Understanding the Scope and Claims of United States Patent 8,575,135
Introduction
United States Patent 8,575,135, issued on November 5, 2013, is a significant patent in the field of antiviral compounds, particularly those used in the treatment of viral diseases such as hepatitis C. This patent is assigned to Gilead Sciences, Inc., a leading pharmaceutical company known for its innovative treatments in the area of viral infections.
Patent Overview
Inventors and Assignee
The patent was invented by a team of researchers including Elizabeth M. Bacon, Jeromy J. Cottell, Ashley Anne Katana, Darryl Kato, Evan S. Krygowski, John O. Link, James Taylor, Chinh Viet Tran, Martin Teresa Alejandra Trejo, Zheng-Yu Yang, and Sheila Zipfel. The assignee of the patent is Gilead Sciences, Inc.[1][4].
Scope of the Patent
Antiviral Compounds
The patent disclosure is related to antiviral compounds, compositions containing these compounds, and therapeutic methods involving their administration. These compounds are designed to inhibit viral replication, specifically targeting RNA-dependent RNA viral replication, which is crucial for the treatment of hepatitis C virus (HCV) infections[1][4].
Therapeutic Methods
The patent includes therapeutic methods that involve the administration of these antiviral compounds. These methods are aimed at treating viral diseases in mammals, with a particular focus on HCV NS5B polymerase inhibitors. The compounds are part of a broader class of nucleoside phosphoramidates, which are known for their efficacy in treating HCV[1][4].
Claims of the Patent
Independent Claims
The patent contains several independent claims that define the scope of the invention. These claims typically include the structure of the antiviral compounds, their stereoisomers, salts, hydrates, solvates, and crystalline forms. The claims are detailed to ensure that the patent covers a wide range of potential variations of the compounds while maintaining their therapeutic efficacy[1][4].
Dependent Claims
In addition to the independent claims, the patent also includes dependent claims that further specify the characteristics of the antiviral compounds. These dependent claims often relate to specific aspects such as the chemical structure, synthesis methods, and pharmaceutical compositions containing these compounds[1].
Patent Expiration Dates
Key Dates
The patent is set to expire on November 16, 2032. This expiration date is critical as it determines when generic versions of the drug can be developed and marketed in the United States. Until this date, Gilead Sciences, Inc. retains exclusive rights to manufacture and distribute the drug[1][5].
Patent Landscape
Related Patents
The patent landscape surrounding US 8,575,135 includes several other patents related to antiviral compounds and nucleoside phosphoramidates. For example, patents such as US 8,580,765 and US 8,618,076, also assigned to Gilead Pharmasset LLC, cover similar compounds and therapeutic methods. These patents collectively protect a broad range of antiviral treatments developed by Gilead Sciences[1][5].
Litigation and Challenges
The patent has faced challenges from organizations such as the Initiative for Medicines, Access & Knowledge (I-MAK), Inc., which have sought to invalidate certain claims through post-grant review proceedings. However, these challenges have been denied, maintaining the patent's validity[5].
Impact on Innovation and Access
Patent Scope and Quality
The scope and quality of patents like US 8,575,135 are often debated in the context of innovation and access to medicines. Broad and clear claims can facilitate innovation by providing clear boundaries for what is protected, while overly broad or unclear claims can lead to litigation and hinder access to generic alternatives[3].
Economic and Social Implications
The expiration of this patent in 2032 will have significant economic and social implications. It will allow other pharmaceutical companies to develop generic versions of the drug, potentially reducing costs and increasing access to treatment for patients with HCV and other viral infections.
Conclusion
United States Patent 8,575,135 is a pivotal patent in the field of antiviral treatments, particularly for hepatitis C. Its scope and claims are carefully defined to protect a range of therapeutic compounds and methods. The patent landscape surrounding this invention is complex, with multiple related patents and ongoing legal challenges. As the patent approaches its expiration date, it is crucial to consider the implications for innovation, access to medicines, and the broader healthcare landscape.
Key Takeaways
- Patent Scope: Covers antiviral compounds, compositions, and therapeutic methods.
- Expiration Date: November 16, 2032.
- Assignee: Gilead Sciences, Inc.
- Related Patents: Includes other patents on nucleoside phosphoramidates.
- Litigation: Faced challenges from I-MAK, Inc., but claims remain valid.
- Impact: Expiration will affect access to generic treatments and innovation in antiviral therapies.
FAQs
Q: What is the main focus of United States Patent 8,575,135?
A: The main focus is on antiviral compounds and therapeutic methods for treating viral diseases, particularly hepatitis C.
Q: Who are the inventors of this patent?
A: The inventors include Elizabeth M. Bacon, Jeromy J. Cottell, Ashley Anne Katana, and several others.
Q: When is the patent set to expire?
A: The patent is set to expire on November 16, 2032.
Q: What are the implications of the patent's expiration?
A: The expiration will allow for the development of generic versions of the drug, potentially reducing costs and increasing access to treatment.
Q: Have there been any challenges to the patent's validity?
A: Yes, there have been challenges from organizations like I-MAK, Inc., but these have been denied, maintaining the patent's validity.
Sources
- Generic Vosevi Availability - Drugs.com
- Antiviral compounds - Patent US-2013156732-A1 - PubChem
- Patent Claims and Patent Scope - Hoover Institution
- US8575135B2 - Antiviral compounds - Google Patents
- Epclusa patent expiration - Pharsight
