United States Patent RE49110: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent RE49110, titled "Pharmaceutical formulations containing dopamine receptor ligands," is a significant patent in the pharmaceutical industry, particularly in the realm of psychiatric and neurological treatments. This patent protects the drug VRAYLAR, which is used for various psychiatric disorders.
Inventors and Assignee
The patent was invented by Ranajoy Sarkar, Mahendra G. Dedhiya, and Anil Chhettry, and is assigned to Richter Gedeon Nyrt.[1][4].
Abstract and Summary
The patent pertains to stable and bioavailable immediate release formulations that contain dopamine receptor ligands. These formulations are designed to treat various disorders, including psychiatric conditions. The invention also describes methods for administering these formulations to achieve therapeutic effects[1][4].
Claims and Scope
Claim Types
The patent includes claims related to the use, composition, formulation, and dosage form of the pharmaceuticals. These claims are crucial in defining the scope of the patent and what is protected under it[1].
Independent Claim Length and Count
Research on patent scope suggests that the length and count of independent claims can be metrics for measuring patent breadth. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process[3].
Specific Compounds and Formulations
The patent specifically mentions formulations containing compounds like cariprazine hydrochloride, which is the active ingredient in VRAYLAR. These formulations include excipients such as lactose monohydrate, pregelatinized starch, mannitol, and dicalcium phosphate dihydrate. The formulations are designed to provide specific in vivo plasma profiles, ensuring effective and safe drug delivery[4].
Patent Landscape
International Protection
Patent RE49110 has thirty-seven patent family members in thirty-three countries, indicating a broad international protection strategy. This extensive coverage is crucial for maintaining market exclusivity and protecting the intellectual property globally[1].
Freedom to Operate (FTO) and Landscape Analysis
In the context of FTO and landscape studies, patents like RE49110 are analyzed to identify scope concepts—key claim limitations that are repeated or shared across the patent portfolio. This analysis helps in understanding the patent's position within the broader landscape and ensures that there are no infringements on existing patents[5].
Examination Process and Patent Quality
The examination process for this patent, like many others, involves narrowing the scope of claims to ensure clarity and validity. The data suggests that narrower claims at publication are associated with a higher probability of grant and a shorter examination process, which aligns with the strategy employed for RE49110[3].
Expiration and Generic Entry
The patent's expiration date is critical for understanding when generic versions of the drug can enter the market. As of the current information, the exact expiration date is not specified, but it is essential to monitor this for any updates that could impact market dynamics[1].
Therapeutic Applications
The formulations protected by this patent are used to treat various psychiatric disorders, including schizophrenia and bipolar disorder. The specific compound, cariprazine, acts as a dopamine receptor partial agonist, providing therapeutic benefits without the full agonist effects that can lead to side effects[4].
Regulatory Compliance
The patent adheres to FDA guidelines for immediate release solid oral dosage forms and extended release oral dosage forms. Compliance with these guidelines ensures that the formulations meet the necessary standards for safety and efficacy[4].
Key Formulations and Dosage
The patent describes several exemplary formulations, including those with cariprazine hydrochloride and various excipients. The dosage forms are designed to provide specific pharmacokinetic profiles, such as mean Cmax, AUC, and Tmax, which are critical for the drug's therapeutic efficacy[4].
Industry Impact
Patents like RE49110 play a significant role in the pharmaceutical industry by protecting innovative formulations and ensuring that the inventors and assignees can recoup their investment in research and development. This protection also incentivizes further innovation in the field of psychiatric treatments.
Legal and Regulatory Considerations
The legal status of the patent, including any challenges or disputes, is crucial for understanding its validity and enforceability. The patent's compliance with regulatory requirements and its position within the broader patent landscape are key factors in its legal standing[2].
Conclusion
United States Patent RE49110 is a critical patent in the pharmaceutical industry, protecting innovative formulations of dopamine receptor ligands. The patent's scope, claims, and international protection strategy are designed to ensure market exclusivity and protect the intellectual property of the inventors and assignees.
Key Takeaways
- Protection of VRAYLAR: The patent protects the drug VRAYLAR, which is used for treating psychiatric disorders.
- International Coverage: The patent has extensive international protection with thirty-seven patent family members in thirty-three countries.
- Specific Formulations: The patent describes specific formulations with cariprazine hydrochloride and various excipients.
- Regulatory Compliance: The formulations comply with FDA guidelines for immediate and extended release oral dosage forms.
- Therapeutic Applications: The drug is used to treat schizophrenia and bipolar disorder.
- Patent Landscape: The patent is part of a broader landscape analyzed for FTO and scope concepts.
Frequently Asked Questions (FAQs)
Q: What drug does Patent RE49110 protect?
A: Patent RE49110 protects the drug VRAYLAR.
Q: Who are the inventors of Patent RE49110?
A: The inventors are Ranajoy Sarkar, Mahendra G. Dedhiya, and Anil Chhettry.
Q: What is the therapeutic use of the formulations described in Patent RE49110?
A: The formulations are used to treat various psychiatric disorders, including schizophrenia and bipolar disorder.
Q: Does the patent comply with FDA guidelines?
A: Yes, the patent complies with FDA guidelines for immediate and extended release oral dosage forms.
Q: How many countries have patent family members for RE49110?
A: There are thirty-seven patent family members in thirty-three countries.
Cited Sources
- Drug Patent Watch: "Patent RE49110" - Detailed information on drug patent RE49110.
- CAFC: "SAWSTOP HOLDING LLC v. VIDAL" - Court opinion on patent appeal.
- SSRN: "Patent Claims and Patent Scope" - Paper on measuring patent scope.
- Google Patents: "USRE49110E1 - Pharmaceutical formulations containing dopamine receptor ligands" - Detailed patent information.
- YouTube: "FTO and Patent Landscape Analysis: A Radically New Approach" - Video on FTO and landscape analysis.
