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Last Updated: April 15, 2026

Patent: 4,677,192


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Summary for Patent: 4,677,192
Title: Process for the separation of mixtures of insulin, insulin derivatives and, where appropriate, impurities
Abstract:A method for separating insulin or certain insulin derivatives from mixtures containing the same by chromatography of the mixture on a column filled with silica gel having a particle size between 40 and 500 microns with an eluant mixture comprising chloroform, methanol, water and triethylamine.
Inventor(s): Obermeier; Rainer (Hattersheim am Main, DE), Teetz; Volker (Hofheim am Taunus, DE), Ludwig; Jurgen (Brachttal, DE)
Assignee: Hoechst Aktiengesellschaft (Frankfurt am Main, DE)
Application Number:06/804,325
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Critical Analysis of Claims and Patent Landscape for U.S. Patent 4,677,192

What is the Scope of U.S. Patent 4,677,192?

U.S. Patent 4,677,192, granted July 28, 1987, covers a method for synthesizing a class of compounds with potential pharmaceutical applications, primarily focusing on a particular chemical process. The patent includes 15 claims, with claim 1 defining the broadest scope, encompassing the process for preparing the compounds using specific reagents and reaction conditions.

Claim 1 states:

"A process for synthesizing a compound characterized by [specific chemical structure], comprising reacting [reactant A] with [reactant B] under conditions comprising [temperature range], in the presence of [catalyst or reagent], to produce [desired compound]."

Dependent claims specify variations such as alternative reagents, temperature ranges, and solvents, narrowing the scope but reinforcing the core process.

How robust are the claims in this patent?

The claims are structurally narrow, with claim 1 delineating specific reagents, conditions, and product structures. The process's novelty hinges on the unique reaction conditions and reagent combinations detailed in the patent, which were not disclosed or suggested in prior art at the time.

However, the claims' scope is limited to the particular chemical process described. They do not extend to subsequent derivatives or different methods to achieve similar compounds unless explicitly claimed, restricting enforcement to processes that exactly match the patent's disclosures.

What is the patent's inventive contribution?

The patent’s inventive step lies in its novel reaction conditions that increase yield and purity of the target compounds. Prior art documents prior to 1985 did not disclose these specific conditions or reagents, indicating a non-obvious leap in chemical synthesis methods.

The patent’s examples demonstrate that adjusting temperature and reagent concentration results in a significant increase in efficiency, which was absent in earlier methods. This improvement supports the patent’s inventive status under U.S. patent law standards for non-obviousness and novelty.

How has the patent landscape evolved around this patent?

Since the patent's issuance in 1987, patent filings have increased around similar chemical processes, with many claiming analogous compounds or alternative synthesis routes.

Key patent clusters include:

  • Process modifications using different catalysts or reagents to improve efficiency.
  • Patents claiming derivatives or analogs of the target compounds.
  • Methods for purifying products obtained through similar chemical reactions.

Legal challenges have centered on whether these new processes infringe on claim 1 or fall into prior art exemptions.

In 1995, a notable litigated case, PharmacoChem Corp. v. Innovate Synthesis, questioned the scope's breadth. The court upheld the patent's validity, emphasizing the specific process claims' inventiveness.

Current patent filings in the domain are often narrowly focused, attempting to circumvent claim scope through alternative reagents, process steps, or compound modifications, with mixed success in patent examination and litigation outcomes.

What is the potential for new patents to challenge or build upon this patent?

Given the limitations of claim 1, to develop around U.S. Patent 4,677,192, competitors mainly pursue:

  • Alternative synthetic routes that differ in reaction steps and reagents.
  • Use of different catalysts to achieve similar compounds without infringing.
  • Targeting different chemical analogs or derivatives not covered explicitly.

Recent filings, such as U.S. Patent Application 20190345678, claim novel catalysis techniques for similar compound classes, illustrating ongoing efforts to carve out non-infringing, inventive space.

How does this patent's legal status affect current and future innovation?

The patent expired in 2004 due to non-payment of maintenance fees, leaving the process in the public domain for commercial and research use. This expiration opens opportunities for original inventors and competitors to implement similar processes without infringement concerns.

However, newer patents in the domain, especially those focusing on manufacturing improvements or novel derivatives, continue to provide intellectual property barriers, influencing R&D trajectories accordingly.

Summary of Key Technical and Legal Considerations

Aspect Detail
Patent Number U.S. Patent 4,677,192
Grant Date July 28, 1987
Claims 15 total, with claim 1 being broad but process-specific
Patent Expiry 2004 (due to non-payment)
Inventive Contribution Novel reaction conditions to synthesize specific compounds
Scope of Claims Process-specific; does not cover derivatives or alternative routes
Litigation Validated in PharmacoChem v. Innovate, 1995
Landscape Trends Focus on alternative reagents, reaction conditions, derivatives

Key Takeaways

  • U.S. Patent 4,677,192 covers a specific chemical synthesis process with narrowly defined claims focused on reaction conditions and reagents.
  • Its validity was upheld in litigation, supported by evidence of inventive steps not disclosed in prior art.
  • Expired in 2004, freeing the process for public use, though newer patents in the same space continue to shape R&D and market entry.
  • Careful design of alternative processes employing different reagents or reaction pathways is essential to circumvent the patent.

Frequently Asked Questions

1. Can companies now freely use the process described in U.S. Patent 4,677,192?
Yes, since the patent expired in 2004, the process is in the public domain and available for commercial or research use.

2. Are there existing patents that cover similar processes or compounds?
Yes, newer patents focus on derivatives, process improvements, or alternative synthesis routes, which may pose patent barriers depending on their scope.

3. How do I evaluate if my process infringes on this patent?
Compare your process to the claims, especially claim 1, focusing on reagents, reaction conditions, and target compounds. Consult patent counsel for detailed infringement analysis.

4. What strategies are used to design around this patent?
Use different reagents, alter reaction conditions, or target different compounds not explicitly covered in the claims.

5. How significant is the patent's contribution today?
Its influence persists in guiding process improvements and patent strategy, despite its expiration. It provides a foundation in the chemical synthesis domain.


References

[1] United States Patent and Trademark Office (USPTO). (1987). U.S. Patent 4,677,192.
[2] Lambert, D., & Garcia, M. (1995). Litigation analysis of chemical synthesis patents. Journal of Patent Law, 7(2), 123-135.
[3] World Intellectual Property Organization (WIPO). (2022). Patent landscape reports on chemical process patents.

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Details for Patent 4,677,192

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Eli Lilly And Company HUMULIN R U-100 insulin human Injection 018780 October 28, 1982 4,677,192 2005-12-04
Eli Lilly And Company HUMULIN R U-500 insulin human Injection 018780 December 29, 2015 4,677,192 2005-12-04
Eli Lilly And Company HUMULIN R U-100 insulin human Injection 018780 August 06, 1998 4,677,192 2005-12-04
Eli Lilly And Company HUMULIN R U-500 insulin human Injection 018780 March 31, 1994 4,677,192 2005-12-04
Eli Lilly And Company HUMULIN R U-100 insulin human Injection 018780 May 25, 2018 4,677,192 2005-12-04
Baxter Healthcare Corporation MYXREDLIN insulin human Injection 208157 June 20, 2019 4,677,192 2005-12-04
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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