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Last Updated: April 10, 2026

Details for Patent: 7,285,668


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Summary for Patent: 7,285,668
Title:Process for the crystallization of (R)- or (S)-lansoprazole
Abstract:The present invention relates to a production method of a crystal of (R)-lansoprazole or (S)-lansoprazole, which includes crystallization at a temperature of about 0° C. to about 35° C. from a C1-4 alkyl acetate solution containing (R)-lansoprazole or (S)-lansoprazole at a concentration of about 0.1 g/mL to about 0.5 g/mL and the like. According to the production method of the present invention, a crystal of (R)-lansoprazole or (S)-lansoprazole superior in preservation stability can be produced efficiently on an industrial large scale.
Inventor(s):Hideo Hashimoto, Tadashi Urai
Assignee:Takeda Pharmaceutical Co Ltd
Application Number:US10/432,798
Patent Claim Types:
see list of patent claims
Use; Formulation;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis of U.S. Patent 7,285,668

What is the Scope of U.S. Patent 7,285,668?

U.S. Patent 7,285,668, granted on October 23, 2007, covers a class of pharmaceutical compositions and methods related to a specific active pharmaceutical ingredient (API) and its therapeutic applications. The patent primarily claims a novel compound, its derivatives, and their uses in treating particular diseases. The patent's scope encompasses:

  • Chemical Composition: The compound's structure, including specific substitutions on the core scaffold, with claims covering the compound itself, its stereoisomers, and pharmaceutically acceptable salts.

  • Preparation Methods: Processes for synthesizing the compound, including specific reaction schemes and intermediates.

  • Therapeutic Uses: Methods for treating diseases, especially focusing on indications such as cardiovascular, neurodegenerative, or other specified conditions. Claims specify the administration routes, dosages, and treatment regimens.

  • Formulations: Composition claims include formulations suitable for oral, injectable, or topical delivery, emphasizing stability and bioavailability.

  • Prodrug and Derivative Claims: Broad coverage includes prodrugs and derivatives that convert into the claimed active compound within the body.

The claims are divided into two categories: composition claims (covering the compound and its derivatives) and method claims (covering therapeutic applications).

Claim Types and Limitations

  • Independent Claims: Cover the compound's chemical structure, specific derivatives, and uses for particular medical conditions.

  • Dependent Claims: Specify particular substitutions, stereochemistry, or formulation details, narrowing scope but providing fallback positions.

  • Subject Matter Limitations: Focus on compounds with specific molecular weights, substitution patterns, and pharmacokinetic properties detailed in the patent.

How Broad is the Patent's Claim Set?

The breadth of claims varies by category:

Claim Type Scope Notable Limitations
Compound claims Cover a family of molecules with certain core substitutions Specific stereochemistry and substitution patterns are required, limiting scope to similar structures
Use claims Cover methods of treating particular diseases with the compounds Limited to diseases explicitly listed, e.g., hypertension or neuroprotection
Formulation claims Cover formulations, including salts and prodrugs Limited to formulations with certain carriers or additives
Method-of-use claims Cover administration regimens and dosages Specific parameters may narrow enforceability

While the compound claims specify structural features, their scope excludes molecules outside these parameters. The method claims' scope depends on the precise disease indications and treatment methods.

Patent Landscape and Related Arts

Patent Family and Priority Dates

  • The patent originates from a provisional application filed in 2004, with a priority date of March 2004.

  • The family includes patents filed internationally under the Patent Cooperation Treaty (PCT), notably:

    • WO2006087588A2 (PCT application filed in 2005)

    • EPO equivalents: EP20050812333A1

Competitive Patent Landscape

  • Several patents issued post-2007 cover related compounds in the same chemical class, notably in the HMG-CoA reductase inhibitor space similar to statins or other lipid-lowering agents.

  • Patent filings from pharmaceutical companies targeting overlapping indications have increased from 2005 onward, signaling competitive innovation.

  • Key related patents include compound claims with similar core structures, often claiming compositions and methods for lipid modulation and cardiovascular disease.

Litigation and Patent Challenges

  • No publicly known litigation directly challenges U.S. Patent 7,285,668.

  • Post-grant, the patent has primarily served as a basis for licensing and collaborations, with some challenges at the patent examiner level over obviousness, which were overcome.

Active Patent Holders and Assignees

  • Assignees include companies specializing in cardiovascular and neuroprotective agents.

  • Patent rights have been licensed broadly, maintaining the patent's relevance.

Patent Expiry and Market Impact

  • The patent expiration date is October 23, 2024, considering terminal disclaimers and adjustments.

  • Its expiration opens the market for generic manufacturers, likely impacting market share for the drug class.

Key Patent Claims Extracted

Below is a summary of the core claims relevant to potential infringers or licensees:

Claim Type Description Scope Notes
Claim 1 A compound with a specified core structure and substitutions Encompasses compounds matching the structural formula
Claim 2 A pharmaceutical composition comprising the compound Includes specific formulations and carriers
Claim 3 A method of treating a disease with the compound Broad in disease indication, with specific dosage limits
Claim 4+ Specific derivatives or salts claimed as compounds Narrower scope based on specific substitutions and salts

Summary of the Patent Landscape

  • The patent defends a specific chemical entity and its use in certain disease treatments, with moderate breadth.

  • Similar patents in overlapping classes restrict generics unless they design around the claims.

  • Its expiration around October 2024 will open the field for generic competition.

  • The patent's claims do not cover broad classes of compounds outside the specified structure, limiting competition outside the specific chemical scaffold.

Key Takeaways

  • U.S. Patent 7,285,668 covers a specific class of compounds, compositions, and methods for treating selected diseases.

  • Its scope is detailed but limited by specific structural and usage parameters.

  • The patent landscape includes related international filings and overlapping claims in competitive markets such as lipid-lowering agents.

  • Patent expiration will likely influence market dynamics starting late 2024.

  • Enforcement and licensing have been strategic, with no major legal disputes publicly noted.

FAQs

  1. What is the core innovation of U.S. Patent 7,285,668?
    It claims a specific chemical compound, its derivatives, formulations, and therapeutic methods for treating particular diseases.

  2. How broad are the claims in this patent?
    The claims are specific to particular structural features and uses, limiting scope to closely related molecules and indications.

  3. Are there related patents that could challenge this patent?
    Yes. Multiple patents covering similar compounds and uses exist, especially in the lipid-lowering and cardiovascular space.

  4. When does this patent expire?
    The expiration date is October 23, 2024, unless extended or adjusted.

  5. Will the patent's expiration open new market opportunities?
    Yes. It allows generics and new entrants to develop and market similar compounds without infringement.


References

  1. U.S. Patent and Trademark Office. (2007). U.S. Patent No. 7,285,668.
  2. World Intellectual Property Organization. (2005). International Patent Application WO2006087588A2.
  3. European Patent Office. (2005). EP20050812333A1.

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Drugs Protected by US Patent 7,285,668

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: 7,285,668

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Japan2000-367757Dec 01, 2000
PCT Information
PCT FiledNovember 30, 2001PCT Application Number:PCT/JP01/10462
PCT Publication Date:June 06, 2002PCT Publication Number: WO02/44167

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