United States Patent 5,470,567: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,470,567, titled "Storage stable tretinoin and 4-hydroxy anisole containing topical compositions," is a significant patent in the field of dermatology and pharmaceuticals. This patent, granted to a specific inventor or entity, covers a particular formulation of tretinoin, a derivative of vitamin A, which is commonly used in the treatment of acne and other skin conditions.
Background
Tretinoin, also known as all-trans retinoic acid, is a widely used topical treatment for various skin disorders. However, its stability and efficacy can be compromised by factors such as light, oxygen, and moisture. The invention described in US Patent 5,470,567 addresses these issues by developing a stable formulation that includes 4-hydroxy anisole as an antioxidant.
Scope of the Patent
Invention Overview
The patent describes a topical composition that contains tretinoin and 4-hydroxy anisole. This formulation is designed to enhance the stability of tretinoin, ensuring its effectiveness over a longer period. The composition can include various other ingredients such as solvents, emollients, and preservatives to improve its topical application and shelf life[2].
Claims
The patent includes several claims that define the scope of the invention. These claims typically cover:
- Composition Claims: These specify the exact formulation of the topical composition, including the amounts of tretinoin and 4-hydroxy anisole.
- Method Claims: These describe the methods of preparing the composition.
- Use Claims: These outline the intended uses of the composition, such as treating acne or other skin conditions.
For example, the patent might claim a composition comprising:
- A solution of 0.01% retinoic acid (tretinoin)
- An amount of 4-hydroxy anisole sufficient to act as an antioxidant
- Other components such as isopropanol, butylated hydroxyanisole, and triacontan-1-ol[2].
Patent Claims Analysis
Claim Structure
The claims in US Patent 5,470,567 are structured to provide broad protection for the invention while also being specific enough to distinguish it from prior art. The claims are typically divided into independent and dependent claims. Independent claims stand alone and define the invention, while dependent claims further limit the scope of the independent claims.
Claim Scope
The scope of the claims is crucial as it determines the extent of protection granted by the patent. For instance, if a claim is too broad, it may be challenged for being overly generic or covering ineligible subject matter. Conversely, if it is too narrow, it may not provide sufficient protection against infringement.
Patent Landscape
Prior Art and Novelty
To be patentable, an invention must be novel, meaning it must not have been previously disclosed in the prior art. The novelty requirement ensures that the invention adds something new to the existing body of knowledge. In the case of US Patent 5,470,567, the invention must have introduced a new and non-obvious way of stabilizing tretinoin using 4-hydroxy anisole that was not previously known or disclosed[4].
Nonobviousness
In addition to novelty, the invention must also be nonobvious. This means that the invention must be significantly different from existing solutions and not an obvious combination of prior art elements. The nonobviousness requirement is a critical test to ensure that the patent is granted for a truly innovative invention rather than a trivial modification of existing technology[4].
International Patent Landscape
The patent landscape for tretinoin formulations is complex and global. Similar patents may exist in other countries, and the international patent landscape must be considered to understand the full scope of protection and potential challenges. For example, the European Patent Office (EPO), Japan Patent Office (JPO), and other international intellectual property offices may have similar or related patents that could impact the global market for this invention[1].
Economic and Legal Implications
Market Impact
The grant of US Patent 5,470,567 can significantly impact the market for tretinoin-based topical treatments. The patent holder has exclusive rights to manufacture, use, sell, or import the invention in the United States until the patent expires. This can give the patent holder a competitive advantage in the market and allow them to set prices and control distribution[4].
Challenges and Reviews
The patent can be challenged through various administrative and judicial proceedings. For instance, the Patent Trial and Appeal Board (PTAB) can review the patentability of the claims through Inter Partes Review (IPR) or Post-Grant Review (PGR) proceedings. These proceedings can be initiated by third parties who may argue that the patent does not meet the requirements of novelty, nonobviousness, or subject matter eligibility[4].
Expiration and Generic Entry
Patent Expiration
The patent's expiration date is crucial for understanding when generic versions of the product can enter the market. Once the patent expires, other companies can manufacture and sell similar products without infringing on the original patent. For US Patent 5,470,567, the expiration date would typically be 20 years from the filing date of the patent application, assuming all maintenance fees have been paid[5].
Generic Competition
After the patent expires, generic manufacturers can enter the market, potentially reducing prices and increasing competition. This can benefit consumers by providing more affordable options but may also impact the original patent holder's market share and revenue.
Key Takeaways
- Stable Formulation: The patent describes a stable formulation of tretinoin using 4-hydroxy anisole as an antioxidant.
- Claims Structure: The claims are structured to provide broad yet specific protection for the invention.
- Novelty and Nonobviousness: The invention must meet the requirements of novelty and nonobviousness to be patentable.
- Market Impact: The patent can give the holder a competitive advantage in the market for tretinoin-based treatments.
- Challenges and Reviews: The patent can be challenged through PTAB proceedings.
- Expiration and Generic Entry: The patent's expiration date determines when generic versions can enter the market.
FAQs
Q: What is the main invention described in US Patent 5,470,567?
A: The main invention is a topical composition containing tretinoin and 4-hydroxy anisole, designed to enhance the stability of tretinoin.
Q: What are the key components of the composition claimed in the patent?
A: The composition includes tretinoin, 4-hydroxy anisole, and other ingredients such as isopropanol, butylated hydroxyanisole, and triacontan-1-ol.
Q: How long does a US patent typically last?
A: A US patent typically lasts for 20 years from the filing date of the patent application, assuming all maintenance fees are paid.
Q: Can the patent be challenged after it is granted?
A: Yes, the patent can be challenged through administrative proceedings such as Inter Partes Review (IPR) or Post-Grant Review (PGR) before the Patent Trial and Appeal Board (PTAB).
Q: What happens when the patent expires?
A: When the patent expires, generic manufacturers can produce and sell similar products, potentially reducing prices and increasing competition in the market.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- Google Patents - CN1225247C: https://patents.google.com/patent/CN1225247C/en
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Congressional Research Service - The Patent Trial and Appeal Board and Inter Partes Review: https://crsreports.congress.gov/product/pdf/R/R48016
- DrugPatentWatch - Patent 5,470,567: https://www.drugpatentwatch.com/p/patent/5470567
