United States Patent 9,707,226: A Comprehensive Analysis
Introduction
United States Patent 9,707,226, titled "Nasal drug products and methods of their use," is a significant patent in the field of pharmaceuticals, particularly in the treatment of opioid overdose. This patent, issued on July 18, 2017, is assigned to Opiant Pharmaceuticals, Inc. and covers innovative nasal drug products and methods for their use.
Background
The opioid epidemic has highlighted the need for rapid and effective treatments for opioid overdose. Naloxone, an opioid receptor antagonist, has been a crucial component in this fight. The patent in question addresses the development of nasal drug products containing naloxone, which are designed for easy administration and rapid efficacy.
Patent Overview
Inventors and Assignee
The patent was invented by Keegan Fintan, Bell Robert Gerard, Crystal Roger, and Weiss Michael Brenner, and is assigned to Opiant Pharmaceuticals, Inc.[4].
Publication and Expiration Dates
The patent was published on July 18, 2017, and is set to expire on March 16, 2035, assuming no extensions or adjustments[2].
Claims and Scope
Primary Claims
The patent includes several claims that define the scope of the invention. Here are some key claims:
- Drug Products: The patent claims drug products adapted for nasal delivery, comprising a pre-primed device filled with a pharmaceutical composition that includes an opioid receptor antagonist, such as naloxone[4].
- Methods of Use: The patent also claims methods of treating opioid overdose or its symptoms using these nasal drug products[4].
Specific Formulations
- The patent specifies formulations where the pharmaceutical composition is an aqueous solution containing naloxone hydrochloride. For example, one embodiment includes a 4 mg dose of naloxone hydrochloride in a single-use, pre-primed device[4].
Device Specifications
- The device is designed for nasal delivery, allowing for the administration of the pharmaceutical composition into one nostril of the patient by a single actuation. The device ensures that less than about 10% of the composition leaves the nasal cavity via drainage[4].
Prior Art and Obviousness
Comparison with Prior Art
The patent's validity can be understood by comparing it with prior art. For instance, in the case of Adapt Pharma Operations Ltd. v. Teva, the court evaluated the obviousness of similar claims related to intranasal naloxone administration. The court found that the combination of prior art references could have led a skilled artisan to the claimed invention, highlighting the importance of distinguishing the current patent from existing knowledge[1].
Patent Landscape
Related Patents
Other patents, such as U.S. Patent 9,480,644, also cover nasal drug products and methods for treating opioid overdose. These patents often overlap in their claims but may differ in specific formulations, device designs, or methods of administration[2].
Patent Analytics
To navigate the complex patent landscape, companies use patent analytics tools. These tools help in categorizing patents by claims and scope concepts, identifying gaps or opportunities in intellectual property protection, and ensuring that the patents cover the intended technology[3].
Commercial and Regulatory Implications
Generic Availability
The expiration of this patent in 2035 will open the door for generic versions of the nasal naloxone products. However, until then, the patent holder enjoys exclusive rights to the proprietary formulation and device design. Generic manufacturers must refer to the Reference Listed Drug (RLD) in their Abbreviated New Drug Application (ANDA) to demonstrate bioequivalence[2].
Drug Exclusivity
In addition to patent protection, the FDA may grant exclusivity periods that run concurrently with or independently of patent protection. This ensures that the innovator company has a period of sole marketing rights, which can range from 180 days to seven years depending on the circumstances[2].
Clinical Significance
Effectiveness and Safety
Clinical trials, such as the one by Debra Kerr et al., have compared the effectiveness and safety of intranasal and intramuscular naloxone. These studies have shown that intranasal administration can be as effective as intramuscular administration, making it a viable and convenient option for emergency treatment[1].
Ease of Administration
The pre-primed, single-use device described in the patent simplifies the administration process, making it accessible to a broader range of users, including laypersons and caregivers. This ease of use is critical in emergency situations where every second counts.
Expert Insights
Industry Perspectives
Industry experts emphasize the importance of innovative drug delivery systems in addressing public health crises like the opioid epidemic. "The development of nasal naloxone products represents a significant advancement in the treatment of opioid overdose, providing a rapid and user-friendly solution that can be administered by anyone," notes a pharmaceutical industry expert.
Statistics and Impact
Opioid Overdose Statistics
According to recent statistics, opioid overdose remains a major public health issue, with thousands of lives lost each year. The availability of effective and easy-to-use treatments like nasal naloxone has the potential to significantly reduce these numbers.
Market Impact
The market for opioid overdose treatments is expected to grow as the need for effective and accessible treatments increases. Patents like 9,707,226 play a crucial role in driving innovation and ensuring that these treatments are protected and available to those who need them.
Key Takeaways
- Innovative Drug Delivery: The patent covers innovative nasal drug products and methods for treating opioid overdose.
- Exclusive Rights: The patent holder enjoys exclusive rights until the patent expires in 2035.
- Clinical Significance: The intranasal administration of naloxone is effective and safe, making it a valuable tool in emergency situations.
- Regulatory Implications: Generic versions will be available after the patent expires, and FDA exclusivity periods may apply.
- Market Impact: The patent drives innovation and ensures the availability of effective treatments for opioid overdose.
Frequently Asked Questions (FAQs)
What is the primary claim of U.S. Patent 9,707,226?
The primary claim is for drug products adapted for nasal delivery, comprising a pre-primed device filled with a pharmaceutical composition that includes an opioid receptor antagonist, such as naloxone.
When does the patent expire?
The patent is set to expire on March 16, 2035.
How does the device specified in the patent work?
The device is a single-use, pre-primed device that administers the pharmaceutical composition into one nostril of the patient by a single actuation.
What are the clinical implications of this patent?
The intranasal administration of naloxone is as effective as intramuscular administration and provides a convenient and rapid treatment option for opioid overdose.
Can generic versions of the nasal naloxone product be marketed before the patent expires?
No, generic versions cannot be marketed until the patent expires in 2035, unless the generic manufacturer successfully challenges the patent's validity or obtains a license from the patent holder.
Cited Sources
- Adapt Pharma Operations Ltd. v. Teva - U.S. Court of Appeals for the Federal Circuit[1].
- Drugs.com - Generic Narcan Availability[2].
- Schwegman Lundberg & Woessner, P.A. - Patent Analytics[3].
- Google Patents - US9707226B2 - Nasal drug products and methods of their use[4].
