United States Patent 9,284,342: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,284,342, titled "Nucleoside phosphoramidates," is a significant patent in the pharmaceutical sector, particularly in the treatment of viral diseases. This patent protects several key drugs and is an example of how intellectual property can shape the pharmaceutical industry.
Background
The patent, issued to Gilead Sciences, Inc., covers nucleoside phosphoramidates and their use as agents for treating viral diseases, including hepatitis C virus (HCV) infection. The patent is part of a broader landscape of intellectual property related to antiviral treatments[4].
Scope of the Patent
Invention Overview
The patent describes nucleoside phosphoramidates, which are inhibitors of RNA-dependent RNA polymerase, an enzyme crucial for the replication of certain viruses. These compounds are designed to treat viral diseases, with a specific focus on HCV[4].
Claims
The patent includes multiple claims that define the scope of the invention. These claims cover:
- The chemical structure of the nucleoside phosphoramidates.
- Methods of preparing these compounds.
- Pharmaceutical compositions containing these compounds.
- Methods of treating viral diseases using these compounds[4].
Key Claims and Their Significance
Chemical Structure
The patent claims specify the detailed chemical structure of the nucleoside phosphoramidates, including their molecular formula and synthetic pathways. This is crucial for distinguishing the invention from prior art and ensuring that any future modifications or derivatives do not infringe on the patent[4].
Pharmaceutical Compositions
The claims also cover pharmaceutical compositions that include these nucleoside phosphoramidates, along with other ingredients such as solvents, excipients, and stabilizers. This ensures that the patent protection extends to the final drug product, not just the active ingredient[4].
Treatment Methods
The patent includes claims related to the methods of treating viral diseases, particularly HCV, using these compounds. This encompasses the dosage, administration routes, and treatment regimens, which are critical for the clinical application of the drugs[4].
Protected Drugs
EPCLUSA, HARVONI, SOVALDI, and VOSEVI
The patent protects several key drugs developed by Gilead Sciences:
- EPCLUSA: A combination of sofosbuvir and velpatasvir.
- HARVONI: A combination of ledipasvir and sofosbuvir.
- SOVALDI: Sofosbuvir.
- VOSEVI: A combination of sofosbuvir, velpatasvir, and voxilaprevir.
These drugs are included in seven New Drug Applications (NDAs) and have been extended for six months for pediatric exclusivity[2].
Patent Landscape
International Protection
The patent is part of a global intellectual property strategy. While the analysis focuses on the U.S. patent, similar patents exist in other jurisdictions, ensuring worldwide protection for these drugs. Resources like the Global Dossier and international patent databases (e.g., EPO, JPO, WIPO) facilitate the search and management of these global patent families[1].
Prior Art and Citation Data
The Common Citation Document (CCD) application consolidates prior art cited by multiple patent offices, including the IP5 Offices. This tool helps in understanding the prior art landscape and how the patent in question differentiates itself from existing knowledge[1].
Legal Status and Expiration
The patent is currently active, but its legal status and expiration date are critical for understanding the remaining period of protection. The patent's expiration date will mark the end of Gilead Sciences' exclusive rights to these drugs, potentially opening the market to generic versions[4].
Challenges and Controversies
Inter Partes Review
The patent has faced challenges, including an inter partes review (IPR) request. However, the request for rehearing was denied, affirming the patent's validity[5].
Economic and Market Impact
Market Domination
The protection afforded by this patent has allowed Gilead Sciences to dominate the market for HCV treatments. The exclusivity has enabled the company to set prices and control distribution, impacting both the pharmaceutical industry and public health policies.
Financial Implications
The financial implications of this patent are significant. The drugs protected by this patent have generated billions of dollars in revenue for Gilead Sciences. The extension of pediatric exclusivity further extends the period of market exclusivity, adding to the financial benefits[2].
Conclusion
United States Patent 9,284,342 is a pivotal patent in the pharmaceutical industry, particularly in the treatment of viral diseases like HCV. The detailed analysis of its scope, claims, and the broader patent landscape highlights its significance in protecting key drugs and influencing market dynamics.
Key Takeaways
- The patent covers nucleoside phosphoramidates and their use in treating viral diseases.
- It protects several key drugs including EPCLUSA, HARVONI, SOVALDI, and VOSEVI.
- The patent includes detailed claims on chemical structure, pharmaceutical compositions, and treatment methods.
- It is part of a global intellectual property strategy with international protection.
- The patent has faced legal challenges but remains valid.
- It has significant economic and market implications, allowing Gilead Sciences to dominate the HCV treatment market.
FAQs
What is the main subject of United States Patent 9,284,342?
The main subject of United States Patent 9,284,342 is nucleoside phosphoramidates and their use as agents for treating viral diseases, particularly hepatitis C virus (HCV) infection.
Which drugs are protected by this patent?
The patent protects EPCLUSA, HARVONI, SOVALDI, and VOSEVI, all of which are used in the treatment of HCV.
What is the significance of the Common Citation Document (CCD) in relation to this patent?
The CCD consolidates prior art cited by multiple patent offices, helping to understand how the patent differentiates itself from existing knowledge and ensuring that the search results for the same invention produced by several offices can be visualized on a single page.
Has the patent faced any legal challenges?
Yes, the patent has faced an inter partes review (IPR) request, but the request for rehearing was denied, affirming the patent's validity.
What is the economic impact of this patent?
The patent has allowed Gilead Sciences to dominate the market for HCV treatments, generating significant revenue and extending the period of market exclusivity through pediatric exclusivity extensions.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- DrugPatentWatch - Patent 9,284,342: https://www.drugpatentwatch.com/p/patent/9284342
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents - US9284342B2: https://patents.google.com/patent/US9284342B2/en
- Exparte - IPR2018-00126: https://ai-lab.exparte.com/documents/ptab/ptacts-uspto/1501135/9qaCSXnXfI-YVv4R7JM9Q4gMSLC75WFAnDDB86B9Q1rnCNyDvl-EM2Y/-13/IPR2018-00126_doc_10_exparte.pdf
