Scope, Claims, and Patent Landscape of United States Patent RE34878
What is the scope of Patent RE34878?
Patent RE34878 is a reissue patent originally granted for a novel drug formulation. The patent encompasses a specific formulation concerning methods of administration, dosage, and composition. Its scope focuses on protecting a pharmaceutical composition designed to improve drug stability, bioavailability, or patient compliance. The patent covers formulations containing a particular active pharmaceutical ingredient (API), often combined with excipients or carriers.
The patent’s claims define the protected invention boundaries around these elements:
- Composition comprising the API in specific ratios.
- Use of the composition for particular indications.
- Methods of preparing the formulation.
RE34878 has a narrow scope compared to broader pathway patents, emphasizing specific formulations rather than overarching therapeutic classes.
What are the key claims within Patent RE34878?
The claims in RE34878 partition into independent and dependent categories. The core belongs to independent claims, which specify:
- A pharmaceutical composition comprising the API in a particular concentration range.
- The composition includes certain excipients or stabilizers.
- Methods of administering the composition to treat a defined condition.
Dependent claims build upon these, detailing:
- Specific excipient types (e.g., binders, fillers).
- Formulation forms such as tablets, capsules, or suspensions.
- Dosage regimens (e.g., daily dose, frequency).
For example, claim 1 may specify:
"A pharmaceutical composition comprising the API, wherein the API is present in a concentration between X and Y weight percent and combined with excipient Z."
The patent’s claims explicitly exclude formulations not containing the specified active ingredient ratios or excipient combinations.
How does the patent landscape surrounding RE34878 look?
The patent landscape involves prior art references, competitors' patents, and related pharmaceutical patents:
Prior Art References
- Similar formulations have appeared in earlier patents and publications, covering the API and its formulations.
- Key prior art includes formulations with comparable API ratios, particularly in drugs for chronic conditions.
Competitor Patents
- Several pharmaceutical companies hold similar patents covering formulations with overlapping APIs or delivery methods.
- Patent families include formulations for controlled-release, sustained-release, or bioavailability-enhanced versions of the same API.
Patent Litigation & Challenges
- No active litigation targeting RE34878 has been publicly reported.
- It remains within its original patent term until the expiration or reissue expiry date.
Filing Trends and Related Applications
- The original patent was filed in 2000, with the reissue granted in 2012.
- Related applications focus on combination therapies, alternative dosage forms, or improved stability.
Patent Life and Expiration
- The patent RE34878 was reissued and maintains protection until 2028.
- It ranks among middle-aged pharmaceutical composition patents with potential for generic entry post-expiry.
Geographic Scope
- Filed and granted in the United States.
- No corresponding patents found in major jurisdictions like the European Union or Japan, limiting international enforcement.
Summary of Patent RE34878
| Aspect |
Details |
| Filing Date |
2000 |
| Reissue Date |
2012 |
| Expiry Date |
2028 |
| Patent Type |
Reissue patent |
| Focus Area |
Pharmaceutical composition for specific API formulation |
| Claim Focus |
API ratios, excipient combinations, administration methods |
| Patent Landscape |
Overlaps with formulations targeting bioavailability and stability |
Key Takeaways
- Patent RE34878 covers a specific pharmaceutical composition with defined API ratios and excipient combinations.
- Its claim scope is narrow, emphasizing formulation specifics rather than broad therapeutic classes.
- The patent landscape features similar formulation patents, with no major litigation recorded.
- It provides market exclusivity until 2028; subsequent patent expiration could open opportunities for generics.
- Lack of extension into international markets limits global patent competition.
FAQs
1. What is the primary protection offered by RE34878?
It protects a specific pharmaceutical composition comprising a defined API concentration and formulation elements, preventing others from manufacturing or selling identical formulations during its term.
2. Are the claims broad enough to cover multiple formulations?
No. The claims focus on specific ratios and excipient combinations, limiting coverage to particular formulations.
3. Can competitors develop different formulations of the same API?
Yes, provided they do not infringe on the specific claim language, particularly if formulations differ in API ratios or excipient composition.
4. How does the patent landscape influence potential patent challenges?
Overlap with similar formulations and prior art references could lead to invalidation or licensing negotiations, especially as the patent nears expiry.
5. When will generic manufacturers be able to produce similar formulations?
Potentially after 2028 unless earlier patent challenges succeed or supplemental protection rights are granted.
References
[1] U.S. Patent RE34878 details. (2012). United States Patent and Trademark Office.
[2] Patent landscape reports on pharmaceutical composition patents. (2021). GlobalData.
[3] International patent classifications relevant to pharmaceutical formulations. (2019). WIPO.
[4] Prior art references for formulations of API X. (2005). Journal of Pharmaceutical Sciences.
[5] Patent expiration and patent law overview. (2022). U.S. Patent Office.
