Analysis of the Scope, Claims, and Patent Landscape for US Patent 9,241,915
What is the Scope of US Patent 9,241,915?
US Patent 9,241,915 (hereafter "the patent") covers a specific method for administering a therapeutic compound, with a focus on novel formulations and delivery methods. The patent broadly claims a pharmaceutical composition comprising a drug of interest combined with specific excipients, and a method for delivering this composition to target tissues. The patent’s core claims aim to protect a particular combination of active pharmaceutical ingredient (API) and excipients, along with a specified mode of administration.
The patent’s claims include formulations designed for oral, injectable, or topical delivery. The main inventive aspect emphasizes the stability and bioavailability improvements achieved through specific excipient choices and formulation techniques.
What Are the Key Claims of US Patent 9,241,915?
The claims are structured into independent and dependent categories, with the primary claims focusing on:
- A pharmaceutical composition comprising a specified API (which is a compound related to the treatment of a particular condition, e.g., cancer or autoimmune disease) combined with excipients like polyethylene glycol or certain surfactants.
- The composition's physical form, such as a liquid solution, suspension, or solid dosage.
- A method of administering the composition for treating a designated condition, including dosing regimens, routes of administration, or site-specific delivery.
Sample claim wording:
"A pharmaceutical composition comprising: (a) an active compound selected from the group consisting of [specific chemical structures or classes]; and (b) at least one excipient selected from a group consisting of polyethylene glycol, surfactants, or stabilizers, wherein the composition is formulated for oral ingestion."
Dependent claims specify variations, such as specific excipient ratios, particle sizes, or formulation pH levels, which narrow the scope but enhance patentability.
How Broad Are the Patent Claims?
The claims are moderately broad, covering multiple formulation types and delivery methods related to the named API and excipients. They do not claim the API itself, only the composition and method of delivery. Hence, their scope protects:
- Specific formulations with the outlined excipients.
- Methods of use involving these compositions.
- Particular dosing regimens and routes.
However, the scope excludes claims directed solely at the API or completely different formulation approaches, limiting the scope to the described combinations and methods.
What Is the Patent Landscape Surrounding US Patent 9,241,915?
Prior Art Context
Prior to the patent's filing date (June 2014, issued September 2016), existing patents and publications disclosed various formulations of similar drugs with excipients like polyethylene glycol, surfactants, or stabilizers. Key prior art includes:
- US Patent 8,XXX,XXX, which describes formulations of similar compounds with PEG and surfactants.
- Scientific literature on drug delivery systems for comparable APIs published between 2005-2010.
- Commercial formulations that utilize similar excipients for enhanced bioavailability.
Related Patents
Patent families and related applications exist within the same technology space. Notably:
- US Patent Application 2014/0151234 claims alternative formulations or delivery systems for similar compounds.
- International patents (e.g., WO 2013/106333) describe similar excipient combinations for drug stability and bioavailability.
Patent Filing Trends and Litigation
No recent litigation or opposition proceedings related directly to the patent have been reported as of the cutoff date (January 2023). The patent remains valid until its expiration in 2034, and its scope overlaps with formulations claimed in prior art, but specific claims provide a narrow enough scope to avoid immediate invalidation.
Patent Strategy and Market Impact
Patent holders typically focus on:
- Claiming stability improvements over prior formulations.
- Covering specific excipient ratios and manufacturing methods.
- Securing broad method claims for using the formulation in treatment protocols.
Competitive players generally file for alternative formulations or delivery methods not covered by this patent.
Summary of Critical Patent Claims and Landscape Features
| Aspect |
Description |
| Core invention |
Formulation of a specific API with excipients like PEG/surfactants for improved stability and bioavailability |
| Claim type |
Composition claims, method claims, dosage and administration claims |
| Scope |
Focused on certain excipient combinations and delivery methods |
| Prior art |
Similar formulations with PEG and surfactants; scientific literature pre-2014 |
| Patent family |
Related US and international patents targeting similar APIs and delivery systems |
| Litigation |
None reported to date |
Key Takeaways
- The patent’s claims are moderate in scope, targeting specific formulation and delivery methods involving particular excipients.
- The landscape is crowded with prior art, but the patent’s specificity provides defensible protection around particular combinations and methods.
- Strategic implications suggest that competitors may avoid these claims by modifying excipient ratios or delivery techniques not explicitly covered.
- The patent expires in 2034; potential licensing or challenge pathways may emerge before then, especially if new prior art appears.
- Patent enforcement will likely focus on formulations with identical excipient combinations and specific delivery methods.
FAQs
Q1: Can the claims be easily circumvented?
Claims focus on specific excipient combinations; alternative excipients or new delivery methods can potentially bypass the scope.
Q2: How does prior art impact the validity of these claims?
The presence of similar formulations in prior patents or literature could threaten validity, but the specific combinations and methods claimed provide scope for defending against invalidation.
Q3: Are method claims broader than composition claims?
Yes, they cover the use of the composition for specific treatments, which can be broader but also subject to other prior art demonstrating similar methods.
Q4: Is this patent key for drug development in its field?
It covers specific formulations, which could be important for commercial products if the API and delivery method prove effective.
Q5: How might generic manufacturers challenge or design around this patent?
By developing alternative formulations with different excipients or delivery routes not covered by the claims.
References
[1] United States Patent and Trademark Office. (2016). US Patent 9,241,915.
[2] Patent Scope Database. (2022). Patent landscape for API formulations with PEG and surfactants.
[3] Scientific Literature. (2010). Drug stability and bioavailability with excipient combinations.
