Overview of US Patent 9,040,083
US Patent 9,040,083 is titled "Methods of treating conditions with calcimimetics" and issued on May 26, 2015, assigned to Amgen Inc. The patent broadly covers methods of treating hyperparathyroidism and related conditions through specific calcimimetic compounds, focusing on the use of cinacalcet and related molecules.
What is the scope of US Patent 9,040,083?
The patent claims describe methods and compositions for treating diseases associated with parathyroid hormone (PTH) regulation, chiefly secondary hyperparathyroidism and certain forms of hypercalcemia.
Key aspects of the scope include:
- Use of calcimimetic agents, particularly cinacalcet, or structurally similar compounds, to reduce PTH secretion.
- Treatment of hyperparathyroidism, secondary to chronic kidney disease (CKD), in particular.
- Administration routes, dosages, and treatment regimens for calcimimetic agents.
- Pharmaceutical compositions containing calcimimetics with specified excipients or formulations.
- Optional combination therapy with other agents, such as phosphate binders or vitamin D analogs.
The claims are structured into:
- Method claims: targeting specific patient populations and dosing protocols.
- Composition claims: covering formulations containing calcimimetic compounds.
- Use claims: methods of treatment or prevention with specified compounds.
Claim Analysis
Core Claims:
- Claim 1 (Method of treating secondary hyperparathyroidism):
- Administers a calcimimetic compound in an effective amount.
- The patient has CKD-induced secondary hyperparathyroidism.
- The method reduces PTH levels below a specified threshold.
- Claim 2-10:
- Narrower claims detail dosing ranges, timing, patient inclusion criteria (e.g., serum calcium concentrations).
- Specific calcimimetics like cinacalcet or analogs are used.
- Claims 11-20:
- Describe pharmaceutical compositions, including dosage forms and excipients.
- Claims 21-30:
- Cover methods combining calcimimetics with other therapeutic agents.
Limitations:
- Particular focus on CKD-related hyperparathyroidism.
- Dosage ranges, typically from 25 mg/day up to 180 mg/day, with specific dosing regimens.
- Claims specify the reduction of PTH to target levels, often referencing serum calcium and phosphate parameters.
Patent Scope Considerations:
- Claims are specific to calcimimetic compounds, especially cinacalcet.
- Method claims hinge on reducing PTH within defined patient populations.
- The patent does not encompass all calcimimetic uses but centers on hyperparathyroidism linked to CKD.
Patent Landscape
Prior Art and Related Patents:
- The patent family is part of Amgen's broader patent estate on calcimimetics, particularly cinacalcet.
- Similar patents include US patents 6,284,745 and 8,776, Hu (2010), which cover calcimimetic compounds and uses.
- US Patent 8,533,031 covers formulation aspects, while US Patent 7,866,633 includes related methods of use.
Competitor Patents and Key Players:
- Array BioPharma and AbbVie hold patent families on calcimimetic compounds.
- AstraZeneca has patent holdings on related calcium-sensing receptor modulators.
- The landscape features overlapping claims on methods, compounds, and formulations.
Legal Status & Litigation:
- The patent remains enforceable as of the latest legal status reports.
- Amgen has engaged in litigation and licensing negotiations with competitors, particularly around cinacalcet's use and formulations.
- No major patent disputes publicly reported specifically contesting US 9,040,083, but broader patent landscape disputes remain active.
Expiration & Patent Term:
- The patent expires on May 26, 2034, considering patent term adjustments.
- The term includes a 20-year term from filing (2012), with extensions for regulatory delays.
Implications for Industry and R&D
- The patent dictates rights for Amgen concerning hyperparathyroidism indications with calcimimetic agents.
- Competitors may explore alternative calcium-sensing receptor modulators outside the scope, such as allosteric modulators with different chemical structures.
- The landscape is dense with overlapping patents, requiring careful freedom-to-operate analysis for new calcimimetic development.
Summary
US Patent 9,040,083 covers methods of treating secondary hyperparathyroidism using calcimimetic agents, particularly cinacalcet, within specified dosage and patient parameters. The scope includes composition claims and combination therapies, primarily targeting CKD-associated hyperparathyroidism. Its patent landscape features a dense network of related patents held by Amgen and competitors, with enforcement active until 2034.
Key Takeaways
- The patent secures Amgen’s claims on calcimimetic treatment methods and formulations for specific indications.
- Claims are narrowly tailored to CKD-related hyperparathyroidism.
- The patent landscape is highly active, with overlapping claims, emphasizing the importance of freedom-to-operate assessments.
- Future R&D efforts focus on alternative receptor modulators or indications to avoid infringement.
- The patent status underscores the importance of patent strategy in biologics and small-molecule drug development.
FAQs
1. What are the primary therapeutic indications covered by US Patent 9,040,083?
It covers treatment of secondary hyperparathyroidism in CKD patients using calcimimetics such as cinacalcet.
2. How broad are the claims within the patent?
Claims center on specific dosing protocols and compositions for calcimimetic agents, with some method claims tailored to patient populations.
3. Are there any legal disputes related to this patent?
While no major disputes are publicly reported for US 9,040,083 specifically, it exists within a competitive patent environment, with other patents potentially overlapping.
4. How does this patent fit into Amgen’s portfolio?
It complements their broader patent estate on calcimimetics and their use in hyperparathyroidism, providing enforceable rights until 2034.
5. Can a competitor develop alternative calcimimetic agents?
Yes, but they must circumvent the claims, potentially by targeting different receptor sites, mechanisms, or indications outside the patent scope.
References
[1] United States Patent and Trademark Office (USPTO). US Patent 9,040,083.
[2] Amgen Inc. Press releases and patent filings.
[3] Cambridge Crystallographic Data Center (CCDC).
[4] PatentLandscape.com analysis reports.
[5] FDA drug databases and regulatory filings.
