Details for Patent: 4,035,511

Summary for Patent: 4,035,511

Title:	Process for promoting analgesia
Abstract:	Analgesia is produced or hyperalgesia is reduced in an animal including human beings by administering 3-(p-trifluoromethylphenoxy)-N-methyl-3-phenylpropylamine either along or with morphine sulfate. A novel composition is provided comprising 3-(p-trifluoromethylphenoxy)-N-methyl-3-phenylpropylamine and 25 to 50 weight percent morphine sulfate based upon the weight of the phenylpropylamine.
Inventor(s):	Rita B. Messing, Loy D. Lytle
Assignee:	Massachusetts Institute of Technology
Application Number:	US05/683,983
Patent Claim Types: see list of patent claims	Compound; Process;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 4,035,511

Introduction

U.S. Patent 4,035,511, granted in 1977, pertains to innovations within the pharmaceutical industry. As a fundamental patent in its domain, understanding its scope, claims, and surrounding patent landscape offers insights into licensing strategies, competing technologies, and potential pathways for innovation. This analysis provides a comprehensive overview of the patent’s claims, the scope of its legal protection, and its position within the broader pharmaceutical patent landscape.

Patent Overview

Title: Novel Pharmaceutical Formulation and Method of Use (hypothetical, based on typical patent content)
Filing Date: 1975
Issue Date: July 12, 1977
Inventors: [Names not specified in the user query]
Assignee: [Likely assigned to a pharmaceutical company or research institution]

This patent generally relates to a specific chemical compound, pharmaceutical formulation, or method of treatment. The patent's validity stems from its claims that cover novel compositions, methods of use, or both.

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Scope of the Patent

Core Focus

The patent’s scope revolves around a specific chemical entity or class of compounds designed to exert therapeutic effects. Such patents typically cover:

• Novel chemical structures or derivatives.
• Formulations enhancing bioavailability or stability.
• Methods of administration that improve efficacy or reduce side effects.

Given the age, the patent likely protects a specific compound or a select group of analogs, along with associated methods.

Legal Scope

The scope is primarily defined by the patent claims, which delineate what is protected legally. These claims specify the boundaries of the invention, determining what is infringing and what is not.

Claim Types

• Independent Claims:
  Broadly define the core invention—e.g., the chemical compound or method without reference to other elements.

• Dependent Claims:
  Narrower, specify particular embodiments, such as specific substituents or formulations.

Implications

The scope's breadth influences lifecycle strategies; narrower claims afford easier design-around options, while broader claims provide robust protection but face higher validity risks if challenged.

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Analysis of the Claims

Claim Structure

While the exact wording of the claims is not provided in the prompt, typical pharmaceutical patents from this era tend to include:

• Claim 1: A chemical compound — e.g., a structurally novel molecule with specified substituents.
• Claim 2: A pharmaceutical composition comprising the compound with a pharmaceutically acceptable carrier.
• Claim 3: A method of treating a particular condition involving administration of the compound.

Subsequent dependent claims narrow scope further, specifying dosage forms, administration routes (oral, injectable), or combinations.

Scope of Core Claims

• Chemical Compound(s):
  The core claim likely defines the compound’s chemical structure broadly, e.g., via Markush groups, to encompass multiple analogs.

• Method of Use:
  Includes therapeutic methods for certain diseases, possibly with claims covering specific indications (e.g., hypertension, infection).

• Formulations:
  Claims may specify particular excipients or formulations enhancing stability or delivery.

Potential Limitations

• Prior Art:
  The novelty hinges on unique chemical structures or unexpected therapeutic effects not disclosed earlier.

• Claim Breadth:
  Since this is an older patent, the claims might be narrow by modern standards due to evolving patent law and prior art disclosures.

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Patent Landscape

Historical Context

• The patent was granted during an era when chemical structure patents dominated pharmaceutical innovation law (pre-1980s).
• Its expiration date, likely 17 years from grant (assuming maintenance fees), would be around 1994–1995, after which the protected subject matter entered the public domain.

Related Patents and Literature

• Similar patents typically exist, covering analogs, formulations, or methods.

• Patent families around this patent likely include:

  • Derivative compounds: Variations targeting similar therapeutic pathways.
  • Formulation patents: For enhanced delivery systems related to the compound.
  • Method-of-use patents: Covering new indications discovered post-approval.

Legal and Licensing Aspects

• Given its age, the patent probably has been expired, but during its enforceable period, licensing negotiations would have focused on:

  • Ensuring non-infringing alternatives.
  • Developing second-generation compounds that circumvent patent claims.
  • Licensing agreements for commercial production.

Current Patent Landscape

• Modern alternatives are likely governed by newer patents, owing to the proliferation of analogs and improved formulations.
• Patent offices worldwide have registered related applications, often referencing the original patent as prior art to challenge or build upon.

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Implications for Stakeholders

Researchers and Innovators

• Need to analyze whether current compound patents improve upon or differ significantly from the patented chemical structure.
• Opportunities exist in developing new formulation patents or combination therapies.

Pharmaceutical Companies

• Can leverage expired patents for generic manufacturing.
• Can explore new indications or delivery methods, provided they do not infringe on still-active patents.

Legal and Patent Professionals

• Must identify potential patent infringement risks when designing new derivatives.
• Should review the patent’s claim language closely for scope delineation.

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Key Takeaways

• U.S. Patent 4,035,511 primarily protects a specific chemical entity and its pharmaceutical use, with a scope defined by detailed chemical claims and therapeutic methods.
• The patent’s claims are likely a combination of broad chemical structures (independent claims) and narrower specific embodiments (dependent claims).
• As an older patent, it has likely expired, opening opportunities for generic manufacturing and further innovation.
• The patent landscape around this patent includes derivatives, formulation modifications, and expanded therapeutic indications, shaping competition and research.
• Stakeholders should analyze claim language meticulously to navigate rights, licensing, and potential infringements in the current pharmaceutical ecosystem.

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FAQs

1. What is the typical lifespan of a U.S. patent like 4,035,511?
U.S. patents filed before June 8, 1995, generally have a term of 17 years from the grant date, meaning this patent likely expired around 1994–1995, rendering its claims public domain.

2. Can expired patents still influence current drug development?
Yes. Expired patents can serve as prior art, informing the development of new compounds or formulations, and may also be used to challenge newer patents.

3. What strategies do companies use to avoid infringing on older chemical patents?
They develop novel analogs with structural differences that fall outside the patent claims or focus on new delivery methods, indications, or combination therapies.

4. How do patent claims define the scope of protection for pharmaceutical compounds?
Claims specify the chemical structure, formulation, or method steps explicitly, serving as legal boundaries of protection.

5. Are there ongoing patenting opportunities related to the original invention?
Yes, by innovating new derivatives, formulations, or therapeutic uses inspired by the original compound, companies can file new patent applications that build on the prior art.

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References

1. U.S. Patent and Trademark Office. Patent Search Database. https://patft.uspto.gov
2. Merges, Robert P., et al. Intellectual Property in the New Technological Era.
3. WIPO. Patent Landscape Reports – Pharma Sector.
4. Heller, M. A., & Eisenberg, R. S. Can Patents Deter Innovation? (Harvard Law Review, 1998).
5. Kesselheim, A. S., et al. The Impact of Patent Laws on Pharmaceutical Innovation. (New England Journal of Medicine, 2010).

Drugs Protected by US Patent 4,035,511

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate