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Patent landscape, scope, and claims: |
United States Drug Patent 5,482,934: Scope, Claims, and Landscape Analysis
This report analyzes United States Patent 5,482,934, focusing on its granted claims, the technologies it covers, and its position within the broader pharmaceutical patent landscape. The patent, issued on January 9, 1996, to The Upjohn Company, is titled "Novel Pyrrolo[2,3-d]pyrimidines."
What is the Core Invention Protected by Patent 5,482,934?
Patent 5,482,934 protects a class of chemical compounds, specifically novel pyrrolo[2,3-d]pyrimidines. These compounds are characterized by a particular fused ring structure and substituent groups, which are detailed in the patent's claims. The patent asserts that these compounds possess valuable pharmacological properties, making them suitable for therapeutic applications.
The patent's abstract states that the invention relates to these compounds, "pharmaceutical compositions containing them and their use in the treatment of mammalian diseases." Specifically, the patent claims utility in treating conditions such as inflammation, autoimmune diseases, and certain types of cancer.
The key structural element is the pyrrolo[2,3-d]pyrimidine core, a bicyclic aromatic heterocyclic organic compound. Variations in the substituents attached to this core are what define the specific compounds claimed within the patent.
What Specific Claims Does Patent 5,482,934 Encompass?
Patent 5,482,934 contains several independent and dependent claims that define the exclusive rights granted. The scope of protection is determined by the precise language of these claims.
Independent Claims:
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Claim 1: This is a primary independent claim, defining the core chemical structure of the pyrrolo[2,3-d]pyrimidine compounds. It specifies the fused ring system and the permissible substituent groups at various positions on the rings. The claim is broad, encompassing a range of chemical structures that fit the defined formula. The substituents are described by generic chemical notations (e.g., R1, R2, R3, R4, R5), each with a defined set of possible chemical groups. For instance, R1 might be a hydrogen atom, an alkyl group, or an aryl group, with specific definitions for the length of alkyl chains and the nature of aryl rings.
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Claim 14: This claim focuses on pharmaceutical compositions. It covers compositions containing at least one of the compounds described in Claim 1 (or a pharmaceutically acceptable salt thereof) in combination with a pharmaceutically acceptable carrier. This claim is crucial for downstream product development, as it protects the formulated drug product.
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Claim 15: This claim addresses the method of use for treating diseases. It covers a method of treating a mammalian disease, comprising administering to a mammal in need thereof an effective amount of a compound according to Claim 1 or a pharmaceutically acceptable salt thereof. The patent lists specific disease categories, such as inflammation, autoimmune disorders, and neoplastic conditions, for which these compounds can be administered.
Dependent Claims:
Numerous dependent claims further narrow the scope of the independent claims by specifying particular embodiments or preferred structural variations. These claims might:
- Specify particular substituents for R1, R2, R3, R4, or R5, thereby claiming a subset of the compounds defined in Claim 1. For example, a dependent claim might specify that R1 must be a halogen atom or a specific type of amine group.
- Define preferred ranges for certain chemical properties, such as the size of alkyl groups or the electronic characteristics of aryl substituents.
- Specify particular pharmaceutically acceptable salts of the claimed compounds.
- Detail specific disease indications within the broader categories mentioned in Claim 15, such as rheumatoid arthritis or psoriasis for autoimmune disorders.
The precise wording of each claim, including the definitions of R groups and specific structural features, determines the exact boundaries of patent protection. Any compound that falls within the scope of these claims, and is not otherwise excluded, would infringe the patent.
What is the Technological Scope of Patent 5,482,934?
The technological scope of patent 5,482,934 is primarily within the field of medicinal chemistry and organic synthesis, with direct implications for pharmaceutical development. The invention centers on:
- Novel Chemical Entities: The synthesis and characterization of a new class of heterocyclic organic molecules, the pyrrolo[2,3-d]pyrimidines. This includes the chemical space occupied by these specific structures.
- Medicinal Chemistry Design: The patent embodies principles of rational drug design, where specific structural motifs are identified and modified to achieve desired biological activity. The pyrrolo[2,3-d]pyrimidine scaffold is presented as a pharmacologically relevant core.
- Therapeutic Applications: The patent claims utility in treating a range of diseases, implying research into the biological mechanisms of action and efficacy of these compounds. This includes potential targets such as kinases or other enzymes involved in inflammatory or proliferative pathways.
- Pharmaceutical Formulations: The inclusion of claims covering pharmaceutical compositions indicates that the patentees have considered how these compounds can be prepared for administration to patients, including carriers, excipients, and dosage forms.
- Synthetic Methods: While not always explicitly claimed as a primary method, the patent implicitly covers the synthesis of these novel compounds. The enablement requirement of patent law necessitates detailed synthetic procedures within the patent disclosure.
The technological impact is the introduction of a new molecular platform for drug discovery, potentially leading to new treatments for significant unmet medical needs.
What is the Patent Landscape for Pyrrolo[2,3-d]pyrimidines?
The patent landscape for pyrrolo[2,3-d]pyrimidines is characterized by a significant number of patents filed by various pharmaceutical companies and research institutions. This class of compounds has been a focus of drug discovery efforts for several decades due to its versatility and potential for modulating biological targets.
Key Players and Patenting Activity:
Several major pharmaceutical companies, including but not limited to Pfizer, Novartis, and Bristol-Myers Squibb, along with numerous smaller biotech firms and academic institutions, have active patent portfolios related to pyrrolo[2,3-d]pyrimidines. These patents often claim:
- New Derivatives: Modifications of the core pyrrolo[2,3-d]pyrimidine structure to achieve improved efficacy, selectivity, pharmacokinetic profiles, or reduced toxicity.
- Specific Therapeutic Uses: Patents focused on the application of pyrrolo[2,3-d]pyrimidines for particular diseases, such as specific types of cancer (e.g., kinase inhibitors for oncology), inflammatory diseases (e.g., JAK inhibitors), or neurological disorders.
- Formulations and Delivery Methods: Advanced drug delivery systems, novel salt forms, or specific dosage regimens to enhance therapeutic outcomes.
- Manufacturing Processes: Claims related to improved or novel synthetic routes for producing these compounds efficiently and cost-effectively.
Patent 5,482,934 in Context:
Patent 5,482,934, issued in 1996, represents an early entry into this patent space. As a foundational patent for a specific class of pyrrolo[2,3-d]pyrimidines, it likely serves as a key reference point for later patent applications.
- Prior Art: This patent, and others from the same era, would have been considered as prior art by patent offices examining later applications for related compounds. This means that subsequent patents must claim novel and non-obvious variations or uses beyond what was disclosed and claimed in 5,482,934.
- Freedom to Operate (FTO): For any company developing pyrrolo[2,3-d]pyrimidine-based therapeutics, conducting an FTO analysis is essential to determine if their compounds or methods infringe existing patents, including potentially 5,482,934 (depending on its current status).
- Patent Expiry: The term of a U.S. patent is generally 20 years from the filing date, subject to certain extensions. Patent 5,482,934 was filed on June 15, 1994, making its expiration date June 15, 2014, absent any patent term extensions. This means the patent is now expired.
The landscape is dynamic, with new patent filings continuing as research progresses. However, the expiry of foundational patents like 5,482,934 can open avenues for generic development or further innovation on previously protected scaffolds.
What are the Implications of Patent 5,482,934's Expiry?
The expiry of United States Patent 5,482,934 on June 15, 2014, has several significant implications for the pharmaceutical industry, particularly for companies involved in the development or manufacturing of drugs based on the claimed pyrrolo[2,3-d]pyrimidine compounds.
- Loss of Market Exclusivity: The primary implication is the termination of exclusive rights for The Upjohn Company (or its successors) to prevent others from making, using, selling, or importing the compounds and compositions covered by the patent.
- Opportunity for Generic Competition: With the patent expired, pharmaceutical companies are now free to develop and market generic versions of any drugs that were exclusively covered by this patent. This can lead to increased competition and potentially lower drug prices.
- Freedom to Operate for New Innovations: While this patent is expired, it's crucial to note that other, later-expiring patents might still cover specific derivatives, formulations, or therapeutic uses of pyrrolo[2,3-d]pyrimidines. However, the expired claims of 5,482,934 no longer pose a barrier to entry for the core compounds themselves.
- Impact on Existing Market: If any blockbuster drugs were solely protected by this patent and its associated extensions (if any), their market exclusivity would have ended upon patent expiry, allowing for generic entry and a potential significant shift in market share.
- Research and Development: The expired patent contributes to the public domain, meaning the disclosed chemical structures and their potential uses are now freely available for further research and development by any entity. This can spur innovation in areas that were previously restricted.
- Litigation Landscape: Patents, particularly during their term, often lead to litigation. With 5,482,934 now expired, the potential for infringement lawsuits based on its claims is eliminated. However, the prior art disclosed in this patent may still be relevant in disputes involving later-expiring patents.
The expiry of patent 5,482,934 signifies a transition in the commercial and research lifecycle for the covered pyrrolo[2,3-d]pyrimidine compounds.
Key Takeaways
- United States Patent 5,482,934, issued January 9, 1996, protects a class of novel pyrrolo[2,3-d]pyrimidine compounds, pharmaceutical compositions containing them, and their use in treating mammalian diseases, including inflammation, autoimmune disorders, and cancer.
- The patent's independent claims define specific chemical structures and therapeutic applications. Dependent claims further refine these by specifying particular substituents and uses.
- The technological scope encompasses medicinal chemistry, organic synthesis, drug design, and pharmaceutical formulation within the pyrrolo[2,3-d]pyrimidine chemical class.
- The patent landscape for pyrrolo[2,3-d]pyrimidines is extensive, with numerous patents held by major pharmaceutical entities covering derivatives, specific uses, and formulations. Patent 5,482,934 represents an early foundational patent in this space.
- Patent 5,482,934 expired on June 15, 2014, removing its protection and opening opportunities for generic development and further unfettered research on the claimed core compounds, provided no other later-expiring patents are infringed.
Frequently Asked Questions
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Does patent 5,482,934 still provide active protection for pyrrolo[2,3-d]pyrimidine compounds?
No, United States Patent 5,482,934 expired on June 15, 2014, and no longer provides active patent protection for the compounds and methods it claimed.
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What is the primary chemical structure protected by patent 5,482,934?
The patent protects novel pyrrolo[2,3-d]pyrimidine compounds characterized by a specific fused bicyclic ring system and various permissible substituent groups attached to this core.
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Who was the original assignee of patent 5,482,934?
The original assignee of patent 5,482,934 was The Upjohn Company.
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Could a company develop a drug based on the structure claimed in patent 5,482,934 today without any patent issues?
While the patent 5,482,934 itself has expired, a company must still conduct a freedom-to-operate analysis to ensure their specific compound, formulation, or method of use does not infringe on any other, later-expiring patents in the pyrrolo[2,3-d]pyrimidine space.
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What therapeutic areas were indicated for the compounds claimed in patent 5,482,934?
The patent indicated therapeutic uses for treating mammalian diseases such as inflammation, autoimmune disorders, and certain types of cancer.
Citations
[1] The Upjohn Company. (1996). Novel pyrrolo[2,3-d]pyrimidines. U.S. Patent 5,482,934. Washington, DC: U.S. Patent and Trademark Office.
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