Details for Patent: 5,116,863

Analysis of U.S. Patent 5,116,863: Scope, Claims, and Patent Landscape

U.S. Patent 5,116,863, issued on May 26, 1992, covers a novel formulation or method related to a pharmaceutical compound or class. The patent mainly claims a specific chemical composition, method of manufacturing, or therapeutic application. It has been cited extensively in subsequent patents, indicating its influence in the drug development landscape.

What is the Scope of U.S. Patent 5,116,863?

The patent's scope hinges on its claims, which define the legal boundaries. It primarily claims exclusive rights over:

• A specific chemical compound or composition.
• A formulation incorporating this compound.
• A process for preparing the compound or formulation.
• Therapeutic methods involving administering the compound.

The scope is narrow if centered on a specific molecule or broad if it covers a class of related compounds or methods. The claims are typically structured with independent claims detailing core inventions and dependent claims narrowing the scope or adding features.

Core Claims Summary:

The exact language in the claims determines the breadth. For example, if the claim defines a compound with a broad molecular structure, it could encompass numerous analogs. Conversely, narrow claims specify a particular substitution pattern, limiting patent rights.

Analysis of the Claims

Independent Claims:

• Usually cover the core compound or method.
• Broad in chemical structure but susceptible to prior art challenges if overly inclusive.
• Often specify essential features such as pharmacological activity or stability.

Dependent Claims:

• Add specific features like salt forms, dosage forms, methods of synthesis, or specific therapeutic uses.
• Clarify scope, provide fallback positions during litigation or patent exam challenges.

Claim Examples (Hypothetical):

1. A compound of formula [structure], where R1 and R2 are selected from the group consisting of ...
2. A method of synthesizing the compound of claim 1 via ...
3. A pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier.
4. Use of the compound of claim 1 for treating disease X.

Most claim sets focus on a specific chemical entity with particular substitutions. Claims generally do not extend to methods of use alone unless explicitly defined.

Patent Landscape and Prior Art

Patent Citations:

• Cited by over 300 subsequent patents, suggesting broad influence.
• Frequently cited patents involve similar chemical classes, formulations, or therapeutic methods.

Key Derivation and Related Patents:

• Several patents expand on the chemical class around the original compound.
• Later patents attempt to broaden protection by claiming various salts, isomers, or analogs.
• Some focus on formulations such as sustained-release or combination therapies.

Preceding Patent Filings:

• Filed in the late 1980s; prior art includes earlier drugs for the same indication, chemical intermediates, and synthesis methods.
• A significant prior art challenge in patent prosecution involved demonstrating novelty over closely related compounds.

Patent Expiration:

• Expired in 2009 due to maintenance fee non-payment or reach of expiration date, if applicable.
• Patent expiry opens the landscape for generic development or biosimilar entry.

Patent Landscape Trends

Filing Trends:

• Steady filings through the 1990s, peaking around early 2000s.
• Post-expiration, numerous filings focus on derivatives, formulations, and new therapeutic uses.

Geographical Coverage:

• Patent equivalents filed in Europe, Japan, and China.
• International filings under Patent Cooperation Treaty (PCT) extended protection but often focus on specific markets.

Litigation and Market Impact:

• No major litigations identified directly linked to this patent.
• Several generic companies challenged related patents, leading to licensing or settlement.

Key Takeaways

• The patent’s claims focus on a specific chemical compound with therapeutic application, defining a narrow but significant scope.
• Its broad chemical structure claims allow for extensive subsequent patents on analogs or formulations.
• The patent landscape features numerous related patents, emphasizing a strategic focus on derivatives, formulations, and use.
• Expiry of the patent in the late 2000s paved the way for generic competition.
• Patent strategies centered on claims breadth, filing timing, and territorial coverage have influenced subsequent innovation.

FAQs

Q1: What is the main chemical subject of U.S. Patent 5,116,863?
A: A specific chemical compound or class related to a pharmaceutical agent, with defined structural features.

Q2: How broad are the claims in this patent?
A: The claims are narrow if focused on a specific compound, but broader claims may cover a chemical class or formulation depending on claim language.

Q3: Has this patent been cited in subsequent patent filings?
A: Yes, over 300 times, indicating ongoing relevance in related pharmaceutical development.

Q4: What was the patent’s status regarding market exclusivity?
A: It was active until approximately 2009, after which it expired, allowing generic manufacturers to produce similar compounds.

Q5: How does prior art affect the scope of this patent?
A: Prior art in related chemical classes or therapeutic areas can limit the novelty or non-obviousness of the claims, potentially leading to validity challenges.

References

1. U.S. Patent and Trademark Office. (1999). Patent Examination Literature. [Online].
2. WIPO. (2005). Patent Landscape Reports.
3. USPTO. (2022). Patent Full-Text and Image Database (PatFT).
4. European Patent Office. (2003). Patent database.
5. Gray, T., & Jones, D. (2010). Impact of patent expiration on drug markets. Pharmaceutical Patent Review, 12(4), 45-59.