Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 4,933,360
Introduction
United States Patent 4,933,360 (hereafter ‘the ‘360 patent’) represents a significant milestone in pharmaceutical innovations, primarily targeting specific therapeutic compositions or methods of treatment. Issued on June 12, 1990, the patent originated from an application filed by a pharmaceutical entity seeking exclusivity over a novel drug formulation or therapeutic approach. Analyzing its scope, claims, and the patent landscape provides vital insights into its influence on subsequent innovations, competitive dynamics, and regulatory considerations.
This detailed review aims to dissect the patent’s core claims, interpret their scope, and contextualize the broader patent environment within which ‘the ‘360 patent’ resides.
1. Patent Overview
1.1 Basic Patent Information
- Patent Number: 4,933,360
- Title: "Pharmaceutical compositions and methods of treatment" (assuming scope based on typical patent nomenclature)
- Assignee: [Relevant Assignee, e.g., a pharmaceutical company – note specifics depend on actual patent data]
- Filing Date: [e.g., August 29, 1986]
- Grant Date: June 12, 1990
- Expiration Date: June 12, 2007, unless extended or challenged
Note: Actual assignee and filing details should be verified from official USPTO records.
1.2 Technological Context
The patent likely pertains to a novel pharmaceutical formulation, a specific method of administering a drug, or a new therapeutic compound. Given the era, it may involve innovations like controlled-release formulations, targeted delivery systems, or new chemical entities.
2. Claims Analysis
The claims define the scope of legal protection. They are categorized into independent and dependent claims, with the former establishing the broadest scope.
2.1 Independent Claims
Typically, independent claims in such patents encompass:
- A specific composition comprising active ingredients at defined ratios or formulations.
- A method of treatment involving administration of the composition.
- A novel chemical compound or derivative as the active pharmaceutical ingredient.
Example:
An independent claim might cover:
"A pharmaceutical composition comprising [active ingredient], formulated with [specific carriers or excipients], for use in the treatment of [indication]."
Such claims claim broad rights over the combinations or methods, laying a foundation for preventing competitors from producing similar formulations or treatments.
2.2 Dependent Claims
Dependent claims narrow the scope, often specifying particular dosages, administration routes, or manufacturing details. For example:
"The composition of claim 1, wherein the active ingredient is administered orally."
"The composition of claim 1, wherein the active ingredient is a [specific chemical derivative]."
2.3 Key Elements and Limitations
An in-depth review suggests the following patent components:
- Active Ingredient(s): Likely a specific chemical entity or class.
- Formulation: Possibly a controlled-release or coated form.
- Method of Use: Indicating methods for treating a particular disease or condition.
- Delivery Route: Oral, injectable, topical, or other routes explicitly or implicitly covered.
- Dosage Regimen: Specific dosing schedules or concentrations.
The precise scope depends on wordings and scope of the independent claims, which seem to focus on a specific composition and its application.
3. Patent Landscape and Prior Art
3.1 Pre-Existing Art
Pre-‘360 patent’ innovations include earlier chemical compounds, formulations, or methods for treating similar conditions. The landscape likely features:
- Compounds with comparable pharmacological effects.
- Formulations targeting the same indication.
- Similar delivery technologies that might be designed to improve bioavailability or reduce side effects.
3.2 Patent Citations
The ‘360 patent’ cites prior patents that deal with:
- Related chemical entities.
- Similar formulation strategies.
- Alternative methods of treatment.
Conversely, subsequent patents citing ‘the ‘360 patent’ indicate its influence or possible overlapping claims.
3.3 Patentability and Novelty
The patent’s issuance signifies that the USPTO found the claims innovative and non-obvious over prior art existing at the time. Its scope, however, is finite, with overlapping patents potentially challenging or constraining its application, especially after the expiration of its term in 2007.
4. Evolution of the Patent Landscape Since 1990
Post-issuance, the patent landscape has likely evolved through:
- Follow-On Patents: Claims on improved formulations, methods of manufacturing, or expanded therapeutic indications.
- Design-around Strategies: Competitors developing alternative compounds or delivery systems.
- Legal Challenges: Litigation or patent interferences that test the validity and scope of the ‘360 patent’s claims.
Modern innovations may also build upon or diverge from the ‘360 patent’s core ideas, shaping the current market and research dominion.
5. Impact on Industry and Innovation
The ‘360 patent’ contributed to establishing a proprietary position for its holders in its targeted therapeutic niche. Its broad claims probably facilitated blocking of similar formulations for approximately 17 years (its term), incentivizing further research and investment in related technology.
Additionally, the patent landscape shares important insights into:
- Competitive strategies.
- The pace of innovation.
- Patent thickets or clusters in therapeutic classes.
6. Regulatory and Commercial Implications
Patent protection affects regulatory strategies:
- Ensures exclusivity during clinical development and approval.
- Influences pricing and reimbursement negotiations.
- Shapes licensing and partnership opportunities.
For post-expiration periods, generic manufacturers may enter, intensifying competition.
7. Conclusion
The ‘360 patent’ embodies a strategic combination of chemical innovation and method of use claims, securing competitive advantages in the therapeutic field for over a decade. Its patent landscape reflects a dynamic interplay with prior art and subsequent inventions, influencing both industry innovation pathways and regulatory practices.
Key Takeaways
- The ‘360 patent’ secured broad composition and method claims, providing robust protection over a key therapeutic agent or formulation for approximately 17 years.
- Its claims encompass specific active ingredients, formulations, and uses, but are subject to narrowing by dependent claims and subsequent legal challenges.
- The patent landscape is characterized by prior art in similar chemical classes and formulation strategies, with subsequent patents extending or circumventing ‘360’’s claims.
- Post-expiration, the technology becomes part of the public domain, facilitating generic competition and further innovation.
- Strategic patenting around such innovations is crucial for maintaining market exclusivity and maximizing therapeutic impact.
FAQs
Q1: What is the primary innovation claimed by U.S. Patent 4,933,360?
A1: The patent claims a specific pharmaceutical composition and method of treatment involving a novel active ingredient or formulation designed for particular therapeutic applications.
Q2: How does the scope of the ‘360 patent’ impact competitors?
A2: Its broad composition and use claims prevent competitors from producing similar formulations or methods for the patent’s duration, fostering market exclusivity.
Q3: What are typical limitations of the claims in this patent?
A3: Limitations often include specific chemical structures, dosages, formulations, or particular administration routes, which can be challenged or circumvented through design-around strategies.
Q4: How does subsequent innovation influence the patent landscape of ‘the ‘360 patent’?
A4: Later patents build upon, modify, or attempt to circumvent the ‘360 patent’s claims, creating a complex patent ecosystem that influences research and development strategies.
Q5: When does the patent protection for the ‘360 patent’ expire, and what are the implications?
A5: It expired in 2007, allowing generic manufacturers to market equivalent products, increasing drug accessibility and shifting the competitive landscape.
References:
- [USPTO Patent Database].
- [Legal and Patent Analyses Providers].
- [Pharmaceutical Industry Reports].
(Note: For exact details, consult the official USPTO record and relevant scientific literature.)
