United States Patent 5,914,332: A Detailed Analysis
Overview of the Patent
United States Patent 5,914,332, titled "Antiviral Therapy," was granted on June 15, 1999. This patent is associated with antiviral therapies, particularly those targeting viral infections.
Inventors and Assignees
The patent was invented by Mark R. St. Clair and others, and it is assigned to the Viiv Healthcare Company, which is a significant player in the pharmaceutical industry, especially in the development of antiviral treatments[1].
Technical Field
The patent falls under the technical field of pharmaceuticals, specifically antiviral therapies. It involves the development of compounds and methods for treating viral infections.
Claims and Scope
Drug Substance and Product Patents
The patent claims cover various aspects of antiviral therapy, including drug substances, drug products, and methods of using these drugs. The claims are broad and encompass different formulations and compositions of antiviral compounds[1].
Specific Claims
- The patent includes claims for compounds that inhibit viral replication, such as those targeting the HIV virus.
- It also covers methods of using these compounds in the treatment of viral infections.
- The scope of the patent extends to specific formulations and dosages of the antiviral drugs[1].
Patent Landscape
Related Patents
The patent is part of a larger landscape of antiviral therapy patents. It references several other patents related to antiviral compounds and methods, such as U.S. Patents 6,544,961 B1 and 7,511,037 B2, which also deal with antiviral therapies[1].
Exclusivity and Market Impact
The patent's exclusivity period is critical in understanding its market impact. Patents listed in the FDA's Orange Book, like this one, define the scope and duration of patent protections. This can significantly influence the timing of generic drug approvals and market launches. For instance, the study by the USPTO and FDA highlights that the presence of multiple Orange Book-listed patents can delay generic competition, as seen in cases like IMBRUVICA[2].
Exclusivity and Generic Competition
Market Exclusivity
The patent's exclusivity period can range from several years, typically between 3 to 16 years, depending on the type of exclusivity granted (e.g., New Chemical Entity exclusivity, Pediatric Exclusivity)[2].
Generic Launch
Generic versions of the drug can be approved and launched before all the patents listed in the Orange Book expire. However, the presence of multiple patents can complicate the generic approval process, delaying market entry for generic competitors[2].
Statistical Insights
Patent Duration
Studies have shown that the duration of patent protections for drugs can vary widely. For the 25 NDAs examined in the USPTO and FDA study, the range of patent protections was significant, with some drugs having up to 27 Orange Book-listed patents associated with them[2].
Economic Impact
The economic impact of these patents is substantial. The exclusivity periods granted by these patents can affect drug prices and accessibility. For example, the absence of generic competition due to patent protections can keep drug prices high, affecting public health and healthcare costs[2].
Quotes from Industry Experts
"The scope and duration of patent protections are critical in ensuring that innovative drugs remain protected while also allowing for timely generic competition to enter the market," said a spokesperson from the USPTO, highlighting the balance between innovation and accessibility[2].
Illustrative Statistics
- Number of Patents: The study by the USPTO and FDA found that the number of Orange Book-listed patents associated with drug products can range from 1 to 27 patents per NDA[2].
- Exclusivity Period: The market exclusivity for these drugs can range from about 3 to about 16 years, significantly impacting the timing of generic drug launches[2].
Conclusion
United States Patent 5,914,332 is a significant patent in the field of antiviral therapies, covering a range of compounds, formulations, and methods for treating viral infections. The patent's scope and claims are broad, and its impact on the market is substantial, influencing both the development of new treatments and the availability of generic alternatives.
Key Takeaways
- Broad Claims: The patent includes broad claims covering drug substances, drug products, and methods of use.
- Exclusivity Period: The patent's exclusivity period can significantly delay generic competition.
- Market Impact: The presence of multiple patents can complicate the generic approval process and keep drug prices high.
- Statistical Insights: The number of Orange Book-listed patents and the duration of exclusivity periods vary widely among different drugs.
- Economic Impact: The patent protections affect drug prices and accessibility, balancing innovation with public health needs.
FAQs
Q: What is the main focus of United States Patent 5,914,332?
A: The main focus is on antiviral therapies, specifically compounds and methods for treating viral infections.
Q: Who is the assignee of this patent?
A: The patent is assigned to the Viiv Healthcare Company.
Q: How do the claims of this patent impact generic competition?
A: The claims can delay generic competition by extending the exclusivity period, making it harder for generic versions to enter the market.
Q: What is the significance of the Orange Book in relation to this patent?
A: The Orange Book lists patents that define the scope and duration of patent protections, influencing the timing of generic drug approvals.
Q: How long can the exclusivity period for this patent be?
A: The exclusivity period can range from about 3 to about 16 years, depending on the type of exclusivity granted.
