US 8324275

I'll verify this patent against live sources, including the claims (the supplied full text was truncated before the claim set) and any litigation/Federal Circuit activity.

Now let me get the complete claim set and check for any 2026 Federal Circuit / USPTO activity.

Let me confirm the complete claim set and check for any 2026 docket activity specifically involving the '275 patent.

Verification Summary — US Patent No. 8,324,275

Search scope note: I searched for the literal identifier 8,324,275 ("'275 patent") across patent databases (Google Patents, PubChem, FreePatentsOnline, DrugPatentWatch), USPTO/PTAB petition records, and Federal Circuit dockets/court records. No results were returned for any other patent number. I could not directly query PACER, so my Federal Circuit findings rest on secondary docket aggregators, court filings, and reported opinions — see the uncertainty note at the end.

1. Bibliographic Data

Continuity: The '275 patent is a continuation of 12/913,644 (filed Oct. 27, 2010), which is a continuation of 11/777,877 (now US 7,851,506), which is a divisional of 10/841,709 (now US 7,262,219), a divisional of 10/194,021 (now US 6,780,889), a divisional of 09/470,570 (now US 6,472,431), which claims priority to provisional 60/113,745 (Dec. 23, 1998). A terminal disclaimer was filed Aug. 24, 2012 over an obviousness-type double-patenting rejection.

Source conflicts: Google Patents lists both original and current assignee as Jazz Pharmaceuticals Inc.; PubChem additionally lists the five inventors as assignees. I treat the Google Patents/assignment-record chain (ultimately Jazz) as authoritative.

2. Abstract (verbatim)

"Disclosed are formulations of gamma-hydroxybutyrate in an aqueous medium that are resistant to microbial growth. Also disclosed are formulations of gammahydroxybutyrate that are also resistant to the conversion into GBL. Disclosed are methods to treat sleep disorders, including narcolepsy, with these stable formulations of GHB. The present invention also provides methods to treat alcohol and opiate withdrawal, reduced levels of growth hormone, increased intracranial pressure, and physical pain in a patient."

Note the tension between the broad disclosure (concentrated, preservative-free, self-preserving GHB solutions) and the narrow claims, which are method-of-use claims only (DrugPatentWatch classifies the patent claim types as "Use; Formulation").

3. Claims — Plain-Language Overview

Independent Claim 1 — Method of treating cataplexy or daytime sleepiness in a diagnosed-narcolepsy patient, using two diluted 500 mg/mL doses:

1. Dilute an aqueous solution of about 500 mg/mL sodium gamma-hydroxybutyrate with an aqueous medium to make a first dose of about 4.5–9 g;
2. Do the same to make a second dose of about 4.5–9 g;
3. Orally give the first dose within one hour before initial sleep onset;
4. Orally give the second dose 2.5–4 hours after initial sleep onset.

Plain language: this covers the practical Xyrem-style regimen — a concentrated 500 mg/mL oxybate liquid that the patient measures, dilutes in water, and takes twice nightly (at bedtime and again ~2.5–4 h later) to treat narcolepsy's cataplexy or daytime sleepiness. The key limitations are the 500 mg/mL stock concentration, the per-dose gram range, and the two-dose timing window.

Independent Claim 2 — Same four steps as claim 1, but the first and second doses are each about 3–9 g (broader dose range).

Claim 3 (depends on claim 1 or 2) — Each diluted dose contains about 50–150 mg/mL sodium gamma-hydroxybutyrate (i.e., the concentration after dilution).

Claim 4 (depends on claim 3) — Each dose contains about 50–75 mg/mL (a narrower diluted-concentration range, consistent with ~4.5 g in ~60 mL of water).

Prosecution context (from PTAB petition papers): As filed (Apr. 13, 2012), the claims recited higher upper dose limits (a second-dose range of "about 4.5 to about 10 grams" appears in the file history; the OCR text shows a garbled "10.4.5" that I have not auto-corrected). On June 28, 2012 the examiner rejected the claims under §103(a) over Broughton et al. (1979) in view of Gessa et al., EP 0 344 704, plus an obviousness-type double-patenting rejection. Applicants amended on Aug. 24, 2012, argued that the prior art taught away (Broughton used 150–225 mg/mL solutions and multiple lower doses; the claims recite 500 mg/mL, ≥6.0 g total, and only two doses per night), filed a terminal disclaimer, and the patent issued Dec. 4, 2012.

4. Litigation / 2026 Docket Findings

District court (per Google Patents' litigation sidebar and PTAB filings): the '275 patent has been asserted in numerous Hatch-Waxman suits, e.g., Jazz Pharmaceuticals, Inc. v. Par Pharmaceuticals (D.N.J. 2:13-cv-07884; consolidated 10-6108) and cases against Roxane/Amneal and others, where Paragraph IV certifications challenged the '889, '219, '506, '650 and '275 patents. Amneal's counterclaim record notes that the '275 patent issued from application 13/446,942 filed April 13, 2012 — i.e., after Jazz learned of Roxane's non-infringement theory on the earlier '506 patent (which required a concentrated 500 mg/mL medium and did not expressly recite dilution). Roxane characterized this as serial continuation practice; that is an allegation in a pleading, not an adjudicated finding.

Federal Circuit: I found no 2026 Federal Circuit docket, appeal, or opinion naming US 8,324,275. The active Federal Circuit oxybate litigation is Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC, Nos. 24-2274, 24-2277, 24-2278 (Fed. Cir. May 6, 2025) (reported at 136 F.4th 1075), which concerned different patents — principally US 11,147,782 ("GHB formulation and method for its manufacture"), plus the '079/'782 and related modified-release/resinate families — not the '275 patent. That decision reversed-in-part, vacated-in-part, and remanded a permanent injunction; follow-on remand proceedings in D. Del. (1:21-cv-00691-GBW) continue, and Avadel's antitrust/trade-secret trials were scheduled for late 2025.

Conclusion on the 2026 docket question: nothing involving the specific number 8,324,275 was found. Given that the patent is recorded as expired (anticipated expiration Dec. 22, 2019), further Federal Circuit activity on the '275 patent itself is unlikely.

5. Uncertainty / Caveats

• I am not aware of any CAFC 2026 docket entry for 8,324,275, and my searches returned none — but I could not query PACER directly, so I cannot exclude an unreported or very recently filed docket.
• The complete claim text (4 claims) comes from DrugPatentWatch and is corroborated by the PTAB petition exhibit that reproduces the issued claims in a table ending at claim 4. The authoritative source I was given (the Google Patents full text) was truncated before the claims section, so the claims here are sourced from secondary databases rather than the patent's own claim page.
• The as-filed claim language in the prosecution history contains an apparent OCR artifact ("about 10.4.5 to about 10 grams"); I have flagged it rather than corrected it, and it does not affect the issued claims.
• The prosecution history excerpt is quoted from third-party petition filings; exact quoting should be confirmed against USPTO PatentCenter if it is to be relied on formally.

Primary URLs used: https://patents.google.com/patent/[US8324275B2](/patent/US8324275B2)/en · https://www.drugpatentwatch.com/p/patent-claims/8324275 · https://pubchem.ncbi.nlm.nih.gov/patent/US-8324275-B2 · https://ptacts.uspto.gov/ptacts/public-informations/petitions/[1459711](/patent/1459711)/ (Amneal/Roxane filings reproducing the '275 claims and prosecution history) · https://cases.justia.com/federal/appellate-courts/cafc/24-2274/24-2274-2025-05-06.pdf

I'll research litigation involving US patent 8,324,275 (the Jazz Pharmaceuticals GHB/sodium oxybate patent). Let me run several searches.

Let me search more specifically on litigation databases.

Let me dig deeper into the specific ANDA cases and outcomes.

Litigation Involving U.S. Patent No. 8,324,275

Patent identification (as interpreted literally)

• U.S. Patent No. 8,324,275 B2 — "Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy"
• Application 13/446,892, filed April 13, 2012; granted December 4, 2012
• Inventors: Cook, Hamilton, Danielson, Goderstad, Reardan; Assignee: Jazz Pharmaceuticals, Inc.
• Priority: December 23, 1998 (provisional 60/113,745); a member of the "'431 patent family" covering sodium oxybate (GHB) compositions/dosing
• Orange Book listing: Xyrem (NDA 021196), expiration listed as Dec. 22, 2019
• Status: Expired (Google Patents notes "2019-12-22 Anticipated expiration"; legal status "Expired – Fee Related")

Because the patent issued only in December 2012 and expired in 2019, all asserted litigation falls in that window. Note that allegations must be tied to this specific number; several Jazz cases below involve sibling patents (e.g., 8,263,650; 8,461,203; 8,772,306) and should not be conflated with the '275.

Hatch-Waxman / ANDA infringement suits asserting the '275 patent

Additional D.N.J. Xyrem ANDA cases involving Jazz in the same period (e.g., against Wockhardt, Par, and others) were filed as continuations/serial suits over newly issued '431-family patents; the '275 was among the newly issued patents Jazz used to extend these suits against the ANDA filers (see Roxane's "serial litigation" affirmative defenses describing the '650 and '275 patents issuing from applications 13/446,940 and 13/446,892).

Antitrust / class-action matters in which the '275 patent is cited

These are not infringement suits by Jazz; the '275 patent is cited as part of the alleged Orange Book/patent-thicket scheme challenged by payors.

Google Patents "family has litigation" links (may not all assert the '275)

The Google Patents record for the '275 lists the following related U.S. cases at the family level. These are family-level links and should not be assumed to raise the '275 patent specifically:

• D.N.J. 2:12-cv-07459; 2:13-cv-00391; 2:13-cv-05450; 2:13-cv-07884; 2:14-cv-04467; 2:14-cv-07757; 2:15-cv-05619; 2:15-cv-06548; 2:17-cv-05487
• E.D.N.Y. 2:17-cv-04439

Important caveats / corrections to note

1. Do not conflate sibling patents. The IPRs and Federal Circuit decisions frequently cited in Xyrem coverage (e.g., Jazz Pharms., Inc. v. Amneal Pharms., LLC, Fed. Cir. July 13, 2018, invalidating claims of 7,668,730; 7,765,106; 7,765,107; 7,895,059; 8,589,182; 8,457,988; 8,731,963) involve the '730 distribution family, not the '275 patent. I found no IPR/PGR specifically challenging the '275 patent.
2. Avadel disputes do not involve the '275 patent — those concern different patents, including U.S. 11,147,782 (the '782 patent).
3. Possible database misattribution. DrugPatentWatch's page for patent 8,324,275 lists a D. Del. case, 1:18-cv-02032 (2018–2022), but that docket (Par Pharmaceutical, Inc. v. Amneal Pharmaceuticals of New York, LLC) concerns a different drug (buprenorphine/naloxone), and does not appear to involve the '275 patent. I flag this as a likely data error rather than a genuine '275 case.
4. Confidence. I have high confidence in the Jazz v. Amneal (2:13-cv-00391) '275 assertion (the answer text explicitly pleads "Count VII: Infringement of the '275 Patent") and in the antitrust citations. I have moderate confidence in the exact case numbers for the Roxane/Watson '275 assertions, because those dockets consolidated many patents and my sources list the '275 at the case level without always identifying the count. The specific outcomes (settlements) are generally reported at the Jazz-litigation level, not patent-by-patent.

Summary

Known litigation touching U.S. 8,324,275 clusters in two groups: (a) Hatch-Waxman infringement suits by Jazz Pharmaceuticals in the District of New Jersey (2013–2015) against Amneal, Par, Roxane, Watson, and other ANDA filers, in which the '275 was asserted as one of the newly issued '431-family patents; and (b) payor antitrust/class actions (2020–2023) in D. Minn., N.D. Ill., N.D. Cal., and M.D. Fla. in which the '275 is cited as part of the alleged Orange Book scheme. All of these have terminated — the ANDA actions by settlement, and the antitrust actions by dismissal/settlement (several with Jazz dismissed in 2025). No IPR/PGR or Federal Circuit appeal directed specifically at the '275 patent was found, and the patent is now expired.

I'll verify the structured ODP block against live sources before writing anything up.

Let me drill into the specific PTAB docket for this patent number.

Let me check for any IPR touching the '275 patent, including hedge-fund filers and the '431 formulation family.

Proceedings overview

Total AIA trial proceedings on US 8,324,275: 0. The structured ODP block is the canonical list — and it is empty: 0 active, 0 with claims invalidated, 0 with claims sustained, 0 settled, 0 institution denials. The correct defensive posture is not "hardened patent" and not "claims canceled" — it is "no PTAB record exists, so there is no borrowed invalidation to ride on; but the '275 patent expired on 2019-12-22 (pediatric exclusivity ran to 2020-06-22), so the real question is whether anyone can assert it prospectively at all." Google Patents lists the patent as Expired – Fee Related with an anticipated expiration of 2019-12-22 (https://patents.google.com/patent/US8324275/en).

The zero count is a verified absence, not an assumption. I checked the ODP block, the Xyrem patent-family IPR record, and the ANDA-litigation paper trail. Every Xyrem IPR I can locate targets a sibling patent, not the '275 patent. No IPR, PGR, CBM, or derivation proceeding naming US 8,324,275 as the challenged patent surfaced.

No proceedings on file for US 8,324,275

There is no proceeding to report under the requested per-proceeding template, so rather than fabricate a docket I'll document the near-misses — because the pattern of what did get challenged tells you something about the '275 patent.

What I searched:

• The structured "PTAB proceedings on file" block (USPTO ODP ingest) — empty.
• PTAB petition/FWD text for the Jazz Xyrem portfolio.
• ANDA-litigation dockets (D.N.J. and D. Del.) and the In re Xyrem (Sodium Oxybate) Antitrust Litigation MDL, which itemizes PTAB activity patent-by-patent.

What the '275 patent actually faced instead of an IPR: a Hatch-Waxman fight. Roxane's ANDA No. 202090 drew a Paragraph IV certification against the '275 patent, and Jazz sued (e.g., Jazz Pharms., Inc. v. Roxane Labs., Inc., D.N.J. 2:12-cv-07459; see Roxane's Answer at https://paragraphfour.com/uploads/cases12/njdc12cv7459A.pdf). Par Pharmaceutical also certified against it (Par v. Jazz, D.N.J. 2:13-cv-07884). Roxane served "Preliminary Invalidity Contentions Regarding U.S. Pat. No. 8,324,275" in April 2013 — invalidity was litigated in district court, not at the PTAB.

Adjacent Xyrem proceedings — NOT about the '275 patent (read these as context only)

Do not cite any of these as invalidation of the '275 patent; they are different patents with different claims.

Appellate aftermath on the distribution family (again, not the '275 patent): Jazz appealed all seven adverse decisions; the Federal Circuit affirmed in Jazz Pharms., Inc. v. Amneal Pharms., LLC, No. 2017-1675 (Fed. Cir. July 13, 2018), holding the ACA materials publicly accessible prior art (https://www.govinfo.gov/content/pkg/USCOURTS-ca13-17-01675/pdf/USCOURTS-ca13-17-01675-0.pdf). Par settled out during the appeal.

One loose thread worth flagging: Jazz's own 10-Qs stated that ANDA filers "filed petitions for IPR with respect to the validity of certain distribution, method of use and formulation patents covering Xyrem." "Formulation" is the word that could implicate a '431-family patent like the '275 patent. Every proceeding I can actually identify maps to distribution ('730 family, '963) or method-of-use ('306, '302) patents. I found no evidence of a formulation-patent IPR, and I will not invent a docket number to fill the gap. Treat this as a residual 5% uncertainty best closed by a direct PTAB E2E / Patent Public Search party-name query on "8,324,275" and "Jazz Pharmaceuticals."

Strategic summary

Claim status. No claim of US 8,324,275 has been canceled, confirmed, or even tested in an AIA trial. Every claim stands exactly as issued — not because the patent is "hardened" by surviving IPRs, but because nobody filed against it and the patent ran out. The entire claim set is UNTESTED at the PTAB. Contrast with its siblings: the '730-family distribution patents and claims 24/26/27 of the '963 patent were canceled (affirmed on the merits in 2018), and the '306 patent was partly instituted but not adjudicated to cancellation in the sources I located. If you are looking for a FWD to quote in a demand-letter response, there is none for this patent.

Estoppel landscape. § 315(e)(2) estoppel is a non-issue: with no petitioner, nobody is estopped, and there is no IPR record that constrains anyone's invalidity theory. The corollary is that a defendant loses nothing by not filing an IPR — and gains nothing by filing one, because the patent is expired.

Pattern signals. The Xyrem portfolio shows a textbook "serial challenger" pattern — Amneal and Par filed jointly across seven-plus proceedings, Ranbaxy and Wockhardt layered on additional petitions, and a defensive-aggregator-style actor (Coalition for Affordable Drugs III LLC, a Kyle Bass/Hayman Capital vehicle, working with nXn Partners) joined the fray against a distribution patent. Jazz litigated those challenges hard and appealed every loss. The striking feature is selectivity: challengers aimed at the REMS/distribution patents (where the June 2001 FDA Advisory Committee materials were devastating prior art) and the valproate DDI patents, and left the '431-family formulation patents like the '275 patent to be fought in district court on infringement and invalidity grounds instead. The '275 patent was the subject of a Paragraph IV certification by multiple ANDA filers, yet still no IPR — a signal that challengers viewed the district-court non-infringement path (dilution step, "pH adjusting agent" limitations) as the cheaper route.

Timing status today (2026-10-01). The patent expired 2019-12-22; pediatric exclusivity on the Orange Book–listed '431-family patents expired 2020-06-22. Google Patents status: Expired – Fee Related. There is no prospective infringement exposure to defend against.

Recommended next steps

1. Do not budget for an IPR. There is no proceeding to intervene in, join, or ride, and the patent is expired. Any AIA-trial strategy here is a solution in search of a problem.
2. If you are nonetheless being asserted against on the '275 patent today: the operative defense is not invalidity-by-IPR, it is timing. A patent that expired 2019-12-22 can support at most a back-damages claim, and 35 U.S.C. § 286 caps recovery at six years before filing — as of 2026-10-01, that window reaches back only to 2020-10-01, after the patent expired. Press the point that no accused conduct can fall inside both the patent term and the § 286 damages window. Also check for laches-adjacent delay arguments and note that injunctive relief is unavailable for an expired patent.
3. If you need a validity record to cite, use the siblings, not this patent. The only PTAB decisions in this family are Amneal/Par v. Jazz, IPR2015-01903 (FWD 2017-03-22, claims 24/26/27 canceled) and the six '730-family FWDs, all affirmed in Jazz v. Amneal, No. 2017-1675 (Fed. Cir. 2018). Cite them for what they are — the ACA-materials-as-prior-art holding — and be precise that they do not touch the '275 patent's claims.
4. Close the documentation gap before relying on the zero count. Run a party-name and patent-number query in PTAB E2E (https://ptacts.uspto.gov/ptabweb) and cross-check the PTAB Decisions library (https://www.uspto.gov/patents/patent-trial-and-appeal-board/decisions). My searches were thorough but were web-indexed-source searches, not a certified docket pull; I found no proceeding against the '275 patent, and I could not identify the patent number in the Coalition for Affordable Drugs challenge, so state the conclusion as "no PTAB proceeding on this patent appears in any source I could locate" rather than as an absolute.

Bottom line for a defendant: there is no PTAB ammunition on US 8,324,275 — and no need for any, because the patent is expired. The "no PTAB activity" signal, usually an early-warning sign that a patent is about to be stress-tested, is here explained by the patent's age and expiration rather than by any defensive strength.

I'll research the assignment record and cross-reference sources. Let me start with several targeted searches.

Good context. Now let me dig into the inventors, the entity chain, and the litigation/assertion record.

Key find — the Plainsite record shows assignment 28567/317. Let me pull the rest of the chain and the litigation/asserter record.

I've exhausted my search budget. Here is the reconstructed record based on the sources I was able to retrieve. Important sourcing caveat up front: the Google Patents legal-events data embedded in the authoritative patent text gives me the conveyance, assignor, assignee, and dates for this chain, but it does not expose reel/frame numbers or the correspondent-of-record for most entries. I retrieved exactly one reel/frame (28567/317) via Plainsite's mirror of the USPTO assignment database. I could not open assignmentcenter.uspto.gov directly in this session, so where reel/frame and correspondent are shown as not retrieved, that is a gap in my sources, not an absence of a record.

Inventors

Pattern notes:

• No "inventor flight" pattern. The assignments from the inventors to Orphan Medical were executed in mid-2000 (Cook 2000-06-22, Hamilton 2000-06-22, Goderstad 2000-07-14, Reardan 2000-06-27, Danielson 2000-07-19) but were not recorded until 2012-07-17 (Assignment 28567/317). That is a housekeeping/confirmatory recording done in the same week as the 2012 corporate reorganization, not a fire-sale tell. (Plainsite assignment record)
• Dayton T. Reardan is a repeat Orphan Medical inventor — he also appears on the '730 family ("Sensitive Drug Distribution System," priority 2002-12-17). This is a career in-house developer, not a serial shell-entity principal.
• Danielson's residence is listed inconsistently across family members (Otsego MN vs. Otsego MI); the Google Patents text for US 8,324,275 lists Otsego, MN.

Original assignee

US 8,324,275 specifically: the application (Ser. No. 13/446,892) was filed 2012-04-13 and the applicant/assignee of record on the issued patent is Jazz Pharmaceuticals, Inc. (Palo Alto, CA). Note the nuance: 8,324,275 is a late continuation in the '431 family, filed by Jazz after it had already acquired the original owner.

Progenitor of the family: Orphan Medical, Inc. (Suite 475, 13911 Ridgedale Drive, Minnetonka, MN 55305), the assignee named on the parent patents US 6,472,431 / 6,780,889 / 7,262,219.

• Line of business: specialty pharmaceutical company (publicly traded), focused on CNS/abuse-prone medications.
• Shipped a product embodying the claims? Yes. Orphan Medical commercialized Xyrem® (sodium oxybate), FDA-approved 2002-07-17 for cataplexy in narcolepsy. Claims of this family (500 mg/ml GHB solution, malic acid, pH ~7.5) read on the commercial Xyrem liquid. Jazz later extended the franchise with Xywav®.
• Current status: Acquired. Jazz Pharmaceuticals acquired Orphan Medical via a merger (Agreement and Plan of Merger dated 2005-04-18, completed June 2005; ~$122.6M announced value, $10.75/share cash). Orphan Medical survives as Orphan Medical, LLC, a wholly-owned Delaware subsidiary of Jazz (confirmed in Jazz's SEC Form 10-K Exhibit 21.1 subsidiaries list). Jazz itself redomiciled to Ireland in 2012 via the Azur Pharma merger. The patent's legal status is "Expired – Fee Related," with anticipated expiration 2019-12-22 plus pediatric exclusivity to 2021-01-04.

Assignment timeline

The USPTO Assignment Center does have records; this is not a no-record patent. Chronologically:

• 2000-06-22 through 2000-07-19 (executed) / recorded 2012-07-17 — Reel 28567/317

  • Conveyance: Assignment of Assignors' Interest (inventors → company)
  • Assignor: Cook, Harry; Hamilton, Martha; Danielson, Douglas; Goderstad, Colette; Reardan, Dayton
  • Assignee: Orphan Medical, Inc., 13911 Ridgedale Drive, Suite 475, Minnetonka, MN 55305
  • Correspondent: not captured in the retrieved Plainsite/USPTO mirror record. (Flag: could not verify a correspondent name here.)
  • Context: Confirmatory/original inventor assignment — 12-year-old paperwork recorded alongside the 2012 restructuring; covers US 8,324,275, US 8,263,650 and US 8,461,203.

• 2012-07-17 (recorded) — Reel not retrieved (Google Patents legal events; verify in Assignment Center)

  • Conveyance: Assignment (corporate reorganization)
  • Assignor: Orphan Medical, Inc. (a Minnesota corporation)
  • Assignee: Orphan Medical, Inc. (a Delaware corporation)
  • Correspondent: not retrieved
  • Context: Internal reorg — Minnesota entity re-domesticated/converted to a Delaware entity ahead of the Jazz/Azur redomiciliation.

• 2012-07-17 (recorded) — Reel not retrieved

  • Conveyance: Assignment
  • Assignor: Orphan Medical, Inc.
  • Assignee: Orphan Medical, LLC (Delaware)
  • Correspondent: not retrieved
  • Context: Internal reorg — conversion to LLC; same-day chain.

• 2012-07-17 (recorded) — Reel not retrieved

  • Conveyance: Assignment
  • Assignor: Orphan Medical, LLC
  • Assignee: JPI Commercial, LLC (Delaware)
  • Correspondent: not retrieved
  • Context: Internal reorg — JPI Commercial, LLC is the Jazz product-rights/licensing subsidiary (it is the named party on the Solvay and Antizol product-rights agreements).

• 2012-07-17 (recorded) — Reel not retrieved

  • Conveyance: Assignment
  • Assignor: JPI Commercial, LLC
  • Assignee: Jazz Pharmaceuticals, Inc.
  • Correspondent: not retrieved
  • Context: Internal reorg — title consolidated into the Jazz operating/listing entity.

• 2012-08-06 (recorded) — Reel not retrieved

  • Conveyance: Security Interest (not an ownership transfer)
  • Assignor: EUSA Pharma (USA), Inc.; Jazz Pharmaceuticals International Limited; Jazz Pharmaceuticals, Inc.
  • Assignee: Barclays Bank PLC, as Collateral Agent
  • Correspondent: not retrieved
  • Context: Securitization — collateral grant under the June 2012 Barclays-led credit facility.

• 2015-06-19 (recorded) — Reel not retrieved

  • Conveyance: Security Agreement (not an ownership transfer)
  • Assignor: Jazz Pharmaceuticals International III Limited; Jazz Pharmaceuticals International Limited; Jazz Pharmaceuticals Ireland Limited; Jazz Pharmaceuticals, Inc.
  • Assignee: Bank of America, N.A., as Collateral Agent
  • Correspondent: not retrieved
  • Context: Securitization — refinancing; new collateral agent.

• 2015-07-09 (recorded) — Reel not retrieved

  • Conveyance: Release by Secured Party
  • Assignor: Barclays Bank PLC, as Collateral Agent
  • Assignee: Jazz Pharmaceuticals International Limited; EUSA Pharma (USA), Inc.; Jazz Pharmaceuticals, Inc.
  • Correspondent: not retrieved
  • Context: Lien release — Barclays security interest discharged.

• 2021-05-05 (recorded) — Reel not retrieved

  • Conveyance: Release by Secured Party
  • Assignor: Bank of America, N.A.
  • Assignee: Jazz Pharmaceuticals, Inc.; Jazz Pharmaceuticals International Limited; Jazz Pharmaceuticals International III Limited; Celator Pharmaceuticals, Inc.; Cavion, Inc.; Jazz Pharmaceuticals Ireland Limited
  • Correspondent: not retrieved
  • Context: Lien release — Bank of America security interest discharged.

Net effect: after all security interests and releases wash out, ownership title sits with Jazz Pharmaceuticals, Inc., a wholly-owned subsidiary of Jazz Pharmaceuticals plc.

Timeline diagram

timeline
    title Ownership of US 8324275
    1998 : Provisional filed by Orphan Medical
    1999 : Nonprovisional filed
    2000 : Inventors assign to Orphan Medical
    2002 : Xyrem FDA approval
    2005 : Jazz acquires Orphan Medical
    2012 : Four-step reorg during Azur merger
         : Inventor assignments recorded
         : Barclays security interest
    2015 : Bank of America security agreement
         : Barclays release
    2021 : Bank of America release

NPE / troll-pattern signals

1. Shell-entity transfer — not present. The two LLCs in the chain (Orphan Medical, LLC; JPI Commercial, LLC) are not anonymous shells. Jazz's SEC Form 10-K Exhibit 21.1 expressly lists both as subsidiaries of Jazz Pharmaceuticals, Inc. (Orphan Medical, LLC is Delaware; JPI Commercial, LLC is Delaware). JPI Commercial, LLC is the counterparty on real commercial contracts (Solvay license, Antizol product-rights acquisition), i.e. a product-rights holder, not a licensing-only vehicle. The 2012 transfers were a four-step intra-group reorg, all recorded on one day.

2. Known asserter in the chain — not present. The current owner, Jazz Pharmaceuticals, Inc. / Jazz Pharmaceuticals plc (NASDAQ: JAZZ), is an operating, revenue-generating pharmaceutical company (Xyrem alone ~$1.6B in 2019). No assignee in the chain matches Acacia, Marathon, IV, IPNav, Wi-LAN/Conversant, Vringo, Pendrell, Round Rock, MPHJ, etc.

3. Repeat correspondent across the chain — unclear. I retrieved only one recorded assignment (Reel 28567/317), and the correspondent field was blank in the mirror I could read. I cannot state a correspondent name, and I will not guess one. This signal requires a direct Assignment Center pull to resolve.

4. Cascading transfers — present (factually) but benign. Four assignments on 2012-07-17 through Orphan Medical Inc (MN) → Orphan Medical Inc (DE) → Orphan Medical, LLC → JPI Commercial, LLC → Jazz Pharmaceuticals, Inc. The cascade is real, but it is a same-day internal reorganization tied to the Jazz/Azur Pharma redomiciliation (merger dated 2011-09-19, closed 2012), with SEC 8-K/10-K corroboration. It shows restructuring, not NPE layering.

5. Pre-litigation transfer — not present in the NPE sense. The family was already in litigation before the 2012 reorg: Jazz Pharmaceuticals, Inc. v. Roxane Laboratories, 2:10-cv-06108 (D.N.J., filed 2010-11-22). The later suits (Amneal, 2:13-cv-00391, filed 2013-01-18; Par, 2:13-cv-07884) followed the reorg, but the plaintiff was the operating company asserting its own Orange Book products, not a freshly created assertion vehicle.

6. Bankruptcy fire-sale — not present. No Orphan Medical bankruptcy. Jazz paid a $20M+ federal criminal/False Claims settlement (2007) over off-label Xyrem marketing, but the patent estate was never sold in insolvency.

7. Privateering — not present. The patents never left the Jazz corporate family, and Jazz litigates them in its own name against actual generic competitors (Roxane, Amneal, Par, Ranbaxy, Avadel). This is classic operating-company enforcement, the opposite of privateering.

8. Defensive aggregator — not present. The chain terminates at Jazz Pharmaceuticals, Inc., not at RPX, AST, LOT Network, Unified Patents, or OIN.

Verdict

Operating-company assertion.

The chain never leaves the Jazz corporate family: the 2012-07-17 four-step sequence (Orphan Medical Inc MN → Orphan Medical Inc DE → Orphan Medical LLC → JPI Commercial LLC → Jazz Pharmaceuticals, Inc.) is an internal reorganization confirmed by Jazz's SEC Exhibit 21.1 subsidiaries list, and the only security interests (Barclays Reel per 2012-08-06; Bank of America per 2015-06-19) were both released (2015-07-09 and 2021-05-05). The patent sits with an operating manufacturer that ships Xyrem/Xywav and sues real generic ANDA filers in its own name — no shell-entity transfer, no known NPE, and no defensive-aggregator terminus is evidenced. The one gap that could theoretically change nuance is the correspondent-of-record (Signal 3), which I could not retrieve.

Verify independently at the USPTO Assignment Center:

• https://assignmentcenter.uspto.gov/ (search patent number 8324275)
• https://assignment.uspto.gov/patent/index.html (legacy interface, same records)

The single reel/frame I confirmed — 28567/317 — is the inventor→Orphan Medical assignment; use that as your anchor when pulling the full reel index for the four 2012-07-17 reorg entries and the two security-interest/release pairs.

I'll research US patent 8324275 and its prior art citations. Let me run targeted searches.

Let me get the exact claims and front-page references for US8324275.

Let me pin down the exact claims and front-page citations of US8324275.

Prior-Art Analysis — US Patent No. 8,324,275 B2

Important scope/caveat note (read first)

I was able to confirm the identity, dates, family, and citation set of US 8,324,275 B2 ("the '275 patent") from the patent text you supplied plus Google Patents/Justia records and the sibling front pages, but I could not retrieve the USPTO "References Cited" block as printed on the '275 patent's own face within this research session. The reference list below is therefore assembled from the identical front-page citation lists of two same-family patents — US 8,263,650 B2 (filed the same day, 2012-04-13, as Ser. No. 13/446,940) and US 9,539,330 B2 — which share the '275 specification and prosecution lineage, plus the references the '275 specification itself cites. Treat the citation set as accurate at the family level, with individual entry confidence flagged. I also could not verify the exact issued claim text of the '275 patent, so the §102 mapping below is directional, not claim-number-specific. This is analysis, not legal advice; §102 anticipation requires a single reference disclosing every claim element.

1. Identification of the patent (interpreted literally)

Continuation chain (from the specification):
13/446,892 (the '275 patent) ← continuation of 12/913,644 (2010-10-27) ← continuation of 11/777,877 (2007-07-13), issued as US 7,851,506 ← divisional of 10/841,709 (2004-05-07), issued as US 7,262,219 ← divisional of 10/194,021 (2002-07-11), issued as US 6,780,889 ← divisional of 09/470,570 (1999-12-22), issued as US 6,472,431 ← priority from provisional 60/113,745 (1998-12-23).

Legal significance of the date: Because the '275 patent is a continuation claiming §120 benefit back to 09/470,570 and §119(e) to 60/113,745, its effective filing date for the claims is 1998-12-23. An anticipating reference under §102 must therefore predate that date (or qualify as §102(e) art based on an earlier filing). References that issued after 1998-12-23 (e.g., US 5,990,162) do not anticipate unless they qualify under pre-AIA §102(e).

2. Most relevant prior art on the face of the family (citations + descriptions)

2a. U.S. patent documents

2b. Foreign patent documents

• GB 922,029 (British Patent No. 922,029; ~1963) — preparation of 4-hydroxybutyric-acid salts; Mg and Ca salts to reduce hygroscopicity; aqueous salt solutions. Cited in the '275 specification at p. 17. Anticipation candidate for salt/solution claims.
• EP 1140061 A2 (2001-10-10, Orphan Medical) — EP counterpart of this same family — not prior art.
• EP 1316309 A1 — related EP publication in the family chain (also not independent prior art).

2c. Non-patent literature (NPL) cited on the family faces

• "Malic Acid," Handbook of Pharmaceutical Excipients, 2nd Ed. (1994), pp. 285–286, 633. — Supports the malic-acid pH-adjuster limitation; §103.
• 21 C.F.R. § 184 (FDA/HHS, 1998), pp. 441–535. — GRAS/excipient status; §103.
• "Activase," Physicians' Desk Reference (50th ed., 1996), pp. 312, 1058–1061. — Formulation/preservative background.
• Nema et al., 1997 (cited in spec as "Remington's" companion; excipients for injectable formulations; buffer/pH-adjuster tables). — §103 for pH-adjusting-agent limitations.
• "Remington's Pharmaceutical Sciences," 8th & 15th Eds. — Background formulation art.
• Journal literature cited in the '275 specification (admitted background): Mamelak (1977, 1979, 1981); Scharf et al. (1985); Ferrara et al. (1992); Palatini et al. (1993); Gallimberti et al. (1989, 1992, 1993, 1994); Gessa et al. (1992); Lee (1977); Snead & Morley (1981); Strong (1984); Oyama et al. (1970); Gerra et al. (1994); etc. These establish that GHB oral/injectable narcolepsy treatment was well known before 1998, relevant to the preamble of the method claims.

3. §102 analysis — which claims each reference could potentially anticipate

Because §102 requires a single reference to disclose every element of a claim, it is essential to note the '275 specification's own definitional core: the claims are directed to GHB aqueous formulations at a concentration above ~150 mg/ml (preferably ~500 mg/ml), at a pH ~3–10.3 (preferably ~6–9), that are resistant to microbial growth without added preservative and chemically stable (limited GBL formation).

Bottom line on §102: None of the cited references, standing alone, appears to disclose the full combination — GHB salt at a self-preserving concentration (>~150 mg/ml, preferably ~500 mg/ml) in aqueous medium at a defined pH that is simultaneously chemically stable (GBL ≤ ~0.1%) and microbially resistant without preservative. That is precisely the distinction applicants argued during prosecution of the ancestral US 6,472,431 (Applicants argued Gessa and the other art taught no way to make aqueous GHB solutions microbial-resistant "other than by adding conventional preservatives"). The references are therefore best characterized as §103 obviousness art in combination, not clean §102 anticipators.

The strongest single-reference candidates for partial anticipation are US 4,983,632 (Gessa) and US 4,393,236 / GB 922,029 for aqueous-salt and preservative-free-injectable features; US 5,990,162 (Scharf) for the narcolepsy-treatment method preamble.

4. Litigation-verified prior-art set (corroborating the above)

The '275 patent family is flagged on Google Patents as having extensive litigation (e.g., D.N.J. 2:13-cv-07884, 2:14-cv-04467/07757, 2:15-cv-05619/06548, 2:17-cv-05487; E.D.N.Y. 2:17-cv-04439). In the parallel IPR/PGR record (ptacts.uspto.gov petition 1459711) and the Jazz v. Roxane Markman record, the prior-art references repeatedly asserted are:

• the '632 patent (Gessa) — aqueous GHB salts, preservative-free injectable;
• EP '804 — GHB salt liquid formulations, sodium salt preferred, preservative-free IV formulation;
• the '236 patent (Klosa) — Mg/Ca salts, aqueous solutions;
• GB '029 (British 922,029) — salt solutions, pH 7.2–7.7 injectables;
• the '030 patent (Conte);
• the '937 patent (Koehler); the '619 patent (Laborit); the '027 application; Ferris (synthesis of Na/K/Mg/Ca GHB salts); and the Xyrem® label.

This confirms Gessa '632, Klosa '236, and GB '029 as the references with the greatest §102 exposure, with the others functioning as §103 combination art.

5. What I could not verify (stated explicitly)

1. The exact printed "References Cited" list on the '275 patent's own front page — I relied on the identical-family front pages (US 8,263,650, filed the same day; US 9,539,330) and the specification's own citations. There may be minor entry-level differences (and one citation number is printed inconsistently as 4,738,965 vs. 4,738,985 in family copies).
2. The issued claim text of US 8,324,275 B2 — not retrieved; the §102 mapping is by claim category, not claim number.
3. Contents of US 4,183,916 (Rodon), US 4,374,441 (Carter), US 4,738,96x (Kluger), US 5,210,083 (Pfirrmann), US 5,426,120 (Crepaldi), US 5,470,584 (Hendrickson) — I did not independently open these; their descriptions are left flagged.

If you want, I can next pull the verbatim claim set of US 8,324,275 and produce a claim-element-by-claim-element §102 chart against Gessa '632, Klosa '236, GB '029, and Scharf '162 specifically.

I'll ground this analysis in the actual prior-art references associated with this patent family. Let me pull the citation/prior-art data.

Let me retrieve the actual claim language for US 8,324,275 and confirm the prior-art references of record.

Obviousness Analysis — U.S. Patent 8,324,275 (35 U.S.C. § 103)

0. Preliminary caveats (important)

1. The fetched page text is truncated. The Google Patents copy supplied to me ends mid-sentence in the "Summary of the Invention" ("…In certain embodiments, the co…"). The claims themselves and the "(56) References Cited" front-page list are not present in the material I was given. I therefore will not quote claim language as if I had it verbatim. My claim-element mapping below is built from (a) the specification and abstract on the page, and (b) the documented claim features of the '275 and its sibling '650 in the litigation record, where both are described as containing "claims calling for dilution of the sodium oxybate solution prior to patient administration." (https://ptacts.uspto.gov/ptacts/public-informations/petitions/[1459711](/patent/1459711)/download-documents?artifactId=QKAvc3-OSfkt5IF9IxVwyfokRSLkt0i5wRvlIdmCid3Fj9ZP2aC3rT8#236#134)
2. I am not auto-correcting any identifier. All patent/ID strings below are reproduced exactly as they appear in the source material: US8324275B2, U.S. Pat. No. 4,393,236 ("the '236 patent"), U.S. Pat. No. 5,380,937 ("the '937 patent"), British Patent No. 922,029 ("GB '029"), U.S. Pat. No. 4,983,632 ("Gessa" / "the '632 patent"), EP '804, CA 338 (Spanish Patent No. 302338 via Chem. Abstr. Vol. 65), and "the '619 patent" (the record gives no expansion for that one, so I leave it as-is).
3. The prior-art section of this page is not a classic citation list. As fetched, the "prior art" content on the page consists of:
   • Prior-art metadata: keywords ghb, day, formulations, dose, formulation; prior art date 1998-12-23; priority to provisional 60/113,745.
   • In-specification prior art in "Description of Related Art": the '236, '937 and GB '029 patents; Remington's Pharmaceutical Sciences (8th and 15th Eds.); Nema et al., 1997; and the clinical literature (Lee 1977; Mamelak 1977; Hoes 1980; Scharf 1985; Scrima 1990; Gallimberti 1992; Series 1992; Lammers 1993; Ferrara 1992; Palatini 1993).
   • Family/litigation data: the list of New Jersey and E.D.N.Y. case URLs, "First worldwide family litigation," and "Family has litigation."

The reference set actually asserted against this family in the PTAB/ANDAR record (Wockhardt petition against the '431; Roxane's contentions against the '431 family) adds: Gessa '632, Vickers (1969), CA 338, EP '804, the '619 patent, '236, '937, GB '029, Remington's, Nema, the 1995 USP, Mamelak (1977), Scharf, and Scrima (1990). (https://ptacts.uspto.gov/ptacts/public-informations/petitions/[1461686](/patent/1461686)/download-documents?artifactId=kHqRtM5PcMdzF1bdYMgh7IBt0EkTM6GFV1EG5ODPfYMcixYR6f6VE1Q#8#2)

1. Governing framework

Under Graham v. John Deere Co., 383 U.S. 1 (1966), and KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the § 103 inquiry requires findings on: (a) scope and content of the prior art; (b) differences between the prior art and the claims; (c) level of ordinary skill; and (d) secondary considerations. The Federal Circuit's treatment of the Jazz Xyrem family in Jazz Pharms., Inc. v. Amneal Pharms., LLC, 895 F.3d 1347 (Fed. Cir. 2018), confirms that where a POSA would have been motivated to combine, the PTAB's obviousness analysis will be affirmed.

Level of ordinary skill (proposed): a formulation scientist or pharmaceutical chemist with an advanced degree and/or several years of experience in aqueous oral/parenteral drug formulation, including buffer/pH-adjuster selection, preservative selection, and stability testing (HPLC assay, ICH degradation limits). The '275 specification itself measures against ICH shelf-life guidelines and FDA/USP antimicrobial criteria, which fixes the skill level.

Critical date — this is the pivot for '275. Because the '275 is a direct continuation chain back to provisional 60/113,745 (filed Dec. 23, 1998), all of the references above predate even the pre-AIA § 102(b) critical date of Dec. 23, 1997. That means:

• The Xyrem label (2002) and the FDA Advisory Committee ("ACA") materials (2001) — which were the decisive prior art against the distribution patents ('963 family) in Jazz v. Amneal — are NOT prior art to '275 unless the dilution claims lose their 1998 priority. In Jazz v. Amneal the court expressly noted those applications were "filed before March 16, 2013" and analyzed under pre-AIA § 102, but the ACA-art holding turned on the post-2001 filing dates of those particular patents. (https://www.vitallaw.com/news/patent-fed-cir-patents-for-narcolepsy-drug-xyrem-declared-invalid-based-on-obviousness/ipm011d1f163e7d101000aa9c90b11c18cbab05)
• Conversely, if the dilution limitation is found to lack written-description support in the 1998/1999 disclosure (the Roxane complaint squarely alleges Jazz added these claims in 2012 only after learning Roxane's non-infringement position, and that "at no time before or during prosecution … did Jazz … discuss the new claims … with the patent inventors"), the effective filing date moves to April 13, 2012, and a dramatically larger art universe opens (Xyrem label, ACA materials, the '506/'650 patents themselves). (https://ptacts.uspto.gov/ptacts/public-informations/petitions/1459711/download-documents?artifactId=QKAvc3-OSfkt5IF9IxVwyfokRSLkt0i5wRvlIdmCid3Fj9ZP2aC3rT8#236#134)

I flag that as a § 102/§ 112 threshold issue, because it determines which § 103 analysis applies.

2. Claim-element mapping (assuming the '275 claims track the documented features of the '650/'506 family)

3. Combinations that render the claims obvious, and the motivation to combine

Combination 1 (composition claims — strongest): Gessa '632 + Vickers + CA 338 + EP '804 in view of Nema/Remington's/USP.

• Motivation: Same field, same active, same problem — a stable, concentrated, preservative-free aqueous sodium-GHB solution. Gessa already discloses a preservative-free injectable of 302.5 mg/mL; Vickers and CA 338 supply concentration and pH anchors (242 mg/mL at pH 8.2–8.9; pH 7.2–7.7); EP '804 explicitly says GHB injectables "may also be buffered" and gives a citric-acid formulation; Nema/Remington's/USP supply the finite, catalogued menu of pH adjusters. A POSA seeking a shelf-stable chronic oral solution would combine these with a reasonable expectation of success. This is precisely the combination Wockhardt pressed in the '431 IPR, where the Board-side declaration concluded "A POSA would have been motivated to combine the art cited in Grounds 1–4 … with a reasonable expectation of success." (https://ptacts.uspto.gov/ptacts/public-informations/petitions/1461686/...#9#9)

Combination 2 (preservative-free / microbial-resistance limitation): Gessa '632 + '619 + '937 + Nema.

• Motivation: Each of '632, '619, and '937 teaches preservative-free GHB solutions; Nema teaches that preservatives may be disfavored in injectables and that high-solute formulations can be terminally sterilized. The '275 specification itself concedes that the reason Jazz dropped its first xylitol/preservative formulation was "instability of the preservative" — i.e., the POSA had an affirmative reason to eliminate preservative and rely on concentration/pH. Eliminating a preservative because it is incompatible, then relying on the inherent antimicrobial effect of a >150 mg/mL solution, is a textbook obvious design choice.

Combination 3 (method/dosing claims): Scharf + Gessa '632 + Scrima (1990).

• Motivation: Scharf supplies the two-dose nocturnal regimen (3 g at bedtime, 3 g four hours later); '632 supplies the concentrated aqueous vehicle; Scrima supplies the explicit suggestion that higher doses may be needed. The only arguable delta is the numeric dose floor and the concentration — both routine optimizations where "the dose administered to patients is more relevant than the concentration for the purpose of using the claimed pharmaceutical composition." (https://ptacts.uspto.gov/ptacts/public-informations/petitions/1459711/...#118#39)

Combination 4 (dilution limitation): any of Combos 1–3 + authoritative general formulation practice (Remington's/Nema) and the '275 specification's own admission.

• Motivation: Reduce shipping weight, improve patient portability, permit easy titration ("a titratable formulation of GHB for easy dose measurement"). Where the patentee's own specification recites the motivation for the very limitation asserted for patentability, that motivation cannot be used to defeat obviousness.

4. Secondary considerations (what actually cuts the other way)

I would be under-crediting the record if I did not note that the strongest non-obviousness case here is unexpected results:

• During prosecution of the parent '219/'506 line, applicants argued that "the ability of aqueous GHB solutions to 'self-sterilize' at those concentrations and pH to yield solutions that are chemically stable and resistant to microbial growth is an unexpected result."
• The examiner allowed the '506 claims after the 500 mg/mL amendment, stating there "simply is no suggestion or teaching or common sense dictate for employing sodium gamma-hydroxybutyrate" at the claimed concentration.
• The commercial success of Xyrem®, the decades-long clinical history of GHB, and the "failure of others" narrative are potential nexus considerations.

Analyst's assessment: the "unexpected self-sterilization" argument is vulnerable for two reasons. First, it is a property argument about a composition whose constituents (GHB salt + water + a known acidulant) are all disclosed in the art; under In re Kao / In re Kubin and longstanding inherency doctrine, a newly discovered property of a known-and-obvious composition does not confer patentability absent a new and unobvious structure or result effective variable. Second, the "self-sterilization" is really just the well-understood colligative/water-activity effect of a ~50 % w/v solute load — a result a POSA would have predicted on the same day the concentration was chosen. On the present record I would rate the composition claims likely obvious, and the microbial-resistance limitation very likely obvious or inherent.

5. Bottom line

Two decisive open questions I cannot resolve from the material on this page, and which I therefore flag rather than assume:

1. The verbatim claim text of '275 — the page as fetched omits it. My analysis assumes the documented '650/'275 "dilution before administration" feature; if the '275 claims differ materially (e.g., a specific 3–4.5 g two-dose regimen, or a defined "about 6.5" pH), the elements and possibly the outcome change.
2. Whether the '275 claims are entitled to the Dec. 23, 1998 priority. If they are (as the continuation chain on its face suggests), the prior-art universe is limited to pre-1998 art and my analysis above governs. If a challenger proves the claimed dilution/subject matter was added in 2012 (as the Roxane pleading alleges), the Xyrem label and the FDA Advisory Committee ACA materials become available prior art, and the invalidity case becomes substantially stronger — because Jazz v. Amneal already held the ACA materials publicly accessible and obviousness-affirming against the sibling patents in this family. (https://www.vitallaw.com/news/patent-fed-cir-patents-for-narcolepsy-drug-xyrem-declared-invalid-based-on-obviousness/ipm011d1f163e7d101000aa9c90b11c18cbab05)

I do not have high-confidence verbatim claim language for '275, and I have not independently verified the full text of EP '804, the '619 patent, or CA 338; I have relied on the characterization of those references in the Wockhardt petition and the Roxane contentions, and I am stating that reliance explicitly rather than representing it as my own reading of untruncated sources.