Scope, Claims, and US Patent Landscape for US Drug Patent 10,105,365

US Patent 10,105,365 claims a specific class of oral solid dose drug products and HCV treatment regimens built around (i) defined polymer load ranges (350 mg to 2,500 mg; narrower 500 mg to 1,000 mg), (ii) optional stabilizing and release rate-modifying polymer architectures, (iii) optional surfactants, (iv) explicit multi-drug composition structure (Compound 1, Compound 2, ritonavir in a first composition; Compound 4 or a salt in a second composition), and (v) pharmacokinetic targets (AUC∞ and Cmax) when three units are dosed under non-fasting conditions. The claim set also includes a once-daily dosing method for treating HCV infection with either one or three dosage units.

Because the asserted claims are so structurally and numerically tight (polymer amounts by mg; salt form; drug component partitioning; PK ranges under non-fasting dosing), they create a landscape in which design-around efforts concentrate on shifting polymer quantity outside the mg bands, altering the number of units per daily dose, avoiding the specific salt form, or changing the PK exposure profile so as to avoid the claimed AUC∞/Cmax ranges.

What does the claim set actually cover?

1) What is the core product claim scope (independent vs dependent)

The document’s product coverage starts with a broad independent structure:

Claim 1: Oral solid dosage form comprising:
- a pharmaceutically acceptable drug ingredient (written as “Compound(s) … or a pharmaceutically acceptable salt thereof” in the claim text provided), and
- a pharmaceutically acceptable polymer or combination of polymers in 350 mg to 2,500 mg.

From there, the set tightens scope through polymer loading bands, polymer “architecture” (stabilizing vs release rate-modifying), polymer species lists, optional excipients (surfactant), total tablet weight range, and multi-composition/multi-compound organization.

Key dependent constrainers:

Narrow polymer amount band:
- Claim 2: polymer 500 mg to 1,000 mg.
Stabilizing + release rate-modifying polymer split:
- Claim 3 / Claim 24 / Claim 45: require both stabilizing polymer(s) and release rate-modifying polymer(s), with the option that they are the same or different.
Specific polymer species lists:
- Claim 4 / Claim 25 / Claim 46 define candidate stabilizing polymers and release rate-modifying polymers.
- Claim 5 / Claim 26 / Claim 27 limit the polymer(s) to copovidone and/or hypromellose.
Surfactant addition:
- Claim 6 / Claim 27 / Claim 48: optional pharmaceutically acceptable surfactant(s).
Total dosage unit weight range:
- Claim 7 / Claim 28 / Claim 49: total weight 1,000 mg to 1,600 mg.

2) How does the claim set define the drug system and composition partitioning?

The claims then specify a two-part composition structure:

Claim 8 / Claim 29: solid dosage form comprises a first composition and a second composition.
Claim 9 / Claim 30:
- first composition comprises Compound 1, Compound 2, and ritonavir
- second composition comprises Compound 4 or a pharmaceutically acceptable salt thereof
Claim 10–14 / Claim 31–35: add quantitative excipient constraints on the second and first compositions:
- second composition:
- stabilizing polymer 10% to 60% by weight (Claim 10 / Claim 31)
- release rate-modifying polymer 5% to 60% by weight (Claim 11 / Claim 32)
- first composition:
- surfactant 5% to 10% by total weight (Claim 12 / Claim 33)
- hydrophilic polymer 70% to 85% by total weight (Claim 13 / Claim 34)
- hydrophilic polymer includes copovidone (Claim 14 / Claim 35)
Salt form specificity for Compound 4:
- Claim 15–17 / Claim 36–38: alkali metal salt of Compound 4, specifically sodium monohydrate salt, with an explicit unit amount:
- 216.2 mg sodium monohydrate salt of Compound 4 (Claim 17 / Claim 38)

This partitioning matters for infringement analysis because a generic that uses the same polymers and same drugs but changes how ingredients are distributed across internal sub-compositions may avoid the claim structure.

3) What PK-triggered coverage exists (AUC∞ and Cmax ranges)?

The claim set includes multiple product claims where infringement hinges on pharmacokinetic exposure windows under a defined dosing condition: a single dose consisting of three of the solid dosage forms administered to humans under non-fasting conditions.

Claim 20: defines AUC∞ windows for Compound 1, Compound 2, ritonavir, and Compound 4 when three units are dosed together (non-fasting).
Claim 21 / Claim 22: provide narrower sub-ranges within the claim 20 structure.
Claim 41–43: mirror the PK approach but use Cmax (Claim 41/42) and include AUC∞ in Claim 43.

The PK coverage is not merely supportive; it is embedded into the product definition. That increases the evidentiary burden for enforcement because a comparison requires exposure data under the same non-fasting, three-unit dosing context.

Detailed claim-by-claim scope map (condensed)

Polymer load and architecture

Claim(s)	Product type limitation	Polymer quantitative limitation	Polymer species / classes	Additional excipient constraints
1	solid dosage form	350–2,500 mg polymer(s)	not limited in Claim 1	none stated
2	solid dosage form	500–1,000 mg polymer(s)	not limited beyond Claim 1	none stated
3	solid dosage form	inherits Claim 1 amounts	stabilizing polymer + release rate-modifying polymer; same or different allowed	none stated
4	solid dosage form	inherits Claim 1 amounts	stabilizers: copovidone, PVP, HPMC, polyvinyl caprolactam-PVAc-PEG graft copolymer; release modifiers: PVP, HPMC, ethylcellulose, copovidone, PVAc, methacrylate/methacrylic free acid copolymers, PEGs, polaxamers	none stated
5	solid dosage form	inherits Claim 1 amounts	polymer limited to copovidone + hypromellose combinations	none stated
6	solid dosage form	inherits Claim 1 amounts	none	optional surfactant(s)
7	solid dosage form	inherits Claim 1 amounts	none	total weight 1,000–1,600 mg

Two-part formulation and composition contents

Claim(s)	Composition partition	First composition	Second composition	Key quantitative excipient constraints	Salt specificity
8	first + second composition	none	none	none	none
9	specifies contents	Compound 1 + Compound 2 + ritonavir	Compound 4 or salt	none	none
10	polymer distribution (second)	none	stabilizing polymer 10–60 wt%	release rate-modifying polymer 5–60 wt% (Claim 11)	none
12	surfactant distribution (first)	surfactant 5–10 wt%	none	hydrophilic polymer 70–85 wt% (Claim 13)	none
13–14	hydrophilic distribution (first)	hydrophilic polymer 70–85 wt%	none	hydrophilic includes copovidone	none
15–17	salt selection	none	Compound 4 salt = alkali metal	none	sodium monohydrate, 216.2 mg (Claim 17)

PK-based claims: AUC∞ and Cmax under defined dosing

Claim(s)	Exposure metric	Dosing condition	Exposure bands (high-level)	Polymer amount linkage
20	AUC∞	single dose of three units; humans; non-fasting	Compound 1: 2,000–25,000; Compound 2: 800–2,000; ritonavir: 3,000–18,000; Compound 4: 4,000–30,000 (ng·hr/mL)	inherits 350–2,500 mg polymer range
21	AUC∞ narrower	same as Claim 20	Compound 1: 2,500–15,000; Compound 2: 1,000–2,000; ritonavir: 4,000–12,000; Compound 4: 6,000–20,000	inherits Claim 20
22	AUC∞ narrower	same	Compound 1: 4,000–5,000; Compound 2: 1,500–2,000; ritonavir: 7,000–9,000; Compound 4: 10,000–20,000	inherits Claim 20
41	Cmax	single dose of three units; non-fasting	Compound 1: 200–4,000; Compound 2: 50–200; ritonavir: 500–2,500; Compound 4: 400–2,000 (ng/mL)	inherits 350–2,500 mg polymer range
42	Cmax narrower	same	Compound 1: 350–2,200; Compound 2: 90–180; ritonavir: 700–2,000; Compound 4: 750–1,500	inherits Claim 41
43	AUC∞ included	same dosing condition	repeats Claim 20 AUC∞ band	inherits Claim 41

There is also an internal polymer range narrowing within PK claims:

Claim 23 / Claim 44: polymer amount in PK claims restricted to 500 mg to 1,000 mg.

Method claims (treatment regimen)

Claim(s)	Indication	Dosing frequency	Number of solid dosage forms	Relationship to product claims
18	treating HCV	once daily	at least one unit	administer “at least one solid dosage form of claim 1”
19	treating HCV	once daily	three units	administer “three solid dosage forms of claim 1”
39	treating HCV	once daily	at least one unit	administer “at least one solid dosage form of claim 20”
40	treating HCV	once daily	three units	administer “three solid dosage forms of claim 20”
60	treating HCV	once daily	at least one unit	administer “at least one solid dosage form of claim 41”
61	treating HCV	once daily	three units	administer “three solid dosage forms of claim 41”

What matters for infringement and design-around

1) Polymer mg ranges are an enforceable “mechanical” lever

The product claim begins with polymer amount in mg:

350 mg to 2,500 mg (Claim 1/20/41)
500 mg to 1,000 mg (Claim 2/23/44)

A design-around strategy at the formulation level can target:

moving the polymer(s) load below 350 mg or above 2,500 mg, or
moving it outside 500–1,000 mg if operating within the tighter PK subspace (Claim 2/23/44).

2) Two-level polymer architecture constrains selection and combination

Claims 3 and 24 require both:

stabilizing polymer(s), and
release rate-modifying polymer(s), with allowance that they can be the same or different.

If a competitor chooses a single polymer role (for example, a single polymer without a stabilizing and release-modifying split as argued in prosecution), that can attempt to avoid the architecture-dependent dependent claims.

3) Specific polymer lists create a higher certainty risk

The stabilizing and release-modifying polymer lists in Claims 4/25/46 are relatively broad, covering common HCV formulation polymers (copovidone/PVP/HPMC/ethylcellulose/PVAc/PEGs/polaxamers/methacrylate free acid copolymers). The list reduces ambiguity for claim construction because many standard excipients are named.

The safer design-around is not “pick a different polymer” within the same family; it is to change the polymer set so that it does not fall within the named stabilizing/release-modifying lists (or avoid the architecture dependencies entirely).

4) Multi-compartment formulation partitioning is a structural constraint

Claims 8–14 and 29–35 explicitly bind:

first composition ingredients: Compound 1 + Compound 2 + ritonavir
second composition: Compound 4 (salt allowed)
surfactant level in first composition: 5–10 wt%
hydrophilic polymer level in first composition: 70–85 wt%, including copovidone
stabilizing/release-modifying polymer wt% ranges in second composition: 10–60 wt% and 5–60 wt%

A generic can match drug exposure but still avoid if it:

collapses into a single composition without a first/second split as required, or
re-partitions excipients outside the claimed compartment percentages.

5) Salt form and exact amount are high-friction

The Compound 4 salt selection is constrained to:

alkali metal salt
specifically sodium monohydrate salt
specific amount: 216.2 mg

Even if sodium monohydrate is used, the claim provided includes a specific amount constraint. Altering salt form (another hydrate or anhydrous) or changing unit mass can be a direct avoidance lever.

6) PK windows are a moving target and a litigation focal point

The PK claims (Claims 20–22 and 41–43) require defined AUC∞ and Cmax windows under:

single dose consisting of three units
non-fasting conditions

That creates a claims-to-data mapping. A product that stays outside PK bands can avoid those PK-dependent claims even if it uses the same polymer and salt architecture, unless the broader non-PK product claims still read.

Patent landscape implications (what this claim set signals)

What this patent is positioned to block

The claim structure suggests the patent is designed to cover: 1) oral solid dose HCV regimens using a specific multi-drug combination including ritonavir and two other compounds (Compound 1 and Compound 2) plus a second-compartment Compound 4 salt, and
2) a polymer-based solid dosage formulation architecture that drives non-fasting exposure into particular windows when three units are dosed together.

That means the practical enforcement target is likely:

products attempting to replicate exposure profiles of a ritonavir-boosted HCV regimen in non-fasting conditions using polymer-controlled release and hydrophilic/copolymer systems.

Where competitors typically attack

Given the claim architecture, most credible design-around paths concentrate on:

polymer load (mg) shifts (outside 350–2,500 mg or 500–1,000 mg)
avoiding the stabilizing + release-modifying polymer “dual role” framework as defined in the dependent claims
altering excipient compartment distribution (first vs second composition), including surfactant and hydrophilic polymer wt%
changing the Compound 4 salt form away from sodium monohydrate and/or altering its unit mass
tuning clinical exposure so that AUC∞ and/or Cmax fall outside the cited non-fasting three-unit PK bands

Claim coverage summary for decision makers

A. Strongest product claim anchors

Polymer mg band: 350–2,500 mg (Claim 1; also mirrored in PK product claims 20 and 41)
Total weight: 1,000–1,600 mg (Claim 7/28/49)
Compartmentalization: first composition (Compound 1, Compound 2, ritonavir) + second composition (Compound 4 salt) (Claims 8–9/29–30)
Salt: Compound 4 sodium monohydrate salt, 216.2 mg (Claims 17/38)
PK: defined exposure windows under non-fasting three-unit dosing (Claims 20–22 and 41–43)

B. Narrowest choke points (hard to design around)

Sodium monohydrate salt plus explicit mass (216.2 mg)
Compartment-specific excipient percentages
PK ranges tied to non-fasting dosing of three units (AUC∞ and Cmax)

Key Takeaways

US 10,105,365 is built around polymer-controlled oral solid dosage forms with explicit polymer load in mg and optional but enforceable dual-role polymer architecture (stabilizing + release rate-modifying).
The formulation is structurally constrained by a two-compartment system: first composition (Compound 1 + Compound 2 + ritonavir) and second composition (Compound 4 sodium monohydrate salt), with compartment-specific surfactant and polymer weight percentages.
The tightest coverage sits in the PK-dependent claims, which require non-fasting exposure windows when three units are dosed together (AUC∞ and Cmax bands).
Design-around leverage is strongest where it can move formulation inputs outside the mg bands, change salt form/mass, alter compartment excipient percentages, and shift PK exposures so they exit the cited non-fasting three-unit windows.

FAQs

1) Do the PK claims require the same formulation as the basic polymer claims?

Yes. The PK-dependent product claims (Claims 20–22 and 41–43) still require the polymer loading constraints and formulation structure embedded in those claims, then add PK windows under a specific dosing scenario (three-unit non-fasting dosing).

2) What is the most direct formulation parameter to change to avoid the broadest product claims?

The polymer amount. The broadest independent framework ties to polymer(s) in 350–2,500 mg (Claim 1; also incorporated in PK product claims). Moving outside those mg bands is the most direct lever.

3) Can a product avoid infringement by changing the salt form of Compound 4?

Yes. The claims include a dependent salt-specific constraint to sodium monohydrate salt of Compound 4 and further specify 216.2 mg. Avoiding that salt form and/or mass can target the dependent salt claims.

4) Does the dosing method cover both single-unit and three-unit daily regimens?

Yes. Method claims include once-daily administration of at least one unit (Claims 18, 39, 60) and once-daily administration of three units (Claims 19, 40, 61).

5) What is the key clinical test condition for the PK-dependent coverage?

PK is defined under non-fasting conditions with a single dose consisting of three of the claimed solid dosage forms.

References

[1] US Patent 10,105,365 (provided claim text).

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	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016		DISCN	Yes	No	10,105,365	⤷ Start Trial	Y			TREATMENT OF HCV INFECTION USING DASABUVIR/OMBITASVIR/PARITAPREVIR/RITONAVIR FIXED DOSE COMBINATION	⤷ 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
European Patent Office	3089757	⤷ Start Trial
Taiwan	201609195	⤷ Start Trial
World Intellectual Property Organization (WIPO)	2015103490	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 10,105,365

Which drugs does patent 10,105,365 protect, and when does it expire?

Summary for Patent: 10,105,365