United States Patent 11,160,779: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 11,160,779, titled "Methods of providing solriamfetol therapy to subjects," is a significant patent in the pharmaceutical sector, particularly in the treatment of conditions such as excessive daytime sleepiness associated with narcolepsy, obstructive sleep apnea, and shift work sleep disorder. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of Solriamfetol
Solriamfetol, also known as [R]-2-amino-3-phenylpropylcarbamate, is a dopamine and norepinephrine reuptake inhibitor. It was approved by the U.S. Food and Drug Administration (FDA) for the treatment of excessive daytime sleepiness in adults with narcolepsy and obstructive sleep apnea[1].
Scope of the Patent
The patent 11,160,779 focuses on methods to decrease adverse effects associated with solriamfetol therapy. Here are the key aspects of its scope:
Therapeutic Methods
The patent describes specific methods for administering solriamfetol to minimize adverse effects. This includes dosing regimens, timing of administration, and patient monitoring strategies to mitigate side effects such as anxiety, insomnia, and increased heart rate[1].
Patient Population
The methods outlined in the patent are tailored for subjects with specific conditions, including narcolepsy and obstructive sleep apnea. The patent also considers the overall health profile of the patient, including any comorbidities that might affect the treatment outcome.
Claims of the Patent
The claims of the patent are crucial as they define the legal boundaries of the invention. Here are some key claims:
Independent Claims
- Claim 1 typically outlines the broadest scope of the invention, which in this case involves a method for treating excessive daytime sleepiness by administering a specific dose of solriamfetol.
- Subsequent independent claims may narrow down the scope by specifying particular dosing schedules, patient populations, or monitoring protocols[1].
Dependent Claims
- These claims build upon the independent claims and provide additional specificity. For example, a dependent claim might specify the timing of the dose (e.g., morning administration) or the use of additional medications to mitigate side effects.
Patent Landscape
Understanding the patent landscape is essential for navigating the intellectual property rights surrounding solriamfetol therapy.
Related Patents
- Other patents related to solriamfetol may cover different aspects such as the synthesis of the compound, other therapeutic uses, or different formulations. These patents could be held by the same or different entities, influencing the overall patent landscape.
- For instance, if there are patents covering the synthesis of solriamfetol, these would need to be considered when manufacturing the drug, even if the method of therapy is patented separately[1].
Patent Analytics
Using patent analytics tools, such as those described by Schwegman, can help in categorizing and analyzing the scope concepts of various patents related to solriamfetol. This includes creating claim charts and matrices to identify gaps in coverage and potential future design opportunities[3].
Expiry and Validity
The patent's validity and expiry date are critical. The patent 11,160,779 is active, but its expiry date will be determined by the filing date and any patent term adjustments (PTA) or extensions granted. Understanding the expiry dates of related patents, such as those discussed in the Allergan case, can provide insights into the competitive landscape and potential generic entry points[2].
Legal Considerations
Presumption of Validity
Under 35 USC 282, each claim of a patent is presumed valid. However, this presumption can be challenged through various defenses, including obviousness-type double patenting or lack of written description[5].
Obviousness-Type Double Patenting
This doctrine, as seen in the Allergan case, can invalidate a patent if the claims are not patentably distinct from earlier-filed or earlier-issued patents. Ensuring that the claims of the 11,160,779 patent are distinct from any earlier patents is crucial for maintaining its validity[2].
Practical Applications
Clinical Practice
The methods described in the patent can be directly applied in clinical practice to improve patient outcomes. Healthcare providers can follow the specified dosing regimens and monitoring protocols to minimize adverse effects and maximize the therapeutic benefits of solriamfetol.
Pharmaceutical Industry
For pharmaceutical companies, understanding the scope and claims of this patent is essential for developing and marketing solriamfetol-based treatments. It helps in avoiding infringement and identifying opportunities for innovation and differentiation.
Key Takeaways
- Specific Therapeutic Methods: The patent outlines specific methods to reduce adverse effects associated with solriamfetol therapy.
- Patient Population: The methods are tailored for subjects with narcolepsy and obstructive sleep apnea.
- Claims Structure: Independent and dependent claims define the scope of the invention.
- Patent Landscape: Understanding related patents and using patent analytics tools is crucial for navigating the intellectual property landscape.
- Legal Considerations: The patent is presumed valid, but challenges such as obviousness-type double patenting must be considered.
FAQs
Q: What is the primary focus of the United States Patent 11,160,779?
A: The primary focus is on methods to decrease adverse effects associated with solriamfetol therapy.
Q: What conditions is solriamfetol used to treat?
A: Solriamfetol is used to treat excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea.
Q: How can patent analytics tools help in understanding the patent landscape?
A: Patent analytics tools help in categorizing and analyzing the scope concepts of various patents, identifying gaps in coverage, and highlighting future design opportunities.
Q: What is the significance of the presumption of validity under 35 USC 282?
A: Each claim of a patent is presumed valid, but this presumption can be challenged through various defenses.
Q: What is obviousness-type double patenting, and how does it affect patent validity?
A: Obviousness-type double patenting can invalidate a patent if the claims are not patentably distinct from earlier-filed or earlier-issued patents.
Sources
- US11160779B2 - Methods of providing solriamfetol therapy to subjects
- ALLERGAN USA, INC. v. MSN LABORATORIES PRIVATE LTD.
- Patent Analytics | Intellectual Property Law
- hfto-2021-patent-analysis.pdf - Department of Energy
- 35 USC 282: Presumption of validity; defenses
