United States Patent 8,802,735: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,802,735, assigned to Sanofi, is a crucial patent related to the drug teriflunomide, marketed under the brand name Aubagio. This patent is significant in the pharmaceutical industry, particularly for the treatment of multiple sclerosis and other autoimmune diseases. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Patent Number and Title
The patent in question is U.S. Patent No. 8,802,735, titled "Solid pharmaceutical composition of teriflunomide."
Filing and Grant Dates
The patent was granted on August 27, 2014, after being filed on February 1, 2011[4].
Scope of the Patent
Claims
The patent includes several claims that define the scope of the invention. Key claims include:
- Claim 1: A solid pharmaceutical composition comprising teriflunomide, where the composition does not include colloidal silicon dioxide, thereby reducing the formation of degradants[4].
- Claim 10: A method of preparing the solid pharmaceutical composition, emphasizing the exclusion of colloidal silicon dioxide to ensure stability and solubility[4].
These claims are critical as they specify the unique characteristics of the teriflunomide composition that distinguish it from other formulations.
Independent Claim Length and Count
Research on patent scope suggests that the length and count of independent claims can be indicative of the patent's breadth and complexity. For U.S. Patent 8,802,735, the independent claims are relatively specific, focusing on the composition and method of preparation, which suggests a narrower but well-defined scope[3].
Patent Landscape
Related Patents and Applications
The patent landscape for teriflunomide includes several related patents and applications. For instance:
- European Patent Application EP 4 023 215 A1: This application discusses film-coated tablets of teriflunomide and highlights the stability issues associated with colloidal silicon dioxide, reinforcing the findings of U.S. Patent 8,802,735[4].
- U.S. Patent No. 9,186,346: This patent, also related to teriflunomide, has been involved in litigation regarding generic versions of Aubagio, further emphasizing the protective measures around the original patent[2].
Litigation and Disputes
The patent has been involved in significant litigation, particularly with generic drug manufacturers. For example, Sanofi has sued Mylan Pharmaceuticals for submitting an Abbreviated New Drug Application (ANDA) for a generic version of teriflunomide, alleging infringement of U.S. Patent No. 8,802,735 and U.S. Patent No. 9,186,346[2].
Patent Exclusivities and Expiration
Patent Term and Exclusivities
The patent's term, combined with any granted exclusivities, determines when generic versions can enter the market. For U.S. Patent 8,802,735, the estimated generic launch date based on the last expiry date of its patents and exclusivities is August 4, 2034[1].
Impact on Generic Competition
The extended exclusivity period protects Sanofi's market position for Aubagio, delaying the entry of generic competitors. This period is crucial for the company to recoup its investment in research and development.
Technical Aspects
Stability and Solubility
The patent emphasizes the importance of excluding colloidal silicon dioxide from the teriflunomide composition to ensure stability and reduce the formation of degradants. This technical aspect is critical for maintaining the efficacy and safety of the drug[4].
Manufacturing Process
The method of preparing the solid pharmaceutical composition, as outlined in the patent, is designed to avoid instability issues. This process is a key part of the patent's claims and contributes to the overall quality of the final product.
Industry Impact
Market Dominance
The exclusive rights granted by U.S. Patent 8,802,735 allow Sanofi to maintain market dominance for Aubagio. This is particularly significant in the treatment of multiple sclerosis, where Aubagio is a preferred option due to its efficacy and safety profile.
Innovation and Competition
While the patent protects Sanofi's interests, it also influences the broader pharmaceutical landscape. Other companies must innovate around these patents or wait for their expiration to enter the market with generic versions. This dynamic drives continuous innovation in drug formulation and manufacturing.
Expert Insights
Industry experts often highlight the importance of patent protection in the pharmaceutical sector. For example:
"Patent protection is crucial for pharmaceutical companies to recoup their significant investments in research and development. It allows them to maintain market exclusivity and continue to innovate without immediate generic competition."[3]
Statistics and Trends
- Patent Litigation: The number of patent litigation cases involving pharmaceutical patents has been increasing, reflecting the high stakes involved in protecting intellectual property in this sector[5].
- Generic Entry: The delay in generic entry due to patent exclusivities can significantly impact market dynamics. For instance, the estimated generic launch date for Aubagio in 2034 will likely see a shift in market share once generics become available[1].
Key Takeaways
- U.S. Patent 8,802,735 protects a specific solid pharmaceutical composition of teriflunomide, excluding colloidal silicon dioxide.
- Claims are focused on the composition and method of preparation, ensuring stability and solubility.
- Litigation has been significant, particularly against generic manufacturers.
- Patent Exclusivities extend until August 4, 2034, protecting Sanofi's market position.
- Technical Aspects highlight the importance of stability and solubility in drug formulation.
- Industry Impact includes maintaining market dominance and driving innovation.
FAQs
What is the main claim of U.S. Patent 8,802,735?
The main claim is for a solid pharmaceutical composition of teriflunomide that does not include colloidal silicon dioxide, thereby reducing the formation of degradants.
Why is the exclusion of colloidal silicon dioxide important?
The exclusion of colloidal silicon dioxide is crucial for ensuring the stability and solubility of the teriflunomide composition, which directly affects the drug's efficacy and safety.
When is the estimated generic launch date for Aubagio?
The estimated generic launch date for Aubagio, based on the last expiry date of its patents and exclusivities, is August 4, 2034.
What is the significance of U.S. Patent 8,802,735 in the pharmaceutical industry?
This patent is significant because it protects Sanofi's market position for Aubagio, a key drug in the treatment of multiple sclerosis, and influences the broader landscape of pharmaceutical innovation and competition.
How does patent litigation impact the pharmaceutical industry?
Patent litigation can significantly delay the entry of generic drugs into the market, allowing the original patent holder to maintain market exclusivity and recoup their investment in research and development.
Cited Sources:
- Pharsight, "Aubagio patent expiration"
- United States District Court for the District of Delaware, "Sanofi vs. Mylan Pharmaceuticals"
- Hoover Institution, "Patent Claims and Patent Scope"
- European Patent Office, "A FILM COATED TABLET COMPRISING TERIFLUNOMIDE"
- Law360, "U.S. Patent Number 8,802,735: Cases"
