United States Patent RE48923: Scope of Claims and US Patent Landscape

RE48923 is a U.S. reissue that centers on (i) a crystalline form of “Compound I” defined by copper Kα (Cu-Kα) PXRD parameters and (ii) pharmaceutical compositions made using that crystalline form by dissolving it with a hydrophilic polymer and forming solid dispersions, including via spray drying or molten/rubbery polymer melt-quench routes. The claim set is structured to cover both product-by-structure (crystalline form) and process (making the composition), with multiple dependent claim “claim subsets” tied to specific PXRD peak sets (Table/Figure/Pattern G) and to the presence and handling of a hydrophilic polymer.

What does RE48923 protect?

1) Product protection: crystalline forms of Compound I (PXRD-defined)

RE48923 contains crystalline-form claims that are purely structural/analytical, defined by Cu-Kα PXRD peaks measured under a fixed diffractometer configuration:

Copper anode tube: 40 kV / 30 mA
Germanium monochromator: monochromatic Cu-Kα, λ = 1.54178 Å
Peak definition: two theta (° 2θ) values ±0.2° with optional “further comprising” additional peaks
One claim refers to a named “Pattern G” reference instead of listing full peak sets.

Core crystalline-form claim coverage includes:

Claim 32: a crystalline form with a 17.62 ± 0.2° 2θ peak.
Claim 33: adds 13.75 ± 0.2° 2θ.
Claim 34: adds 11.11 ± 0.2° 2θ.
Claim 35: a crystalline form with a 10.16 ± 0.2° 2θ peak.
Claims 36-40: further constrain Claim 35 by:
- anhydrous designation (Claim 36)
- additional peak sets (Claims 37-39)
- and/or named Pattern G (Claim 40).

Key crystalline-form peak sets within RE48923

A. 17.62°-anchored family

Claim 32: 17.62 ± 0.2° 2θ
Claim 33: 17.62 ± 0.2° + 13.75 ± 0.2°
Claim 34: 17.62 ± 0.2° + 13.75 ± 0.2° + 11.11 ± 0.2°

B. 10.16°-anchored family

Claim 35: 10.16 ± 0.2° 2θ

Additional peak sets:

Claim 37: + 21.30 ± 0.2° and 23.66 ± 0.2°
Claim 38: a 9-peak set:
- 5.31, 11.11, 12.60, 13.75, 15.29, 15.96, 19.71, 21.30, 22.88 (all ±0.2°)
Claim 39: a broader 18-peak set:
- 5.31, 10.62, 11.11, 12.60, 13.75, 15.29, 15.96, 17.62, 18.19, 19.16, 19.71, 20.58, 21.30, 22.40, 22.88, 23.66, 26.40, 26.74 (all ±0.2°)
Claim 40: Pattern G (binding to an internal reference pattern)

2) Process protection: making pharmaceutical compositions using the PXRD-defined crystalline form

The process claims focus on dissolving a specific crystalline form of Compound I in a solvent with a hydrophilic polymer, and then forming a solid dispersion via:

Spray drying (volatile solvent route): claims 2, 5, 8, 11, 14, 17, 20, and 21.
Melt/rubbery polymer solidification (molten or rubbery polymer route): claims 3, 6, 9, 12, 15, 18, 19? and 21.
Or a process route that dissolves the crystalline form (Claims 1, 4, 7, 10).

The defining limitation that ties the process to the crystalline form is the PXRD peak pattern measured under the same fixed Cu-Kα PXRD conditions.

Representative core process claim structure

Independent “process frame”:
- Dissolve/combining crystalline form of Compound I with a solvent and hydrophilic polymer
- Crystalline form must exhibit specified PXRD peaks under Cu-Kα (λ 1.54178 Å) conditions
- Use PXRD lists from internal Tables 1-10, FIGS. 1-10, or explicit peak enumerations

Key independent/process claims include:

Claim 1: dissolving combining crystalline form (defined by PXRD) with hydrophilic polymer; explicit requirement for 17.62 ± 0.2° 2θ.
Claim 7: dissolving a crystalline form in a solvent; explicit requirement for PXRD pattern from FIGS. 1-10.
Claim 13: dissolving crystalline form where the PXRD peak set is explicitly enumerated (10 peaks including 17.62 ± 0.2° 2θ).
Claim 16 and Claim 19: dissolving crystalline forms with broader, explicitly enumerated peak sets.

Solvent handling and solid dispersion formation

The claim set makes the solid dispersion method a switch controlled by the solvent/polymer state:

Volatile solvent route (spray drying)
- Claims: 2, 5, 8, 11, 14, 17, 20
- Outcome: solid dispersion comprising amorphous Compound I (with polymer in spray-dried compositions where polymer is included)
Molten or rubbery polymer route (melt-quench solidification)
- Claims: 3, 6, 9, 12, 15, 18, 21
- Outcome: solid dispersion comprising amorphous Compound I and the polymer
Explicit anhydrous constraint appears when the crystalline form is explicitly “anhydrous” (Claim 24 route and dependent 27).

How tightly are the claims tied to PXRD measurement conditions?

RE48923 hard-codes:

diffractometer configuration (Cu anode, 40 kV/30 mA),
germanium monochromator,
Cu-Kα wavelength (1.54178 Å),
and peak tolerance (±0.2°).

This matters for scope because the infringement trigger is not just “X-ray peaks exist,” but that they exist at the specified positions under a specified analytical setup. The claims also use internal references:

“one of Tables 1-10”
“one of FIGS. 1-10”
“Pattern G”

That internal reference approach typically functions like a “definition key”: as long as the accused material matches the referenced crystalline form’s PXRD signature, the claim can be asserted even if the defendant uses different wording for the crystalline form.

What is the practical claim coverage across formulation technologies?

1) Solid dispersion enablement

RE48923 covers solid dispersion creation by:

spray drying a dissolved mixture to yield amorphous Compound I (Claims 2 and 8; also product outcome language in Claims 14 and 17)
cooling/solidifying from a melt or rubbery polymer to yield amorphous Compound I and polymer (Claims 3 and 9; also Claim 15 and 18)

2) Polymer role

Only certain process claims explicitly require a hydrophilic polymer (Claims 1-6, 2-3, and analogous extensions). Other process claims omit “polymer” in the independent frame (Claims 7 and 13-21), but still depend on “dissolving a crystalline form” and then either spray drying or solidifying, depending on the solvent/polymer state language.

Net effect: the claim set is optimized to catch the common “crystalline form to amorphous solid dispersion” workflow using polymer carriers.

3) Crystalline form selection

RE48923 provides multiple crystalline-form definitions, so a product-development program that switches between polymorphs or desolvated forms can still fall within the same patent family if those forms match any of the defined PXRD patterns.

Claim map: key claim themes and what each one locks down

Claim number(s)	Claim type	Primary binding element	Solid dispersion route
1, 4, 7, 10	Process	Crystalline form defined by PXRD (Table/Figure or explicit 17.62) + Cu-Kα conditions	None stated in independent frame unless dependent
2, 5, 8, 11	Process	Same PXRD-defined crystalline form + hydrophilic polymer (in Claims 2/5 frame)	Spray drying (volatile solvent) to amorphous Compound I (with polymer where required)
3, 6, 9, 12	Process	Same PXRD-defined crystalline form + molten/rubbery polymer	Cooling/solidifying to amorphous Compound I + polymer
13-15	Process	Explicit 10-peak PXRD set including 17.62 ±0.2°	Spray drying (14) or melt route (15)
16-18	Process	Explicit broader PXRD set starting with 10.16 ±0.2° + many additional peaks	Spray drying (17) or melt route (18)
19-21	Process	Even broader PXRD set (includes peaks up to 33.46 ±0.2°)	Spray drying (20) or melt route (21)
24-31	Process	Crystalline form “anhydrous” + PXRD peak patterns (10.16 route; includes Pattern G reference in 31)	Spray drying (25) or melt route (26); 27 is anhydrous
32-34	Product	17.62 ±0.2°; adds 13.75 and 11.11	N/A
35-40	Product	10.16 ±0.2°; adds anhydrous + peak sets or Pattern G	N/A

What is the enforcement surface: product claims vs process claims?

RE48923 gives two enforcement paths:

1) Direct claim capture of material

Selling or manufacturing the PXRD-defined crystalline form itself can trigger the product (crystalline form) claims (32-40).

2) Capture of manufacturing steps for dosage-form intermediates

Manufacturing a solid dispersion or pharmaceutical composition by dissolving the PXRD-defined crystalline form with a polymer and applying spray drying or melt solidification can trigger the process claims (1-31).

Because the solid dispersion outcome states amorphization (at least where claims explicitly say “thereby creating a solid dispersion comprising amorphous Compound I”), RE48923 is positioned to cover the formulation stage after polymorph selection.

US patent landscape for RE48923: what can be concluded from the claim text alone

No filing history, family members, priority date, assignee, expiration date, continuation status, or prosecution documents were provided with the input. Without those, a complete US landscape analysis that identifies specific, named competing patents, office actions, and citation networks cannot be produced from the claim text alone.

What can be established from the claim language is the likely technical “center of gravity” and therefore the likely landscape segmentation:

Likely adjacent patent buckets impacted by RE48923’s claim scope

PXRD-defined polymorph/desolvate claims (crystalline form product claims)
Solid dispersion via spray drying using crystalline-to-amorphous conversion
Polymer melt or rubbery polymer dispersion formation (melt/quench solid dispersions)
Analytical-method-locked definitions (Cu-Kα diffractometer settings and peak tolerance)
Anhydrous form constraints (explicitly “anhydrous” for the 10.16 route in claim 24 and dependent 27)

Likely competitor strategies

Formulate from different crystalline polymorphs whose PXRD peak sets do not match the enumerated peaks or Pattern G.
Use different analytical definitions to argue non-infringement (for claims that depend on exact PXRD matching under specified settings).
Shift manufacturing route to avoid the claimed steps (for process claims): e.g., circumvent spray drying and polymer melt solidification, though the claim set already covers both major routes.

These are inference-level strategy buckets, not a citation-level landscape.

Scope stress points: where validity and design-around are most likely to concentrate

(From claim structure only, not from external file wrappers.)

1) PXRD signature boundary

The crystalline form is defined by specific peak positions within ±0.2°. Slight differences in sample prep, instrument geometry, or sample hydration state can be used in non-infringement arguments, depending on what evidence is available.

2) “Pattern G” and internal references

Pattern-based referencing can make claim scope broader and easier to prove for the patentee if the reference pattern is well supported in the specification.

3) Anhydrous limitation

Claims that require anhydrous forms (Claim 24, dependent 27) narrow enforcement to materials that meet that definition.

4) Polymer requirement

Claims with explicit hydrophilic polymer presence are narrower than those that omit it in the independent frame. However, dependent claims bring polymer requirements back in via their dependency chain.

Key Takeaways

RE48923 protects a PXRD-defined crystalline form of “Compound I” using fixed Cu-Kα PXRD measurement conditions and specific peak sets (including ±0.2° tolerances) plus at least one named reference (Pattern G).
The process claims protect making pharmaceutical compositions/solid dispersions by dissolving the specific crystalline form with a hydrophilic polymer and then forming an amorphous solid dispersion via either spray drying (volatile solvent) or melt/rubbery polymer solidification (cooling and solidifying).
Enforcement can target both material (crystalline form) and manufacturing steps for solid dispersions and compositions derived from that crystalline form.
A full US competitor landscape (specific patents, citations, and assignee positions) cannot be completed from the claim text provided; the language indicates RE48923 sits squarely in polymorph definition plus solid dispersion formulation.

FAQs

1) Does RE48923 cover amorphous Compound I only, or also crystalline forms?

It covers both: it has crystalline form product claims (32-40) and process claims that create solid dispersions comprising amorphous Compound I through spray drying and/or melt-based solidification.

2) What PXRD method details are embedded in the claims?

The claims fix the instrument method: Cu anode 40 kV/30 mA, germanium monochromator, and Cu-Kα λ = 1.54178 Å, with peak positions measured as two theta (° 2θ) ±0.2°.

3) Is “Pattern G” the only way peaks can be specified?

No. The claim set specifies peaks numerically (e.g., 17.62 ± 0.2° 2θ, or multi-peak enumerations) and also references “one of Tables 1-10,” “one of FIGS. 1-10,” and Pattern G.

4) Are spray drying and melt solidification both claimed?

Yes. Spray drying is tied to volatile solvent language; melt/rubbery polymer solidification is tied to molten or rubbery polymer language.

5) Where is “anhydrous” required?

For at least the 10.16-based crystalline form route: Claims 24 and 27 explicitly require the crystalline form to be anhydrous.

References

No external sources were provided in the prompt, and no patent document metadata (publication number, assignee, priority, cited art, or prosecution history) was included. Therefore, no compliant source citations can be generated.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Abbvie	MAVYRET	glecaprevir; pibrentasvir	PELLETS;ORAL	215110-001	Jun 10, 2021		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial			Y		⤷ Start Trial
Abbvie	MAVYRET	glecaprevir; pibrentasvir	TABLET;ORAL	209394-001	Aug 3, 2017		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial			Y		⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015255784	⤷ Start Trial
Australia	2020203494	⤷ Start Trial
Canada	2945205	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: RE48923

Which drugs does patent RE48923 protect, and when does it expire?

Summary for Patent: RE48923