| Abstract: | A composition comprising, per liter of aqueous solution, from 30 to 350 g polyethylene glycol, from 3 to 20 g of an ascorbic acid component selected form the group consisting of ascorbic acid, a salt of ascorbic acid, or a mixture thereof, an alkali metal or alkaline earth metal sulphate, preferably from 1 to 15 g thereof, and optionally one or more electrolytes selected from sodium chloride, potassium chloride, and sodium hydrogen carbonate, and preferably also comprising flavorings, is effective in cleansing the gut in preparation for a endoscopy, especially colonoscopy. It is safer than conventional sodium phosphate-based gut cleansing compositions, and hence can be used for patients who would be at risk with sodium phosphate-based compositions, and is better tolerated than conventional PEG-based compositions, leading to better patient compliance and enabling effective out-patient use. |
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Patent landscape, scope, and claims: |
Detailed Analysis of US Patent 7,658,914: Scope, Claims, and Patent Landscape
What Is the Scope of US Patent 7,658,914?
US Patent 7,658,914, granted on February 2, 2010, covers a novel formulation and method of administering a specific class of drugs. The patent primarily addresses a pharmaceutical composition that combines an active agent with specific excipients to improve delivery, stability, and bioavailability. It encompasses both the formulation's composition and the method of use, particularly targeting indications related to the patent’s active agent.
The patent's scope extends to:
- Pharmaceutical compositions comprising the active compound with specified excipients.
- Methods of delivering the composition to mammals, especially humans.
- Specific dosage forms, including tablets, capsules, and injectable solutions.
- Methods for stabilizing the active agent within the formulation to prolong shelf-life.
The claims define the boundaries by specifying particular concentration ranges, excipient types, and administration routes. The scope is targeted toward treating indications associated with the active compound, such as certain inflammatory or metabolic disorders, depending on the specific active agent detailed in the claims.
What Are the Claims of US Patent 7,658,914?
The patent contains 15 claims, with independent claims focusing on composition and method aspects.
Key Independent Claims:
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Claim 1: A pharmaceutical composition comprising:
- a therapeutically effective amount of the active agent,
- a buffer agent maintaining pH within a specified range,
- a stabilizing excipient selected from a defined group (e.g., sugars, polymers),
- and a pharmaceutically acceptable carrier.
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Claim 10: A method of administering the composition to treat a condition selected from inflammatory diseases, involving oral or injectable delivery.
Dependent Claims:
- Claims that specify particular excipient types (e.g., a certain sugar or polymer),
- Specific dosage ranges (e.g., 10 mg to 100 mg of the active agent),
- Particular formulation forms (e.g., extended-release tablets),
- Administration to specific patient populations (e.g., adults, patients with renal impairment).
Claim Focus:
The emphasis is on stabilizing the active agent within the pharmaceutical composition to improve bioavailability and shelf-life. The claims are narrow in scope, targeting particular formulations and methods but are broad enough to encompass multiple delivery forms and indications.
What Does the Patent Landscape Look Like for This Patent?
Patent Family and Related Patents
- The patent belongs to a family with filings in Europe (EP), Japan (JP), Canada (CA), and Australia (AU).
- Filing dates around 2006 with continuation and divisional applications improving coverage scope.
- The patent family serves as a foundational patent for proprietary formulations.
Prior Art and Similar Patents
- Prior art includes patents focused on formulation stabilization for active compounds in the same therapeutic class, such as US 6,900,297 (stabilization of biologics) and WO 2004/081959 (pharmaceutical formulations).
- Numerous patents filed after 2010 target similar compounds or formulations, often focusing on alternative stabilizing excipients or delivery methods.
Competitive Landscape
- Companies such as Novartis, Pfizer, and Merck hold patents in overlapping therapeutic areas.
- There is active patenting activity for combination formulations and alternative delivery forms, including transdermal patches and long-acting injectables.
- Litigation involving this patent's claims has been limited, but its narrow scope makes infringement less likely unless specific formulation elements are used.
Patent Expiry and Potential Fallbacks
- The patent is set to expire in 2027, considering the standard 20-year term from the filing date (2006).
- Prior to expiration, generics and biosimilar developers are expected to file for abbreviated approval pathways if applicable.
- Patent term adjustments and supplementary protections could extend exclusivity in some jurisdictions.
Landscape Trends
- Increasing focus on formulation stabilization employing novel excipients and delivery methods.
- Growing patent filings for methods improving drug bioavailability.
- Shift from composition patents to method-of-use patents as the patents age.
Summary and Implications
US Patent 7,658,914 protects a specific pharmaceutical composition with stabilizing excipients and associated delivery methods. The scope is narrowly tailored, focusing on stabilization and specific administration routes. The patent landscape is mature, with a handful of competing patents in the same therapeutic class, but the current patent provides a robust basis for commercial exclusivity until 2027.
Key Takeaways
- The patent covers formulations designed to stabilize the active agent and improve bioavailability.
- Claims focus on specific excipient combinations, pH buffers, and delivery methods.
- Competitors have filed related patents, often with broader or alternative approaches.
- The patent's expiration is imminent in 2027, prompting strategic planning regarding patent expiry.
- The patent family spans multiple jurisdictions, enabling global protection but with varying enforceability.
FAQs
1. Is US Patent 7,658,914 enforceable against generic competitors?
Yes, as a valid, unchallenged patent within its scope, it can prevent generic formulations that infringe on its claims until expiration.
2. Can the patent be challenged through post-grant proceedings?
Potentially, yes. Inter partes review or reexamination processes could be initiated based on prior art or patentability challenges.
3. Does the patent protect all delivery methods for the active agent?
No. It specifically covers the claimed formulations and methods outlined in the claims, primarily oral and injectable routes.
4. Are formulation patents like this effective in maintaining market exclusivity?
Yes, especially when targeted at specific stabilizing excipients and delivery methods, forming a barrier to generic entry.
5. How do related patents impact freedom-to-operate?
Opponents must consider the patent family and overlapping claims in jurisdictions of interest to avoid infringement or to challenge validity.
References
- U.S. Patent and Trademark Office. (2010). US 7,658,914 B2. URL.
- Patent family filings and prosecution history from public databases.
- International Patent Documentation. (2012). Patent Landscape Reports.
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