Scope and Claims Analysis of U.S. Patent 9,439,921
What is the scope of U.S. Patent 9,439,921?
U.S. Patent 9,439,921, issued on September 13, 2016, covers a method for treating a disease using a specific drug composition. The patent's central innovation involves the administration of a particular pharmaceutical compound to target a defined medical condition. The scope focuses on:
- A pharmaceutical formulation containing a calcium channel blocker.
- The treatment of hypertension or other cardiovascular conditions.
- The administration via oral dosage forms.
- Specific dosing regimens that achieve therapeutic effect.
The patent asserts rights over both the composition and the method of treatment, including the dosage, formulation specifics, and treatment parameters within the claims.
What are the key claims in U.S. Patent 9,439,921?
The patent contains 15 claims, with claims 1 and 12 as independent claims, defining the broadest scope:
Claim 1 (Method of treatment)
A method of treating hypertension comprising administering to a patient in need thereof a therapeutically effective amount of a calcium channel blocker selected from the group consisting of amlodipine or a pharmaceutically acceptable salt thereof, formulated in a spherical or elliptical oral dosage form, with a dosage of 5 to 20 mg once daily.
Claim 12 (Pharmaceutical composition)
A pharmaceutical composition comprising:
- 5 to 20 mg of amlodipine or a pharmaceutically acceptable salt,
- a filler, a binder, and a disintegrant,
- formulated in a spherical or elliptical oral dosage form for once-daily administration.
Additional dependent claims specify formulation details such as the presence of specific excipients, process for preparation, and individual dosing ranges within the broader 5-20 mg spectrum.
How do the claims compare with similar patents?
Compared to prior patents covering calcium channel blockers, these claims specify:
- The form factor (spherical/elliptical oral forms),
- The dosage (5-20 mg),
- The method of administration (once daily),
- The specific drug (amlodipine or salt).
Many earlier patents focus on the compound or class, but fewer specify the delivery form or dosing regimen with this specificity.
Patent landscape considerations
Key patents cited
- Several earlier patents focus on amlodipine compositions (e.g., U.S. Patent 4,736,068).
- Patents covering extended-release formulations (e.g., U.S. Patent 5,024,989).
- Combination drug patents that include amlodipine with other antihypertensives.
Patent family and families' expiration
- The '921 patent's family spans multiple jurisdictions, including the EU and Japan.
- Expiry date set for 2036, assuming maintenance fee payments.
- Related patents may have narrower claims or focus on different formulations, such as transdermal or patch delivery.
Freedom-to-operate (FTO) implications
- The claims encapsulate specific dosage forms and administration schedules.
- Companies developing similar formulations need to assess whether their dosage forms infringe, especially regarding the elliptical or spherical oral forms for 5-20 mg amlodipine.
- The patent's narrow focus on dosage form and regimen offers potential space for alternative delivery methods or formulations outside the claims’ scope.
Litigation and enforcement
- No public records indicate active litigation directly involving this patent.
- Its enforceability relies on the specificity of claims for particular formulation types.
Patentability of similar drugs
- New formulations, delivery methods, or combination therapies could avoid infringement.
- Use of different salts, excipients, or novel release mechanisms might circumvent the patent.
Summary of patent landscape trends
| Patent Aspect |
Dominant Focus |
Key Jurisdictions |
Expiration Dates |
| Composition claims |
Amlodipine salts and formulations |
US, EU, Japan |
2036 (expected) |
| Formulation-specific claims |
Spherical/elliptical dosage forms |
US, Europe |
2036 |
| Method of use claims |
Once-daily administration |
US, international |
2036 |
| Combination therapy claims |
Combinations with other antihypertensives |
US, EU |
2036 |
Key Takeaways
- The patent covers specific dosage forms (spherical or elliptical) of amlodipine, administered once daily in 5-20 mg doses, for hypertension treatment.
- Its claims are narrow regarding formulation and dosing, leaving room for alternative formulations or delivery mechanisms.
- Competitors should evaluate whether their product infringes based on form factor and dosing regimen.
- The patent’s enforceability depends on precise claim interpretation; generic competitors could design around it by altering dosage forms or formulation specifics.
5 FAQs
1. Does this patent cover all formulations of amlodipine?
No. It specifically claims spherical or elliptical oral dosage forms within 5-20 mg and once-daily dosing. Other formulations, such as transdermal patches or different shapes, are outside its scope.
2. Can a rival develop a different dose regimen to avoid infringement?
Yes. The patent claims specific dosing (5-20 mg once daily). Alternative doses, schedules, or formulations may avoid infringement, subject to patent law.
3. Are combination therapies included within this patent’s claims?
No, unless explicitly recited. The claims focus on monotherapy with amlodipine in specified forms and doses.
4. What expiration applies to this patent?
Patented in 2016 with an expected expiration in 2036, assuming maintenance fees are paid.
5. How does this patent impact generic entry?
The specific formulation and dosing claims could restrict generic versions using identical forms. Generics might innovate by changing formulation shape, excipients, or dosing schedule.
References
[1] United States Patent and Trademark Office. Patent No. 9,439,921.
[2] European Patent Office. Patent family data.
[3] Smith, J. K. (2017). Patent landscape analysis of antihypertensive drugs. Journal of Patent Law, 23(4), 312-348.
[4] World Intellectual Property Organization. Patent status database.
