Last updated: February 19, 2026
This report analyzes China drug patent CN100593419, focusing on its scope, specific claims, and the surrounding patent landscape. The patent, filed on June 28, 2002, and granted on January 28, 2009, is assigned to Shandong Xinhua Pharmaceutical Co., Ltd. It pertains to a specific compound and its pharmaceutical composition, with potential applications in treating cardiovascular diseases.
What is the Primary Focus of Patent CN100593419?
The core of patent CN100593419 lies in a novel chemical compound, identified by its chemical name, and pharmaceutical compositions containing this compound. The patent describes the preparation and therapeutic utility of this compound, primarily for its effects on the cardiovascular system.
What are the Key Claims within Patent CN100593419?
The patent's claims define the exclusive rights granted to the assignee. CN100593419 includes a series of claims covering the compound itself, its preparation, and its medicinal applications.
Claim 1: The Compound
Claim 1 defines the specific chemical entity that is the subject of the patent. The patent literature identifies this compound as 7-(2-hydroxy-3-isopropylamino-propoxy)-3,4-dihydro-1(2H)-isoquinolinone. This claim establishes the foundational intellectual property for the molecule.
Claim 2: Pharmaceutical Compositions
Claim 2 extends the patent protection to pharmaceutical compositions that include the compound defined in Claim 1, along with pharmaceutically acceptable excipients. This broadens the protection to the formulated drug product, encompassing various dosage forms like tablets, capsules, or injections. The specific excipients are not detailed in the primary claim but are understood to be inert substances that facilitate drug delivery and stability.
Claim 3: Method of Preparation
Claim 3 covers the method of preparing the compound claimed in Claim 1. This claim protects the specific synthetic route or process developed by the assignee to produce the active pharmaceutical ingredient (API). This can be crucial in preventing competitors from using the same efficient or cost-effective manufacturing method.
Claim 4: Therapeutic Use
Claim 4 asserts the patent holder's exclusive right to use the compound for the treatment of specific diseases. In CN100593419, this therapeutic use is explicitly stated as the treatment of cardiovascular diseases. This claim is vital as it covers the application of the compound for medical purposes, irrespective of the exact formulation or preparation method.
Claim 5: Specific Disease Treatment
Claim 5 further refines the therapeutic application by specifying the treatment of hypertension. This narrower claim provides protection for a more targeted indication within the broader category of cardiovascular diseases, allowing for specific indications to be individually protected.
What is the Scope of Protection Afforded by the Patent?
The scope of patent CN100593419 encompasses the chemical structure of the novel compound, its synthesis, pharmaceutical formulations containing it, and its therapeutic application, particularly for cardiovascular conditions like hypertension. The patent grants the assignee exclusive rights to make, use, sell, and import the claimed invention within China during its term.
What are the Implications of the Patent's Filing and Grant Dates?
The patent was filed on June 28, 2002, and granted on January 28, 2009. Under Chinese patent law, the term of a utility patent is 20 years from the filing date. Therefore, the effective term of patent CN100593419 is from June 28, 2002, to June 27, 2022. This means the patent has expired and is no longer in force.
What is the Chemical Structure of the Patented Compound?
The patented compound is 7-(2-hydroxy-3-isopropylamino-propoxy)-3,4-dihydro-1(2H)-isoquinolinone. This chemical nomenclature describes a molecule with a dihydroisoquinolinone core substituted at the 7-position with a complex propoxy chain featuring a hydroxyl group and an isopropylamino group.
What are the Identified Therapeutic Applications?
The patent explicitly identifies the treatment of cardiovascular diseases as the primary therapeutic application. A more specific indication within this category is the treatment of hypertension. These applications suggest the compound acts on mechanisms regulating blood pressure or cardiac function.
Who is the Assignee of Record?
The assignee of patent CN100593419 is Shandong Xinhua Pharmaceutical Co., Ltd. This entity is a significant pharmaceutical manufacturer in China, known for its production of active pharmaceutical ingredients and finished dosage forms.
What is the Patent Landscape Surrounding CN100593419?
Analyzing the patent landscape for this compound and its therapeutic area requires examining patents filed before, during, and after CN100593419's active term. While CN100593419 has expired, the broader landscape includes potential follow-on patents, process patents, and patents for related compounds or alternative treatments for cardiovascular diseases.
Key Areas of Patent Activity for Cardiovascular Drugs in China:
- Novel Chemical Entities (NCEs): Patents claiming new molecular structures with cardiovascular activity.
- Polymorphs and Salts: Patents protecting specific crystalline forms or salt forms of existing drugs, which can offer improved bioavailability or stability.
- Formulations and Drug Delivery Systems: Patents covering novel ways to deliver cardiovascular drugs, such as extended-release formulations or combination therapies.
- Manufacturing Processes: Patents protecting efficient, cost-effective, or environmentally friendly methods for synthesizing cardiovascular APIs.
- New Medical Uses: Patents claiming the use of known compounds for treating new cardiovascular conditions or patient populations.
Given that CN100593419 has expired, any competitive landscape analysis would focus on:
- Generic Competition: The potential for other companies to manufacture and sell the compound now that patent protection has lapsed.
- Evergreening Strategies: Shandong Xinhua Pharmaceutical Co., Ltd. might have filed or could file subsequent patents on improved formulations, new indications, or manufacturing processes for the same compound to extend market exclusivity.
- Competing NCEs: The development and patenting of structurally different compounds that target the same or similar pathways for treating cardiovascular diseases.
A comprehensive landscape analysis would involve searching patent databases for patents filed by Shandong Xinhua Pharmaceutical Co., Ltd. and its competitors relating to isoquinolinone derivatives, beta-blockers, or other antihypertensive agents. Specific search terms would include the chemical name of the compound, its CAS number (if available), and keywords related to cardiovascular diseases and hypertension.
What is the Status of the Patent?
Patent CN100593419 was granted on January 28, 2009, and expired on June 27, 2022. It is no longer in force.
What are the Potential Business Implications of this Patent and its Expiry?
The expiry of patent CN100593419 opens the market to generic competition. Shandong Xinhua Pharmaceutical Co., Ltd. loses its exclusive rights to manufacture, sell, and import the patented compound and its associated pharmaceutical compositions in China.
- Generic Manufacturers: Companies specializing in generic drug production can now seek regulatory approval to market their versions of the drug, provided they can demonstrate bioequivalence and meet other regulatory requirements. This typically leads to a significant decrease in drug prices.
- Shandong Xinhua Pharmaceutical Co., Ltd.: The company will likely face reduced market share and revenue for this specific product. Its strategy may shift to other pipeline drugs, life cycle management of existing products through new indications or formulations (if still patentable), or focusing on manufacturing the API for generic players.
- Healthcare Providers and Patients: The availability of generics should lead to lower treatment costs for cardiovascular diseases, improving access to medication.
The patent's expiry marks a transition from a period of market exclusivity for the innovator to a competitive generic market.
Key Takeaways
- Patent CN100593419, assigned to Shandong Xinhua Pharmaceutical Co., Ltd., protected the compound 7-(2-hydroxy-3-isopropylamino-propoxy)-3,4-dihydro-1(2H)-isoquinolinone and its pharmaceutical compositions for treating cardiovascular diseases, specifically hypertension.
- The patent was filed on June 28, 2002, and granted on January 28, 2009, with an expiry date of June 27, 2022.
- The patent is no longer in force, meaning its exclusive rights have lapsed.
- The expiry of the patent permits generic manufacturers to enter the market, likely leading to increased competition and reduced drug pricing.
- Shandong Xinhua Pharmaceutical Co., Ltd. will experience a shift from market exclusivity to a competitive environment for the patented compound.
Frequently Asked Questions
1. Can Shandong Xinhua Pharmaceutical Co., Ltd. still enforce patent CN100593419?
No, patent CN100593419 expired on June 27, 2022. Its exclusive rights are no longer enforceable.
2. What does "pharmaceutically acceptable excipients" mean in the context of Claim 2?
Pharmaceutically acceptable excipients are inactive ingredients that are safely incorporated into a drug formulation to aid in its manufacturing, delivery, stability, and patient acceptance. Examples include binders, fillers, disintegrants, and coatings.
3. Are there any related patents still in force that might affect generic entry?
A thorough patent landscape search would be required to determine if Shandong Xinhua Pharmaceutical Co., Ltd. or other entities hold any valid patents on alternative forms, improved formulations, or new indications of the compound that could impact generic market entry. However, the core compound and its original use are no longer protected.
4. What are the typical steps for a generic manufacturer to bring a product to market after patent expiry?
A generic manufacturer must file an Abbreviated New Drug Application (ANDA) or equivalent with the relevant regulatory authority. This typically involves demonstrating bioequivalence to the reference listed drug and ensuring manufacturing processes meet quality standards.
5. What is the significance of the patent covering the "method of preparation" (Claim 3)?
Claim 3 protected the specific process used to synthesize the active pharmaceutical ingredient. Competitors would need to develop their own non-infringing synthetic routes to produce the compound if this claim were still active and held by the assignee. Now that the patent has expired, this claim is also expired.
Citations
[1] Shandong Xinhua Pharmaceutical Co., Ltd. (2009). China Drug Patent CN100593419. The State Intellectual Property Office of the People's Republic of China.
[2] Chinese Patent Law. (n.d.). Retrieved from Official website of the China National Intellectual Property Administration.
