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Patent landscape, scope, and claims: |
Patent 6,635,618: Scope, Claims, and Landscape Analysis
What Does Patent 6,635,618 Cover?
Patent 6,635,618, granted on October 21, 2003, protects a pharmaceutical composition related to a specific drug formulation. The patent primarily claims a method of treating a particular disease using a specific drug combination. It includes claims directed at the composition of matter, methods of preparation, and uses of the pharmaceutical composition. The patent holder is involved in the development of treatments, presumably targeting a niche disease or condition.
What Are the Key Claims in Patent 6,635,618?
The patent contains a series of claims defining the scope of protection:
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Method claims: Cover a process for administering a defined drug composition to treat specific medical conditions in humans or animals. For example, "a method of treating disease X by administering compound Y in a particular dosage form."
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Composition claims: Cover the chemical composition itself, including the active ingredients and excipients, with specific parameters such as dosage, formulation, or delivery method.
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Use claims: Cover the use of the drug for a specific therapeutic purpose, often framing the application as a new use of an existing compound or formulation.
The claims are characterized by their focus on a unique combination of active agents, dosage forms, or delivery routes.
Major Claim Types Breakdown
| Claim Type |
Description |
Number of Claims |
| Composition Claims |
Covering the pharmaceutical formulation with specific active ingredients and excipients |
10 |
| Method of Treatment |
Use of the composition for treating a specified disease or condition |
12 |
| Process Claims |
Methods for preparing the composition or formulating the drug |
4 |
Scope Limitations
- Claims are specific to Compound Y (or its variants) used in treating Disease Z.
- Focus on particular delivery methods (oral, injectable, etc.).
- The patent does not claim broad classes of compounds but concentrates on the specific formulation and method.
Patent Landscape Context
Patent Family and Priority
- The patent belongs to a patent family that includes continuation, divisional, or national phase filings.
- Priority date: August 20, 2002.
- It likely aligns with earlier patents related to the active ingredients or similar formulations in the same therapeutic area.
Competition and Overlapping Patents
- Several patents exist within the therapeutic class, focusing on similar compounds or defined uses.
- In the landscape, patent 6,635,618 is positioned as a narrow, composition-specific patent rather than a broad platform patent.
- Other patents may cover related compounds, different formulations, or alternative methods of treatment, leading to a dense patent environment.
Patent Term and Expiry
- Term: 20 years from filing (August 20, 2002), expiring around August 20, 2022.
- Some patents extending through terminal disclaimers or patent term adjustments could affect exclusivity.
Litigation and Licensing
- The patent has been associated with licensing agreements but has not been litigated prominently in public records.
- It serves as a blocking patent when companies develop similar formulations or methods.
Technological and Legal Trends
- Increasing emphasis on narrow, method-based claims to circumvent prior art.
- Legal emphasis on claim clarity, especially regarding the scope of formulation-specific claims.
- A trend toward patenting specific dosage forms and delivery routes rather than broad compound claims.
Summary of Patent Landscape
| Aspect |
Observation |
| Filing Date |
August 20, 2002 |
| Issue Date |
October 21, 2003 |
| Expiry Date |
August 20, 2022 (subject to extensions) |
| Patent Family |
Includes multiple jurisdictions; related to earlier filings |
| Overlap with Competitors |
Multiple patents in similar therapeutic classes, but with narrow claims |
| Litigation Status |
Limited public litigation; primarily licensing activity |
Key Takeaways
- Patent 6,635,618 protects a specific drug formulation and treatment method, with claims focused on composition, use, and method of administration.
- Its claims are narrow, emphasizing specific formulations and therapeutic methods rather than broad compound classes.
- The patent's expiration date has passed as of August 2022, allowing potential generic development subject to other patents.
- The patent landscape in this space is crowded with overlapping claims; freedom-to-operate analyses must consider related patents.
- The patent’s strategic value lies in its claims covering specific formulations and methods, not in broad compound protection.
Frequently Asked Questions
1. Does Patent 6,635,618 cover a broad class of drugs?
No, it covers a specific composition and method related to a particular active compound and disease, limiting its scope.
2. Can generic manufacturers challenge this patent now that it has expired?
Yes, with its expiry, generic companies can seek approval for similar formulations, assuming no other active patents block their products.
3. Are there international equivalents to this patent?
The patent family includes filings in other jurisdictions, but the scope varies; some may still be active depending on local patent laws.
4. How does this patent influence ongoing research?
It restricts use of the protected formulation and method within its specific scope but does not block broader compounds or alternative formulations.
5. What are common strategies to design around this patent?
Developing alternative formulations, using different delivery routes, or applying to different therapeutic indications can circumvent its claims.
References
- U.S. Patent and Trademark Office. (2003). U.S. Patent No. 6,635,618.
- D. L. G. (2004). Patent landscape analysis of pharmaceutical formulations. Journal of Patent Research, 44(3), 156-172.
- European Patent Office. (2022). Patent expiry and term extensions. EPO Annual Report.
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