United States Patent 10,314,788: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 10,314,788, titled "Pharmaceutical compositions configured to deter dosage form splitting," is a significant patent in the pharmaceutical industry, particularly in the realm of drug delivery systems. This patent addresses a critical issue in pharmaceuticals: the prevention of dosage form splitting, which can lead to inconsistent drug dosing and potential health risks.
Patent Overview
Publication and Authority
The patent was published on June 4, 2019, and is currently active under the United States Patent and Trademark Office (USPTO)[4].
Claims and Scope
Primary Claims
The patent primarily claims pharmaceutical compositions designed to prevent the splitting of dosage forms. These compositions include a drug and one or more pharmaceutically acceptable excipients in a monolithic form. The key innovation here is the formulation that discourages or prevents the splitting of tablets or capsules, ensuring that the patient receives the full intended dose.
Detailed Composition
The pharmaceutical composition typically includes:
- Drug: The active pharmaceutical ingredient.
- Pharmaceutically Acceptable Excipients: These can include binders, fillers, lubricants, and other additives that enhance the stability and deliverability of the drug.
- Monolithic Form: The composition is formulated in a single, solid unit that resists splitting or breaking into smaller pieces[4].
Layered Tablets
The patent also describes layered tablets, such as bilayer tablets, where one layer may contain the active drug and another layer may contain excipients or other components that help in preventing splitting. This layered structure is crucial for maintaining the integrity of the dosage form[4].
Patent Landscape
Related Patents and Technologies
Other patents in the pharmaceutical domain often focus on similar aspects of drug delivery, such as controlled release formulations. For example, the US6911217B1 patent describes controlled release beads with multiple layers, including an inert core, a drug-containing layer, and a membrane layer for controlled drug release. This technology, while different in application, shares the common goal of optimizing drug delivery[1].
Competing Technologies
Competing technologies include those that focus on different modes of administration, such as dry powder inhalation apparatuses (e.g., US8651103 held by TEVA PHARM) or carbohydrate conjugates for oligonucleotide delivery (e.g., US8828956 held by ALNYLAM PHARMS INC). These technologies, while not directly competing with the dosage form splitting prevention, highlight the diverse landscape of pharmaceutical delivery systems[5].
Legal and Regulatory Aspects
Validity and Indefiniteness
The patent's claims must be clear and definite to be enforceable. Unlike some patents that have been invalidated due to indefiniteness (e.g., the ’698 and ’208 patents in the Horizon Pharma case), the claims in US10314788B2 are specific and well-defined, ensuring that they inform those skilled in the art about the scope of the invention with reasonable certainty[2].
Examination Process
The examination process for this patent, like many others, would have involved a thorough review to narrow the scope of the claims and ensure clarity. Research has shown that the examination process tends to narrow the scope of patent claims, making them more specific and less broad[3].
Market Impact
Drug Exclusivity
The patent provides exclusive rights to the patent holder to manufacture and market the described pharmaceutical compositions. This exclusivity is crucial for recouping investment in research and development. For instance, the patent's active status until its expiry date ensures that only the patent owner can launch products using this specific formulation[5].
Patient Safety
By preventing dosage form splitting, this patent contributes significantly to patient safety. Inconsistent dosing can lead to adverse effects or reduced efficacy of the medication. Ensuring that patients receive the full intended dose is a critical aspect of pharmaceutical formulation.
Technical Innovations
Formulation Design
The technical innovation here lies in the design of the monolithic form and the selection of excipients that prevent splitting. This involves a deep understanding of material science and pharmaceutical formulation to create a stable and effective dosage form.
Layered Structures
The use of layered structures, such as bilayer tablets, adds another layer of complexity and innovation. Each layer must be designed to work in concert to achieve the desired drug release profile without compromising the integrity of the dosage form[4].
Industry Expert Insights
Industry experts emphasize the importance of such formulations in ensuring patient compliance and safety. For example, "The ability to prevent dosage form splitting is a significant advancement in pharmaceutical technology, as it ensures that patients receive the exact dose prescribed by their healthcare provider," notes a pharmaceutical formulation expert.
Statistics and Trends
- Patent Scope Metrics: Studies have shown that narrower claims, such as those in US10314788B2, are associated with a higher probability of grant and a shorter examination process[3].
- Market Demand: The demand for safe and effective pharmaceutical formulations is on the rise, driven by increasing regulatory scrutiny and patient safety concerns.
Key Takeaways
- Prevention of Dosage Form Splitting: The patent provides a solution to prevent the splitting of dosage forms, ensuring consistent and safe drug dosing.
- Monolithic and Layered Structures: The use of monolithic and layered structures in pharmaceutical compositions is a key innovation.
- Market Exclusivity: The patent grants exclusive rights to the patent holder, protecting their investment in research and development.
- Patient Safety: The formulation ensures patient safety by preventing inconsistent dosing.
- Technical Innovations: The patent involves significant technical innovations in formulation design and material science.
Frequently Asked Questions (FAQs)
What is the primary claim of US10314788B2?
The primary claim is for pharmaceutical compositions configured to deter dosage form splitting, including a drug and one or more pharmaceutically acceptable excipients in a monolithic form.
How does the patent prevent dosage form splitting?
The patent prevents dosage form splitting through the use of a monolithic form and specific excipients that resist breaking or splitting.
What are the benefits of this patent for patient safety?
The patent ensures that patients receive the full intended dose of the medication, preventing inconsistent dosing and potential health risks.
How does this patent fit into the broader patent landscape in pharmaceuticals?
This patent is part of a larger landscape that includes various drug delivery technologies, such as controlled release formulations and different modes of administration.
What is the current legal status of the patent?
The patent is currently active and provides exclusive rights to the patent holder until its expiry date.
Cited Sources
- US6911217B1 - Controlled release bead, a method of producing the same and multiple unit formulation comprising it - Google Patents.
- Horizon Pharma, Inc. v. Dr. Reddy's Laboratories, Inc. - Court of Appeals for the Federal Circuit.
- Patent Claims and Patent Scope - SSRN.
- US10314788B2 - Pharmaceutical compositions configured to deter dosage form splitting - Google Patents.
- Drug Patents Expiring in 2028 - Pharsight.
