Detailed Analysis of the Scope and Claims of United States Patent 10,182,995
Introduction
United States Patent 10,182,995, issued on January 22, 2019, is a significant patent in the field of pharmaceuticals, particularly for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). This patent, assigned to Ironshore Pharmaceuticals & Development, Inc., outlines innovative therapeutic compositions and methods for delivering methylphenidate in a unique formulation.
Inventors and Assignee
The patent was invented by David Lickrish and Feng Zhang, and it is assigned to Ironshore Pharmaceuticals & Development, Inc., based in Camana Bay, Cayman Islands[2].
Patent Scope and Claims
Therapeutic Compositions
The patent describes therapeutic compositions designed to deliver a therapeutic amount of methylphenidate, a common medication for ADHD. These compositions are formulated to provide a delayed and extended release of the active drug. The dosage form is characterized by a lag time prior to the release of the drug, typically ranging from 6 to 8 hours or longer, followed by a sustained release period[2][5].
Delayed and Extended Release Formulation
The delayed release mechanism ensures that the drug is not immediately absorbed into the bloodstream, allowing for a controlled and sustained therapeutic effect. This formulation is particularly beneficial for patients who require a consistent level of medication throughout the day, especially in the context of ADHD where maintaining focus and attention is crucial[2].
Administration Timing
The patent specifies that the dosage form can be administered at night, with the drug release delayed for several hours. This timing allows the medication to become effective during the morning hours when the patient is most active, thereby providing a full day of therapeutic coverage[2].
Patent Claims
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims cover the specific formulation of the therapeutic compositions, the method of delivery, and the timing of the drug release. For example, Claim 1 describes a pharmaceutical composition comprising a delayed release formulation of methylphenidate, where the release is delayed for at least 4 to 6 hours or longer[5].
Dependent Claims
Dependent claims further specify the details of the formulation, such as the type of excipients used, the dosage strength, and the method of manufacturing. These claims help to narrow down the scope of the invention and provide additional protection against infringement[5].
Patent Landscape
Related Patents
The patent is part of a series of related patents filed by Ironshore Pharmaceuticals & Development, Inc. These include patents such as 10,292,937, 11,241,392, and 9,283,214, all of which pertain to similar therapeutic compositions and methods for treating ADHD. These patents collectively form a robust intellectual property portfolio for the company in this therapeutic area[2].
Patent Expiration Dates
The patent is set to expire on March 23, 2032, which is consistent with the expiration dates of the related patents. This provides a significant period of exclusivity for Ironshore Pharmaceuticals & Development, Inc. to market and distribute their therapeutic compositions without generic competition[2].
Impact on Treatment of ADHD
Clinical Benefits
The delayed and extended release formulation of methylphenidate offers several clinical benefits, including improved patient compliance and reduced side effects associated with immediate release formulations. The sustained release profile helps maintain therapeutic levels of the drug throughout the day, enhancing the overall efficacy of the treatment[2].
Market Significance
The patent represents a significant advancement in the treatment of ADHD, offering a unique and effective formulation that addresses the needs of patients and healthcare providers. The market for ADHD medications is substantial, and this patent positions Ironshore Pharmaceuticals & Development, Inc. as a key player in this therapeutic area[2].
Patent Quality and Scope
Claim Clarity and Scope
The patent claims are carefully crafted to ensure clarity and specificity, which is crucial for maintaining patent quality. The use of specific metrics such as independent claim length and count helps in measuring the scope of the patent, ensuring that the claims are neither overly broad nor too narrow[3].
Examination Process
The patent underwent a rigorous examination process at the U.S. Patent and Trademark Office (USPTO), which is reflected in the detailed claims and descriptions. The examination process tends to narrow the scope of patent claims, ensuring that the granted patent is valid and enforceable[3].
Conclusion
United States Patent 10,182,995 is a critical intellectual property asset for Ironshore Pharmaceuticals & Development, Inc., providing a unique and effective therapeutic composition for the treatment of ADHD. The patent's scope and claims are well-defined, ensuring a strong position in the market and significant clinical benefits for patients.
Key Takeaways
- The patent describes a delayed and extended release formulation of methylphenidate for ADHD treatment.
- The formulation includes a lag time prior to drug release, typically 6 to 8 hours or longer.
- The patent is part of a series of related patents filed by Ironshore Pharmaceuticals & Development, Inc.
- The patent expires on March 23, 2032.
- The formulation offers improved patient compliance and reduced side effects.
- The patent represents a significant advancement in ADHD treatment and positions the company as a key market player.
FAQs
What is the main innovation of United States Patent 10,182,995?
The main innovation is the development of a delayed and extended release formulation of methylphenidate for the treatment of ADHD.
Who are the inventors of this patent?
The inventors are David Lickrish and Feng Zhang.
What is the assigned company for this patent?
The assigned company is Ironshore Pharmaceuticals & Development, Inc.
When does the patent expire?
The patent expires on March 23, 2032.
What are the clinical benefits of this formulation?
The formulation offers improved patient compliance and reduced side effects associated with immediate release formulations, maintaining therapeutic levels of the drug throughout the day.
Cited Sources:
- United States Patent and Trademark Office. US10905652.pdf.
- Drugs.com. Generic Jornay PM Availability.
- Hoover Institution. Patent Claims and Patent Scope.
- United States Patent and Trademark Office. US11241392.pdf.
- Unified Patents Portal. US-10182995-B2.
