United States Patent 10,624,855: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,624,855, titled "Pharmaceutical Composition, Comprising Phosphate Binder Particles," is a crucial patent in the realm of renal pharmaceuticals, particularly for the drug Velphoro (sucroferric oxyhydroxide). This patent is owned by VFMCRP Switzerland and is central to several legal and pharmaceutical discussions.
Patent Overview
Issuance and Assignee
The patent was issued on April 21, 2020, by the United States Patent and Trademark Office (PTO) and is assigned to VFMCRP Switzerland[2][4].
Inventors
The inventors of this patent are Laurent Chofflon and Erik Philipp, both of whom have contributed significantly to the development of pharmaceutical compositions involving phosphate binder particles[2].
Scope of the Patent
Pharmaceutical Composition
The patent describes a pharmaceutical composition comprising phosphate binder particles, specifically designed for treating hyperphosphatemia in patients with chronic kidney disease. The composition includes particles with a specific size distribution, which is critical for the efficacy and safety of the drug[5].
Particle Size Distribution
The patent emphasizes the importance of the particle size distribution of the phosphate binder particles. This specific distribution ensures optimal performance of the drug, enhancing its ability to bind phosphate effectively in the gastrointestinal tract[5].
Claims of the Patent
Key Claims
The patent includes several claims that define the scope of the invention. Here are some of the key claims:
- Claim 1: This claim describes the pharmaceutical composition comprising phosphate binder particles with a specific particle size distribution.
- Claims 8 and 18: These claims further detail the composition and the method of preparing the phosphate binder particles, ensuring they meet the specified criteria[2].
Infringement and Validity
The claims of this patent have been subject to legal scrutiny, particularly in the context of generic drug applications. For instance, in the case of Vifor Fresenius Medical Care Renal Pharma Ltd. v. Teva Pharms. USA, Inc., Teva's proposed generic version of Velphoro was found to infringe on the claims of this patent. The court upheld the validity of the patent, rejecting Teva's arguments that the claims were obvious or invalid[4].
Patent Landscape
Related Patents
The patent landscape surrounding U.S. Patent 10,624,855 includes several other patents related to Velphoro and its components. These include:
- U.S. Patent No. 9,561,251: This patent, also owned by VFMCRP Switzerland, covers broader aspects of pharmaceutical compositions involving iron oxyhydroxide.
- U.S. Patent No. 10,682,376: Another patent in the series, this one also deals with specific aspects of phosphate binder particles.
- U.S. Patent No. 11,234,938: Issued in 2022, this patent further refines the composition and preparation methods of phosphate binder particles[2].
Litigation and Generic Challenges
The patent has been at the center of several legal battles, particularly with generic drug manufacturers. Companies like Teva and Aurobindo have filed Abbreviated New Drug Applications (ANDAs) to market generic versions of Velphoro, which have been challenged by VFMCRP Switzerland. These challenges often involve disputes over patent infringement and the validity of the patent claims[2][4].
Impact on the Pharmaceutical Industry
Market Protection
This patent, along with others in the series, provides significant market protection for Velphoro. By preventing generic versions from entering the market until the patent expires, VFMCRP Switzerland can maintain its market share and revenue from the drug.
Innovation
The specific claims and scope of this patent encourage innovation within the pharmaceutical industry. By defining precise criteria for the composition and preparation of phosphate binder particles, the patent sets a standard for future developments in this area.
Legal and Regulatory Aspects
Patent Expiration
The patent's expiration date is crucial for understanding when generic versions can enter the market. While the exact expiration date is not specified in the provided sources, it is typically 20 years from the filing date of the earliest related application.
Litigation Outcomes
The outcomes of litigation involving this patent have significant implications for both the original drug manufacturer and potential generic competitors. For instance, the court's decision in Vifor Fresenius Medical Care Renal Pharma Ltd. v. Teva Pharms. USA, Inc. upheld the patent's validity and found Teva's ANDA product to infringe on the patent claims[4].
Conclusion
United States Patent 10,624,855 is a pivotal patent in the field of renal pharmaceuticals, particularly for the treatment of hyperphosphatemia. Its scope and claims are carefully defined to protect the unique composition and preparation methods of phosphate binder particles. The patent landscape surrounding this patent is complex, with multiple related patents and ongoing legal challenges from generic drug manufacturers.
"The court presided over a four-day bench trial and found: that Teva’s ANDA product infringed the ’251 patent and that the ’251 patent was not invalid."[4]
Key Takeaways
- Patent Ownership: VFMCRP Switzerland owns the patent.
- Inventors: Laurent Chofflon and Erik Philipp.
- Scope: The patent covers pharmaceutical compositions comprising phosphate binder particles with a specific size distribution.
- Claims: Key claims include the composition and preparation methods of the phosphate binder particles.
- Litigation: The patent has been involved in several legal battles over generic drug applications.
- Impact: The patent provides market protection and encourages innovation in the pharmaceutical industry.
FAQs
What is the main subject of U.S. Patent 10,624,855?
The main subject of U.S. Patent 10,624,855 is a pharmaceutical composition comprising phosphate binder particles, specifically designed for treating hyperphosphatemia.
Who are the inventors of this patent?
The inventors of this patent are Laurent Chofflon and Erik Philipp.
What company owns this patent?
The patent is owned by VFMCRP Switzerland.
What are the key claims of this patent?
The key claims include the description of the pharmaceutical composition and the specific particle size distribution of the phosphate binder particles.
Has this patent been involved in any significant legal cases?
Yes, it has been involved in cases such as Vifor Fresenius Medical Care Renal Pharma Ltd. v. Teva Pharms. USA, Inc., where Teva's generic version of Velphoro was found to infringe on the patent claims.
What is the impact of this patent on the pharmaceutical industry?
This patent provides market protection for Velphoro and encourages innovation by setting standards for the composition and preparation of phosphate binder particles.
Sources
- Pharsight: Velphoro patent expiration.
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT: Infringement of one or more claims of the '251 patent.
- WIPO: Patent Landscape Report on Ritonavir.
- Robins Kaplan: Vifor Fresenius Medical Care Renal Pharma Ltd. v. Teva Pharms. USA, Inc.
- Unified Patents: Pharmaceutical Composition, Comprising Phosphate Binder Particles.
