US Patent 8,105,626 (lansoprazole granule capsule) scope, claim map, and US patent landscape
US 8,105,626 is a US patent focused on a specific lansoprazole granule-in-capsule architecture, defined by (i) a high lansoprazole loading range, (ii) incorporation of specific basic inorganic salts in tightly defined weight ratios to lansoprazole, and (iii) a defined two-step coating system (intermediate coating plus enteric coating) with specified coating amounts and granule particle-size windows. Independent claim 1 also recites capsule/therapeutic use coverage and enables parameter-driven design-around through particle size and coating weight percentages.
What claims are in US 8,105,626 and what is the protected capsule granule architecture?
Answer: The patent protects a capsule comprising lansoprazole-containing granules where the granules have a principal ingredient layer with a high lansoprazole content (>=12% by weight) plus basic inorganic salts (0.2 to 0.4 parts by weight per 1 part lansoprazole), followed by (a) an intermediate coating layer at 0.02 to 1.5 parts by weight per 1 part lansoprazole granules and (b) an enteric coating layer at 10% to 70% by weight of the granules before enteric coating, with granule average particle size 600 to about 2500 µm.
Claim set overview (scope tiers)
| Claim |
Claim focus |
Key structural boundaries that matter for infringement |
| 1 (independent) |
Core-defined granule stack + coating ratios + particle size |
Lansoprazole principal layer >=12% w/w of granules; basic inorganic salt 0.2 to 0.4 (by wt) per 1 part lansoprazole; intermediate coating 0.02 to 1.5 (wt parts) per 1 part lansoprazole granules; enteric coating 10% to 70% of pre-enteric granules; granule avg particle size 600 to ~2500 µm; coating layers formed in sequence; core under principal layer |
| 2 |
Salt class narrowing |
Basic inorganic salts include sodium/potassium/aluminum/magnesium/calcium basic salts |
| 3 |
Salt narrowing |
Only magnesium or calcium salts |
| 4 |
Intermediate coating narrowing |
Intermediate coating 0.05 to 1.0 parts per 1 part lansoprazole |
| 5 |
Enteric coating narrowing |
Enteric coating 10% to 50% (w/w of pre-enteric granules) |
| 6 |
Core excipient class |
Core materials among sucrose, starch, lactose, crystalline cellulose |
| 7 |
Enteric polymer class |
Enteric water-soluble polymer |
| 8 |
Enteric polymer narrowing |
Methacrylic acid copolymer |
| 9 |
Particle size narrowing |
Granule avg particle size 1000 to 2000 µm |
| 10 |
Lansoprazole loading narrowing |
Lansoprazole loading 12% to 40% w/w of total granules |
| 11 |
Indication coverage |
Treatment/prevention claims for multiple upper GI disorders and H. pylori eradication and hemorrhage suppression |
| 12 |
Salt example narrowing |
Magnesium carbonate |
| 13-17 |
Capsule sizes and dose strengths |
No. 3-5 capsule with 30 mg; No. 4-5 with 15 mg; No. 1-3 with 60 mg R-isomer; No. 2-4 with 40 mg R-isomer; No. 3-5 with 30 mg R-isomer |
| 18 |
Combination product |
Pharmaceutical composition combining an antimicrobial agent with the claim 1 capsule |
Claim 1 “hard” limiting parameters (infringement-relevant)
- Lansoprazole principal ingredient layer loading: at least 12% by weight of the total granules.
- Basic inorganic salt loading: 0.2 to 0.4 parts by weight per 1 part by weight lansoprazole (or salt or optically active isomer).
- Intermediate coating layer quantity: 0.02 to 1.5 parts by weight per 1 part by weight of the lansoprazole-containing granules.
- Enteric coating layer quantity: 10% to 70% by weight based on the total amount of granules before coating of the enteric coating.
- Granule particle size: average 600 µm to about 2500 µm.
- Layer sequencing: principal ingredient layer on a core, intermediate coating formed on principal layer, enteric coating formed on intermediate layer.
- Enteric polymer option (via dependent claims): enteric water-soluble polymer, including methacrylic acid copolymers (claims 7-8).
Dependent claims that create “design-around tripwires”
- Salt identity constraints (claims 2-3, 12): moving outside the enumerated basic inorganic salt categories, or away from magnesium/calcium salts, can reduce direct claim coverage.
- Intermediate and enteric coating windows (claims 4-5): shifting coating weights below/above the recited bands can avoid claim 1 if the formulation lands outside all dependent bands.
- Particle size band (claims 1 vs 9): claim 9 tightens particle size to 1000-2000 µm.
- Enteric polymer identity (claims 7-8): if the enteric system is not a “water-soluble polymer” or not a methacrylic acid copolymer, dependent coverage weakens (but claim 1 can still be asserted if claim 1 is interpreted broadly on enteric coating by composition without polymer identity).
- Dose strength/size pairings (claims 13-17): these are narrow capsule size plus dose ranges. They create strong “commercial product fit” but may be avoided by using different strength configurations or capsule size norms (if legitimately different from the recited “No.” ranges).
- Indication claim 11: product label/clinical use matters for direct method-of-use coverage; however, many jurisdictions treat product claims separately from use claims for enforcement posture.
How broad is claim 1 relative to dependent claims 2-18?
Answer: Claim 1 is broad on formulation architecture but narrow on defined quantitative ranges for salt loading, coating weight percentages, and particle size. Dependent claims narrow those ranges and/or specify salt and enteric polymer identities.
Scope stratification
What is the claimed enteric coating system and polymer scope?
Answer: The enteric coating layer is formed on the intermediate coating layer. Dependent claims specify that the enteric coating comprises an enteric water-soluble polymer and identify methacrylic acid copolymer as an example/narrowed option.
Polymer coverage
- Enteric water-soluble polymer (claim 7): this creates a compositional requirement for dependent coverage.
- Methacrylic acid copolymer (claim 8): dependent narrowing.
Coating quantity boundaries
Even if polymer differs, claim 1 can still be asserted if the coating architecture and weight ratios match:
- Enteric coating amount: 10% to 70% by weight (of total granules before enteric coating).
What does the patent cover on dosing and capsule sizing (claims 13-17)?
Answer: It maps formulation to “No. X-Y” capsule sizes with specific lansoprazole dose strengths and specific stereoisomer dosing.
Dose/size mapping in dependent claims
| Claim |
Capsule “No.” range |
Dose strength |
Active definition |
| 13 |
No. 3 to 5 |
30 mg |
lansoprazole (not limited to R-isomer in claim 13) |
| 14 |
No. 4 to 5 |
15 mg |
lansoprazole |
| 15 |
No. 1 to 3 |
60 mg |
lansoprazole or R-isomer |
| 16 |
No. 2 to 4 |
40 mg |
R-isomer |
| 17 |
No. 3 to 5 |
30 mg |
R-isomer |
Practical implication for product fit
- If a commercial product uses different strength/capsule size pairings than these, dependent claims 13-17 may not read cleanly even if the underlying granule/capsule architecture matches claim 1.
What patents protect lansoprazole granules with basic inorganic salts and enteric coating in the US?
Answer: From the claim text alone, US 8,105,626 targets a niche at the intersection of (i) salt-stabilized lansoprazole granules, (ii) controlled intermediate coating, and (iii) enteric coating weight ranges with defined particle size.
However: no usable public patent landscape can be produced here because no bibliographic data (assignee, filing date, priority, related continuation families, examiner, cited art, and prosecution history) is provided for US 8,105,626, and the prompt contains only claim text, not the patent’s full record or any linked US family members.
When does US 8,105,626 lose exclusivity in the US?
Answer: Cannot be stated from the provided information. Patent term depends on filing/priority dates and any PTA/PTE adjustments; none are provided.
What generic entry risks exist for lansoprazole capsule formulations under this patent?
Answer: The main litigation risk is the likelihood of “parameter overlap” with generic products that use:
- lansoprazole granules at >=12% w/w loading,
- magnesium and/or calcium basic inorganic salts at 0.2 to 0.4 parts per 1 part lansoprazole,
- intermediate and enteric coating weight ratios inside the recited windows,
- granule particle size averaging 600 to about 2500 µm,
- enteric coatings that could be methacrylic acid copolymers (if they use that polymer system),
- and capsule size/dose configurations that line up with dependent claims.
Design-around levers explicitly available from claim language
- Reduce or increase basic inorganic salt ratio outside 0.2-0.4 per 1 part lansoprazole.
- Shift intermediate coating outside 0.02-1.5 parts (or outside tightened 0.05-1.0).
- Shift enteric coating amount outside 10%-70% (or outside 10%-50%).
- Move granule particle size average outside 600-~2500 µm (or outside 1000-2000 µm).
- Use different enteric polymer classes to avoid dependent 7-8 (though claim 1 could still remain relevant depending on claim interpretation and evidence).
- Avoid dependent dose/capsule “No.” pairings (claims 13-17).
- Avoid combination scope in claim 18 by not marketing the capsule in combination with an antimicrobial agent.
How can infringement be proved given this claim structure?
Answer: Claim 1 is quantitatively defined, so infringement evidence will typically center on analytical characterization of the marketed granules and coatings:
- assay of lansoprazole content as % w/w of granules,
- identification and quantitation of basic inorganic salts and their weight ratio to lansoprazole,
- measurement of intermediate and enteric coating amounts (mass balance),
- measurement of granule particle size distribution and the “average” metric,
- confirmation of layer sequence (principal layer on core, intermediate coating on principal, enteric coating on intermediate),
- and matching capsule “No.” and mg strength for dependent claims.
Key Takeaways
- US 8,105,626 claim 1 protects a lansoprazole capsule formulation defined by numeric constraints: >=12% w/w lansoprazole, 0.2-0.4 wt-part basic inorganic salts per 1 wt-part lansoprazole, intermediate coating 0.02-1.5 wt parts per 1, enteric coating 10%-70% w/w, and granule particle size 600 to ~2500 µm, with a specific layer architecture.
- Dependent claims narrow by salt identity (Mg/Ca, Mg carbonate), coating sub-ranges, core excipient categories, enteric polymer identity (methacrylic acid copolymer), particle size tight band (1000-2000 µm), and dose/capsule size pairing.
- Commercial risk concentrates on generic products that land inside those quantitative windows and match marketed strength/capsule size categories; parameter shifts (salt ratio, coating weight %, particle size) are the most direct claim-avoidance levers stated in the text.
FAQs
1) What part of claim 1 is usually the hardest to design around?
The combination of salt ratio plus coating weight percentages plus particle size. Many alternative formulations fail multiple boundaries simultaneously.
2) Does claim 1 require methacrylic acid copolymer to be present?
No. Methacrylic acid copolymer is required only for dependent claim 8; claim 1 requires an enteric coating layer but does not, in the provided claim text, lock the polymer to methacrylic acid copolymer.
3) If a product matches the coating architecture but uses a different basic inorganic salt, is it still within the patent?
It can still fall within claim 1 if the salt is a “basic inorganic salt” within the required 0.2-0.4 ratio window; dependent claims 2-3-12 further narrow allowable salts.
4) Can a generic avoid the patent by changing capsule size while keeping the same dose?
Dependent claims 13-17 tie specific strengths to “No.” capsule ranges. Changing the capsule size range can help avoid those dependent claims, though claim 1 could remain in play.
5) Does claim 18 create exposure only if the antimicrobial is co-formulated?
Yes. Claim 18 is limited to a “combination of an antimicrobial agent and the capsule according to claim 1,” so the marketing/combination form matters for coverage.
References (APA)
- Provided in prompt only: Claim text for US Patent 8,105,626 (lansoprazole capsule comprising coated granules).
