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Patent landscape, scope, and claims: |
Analyzing the Scope and Claims of United States Patent 6,828,339
Introduction
United States Patent 6,828,339, issued on December 7, 2004, is a significant patent in the pharmaceutical industry, particularly related to the drug Amlodipine Besylate. This patent, owned by Synthon Pharmaceuticals Inc., has undergone various stages of its lifecycle, including expiration. Here, we will delve into the details of its scope, claims, and the broader patent landscape.
Patent Overview
Patent Number and Issue Date
- The patent number is US6,828,339, and it was issued on December 7, 2004[4].
Patent Expiration
- The patent has expired, with the critical expiration date being January 7, 2013[4].
Scope of the Patent
Drug and Active Ingredient
- The patent pertains to Amlodipine Besylate, a calcium channel blocker used to treat high blood pressure and coronary artery disease. The scope includes the drug substance (active ingredient) and its formulation or composition[1].
Claims and Inventions
- The patent claims cover specific aspects of Amlodipine Besylate, including its chemical composition, formulation, and possibly methods of use. These claims are crucial for understanding what is protected under the patent and what would constitute infringement[3].
Patent Claims Analysis
Claim Types
- The patent includes claims that are categorized into drug substance patents, drug product patents, and possibly method of use patents. These claims are essential for defining the scope of protection and exclusivity[1].
Claim Specificity
- Each claim must be novel, non-obvious, and adequately described and disclosed so that another person skilled in the art can make and use the claimed invention. This ensures that the patent claims are clear, reducing ambiguity and strengthening their enforceability[1][3].
Patent Landscape
Prior Art and Patentability Search
- A thorough patentability search would have been conducted to ensure that the invention was novel and non-obvious over the prior art. This search involves analyzing existing technologies and inventions to articulate how the new invention differs and advances the state of the art[3].
Competitive Landscape
- Understanding the competitive landscape is crucial. This involves identifying other patents held by key companies or individuals in the relevant field to uncover related technologies and potential design-arounds by competitors[3].
Follow-On Patents and Exclusivity
Follow-On Innovations
- Even after the initial patent issuance, companies may file follow-on patent applications for improvements such as new dosage forms, routes of administration, or expanded uses of the active ingredient. These follow-on patents can extend market exclusivity beyond the expiration of the earlier patent[1].
Market Exclusivity
- The market exclusivity period for drugs like Amlodipine Besylate can vary, but it is generally influenced by the timing of generic competition and the expiration of listed patents in the Orange Book. For Amlodipine Besylate, the exclusivity period has expired, allowing generic versions to enter the market[1][4].
Enforcement and Licensing
Enforcement Readiness
- A thorough patentability search ensures that the patent claims are well-supported and defensible, strengthening the patent holder’s position in legal actions. Even though the patent has expired, understanding the historical context of its enforcement is crucial for similar patents[3].
Licensing Strategies
- Knowing the patent landscape allows patent holders to identify potential licensees and negotiate favorable terms. Although the patent has expired, the strategies used during its active period can inform future licensing negotiations for related patents[3].
Practical Implications
Generic Competition
- With the expiration of the patent, generic versions of Amlodipine Besylate can now be manufactured and sold, increasing competition in the market. This competition can drive down prices and improve patient access to the medication[4].
Innovation Cycle
- The expiration of a patent like US6,828,339 marks the end of one cycle of innovation but also opens opportunities for new innovations and improvements in the drug or its delivery methods. Companies may continue to innovate and file new patents to maintain market leadership[1].
Key Takeaways
- Patent Scope and Claims: The patent covers specific aspects of Amlodipine Besylate, including its composition and formulation.
- Patent Expiration: The patent has expired, allowing generic competition.
- Follow-On Patents: Companies can file follow-on patents to extend market exclusivity.
- Enforcement and Licensing: A thorough patentability search is crucial for enforcement and licensing strategies.
- Market Impact: Patent expiration increases competition and can improve patient access to medications.
FAQs
Q: What is the significance of United States Patent 6,828,339?
- This patent is significant because it protected Amlodipine Besylate, a widely used medication for high blood pressure and coronary artery disease.
Q: What type of claims does the patent include?
- The patent includes claims related to the drug substance, drug product, and possibly methods of use.
Q: Why is a thorough patentability search important?
- A thorough patentability search ensures that the invention is novel and non-obvious, and it helps in crafting precise and well-defined patent claims.
Q: What happens when a patent like US6,828,339 expires?
- When the patent expires, generic versions of the drug can be manufactured and sold, increasing competition and potentially reducing prices.
Q: Can companies extend market exclusivity beyond the initial patent expiration?
- Yes, companies can file follow-on patents for improvements to extend market exclusivity beyond the expiration of the earlier patent.
Sources
- USPTO-FDA Report on Drug Patent and Exclusivity - USPTO
- US-7279492-B2 - Unified Patents Portal
- Understanding Patentability Searches: Importance, Process, and Best Practices - TT Consultants
- Amlodipine Besylate patent expiration - Pharsight
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