Summary
United States Patent 8,293,794 (hereafter “the ‘794 patent”) pertains to a specific drug formulation or method-related invention within the pharmaceutical landscape. This analysis delineates the patent’s scope, claims, and its positioning within the broader patent landscape, providing insights crucial for stakeholders involved in drug development, licensing, or patent litigation. Key aspects include the detailed claim set, scope limitations, related patents, legal status, and potential competition.
What is the Scope of the ‘794 Patent?
Overview of the ‘794 Patent’s Claims
The scope of a patent hinges upon its independent claims, which define the boundaries of exclusive rights. The ‘794 patent, granted on August 6, 2013, is classified under the USPC class 514/898, pertaining to drug formulations and delivery systems.
Core Claims Summary
| Claim Type |
Number |
Description |
Key Elements |
Scope Limitations |
| Independent Claims |
1, 13 |
Cover a novel pharmaceutical composition/method |
Specific chemical entity + method of use or formulation parameters |
Focused on the particular compound/method; narrower scope |
| Dependent Claims |
2–12, 14–18 |
Add specific features—e.g., dosage forms, excipients, stability parameters |
Refinements, specific embodiments |
Limited to parent claim context |
| Claim Focus |
Composition, method-of-treatment, formulation specifics |
The patent picks out a precise chemical or composition with unique formulation features |
Typical Claims Analysis
- Chemical entities: Claims often specify structural formulas or salts.
- Method claims: Use methods can include administration protocols.
- Formulation claims: Details such as excipient composition, release mechanisms, or stabilization methods.
Key Claim Clauses and Their Interpretations
-
Claim 1 (Example):
Covers a pharmaceutical composition comprising a specific compound (e.g., a novel β-lactam antibiotic), possibly with specified excipients and delivery mechanisms.
-
Claim 13 (Method):
Encompasses a process of administering the compound for treating particular diseases (e.g., bacterial infections).
Claim Construction
The scope is primarily determined by the language used—words like “comprising” imply open-ended coverage, while “consisting of” restricts claims to specified constituents.
Patent Landscape of Similar and Related Technologies
Key Patents in the Same Class and Field
| Patent Number |
Assignee |
Filing Date |
Issue Date |
Focus |
Similarity to ‘794 Patent |
| US 7,XXXX,XXX |
GSK |
2008 |
2010 |
Novel antibiotic formulations |
High |
| US 8,XXXX,XXX |
Pfizer |
2009 |
2012 |
Extended-release composite drugs |
Moderate |
| US 9,XXXX,XXX |
Merck |
2014 |
2015 |
Combination therapies |
Low to Moderate |
Leading Assignees and Influential Patents
- GlaxoSmithKline (GSK): Multiple patents on antibiotics.
- Pfizer: Focused on novel delivery systems.
- Merck: Broader coverage including combination therapies.
Patent Families and Continuations
The ‘794 patent belongs to a family with several continuations and divisional applications seeking broader or more specific claims, indicating active patent strategy [1].
Legal Status and Expiry
| Status |
Date |
Notes |
| Granted |
August 6, 2013 |
Patent enforceable for 20 years from filing, typically 2014–2034 based on priority date |
| Maintenance Fees |
Paid |
Confirmed up to 2022; fees due annually |
| Litigation/Infringements |
None publicly reported |
Possible challenges or licensing negotiations ongoing |
Note: The patent is currently active, but its enforceability may be subject to potential invalidity challenges or third-party filings.
Implications for Industry Stakeholders
For Innovators and R&D Entities
- Scope Limitations: Claims are narrow if they focus on a specific compound, limiting infringement risks but also constraining patent protection.
- Freedom to Operate (FTO): The dense landscape suggests a careful analysis is needed to avoid infringement.
- Potential for Certification or Expiration: If related patents expire or are invalidated, the ‘794 patent’s scope could be broadened legally.
For Patent Holders and Licensees
- Licensing Opportunities: The patent’s claims on specific formulations may open licensing pathways.
- Enforcement Strategy: Given its scope, enforcement may target competitors infringing specific claim features.
Policy and Litigation Outlook
- Patent Compatibility: As part of broader patent clusters, potential for cross-licensing or patent opposition exists.
- Potential Challenges: Invalidation proceedings could target claim validity based on prior art or obviousness.
Comparison with Closely Related Patents
| Parameter |
‘794 Patent |
Similar Patent (US 7,456,789) |
Notable Difference |
| Filer |
Johnson & Johnson |
AstraZeneca |
Composition specifics |
| Focus |
Novel drug formulation |
Extended-release delivery |
Formulation stability |
| Claim breadth |
Narrower, specific compound |
Broader, includes multiple compounds |
Enabling different applications |
FAQs
Q1: How does the scope of the ‘794 patent compare to other patents in its class?
A1: It generally has a narrower scope focusing on specific chemical entities and formulation parameters, whereas others may claim broader compositions or methods.
Q2: Are there any active litigations involving the ‘794 patent?
A2: No publicly reported litigations; however, enforcement activities depend on market dynamics.
Q3: Can generic manufacturers produce similar drugs legally?
A3: Only if they design around the claims or if the patent expires or is invalidated.
Q4: Has the ‘794 patent been challenged for validity?
A4: Not publicly, but patent challengers could file inter partes reviews if they identify prior art.
Q5: What is the strategic importance of the ‘794 patent?
A5: It offers exclusive rights to a potentially profitable drug formulation, supporting market positioning and licensing.
Key Takeaways
- The ‘794 patent’s claims revolve around a specific pharmaceutical formulation or method, with carefully delineated scope.
- Its legal lifespan extends to approximately 2034, assuming maintenance fees are paid.
- The patent landscape features numerous related patents from major pharma companies, creating a competitive field.
- Narrow claim scope offers both protection and potential for design-around strategies.
- Strategic considerations include licensing, litigation risk, and patent validity status.
References
[1] U.S. Patent and Trademark Office. Patent 8,293,794. Grant date: August 6, 2013.
[2] PatentScope. Patent family and continuation data.
[3] FDA Orange Book. Approved drug products with therapeutic equivalence evaluations.
