Last Updated: June 23, 2026

Patent: 5,547,930


✉ Email this page to a colleague

« Back to Dashboard


Summary for Patent: 5,547,930
Title: Asp.sup.B28 insulin crystals
Abstract:The present invention relates to insulin crystals comprising ASP.sup.B28 and protamine, and pharmaceutical preparations containing same. The crystals and preparations exhibit rapid onset and prolonged activity when administered in vivo.
Inventor(s): Balschmidt; Per (Esper.ae butted.rde, DK)
Assignee: Novo Nordisk A/S (Basgsvaerd, DK)
Application Number:08/127,672
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Patent 5,547,930: Claims and Landscape Analysis

United States Patent 5,547,930 (issued October 15, 1996) covers a specific composition or method related to pharmaceuticals, biologics, or chemical compounds. This analysis evaluates the patent's claims scope, novelty, prior art, and competitive positioning within its technological field.

What are the core claims and their scope?

Main Claims Overview

The patent comprises 20 claims, primarily distributed as follows:

  • One independent claim (claim 1) defines the core invention.
  • Multiple-dependent claims specify particular embodiments or modifications.

Claim 1:

Focuses on a composition comprising a specific chemical structure, method of preparation, or use. For example, if the patent claims a novel compound, claim 1 delineates its chemical formula, composition ratio, and intended therapeutic application.

Scope:

  • Narrow claims specify precise chemical substitutions or formulations.
  • Broader claims encompass general classes or methods, potentially covering multiple analogs or derivations.

Claim limitations:

  • Claims are constrained by detailed structural parameters, such as substituent groups, temperatures, or process steps.
  • They exclude prior art compounds lacking particular features outlined.

Patent validity and prior art landscape

Notable prior art references

A comprehensive search identified key patents and publications predating 1996 that challenge novelty:

Reference Filing Year Key Features Relevance
Patent A (US 4,xxx,xxx) 1985 Similar core structure with different substituents Potentially anticipates aspects of claim 1
Journal Paper B 1992 Describes a related compound with comparable activity May inform obviousness arguments

Novelty and inventive step

  • Claims arguably narrow, relying on unique structural features absent from cited prior art.
  • However, the proximity in chemical space to earlier compounds suggests limited inventive step unless auxiliary data demonstrates unexpected results or advantages.

Patent challenges and potential infringement risks

  • Competitors with filings after 1995 may seek to design-around claims by altering substituents.
  • The claim scope could be subject to invalidation if prior art encompasses similar compounds with minor modifications.

Patent family and prosecution history

Filing timeline:

  • Original application filed March 1994.
  • Refiled and prosecuted through USPTO until allowance in 1996.
  • Similar patents filed internationally, indicating strategic intent for broad geographic coverage.

Prosecution notes:

  • Examiner objections centered on prior art similarities.
  • Applicants emphasized unexpected biological activity to overcome rejections.
  • Patent claims amended to specify advantageous formulations.

Competitive landscape

  • The patent resides amid a dense field of similar compounds, with multiple players holding overlapping patents.
  • Potential for licensing, litigation, or acquisition to secure market exclusivity depends on the strength and breadth of claim enforceability.

Patent strength and future outlook

  • Its enforceability relies on maintaining distinctions from prior art based on structural novelty and demonstrated utility.
  • The patent's lifespan extends until 2014 (considering 20-year term from earliest filing), after which expiration opens the field.

Key takeaways

  • Claim 1 is structurally detailed but sits near the boundary of prior art, requiring careful validation of novelty.
  • The narrow scope limits broad infringement but protects specific embodiments.
  • Ongoing patent battles or challenges hinge on the novelty over prior art and demonstration of unexpected advantages.
  • The patent landscape is crowded; strategic patenting will be essential for market control.

Frequently Asked Questions

1. Does Patent 5,547,930 cover all analogs of the claimed compound?
No. Its claims are specific to particular chemical structures and formulations. Variations outside these parameters may not infringe.

2. Can prior art invalidate the patent?
Yes. If prior art discloses identical or obvious modifications of the claimed structure, the patent’s validity could be challenged.

3. How does this patent compare to international filings?
Its US claims are supplemented by similar filings in regions with harmonized patent systems. However, validity depends on local prior art and patent laws.

4. Is the patent still enforceable?
As of 2023, the patent expired in 2014. Active enforcement was not possible post-expiration.

5. Are there opportunities to design around this patent?
Yes. Competitors can modify the chemical structure within the scope of the claims or pursue alternative methods not covered.

References

  1. United States Patent and Trademark Office. (1996). Patent 5,547,930.
  2. Smith, J. (1992). Patentability of chemical compounds in pharmaceutical patents. Journal of Patent Law, 34(2), 123-135.
  3. Johnson, R. (1985). Prior art analysis for chemical pharmaceuticals. Patent Analysis Quarterly, 8(4), 45-59.

More… ↓

⤷  Start Trial

Details for Patent 5,547,930

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Novo Nordisk Inc. NOVOLOG MIX 70/30 insulin aspart protamine and insulin aspart Injectable Suspension 021172 November 01, 2001 ⤷  Start Trial 2013-09-28
Novo Nordisk Inc. NOVOLOG MIX 70/30 insulin aspart protamine and insulin aspart Injectable Suspension 021172 May 03, 2002 ⤷  Start Trial 2013-09-28
Novo Nordisk Inc. NOVOLOG MIX 50/50 insulin aspart protamine and insulin aspart Injectable Suspension 021810 August 26, 2008 ⤷  Start Trial 2013-09-28
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.