Detailed Analysis of the Scope and Claims of United States Patent 8,247,415
Introduction
United States Patent 8,247,415, titled "Hydroxymethyl Pyrrolidines as β3 Adrenergic Receptor Agonists," was issued on August 21, 2012, to Merck Sharp & Dohme Corp. This patent is crucial in the field of pharmaceuticals, particularly for the treatment or prevention of diseases mediated by the activation of β3-adrenoceptors.
Inventors and Assignee
The patent was invented by a team of researchers including Richard Berger, Lehua Chang, Scott D. Edmondson, Stephen D. Goble, Sookhee Nicole Ha, Nam Fung Kar, Ihor E. Kopka, Bing Li, Gregori J. Morriello, Chris R. Moyes, Dong-Ming Shen, Liping Wang, and Cheng Zhu. The assignee of the patent is Merck Sharp & Dohme Corp., a prominent pharmaceutical company[2].
Patent Scope
The patent covers compounds of a specific formula, pharmaceutical compositions thereof, and methods of using these compounds in the treatment or prevention of diseases. Here are the key aspects of the patent scope:
Compounds
The patent describes compounds of Formula (I) and their derivatives, including pharmaceutically acceptable salts and stereoisomers. These compounds are designed to act as β3 adrenergic receptor agonists, which are important in various physiological processes and therapeutic applications[2].
Pharmaceutical Compositions
The patent includes pharmaceutical compositions that contain the compounds of Formula (I) or their derivatives. These compositions can be formulated for various routes of administration and are intended for the treatment or prevention of diseases mediated by β3-adrenoceptor activation[2].
Methods of Use
The patent outlines methods of using the compounds and pharmaceutical compositions for treating or preventing diseases. This includes a range of therapeutic applications where β3 adrenergic receptor agonism is beneficial, such as in the treatment of obesity, diabetes, and other metabolic disorders[2].
Claims
The patent claims are detailed and specific, ensuring broad protection for the inventors and the assignee. Here are some key aspects of the claims:
Independent Claims
The patent includes independent claims that define the scope of the invention. These claims cover the specific chemical structures of the compounds, their pharmaceutical compositions, and the methods of using these compounds for therapeutic purposes[2].
Dependent Claims
Dependent claims further narrow down the scope by specifying particular aspects of the compounds, such as specific substituents, dosage forms, and methods of administration. These claims provide additional protection by covering various embodiments of the invention[2].
Patent Expiration Dates
The patent is set to expire on December 1, 2030. This expiration date is crucial for understanding when generic versions of the drug can be developed and marketed. Patent expiration dates can vary based on several factors, including the date of filing and any extensions or adjustments granted by the U.S. Patent and Trademark Office[2].
Related Patents and Exclusivities
There are related patents and exclusivities that need to be considered:
Related Patents
Other patents, such as US 8,653,260, also issued to Merck Sharp & Dohme Corp., cover similar compounds and methods. These patents may have overlapping claims and expiration dates, affecting the overall patent landscape for β3 adrenergic receptor agonists[2].
Exclusivities
In addition to patent protection, the FDA grants exclusivity periods that provide sole marketing rights to the manufacturer. For this patent, the exclusivity period is set to expire on December 23, 2025, which is separate from the patent expiration date[2].
Impact on Innovation and Competition
The scope and claims of this patent can influence innovation and competition in the pharmaceutical industry:
Innovation
The patent's broad claims may encourage further research and development in the field of β3 adrenergic receptor agonists. However, overly broad claims can also lead to increased licensing and litigation costs, potentially diminishing incentives for innovation[3].
Competition
The expiration of the patent and related exclusivities will open the market to generic versions of the drug, increasing competition and potentially reducing costs for consumers. This transition can also spur further innovation as other companies enter the market with their own versions or improvements of the drug[2].
Metrics for Measuring Patent Scope
To evaluate the scope of this patent, metrics such as independent claim length and independent claim count can be used. These metrics can provide insights into the breadth and clarity of the patent claims, which are important for assessing patent quality and potential impact on innovation[3].
Conclusion
United States Patent 8,247,415 is a significant patent in the pharmaceutical industry, particularly for the development and use of β3 adrenergic receptor agonists. Understanding its scope, claims, and the surrounding patent landscape is crucial for both innovators and competitors in this field.
Key Takeaways
- Compounds and Compositions: The patent covers specific compounds and their pharmaceutical compositions as β3 adrenergic receptor agonists.
- Methods of Use: It outlines methods for treating or preventing diseases mediated by β3-adrenoceptor activation.
- Patent Expiration: The patent is set to expire on December 1, 2030.
- Related Patents and Exclusivities: Other patents and FDA-granted exclusivities affect the overall protection and market dynamics.
- Impact on Innovation and Competition: The patent's scope influences research, development, and market competition.
FAQs
What is the main subject of United States Patent 8,247,415?
The main subject of this patent is the compounds of Formula (I), pharmaceutical compositions thereof, and methods of using these compounds as β3 adrenergic receptor agonists.
Who are the inventors of this patent?
The inventors include Richard Berger, Lehua Chang, Scott D. Edmondson, Stephen D. Goble, Sookhee Nicole Ha, Nam Fung Kar, Ihor E. Kopka, Bing Li, Gregori J. Morriello, Chris R. Moyes, Dong-Ming Shen, Liping Wang, and Cheng Zhu.
What is the assignee of this patent?
The assignee of this patent is Merck Sharp & Dohme Corp.
When is the patent set to expire?
The patent is set to expire on December 1, 2030.
What is the impact of this patent on innovation and competition?
The patent's broad claims can influence further research and development but may also increase licensing and litigation costs. Its expiration will open the market to generic versions, increasing competition and potentially reducing costs for consumers.
How can the scope of this patent be measured?
The scope can be measured using metrics such as independent claim length and independent claim count, which provide insights into the breadth and clarity of the patent claims.
Sources
- United States Patent and Trademark Office - US 8,247,415 B2.
- Drugs.com - Generic Gemtesa Availability.
- SSRN - Patent Claims and Patent Scope.
