for the patent owner to moot the petitioner's strongest mapping.

4. Institution decision (the "outcome")

On 2026-08-13, the Director denied institution under § 324(a), ordering that "Petitioner's petition is denied." The decision states it considered "the arguments and evidence presented for merits and non-discretionary considerations" and referenced Paper 6 ("Notice"), at 2 — i.e., the proceeding was resolved within the USPTO's current practice of issuing batched "Notice of Decisions on Institution," in which the Director (rather than a three-judge panel) makes the institution call after review of discretionary and non-discretionary considerations under §§ 314(a)/324(a).

Two caveats for accuracy:

  • The decision's caption reads **"Decision Denying Institution of Inter Partes Review"** even though this is a PGR. That appears to be a clerical caption error in the document as circulated; the body consistently applies PGR standards (§ 324(a), "more likely than not").
  • Because the Director himself issued the decision, the ordinary Director Review path (normally invoked by a party after a Board panel decision) was not available to Par Health. Denial of institution is in any event shielded from judicial review by § 324(e). No appeal was taken, and none is available.

5. Claim construction, discovery, trial, post-trial motions, settlement

  • Markman/claim construction: None. The petition included proposed constructions, but no construction was adopted or relied upon, because the case ended on the prior-art-qualification threshold.
  • Discovery: None of significance. PGR discovery is limited and post-institution (37 C.F.R. § 42.51); with institution denied, no depositions, no cross-examination of the Ex. 1003 declarant, and no routine or additional discovery occurred.
  • Trial/verdict/JMOL/fees: Not applicable. There was no oral argument and no final written decision. The America Invents Act contains no fee-shifting mechanism for PTAB trials, so no fees motion.
  • Settlement/dismissal: None reported. The case simply terminated by denial of institution; the parties remain adverse in the marketplace.
  • Estoppel effect: Because institution was denied, no § 315(e) estoppel attaches to Par Health. Par Health is not barred from asserting the same Biomed-based invalidity theories in district court, subject to ordinary issue-preclusion and evidentiary rules.

6. Counsel of record (updating the earlier sections)

Public PTAB databases now list:

  • Petitioner Par Health, Inc.: "Berman, Richard et al" (IPVerse/Greyb).
  • Patent Owner InfoRLife, S.A.: "Harston, Aydin et al" (IPVerse/Greyb) — consistent with Rothwell Figg, Ernst & Manbeck, P.C., which publicly claims the win: "Rothwell Figg successfully defended InforLife, S.A. against a Post-Grant Review (PGR) challenge to U.S. Patent No. 12,370,153." This aligns with Rothwell Figg's prior representation of InfoRLife in InfoRLife SA v. Sagent Pharmaceuticals (D. Del.), per the earlier section of this case file.

I could not verify, from a reliable source, which firm employs petitioner's counsel Richard Berman, nor the full attorney roster on either side; the copy of the decision that surfaces in search results is hosted on finnegan.com, which may indicate Finnegan, Henderson, Farabow, Garrett & Dunner as petitioner

Plaintiff representatives

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

As of May 30, 2026, the specific counsel of record for petitioner Par Health, Inc. in PGR2026-00036 has not been explicitly identified through public docket searches. PTAB dockets, especially in the early stages, typically do not immediately list all counsel in a format easily searchable by general web queries.

However, based on the background of Par Health, Inc. (formed from the merger of Mallinckrodt and Endo) and the nature of the patent in question (pharmaceutical formulations), it is possible to identify firms known for representing generic pharmaceutical companies in high-stakes patent litigation, particularly in Post-Grant Review (PGR) proceedings before the PTAB.

Firms with strong reputations in this area that have represented similar clients include:

  • Sterne Kessler is noted for its extensive experience in pharmaceutical patent litigation, including Abbreviated New Drug Application (ANDA) and Biologics Price Competition and Innovation Act (BPCIA) matters, and has represented Mallinckrodt Pharmaceuticals in past patent suits. They are among the most active firms at the U.S. Court of Appeals for the Federal Circuit.
  • Quinn Emanuel Urquhart & Sullivan, LLP has a significant patent litigation practice, with over 80% of their IP cases involving patents. They have a deep bench of life sciences attorneys who have litigated over 300 ANDA cases and other pharmaceutical licensing disputes. Quinn Emanuel has also secured victories for innovator pharmaceutical companies in Hatch-Waxman patent litigation.
  • Paul Hastings LLP is recognized for its patent litigation practice in the pharma and tech industries, with experience in over 200 post-grant review and IPR proceedings. They have represented major corporations, universities, and individual inventors in litigation spanning pharmaceuticals, medical devices, and biotechnology.
  • Ballard Spahr handles complex infringement matters for innovators in life sciences, including post-grant review proceedings before the PTAB, and has experience with patent infringement and related antitrust and Hatch-Waxman claims.
  • Cozen O'Connor represents diverse clients in complex patent matters, including federal district court litigation and PTAB proceedings, across industries such as pharmaceuticals, life sciences, and medical devices. Many of their IP litigators have advanced degrees in chemistry, biology, immunology, and biophysics.

Without access to the specific docket for PGR2026-00036, it is not possible to definitively name the counsel of record at this time. Filings for PTAB cases are made publicly available through the USPTO's Patent Trial and Appeal Board End-to-End (PTAB E2E) system, which would contain the appearances of counsel.

Defendant representatives

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

I'll research counsel for the patent owner (Inforlife SA, the party listed as "defendant" in the metadata) and verify the petitioner identification.

Counsel of Record — PGR2026-00036

Threshold correction on framing. The task asks for counsel for the "defendant(s)." In this PGR there is no plaintiff/defendant pair — the role metadata labels "Defendant(s): Inforlife SA" corresponds to the Patent Owner / Respondent, InfoRLife, S.A. (also spelled "InforLife, S.A."). Its adversary, Par Health, Inc., is the Petitioner. I therefore report Patent Owner counsel as the answer, with Petitioner counsel noted separately for context. I also flag two contradictions with the case metadata at the bottom.


Patent Owner (Respondent) — InfoRLife, S.A.

1. Aydin H. Harston, Ph.D. — lead counsel / Respondent counsel of record

  • Firm: Rothwell, Figg, Ernst & Manbeck, P.C. — Washington, D.C. (607 14th Street, N.W., Suite 800); e-mail of record: aharston@rfem.com; USPTO Reg. No. 65,249.
  • Grounding: Listed as "Respondent Counsel … Harston, Aydin et al." in the IP Verse PTAB case profile for PGR2026-00036, and appears first in the counsel service block of the Director's 13 Aug. 2026 institution decision ("Aydin Harston … Rothwell, Figg, Ernst & Manbeck, P.C."). Rothwell Figg's own case write-up confirms the firm "successfully defended InforLife, S.A." in this PGR through the Patent Owner's Preliminary Response.
  • Relevant experience: Ph.D. biochemist; named "Life Sciences Star" in LMG Life Sciences (2025) and WIPR Leaders 2026; represented Coherus as patent owner in Fresenius Kabi USA v. Coherus BioSciences, PGR2019-00064 (Board upheld the '039 adalimumab/Humira® biosimilar formulation patent); represented Acrux in Acrux DDS v. Kaken Pharm., IPR2017-00190 (all claims of the Jublia® patent cancelled). Experience squarely on point for sterile/ready-to-use injectable formulation patents.

2. Jennifer Nock — back-up / co-counsel of record

  • Firm: Rothwell, Figg, Ernst & Manbeck, P.C. — Washington, D.C.; e-mail of record: jnock@rfem.com.
  • Grounding: Second named attorney in the service block of the 13 Aug. 2026 decision; also named a Life Sciences Star (LMG Life Sciences 2025) alongside Harston.
  • Note: I did not locate a standalone case-specific bio entry for her work in this PGR, so the depth of her substantive role beyond appearing on the service block is not independently documented in the sources I found.

3. In-house counsel / local counsel: No in-house attorney for InfoRLife, and no local (district-court-style) counsel, appears in any public source. PTAB practice does not require local counsel, so none would be expected.

Practical note on InfoRLife's counsel bench: Rothwell Figg is InfoRLife's long-standing patent litigation firm in the U.S. It represented InfoRLife (with Morris, Nichols, Arsht & Tunnell as Delaware counsel) as plaintiff in the Hatch-Waxman suits InfoRLife SA v. Hikma Pharmaceuticals USA, No. 1:21-cv-01764 (D. Del.) and InfoRLife SA v. Sagent Pharmaceuticals, No. 1:25-cv-00387 (D. Del.). The PGR team (Harston, Nock) sits in that same firm relationship, so this is a continuity defense rather than a new engagement.

Petitioner — Par Health, Inc. (for context only)

  • IP Verse lists "Berman, Richard et al." as Petitioner counsel. I could not verify Richard Berman's firm, office, or a case-specific appearance document, so I decline to name a firm. One weak, non-dispositive lead: the full text of the 13 Aug. 2026 decision is hosted on finnegan.com's document server, which often (but not always) signals the prevailing/participating firm's own posting — I would not treat that as proof of Finnegan Henderson's involvement.

Explicit sourcing caveats

  • I was not able to pull the PTAB E2E docket sheet itself or the Updated Mandatory Notices (37 C.F.R. § 42.8) for PGR2026-00036. Those filings are the authoritative source for the complete counsel roster and would capture any additional back-up counsel not named in the decision's service block. The two names above are those affirmatively appearing in the record documents I could access.
  • The Patent Owner's Preliminary Response (Paper 5) is public (not sealed) — the decision quotes it extensively — but I did not retrieve its signature block, so I cannot rule out a third Rothwell Figg attorney appearing only on that paper.

Contradictions with the existing case sections / metadata — flagged

  1. Prior "Plaintiff representatives" section is unsupported and partly wrong. It speculated that Sterne Kessler, Quinn Emanuel, Paul Hastings, Ballard Spahr, or Cozen O'Connor likely represent the petitioner, based on Par Health's Mallinckrodt/Endo lineage. No source supports those attributions; the only counsel data available names "Harston" for the patent owner and "Berman, Richard et al." for the petitioner. That section should be treated as superseded by this one.
  2. Status: Metadata says "Pending." Multiple sources report that on 13 Aug. 2026 the Director (Under Secretary John A. Squires) denied institution of PGR2026-00036 on the merits — finding Petitioner failed to show Biomed (Ex. 1005) qualified as a § 102(a)(1) printed publication under Hulu v. Sound View. IP Verse lists status "Institution Denied" with an institution decision date of 13 Aug. 2026. The proceeding is therefore effectively terminated, not pending.
  3. Filing date: Metadata gives 2026-04-02; IP Verse and Ex Parte both list the petition filing date as 25 Mar. 2026 (Arctic Invent says 23 Mar. 2026). The 2 April date may be the "Notice of Filing Date Accorded" rather than the petition date. Worth reconciling.
  4. The prior overview's guess that the patent "likely pertains to pharmaceutical substances, formulations, or related manufacturing processes" undersells it: the '153 patent claims a ready-to-use, sterile, preservative-free ketamine premix infusion with long-term stability.