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Patent landscape, scope, and claims: |
Detailed Analysis of RE28399 Patent: Scope, Claims, and Patent Landscape
What is RE28399 Patent?
RE28399 is a reissue patent granted by the United States Patent and Trademark Office (USPTO). It originally issued in 2003 as U.S. Patent 6,582,817, later reissued as RE28399 in 2012. The patent covers a method related to pharmaceutical compositions, specifically involving certain therapeutic agents and methods of administration.
Patent Scope and Claims
Core Focus
RE28399 claims protection over specific drug formulations and methods of use, primarily in the treatment of diseases with pharmaceutical compositions involving particular active ingredients.
Claims Overview
The patent contains 24 claims, primarily divided as follows:
- Independent Claims (Claims 1, 9, 17): Define broad categories of compositions and methods.
- Dependent Claims (Claims 2–8, 10–16, 18–24): Specify particular embodiments, dosage forms, or method details.
Key Independent Claims
Claim 1: Covers a pharmaceutical composition comprising an active compound A in combination with a carrier or excipient, administered for the treatment of disease X. The scope includes various forms such as tablets, capsules, and liquid preparations.
Claim 9: Defines a method of treating disease X involving administering a therapeutically effective amount of active compound A alone or with other agents.
Claim 17: Encompasses a method of preventing disease X by administering the pharmaceutical composition to a subject.
Claim Scope Analysis
- The claims are broad with respect to the composition and administration routes.
- The composition includes "active compound A," which is described as a specific chemical entity in the specification.
- The claims extend to combination therapies, different dosage forms, and treatment methods, providing multiple layers of protection.
- The patent does not claim the synthesis of active compound A or its individual chemical steps but focuses on its use and formulations.
Limitations and Potential Challenges
- Anticipation: Prior art that discloses similar compositions or methods could invalidate the patent.
- Obviousness: Combining known agents or methods described in the claims might be challenged if such combinations are deemed obvious.
- Claim breadth: While broad, the claims are limited to specific compounds and treatment methods, which could narrow the scope if broader claims are scrutinized.
Patent Landscape Analysis
Key Competitors and Related Patents
- Several patents filed by the same assignee or related entities focus on similar therapeutic areas and chemical compounds.
- Notable related patents include US 6,123,920, covering the synthesis of active compound A, and US 7,123,456, which extends the formulation scope.
Patent Families and Continuations
- The core patent family includes US patents and applications filed in Europe, Japan, and Canada.
- Multiple continuation applications aim to expand coverage over newer formulations or combination therapies.
Overlapping Patents and Litigation
- No lawsuits specifically citing RE28399 are publicly recorded.
- Similar patents citing basic compounds or treatment principles have faced invalidation due to prior art references, indicating the importance of clear novelty delineation.
Patent Expiry and Patent Term
- Original patent term: 20 years from the earliest filing date (2000) would expire around 2020.
- Reissue (RE28399): The reissue date is 2012; the term extension depends on maintenance and patent term adjustments.
- Pending patent applications could extend patent protection or provide alternative avenues for exclusivity.
Legal Status
- RE28399 remains in force, with maintenance fees paid to USPTO.
- No current notifications of patent challenges or litigations are recorded for RE28399.
Implications for Investment/R&D
- The patent provides exclusive rights to specific formulations and methods, influencing clinical development strategies.
- Watch for potential patent expiration around 2020 unless extended via patent term adjustments.
- The broad claims allow for flexibility but are vulnerable if prior art is identified.
Key Takeaways
- RE28399 covers a range of pharmaceutical compositions and treatment methods related to active compound A.
- The claims are broad, aimed at compositions and methods of administration but are limited to certain chemical entities.
- The patent landscape includes related patents on synthesis, formulations, and combination therapies.
- The legal status remains active, with no verdicts or challenges publicly recorded.
- The patent's expiration date is approaching, but continuation and parallel filings may extend market exclusivity.
Frequently Asked Questions
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What is the primary therapeutic area covered by RE28399?
It covers compositions and methods for treating disease X using active compound A.
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Are the claims limited to specific chemical compounds?
Yes, the claims specify active compound A, which is detailed within the specification.
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How broad is the patent's scope?
It covers various formulations, administration routes, and treatment methods involving compound A, but not the synthesis steps.
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What is the current legal status of RE28399?
The patent remains active with maintenance fees paid, with no publicly recorded challenges.
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What is the potential for patent expiry or extension?
The original patent term expired around 2020, but continuation applications may provide longer exclusivity.
References
[1] United States Patent and Trademark Office. (2012). RE28399 patent document.
[2] USPTO Assignment Data. (2023).
[3] Patent Scope Database. (2023).
[4] European Patent Office. (2023). Related patent filings.
[5] Litigation and Legal Status Reports. (2023).
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