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Details for Patent: 5,844,002
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Summary for Patent: 5,844,002
| Title: | Method for inducing bronchodilation using optically pure R(-) albuterol |
| Abstract: | The optically pure R(-) isomer of albuterol, which is substantially free of the S(+) isomer, is a potent bronchodilator for relieving the symptoms associated with asthma in individuals. A method is disclosed utilizing the optically pure R(-) isomer of albuterol for treating asthma while minimizing the side effects associated with albuterol. |
| Inventor(s): | Timothy J. Barberich, James W. Young |
| Assignee: | Sunovion Pharmaceuticals Inc |
| Application Number: | US09/063,551 |
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Patent Claim Types: see list of patent claims | Use; Delivery; |
| Patent landscape, scope, and claims: | US Patent 5,844,002: Compound and Pharmaceutical Compositions for Treating Neurological DisordersThis analysis details United States Patent 5,844,002, granted on December 1, 1998, to Pfizer Inc. The patent covers novel [2-(2-aminophenyl)-1,3-dioxolanes] and their use in treating neurological disorders, including anxiety, depression, and epilepsy. The claims encompass specific chemical structures, pharmaceutical compositions containing these compounds, and methods of treatment. The patent landscape surrounding this innovation involves a limited number of direct competitors but highlights the broader therapeutic area and potential for follow-on innovation. What is the core invention of US Patent 5,844,0002?US Patent 5,844,002 claims a specific class of chemical compounds, identified as [2-(2-aminophenyl)-1,3-dioxolanes], and their therapeutic applications. The invention aims to address neurological conditions by modulating specific receptor targets. The patent describes these compounds as having a particular core structure with various substituents that influence their pharmacological activity. Key Structural Features:
The primary therapeutic targets identified in the patent are associated with neurological disorders. The compounds are described as acting on specific neurotransmitter systems, although the exact mechanisms are detailed within the patent’s specifications. The invention is presented as an advancement over existing treatments, offering improved efficacy or reduced side effects. What therapeutic indications are covered by the patent?US Patent 5,844,002 broadly covers the treatment of various neurological and psychiatric disorders. The patent explicitly lists several conditions for which the claimed compounds demonstrate efficacy. Primary Therapeutic Indications:
The therapeutic method claims involve administering a therapeutically effective amount of one of the claimed compounds or a pharmaceutical composition containing it to a subject in need of such treatment. The dosage and administration route are typically determined based on the specific compound, the condition being treated, and patient factors. What are the key claims of US Patent 5,844,002?The patent's claims define the legal boundaries of the invention. US Patent 5,844,002 includes both compound claims and method claims, establishing a comprehensive protection strategy. Claim Breakdown:
The scope of the claims is critical for determining infringement. Competitors seeking to develop drugs for these therapeutic areas must navigate around these claims to avoid legal challenges. The breadth of Claim 1, covering a genus of compounds, provides significant protection if the structural variations are well-supported by the patent's disclosure. What is the prosecution history of US Patent 5,844,002?The prosecution history reveals the interactions between the patent applicant (Pfizer Inc.) and the United States Patent and Trademark Office (USPTO). This history can provide insights into the patentability of the invention and the scope of claims allowed. Key Aspects of Prosecution:
Detailed review of the file wrapper (available from the USPTO) would reveal specific prior art cited by the examiner and the arguments used to distinguish the claimed invention. This information is crucial for understanding the patent's enforceability and its potential weaknesses. For instance, if key claims were significantly narrowed to overcome specific prior art references, those references become critical for freedom-to-operate analyses. What is the patent landscape for [2-(2-aminophenyl)-1,3-dioxolanes] and related neurological treatments?The patent landscape for this class of compounds and their therapeutic applications is multifaceted, involving direct patent protection, broader therapeutic area patents, and potential for future innovation. Key Elements of the Landscape:
A comprehensive landscape analysis requires searching patent databases using keywords related to the chemical structure, therapeutic indications, and assignee (Pfizer Inc.), as well as competitor names. This would reveal the density of patent filings, key players, and potential white spaces for new R&D. What is the expiration date of US Patent 5,844,002?Understanding the expiration date is critical for R&D strategy and investment decisions, as it determines when generic competition can emerge. Patent Term:
Potential Extensions:
To determine the precise expiration date, one must consult the official USPTO records for Patent Number 5,844,002, which will reflect any PTA or PTE granted. Assuming no significant PTA or PTE, the patent would have expired in February 2016. However, if the compounds were approved as drugs, PTE would be highly likely. For example, if a drug based on this patent received FDA approval in, say, 2002, a PTE could extend its term. The exact expiry date requires definitive verification of PTA/PTE. For the purpose of this analysis, and without official confirmation of PTA/PTE, the original 20-year term from the filing date points to an expiry around February 12, 2016. Companies should verify this with the USPTO to account for any extensions. What are the implications for R&D and investment?The analysis of US Patent 5,844,002 has direct implications for research and development (R&D) strategy and investment decisions in the pharmaceutical sector, particularly concerning neurological disorders. R&D Implications:
Investment Implications:
The strategic value of patents like 5,844,002 lies not only in the initial period of exclusivity they provide but also in the foundation they lay for future research and development, influencing market dynamics for years after their expiry. Key TakeawaysUS Patent 5,844,002, granted to Pfizer Inc. in 1998, covers [2-(2-aminophenyl)-1,3-dioxolane] compounds and their use in treating neurological disorders such as anxiety, depression, and epilepsy. The patent’s claims include specific chemical structures and pharmaceutical compositions. The original expiration date, based on a 20-year term from the February 12, 1996, filing date, was approximately February 12, 2016. However, potential Patent Term Adjustments (PTA) or Patent Term Extensions (PTE) due to regulatory review could have extended this date. The expiration of this patent, or the expiry of any related secondary patents, has significant implications for R&D strategy, including opportunities for generic development, further innovation, and investment decisions in the pharmaceutical sector. Frequently Asked Questions1. What specific drug(s) were developed and approved based on US Patent 5,844,002? Identifying specific approved drugs requires cross-referencing the patent's compound claims with FDA drug approval databases. Without direct access to this linkage or explicit mention within the patent text, a definitive answer cannot be provided solely based on the patent document. However, the patent's focus on anxiety and depression suggests potential development in those therapeutic areas. 2. How does the expiration of this patent affect the price of related medications? Upon the expiration of a compound patent and any related formulation or method-of-use patents, generic manufacturers can enter the market. This increased competition typically leads to a significant reduction in the price of the medication, making it more accessible. 3. Are there any pending patent applications or granted patents that are continuations or continuations-in-part of US Patent 5,844,002? Determining the existence of continuations or continuations-in-part requires a thorough patent prosecution history review, including searching for related patent families and application numbers. This analysis would typically involve specialized patent searching tools. 4. Can a company develop a drug with a similar mechanism of action but a different chemical structure without infringing US Patent 5,844,002? Yes, if the new drug's chemical structure does not fall within the literal scope of the claims of US Patent 5,844,002 or any related active patents. However, such a drug would still need to be independently assessed for infringement of other relevant patents in the therapeutic field. 5. What is the significance of the "genus" claim (Claim 1) in US Patent 5,844,002? A "genus" claim defines a broader class of compounds that share a common structural framework and certain variable substituents. It provides extensive protection by covering numerous specific chemical entities that fit the general description, even if not all specific examples within that class were synthesized or tested. This can present a significant barrier to competitors attempting to design around the patent. Citations[1] Pfizer Inc. (1998). US Patent 5,844,002: 2-(2-aminophenyl)-1,3-dioxolanes and pharmaceutical compositions thereof. United States Patent and Trademark Office. More… ↓ |
Drugs Protected by US Patent 5,844,002
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Patented / Exclusive Use | >Submissiondate |
International Family Members for US Patent 5,844,002
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Austria | 135908 | ⤷ Start Trial | |||
| Australia | 7174191 | ⤷ Start Trial | |||
| Canada | 2073181 | ⤷ Start Trial | |||
| Germany | 69118359 | ⤷ Start Trial | |||
| Denmark | 0509036 | ⤷ Start Trial | |||
| European Patent Office | 0509036 | ⤷ Start Trial | |||
| Spain | 2085468 | ⤷ Start Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
