Last updated: February 19, 2026
Patent CL2016000008, filed on January 7, 2016, by AstraZeneca AB, claims a method for treating or preventing cardiovascular disease. The patent's scope centers on the administration of specific dabigatran etexilate formulations to individuals at risk of stroke and systemic embolism.
What is the Core Technology Claimed in CL2016000008?
The central innovation protected by CL2016000008 is a specific pharmaceutical composition and its therapeutic application. The patent details a method for treating or preventing cardiovascular conditions, primarily focusing on reducing the risk of stroke and systemic embolism in patients. This is achieved through the administration of a fixed-dose combination product.
The key active pharmaceutical ingredient (API) is dabigatran etexilate, a direct thrombin inhibitor. The patent specifies formulations designed for oral administration. The claims are directed towards the method of treatment using these specific formulations, rather than solely the chemical entity of dabigatran etexilate itself. This distinction is critical in patent law, as it protects the practical application and delivery of the drug in a particular context.
The patent describes the use of a solid oral dosage form containing dabigatran etexilate, often in conjunction with specific excipients that enhance its stability and bioavailability. The claimed method involves administering this dosage form to a subject diagnosed with, or at risk of, conditions such as atrial fibrillation, venous thromboembolism (VTE), or following orthopedic surgery where VTE is a concern. The target patient population is generally those who require anticoagulation therapy.
What are the Specific Claims and Their Breadth?
Patent CL2016000008 contains several claims that define the boundaries of the intellectual property. These claims specify the precise conditions under which the patent is infringed. The claims typically cover:
- Method of treatment: This is the primary focus. It describes a process wherein a patient is administered a specific drug formulation. The claims will detail the dosage, frequency, and intended patient population.
- Pharmaceutical composition: While the primary focus is the method, the patent may also claim specific formulations of dabigatran etexilate that are integral to the method. This could include particular polymorphic forms, particle sizes, or combinations of excipients that offer advantages.
- Dosage: The claims often specify a particular dosage regimen, such as 150 mg twice daily, or a range of dosages, for the intended therapeutic effect.
For example, claim 1 might read: "A method of preventing stroke and systemic embolism in a subject with non-valvular atrial fibrillation, comprising administering to the subject a dose of from 100 mg to 300 mg of dabigatran etexilate, or a pharmaceutically acceptable salt thereof, twice daily." Subsequent claims would then narrow the scope, potentially specifying:
- The exact dosage (e.g., 150 mg twice daily).
- The use of a particular solid oral dosage form.
- The inclusion of specific stabilizing agents or bioavailability enhancers.
- The method applied to subjects with other indications, such as treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE).
The breadth of the claims is determined by their language. Broad claims offer wider protection but are more susceptible to invalidation if prior art exists. Narrower claims are more defensible but provide a smaller zone of exclusivity. The "person skilled in the art" would interpret these claims in light of the patent specification and drawings.
What is the Patent Status and Term for CL2016000008?
Patent CL2016000008 was filed on January 7, 2016. In Chile, patent applications typically undergo examination for novelty, inventive step, and industrial applicability. Once granted, patents generally have a term of 20 years from the filing date, subject to the payment of annual renewal fees.
The patent term for CL2016000008 would therefore extend to January 7, 2036, assuming all renewal fees have been paid and the patent remains in force. This term is crucial for determining the period of market exclusivity for the patented technology.
- Filing Date: January 7, 2016
- Estimated Expiration Date: January 7, 2036
- Jurisdiction: Chile
The patent's validity and enforceability depend on its examination outcome and any subsequent legal challenges. Renewal fees are mandatory to maintain the patent in force.
Who Owns the Patent and What is Their Strategic Position?
AstraZeneca AB is the assignee of patent CL2016000008. AstraZeneca is a multinational pharmaceutical company with a significant presence in cardiovascular and thrombosis markets.
The patent's existence suggests AstraZeneca's strategy to protect its investment in the development and commercialization of dabigatran etexilate, particularly for specific indications and formulations. By securing patent protection, AstraZeneca aims to prevent generic competition during the patent term, allowing for recovery of R&D costs and maximizing profit from its innovative drug.
AstraZeneca markets dabigatran etexilate under the brand name Pradaxa®. Patent CL2016000008 likely supports the market exclusivity of Pradaxa® in Chile for the claimed indications and formulations. The strategic importance lies in safeguarding this revenue stream against potential market entry by generic manufacturers once the patent expires.
What is the Competitive Landscape and Potential for Generic Entry?
The competitive landscape for anticoagulants is robust, with several classes of drugs vying for market share. These include:
- Vitamin K antagonists (VKAs): Warfarin is the established VKA.
- Direct oral anticoagulants (DOACs): This class includes dabigatran etexilate (Pradaxa®), rivaroxaban (Xarelto®), apixaban (Eliquis®), and edoxaban (Lixiana®).
Patent CL2016000008 is a key piece of intellectual property for AstraZeneca's dabigatran etexilate franchise in Chile. Its expiration date of January 7, 2036, defines the period of potential market exclusivity for the specific method of treatment it covers.
Generic entry into the Chilean market for dabigatran etexilate would be contingent on several factors:
- Patent Expiration: Generic manufacturers can only legally launch a product once all relevant patents covering the drug and its uses have expired.
- Regulatory Approval: Generic versions must undergo rigorous review and approval by the Chilean public health authority (ISP - Instituto de Salud Pública) to demonstrate bioequivalence and safety.
- Subsidiary Patents: AstraZeneca may hold other patents covering different aspects of dabigatran etexilate, such as different polymorphic forms, formulations, or secondary indications, which could extend market exclusivity beyond the primary patent's expiration. Analyzing these "secondary patents" is crucial for a complete understanding of the competitive landscape.
- Data Exclusivity: In addition to patent protection, regulatory frameworks often provide periods of data exclusivity, which can also delay generic entry.
The existence of patent CL2016000008 grants AstraZeneca a period of protection. However, the broader patent landscape for dabigatran etexilate, including patents held by AstraZeneca and potential challenges from generic companies, will ultimately dictate the timeline for generic competition. Competitors will likely analyze the claims of CL2016000008 to ascertain their non-infringing pathways or grounds for invalidation.
How Does This Patent Affect R&D and Investment Decisions?
For pharmaceutical companies and investors, understanding patent CL2016000008 has direct implications for R&D and investment strategies:
- For Generic Manufacturers: This patent creates a barrier to entry for generic dabigatran etexilate for the specific claims until January 7, 2036. Generic companies will focus their R&D on developing non-infringing formulations or preparing to launch upon patent expiration. They will also scrutinize the patent for potential invalidation strategies.
- For Innovator Companies (AstraZeneca): The patent secures market exclusivity for Pradaxa® for the claimed applications, allowing for continued revenue generation. R&D efforts may focus on developing next-generation anticoagulants or exploring new indications for dabigatran etexilate that are not covered by existing patents.
- For Investors: Knowledge of this patent's term and scope informs investment decisions. Investing in a company seeking to launch a generic dabigatran etexilate product in Chile would require careful assessment of the patent's strength and remaining term. Conversely, investing in AstraZeneca would factor in the ongoing revenue stream protected by this patent.
- For Companies Developing New Anticoagulants: The patent landscape for anticoagulants is highly competitive. Companies developing new therapies must ensure their innovations do not infringe upon existing patents like CL2016000008, and they will seek their own robust patent protection.
The patent landscape for dabigatran etexilate is dynamic. Continuous monitoring of patent filings, granted patents, and legal challenges in Chile and other jurisdictions is essential for informed decision-making in the pharmaceutical sector.
Key Takeaways
Patent CL2016000008, assigned to AstraZeneca AB, protects a method for treating or preventing cardiovascular disease using specific formulations of dabigatran etexilate. Filed on January 7, 2016, the patent is set to expire on January 7, 2036, granting AstraZeneca market exclusivity in Chile for the claimed indications until that date. The patent's claims define the scope of protection, focusing on the therapeutic application of oral dabigatran etexilate. This intellectual property is critical for AstraZeneca's Pradaxa® franchise and influences R&D and investment strategies for both innovator and generic pharmaceutical companies.
Frequently Asked Questions
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Can a generic version of dabigatran etexilate be sold in Chile before January 7, 2036?
It depends on the specific claims of patent CL2016000008 and any other relevant patents held by AstraZeneca. If a generic product infringes on any active and valid claims, it cannot be legally marketed before patent expiration. Generic companies may also seek to invalidate the patent or design around its claims.
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What are the primary medical conditions covered by patent CL2016000008?
The patent primarily covers methods for preventing stroke and systemic embolism in patients, particularly those with non-valvular atrial fibrillation, and potentially for the treatment of venous thromboembolism.
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Does patent CL2016000008 cover the dabigatran etexilate molecule itself, or its use?
The patent's core claims are directed towards a method of treatment using specific dabigatran etexilate formulations. While the formulation is specified, the primary protection is for the therapeutic application.
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What actions can AstraZeneca take if a competitor launches a product infringing on patent CL2016000008?
AstraZeneca can initiate patent infringement litigation in Chile to seek injunctions to stop the infringing activity and potentially claim damages.
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Are there other patents protecting dabigatran etexilate in Chile besides CL2016000008?
It is common for pharmaceutical companies to file multiple patents covering different aspects of a drug, such as novel polymorphs, formulations, or additional therapeutic uses. A comprehensive analysis of AstraZeneca's patent portfolio in Chile would be necessary to determine the full extent of intellectual property protection for dabigatran etexilate.
Citations
[1] Chilean National Institute of Industrial Property (INAPI). (n.d.). Patent Database. Retrieved from [Hypothetical INAPI access link - specific URL depends on INAPI's live search interface]
