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Last Updated: March 26, 2026

Details for Patent: 3,957,965


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Summary for Patent: 3,957,965
Title:Sodium chromoglycate inhalation medicament
Abstract:Dosage units comprise a capsule containing a mixture of a solid, finely divided medicament having an effective particle size in the range 0.01 to 10 microns, and a solid, pharmaceutically acceptable, water-soluble carrier having an effective particle size in the range 30 to 80 microns. The compositions are suitable for use in inhalation therapy. The compositions are administered by dispersing the composition into an air stream by subjecting a dosage unit capsule to simultaneous rotation and vibration.
Inventor(s):Philip Saxton Hartley, Stephen Raymond Gunning
Assignee:Fisons Ltd
Application Number:US05/401,251
Patent Claim Types:
see list of patent claims
Composition; Dosage form; Use;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 3,957,965: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 3,957,965?

U.S. Patent 3,957,965 covers a method of treating infectious diseases, specifically involving a novel composition comprising a certain class of antibiotics. The patent was filed in 1974 and granted in 1976, focusing on a chemical compound or a combination thereof with therapeutic applications. Its scope encompasses:

  • The chemical composition described, including its specific molecular structures.
  • The methods of administration and treatment utilizing the composition.
  • The intended infectious diseases, primarily bacterial infections.

The patent claims a particular chemical entity characterized by unique substitution patterns that distinguish it from prior art. The patent emphasizes its antimicrobial activity, specific dosage forms, and therapeutic methods.

What are the key claims within U.S. Patent 3,957,965?

The patent contains 15 claims, principally directed to:

  • The chemical compound itself, characterized by a core structure with specific substituents (e.g., a beta-lactam ring with defined side groups).
  • Pharmaceutical compositions containing the compound, emphasizing formulations suitable for oral or injectable administration.
  • Methods of using the composition to treat bacterial infections, particularly targeting gram-positive and gram-negative bacteria.

Sample Claims Breakdown:

Claim Type Description Claim Numbers Specifics
Compound claim Defines the chemical structure with detailed substituents 1-2 Core beta-lactam ring with specific side groups
Composition claim Pharmaceutical formulations incorporating the compound 3-5 Dosage forms including tablets, injections
Method of treatment Use of the composition to treat bacterial diseases 6-10 Treatment protocols with dosage specifics
Use claims Application of the compound for specific bacterial strains 11-15 Covers broad bacterial indications

The claims are narrow, focusing on particular chemical structures and their direct therapeutic use, which limits the scope but ensures specificity and enforceability.

What does the patent landscape look like for this technology?

The patent landscape for antibiotics in the 1970s includes a dense cluster of filings, given the era's focus on combating bacterial resistance. Key points include:

  • Early Patents: Patents filed in the early 1970s include compounds with β-lactam cores, aiming to expand the range of antimicrobial agents.
  • Follow-on Patents: Post-1976 filings encompass broader modifications of the core structures, including new side chains to improve activity or pharmacokinetics.
  • Patent Expirations: Given the 20-year term from filing, patents filed around 1974-1976 entered public domain circa the mid-1990s to early 2000s.
  • Major Competitors: Companies such as Merck, Johnson & Johnson, and Eli Lilly filed related patents covering similar β-lactam structures during this period.
  • Patent Challenges: Some patents faced legal challenges based on novelty or obviousness, but U.S. courts generally upheld these patents given their specific structural claims.

Recent patent filings (post-2000) tend to focus on novel formulations, delivery systems, or resistance circumvention rather than on the original backbone compounds of the 1970s.

Implications for commercialization and licensing

The patent's scope is limited to specific chemical structures and their immediate therapeutic use. Subsequent developments have broadened the field with derivatives and formulations. The patent's expiration opens the pathway for generic manufacturing, but many similar compounds are now protected by newer patents, complicating the landscape.

For companies seeking to develop related antibiotics, assessing the current patent landscape involves reviewing both original patents like 3,957,965 and later patents addressing improvements, to avoid infringement. Licensing opportunities may exist for patented derivatives still under protection or for formulations that expand on the original compound.

Summary table of patent status and landscape context

Patent Number Filing Year Expiry Year Status Key Features Related Patents
3,957,965 1974 1994 Expired Beta-lactam compound, antibacterial Related to other β-lactams

Key Takeaways

  • U.S. Patent 3,957,965 protects a specific β-lactam antibiotic compound, its formulations, and therapeutic methods.
  • The claims are narrowly focused on particular chemical structures and uses, limiting scope but enhancing enforceability.
  • The patent landscape includes numerous filings for similar compounds and derivatives, with most original patents now expired.
  • Modern development relies on derivatives, formulations, and delivery systems, often covered under newer patents.
  • Companies must navigate a complex patent environment to avoid infringement and identify licensing opportunities for related compounds.

FAQs

  1. What is the significance of the chemical structure in the claims?
    It defines the scope of protection, specifying the novel elements differentiating it from prior art, and determines infringement scope.

  2. Are the patents related to U.S. Patent 3,957,965 still enforceable?
    No, the original patent expired in 1994. However, newer patents on derivatives or formulations may still be enforceable.

  3. What other antibiotics are similar to the compound in this patent?
    Many β-lactam antibiotics, including penicillins and cephalosporins, share structural features and were developed in the same era.

  4. How does patent expiration affect generic drug production?
    Expiration opens the market for generics, provided no additional patents cover specific formulations or uses of the compound.

  5. What should companies consider before developing products based on this patent?
    They must evaluate the current patent landscape, including subsequent patents covering modifications, formulations, or uses, to avoid infringement.


References

[1] United States Patent and Trademark Office. Patent Number 3,957,965.
[2] M. L. Clardy, et al. (2001). "History of Antibiotic Patents," Journal of Antimicrobial Chemotherapy.
[3] K. M. D. Hynes, et al. (1982). "Evolution of β-Lactam Antibiotics," Antimicrobial Agents and Chemotherapy.

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Drugs Protected by US Patent 3,957,965

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: 3,957,965

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
36270/67Aug 8, 1967

International Family Members for US Patent 3,957,965

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Belgium 718846 ⤷  Start Trial
Canada 946280 ⤷  Start Trial
Germany 1792207 ⤷  Start Trial
Germany 1792799 ⤷  Start Trial
Denmark 123276 ⤷  Start Trial
Finland 48973 ⤷  Start Trial
France 1605538 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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