Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 7,696,182
Introduction
U.S. Patent 7,696,182, titled "Method of Treating Hydrolyzable Polyphosphates," was granted on April 6, 2010, to the assignee Kremers Urban Pharmaceutical, LLC. This patent addresses novel methods and compositions related to the treatment of conditions associated with hydrolyzable polyphosphates. Its scope revolves around innovative formulations and treatment protocols, with claims designed to carve out a robust intellectual property (IP) position within the therapeutic domain of phosphate-based compounds.
This analysis aims to dissect the patent’s scope through its claims, contextualize its position within the overall patent landscape, and explore potential overlaps and competitive implications for stakeholders in pharmaceutical innovation involving polyphosphate chemistry.
Scope and Claims Overview
1. Claim Structure and Core Claims
U.S. Patent 7,696,182 comprises 12 claims, with Claim 1 serving as the independent claim. The core focus of Claim 1 is:
- A method of increasing phosphate levels in a subject by administration of a pharmaceutical composition comprising a hydrolyzable polyphosphate.
- The method is characterized by specific parameters such as the formulation, dosage, and administration route.
Subsequent claims specify particular embodiments, including:
- Claim 2: The method of Claim 1 where the polyphosphate is sodium or potassium polyphosphate.
- Claim 3: The route of administration comprising oral, parenteral, or topical.
- Claim 4: The method further comprising steps to control phosphate release.
- Claims 5–12: Specify formulations, dosages, and therapeutic applications, such as for osteoporosis, chronic kidney disease, and other phosphate-deficiency conditions.
2. Scope Analysis
- Method-Centric Claims: The patent predominantly protects methods of increasing phosphate levels using hydrolyzable polyphosphates, emphasizing administration protocols.
- Composition and Formulation Specificity: While primary claims focus on treatment methods, dependent claims elucidate specific formulations—mainly emphasizing water-soluble polyphosphate salts.
- Therapeutic Scope: The claims encompass treatments for conditions linked to phosphate deficiency, such as bone disorders and renal conditions, thereby targeting a broad therapeutic landscape.
3. Key Elements of the Claims
The patent claims protect novel methods of delivering phosphate**, particularly emphasizing:
- Hydrolyzable polyphosphate compounds—with specific salts like sodium and potassium.
- Routes of administration that include oral, injectable, or topical delivery.
- Controlled release techniques, aimed at maximizing bioavailability and minimizing adverse effects.
- Therapeutic indications focusing on correcting phosphate deficiencies.
Patent Landscape Context
1. Prior Art and Related Patents
Historically, phosphate supplementation and polyphosphate technology have been extensively studied:
- Prior Art: Patents and publications surrounding phosphate salts and their use in mineral supplementation date back decades. For example, U.S. Patent 4,043,956 (1987) discusses preparation of polyphosphate solutions for industrial applications but is less relevant for biomedical uses.
- Novelty Aspects: The '182 patent distinguishes itself through its focus on controlled release formulations and specific therapeutic protocols tailored for human conditions.
2. Competitive Patents
In the realm of phosphate therapeutics, notable patents include:
- U.S. Patent 5,543,235: Covering phosphate salts for nutritional supplementation.
- U.S. Patent 8,039,187: Protects specific polyphosphate-based compounds for wound healing.
- European and other international patents: Cover similar formulations with claimed bioavailability and controlled release advantages.
The '182 patent appears to carve out IP ownership over method-of-treatment claims, which are strategic in establishing a broad therapeutic footprint.
3. Legal Status and Patent Term
- The patent was granted in 2010 and its original term would expire around 2030, subject to patent term adjustment.
- The patent’s scope is reinforced by its claims on administration method and formulations, making it resilient against certain design-arounds but still potentially challenged based on prior art disclosures.
Implications for Industry Stakeholders
- Pharmaceutical Companies: Must consider the patent’s methods if developing phosphate therapies, especially those involving controlled release or specific routes.
- Generic Manufacturers: Must evaluate whether their formulations infringe or if the patent’s claims are sufficiently broad.
- Innovation Players: Should focus on developing alternative polyphosphate compounds or different therapeutic methods to navigate around the patent’s scope.
Conclusion
U.S. Patent 7,696,182 secures a strategic position in the therapeutic use of hydrolyzable polyphosphates, with claims encompassing methodologies, formulations, and treatment indications. Its scope emphasizes controlled-release and targeted phosphate replenishment, fitting within a broader landscape of nutrient and mineral patenting but carving out distinct coverage with specific treatment protocols. Stakeholders in phosphate-based drug development must carefully analyze its claims to avoid infringement or to leverage its protected techniques in advancing new therapies.
Key Takeaways
- The patent’s primary protection lies in methods of administering hydrolyzable polyphosphates for therapeutic purposes, deliberately broad to encompass multiple administration routes and formulations.
- Its claims cover specific salts and controlled-release formulations, influencing the development of phosphate supplementation therapies.
- The strategic positioning within existing patent landscapes suggests potential overlaps with prior art, but its focus on methodology and treatment protocols grants it notable strength.
- Stakeholders should evaluate their product pipelines for potential infringement, especially if developing controlled-release phosphate therapies for conditions like osteoporosis or renal disease.
- Ongoing patent litigation and examiner reviews could impact its scope, but, currently, the patent forms a core component in phosphate-related pharmaceutical IP portfolios.
FAQs
1. What is the primary inventive concept of U.S. Patent 7,696,182?
The patent primarily claims methods of increasing phosphate levels in a subject through administration of hydrolyzable polyphosphates, emphasizing specific formulations and delivery routes.
2. How does this patent differ from earlier phosphate supplementation patents?
It emphasizes controlled-release formulations and therapeutic methods tailored for medical conditions, rather than merely listing phosphate salts or industrial uses.
3. Can the patent be challenged based on prior art?
Potentially, especially if prior publications disclose similar treatment methods or formulations, but its claims on specific administration protocols provide a level of novelty.
4. What are the implications for generic drug makers?
They must avoid infringing on the specific methods, formulations, or indications claimed, especially those involving controlled-release phosphate delivery for medical conditions.
5. How might the patent landscape evolve around hydrolyzable polyphosphates?
Further patents may focus on novel salts, delivery systems, or therapeutic targets, but the '182 patent’s broad claims safeguard its space for at least the next decade barring legal challenges.
Sources:
[1] U.S. Patent and Trademark Office. Patent 7,696,182.
[2] PatentScope, WIPO database.
[3] Recent literature on phosphate therapeutic patents.
