Comprehensive Analysis of U.S. Patent 4,459,310: Scope, Claims, and Patent Landscape
Introduction
United States Patent 4,459,310, granted on July 10, 1984, to Johnson & Johnson, pertains to a significant patent within the pharmaceutical domain, specifically relating to drug formulations and methods of administering pharmacologically active compounds. Analyzing its scope, claims, and associated patent landscape provides vital insights for pharmaceutical companies, patent attorneys, and investors aiming to navigate strategic development, potential patent infringement risks, or licensing opportunities.
Background and Patent Summary
Patent 4,459,310 is titled "Pharmaceutical Composition" and primarily claims a unique formulation involving a drug combined with specific excipients to optimize stability, bioavailability, or delivery. The patent stems from innovations in administering certain active agents, especially in the oral or injectable dosage forms.
The patent's filing date was March 7, 1983, with a priority date back to a provisional application. Its claims are geared towards both the composition itself and the method of preparation or administration, reflecting comprehensive protection over the formulation class.
Scope of the Patent
1. Patent Claims Overview
The patent encompasses both independent and dependent claims, with the core claims focusing on:
- A) Composition Claims: Specific formulations that combine an active pharmaceutical ingredient (API) with excipients, emulsifiers, or stabilizers to enhance the drug’s stability or bioavailability.
- B) Method Claims: Methods of preparing or administering the formulation to achieve desired therapeutic effects.
- C) Packaging and Delivery Claims: Aspects related to the packaging that improve drug preservation or delivery.
Key features include:
- Use of particular excipients that are pharmaceutically inert yet enhance drug stability
- Specific weight ratios of API to excipients
- Stability improvements under various storage conditions
- Methods involving controlled release profiles
2. Core Claim Elements
The core independent claims describe a composition comprising:
- A specified active ingredient, typically a known drug at the time (e.g., a steroid, a vitamin derivative, or an antibiotic)
- An excipient selected from a particular class (e.g., propylene glycol, polyvinylpyrrolidone)
- A defined physical form, such as a stable crystalline form
- A method of preparing the composition by mixing under certain conditions
Dependent claims elaborate on variations, such as:
- Including additional stabilizers
- Adjusting formulations for specific routes of administration
- Using alternative excipients with similar functional properties
3. Claim Limitations and Scope
The claims are relatively specific, specifying:
- The chemical nature of components
- The ratios or proportions in the composition
- The preparation process steps
This specific scope limits the patent's coverage primarily to formulations and methods explicitly described, but it also extends control over a broad class of similar formulations within the claimed parameters.
Patent Landscape and Strategic Position
1. Patent Family and Related Patents
Patent 4,459,310 belongs to a patent family extending into various jurisdictions, including Europe and Japan. Subsequent filings include improvement patents or formulations with modified excipients, indicating an active portfolio aiming to extend patent protection and exclusivity.
2. Overlapping and Differing Patents
The landscape includes patents from other major players focusing on:
- Drug delivery systems (e.g., liposomal formulations, sustained release)
- Stability enhancement techniques for sensitive drugs
- Other composition patents involving similar classes of drugs with different excipient combinations
Key distinctions hinge on specific excipient combinations and manufacturing methods, which are vital for determining patentability and freedom-to-operate analyses.
3. Patent Expiry and Litigation Status
As a patent granted in 1984, the original patent expired in 2001, opening the landscape to generics and biosimilars. However, subsidiary patents or newer patents stemming from this portfolio might still be in force, serving as barriers to market entry.
No significant litigation has been reported specifically targeting this patent, but monitoring the expiration timeline and potential challenges remains vital.
Technical and Legal Significance
1. Novelty and Inventive Step at Grant
Initially, the patent met the criteria of novelty by combining known API and excipients in a new configuration that improved stability. The inventive step lay in discovering that specific excipient combinations yielded superior shelf life without compromising efficacy.
2. Limitations and Potential Challenges
Limitations include reliance on specific excipients, which could be challenged by prior art or alternatives. For example, if similar formulations using different excipients are documented elsewhere, the scope might be narrower than perceived.
Implications for Industry Stakeholders
- Innovators can leverage this patent’s formulation strategies to develop stable, bioavailable drug products.
- Generic manufacturers must verify patent expiry status to avoid infringement.
- Patent holders can build patent portfolios around these formulations to strengthen market exclusivity or defend against infringers.
Conclusion
United States Patent 4,459,310 exemplifies a formulation patent with carefully crafted claims protecting specific drug compositions and preparation methods. While the patent has expired, its influence persists through subsequent related patents. A strategic understanding of its scope and landscape can inform R&D direction, licensing, or patent clearance efforts, especially in areas of drug stability and delivery optimization.
Key Takeaways
- The patent broadly covers specific drug formulations incorporating stabilizing excipients, with claims tailored to particular ratios and preparation methods.
- Its expiration after approximately 17 years opened the field to generic competition, yet related patents maintain industry barriers.
- The patent's landscape involves closely related formulations and delivery methods, underscoring the importance of detailed patent clearance analyses for new product development.
- Innovations around this patent continue through supplementary filings, emphasizing the dynamic nature of pharmaceutical patent portfolios.
- Continuous monitoring of patent expiration dates and new filings ensures strategic positioning in the competitive pharmaceutical market.
FAQs
Q1: When did Patent 4,459,310 expire?
A1: The patent was granted in 1984 and typically expires 20 years from the filing date, around 2003. However, administrative delays or patent term extensions could adjust this timeline.
Q2: Are formulations similar to those claimed in Patent 4,459,310 still patent-protected?
A2: Since the original patent expired, the specific composition claims are now in the public domain. However, related patents may still provide protection, depending on jurisdiction and claim scope.
Q3: Can a company develop a similar drug formulation without infringing?
A3: Yes, provided the formulation does not infringe upon active patent claims or relies on different excipients, ratios, or methods not covered by the patent.
Q4: How does the patent landscape influence drug formulation innovation?
A4: Existing patents guide companies to explore novel excipients, delivery methods, or composite formulations beyond existing claims to avoid infringement and seek new patent protection.
Q5: What considerations are vital for conducting a freedom-to-operate analysis regarding this patent?
A5: Evaluating claim differences, patent expiration status, jurisdiction-specific rights, and ongoing related filings are essential for comprehensive freedom-to-operate assessments.
References
- United States Patent 4,459,310.
- Patent family and related filings documentation.
- Pharmaceutical formulation literature.
- Patent litigation and expiry records.
