United States Patent 10,695,367: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 10,695,367, titled "Pharmaceutical Compositions," is a crucial patent in the pharmaceutical industry, particularly for the drug Velphoro, which is used as a phosphate binder. This patent is owned by VFMCRP Switzerland and is part of a broader patent portfolio protecting Velphoro. Here, we will delve into the scope, claims, and the surrounding patent landscape of this patent.
Patent Overview
Title and Description
The patent, numbered US 10,695,367, is titled "Pharmaceutical Compositions" and pertains to the formulation and use of phosphate binder particles, specifically those used in Velphoro. This patent focuses on the pharmaceutical compositions and methods for their formulation, particularly for oral delivery systems[2][4].
Scope of the Patent
Claims
The patent includes multiple claims that define the scope of protection. These claims are divided into independent and dependent claims. Independent claims define the broadest scope of the invention, while dependent claims narrow down the scope by adding additional limitations.
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Independent Claims: These claims outline the core aspects of the pharmaceutical compositions, including the specific formulations and the methods for preparing these compositions. For example, Claim 1 might describe the general composition of the phosphate binder particles, while subsequent independent claims might detail specific methods of preparation or additional components[4].
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Dependent Claims: These claims build upon the independent claims by adding specific details or limitations. For instance, a dependent claim might specify the exact ratio of ingredients or the particular process steps involved in manufacturing the pharmaceutical composition[4].
Patent Scope Metrics
The scope of a patent can be measured using metrics such as independent claim length and independent claim count. Narrower claims, as indicated by shorter lengths and fewer counts, are often associated with a higher probability of grant and a shorter examination process. This patent, like others in its class, would have undergone a narrowing process during the examination to ensure clarity and validity[3].
Patent Landscape
Related Patents
The patent 10,695,367 is part of a larger family of patents related to Velphoro. Other patents in this family include US 9,561,251, US 10,624,855, US 10,682,376, and several others, all of which protect different aspects of the drug, such as the active ingredient, dosage forms, and methods of administration[1][2].
Expiry Dates
The expiry dates of these patents are crucial for understanding when generic versions of Velphoro might become available. The patent 10,695,367 is set to expire in November 2028, although this date can be affected by legal activities such as patent term extensions or amendments to the claims[1].
Litigation and Infringement
There have been several legal actions related to these patents, particularly concerning the filing of Abbreviated New Drug Applications (ANDAs) by generic manufacturers. For example, VFMCRP Switzerland has sued companies like Aurobindo and Teva for alleged infringement of these patents, seeking declaratory judgments and injunctions to prevent the commercialization of generic versions of Velphoro before the patents expire[2][5].
Legal Activities and Updates
Maintenance Fees and Patent Status
The patent's status is actively maintained through the payment of maintenance fees. Recent activities include the payment of the 4th-year maintenance fee for large entities, which ensures the patent remains active until its expiry date[1].
Recent Litigation
Recent litigation documents show that VFMCRP Switzerland is actively defending its patents against potential infringers. These lawsuits highlight the ongoing efforts to protect the intellectual property surrounding Velphoro and prevent premature generic competition[2][5].
Impact on Generic Launch
The expiry of the patent 10,695,367, along with other related patents, will significantly impact the timing of generic launches for Velphoro. Generic manufacturers are preparing to enter the market as soon as the patents expire, but ongoing litigation and potential extensions could delay these plans[1][2].
Conclusion and Key Takeaways
- Patent Scope and Claims: The patent 10,695,367 protects specific pharmaceutical compositions and methods related to Velphoro, with a focus on phosphate binder particles.
- Patent Landscape: This patent is part of a broader family of patents protecting Velphoro, with various expiry dates and ongoing litigation.
- Legal Activities: Active maintenance and litigation efforts are in place to protect the patent and prevent premature generic competition.
- Impact on Generic Launch: The expiry of this and related patents will determine when generic versions of Velphoro can enter the market.
Key Takeaways
- The patent 10,695,367 is a critical component of the intellectual property protecting Velphoro.
- The patent's scope includes specific formulations and methods for phosphate binder particles.
- Ongoing litigation and patent maintenance activities are crucial for protecting the patent.
- The expiry date of November 2028 is subject to change based on legal activities.
- Generic manufacturers are preparing for market entry upon patent expiry.
FAQs
What is the main subject of the patent 10,695,367?
The main subject of the patent 10,695,367 is the pharmaceutical compositions, specifically the formulations and methods related to phosphate binder particles used in Velphoro.
Who owns the patent 10,695,367?
The patent 10,695,367 is owned by VFMCRP Switzerland.
When is the patent 10,695,367 set to expire?
The patent 10,695,367 is set to expire in November 2028, although this date can be affected by legal activities.
What are the implications of ongoing litigation for generic manufacturers?
Ongoing litigation can delay the entry of generic manufacturers into the market by preventing them from commercially manufacturing, using, offering to sell, or selling their generic versions of Velphoro until the patents expire.
How do maintenance fees impact the patent's status?
Payment of maintenance fees ensures that the patent remains active until its expiry date, protecting the intellectual property rights of the patent owner.
Sources:
- Pharsight: Velphoro patent expiration.
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT: Litigation documents.
- Hoover Institution: Patent Claims and Patent Scope.
- Google Patents: US10695367B2 - Pharmaceutical compositions.
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT: Case 1:20-cv-00911-MN Document 61 Filed 06/24/21.
