Last updated: May 16, 2025
Introduction
China's pharmaceutical sector continues to expand, driven by innovations in traditional and modern medicine. At the center of this growth is patent CN104428024, granted by the China National Intellectual Property Administration (CNIPA). This patent covers a Salvia miltiorrhiza medicinal extract and its preparation method, highlighting advancements in herbal drug development. For business professionals navigating the competitive landscape of drug patents, understanding this patent's intricacies can inform strategic decisions on R&D investments, licensing agreements, and market entry. This analysis delves into the patent's claims, scope, and broader landscape, drawing on official records to provide actionable insights.
Overview of the Patent
CN104428024, filed in 2014 and published in 2015, focuses on a refined extract from Salvia miltiorrhiza, a plant widely used in traditional Chinese medicine for treating cardiovascular and inflammatory conditions. The invention claims a method that enhances the extract's bioavailability and purity, potentially improving efficacy for drugs targeting heart diseases or cancer. According to CNIPA records [1], this patent addresses limitations in existing extraction techniques by introducing a novel process that combines solvent extraction with specific purification steps.
The patent's assignee is a Chinese pharmaceutical company, underscoring Beijing's push to protect indigenous innovations amid global competition. As of the latest data, the patent remains active, with an expiration date in 2034, offering long-term protection in a market where herbal remedies intersect with modern pharmacology. This positions the invention as a key asset in China's strategy to dominate the global traditional medicine market, projected to reach $100 billion by 2025 [2].
Analysis of Claims
The claims in CN104428024 form the core of its legal protection, defining the boundaries of the invention. CNIPA's detailed patent document outlines 15 claims, with the independent claims setting the foundation [1]. Claim 1, for instance, describes a "method for preparing a Salvia miltiorrhiza extract comprising steps of solvent extraction, filtration, and concentration to achieve at least 90% purity of active compounds." This claim emphasizes the process's specificity, requiring precise control of temperature and pH levels to optimize yield.
Dependent claims build on this base, adding layers of innovation. Claim 2 extends Claim 1 by incorporating an additional step of enzymatic treatment to remove impurities, while Claim 5 specifies the use of ethanol as the primary solvent. These elements demonstrate a focus on practical application, potentially covering variations in industrial-scale production. From a business perspective, such claims could enable the patent holder to challenge competitors mimicking the process, as evidenced by similar cases in the CNIPA database where process patents have led to infringement lawsuits [1].
The language of the claims is notably precise, using terms like "at least 90% purity" to quantify improvements over prior art. This rigor limits ambiguity, a common pitfall in pharmaceutical patents, and strengthens enforceability. However, it also narrows the scope, meaning generic manufacturers must innovate around these specifics to avoid litigation. Professionals analyzing this patent should note that the claims prioritize method over composition, which could influence partnership negotiations in sectors like nutraceuticals or oncology drugs.
Scope of the Patent
The scope of CN104428024 extends beyond mere extraction to encompass broader applications in drug formulation and therapeutic use. Under CNIPA guidelines, the patent protects any product or process that directly derives from the claimed method, including derivatives of the Salvia miltiorrhiza extract used in pharmaceuticals [1]. This creates a protective barrier against imitators, particularly in China's burgeoning market for traditional medicine-based drugs, where annual sales exceed $50 billion [2].
Yet, the patent's scope has limitations. It does not cover the raw plant material or general extraction techniques already in the public domain, as per prior art references cited in the document. For example, it excludes basic solvent-based methods documented in earlier patents, focusing instead on the unique purification process. This targeted approach means the patent holder must actively monitor for infringements, such as unauthorized adaptations in over-the-counter supplements.
Business implications are significant: Companies eyeing expansion into Chinese herbal markets must conduct freedom-to-operate analyses. If a product incorporates a similar extraction method, it risks CNIPA enforcement actions, as seen in recent cases where fines reached millions of yuan [3]. Conversely, licensing this patent could open revenue streams, with potential partners in Europe or the U.S. seeking to leverage its validated efficacy for global exports.
Patent Landscape
The patent landscape for CN104428024 reveals a competitive field, with over 200 related patents filed in China for Salvia miltiorrhiza derivatives since 2010 [1]. This patent stands out as a leader in process innovation, but it faces challenges from family patents and international equivalents. Notably, it belongs to a patent family that includes applications in the U.S. (e.g., US20160243156) and Europe, though those were abandoned, limiting its global reach [4].
Competitors include patents like CN103623128, which covers similar herbal extracts but emphasizes different solvents, creating a web of overlapping protections. A search of the CNIPA and WIPO databases shows that while CN104428024 cites 10 prior art references, emerging patents are challenging its novelty, particularly in areas like nanotechnology-enhanced extracts [1]. This dynamic landscape suggests a trend toward consolidation, with larger firms acquiring smaller patents to build defensive portfolios.
For business professionals, this means heightened risks in R&D. Entering the market without a thorough landscape analysis could lead to costly disputes, as illustrated by a 2022 CNIPA ruling where a company paid $2 million in damages for infringing a similar herbal patent [3]. Opportunities exist, however, in collaborative ventures; partnering with the assignee of CN104428024 could provide access to its intellectual property, fostering innovations in personalized medicine or combination therapies.
Implications for Business Professionals
In the high-stakes world of pharmaceutical IP, CN104428024 offers both opportunities and pitfalls. Active voice drives home the point: Secure licensing early to mitigate risks, as delays could erode competitive advantages in China's fast-evolving market. Professionals should prioritize due diligence, using tools like CNIPA's online database to map out potential conflicts and identify collaboration prospects. This patent exemplifies how traditional knowledge can fuel modern business growth, urging executives to integrate IP strategy into their core operations.
Key Takeaways
- CN104428024 provides robust protection for a specific Salvia miltiorrhiza extraction method, emphasizing purity and efficacy enhancements.
- Its claims are precise but limited, focusing on process innovations that could influence licensing and enforcement strategies.
- The broader landscape features intense competition, with related patents potentially challenging its dominance.
- Businesses must conduct thorough analyses to avoid infringement while exploring partnerships for market expansion.
- Expiration in 2034 offers a window for long-term planning, but ongoing developments in herbal patents demand vigilance.
FAQs
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What makes CN104428024 significant in the pharmaceutical industry?
This patent introduces a refined extraction process for Salvia miltiorrhiza that improves compound purity, making it a benchmark for herbal drug development and potentially reducing development costs for new therapies.
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How can businesses check for potential infringement of this patent?
Companies should use CNIPA's patent search tools to compare their processes against CN104428024's claims, consulting IP experts to assess similarities and explore workarounds.
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Does this patent have international equivalents?
While CN104428024 is primarily a Chinese patent, its family includes abandoned applications in other jurisdictions, limiting global enforcement but highlighting export opportunities.
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What are the main challenges to enforcing this patent?
Enforcement may face hurdles due to the patent's process-specific claims and the prevalence of similar technologies, requiring strong evidence in CNIPA proceedings.
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How might this patent impact future R&D in traditional medicine?
It could inspire further innovations by setting a standard for extraction techniques, encouraging businesses to invest in complementary technologies while navigating IP constraints.
Sources
- China National Intellectual Property Administration (CNIPA). Patent database entry for CN104428024. Available at: https://www.cnipa.gov.cn
- Statista. Market size projections for traditional Chinese medicine, 2025 edition.
- CNIPA Annual Report. Case studies on patent infringement rulings, 2022.
- World Intellectual Property Organization (WIPO). Patent family search for CN104428024. Available at: https://www.wipo.int
