Details for Patent: 9,649,318

Which drugs does patent 9,649,318 protect, and when does it expire?

Patent 9,649,318 protects VIVLODEX and is included in one NDA.

This patent has sixteen patent family members in sixteen countries.

Summary for Patent: 9,649,318

Title:	Formulation of meloxicam
Abstract:	Unit dosage forms of meloxicam containing either 5 mg or 10 mg of meloxicam that provide effective pain relief and have desirable pharmacokinetic properties are described. The unit dosage forms can provide pain relief when a single unit dose is administered to a patient and useful for treating pain such as osteoarthritis pain at a relatively low systemic exposure to meloxicam.
Inventor(s):	H. William Bosch
Assignee:	Iceutica Pty Ltd
Application Number:	US14/974,108
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,649,318
Patent Claim Types: see list of patent claims	Composition; Formulation; Dosage form;

Scope and Patent Landscape for US Patent 9,649,318 (Meloxicam Nanoparticle Capsule Claims)

US Patent 9,649,318 is directed to capsule formulations of meloxicam that combine (i) a specific particle size window (D(0.9) between 1200 nm and 4000 nm; median particle size by volume between 100 nm and 1000 nm), with (ii) quantified exposure targets (AUC and Cmax ranges for 5 mg and 10 mg doses; fed vs fasted conditions), and (iii) quantified dissolution performance using a defined USP Apparatus 1 (baskets) test in pH 6.1 phosphate buffer with 0.1% SLS at 37°C, including 80% and optionally 90% dissolution thresholds within defined times. Claim scope is thus tight to formulation properties plus pharmacokinetic performance under specific dosing conditions, not to meloxicam itself or to generic “capsules” in general.

Because you provided only the claim text, the analysis below focuses on claim construction, practical coverage boundaries, and the likely competitive patent landscape around the same technical axis (meloxicam particle size reduction, dissolution testing, and PK equivalence). A full validity/claim-chart-level landscape beyond this requires the patent record (bibliographic data, specifications, prosecution history, and other asserted patents). Under your constraints, this response is limited to what can be derived from the provided claim elements.

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What does US 9,649,318 claim for meloxicam capsule formulations?

Core answer: A capsule containing meloxicam in a specified particle-size range with defined dissolution kinetics under a specific USP Apparatus 1 method and targeted human PK metrics after single-dose administration to healthy adults in fasted or fed states.

Key claim elements (independent framing)

The independent structure is repeated in dependent claims for 5 mg and 10 mg strengths, and for fasted vs fed conditions:

1. Dosage form: capsule
2. Drug amount: 5 mg (Claims 1-4) or 10 mg (Claims 5-13)
3. Particle size (two constraints):
   • Median particle size (volume basis): 100 nm to 1000 nm
   • D(0.9) of meloxicam particles: < 4000 nm and > 1200 nm
4. Dissolution test conditions and thresholds:
   • USP Apparatus 1 (baskets), 100 RPM
   • 500 mL (for 5 mg) or 1000 mL (for 10 mg)
   • pH 6.1 phosphate buffer + 0.1% SLS
   • 37°C ± 0.5°C
   • Claim 1/10: ≥ 80% dissolves in 10 min (5 mg) or 15 min (10 mg)
   • Claim 2/6: ≥ 90% dissolves in time options (5 mg: ≤8/7/6/5 min; 10 mg: ≤14/13/12/11/10/5 min)
5. Human PK targets (healthy adults, single dose):
   • Fasted vs fed conditions are separately constrained for 5 mg (fasted) and 10 mg (fasted and fed)
   • PK metrics include AUC (0-∞), Cmax, and Tmax
   • Some claims are expressed as absolute ranges; others as 80% to 125% of a reference AUC/Cmax value

“Fitness-for-purpose” claim style

The claims are not limited to manufacturing or material properties alone. They require measured clinical exposure behavior in healthy adults under controlled feeding conditions. That combination tends to make claim infringement hinge on formulation performance tests and human study outcomes, not just particle sizing or in vitro dissolution.

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How do the 5 mg fasted claims (1-4) define scope and infringement risk?

Claim 1 (5 mg, fasted): particle size + dissolution + PK exposure

For a capsule with 5 mg meloxicam:

• Median particle size (volume): 100–1000 nm
• D(0.9): 1200–4000 nm (strictly less than 4000 nm and greater than 1200 nm)
• Dissolution: USP App 1 basket, 100 RPM, 500 mL pH 6.1 + 0.1% SLS, 37°C ±0.5°C
  • ≥80% dissolves within 10 minutes
• Fasted human PK targets:
  • Mean AUC (0-∞): 7,500–20,000 h·ng/mL
  • Mean Cmax: 350–950 ng/mL

Claims 2-3 (dependent tighten dissolution and Tmax)

• Claim 2 adds ≥90% dissolution within one of the listed time cutoffs (selectable time period that is part of the claim as written):
  • In the 5 mg test: ≤8 min or ≤7 min or ≤6 min or ≤5 min
• Claim 3 adds median Tmax: 1–3 hours (fasted)

Claim 4 (dependent tightens AUC equivalence to a reference)

• Claim 4 constrains AUC(0-∞) to 80%–125% of 13,610 ng·h/mL

Practical coverage implication: A competitor that makes 5 mg meloxicam particles within the size window but whose in vivo exposure falls outside these AUC/Cmax bands (or whose dissolution is slower than the defined in vitro test) may avoid infringement, even if particle sizing matches. Conversely, a formulation that meets the dissolution and particle size constraints must still hit human PK targets in the claimed ranges.

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How do the 10 mg fasted claims (5-9) change scope versus the 5 mg set?

Claim 5 (10 mg, fasted): wider AUC/Cmax bands and larger dissolution volume

For a capsule with 10 mg meloxicam:

• Median particle size (volume): 100–1000 nm
• D(0.9): 1200–4000 nm
• Dissolution: USP App 1 baskets, 100 RPM, 1000 mL pH 6.1 + 0.1% SLS, 37°C ±0.5°C
  • ≥80% dissolves in ≤15 minutes
• Fasted human PK targets:
  • Mean AUC (0-∞): 16,000–44,000 h·ng/mL
  • Mean Cmax (blood): 700–1,900 ng/mL

Claims 6-7 (dependent tighten dissolution and Tmax)

• Claim 6: ≥90% dissolves within one of the listed time cutoffs in the 10 mg test:
  • ≤14, ≤13, ≤12, ≤11, ≤10, or ≤5 minutes
• Claim 7: median Tmax 1–3 hours (fasted)

Claims 8-9 (dependent tighten AUC and Cmax to reference ranges)

• Claim 8: AUC(0-∞) 80%–125% of 29,173 ng·h/mL
• Claim 9: Cmax 80%–125% of 1,253 ng/mL

Practical coverage implication: Compared with the 5 mg set, the 10 mg claims scale exposure ranges upward and extend dissolution acceptance time (15 minutes vs 10 minutes) and test volume (1000 mL vs 500 mL). But the same D(0.9) and median particle-size constraints persist, meaning the “nanoparticle” distribution is a consistent claim anchor.

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How do the 10 mg fed claims (10-13) affect patent coverage?

Claim 10 (10 mg, fed): capsicle + particle size + dissolution + fed-state PK

For a capsule with 10 mg meloxicam in the fed state:

• Median particle size (volume): 100–1000 nm
• D(0.9): 1200–4000 nm
• Dissolution: USP App 1 baskets, 100 RPM, 1000 mL pH 6.1 + 0.1% SLS, 37°C ±0.5°C
  • ≥80% dissolves in ≤15 minutes
• Fed human PK targets:
  • Mean Cmax: 525–1,500 ng/mL
  • Mean AUC(0-∞): 15,000–42,000 h·ng/mL

Claims 11-13 (dependent tighten Tmax and AUC reference equivalence)

• Claim 11: median Tmax 3–7 hours (fed)
• Claim 12: mean Cmax 80%–125% of 974 ng/mL
• Claim 13: mean AUC(0-∞) 80%–125% of 27,146 ng/mL
  (Claim 13 text shows “AUC(0-∞) that is 80% to 125% of 27,146 ng/ml”)

Practical coverage implication: A formulation that matches particle size and dissolution but produces a fed-state PK profile outside these bounds would fall outside the asserted fed claims. This reduces “blanket” coverage for fed dosing even if fasted dosing overlaps.

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What is the technical “center of gravity” of US 9,649,318: particle size or PK?

Answer: The claim requires both. But infringement analysis typically turns on particle size + dissolution performance first, then confirms that the resulting formulation yields human PK within the stated ranges.

Why particle size is a hard gate

• Median particle size is explicitly bounded to 100–1000 nm
• D(0.9) is bounded to 1200–4000 nm
• These constraints limit the allowed particle distribution. A formulation with narrower size distribution but shifting D(0.9) above 4000 nm or below 1200 nm would miss the core particle-size requirement.

Why dissolution is a hard gate

• Dissolution test method is defined tightly: apparatus, basket, rotation speed, medium composition, pH, SLS level, temperature, and volumes.
• The threshold is also explicit: 80% in a set time (10 min for 5 mg, 15 min for 10 mg), with optional 90% time cutoffs in dependent claims.

Why PK is the final gate

• AUC and Cmax bands are precise and feeding-state dependent.
• Even if a formulation matches particle size and dissolution, PK may not land inside the in vivo windows, particularly if exposure variability is driven by formulation excipients, capsule disintegration, gastric emptying effects, or other formulation factors not expressly recited.

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How strong is US 9,649,318 claim coverage against generics or “same API different formulation” players?

Answer: The patent is strong against products engineered to reproduce the same nanoparticle distribution plus dissolution profile that yields the same human exposure. It is weaker against a challenger that can change any one of: particle size distribution, dissolution kinetics under the specific USP conditions, or in vivo PK under fasted/fed conditions.

Likely design-around levers

1. Shift D(0.9) out of 1200–4000 nm
   • Easiest conceptual lever: change manufacturing and milling/classification to shift the tail of the particle distribution.
2. Pass particle sizing but miss dissolution
   • Alter excipient composition, capsule shell composition, or granulation/processing affecting wetting and dissolution under pH 6.1 + 0.1% SLS at 100 RPM.
3. Match dissolution but miss PK
   • PK can differ due to absorption kinetics, food effects, and formulation disintegration timing even if dissolution appears similar in vitro.

Risk posture for an at-risk product

• If a generic or follow-on formulation aims to claim bioequivalence, it would likely run human PK studies. If those studies are designed to show equivalence but the resulting PK falls inside the claimed AUC/Cmax/Tmax bands, infringement risk increases.
• If the competitor chooses a formulation that yields different Cmax/AUC while remaining therapeutically equivalent, it reduces overlap with the claimed PK windows but may affect regulatory bioequivalence strategy.

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What do the claim terms imply about measurement standards used in enforcement?

Even without the specification, the claims embed test prescriptions. The following are the measurement bottlenecks in practice:

Particle size distribution

• “Median particle size, on a volume basis”
• “D(0.9)”
• Enforcement typically requires a defined particle sizing method (laser diffraction or equivalent), but the claim text only fixes the distribution endpoints, not the method.

Dissolution

The claim defines:

• Apparatus: USP 1 (baskets)
• Rotation speed: 100 RPM
• Medium: pH 6.1 phosphate buffer + 0.1% SLS
• Temperature: 37°C ±0.5°C
• Volume: 500 mL (5 mg claims) vs 1000 mL (10 mg claims)
• Threshold: ≥80% at 10 or 15 min; dependent options for ≥90% at listed time cutoffs

This means any infringement test will likely reproduce these exact conditions.

Human PK

• Healthy adults
• Single dose
• Fasted vs fed state
• Metrics: AUC(0-∞), Cmax, Tmax
• AUC/Cmax sometimes expressed as absolute ranges, sometimes as 80%–125% of a reference value (likely derived from a comparator formulation in the specification or prosecution record)

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How does US 9,649,318 likely sit in a broader meloxicam formulation patent landscape?

Answer: Based on the claim style, the patent belongs to a common cluster: particle-size-engineered, dissolution-enhanced, oral bioavailability improved oral NSAID formulations, often framed as:

• “nanocrystal” or “controlled particle size” approaches
• dissolution method-defined performance
• human PK bridging to show exposure improvements over conventional meloxicam

Adjacent innovation patterns commonly seen around such claims

Even though you did not provide other patent numbers, the structure of 9,649,318 aligns with the following surrounding categories that typically appear in the same families and in competitor filings:

1. Particle size reduction and classification patents
   • milling methods, wet milling, jet milling, microfluidization, sieving/classification to set D(0.9) and median particle size
2. Stabilization and formulation patents
   • wetting agents, surfactant levels (here SLS in dissolution test), and capsule formulation enabling fast dissolution
3. In vivo performance or bioavailability equivalence patents
   • claims tied to AUC/Cmax/Tmax targets in healthy adults under fasted/fed
4. Dissolution profile patents with USP conditions
   • claims that lock down Apparatus 1, speed, medium composition, and time points

What this means for competitive landscape mapping

• Products targeting fasted vs fed exposure will be scrutinized against separate claim sets (5 mg fasted and 10 mg fasted/fed).
• Competitors can reduce risk by moving particle size out of the claimed D(0.9) band or by tuning dissolution kinetics so that ≥80%/≥90% dissolution thresholds are not met within the claimed time windows.
• Any product claiming a “nanoparticle meloxicam” pitch will likely attract infringement mapping around particle distribution and dissolution test parameters.

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Timeline and exclusivity: when does a US patent typically expire?

This cannot be computed from claim text alone. The grant date alone is insufficient to determine:

• earliest effective non-provisional filing date
• term adjustments (PTA)
• terminal disclaimers
• any pediatric extension

Accordingly, this response does not provide an expiration date.

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Key Takeaways

• US 9,649,318 is a capsule-specific, performance-anchored formulation patent for meloxicam: particle size distribution (median 100–1000 nm; D(0.9) 1200–4000 nm), USP 1 dissolution performance in pH 6.1 + 0.1% SLS at 37°C, and human PK targets after single-dose fasted or fed administration.
• Claim scope is tight: meeting only particle size or only dissolution is typically insufficient for infringement; a product must land within the claimed AUC/Cmax/Tmax ranges under the appropriate feeding condition.
• Design-around strategies are most plausible via changing D(0.9) distribution, modifying the formulation to shift dissolution kinetics under the exact USP method, and/or tuning the product to move PK metrics outside the claimed windows.
• Enforcement will likely concentrate on test replication: USP dissolution conditions and particle size endpoints, then confirm clinical PK in healthy adults under fasted/fed conditions.

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FAQs

1. What formulation properties matter most for infringement of US 9,649,318?
   Particle size distribution endpoints (median 100–1000 nm and D(0.9) 1200–4000 nm), USP 1 dissolution performance in pH 6.1 + 0.1% SLS at 100 RPM, and fasted/fed human PK targets (AUC/Cmax/Tmax).

2. Does US 9,649,318 cover meloxicam particles without a capsule dosage form?
   No. The claims are explicitly limited to capsule dosage forms.

3. How are fed-state and fasted-state products separated in the claims?
   Separate claim sets apply to dosing in healthy adults in the fasted state (5 mg and 10 mg fasted claims) versus fed state (10 mg fed claims), with different AUC/Cmax/Tmax ranges.

4. Is the dissolution test tied to exact USP Apparatus 1 parameters?
   Yes. Claims specify basket apparatus, 100 RPM, pH 6.1 phosphate buffer + 0.1% SLS, 37°C ±0.5°C, and fixed volumes (500 mL vs 1000 mL) with time thresholds.

5. Can a generic avoid infringement while matching bioequivalence requirements?
   Potentially, by engineering the formulation so that at least one claimed element is not met, especially the D(0.9) window, the in vitro dissolution thresholds under the claimed test, or the human PK windows in fasted or fed conditions.

Drugs Protected by US Patent 9,649,318

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Iceutica Operations	VIVLODEX	meloxicam	CAPSULE;ORAL	207233-001	Oct 22, 2015		DISCN	Yes	No	9,649,318		Y
Iceutica Operations	VIVLODEX	meloxicam	CAPSULE;ORAL	207233-002	Oct 22, 2015		DISCN	Yes	No	9,649,318		Y

International Family Members for US Patent 9,649,318

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015274838
Brazil	112016027435
Canada	2951383
China	107073010