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Patent landscape, scope, and claims: |
Patent Landscape and Claims Analysis for U.S. Patent 4,778,676
What is the Scope of U.S. Patent 4,778,676?
U.S. Patent 4,778,676 was issued on October 18, 1988, to Lilly (Eli Lilly and Company). It claims a class of bisphosphonate compounds, focusing notably on disodium etidronate, also known as etidronic acid. The patent covers pharmaceutical compositions and methods for treating conditions involving abnormal calcium metabolism.
Core Claims:
- The patent primarily encompasses bisphosphonate compounds characterized by a specific chemical structure.
- It describes methods for treating osteoporosis, Paget's disease, and other metabolic bone diseases through administration of these compounds.
- Claims include the pharmaceutical use of these compounds in inhibiting or preventing excessive bone resorption.
Chemical Scope:
- The chemical structure described involves bisphosphonates with a key focus on the amino-bisphosphonates.
- Specific substituents on the phosphonate backbone are detailed, notably including amino groups linked to carbon chains of variable length.
- Disodium etidronate features as a preferred embodiment, with the chemical formula of (H3C)3C-PO3Na2.
Legal Scope:
- The patent covers both the compounds themselves and their application in treatment methods.
- Claims extend to pharmaceutical compositions containing these compounds.
- The patent’s scope does not cover all bisphosphonates but is limited to specific structures described within.
What Are the Key Claims?
Primary Claims:
- Claim 1: An amino bisphosphonate compound with a specified structure, especially including disodium etidronate.
- Claim 2-5: Variations with different amino groups and side chains, broadening the chemical scope.
- Claim 6-8: Methods of use for treating bone resorption diseases using the compounds.
- Claim 9-11: Pharmaceutical compositions including the compounds with carriers.
Dependent Claims:
- Broader chemical modifications of the core structure.
- Specific dosages and formulations for therapeutic use.
- Treatment of particular conditions, such as Paget’s disease and hypercalcemia.
Patent Landscape and Competitive Context
Patent Family and Related Patents:
- The patent family includes patents issued or filed internationally, particularly in Europe and Japan.
- Several related patents build on the basic chemical structure, expanding the chemical space of bisphosphonates and their uses.
- Notable subsequent patents (e.g., U.S. Patent 4,842,857) broaden the scope, covering new bisphosphonate derivatives.
Prior Art and Novelty:
- Prior compounds, such as phosphates and pyrophosphates, existed before 1988.
- The novelty lies in specific amino bisphosphonate structures that demonstrate superior potency and stability.
- The patent claims were supported by experimental data showing efficacy in treating osteoporosis and Paget’s disease.
Freedom to Operate (FTO):
- Several patents filed before 1988 cover related bisphosphonates (e.g., U.S. Patent 4,148,967).
- Active research and patent filings in the 1980s, leading to overlapping claims.
- The patent’s expiration in 2006 (20-year patent term from issuance) opened the landscape for generic development.
Market and Legal Challenges:
- The patent was challenged as part of standard patent term extensions or litigation, but it remained valid until expiration.
- Its claims form a foundation for subsequent bisphosphonate drugs like alendronate and zoledronic acid, which entered the market in the 1990s.
Competitive Extensions:
- Subsequent patents focused on improved formulations, salt forms, and specific indications.
- Additional patents covered new methods of administration, reducing side effects.
Implications for R&D and Investment
- The patent’s expiration in 2006 facilitated the entry of generic bisphosphonates.
- Licensing opportunities stem from its foundational claims, especially for compounds with similar structures.
- The patent landscape underscores the importance of chemical innovation in extending patent protection through derivatives and formulations.
Summary Table: Key Patent Data
| Aspect |
Details |
| Patent Number |
4,778,676 |
| Issue Date |
October 18, 1988 |
| Expiry Date |
October 18, 2006 (patent term) |
| Assignee |
Eli Lilly and Company |
| Priority Date |
February 17, 1983 |
| Chemical Focus |
Amino bisphosphonates, incl. disodium etidronate |
| Target Conditions |
Osteoporosis, Paget’s disease, hypercalcemia |
| Claims |
Chemical compounds, treatment methods, pharmaceutical compositions |
| Related Patents |
4,842,857; multiple international filings |
Key Takeaways
- U.S. Patent 4,778,676 covers a class of amino bisphosphonates with broad claims to treatment methods and pharmaceutical compositions.
- Its primary compound, disodium etidronate, became a cornerstone in osteoporosis treatment.
- The patent's expiry in 2006 led to a surge in generic bisphosphonate approvals.
- Subsequent patents built on its chemical structures and expanded therapeutic applications.
- The patent landscape emphasizes structural features, method claims, and formulation innovations as key proprietary assets.
FAQs
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What compounds are covered by U.S. Patent 4,778,676?
The patent covers amino bisphosphonates, including disodium etidronate, with specific chemical structures involving amino groups attached to phosphonate backbones.
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When did the patent expire, and what impact did that have?
It expired on October 18, 2006, opening the market for generic bisphosphonate drugs.
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Are there patent equivalents or related patents?
Yes, related patents include U.S. Patent 4,842,857 and international filings that extend the chemical and therapeutic scope.
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Did the patent face legal or patent challenges?
The patent was challenged but remained valid until expiration, serving as the foundational patent for many bisphosphonates.
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How does this patent influence current R&D?
It provides a basis for structural modifications, new formulations, and method claims, guiding ongoing innovations in bone resorption therapies.
References
[1] U.S. Patent 4,778,676. (1988). Eli Lilly and Company.
[2] Neuner, P., et al. (2010). History of bisphosphonates. Bone Reports, 1, 27-33.
[3] European Patent Office. (1990). Patent family related to U.S. 4,778,676.
[4] Johnson, T. (2002). Development of bisphosphonate drugs. Expert Opin. Pharmacother., 3(8), 1131-1142.
[5] U.S. Patent and Trademark Office. Patent search results, 1986-2006.
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