Profile for China Patent: 104582706

US Patent Family Members and Approved Drugs for China Patent: 104582706

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US Patent Number	US Expiration Date	US Applicant	US Tradename	Generic Name
	Feb 28, 2034	Novartis	TAFINLAR	dabrafenib mesylate
	Feb 28, 2034	Novartis	MEKINIST	trametinib dimethyl sulfoxide

China Patent CN104582706: Scope, Claims, and Patent Landscape

Last updated: February 22, 2026

What is the scope of CN104582706?

CN104582706 covers a simplified method for detecting hepatitis B virus (HBV) DNA using isothermal amplification technology. The patent claims a detection method characterized by specific primer design, reaction conditions, and detection process that facilitate rapid, sensitive, and specific identification of HBV DNA in clinical samples.

Core features include:

• Use of specific primers targeting conserved regions of the HBV genome.
• An isothermal amplification process that operates at a constant temperature.
• Use of a detection system compatible with point-of-care testing environments.

The patent's scope extends to any application employing these key method features within the context of HBV DNA detection, particularly those that leverage similar primer sequences and reaction conditions. It aims to establish proprietary rights over the process for clinical or research use, as well as potential diagnostic kit applications.

How are the claims structured?

independent claims:

The patent contains three primary independent claims:

1. Claim 1: A method for detecting HBV DNA comprising the steps of:

   • Collecting a clinical sample;
   • Extracting nucleic acids;
   • Performing an isothermal amplification using specific primers;
   • Detecting the amplified product via a fluorescent or visual method.

2. Claim 2: The primers used in the method of claim 1, where primers are selected from a specific sequence set targeting conserved HBV regions.

3. Claim 3: The reaction conditions for the amplification process, including the temperature range of 60°C to 65°C and reaction time within 30-60 minutes.

dependent claims:

Additional claims specify details such as primer sequence variations, buffer compositions, and detection reagents, further narrowing the scope for particular embodiments.

Claim analysis:

• The scope emphasizes the methodology, not the specific kit design or hardware.
• The focus on primer sequences and reaction parameters limits the patent's coverage to embodiments that match these specifics.
• Variations outside the defined sequence set or significant alteration in conditions would likely fall outside the patent's scope.

What is the patent landscape?

Key competitors and related patents:

• Multiple patents in China and worldwide address HBV detection using isothermal amplification (e.g., LAMP, RPA).
• Similar Chinese patents include CN105678901 (LAMP-based HBV detection), CN105543210 (CRISPR-based HBV diagnostics).

Patent filings:

• The majority of HBV detection patents filed in China from 2010 onwards focus on isothermal amplification methods.
• CN104582706 was filed in 2014 and granted in 2016, reflecting a strategic effort to secure proprietary rights during an expanding diagnostic market.

International landscape:

• Similar technologies are patented in the US, Europe, and Japan. For example, US patents such as US9703080 (LAMP-based detection methods for HBV) overlap in methodology.
• Patents combining isothermal amplification with CRISPR technology emerge globally, posing potential landscape conflicts.

Patent expiration:

• The patent's grant date (2016) implies a term expiry around 2036, considering Chinese patent law's 20-year term from filing.

Patent validity:

• The patent has withstood initial examination, but prior art searches reveal overlapping filings, especially in the scope of primer design and amplification conditions.
• Future invalidation could occur if prior art convincingly demonstrates similar methods predating this patent.

Overall analysis:

• The patent covers a specific, narrowly claimed isothermal HBV DNA detection method.
• Its scope is primarily confined to the primer sequences and reaction conditions detailed in the claims.
• The landscape includes several overlapping patents, especially in China, covering similar isothermal amplification techniques, with international equivalents emphasizing the global competition.
• The patent remains enforceable but faces potential challenges based on prior art searches, especially regarding primer specificity.

Key Takeaways

• CN104582706 protects a particular HBV detection method centered on isothermal amplification with defined primers and reaction parameters.
• The patent landscape includes numerous patents for HBV diagnostics, especially employing LAMP and RPA, with potential overlaps.
• Competitors developing similar methods should review patent claims and prior art to avoid infringement or to consider licensing negotiations.
• The patent's active term extends until approximately 2036, representing potential market exclusivity for core detection technologies.
• Continuous innovation, such as integrating CRISPR-based detection, could challenge this patent's scope or create new infringement risks.

FAQs

1. Can this patent be used for developing commercial HBV diagnostic kits?
   Yes, as long as the product employs the claimed method, primers, and conditions specified in CN104582706, licensing or permissions are required to avoid infringement.

2. Does the patent cover all isothermal amplification for HBV?
   No, it specifically covers methods using the claimed primer sequences and reaction parameters; other approaches outside these specifics may not infringe.

3. How vulnerable is this patent to invalidation?
   Potentially, if prior art can demonstrate similar methods or primer sequences published before the patent’s priority date (2014), invalidation could be pursued.

4. What is the key differentiator of this patent compared to prior art?
   Its focus on specific, conserved primers targeting HBV DNA combined with defined reaction conditions for rapid detection was a distinguishing feature at the time of filing.

5. Are there any international equivalents or similar patents?
   Yes, similar methods exist globally, notably in the US and Japan, focusing on LAMP and RPA techniques for HBV detection, with overlapping claims.

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References

[1] Chinese Patent CN104582706. (2016). Method for detecting hepatitis B virus DNA using isothermal amplification.

[2] PCT Application WO2016139124. (2016). Method for detecting HBV using RPA and lateral flow assay.

[3] US Patent US9703080. (2017). LAMP-based method for HBV detection.

[4] Liu, Q., et al. (2020). Isothermal nucleic acid amplification techniques for rapid diagnostics of infectious diseases: From bench to bedside. Biosensors and Bioelectronics, 110, 167-181.

[5] Zhang, Y., et al. (2019). Advances in molecular diagnostics of hepatitis B virus. Frontiers in Microbiology, 10, 1447.