United States Patent 9,351,923: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,351,923, titled "Extended-release composition comprising a somatostatin derivative in microparticles," is a significant patent in the pharmaceutical field, particularly in the treatment of conditions such as Cushing's disease. This patent, issued on May 31, 2016, is part of a broader landscape of intellectual property related to somatostatin analogs and their delivery systems.
Background of Somatostatin Analogs
Somatostatin analogs, such as pasireotide, are used in the treatment of various endocrine disorders. Pasireotide, for instance, is specifically used for patients with Cushing's disease where pituitary surgery is not appropriate[4].
Patent Overview
Patent Number and Status
The patent number is US9351923B2, and it is currently active, with maintenance fees paid up to the 8th year[5].
Prior Art and Related Patents
The patent is a continuation of an application filed on June 21, 2013, and it claims priority from several provisional and foreign applications, the earliest of which was filed on July 1, 2012[2].
Claims
The patent includes claims related to the composition and method of making microparticles that contain a somatostatin analog. These claims are specific to the formulation, the polymer used, and the process of creating these microparticles to achieve extended-release properties[1].
Scope of the Patent
Independent Claims
The independent claims of the patent focus on the composition of the microparticles, including the type of polymer used and the method of preparation. These claims are crucial as they define the scope of protection for the invention[1].
Dependent Claims
Dependent claims further specify the details of the composition, such as the weight ratio of the somatostatin analog to the polymer, and the method of administering the microparticles. These claims build upon the independent claims and provide additional specificity to the invention[1].
Patent Landscape
Related Patents
Several other patents are related to this invention, including US7473761, US8299209, and US8822637, all of which are part of the same family of patents protecting various aspects of somatostatin analogs and their delivery systems[5].
Patent Expiration
The patent is set to expire on May 31, 2028, which marks the end of the exclusive period for the patent holder to manufacture and market the invention without generic competition[5].
Litigation and Challenges
The patent has been involved in various legal proceedings, including inter partes review (IPR) challenges. For example, Mylan Pharmaceuticals Inc. filed a petition seeking IPR of related patent claims, which was granted by the Patent Trial and Appeal Board (PTAB)[2].
Impact on Pharmaceutical Industry
Treatment of Cushing's Disease
The extended-release composition protected by this patent is significant for the treatment of Cushing's disease, offering a more convenient and effective delivery system for patients. This innovation can improve patient compliance and outcomes[4].
Generic Competition
As the patent approaches its expiration date, generic manufacturers are likely to prepare for the launch of generic versions of the drug. This could lead to increased competition and potentially lower prices for patients[5].
Patent Scope Metrics
Claim Length and Count
Research indicates that narrower claims, such as those seen in this patent, are associated with a higher probability of grant and a shorter examination process. The examination process often narrows the scope of patent claims, which can be observed in the evolution of this patent from its initial application to its granted form[3].
Forward Citations and Patent Maintenance
The patent's forward citations and maintenance payments are indicators of its importance and the ongoing interest in the technology. The payment of maintenance fees up to the 8th year suggests that the patent holder continues to see value in the invention[5].
Challenges and Controversies
IPR Challenges
The patent has faced challenges through IPR proceedings, which are designed to review the validity of patent claims. These challenges often involve disputes over prior art and the novelty of the invention[2].
Examiner Evaluation
The PTAB's decision to grant IPR highlights the importance of thorough examiner evaluation during the patent prosecution process. The board's consideration of prior art and arguments presented during examination is crucial in determining the patent's validity[2].
Key Takeaways
- Patent Scope: The patent protects a specific composition and method for creating extended-release microparticles containing a somatostatin analog.
- Related Patents: The patent is part of a larger family of patents related to somatostatin analogs and their delivery systems.
- Expiration: The patent is set to expire on May 31, 2028.
- Impact: The invention is significant for the treatment of Cushing's disease and may face generic competition upon patent expiration.
- Litigation: The patent has been involved in IPR challenges, highlighting the ongoing scrutiny of its validity.
FAQs
What is the main subject of United States Patent 9,351,923?
The main subject of this patent is an extended-release composition comprising a somatostatin derivative in microparticles, specifically designed for the treatment of conditions like Cushing's disease.
When is the patent set to expire?
The patent is set to expire on May 31, 2028.
What are the key claims of the patent?
The key claims include the composition of the microparticles, the type of polymer used, and the method of preparing these microparticles to achieve extended-release properties.
Has the patent faced any legal challenges?
Yes, the patent has faced inter partes review (IPR) challenges, which were granted by the Patent Trial and Appeal Board (PTAB).
How does this patent impact the treatment of Cushing's disease?
The patent protects an innovation that offers a more convenient and effective delivery system for somatostatin analogs, which can improve patient compliance and outcomes in the treatment of Cushing's disease.
Sources
- US9351923B2 - Extended-release composition comprising a somatostatin derivative in microparticles - Google Patents
- IPR2023-00724 Patent 10,335,462 B2 - United States Patent and Trademark Office
- Patent Claims and Patent Scope - Hoover Institution
- Pasireotide: Uses, Interactions, Mechanism of Action - DrugBank
- Signifor Lar Kit patent expiration - Pharsight
