United States Patent 9,439,905: A Detailed Analysis of Scope, Claims, and Patent Landscape
Overview of the Patent
United States Patent 9,439,905, titled "Risperidone-containing implants and methods of use thereof," is a significant patent in the field of pharmaceuticals, particularly in the treatment of mental health disorders. Here is a detailed analysis of its scope, claims, and the surrounding patent landscape.
Inventors and Assignees
The patent was issued to inventors Steven Siegel and Karen Winey, and it is assigned to The Trustees of the University of Pennsylvania[5].
Issuance and Expiration Dates
The patent was issued on September 13, 2016, and it is set to expire on January 12, 2025[5].
Scope of the Patent
Drug-Containing Implants
This patent pertains to the development and use of implants that contain the therapeutic drug risperidone. Risperidone is a second-generation antipsychotic medication used to treat various mental health disorders, including schizophrenia and bipolar mania[4].
Composition of the Implants
The implants described in the patent comprise a therapeutic drug (risperidone) and a polymer containing polylactic acid (PLA) and optionally polyglycolic acid (PGA). These biodegradable polymers are designed to release the drug at a substantially linear rate, ensuring a consistent therapeutic level in the subject[5].
Claims of the Patent
The patent includes several key claims that define its scope:
Methods of Drug Release
- The patent claims methods for maintaining a therapeutic level of risperidone in a subject by releasing the drug from the implant at a controlled rate.
- It also claims methods for treating schizophrenia and other diseases and disorders using these implants[5].
Implant Composition
- The claims specify the composition of the implants, including the use of PLA and optionally PGA as the biodegradable polymer matrix.
- The patent also covers various configurations of the implant, such as different shapes and sizes, designed to optimize drug release[5].
Manufacturing Processes
- The patent includes claims related to the manufacturing processes of these implants, ensuring that the drug is uniformly distributed within the polymer matrix and that the implants are produced in a way that maintains their integrity and efficacy[5].
Patent Landscape
Related Patents
The patent landscape surrounding US 9,439,905 includes several related patents that focus on similar aspects of drug delivery and implant technology:
Risperidone Biodegradable Implant (US 10,736,965)
- This patent, also assigned to The Trustees of the University of Pennsylvania, covers similar biodegradable implants containing risperidone and is set to expire on the same date as US 9,439,905[5].
Drug-Containing Implants and Methods of Use Thereof (US 8,221,778)
- Another related patent that deals with drug-containing implants and their methods of use, also involving PLA and PGA polymers[5].
Exclusivities and Patent Protection
- The FDA has granted exclusivities to these implants, which run concurrently with the patent protection. These exclusivities prevent other companies from marketing generic or bioequivalent versions of the drug until they expire[2].
Future Implications
- The expiration of these patents in January 2025 will open the market for generic versions of these implants, provided no further extensions or amendments to the patent claims are made[2][5].
Claim Coverage and Scope Concepts
Analyzing Patent Claims
To fully understand the protection offered by this patent, it is crucial to analyze the claims in the context of scope concepts. This involves categorizing the patents by claims and overarching scope concepts, which helps in identifying gaps or opportunities in the patent landscape[3].
Claim Charts and Coverage
Using tools like ClaimScape® software, companies can generate interactive claim charts to review patent coverage. These charts help technical experts determine whether a particular scope concept is applicable to a target product or method, highlighting areas where claim coverage may be lacking[3].
Key Takeaways
- Patent Scope: The patent covers the composition, manufacturing, and use of risperidone-containing biodegradable implants.
- Claims: The claims include methods for drug release, implant composition, and manufacturing processes.
- Related Patents: Other patents cover similar aspects of drug delivery and implant technology.
- Exclusivities: FDA-granted exclusivities run concurrently with patent protection.
- Expiration: The patent is set to expire on January 12, 2025, which will impact the market for generic versions.
FAQs
What is the primary focus of United States Patent 9,439,905?
The primary focus of this patent is on the development and use of biodegradable implants containing the therapeutic drug risperidone for treating mental health disorders.
Who are the inventors and assignees of this patent?
The inventors are Steven Siegel and Karen Winey, and the patent is assigned to The Trustees of the University of Pennsylvania.
What is the composition of the implants described in the patent?
The implants are composed of risperidone and a polymer containing polylactic acid (PLA) and optionally polyglycolic acid (PGA).
When is the patent set to expire?
The patent is set to expire on January 12, 2025.
What impact will the expiration of this patent have on the market?
The expiration will allow for the potential launch of generic versions of these implants, provided no further extensions or amendments to the patent claims are made.
How do FDA exclusivities affect the market for these implants?
FDA exclusivities prevent other companies from marketing generic or bioequivalent versions of the drug until they expire, running concurrently with the patent protection.
Sources
- US6750341B2 - Preparation of risperidone - Google Patents
- Uzedy patent expiration - Pharsight
- Patent Analytics | Intellectual Property Law - SLWIP
- Risperidone: Uses, Interactions, Mechanism of Action - DrugBank
- Generic Uzedy Availability - Drugs.com
