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Last Updated: March 26, 2026

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
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 Disorders

This 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:

  • Core Scaffold: A 2-(2-aminophenyl)-1,3-dioxolane moiety.
  • Substituents: The patent outlines allowable variations at several positions on the phenyl ring and the dioxolane ring. These variations are crucial for achieving desired therapeutic effects and pharmacokinetic properties.
  • Specific Examples: The patent provides numerous specific chemical examples (e.g., Examples 1-25) that fall within the claimed scope, illustrating the breadth of the invention.

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:

  • Anxiety Disorders: Including generalized anxiety disorder, panic disorder, and social anxiety disorder.
  • Depression: Major depressive disorder and other depressive conditions.
  • Epilepsy: Various seizure disorders.
  • Other Neurological Conditions: The patent also suggests potential utility in conditions such as insomnia and pain, although these are often framed as secondary or related to the primary neurological targets.

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:

  • Claim 1 (Compound): This is the primary compound claim, defining the core chemical structure of the [2-(2-aminophenyl)-1,3-dioxolanes]. It specifies the phenyl ring, the dioxolane ring, and the positions where substituents can be attached, along with the types of substituents allowed. This claim is broad, encompassing a genus of related compounds.
  • Claims 2-10 (Specific Compounds): These claims refer back to Claim 1 and enumerate specific, concretely defined chemical compounds that are exemplified within the patent. These are typically more narrowly defined than the genus claim.
  • Claim 11 (Pharmaceutical Composition): This claim covers a pharmaceutical composition comprising a compound claimed in any of claims 1-10, along with a pharmaceutically acceptable carrier, diluent, or excipient. This protects the formulated drug product.
  • Claims 12-16 (Method of Treatment): These claims cover methods of treating neurological disorders, including anxiety, depression, and epilepsy. The method involves administering a therapeutically effective amount of a compound described in the preceding claims.

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:

  • Filing Date: Application filed on February 12, 1996.
  • Grant Date: Patent granted on December 1, 1998.
  • Office Actions: The prosecution likely involved one or more Office Actions from the USPTO examiner, detailing rejections or objections to the initial claims.
  • Applicant Responses: Pfizer Inc. would have responded to these actions by amending claims, providing arguments, and submitting evidence to overcome rejections.
  • Claim Amendments: Claims may have been narrowed during prosecution to overcome prior art or other patentability issues. This can impact the breadth of protection.

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:

  • Core Patents: US Patent 5,844,002 is the central patent for this specific chemical series. The existence of this patent, and its expiration date (which will be discussed later), is paramount.
  • Compound Patents: While 5,844,002 covers a genus, further patent applications may have been filed for specific novel compounds within this class or for improved analogs discovered later. These would have different filing and expiry dates.
  • Formulation Patents: New drug applications often involve developing novel formulations (e.g., extended-release tablets, specific salt forms) that can be separately patented. These patents can extend market exclusivity beyond the compound patent's expiration.
  • Method of Treatment Patents: Patents can also cover new uses or methods of treating specific conditions with known compounds, even if the compound itself is off-patent.
  • Competitor Patents: Companies working on similar neurological disorders, even with different chemical classes, hold patents that define their innovations. This includes patents on other anxiolytics, antidepressants, and anti-epileptic drugs.
  • Generic Competition: Upon patent expiration, generic manufacturers may seek to produce and market generic versions of drugs covered by this patent. Their ability to do so depends on the expiry of all relevant patents, including formulation and method-of-use patents.

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:

  • Original Expiration: US patents granted after June 8, 1995, generally have a term of 20 years from the filing date.
  • Filing Date: February 12, 1996.
  • Original Expiry (calculated): February 12, 2016.

Potential Extensions:

  • Patent Term Adjustment (PTA): The USPTO may grant PTA to compensate for delays in prosecution caused by the USPTO. This would extend the patent's term beyond the original 20 years.
  • Patent Term Extension (PTE): Under the Hatch-Waxman Act, patents covering human drugs that have undergone lengthy regulatory review (FDA approval process) can be extended by up to five years. This is intended to recover some of the lost patent term during clinical trials and FDA review.

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:

  • Freedom to Operate (FTO): For companies developing new treatments for anxiety, depression, or epilepsy, a thorough FTO analysis is essential. This patent, and any related patents covering specific compounds or formulations, must be reviewed to ensure new product development does not infringe existing intellectual property. Even if the primary compound patent has expired, secondary patents (formulation, method of use) can remain active.
  • Innovation Pathways: The expiration of core patents like 5,844,002 can open avenues for:
    • Generic Drug Development: Companies may focus on developing bioequivalent generic versions of approved drugs based on this patent.
    • New Indication Discovery: If the patent has expired, researchers can explore new therapeutic uses for the disclosed compounds, provided these new uses are not covered by separate, active patents.
    • Next-Generation Compounds: The chemical space defined by the patent can serve as a starting point for designing novel analogs with improved efficacy, safety, or pharmacokinetic profiles, leading to new patentable inventions.
  • Competitive Landscape: Understanding the patent activity of major players like Pfizer in therapeutic areas is crucial for identifying emerging trends and potential competitive threats or collaboration opportunities.

Investment Implications:

  • Generic Investment: The approaching or past expiration of key patents for neurological drugs can signal opportunities for investors in the generic pharmaceutical sector. Companies focused on bringing off-patent drugs to market at lower price points can generate significant revenue.
  • Biotech R&D Investment: For investors funding novel R&D, understanding the patent landscape helps identify areas with less crowded IP, allowing for greater potential for proprietary protection and market exclusivity for new discoveries. Analyzing the patent expiry dates of leading treatments in a therapeutic area helps assess the market runway for new entrants.
  • Risk Assessment: For investments in companies developing drugs for neurological disorders, the strength and expiry of their IP portfolio, including patents like 5,844,002 (or its equivalents), are critical risk factors. A strong patent portfolio mitigates the risk of early generic competition.

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 Takeaways

US 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 Questions

1. 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.

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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

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