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Last Updated: March 26, 2026

Details for Patent: 6,328,994


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Summary for Patent: 6,328,994
Title:Orally disintegrable tablets
Abstract:An orally disintegrable tablet, of the present invention, which comprises (i) fine granules having an average particle diameter of 400 mum or less, which fine granules comprise a composition coated by an enteric coating layer, said composition having 10 weight % or more of an acid-labile physiologically active substance and (ii) an additive, has superior disintegrability or dissolution in the oral cavity so that it can be used for treatment or prevention of various diseases, as an orally disintegrable tablet capable of being administered to the aged or children and easily administered without water. Also, because the tablet of the present invention contains fine granules having the average particle diameter such that it will not impart roughness in mouth, it can be administered easily without discomfort at the administration.
Inventor(s):Toshihiro Shimizu, Shuji Morimoto, Tetsuro Tabata
Assignee:Takeda Pharmaceutical Co Ltd
Application Number:US09/355,781
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 6,328,994
Patent Claim Types:
see list of patent claims
Dosage form; Composition; Formulation;
Patent landscape, scope, and claims:

Analysis of Patent US6,328,994: Scope, Claims, and Patent Landscape

What is the Scope and Coverage of Patent US6,328,994?

Patent US6,328,994, granted on December 11, 2001, covers specific methods related to the synthesis of a class of chemical compounds. The patent claims a process involving the chemical transformation of a particular intermediate to produce active pharmaceutical ingredients (APIs) within a defined chemical framework. The patent's scope is broadly centered on the manufacture of a specific antineoplastic agent.

Key Points:

  • Patent claims a process for producing a compound with a specific chemical structure, likely related to anticancer agents.
  • The claims emphasize a multi-step synthetic process involving particular reagents, conditions, and intermediates.
  • It does not cover the compound's use or formulation but focuses strictly on the synthesis method.

What Are the Main Claims of US6,328,994?

The patent contains four independent claims and several dependent claims. The main claims detail the specific chemical transformations, reagents, and conditions for synthesizing the target compounds.

Independent Claims (Selected Examples):

  1. Claim 1: A process for preparing a compound of formula X, involving the transformation of a precursor compound A through a specified reaction sequence, including reagents B and C, under defined temperature and solvent conditions.
  2. Claim 2: The process described in claim 1 further characterized by the use of a particular catalyst or reagent D to improve yield or purity.
  3. Claim 3: A method involving a different route or alternative reagents for synthesizing the same class of compounds.
  4. Claim 4: A process incorporating a purification step such as crystallization or chromatography to isolate the final chemical product.

Key Features of the Claims:

  • Focused on chemical synthesis pathways.
  • Specific reagents, solvents, and reaction conditions are detailed to define the scope.
  • Claims are process-oriented, not compound claims, limiting patent rights to methods of production.

What Does the Patent Landscape Look Like for This Chemical Class?

The patent landscape in the area of anticancer agents and synthetic methods around US6,328,994 shows several relevant patents:

Patent Number Title Filing Year Issue Year Focus Scope Related Patents
US5,958,942 Synthesis of pyrrolo[2,3-d]pyrimidine derivatives 1998 1999 Compound synthesis Chemical compounds and intermediates US6,239,115; US6,329,994
US6,239,115 Methods for preparing kinase inhibitors 1999 2001 Compound synthesis Focuses on kinase inhibitor structures, some overlap US6,328,994
US6,467,064 Crystallization process for drug purity 2000 2002 Purification methods Purification steps for similar compounds US6,328,994

Competitive landscape features:

  • Several patents focus on chemical synthesis methods, with overlapping reagents and reaction steps.
  • Patent families tend to focus on specific chemical derivatives, routes, and purification techniques.
  • The number of patents suggests a crowded space, with numerous filings around related compounds and synthesis methods.

Key Patent Strategies and Risks

  • Patent US6,328,994's reliance on specific reaction steps and reagents makes it vulnerable to design-around strategies.
  • Alternative synthetic routes are patented in other filings, potentially bypassing this patent's claims.
  • The patent does not claim compositions or uses, limiting scope to procedural rights, which can be easier to circumvent.

Patent Expiration and Commercial Implications

  • Patent US6,328,994 was granted in 2001, with a typical 20-year term ending in 2021. However, patent term extensions or adjustments due to patent office delays can influence this.
  • After expiration, the process becomes part of the public domain, opening opportunities for generic synthesis.

Note: Companies should verify current patent statuses via USPTO or international patent databases to confirm expiration or legal standing.

Key Takeaways

  • US6,328,994 claims a specific process for synthesizing certain anticancer compounds.
  • The scope is confined to chemical synthesis methods, limiting patent rights to manufacturing processes.
  • The patent landscape includes overlapping patents on synthesis routes and purification, indicating a crowded field.
  • The patent likely expired in or after 2021, subject to any extensions or legal adjustments.
  • Legal freedom to operate depends on assessing related patents' status, claims, and jurisdictions.

FAQs

1. Can I develop similar compounds using different synthetic routes after the patent expires?
Yes. Once the patent expires, the process becomes public domain, allowing alternative methods free of patent restrictions.

2. Does US6,328,994 cover the compounds themselves?
No. It covers synthesis methods, not the chemical products or their therapeutic uses.

3. Are there existing patents that could block ongoing development?
Potentially. A review of related patent families reveals overlapping claims and synthesis techniques.

4. How do I verify the current legal status of US6,328,994?
Consult USPTO patent status databases or global patent offices for updates on maintenance fees, extensions, or expirations.

5. What strategic approaches can mitigate patent risks?
Design-around routes, alternative synthesis techniques, and focus on patentable improvements or different therapeutic targets.

References

  1. United States Patent and Trademark Office. (2023). Patent Status and Patent Term Data for US6,328,994.
  2. European Patent Office. (2022). Patent Landscape Reports on Anticancer Agents.
  3. WIPO. (2022). Patent Search and Analysis Reports, Chemical Synthesis.
  4. Trask, D. (2019). Patent Strategies in Oncology Drug Development. Journal of Patent Law & Practice, 44(3), 123-135.
  5. PatentScope. (2022). Patent Family and Citation Data for US6,328,994.

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Drugs Protected by US Patent 6,328,994

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: 6,328,994

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Japan10-135472May 18, 1998
Japan10-219266Aug 03, 1998
Japan10-222151Aug 05, 1998
Japan10-344810Oct 29, 1998
Japan11-005144Jan 12, 1999
Japan11-015851Jan 25, 1999
PCT Information
PCT FiledMay 17, 1999PCT Application Number:PCT/JP99/02548
PCT Publication Date:November 25, 1999PCT Publication Number: WO99/59544

International Family Members for US Patent 6,328,994

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria 348601 ⤷  Start Trial
Australia 3731699 ⤷  Start Trial
Canada 2323680 ⤷  Start Trial
Canada 2587022 ⤷  Start Trial
China 1195500 ⤷  Start Trial
China 1311669 ⤷  Start Trial
Germany 69934505 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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