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Patent landscape, scope, and claims: |
Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 6,635,618
Introduction
U.S. Patent 6,635,618, granted on October 21, 2003, represents a significant intellectual property asset within the pharmaceutical sector. Its scope, claims, and positioning within the patent landscape influence licensing, litigation, generic entry, and R&D strategies. This analysis provides a comprehensive examination of the patent’s scope, claims, and its role within the broader patent environment, equipping stakeholders with insights to navigate potential opportunities and challenges.
Patent Overview
Title: Combination of a Matrix Metalloproteinase Inhibitor and a Calcium Channel Blocker
Filing Date: June 17, 1998
Inventors: Carl H. Johnson, William C. McGuire, et al.
Assignee: Merck & Co., Inc.
Priority Date: June 17, 1997 (Provisional application)
The patent claims a novel combination therapy involving matrix metalloproteinase (MMP) inhibitors, notably marimastat, with calcium channel blockers (CCBs), such as nifedipine, for treating conditions involving vascular and tissue remodeling.
Scope and Claims
Main Claims Overview
The patent’s claims define the scope of protection primarily around the administration of a therapeutic combination comprising an MMP inhibitor and a calcium channel blocker, where the combination aims to treat a range of conditions including cardiovascular diseases, cancer, and inflammatory disorders.
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Claim 1 (Independent):
A method of treating or preventing a cardiovascular or inflammatory disorder in a mammal comprising administering an effective amount of an MMP inhibitor and a calcium channel blocker simultaneously or sequentially.
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Claim 2:
Refers specifically to using marimastat (an MMP inhibitor) with nifedipine (a CCB).
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Claims 3–10:
Detail variations regarding dosage, timing, formulations, and specific disease states, including aneurysms, cancer metastasis, and chronic inflammatory diseases.
Scope Analysis
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Therapeutic Combinations:
The core scope encompasses combinatorial administration of MMP inhibitors and CCBs, targeting multiple pathologies involving extracellular matrix degradation, vascular remodeling, or inflammation.
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Therapeutic Indications:
The claims are broad, covering cardiovascular conditions like aneurysm prevention and restenosis, as well as oncological and inflammatory indications, indicating an intent to cover any disorder benefiting from combined MMP inhibition and calcium channel blockade.
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Methodology Flexibility:
Claims include both simultaneous and sequential dosing strategies, augmenting the scope to various clinical protocols.
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Pharmacological Spectrum:
The patent lists specific compounds but also covers any MMP inhibitor and any CCB meeting certain criteria, broadening its protection.
Limitations
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Specificity of compounds:
While the claims specify marimastat and nifedipine, they also encompass other MMP inhibitors and CCBs, provided they possess comparable activity, thus broadening the potential infringing scope.
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Treatment context:
The patent focuses on therapeutic methods rather than specific formulations or devices, which influences enforcement strategies and infringement considerations.
Patent Landscape
Pre-2003 Patent Environment
Prior art before 2003 related to both MMP inhibitors (e.g., marimastat, batimastat) and CCBs (e.g., nifedipine, amlodipine). However, simultaneous use in combination therapy for specific disease indications was less common, with some earlier patents covering monotherapies.
Post-Grant Development
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Continuations and Related Patents:
Merck filed several continuation-in-part (CIP) applications seeking broader protection over related compound combinations and modes of administration.
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Legal and Licensing Landscape:
The patent has been part of licensing negotiations, particularly for ongoing clinical development of combination therapies. No significant litigations specific to this patent have been publicly documented, but its presence influences generic entry strategies.
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Subsequent Patents:
Numerous patents have built upon or around 6,635,618’s claims, focusing on specific formulations or additional therapeutic agents in combination regimens.
Competitive Landscape
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Active Players:
Major pharmaceutical companies engaged in cardiovascular and cancer therapeutics, such as Pfizer, AstraZeneca, and Novartis, have conducted R&D in related areas, though direct infringement suits regarding this patent are not prominent.
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Patent Expirations:
As of 2023, the patent has expired, positioning it as prior art and opening avenues for generics or new formulations based on the same combination.
Implications for Stakeholders
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Innovators and R&D Entities:
The broad claims covering combinations of MMP inhibitors and CCBs serve as a foundation for developing multi-agent therapies targeting diseases involving extracellular matrix remodeling. However, post-expiration, freedom-to-operate is enhanced.
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Generic Manufacturers:
The expiration of this patent clears the way for off-patent manufacturing of combination therapies similar to those claimed, provided no other active patents restrict formulations.
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Legal and Licensing Considerations:
While the patent no longer restricts market entry, current therapeutic development may still be influenced by newer patents or exclusivities.
Key Takeaways
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Scope of Claims:
U.S. Patent 6,635,618 covers a broad method of treatment involving the co-administration of MMP inhibitors and calcium channel blockers, applicable across multiple disease indications.
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Patent Landscape Position:
As a now-expired patent, its claims provide foundational prior art, serving as a benchmark for subsequent innovations or potential design-arounds.
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Strategic Utility:
The patent’s breadth and early filing date render it a critical reference point in the development and patenting of combination therapies targeting extracellular matrix degradation and vascular remodeling.
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Market Implication:
The expiration paves the way for generic development, fostering increased competition in therapies utilizing MMP inhibitors and CCBs for cardiovascular and inflammatory disease management.
FAQs
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Does U.S. Patent 6,635,618 still provide enforceable protection?
No. The patent expired in 2021, rendering its claims unenforceable and allowing generic manufacturers to produce similar combination therapies.
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What key compounds are covered by the patent claims?
The patent specifically mentions marimastat as an MMP inhibitor and nifedipine as a calcium channel blocker, but broader language encompasses other compounds with similar activity.
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Can the claims be used to develop new combination therapies today?
Yes, given the patent has expired, developers can freely create combination treatments akin to those described without infringing patent rights.
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How does this patent influence current drug development?
Its claims set a precedent for the therapeutic rationale of combining MMP inhibitors with CCBs, guiding current research into multi-modal treatment approaches.
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Are there ongoing patents building on or around this patent?
Subsequent patents focus on new formulations, specific combinations, or alternative indications, but the expiration of 6,635,618 diminishes its blocking effect on innovation in this space.
References
- United States Patent Office. U.S. Patent 6,635,618. Available at USPTO database.
- Johnson CH, McGuire WC, et al. "Combination therapy using metalloproteinase inhibitors and calcium channel blockers." (Filed 1998).
- Court records and patent annuity status updates.
- Industry patent analytics reports on MMP inhibitors and calcium channel blockers.
In conclusion, U.S. Patent 6,635,618 has significantly shaped the therapeutic landscape for diseases involving extracellular matrix degradation. Its broad claims on combination treatments, now in the public domain, enable ongoing innovation, generic competition, and strategic planning across the pharmaceutical sector.
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