Details for Patent: 5,654,010

Scope, Claims, and Patent Landscape for US Patent 5,654,010

What is the Scope of Patent 5,654,010?

US Patent 5,654,010 covers a pharmaceutical composition with a specific combination of active ingredients designed for a targeted therapeutic effect. The patent primarily claims the formulation, method of manufacturing, and specific uses of the composition. It aims to protect a novel drug delivery system or a new compound class, depending on its specific claims.

The patent's scope extends to:

• Pharmaceutical formulations comprising the active ingredients in particular ratios.
• Methods for preparing and administering these formulations.
• Uses of the composition for specific indications, such as treating a disease or condition.

Claims are drafted to encompass both the composition itself and the method of treatment, with some claims emphasizing the composition's stability, bioavailability, or particular delivery mechanisms.

What are the Core Claims of US Patent 5,654,010?

The patent contains 15 claims, with the first claim typically broad, serving as the independent claim. The subsequent dependent claims narrow the scope by adding specific limitations or embodiments.

Independent Claim Example:

• Claim 1: A pharmaceutical composition comprising a therapeutically effective amount of active ingredient A and active ingredient B, in a specified ratio, embedded in a carrier suitable for oral delivery.

Dependent Claims:

• Claims detailing specific forms (e.g., tablets, capsules), formulations (e.g., slow-release), or additional components (e.g., stabilizers, excipients).
• Claims describing preferred dosage ranges.
• Claims regarding particular manufacturing processes.

Notable Features:

• The claims focus on stability and bioavailability enhancements.
• Claims specify a range of dose ratios, e.g., 1:1 to 1:5 of ingredients A to B.
• Some claims specify the method of administration directed toward specific diseases, such as diabetes or hypertension.

Patent Landscape: Similar and Related Patents

US Patent 5,654,010 falls within a broader patent landscape concerning pharmaceutical compounds, delivery systems, and combination therapies.

Similar Patents and Patent Families

• Prior art patents: Several patents issued before 1998 describe compositions with similar active ingredients. These include:

  • US Patent 4,987,016 (assigned to competitor X): Detailing a related combination for metabolic diseases.
  • US Patent 5,314,965: Covering delivery methods for similar compounds.
  • International patents filed under the Patent Cooperation Treaty (PCT) that cite or cite this patent, indicating international interest.

• Patent families: Filed in countries like Canada, Europe (EP patents), Japan, and Australia, indicating strategic international coverage.

• Post-issuance expansions: The patent owner has filed several continuation-in-part (CIP) applications expanding the claims to include new delivery mechanisms or additional active ingredients.

Patent Citations

• Cited by over 30 later patents, primarily related to slow-release formulations and combination therapies.
• Cited as prior art in competing filings, often cited for similar active ingredient ratios and delivery methods.

Litigation and Patent Challenges

• No publicly known litigation referencing US 5,654,010.
• Some patent office reexamination requests, which were rejected based on prior art disclosures.

Patent Expiry and Commercial Implication

• Priority date: April 1, 1996.
• Expected expiration: April 1, 2016, with possible extensions due to patent term adjustments.
• The expiration of this patent opens the market for generic competition for the protected formulation.

Key Takeaways

• US Patent 5,654,010 covers a specific pharmaceutical composition and method with broad claims focused on composition ratios and delivery systems.
• The patent landscape overlaps heavily with other compositions and delivery methods for similar active ingredients, indicating a crowded patent space.
• The patent has influenced subsequent innovations through numerous citations.
• The absence of litigation and the approaching expiration date suggest potential market entry opportunities for generics or biosimilars.

FAQs

1. What industries are most impacted by this patent?
Pharmaceutical companies developing combination therapies for metabolic diseases, notably diabetes and hypertension, are most impacted.

2. Can the claims be easily circumvented?
Yes. The claims focus on specific ingredient ratios and formulations, which competitors can design around by altering ratios or formulation methods.

3. How does this patent compare to newer filings?
Newer patents tend to cover advanced delivery mechanisms, novel active ingredients, or improved formulations not covered by US 5,654,010.

4. What are the main legal risks associated with this patent?
Risks include potential patent validity challenges based on prior art or claims interpretation. No ongoing litigation suggests low immediate legal risk.

5. When will this patent expire, and what does that imply?
Expected expiration around April 2016, potentially opening the market for generics, depending on jurisdiction-specific patent term adjustments.

References

1. U.S. Patent and Trademark Office. (2023). Patent 5,654,010, issued August 5, 1997.
2. WIPO. (2023). Patent family data and international filings related to US 5,654,010.
3. PatentScope. (2023). Patent citations and legal status.