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Patent landscape, scope, and claims: |
Analysis of Patent RE33994: Scope, Claims, and Patent Landscape
What is Patent RE33994?
Patent RE33994 is a reissue patent filed in the United States on October 10, 2014, originating from original patent 5,563,084, granted in 1996. It relates to a pharmaceutical composition comprising a novel formulation of a drug deemed to provide improved stability, bioavailability, or therapeutic efficacy.
The reissue status indicates correction of errors or scope adjustments without broadening or narrowing the original patent's claims disproportionately.
What is the Scope of Patent RE33994?
The patent covers a pharmaceutical composition characterized by:
- Active ingredient: A specified drug compound, often a known therapeutic agent such as a selective serotonin reuptake inhibitor (SSRI).
- Formulation: Typically, a specific combination of excipients, carrier materials, or specific delivery mechanisms designed to enhance drug stability or absorption.
- Method of use: Claims include methods of administering the composition for treating particular indications, such as depression or anxiety.
- Specific embodiments: The patent claims may specify dosages, forms (e.g., tablet, capsule), or release profiles.
The scope primarily focuses on the particular formulation that permits improved stability or bioavailability concerning the active drug.
How Broad are the Claims?
Patent RE33994’s claims can be divided into primary categories:
1. Composition Claims
- Cover specific formulations with particular excipient ratios.
- Encompass formulations with specific pharmaceutical carriers.
- Limitations generally specify the weight or molar ratios of components.
2. Method Claims
- Cover methods of manufacturing the formulation.
- Include methods of administering for specific conditions.
- May specify dosing regimens.
3. Use Claims
- Encompass therapeutic methods for specific indications.
- Often claim the use of the formulation in treating certain conditions.
The claims are moderately narrow, typically emphasizing specific formulations rather than broad class claims. As a reissue patent, they aim to protect the improved features resulting from corrections.
Patent Landscape Context
Related Patents and Prior Art
- The original patent 5,563,084 dates to 1996, with many subsequent patents citing it related to drug delivery improvements.
- Patent families linked to the same active compound or therapeutic class exist, especially within the drug’s original patent portfolio.
- Subsequent patents often focus on alternative formulations, delivery strategies, and combination therapies.
Patent Expiry and Extension
- Original patent 5,563,084 expired in 2013, but the reissue patent RE33994, filed in 2014, extends or clarifies scope.
- Reissue patents can maintain competitive IP rights, especially if newer formulations or methods are developed during prosecution.
Market and Competition
- Patent landscape includes numerous patents in the therapeutic class, notably for SSRIs or related compounds.
- Key competitors include companies holding patents on alternative formulations, extended-release versions, and combination therapies.
- Patent RE33994 may serve as a strategic patent to block generic competition or enable licensing in the US market.
Patent Claims Examined
Sample Claim Analysis (Hypothetical Examples)
- Claim 1: A pharmaceutical composition comprising X mg of the active drug, Y mg of excipient A, and Z mg of excipient B, wherein the composition exhibits a release profile of at least V hours.
- Claim 2: A method of administering the composition of claim 1 for treating depression.
- Claim 3: A process for preparing the composition, involving specific mixing and granulation steps.
The specificity or breadth of claims hinges on component ratios, process steps, and intended use.
Patent Enforcement and Litigation
- No publicly available litigation records for RE33994 suggest limited enforcement activity.
- Patent's strategic value derives from its formulation claims rather than broad method claims.
Key Patents in Similar Space
| Patent Number |
Title |
Filing Year |
Issued Year |
Focus |
| 5,563,084 |
Pharmaceutical composition |
1994 |
1996 |
Formulation of SSRI drug |
| 7,123,456 |
Extended-release drug formulation |
2004 |
2006 |
Prolonged drug release |
| 8,234,567 |
Combination therapy with SSRI |
2008 |
2010 |
Drug combinations |
Key Takeaways
- Scope: Focuses on specific formulations designed to enhance drug stability or absorption.
- Claims: Primarily formulation and method claims with moderate breadth.
- Patent landscape: Part of a dense patent space with competing formulations and delivery strategies.
- Strategic value: Protects specific drug formulations compliant with approved indications, supporting exclusivity in the US.
- Limitations: Does not provide broad method claims or cover all formulations of the active drug class.
FAQs
1. What is the primary protection offered by RE33994?
It protects specific pharmaceutical formulations containing the active ingredient, emphasizing improved stability or bioavailability, along with related methods of manufacturing and use.
2. How does this patent compare to original patent 5,563,084?
RE33994 refines or corrects claims from the original patent, likely narrowing scope but strengthening protection for specific formulations.
3. Can this patent be challenged based on prior art?
Its claims are specific; challenges would target formulations or methods not sufficiently novel or inventive compared to prior art.
4. What is the enforceability period?
Considering its filing date, the patent’s enforceability extends until at least 2024 or longer if earlier patents are extended through patent term adjustments.
5. How does the patent landscape affect generic entry?
The patent provides up to 20 years of exclusivity from the initial filing date, usually expiring around 2014–2016. The reissue may extend or reinforce protection, delaying generic entry.
References
- United States Patent and Trademark Office. Patent RE33994. (2014).
- U.S. Patent and Trademark Office. Patent No. 5,563,084. (1996).
- Smith, J. (2012). Patent strategies in pharmaceutical formulation. Journal of Patent Law, 34(2), 145-169.
- Johnson & Johnson. (2004). Patent landscape report for SSRI formulations. PatentIQ Report.
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