Understanding the Scope and Claims of United States Patent 10,610,489
Introduction to Patent 10,610,489
United States Patent 10,610,489, issued on April 7, 2020, is a significant patent related to the pharmaceutical composition and methods for treating type 2 diabetes. This patent is owned by Boehringer Ingelheim International GmbH and is crucial for the drug Synjardy, which combines empagliflozin and metformin hydrochloride.
Patent Overview
- Patent Title: Pharmaceutical composition, methods for treating and uses thereof
- Issue Date: April 7, 2020
- Assignee: Boehringer Ingelheim International GmbH
- Inventors: Uli Christian Broedl, Sreeraj Macha, Maximilian von Eynatten, Hans-Juergen Woerle[4][5].
Patent Claims
The patent claims are a critical component of any patent, as they define the scope of protection. Here are some key aspects of the claims in Patent 10,610,489:
Independent Claims
Independent claims are those that stand alone and do not depend on other claims. These claims typically define the broadest scope of the invention.
- The patent includes several independent claims that describe the pharmaceutical composition, its components, and the methods for treating type 2 diabetes. For example, Claim 1 might describe the combination of empagliflozin and metformin hydrochloride in specific ratios and formulations[4].
Dependent Claims
Dependent claims build upon the independent claims and provide additional details or limitations.
- Dependent claims may specify particular dosages, administration methods, or patient populations. These claims help to narrow down the invention and provide a clearer picture of what is protected[4].
Patent Scope
The scope of a patent is determined by the claims and the description provided in the patent specification.
Claim Language and Scope
The language used in the claims is crucial for defining the patent scope. Narrower claims are generally easier to enforce but offer less protection, while broader claims may be more challenging to defend but offer wider protection.
- The scope of Patent 10,610,489 is defined by its claims, which cover specific formulations and methods of treatment. The patent scope is also influenced by the prior art and the examination process, which can narrow down the claims to ensure they are novel and non-obvious[3].
Patent Expiration Dates
Understanding the patent expiration dates is vital for predicting when generic versions of the drug can be introduced.
- Patent 10,610,489 is set to expire on September 30, 2030. This date is significant because it marks the end of the exclusive period during which Boehringer Ingelheim can market Synjardy without generic competition[2][5].
Related Patents and Patent Landscape
The patent landscape for Synjardy includes several other patents that protect different aspects of the drug.
Other Relevant Patents
- Patent 7,579,449: Expires on November 5, 2025.
- Patent 7,713,938: Expires on April 15, 2027.
- Patent 10,258,637: Expires on April 3, 2034.
- Patent 11,813,275 and 11,833,166: Both expire on April 3, 2034[2][5].
These patents collectively protect the drug's composition, methods of treatment, and other related aspects, ensuring a comprehensive protection strategy.
Litigation and Generic Approval
Litigation related to patent infringement can significantly impact the approval of generic versions.
- For example, litigation initiated against Alembic Pharmaceuticals Limited for infringement of the '938 patent has delayed the approval of their ANDA (Abbreviated New Drug Application) for a generic version of Synjardy. The final approval cannot be granted until the patent expires or the court decides that the patent is invalid or not infringed[5].
Impact on Innovation and Competition
The patent landscape around Synjardy influences both innovation and competition in the pharmaceutical industry.
- Innovation: The protection offered by these patents incentivizes further research and development by ensuring that the innovator company can recoup its investment.
- Competition: The expiration of these patents will open the market to generic competition, which can drive down prices and increase accessibility of the drug to patients[3].
Conclusion
United States Patent 10,610,489 is a critical component of the intellectual property strategy for Synjardy, a drug used to treat type 2 diabetes. Understanding the claims, scope, and expiration dates of this patent, along with the broader patent landscape, is essential for both the innovator company and potential generic competitors.
Key Takeaways
- Patent Claims: Define the scope of protection for the pharmaceutical composition and methods of treatment.
- Patent Scope: Determined by claim language and the description in the patent specification.
- Expiration Dates: Patent 10,610,489 expires on September 30, 2030.
- Related Patents: Several other patents protect different aspects of Synjardy.
- Litigation: Ongoing litigation can delay the approval of generic versions.
- Impact on Innovation and Competition: Patents balance innovation incentives with future competition.
FAQs
Q: What is the main subject of United States Patent 10,610,489?
A: The main subject is the pharmaceutical composition and methods for treating type 2 diabetes using a combination of empagliflozin and metformin hydrochloride.
Q: Who is the assignee of this patent?
A: The assignee is Boehringer Ingelheim International GmbH.
Q: When does Patent 10,610,489 expire?
A: It expires on September 30, 2030.
Q: Are there any generic versions of Synjardy available?
A: No, there are currently no therapeutically equivalent generic versions of Synjardy available in the United States[2].
Q: What impact do these patents have on the pharmaceutical industry?
A: These patents protect the innovator company's investment, incentivize further research, and will eventually allow for generic competition, driving down prices and increasing drug accessibility.
Sources
- Pharsight: Synjardy patent expiration.
- Drugs.com: Generic Synjardy Availability.
- Hoover Institution: Patent Claims and Patent Scope.
- Google Patents: United States Patent 11,090,323 B2.
- FDA: Empagliflozin and Metformin Hydrochloride Tablets.
