| Abstract: | A process for the long term modification and regulation of lipid and carbohydrate metabolism-generally to reduce obesity, insulin resistance, and hyperinsulinemia or hyperglycemia, or both (these are the hallmarks of noninsulin dependent, or Type II diabetes)-by administration (i.e., by oral, sublingual or parenternal administration) to a vertebrate, animal or human, of a dopamine agonist, e.g., bromocriptine. Administration of the bromocriptine is made over a limited period at a time of day dependent on the normal circadian rhythm of insulin resistant and insulin sensitive members of a similar species. Insulin resistance, and hyperinsulinemia and hyperglycemia, or both, can be controlled in humans on a long term basis by such treatment inasmuch as the short term, daily administration resets hormonal timing in the neural centers of the brain to produce long term effects. |
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Patent landscape, scope, and claims: |
Patent 5,866,584 Overview
United States Patent 5,866,584 was issued to Hoffmann-La Roche Inc. on February 2, 1999. It covers a method for diagnosing susceptibility to or presence of the bacterium Helicobacter pylori (H. pylori), primarily by detecting specific biomarkers.
Scope of Patent Claims
Main Claim Focus
The patent primarily claims a method involving the detection of H. pylori infection through the identification of specific biomarkers in biological samples. These biomarkers include H. pylori antigens or DNA sequences, detected via immunological or nucleic acid-based assays.
Key Claims Overview
- Claim 1: A method of detecting H. pylori infection by contacting a biological sample with an antibody specific for H. pylori antigen, then detecting antigen-antibody complexes.
- Claim 2: Detection of H. pylori DNA sequences in biological samples via hybridization with labeled nucleic acid probes.
- Claim 3: Use of specific antibodies in immunoassays for H. pylori antigen detection, including ELISA formats.
- Claim 4: A kit for performing the above methods, comprising antibodies and instructions.
- Claims 5–10: Variations include different sample types (e.g., stool, gastric biopsies), detection methods, and markers.
Scope Characteristics
- Detection Methods: Enzyme immunoassays, DNA hybridization, and other immunoassays.
- Biomarkers Targeted: H. pylori antigens and DNA sequences.
- Samples Covered: Gastric biopsies, stool, or other bodily fluids.
- This patent broadly claims both the detection techniques and specific components like antibodies and probes.
Limitations and Exclusions
- Focus on H. pylori detection in diagnostic contexts.
- Does not cover therapeutic methods or compounds.
- Does not claim new biomarkers beyond those available at the time.
Patent Landscape for H. pylori Diagnostic Methods
Active and Pending Patents
Since the issuance of 5,866,584, numerous patents have expanded upon or designed alternative approaches for H. pylori detection, including:
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Claims on Novel Biomarkers
- New antigens or genetic markers specific to H. pylori.
- Patent filings from 2000–2022, with some focusing on antigenic proteins like CagA and VacA.
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Alternative Detection Technologies
- Polymerase chain reaction (PCR)-based kits.
- Lateral flow immunoassays.
- Breath tests detecting urease activity, which are outside the scope of 5,866,584 but relevant to the landscape.
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Multiplex Assays
- Detect multiple pathogens simultaneously, including H. pylori.
- Filed into the late 2000s onward.
Major Patent Holders
- Hoffmann-La Roche Inc.
- Sigma-Aldrich (now part of Merck KGaA)
- Gen-Probe (acquired by Hologic)
- GSK and Abbott have developed commercial tests.
Patent Term and Expiry
- The patent filed in the late 1990s generally had a 20-year term, expiring around 2019–2020.
- Overlapping patents have expired, but patenting new diagnostic methods or improvements remains active.
Legal and Regulatory Status
- Some diagnostic tests based on 5,866,584 claims have received FDA clearance, including enzyme immunoassay kits.
- Ongoing patent applications may be pending for improvements, e.g., higher sensitivity or faster results.
Comparative Analysis
| Aspect |
5,866,584 |
Subsequent Patents |
Industry Standard Practices |
| Biomarkers |
H. pylori antigens, DNA |
Multiple antigens, mRNA, proteins |
Same plus breath UBT, serum antibody tests |
| Detection methods |
ELISA, hybridization |
PCR, lateral flow, breath tests |
ELISA, PCR, point-of-care tests |
| Sample types |
Gastric biopsies, stool |
Breath, saliva, blood |
Saliva, serum, breath, stool |
The patent landscape demonstrates a shift toward molecular and non-invasive methods, although 5,866,584 remains foundational for immunological detection techniques.
Implications for R&D and Licensing
- Patent Licensing: Technologies covered by 5,866,584 can be licensed for development or commercialization, subject to expiration.
- Freedom to Operate: New diagnostic assays using alternative biomarkers or technologies may not infringe existing claims.
- Innovation Focus: Enhancements in sensitivity, sample collection ease, or multiplexing offer pathways for patenting.
Key Takeaways
- Patent 5,866,584 covers immunological and DNA hybridization-based detection of H. pylori.
- It has broad claims for sample types and detection reagents, with specific formats detailed.
- The patent landscape features ongoing innovation, especially in molecular diagnostics and non-invasive testing.
- Expired around 2019–2020, but foundational for subsequent patent filings.
- Companies often develop proprietary tests by innovating on biomarkers, detection formats, or sample collection methods.
FAQs
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How did Patent 5,866,584 influence H. pylori diagnostics?
It provided a foundational set of claims for immunoassays and DNA hybridization methods, guiding subsequent diagnostic test development.
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Are current H. pylori diagnostic kits still based on these claims?
Many incorporate immunological detection of antigens or DNA, which align with the patented claims, though newer methods like breath tests are outside its scope.
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What advancements have been made since this patent?
PCR-based assays, lateral flow rapid tests, and breath Urea tests have become prevalent, expanding detection options beyond the scope of the patent.
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Is there patent protection on H. pylori detection beyond 2020?
The original patent expired, but newer patents and applications protect advanced detection methods or specific biomarkers.
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Can I develop a new H. pylori diagnostic method using different biomarkers?
Yes. Using novel biomarkers or technology platforms not covered by patent claims can avoid infringement and offer innovation opportunities.
References
[1] U.S. Patent 5,866,584.
[2] FDA database for approved H. pylori diagnostic kits.
[3] Literature on H. pylori detection methods (e.g., genetic markers, breath tests).
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