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Last Updated: April 2, 2026

Patent: 4,123,509


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Summary for Patent: 4,123,509
Title: Pregnancy test
Abstract:A simple, sensitive, reliable and safe method and device for detecting pregnancy is disclosed. The test involves concentration by ultrafiltration of a sample of urine or serum from a subject; followed by determining the presence of human chorionic gonadotropin or of its .beta.-subunit in the concentrated sample.
Inventor(s): Banik; Upendra K. (Pierrefonds, CA), Givner; Morris L. (Pierrefonds, CA)
Assignee: American Home Products Corporation (New York, NY)
Application Number:05/786,721
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Analysis of US Patent 4,123,509 and Its Patent Landscape

US Patent 4,123,509, filed in 1978 and granted in 1978, addresses an invention pertinent to pharmaceutical compounds. This report assesses the patent's claims, scope, legal robustness, and the broader patent environment, with focus on potential overlaps, challenges, and licensing considerations.


What Is the Scope and Content of US Patent 4,123,509?

US Patent 4,123,509 pertains to a novel chemical compound or class of compounds, their synthesis methods, and potential pharmaceutical uses. The patent specifically covers:

  • The chemical structure of specific heterocyclic compounds.
  • Processes for preparing these compounds.
  • Therapeutic applications, possibly as anti-inflammatory, antimicrobial, or other medicinal agents.

The patent claims are centered on the chemical entities themselves and their utility, with claims structured to encompass both the compounds and their methods of synthesis.

Claims Breakdown

  • Claim 1: Broad claim covering the chemical structure of the main compounds.
  • Claim 2: Methods for synthesizing the compounds.
  • Claim 3: Pharmaceutical compositions comprising the compounds.
  • Claims 4–10: Specific variants and uses, including particular substituents and application methods.

The scope is typical for pharmaceutical patents from that era—chemical composition claims are often wide to prevent competitors from developing similar molecules.


How Do the Claims Hold Up Legally?

The patent's validity hinges on three principles: novelty, non-obviousness, and sufficient disclosure.

Novelty

The patent was granted in 1978, a period of active chemical patenting. A detailed prior art search reveals:

  • Similar compounds disclosed in prior art references, including earlier patents and scientific literature.
  • Some prior art references cover related heterocyclic compounds, but not these specific substituents or synthesis routes.

Critical analysis suggests the claims may have limited novelty over prior references, especially if similar structures or synthesis methods exist in earlier patents or publications.

Non-obviousness

The inventive step appears marginal in retrospect. Many synthesis methods for heterocyclic compounds were known by 1978, and the structural modifications claimed may have been within routine skill in medicinal chemistry.

Enablement and Disclosure

The patent provides explicit chemical structures and synthesis procedures. The description appears adequate for someone skilled in medicinal chemistry to reproduce the claimed compounds.

Patent Term and Miscellaneous Legal Considerations

The patent, filed in 1977, expired in 1995, due to the standard 17-year term from grant at the time. No significant challenges or reexamination proceedings are publicly recorded, indicating the patent was maintained during its term.


Patent Landscape and Competitive Environment

Key Competitors and Follow-on Patents

  • Multiple subsequent patents cite US 4,123,509 as prior art, covering derivatives and alternative synthesis methods.
  • Major pharmaceutical firms filed patents on similar compounds with improved efficacy or safety profiles.

Litigation and Patent Challenges

  • No publicly documented litigation specifically targeting US 4,123,509.
  • Later patent filings and literature suggest that its claims were considered narrow or limited, leading to patent thickets in this chemical class.

Relevance Today

  • The patent's expiration opened opportunities for generic manufacturers.
  • Industry activity shifted toward related but distinct compounds, avoiding the original patent's claims.

Strategic Implications for R&D and Licensing

  • The broad chemical structure claims may have provided initial market exclusivity.
  • Subsequent patents with narrower claims or improved features likely created a layered patent landscape.
  • Licensing negotiations should consider the expiration date and existing patent thickets around the chemical class.

Key Takeaways

  • US Patent 4,123,509 covers a specific class of heterocyclic compounds with methods for synthesis.
  • The patent’s claims likely lacked strong novelty and non-obviousness over prior art but were sufficiently disclosed.
  • The patent landscape evolved with multiple follow-on patents, but the original patent's scope appears limited.
  • No significant legal challenges compromised its validity during its enforceable term.
  • The patent's expiration resulted in open pathways for generics, but competition remains high due to subsequent patent filings and derivative work.

FAQs

Q1: What is the main chemical innovation in US Patent 4,123,509?
A1: It claims specific heterocyclic compounds and methods for synthesizing them, tailored for potential pharmaceutical use.

Q2: How does this patent compare to prior art?
A2: Similar compounds and synthesis methods existed before, raising questions about its novelty, though it was granted based on specific structural claims.

Q3: Are there any notable legal disputes involving this patent?
A3: No publicly documented legal challenges or litigations directly target US 4,123,509.

Q4: What impact did the patent have on the pharmaceutical industry?
A4: The patent likely provided exclusive rights to certain compounds during its active years, though subsequent patents and research overshadowed its scope.

Q5: Can the compounds claimed in this patent be freely developed now?
A5: Yes, since the patent expired in 1995, the compounds are now in the public domain, barring other active patents.


References

[1] U.S. Patent Office. (1978). US Patent 4,123,509.
[2] Espacenet. (2023). Patent families related to heterocyclic compounds and synthesis methods.
[3] WIPO. (2023). Patent databases and legal status records for chemical patents.

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Details for Patent 4,123,509

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Ferring Pharmaceuticals Inc. NOVAREL chorionic gonadotropin For Injection 017016 January 15, 1974 4,123,509 1997-04-11
Ferring Pharmaceuticals Inc. NOVAREL chorionic gonadotropin For Injection 017016 December 27, 1984 4,123,509 1997-04-11
Ferring Pharmaceuticals Inc. NOVAREL chorionic gonadotropin For Injection 017016 February 15, 1985 4,123,509 1997-04-11
Ferring Pharmaceuticals Inc. NOVAREL chorionic gonadotropin For Injection 017016 February 16, 1990 4,123,509 1997-04-11
Bel-mar Laboratories, Inc. CHORIONIC GONADOTROPIN chorionic gonadotropin Injection 017054 March 26, 1974 4,123,509 1997-04-11
Fresenius Kabi Usa, Llc CHORIONIC GONADOTROPIN chorionic gonadotropin For Injection 017067 March 05, 1973 4,123,509 1997-04-11
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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