Understanding the Scope and Claims of United States Patent 10,071,985: A Detailed Analysis
Introduction to Patent 10,071,985
United States Patent 10,071,985, titled "Therapeutic compounds," is a significant patent owned by Gilead Sciences, Inc. This patent is crucial for the protection of Sunlenca, a drug used in the treatment of HIV. Here, we will delve into the details of this patent, including its scope, claims, and the broader patent landscape.
Patent Overview
Patent Title and Assignee
The patent, titled "Therapeutic compounds," is assigned to Gilead Sciences, Inc. It was issued on September 11, 2018, and is one of the key patents protecting Sunlenca[4].
Inventors
The patent lists several inventors, including Graupe Michael, Henry Steven J., Link John O., Saito Roland D., Schroeder Scott D., Stefanidis Dimitrios, Tse Winston C., and Zhang Jennifer R.[4].
Scope of the Patent
Therapeutic Compounds
The patent discloses compounds of specific formulas (Ia, Ib, IIa, and IIb) that are useful in the treatment of Retroviridae viral infections, including HIV. These compounds are part of a broader class of therapeutic agents designed to target and inhibit the replication of the HIV virus[4].
Pharmaceutical Compositions
The patent also covers pharmaceutical compositions that include these compounds, as well as processes for preparing these compounds and intermediates useful in their synthesis. This comprehensive coverage ensures that all aspects of the drug's development and use are protected[4].
Claims of the Patent
Compound Claims
The patent includes claims that specifically describe the chemical structures of the therapeutic compounds. These claims are detailed and precise, ensuring that any attempts to replicate or modify these compounds without authorization would infringe on the patent[4].
Process Claims
In addition to compound claims, the patent also includes process claims that cover the methods for preparing these therapeutic compounds. This includes the synthesis of intermediates and the final pharmaceutical compositions[4].
Use Claims
The patent further includes use claims that specify the therapeutic applications of these compounds, particularly in the treatment of HIV infections. These claims ensure that the patent holder has exclusive rights to use these compounds for the intended medical purposes[4].
Patent Expiration and Generic Availability
Patent Expiration Date
The patent is set to expire on August 17, 2037. This date is critical because it marks the end of the exclusive rights granted to Gilead Sciences, Inc. for the protected compounds and processes[4].
Generic Availability
As of now, there is no generic version of Sunlenca available in the United States. The generic launch date is estimated to be around June 4, 2041, considering the patent landscape and exclusivities associated with Sunlenca[1][4].
Legal Activities and Patent Landscape
Recent Legal Activities
The patent has undergone several recent legal activities, including electronic reviews, petitions, and notifications related to the patent grant process. These activities are important for tracking any changes or challenges to the patent's validity and expiration date[1].
Patent Scope and Quality
The scope of a patent, including its claims, is a critical factor in determining its quality and impact. Research suggests that narrower claims tend to have a higher probability of grant and a shorter examination process compared to broader claims. This is relevant as the examination process often narrows the scope of patent claims to ensure clarity and validity[3].
Impact on Innovation and Competition
Protection of Intellectual Property
The patent provides Gilead Sciences, Inc. with exclusive rights to develop, manufacture, and market Sunlenca, protecting their significant investment in research and development. This protection is essential for encouraging innovation in the pharmaceutical industry[4].
Competitive Landscape
The expiration of this patent will open up the market for generic versions of Sunlenca, potentially increasing competition and reducing costs for patients. However, until then, Gilead Sciences, Inc. maintains a monopoly on the drug, which can impact pricing and accessibility[1][4].
Regulatory and Exclusivity Considerations
FDA Exclusivity
In addition to patent protection, Sunlenca may also benefit from FDA-granted exclusivity periods. These periods can run concurrently with patent protection and further delay the entry of generic competitors into the market[4].
Patent Term Adjustments
The patent term can be adjusted based on various factors, including delays in the regulatory review process. This ensures that the effective patent term is not unduly shortened by administrative delays[4].
Conclusion
United States Patent 10,071,985 is a pivotal patent in the protection of Sunlenca, a crucial drug for HIV treatment. Understanding its scope, claims, and the broader patent landscape is essential for both the pharmaceutical industry and patients.
Key Takeaways
- Patent Title and Assignee: "Therapeutic compounds" assigned to Gilead Sciences, Inc.
- Scope: Covers specific therapeutic compounds, pharmaceutical compositions, and processes for their preparation.
- Claims: Includes compound, process, and use claims.
- Expiration Date: August 17, 2037.
- Generic Availability: Estimated generic launch date is around June 4, 2041.
- Legal Activities: Recent activities include electronic reviews and petitions.
- Impact on Innovation: Protects intellectual property and encourages innovation.
- Regulatory Considerations: Includes FDA exclusivity and patent term adjustments.
FAQs
Q: What is the primary focus of United States Patent 10,071,985?
A: The primary focus is on therapeutic compounds useful in the treatment of HIV infections.
Q: Who is the assignee of this patent?
A: The assignee is Gilead Sciences, Inc.
Q: When is the patent set to expire?
A: The patent is set to expire on August 17, 2037.
Q: Are there any generic versions of Sunlenca available?
A: No, there are currently no generic versions of Sunlenca available in the United States.
Q: How does the patent landscape affect the availability of generic drugs?
A: The patent landscape, including this patent and others, delays the entry of generic competitors until the patents expire or are challenged successfully.
Sources
- Pharsight - GreyB: Sunlenca patent expiration.
- PubChem: Therapeutic compounds - Patent US-10071985-B2.
- SSRN: Patent Claims and Patent Scope.
- Drugs.com: Generic Sunlenca Availability.
- DrugPatentWatch: Patent 10,071,985.
