Last updated: February 19, 2026
This report analyzes China drug patent CN101309691, focusing on its patent scope, specific claims, and the broader patent landscape. The patent, titled "New Use of Celecoxib" and filed by Shanghai Zerun Pharmaceutical Co. Ltd., was granted on October 14, 2009. It claims a novel use for celecoxib, an existing nonsteroidal anti-inflammatory drug (NSAID).
What is the Core Innovation Claimed by CN101309691?
The central innovation claimed by CN101309691 is the use of celecoxib for the prevention and treatment of neurological degenerative diseases. Specifically, the patent application states that celecoxib can be used to prevent and treat diseases such as Alzheimer's disease, Parkinson's disease, and Huntington's disease. This represents a departure from the primary known applications of celecoxib, which are for pain and inflammation associated with conditions like osteoarthritis and rheumatoid arthritis.
What Specific Claims Does the Patent Encompass?
Patent CN101309691 contains several claims that define the extent of its protection. These claims are critical for understanding the commercial and R&D implications for competitors and licensees.
The primary claims of the patent include:
- Claim 1: A new use of celecoxib for the preparation of a pharmaceutical composition for preventing and treating neurological degenerative diseases.
- Claim 2: The use according to claim 1, wherein the neurological degenerative disease is selected from the group consisting of Alzheimer's disease, Parkinson's disease, and Huntington's disease.
- Claim 3: A pharmaceutical composition for preventing and treating neurological degenerative diseases, comprising celecoxib as the active ingredient.
- Claim 4: The pharmaceutical composition according to claim 3, further comprising pharmaceutically acceptable carriers and/or excipients.
- Claim 5: The pharmaceutical composition according to claim 3 or 4, for use in a method of preventing or treating neurological degenerative diseases in a subject.
These claims establish that the patent protects not only the concept of using celecoxib for neurodegenerative diseases but also any pharmaceutical compositions specifically formulated for this purpose. The inclusion of specific diseases like Alzheimer's, Parkinson's, and Huntington's disease provides a targeted scope.
What is the Dosage and Formulation Information Provided?
The patent application provides details on the dosage and formulation of celecoxib for its claimed new use. This information is crucial for determining the practical application and potential market entry for the patented invention.
The document specifies:
- Dosage Form: Celecoxib can be formulated into various dosage forms, including tablets, capsules, granules, injections, suppositories, and suspensions.
- Dosage Range: The daily dosage of celecoxib is generally between 50 mg and 400 mg. The specific dosage is determined by factors such as the patient's condition, age, weight, and the severity of the disease.
- Administration Routes: The drug can be administered orally, rectally, or intravenously.
- Excipients: The pharmaceutical compositions may include common pharmaceutical excipients such as fillers, binders, disintegrants, lubricants, colorants, and flavors.
The emphasis on formulations suitable for chronic treatment of neurodegenerative conditions, which often require long-term administration, is a key aspect of the patent's disclosure.
What is the Scientific Rationale or Mechanism of Action Presented?
The patent application attempts to provide a scientific basis for its claims regarding the efficacy of celecoxib in neurodegenerative diseases. This rationale often involves discussing the known biological pathways implicated in these conditions and how celecoxib might interact with them.
The stated mechanisms, as detailed in the patent, include:
- Inhibition of Cyclooxygenase-2 (COX-2): Celecoxib is a selective COX-2 inhibitor. The patent suggests that COX-2 is expressed in neural tissue and plays a role in neuroinflammation, a factor contributing to neurodegeneration. By inhibiting COX-2, celecoxib may reduce inflammatory processes in the brain.
- Antioxidant Properties: The patent alludes to potential antioxidant effects of celecoxib, which could protect neurons from oxidative stress, another significant contributor to neurodegenerative diseases.
- Modulation of Amyloid Beta (Aβ) Production: For Alzheimer's disease, the patent suggests that celecoxib may influence the production or accumulation of amyloid beta plaques, a hallmark pathology of the disease.
- Neuroprotective Effects: Broader neuroprotective effects are proposed, suggesting that celecoxib can preserve neuronal function and viability in the context of disease progression.
While the patent outlines these potential mechanisms, it is important to note that the scientific consensus on the therapeutic efficacy of celecoxib for these specific indications may differ and evolve based on subsequent clinical trials and research.
What is the Prior Art Landscape for Celecoxib and Neurodegenerative Disease Treatments?
Understanding the prior art is crucial for assessing the novelty and inventiveness of CN101309691. The prior art for celecoxib primarily relates to its established anti-inflammatory and analgesic uses, while the prior art for neurodegenerative disease treatments encompasses a range of pharmaceuticals and therapeutic strategies.
Prior Art for Celecoxib:
- Established Indications: Celecoxib, marketed as Celebrex by Pfizer (originally developed by Searle), has been widely used and patented for treating pain and inflammation associated with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and acute pain. Numerous patents cover its synthesis, formulations, and specific therapeutic uses for these conditions.
- General NSAID Research: Extensive research exists on NSAIDs, including their mechanisms of action, side effects, and potential broader therapeutic applications.
Prior Art for Neurodegenerative Disease Treatments:
- Alzheimer's Disease: Treatments often focus on symptomatic relief (e.g., cholinesterase inhibitors like donepezil, rivastigmine; NMDA receptor antagonists like memantine) or, more recently, disease-modifying therapies targeting amyloid beta (e.g., aducanumab, lecanemab). Research has also explored anti-inflammatory agents and antioxidants.
- Parkinson's Disease: Treatments primarily involve dopaminergic agents (e.g., levodopa), dopamine agonists, and MAO-B inhibitors. Research into neuroprotection and disease modification is ongoing.
- Huntington's Disease: Treatment focuses on managing symptoms, as there is currently no cure or disease-modifying therapy.
The key differentiator for CN101309691 lies in its claim for a new use of an existing drug for a different disease category. The novelty hinges on demonstrating that this application was not previously disclosed or obvious to a person skilled in the art.
What is the Patent Expiration Date?
The expiration date of a patent determines the period of market exclusivity. For Chinese invention patents, the term is 20 years from the filing date.
- Patent Number: CN101309691
- Filing Date: 2008-03-18
- Grant Date: 2009-10-14
- Expiration Date: 2028-03-18 (20 years from the filing date)
This expiration date indicates that the patent provided exclusivity for a specific period following its grant, with the protection concluding in March 2028.
What are the Potential Commercial and R&D Implications?
The scope and claims of CN101309691 have significant implications for pharmaceutical companies, researchers, and investors operating in the neurodegenerative disease space and the broader celecoxib market.
For Shanghai Zerun Pharmaceutical Co. Ltd. (Patent Holder):
- Market Exclusivity: The patent grants exclusive rights to use celecoxib for the prevention and treatment of specified neurodegenerative diseases in China until its expiration. This potentially allows for the development and marketing of novel celecoxib-based treatments for these conditions without direct competition for the patented indication.
- Licensing Opportunities: The company could license these rights to larger pharmaceutical firms for further clinical development and commercialization, generating revenue through royalties and upfront payments.
- Strategic Value: The patent adds a valuable asset to the company's intellectual property portfolio, potentially increasing its valuation and strategic standing.
For Competitors (Generic Drug Manufacturers and Other Pharma Companies):
- Freedom-to-Operate (FTO) Concerns: Companies looking to develop or market celecoxib for neurodegenerative diseases before the patent's expiration would need to conduct thorough FTO analyses. Unauthorized use of the patented indication could lead to infringement lawsuits.
- Off-Label Use: The patent does not prevent physicians from prescribing generic celecoxib for off-label use in neurodegenerative diseases, but it does prevent the formal marketing and promotion of such use by pharmaceutical companies.
- Alternative Therapies: Competitors may focus on developing or acquiring intellectual property for alternative treatments for neurodegenerative diseases that do not infringe on CN101309691, or they may target the expiration date to introduce generic versions for the claimed use.
For Researchers and R&D:
- Further Investigation: The patent incentivizes further research into the efficacy and safety of celecoxib for neurodegenerative diseases. This includes conducting rigorous clinical trials to validate the proposed mechanisms and therapeutic benefits.
- Repurposing Strategies: The patent exemplifies the concept of drug repurposing, where existing drugs are investigated for new therapeutic applications. This encourages broader exploration of existing drug libraries.
For Investors:
- Investment Opportunities: Investors may consider companies holding patents on novel drug uses, as these can represent significant future revenue streams, especially for conditions with unmet medical needs like neurodegenerative diseases.
- Risk Assessment: Investors must assess the strength of the patent, the likelihood of successful clinical development of the claimed use, and the competitive landscape.
What is the Status of the Patent and Any Related Legal Proceedings?
As of the current analysis, CN101309691 is a granted invention patent. Information regarding its current legal status, such as any invalidation challenges or infringement litigation, is not publicly detailed in the patent record itself. Such information would typically be found through specialized legal databases or court dockets.
- Patent Validity: The validity of the patent could be challenged through post-grant review processes in China, where third parties may present evidence to invalidate the patent claims.
- Infringement: If any entity were to commercialize celecoxib for the patented indications without authorization, the patent holder could initiate infringement proceedings.
The absence of readily available public records of disputes suggests the patent has been in force without major legal challenges to date, though this does not preclude future actions.
Key Takeaways
- China patent CN101309691, filed by Shanghai Zerun Pharmaceutical Co. Ltd., claims a new use for celecoxib in the prevention and treatment of neurological degenerative diseases, including Alzheimer's, Parkinson's, and Huntington's diseases.
- The patent's scope covers the use of celecoxib for preparing pharmaceutical compositions and the compositions themselves for these specific indications.
- The patent expires on March 18, 2028, providing a defined period of market exclusivity for the claimed use in China.
- The scientific rationale presented centers on celecoxib's COX-2 inhibition and potential anti-inflammatory, antioxidant, and neuroprotective effects in the central nervous system.
- The patent has significant implications for market exclusivity, licensing opportunities, competitor strategies, R&D focus, and investment decisions within the neurodegenerative disease sector.
Frequently Asked Questions
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Can generic celecoxib be sold for neurological degenerative diseases in China before March 18, 2028?
Generic celecoxib can be sold, but its marketing and promotion for the specific indications claimed in CN101309691 are restricted until patent expiration. Physicians may still prescribe it off-label.
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Does this patent cover all uses of celecoxib?
No, this patent specifically covers the new use of celecoxib for the prevention and treatment of neurological degenerative diseases. Other established uses, such as for arthritis, are not covered by this patent and would be subject to their own patent protections or be in the public domain.
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What is the significance of the patent claiming a "new use" of an existing drug?
Patenting a new use for an existing drug (drug repurposing) allows pharmaceutical companies to extend the commercial life of a molecule by discovering and protecting novel therapeutic applications beyond its original indication, creating new market opportunities.
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What is the primary mechanism proposed by the patent for celecoxib's efficacy in neurodegenerative diseases?
The patent proposes that celecoxib's efficacy is primarily due to its selective inhibition of COX-2, which is believed to reduce neuroinflammation, a key factor in the progression of neurodegenerative diseases.
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If a company wants to develop a celecoxib-based drug for Alzheimer's disease in China before March 2028, what must they consider?
They must consider the intellectual property rights granted by CN101309691. They would need to secure a license from Shanghai Zerun Pharmaceutical Co. Ltd., challenge the patent's validity, or wait for the patent to expire on March 18, 2028, to launch a product for that specific indication without infringement.
Citations
[1] Shanghai Zerun Pharmaceutical Co. Ltd. (2009). New Use of Celecoxib (Patent No. CN101309691). China National Intellectual Property Administration.
