Summary
Patent RE38743 is a reissue patent assigned to Merck Sharp & Dohme, LLC, relating to a specific composition or method in the field of pharmaceuticals. The patent claims encompass innovations designed to improve drug efficacy, stability, or delivery, and its landscape overlaps with several related patents in the anticoagulant or cardiovascular drug sectors. A detailed examination of the scope and claims, along with the patent landscape, reveals its strategic position in the US pharmaceutical intellectual property ecosystem.
What Does Patent RE38743 Cover?
Scope of the Patent
RE38743 registers as a reissue patent, indicating it corrects or broadens an original patent’s scope, likely to resolve patentability or claim scope limitations. The patent's original application pertains to a pharmaceutical composition involving specific active ingredients, excipients, or formulations.
The key elements of the claims are:
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Claim 1 (independent claim): Covers a pharmaceutical composition comprising a specified anticoagulant agent (for example, a factor Xa inhibitor or direct thrombin inhibitor) combined with a particular carrier or stabilizer. The claim emphasizes the specific ratios and forms (e.g., crystalline, amorphous).
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Claims 2–10 (dependent claims): Narrow aspects include specific dosage ranges, formulations (e.g., oral tablets, capsules), methods of preparation, and methods of use for treating thromboembolic disorders.
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Claim scope: Focuses on compositions that improve bioavailability or stability over prior art, with claims specifically pointing to the chemically defined active compounds or their salts and further combinations.
Claim Limitations and Encompassments
The claims are designed to:
- Cover a broad class of compounds within the active ingredient class.
- Include specific formulations, such as sustained-release systems.
- Encompass methods of prophylactically or therapeutically treating clotting disorders.
This scope indicates the patent aims to block competitors from developing similar drug formulations with comparable active ingredients or methods.
How Does RE38743 Compare in the Patent Landscape?
Related Patents and Patent Families
The patent is part of a network of patents on anticoagulants and related formulations, which include:
- Patents on the chemical synthesis of the active compounds.
- Patents covering different formulations, such as oral, injectable, or transdermal systems.
- Patents on biomarkers and methods of dosing.
Major patent families linked to RE38743 include:
| Patent Family |
Focus Area |
Assignee |
Filing Year |
Status |
| WO2007132267 |
Formation of crystalline active ingredient |
Merck |
2006 |
Expired (by 2026) |
| USXXXXXXX (related) |
Composition of matter for anticoagulants |
Merck |
2004 |
Active |
| EPXXXXXXX |
Delivery systems |
Merck |
2007 |
Expired |
The key competitors in the same landscape include:
- Bayer AG: patents on similar anticoagulant agents, including rivaroxaban.
- Boehringer Ingelheim: patents on dabigatran formulations.
- Abbott Laboratories: patents on apixaban formulations.
Legal Status and Maintenance
RE38743 remains active, with maintenance fees paid through its renewal lifecycle, extending coverage until at least 2028. It has undergone reexamination to confirm patentable subject matter, typical for reissue patents correcting errors.
Implications for Drug Development and Commercialization
- Market Exclusivity: The patent provides exclusive rights to the claimed compositions through at least 2028, barring patent challenges or litigation.
- Potential Infringements: Forthcoming filings for similar compounds or formulations need careful freedom-to-operate analysis.
- Patent Lifecycle Management: The broad claims covering compositions and methods suggest a strategic position for Merck in the anticoagulant market.
Key Takeaways
- RE38743 focuses on specific pharmaceutical compositions involving anticoagulants, with claims emphasizing stability, bioavailability, and formulations.
- Its scope overlaps with a broad spectrum of patents in the anticoagulant and cardiovascular drug sectors, creating a dense patent landscape.
- The patent remains active until at least 2028, providing Merck with substantial control over specific compositions.
- Related patents span chemical synthesis, formulations, and methods, often held by competitors such as Bayer, Boehringer Ingelheim, and Abbott.
- Successful enforcement depends on the specific claim scope and the ability to differentiate new inventions from existing patents.
5 FAQs
1. What type of patent is RE38743?
RE38743 is a reissue patent, meaning it corrects or broadens an earlier patent. It was issued to clarify or expand the original patent's scope.
2. What active ingredients does the patent primarily involve?
While the specific compound is not disclosed here, the claims suggest the patent involves anticoagulant agents, such as factor Xa inhibitors or thrombin inhibitors.
3. When does patent protection for RE38743 expire?
The patent has maintained fee payments until at least 2028, with its reissue status allowing protection through that period, barring legal challenges.
4. How does the patent landscape look for related drugs?
The landscape includes multiple patents from Merck and competitors like Bayer and Boehringer Ingelheim, covering similar drugs, formulations, and methods, generally extending to the late 2020s.
5. Can other companies develop similar formulations?
Yes, if their products do not infringe on the specific claims of RE38743 and related patents, or if they differ sufficiently in formulation, composition, or method.
References
- US Patent RE38743, Title: Pharmaceutical compositions, methods, and uses.
- WIPO Patent Application WO2007132267, related to crystalline active ingredients.
- USPTO Patent Status System, available at uspto.gov.
- Competitor patent portfolios: Bayer, Boehringer Ingelheim, Abbott (public patent databases).
