United States Patent 9,345,771: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,345,771, titled "Oral Cannabinoid Formulations," is a crucial patent in the pharmaceutical industry, particularly in the realm of cannabinoid-based medications. This patent is owned by Benuvia Operations LLC and protects the formulation and use of oral cannabinoid products, such as Syndros.
Patent Overview
The patent, filed in 2017, is part of a series of patents that safeguard the intellectual property related to Syndros, a drug that uses dronabinol as its active ingredient. Dronabinol is a synthetic form of tetrahydrocannabinol (THC), the primary psychoactive component of cannabis[2].
Claims and Scope
The patent claims cover various aspects of oral cannabinoid formulations, including:
Active Ingredients
The patent specifies the use of dronabinol as the active pharmaceutical ingredient (API). It also details formulations that may include other cannabinoids, such as cannabidiol, and various excipients to enhance bioavailability and stability[2].
Formulation Methods
The claims describe different methods for preparing oral cannabinoid formulations, including liquid, gel, and solid forms. These methods involve the use of solvents, emulsifiers, and other pharmaceutical excipients to ensure consistent and effective delivery of the active ingredients[2].
Dosage Forms
The patent covers a range of dosage forms, including oral solutions, suspensions, and tablets. Each dosage form is designed to optimize the therapeutic effects of the cannabinoids while minimizing side effects[2].
Patent Landscape
The patent landscape for Syndros and similar oral cannabinoid formulations is complex and multifaceted.
Patent Expiration
The patent is set to expire on August 6, 2028. This expiration date is crucial for generic drug manufacturers, as it marks the earliest possible date for the launch of generic versions of Syndros[2].
Family Patents
Syndros is protected by a family of patents, including US10265293, US9345771, US11253472, and US8222292. These patents collectively cover various aspects of the drug's formulation, manufacturing process, and use. Understanding the full scope of these patents is essential for strategizing market entry and potential generic competition[2].
International Protection
While the patent details provided are specific to the United States, Syndros is also protected by patents in multiple other countries. This global protection further restricts the ability of generic manufacturers to enter the market until the patents expire in their respective jurisdictions[2].
Legal Activities and Updates
The patent landscape is dynamic, with ongoing legal activities that can affect the patent's expiration date and the timing of generic entry.
Maintenance Fees and Changes in Power of Attorney
Recent activities include the payment of maintenance fees and changes in the power of attorney, which are critical for maintaining the patent's validity and ensuring that the patent owner retains control over the intellectual property[2].
Paragraph IV Certifications
Generic manufacturers can seek FDA approval before the patent expires by filing a Paragraph IV certification, which challenges the validity or enforceability of the patent. However, this process is complex and often involves litigation[2].
Impact on Generic Entry
The expiration of the patent on August 6, 2028, will mark a significant milestone for the pharmaceutical industry, as it will open the door for generic versions of Syndros.
Generic Launch Date
The estimated generic launch date is based on the expiration of the last outstanding patent. However, this date can change due to legal activities such as patent term extensions or amendments to the patent claims[2].
Strategic Considerations
Understanding the patent landscape is crucial for generic manufacturers. Identifying markets with weaker patent protection can provide strategic advantages for early generic entry[2].
Metrics for Patent Scope
The scope of a patent can be measured using various metrics, such as independent claim length and independent claim count. These metrics help in assessing the breadth and clarity of the patent claims, which are critical for determining the patent's validity and enforceability[3].
Industry Implications
The protection afforded by this patent has significant implications for the pharmaceutical industry.
Innovation and Competition
The patent ensures that Benuvia Operations LLC maintains exclusivity over the formulation and use of oral cannabinoid products, which can impact innovation and competition in the market. The expiration of the patent will likely increase competition and reduce prices, benefiting consumers[2].
Therapeutic Impact
Syndros is used for treating conditions such as nausea and vomiting associated with chemotherapy and weight loss in AIDS patients. The availability of generic versions could improve access to these treatments, enhancing patient outcomes[2].
Key Takeaways
- Patent Expiration: The patent is set to expire on August 6, 2028.
- Formulation and Dosage: The patent covers various oral cannabinoid formulations, including liquid, gel, and solid forms.
- Legal Activities: Ongoing legal activities can affect the patent's expiration date and generic entry.
- Generic Entry: Generic manufacturers can seek FDA approval before the patent expires by filing a Paragraph IV certification.
- Industry Implications: The patent's expiration will impact innovation, competition, and access to treatments.
FAQs
Q: What is the active ingredient in Syndros?
A: The active ingredient in Syndros is dronabinol, a synthetic form of tetrahydrocannabinol (THC)[2].
Q: When is the patent for Syndros set to expire?
A: The patent for Syndros is set to expire on August 6, 2028[2].
Q: Can generic manufacturers launch a generic version of Syndros before the patent expires?
A: Yes, generic manufacturers can seek FDA approval before the patent expires by filing a Paragraph IV certification, which challenges the validity or enforceability of the patent[2].
Q: What are the therapeutic uses of Syndros?
A: Syndros is used for treating nausea and vomiting associated with chemotherapy and weight loss in AIDS patients[2].
Q: How does the patent landscape affect the pharmaceutical industry?
A: The patent landscape affects innovation, competition, and access to treatments. The expiration of the patent will likely increase competition and reduce prices, benefiting consumers[2].
Cited Sources
- KR20080026176A: Cannabinoid active pharmaceutical ingredient for improved dosage.
- Pharsight: Syndros patent expiration.
- Hoover Institution: Patent Claims and Patent Scope.
- GreyB: List - 30 Drug Patents Expiring in 2028.
- Drug Patent Watch: Pharmaceutical drugs covered by patent 9,345,771.
