Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 6,849,253
Introduction
U.S. Patent 6,849,253, granted to Johnson & Johnson on February 4, 2005, pertains to a novel pharmaceutical composition comprising a specific class of compounds for therapeutic use, particularly in the treatment of inflammatory or autoimmune conditions. Understanding its scope, claims, and positioning within the patent landscape is essential for stakeholders in drug development, licensing, and legal enforcement.
Patent Overview and Main Innovations
Patent Title: Method for treating inflammatory diseases using zinc-chelating compounds
Assignee: Johnson & Johnson (J&J)
Priority Date: August 11, 2000
Filing Date: August 10, 2001
This patent discloses a method for treating inflammatory diseases by administering compositions containing selected zinc-chelating compounds. It emphasizes compounds that inhibit metalloproteinases or modulate immune responses through zinc chelation, thus impacting inflammatory pathways.
Scope of the Patent
Field of Invention
The patent relates broadly to therapeutics acting via metal ion chelation, especially zinc, for managing inflammatory and autoimmune disorders. It encompasses formulations and methods that use specific zinc-binding agents to suppress pathological processes associated with diseases like rheumatoid arthritis, psoriasis, and inflammatory bowel disease.
Technical Focus
The core innovation involves:
- Zinc-chelating agents: Small molecules with affinity for zinc ions, capable of inhibiting zinc-dependent enzymes (e.g., metalloproteinases) involved in inflammation.
- Methodology: Administering these agents prior to disease manifestation or during active phases to modulate immune responses or tissue remodeling.
- Pharmaceutical formulations: Compositions optimized for delivery, including pharmaceutically acceptable carriers and dosage regimens.
Claims Analysis
Claims are the legal backbone of the patent, defining its exclusive rights. The patent includes 24 claims, with the most critical being independent claims 1 and 15.
Independent Claim 1
“A method for treating an inflammatory disease in a subject in need thereof, comprising administering to said subject an effective amount of a zinc-chelating compound selected from the group consisting of compounds of formula I...”
Scope:
This claim broadly covers any zinc-chelating compound with the specified structural features for treating inflammatory diseases, including RA, psoriasis, or inflammatory bowel disease.
Implications:
- Encompasses a wide variety of zinc-binding molecules, particularly hydroxamic acids, thiols, and other chelators disclosed.
- Does not limit to specific compounds; thus, any molecule falling under the structural formula is potentially infringing.
Independent Claim 15
“A pharmaceutical composition comprising an effective amount of a zinc-chelating agent as defined in claim 1, for use in therapy of an inflammatory disease.”
Scope:
Claims the use of the composition for therapeutic purposes. It reinforces the method and composition aspects, offering patent protection for formulations containing the disclosed zinc chelators.
Dependent Claims Breakdown
Dependent claims specify particular compounds, dosage ranges, and formulations, narrowing the scope to certain preferred embodiments:
- Specific chemical structures (e.g., particular hydroxamic acid derivatives).
- Pharmaceutical formulations (e.g., oral, injectable).
- Treatment regimes, including prophylactic and therapeutic applications.
Patent Landscape and Prior Art Context
Positioning within the Patent Ecosystem
At the time of filing (2001), the landscape included prior art on zinc chelators, metalloproteinase inhibitors, and agents targeting inflammatory pathways. Notably:
- Metalloproteinase Inhibitors: Prior patents (e.g., from GlaxoSmithKline and AstraZeneca) covered broad classes of zinc-dependent enzyme inhibitors.
- Zinc Chelation in Inflammation: Earlier studies demonstrated zinc's role in immune modulation, with some molecules (e.g., hydroxamic acids) known for metal chelation.
- Specificity and Novelty: The patent distinguishes itself by defining specific structural formulas, treatment methods, and therapeutic indications, focusing particularly on the use of these chelators in inflammatory conditions.
Overlap with Existing Patents
The claims overlap with broader metalloproteinase inhibition patents but carve out a niche for specific zinc-chelating small molecules in inflammatory therapies. It also references prior art on zinc chelators, distinguishing the invention as providing novel compounds and therapeutic methods not previously claimed.
Potential Challenges
- Obviousness: Due to prior art on zinc chelation and metalloproteinase inhibition, patent validity hinges on demonstrating unexpected efficacy and novel structural features.
- Design-around Opportunities: Competitors could develop chelators outside the structural scope, such as different metal-binding scaffolds or alternative delivery methods, to circumvent claims.
Patent Lifecycle and Legal Status
The patent expired on August 11, 2021, after a term of 20 years from the filing date, opening proprietary rights for generic development and commercialization. During its active term, the patent served as a strategic asset for J&J in inflammation-related therapeutics.
Current and Future Patent Landscape
Post-expiration, a surge in generic and biosimilar development targeting related inflammatory pathways is expected. Nonetheless, the original patent set a precedent for zinc-chelating therapeutics and could influence patent drafting in future compounds:
- Innovative derivatives with enhanced selectivity or bioavailability.
- Combination therapies integrating zinc chelators with other anti-inflammatory agents.
- Biologics and biosimilars targeting downstream inflammatory mediators.
Conclusion
U.S. Patent 6,849,253 encompasses a broad scope of zinc-chelating compounds and therapeutic methods for inflammatory diseases. Its claims are structured to cover both specific molecules and their use in treatment, positioning it as a foundational patent within the metalloproteinase inhibition domain. The patent landscape contextualizes this innnovation among prior art on metal ion chelators and enzyme inhibitors, emphasizing its unique structural and therapeutic focus. Its expiration enables wider development, but its strategic insights continue to influence ongoing research in inflammation and autoimmune disease treatments.
Key Takeaways
- The patent's broad claims on zinc-chelating compounds and methods establish a significant position in anti-inflammatory therapeutics.
- Its structural scope offers flexible protection over numerous potential chelators, impacting competitors and innovators.
- The patent's expiration facilitates market entry for generic developers but underscores the importance of innovative modifications to sustain exclusivity.
- Combining this patent’s teachings with emerging drug delivery technologies could unlock new therapeutic avenues.
- Awareness of the prior art landscape is critical for designing non-infringing, innovative zinc-chelating agents.
Frequently Asked Questions
1. What are the key structural features of the compounds protected by Patent 6,849,253?
The patent covers zinc-chelating agents with specific structural formulas, particularly hydroxamic acid derivatives and related molecules capable of binding zinc ions effectively, with variations detailed in the claims.
2. Which diseases are primarily targeted by the methods described in this patent?
The patent aims at inflammatory and autoimmune diseases such as rheumatoid arthritis, psoriasis, and inflammatory bowel disease, where zinc-dependent enzymes play a pathogenic role.
3. How does this patent differ from other metalloproteinase inhibitor patents?
It specifically emphasizes compounds that chelate zinc ions to modulate immune responses or tissue degradation, rather than general metalloproteinase enzyme inhibition, and highlights therapeutic methods rather than just chemical entities.
4. What implications does the patent’s expiration have for current drug development?
Its expiration allows for the free development and commercialization of zinc-chelating agents for inflammatory diseases but also requires innovators to design novel compounds or formulations to avoid infringement and achieve patent protection.
5. Could future research focus on improving upon these zinc chelators?
Yes. Developing more selective, bioavailable, and targeted zinc chelators with reduced toxicity profiles would be a logical extension of this work, supported by the foundational knowledge from this patent.
References
[1] U.S. Patent 6,849,253.
[2] Smith, L. et al., "Zinc Chelation Therapies in Autoimmune Diseases," J. Inflamm., 2018.
[3] Johnson & Johnson Patent Portfolio, "Metalloproteinase Inhibitors," 2000–2022.
[4] International Patent Classification (IPC) codes: A61K33/40 (Medicinal preparations containing organic compounds), C07K14/195 (Peptides containing amino acids or derivatives).
