United States Patent 9,308,204: A Detailed Analysis
Overview of the Patent
United States Patent 9,308,204, issued on April 12, 2016, is assigned to Pfizer Inc. and pertains to "Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives" and their uses, particularly in the treatment of diseases mediated by sodium-glucose transporter inhibitors (SGLT2 inhibitors)[5].
Inventor and Assignee
The patent was invented by Vincent Mascitti and is assigned to Pfizer Inc., a leading pharmaceutical company[5].
Claims and Scope
Chemical Compounds
The patent describes specific chemical compounds, namely dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives. These compounds contain asymmetric or chiral centers, resulting in different stereoisomeric forms[4].
Therapeutic Uses
The primary use of these compounds is in the treatment of diseases, conditions, and disorders mediated by SGLT2 inhibitors. This is particularly relevant in the context of type 2 diabetes management, where SGLT2 inhibitors play a crucial role in improving glycemic control[5].
Patent Scope Measurement
The scope of a patent can be measured in various ways, including the number of words in its first claim, the number of patent classes, the number of citations, and the number of claims. For this patent, the scope is likely broad due to the specific nature of the chemical compounds and their therapeutic applications. A broader patent scope typically offers more protection against infringers because it is harder to design around[3].
Patent Claims
Claim Structure
The patent includes multiple claims that define the scope of protection. These claims are structured to ensure that any competitor must meet every condition specified to avoid infringement. Longer claims generally indicate a narrower scope, but in this case, the specificity of the chemical compounds and their therapeutic uses suggests a balanced scope that is both protective and focused[3].
Claim Examples
The patent claims include descriptions of the chemical structures, their synthesis, and their therapeutic applications. For instance, the compounds are described in terms of their stereochemistry and the specific diseases they are intended to treat[4].
Patent Landscape
Related Patents
The patent landscape for this invention includes several related patents, such as US Patent 9,439,902, also issued to Pfizer Inc. and related to similar chemical compounds and therapeutic uses. Additionally, patents like US8080580, which cover other aspects of the drug's development and formulation, are part of the broader patent portfolio[5].
Patent Expiration Dates
The patent is set to expire on October 21, 2030. This expiration date is significant because it marks the end of the exclusive rights granted to Pfizer Inc. for the proprietary chemical formulation described in the patent[5].
Regulatory and Legal Aspects
FDA Approval and Exclusivity
The compounds described in this patent are part of drugs that have received FDA approval. For example, the combination of ertugliflozin and sitagliptin, known as STEGLUJAN, was approved by the FDA and has undergone regulatory review, which can impact the patent term extension[2].
Patent Term Extension
The USPTO can extend the patent term based on the regulatory review period, which includes both the testing and approval phases. For STEGLUJAN, Pfizer Inc. sought a patent term extension, and the FDA's verification of the regulatory review period was crucial in determining the eligibility for this extension[2].
Economic and Strategic Implications
Market Protection
The patent provides Pfizer Inc. with exclusive rights to market and manufacture the described compounds, protecting their investment in research and development. This exclusivity is crucial for maintaining market dominance and preventing generic or biosimilar competition during the patent term[5].
Innovation and Competition
The broad scope of the patent can influence innovation in the field by making it more challenging for competitors to develop similar compounds without infringing on the patent. However, it also encourages further research and development of new compounds that can circumvent the existing patent claims[3].
Key Takeaways
- Chemical Compounds: The patent describes specific dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives with therapeutic applications.
- Therapeutic Uses: The compounds are used in treating diseases mediated by SGLT2 inhibitors, particularly type 2 diabetes.
- Patent Scope: The scope is measured by the specificity of the claims, providing balanced protection.
- Related Patents: Part of a broader patent portfolio including other related patents.
- Expiration Date: The patent expires on October 21, 2030.
- Regulatory Aspects: FDA approval and potential patent term extension based on regulatory review.
FAQs
What is the primary therapeutic use of the compounds described in US Patent 9,308,204?
The primary therapeutic use is in the treatment of diseases mediated by SGLT2 inhibitors, particularly type 2 diabetes.
Who is the assignee of US Patent 9,308,204?
The assignee is Pfizer Inc.
What is the expiration date of US Patent 9,308,204?
The patent is set to expire on October 21, 2030.
How is the scope of a patent typically measured?
The scope can be measured by the number of words in the first claim, the number of patent classes, the number of citations, and the number of claims.
Can the patent term of US Patent 9,308,204 be extended?
Yes, the patent term can be extended based on the regulatory review period, as determined by the USPTO and FDA.
Cited Sources
- DrugBank Online: Sitagliptin: Uses, Interactions, Mechanism of Action.
- Federal Register: FDA Approval and Patent Term Restoration for STEGLUJAN.
- Boston University Law: The Ways We've been Measuring Patent Scope are Wrong.
- Google Patents: Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives.
- Drugs.com: Generic Segluromet Availability.
