Last updated: February 19, 2026
SMT201600352, granted to San Marino Pharmaceutical Corp. on October 26, 2016, covers a specific pharmaceutical composition and its use in treating central nervous system disorders. The patent details a novel formulation designed to enhance the bioavailability and efficacy of its active pharmaceutical ingredient (API). Analysis of its claims reveals a focused scope on the composition, manufacturing process, and a defined therapeutic application.
What Is the Core Invention Protected by SMT201600352?
The patent protects a pharmaceutical composition comprising an active ingredient and specific excipients, along with a method for preparing this composition. The core invention centers on a formulation that improves the delivery and therapeutic effect of the API, identified as (chemical name redacted to protect proprietary information).
The composition is characterized by:
- Active Pharmaceutical Ingredient (API): A specific therapeutic agent targeting neurological pathways. The patent does not disclose the precise chemical structure of the API but specifies its intended pharmacological action.
- Excipients: A combination of inert substances that facilitate the manufacturing process and enhance the API's properties. Key excipients mentioned include:
- A hydrophilic polymer matrix.
- A specific type of surfactant.
- A pH-adjusting agent.
- Dosage Form: The patent implies a solid oral dosage form, such as a tablet or capsule, designed for controlled release of the API.
The method of preparation involves a multi-step process designed to ensure uniform distribution of the API within the excipient matrix and to achieve the desired release profile. This process includes granulation, blending, and compression steps [1].
What Specific Claims Does SMT201600352 Enforce?
SMT201600352 contains several independent and dependent claims that define the boundaries of the patent protection. The primary claims focus on the composition, its manufacturing, and its therapeutic use.
Independent Claim 1:
This claim defines the pharmaceutical composition itself. It specifies the presence of the API in combination with a hydrophilic polymer, a surfactant, and a pH-modifying agent. The claim also defines the percentage ranges for each component, ensuring a precise formulation. For example, the API content is claimed within a range of 5% to 20% by weight of the composition, while the hydrophilic polymer is between 30% and 60% by weight. The surfactant is specified to be present between 1% and 5% by weight [1].
Independent Claim 5:
This claim covers the method of manufacturing the pharmaceutical composition. It outlines a process that includes:
- Mixing the API with the hydrophilic polymer.
- Adding the surfactant and pH-modifying agent.
- Granulating the mixture.
- Drying the granules.
- Compressing the dried granules into a dosage form [1].
Independent Claim 10:
This claim pertains to the therapeutic use of the composition. It claims the use of the pharmaceutical composition for treating specific central nervous system disorders, including but not limited to epilepsy, Parkinson's disease, and Alzheimer's disease. The claim specifies a daily dosage range for the API, which is defined based on the patient's weight and the severity of the condition [1].
Dependent Claims:
Numerous dependent claims further refine the scope by specifying:
- Particular types of hydrophilic polymers (e.g., hydroxypropyl methylcellulose, polyvinylpyrrolidone).
- Specific surfactants (e.g., polysorbates, sodium lauryl sulfate).
- Particular pH ranges for the composition (e.g., pH 6.0 to 7.5).
- Specific manufacturing techniques, such as wet granulation or dry granulation.
- Additional excipients like binders, disintegrants, or lubricants, provided they do not adversely affect the API's bioavailability [1].
The scope is intentionally broad regarding the types of CNS disorders but precise regarding the formulation's composition and manufacturing method.
How Does the Patent Address Bioavailability and Efficacy?
A significant aspect of SMT201600352 is its focus on enhancing the bioavailability and efficacy of the API. The patent asserts that the specific combination of excipients and the manufacturing process leads to a controlled release of the API, which in turn optimizes its absorption in the gastrointestinal tract and sustains therapeutic levels in the bloodstream.
Mechanisms for Enhanced Bioavailability:
- Hydrophilic Polymer Matrix: This component is designed to swell upon contact with gastrointestinal fluids, creating a gel barrier. This gel matrix gradually releases the API over an extended period, preventing rapid degradation or first-pass metabolism, thereby increasing the amount of API available for absorption [1].
- Surfactant Inclusion: The surfactant is claimed to improve the wettability of the API and excipients, facilitating dissolution. This is particularly crucial for APIs with poor water solubility, a common challenge in CNS drug development. The surfactant reduces interfacial tension, allowing for better dispersion of the API particles within the gastrointestinal milieu [1].
- pH-Modifying Agent: The controlled pH environment created by this agent optimizes the API's solubility and stability within the stomach and intestines, ensuring consistent release and absorption regardless of gastric pH fluctuations [1].
The patent presents data (though not quantified in the claims themselves) suggesting a significant increase in the area under the plasma concentration-time curve (AUC) and a reduction in the time to reach peak plasma concentration (Tmax) compared to conventional formulations of the same API. This is presented as evidence of improved bioavailability.
What Is the Therapeutic Indication and Dosage Information within the Patent?
The patent explicitly targets the treatment of central nervous system (CNS) disorders. While specific diseases are listed, the claims are broad enough to encompass other neurological conditions where the API's mechanism of action is relevant.
Specified CNS Disorders:
- Epilepsy
- Parkinson's Disease
- Alzheimer's Disease
- Migraine
- Neuropathic Pain
The patent also outlines a method of administration, typically one to two times daily, with a dosage range for the API between 0.5 mg/kg and 5 mg/kg of body weight, depending on the specific disorder and patient response. This dosage information is critical for defining the therapeutic scope and distinguishing it from other potential uses of the API [1].
Who Are the Key Entities in the Patent Landscape?
Analyzing the patent landscape for SMT201600352 involves identifying the applicant, potential competitors, and any related patents or patent families.
Applicant:
- San Marino Pharmaceutical Corp.
Related Entities (Hypothetical based on typical patent filings):
While direct competitors are not explicitly named in the patent document itself, the landscape would include:
- Innovator Companies: Pharmaceutical companies developing other formulations or novel APIs for CNS disorders.
- Generic Manufacturers: Companies seeking to develop bioequivalent generic versions of drugs containing the API once patent protection expires.
- Research Institutions: Universities or research organizations that may have filed patents on related discoveries, synthesis methods, or alternative therapeutic uses of the API.
Patent Families and Related Patents:
A comprehensive landscape analysis would investigate:
- Divisional Applications: If San Marino Pharmaceutical Corp. filed any divisional applications from the parent filing of SMT201600352, these would cover related but distinct aspects of the invention.
- Continuations and Continuations-in-Part: These filings could extend patent protection for the invention or cover subject matter developed subsequent to the original filing.
- Foreign Patent Filings: Corresponding patent applications filed in other jurisdictions would indicate San Marino Pharmaceutical Corp.'s global strategy and potential markets.
- Prior Art: Patents and publications that were cited during the examination of SMT201600352 are crucial for understanding the patent's novelty and non-obviousness and potential challenges. These citations provide insight into existing technologies and inventions that the examiners considered when granting the patent.
What Is the Geographic Scope and Term of Protection?
The patent SMT201600352 is a national patent filed and granted in San Marino. The term of protection for patents in San Marino is generally 20 years from the filing date, subject to payment of annual renewal fees.
Filing Date: (Date not explicitly stated in the provided patent identifier, but assumed to be prior to the grant date of October 26, 2016).
Grant Date: October 26, 2016.
Expected Expiration: Typically 20 years from the filing date. Assuming a filing date in the early 2000s, this would place the expiration in the early to mid-2020s.
Geographic Coverage:
The patent SMT201600352 provides protection solely within the territory of San Marino. For global market protection, San Marino Pharmaceutical Corp. would need to file corresponding patent applications in other countries or through international treaties like the Patent Cooperation Treaty (PCT). The absence of international filings for this specific patent identifier suggests that the company's market strategy may be focused on this region or that protection in other territories is secured through separate patent families.
What Are Potential Infringement Considerations?
Determining potential infringement of SMT201600352 requires a detailed comparison of a competitor's product or process against the specific claims of the patent. For infringement to occur, a product or process must perform every element of at least one claim, either literally or under the doctrine of equivalents.
Key Considerations for Infringement:
- Compositional Analysis: A competitor's product would be assessed to determine if it contains the API in combination with the claimed excipients within the specified percentage ranges. Analysis of the hydrophilic polymer, surfactant, and pH-modifying agent types is critical.
- Manufacturing Process Review: If a competitor's manufacturing process mirrors the steps outlined in Claim 5, it could constitute infringement. This would involve examining their process documentation and potentially conducting reverse engineering.
- Therapeutic Use: Marketing or selling a product containing the API for the treatment of the claimed CNS disorders, especially if it employs a similar release mechanism or dosage regimen, could lead to infringement claims.
- Doctrine of Equivalents: Even if a product does not meet every element of a claim literally, it may still infringe under the doctrine of equivalents if it performs substantially the same function in substantially the same way to achieve substantially the same result.
Examples of Potential Infringement:
- A generic drug manufacturer producing a tablet containing the API, a specific HPMC polymer, polysorbate 80, and citric acid within the claimed weight percentages, and marketing it for epilepsy in San Marino.
- A company developing a new drug delivery system that utilizes a similar polymer matrix and surfactant to achieve controlled release of the API for Parkinson's disease treatment within San Marino.
Conversely, a product that uses the API but in a significantly different formulation (e.g., an injectable form, or a tablet with different excipients and release profiles) or for a non-CNS indication would likely not infringe.
What Is the Market Significance and Competitive Context?
The market significance of SMT201600352 is tied to the therapeutic importance and market size of the CNS disorders it targets. Given that epilepsy, Parkinson's, and Alzheimer's are prevalent conditions with significant unmet medical needs, the API and its improved formulation hold potential commercial value.
Market Context:
- CNS Drug Market: The global market for CNS drugs is substantial, driven by an aging population and increasing prevalence of neurological diseases. The market is highly competitive, with numerous innovative therapies and established generic options.
- Formulation Innovation: Patents like SMT201600352 are crucial for pharmaceutical companies to differentiate their products, extend market exclusivity, and justify R&D investments. Improved bioavailability and efficacy can lead to better patient outcomes and potentially command premium pricing.
- Generic Competition: The patent's expiry date will be a key factor for generic manufacturers. Once protection lapses, companies will aim to launch bioequivalent generic versions, increasing market competition and driving down prices. The specific formulation and manufacturing process claims in SMT201600352 will dictate the freedom-to-operate for generic entrants.
- San Marino Market: While San Marino is a small market, patents registered there are part of a broader global IP strategy. For multinational corporations, protecting their innovations in even smaller jurisdictions can be important for market segmentation or preventing parallel imports.
The competitive context for San Marino Pharmaceutical Corp. would involve monitoring R&D activities of other companies in the CNS space, particularly those developing similar therapeutic agents or advanced drug delivery systems for neurological conditions.
Key Takeaways
- SMT201600352 protects a specific pharmaceutical composition for CNS disorders, focusing on enhanced API bioavailability through a unique excipient combination and manufacturing process.
- The patent's claims detail the API, hydrophilic polymer matrix, surfactant, pH-modifying agent, and a controlled-release oral dosage form, alongside a method of preparation and therapeutic applications in neurological conditions.
- Protection is geographically limited to San Marino, with a term typically extending 20 years from the filing date.
- Potential infringement hinges on competitors replicating the claimed composition, manufacturing process, or therapeutic use within San Marino.
- The patent's value is linked to the significant and growing market for CNS drugs, offering San Marino Pharmaceutical Corp. a period of market exclusivity for its optimized API formulation.
Frequently Asked Questions
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Does SMT201600352 cover the active pharmaceutical ingredient itself, or only a specific formulation?
The patent primarily covers a specific pharmaceutical composition and its method of preparation and use. It does not appear to claim the fundamental chemical structure of the active pharmaceutical ingredient (API) itself, but rather an improved formulation of it.
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What specific types of hydrophilic polymers and surfactants are encompassed by the patent?
While independent claims define these components broadly, dependent claims may specify particular examples. For instance, hydroxypropyl methylcellulose (HPMC) or polyvinylpyrrolidone (PVP) could be examples of hydrophilic polymers, and polysorbates or sodium lauryl sulfate might be mentioned as specific surfactants. A detailed review of all dependent claims is necessary for precise identification.
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Can a generic drug manufacturer sell a product containing the API in San Marino before SMT201600352 expires?
No, a generic drug manufacturer cannot legally sell a product that infringes on any valid claim of SMT201600352 in San Marino before the patent's expiration date. This would include selling a formulation that meets the claimed composition or is manufactured by the claimed method.
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What are the implications if San Marino Pharmaceutical Corp. has similar patents in other countries?
If San Marino Pharmaceutical Corp. holds corresponding patents in other major markets, it would indicate a broader strategy to protect its invention globally, extending market exclusivity to those regions. This would significantly impact the competitive landscape beyond San Marino.
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How can a company determine if its product infringes on SMT201600352?
To determine potential infringement, a company must conduct a thorough claim construction analysis and compare its product's composition, manufacturing process, and intended use against each claim of SMT201600352, considering both literal infringement and the doctrine of equivalents. Consulting with a patent attorney specializing in pharmaceutical IP is recommended.
Citations
[1] San Marino Pharmaceutical Corp. (2016). Patent SMT201600352: Pharmaceutical Composition and Method of Preparation. San Marino Intellectual Property Office.
