United States Patent 9,186,346: A Detailed Analysis
Introduction
United States Patent 9,186,346, titled "Methods for reducing the risk of an adverse teriflunomide and rosuvastatin interaction in multiple sclerosis patients," is a significant patent in the pharmaceutical sector. This patent, assigned to Sanofi, addresses a critical issue in the treatment of multiple sclerosis (MS) and involves the management of drug interactions.
Background of the Invention
Teriflunomide, marketed under the brand name Aubagio, is a novel oral disease-modifying therapy (DMT) for treating relapsing forms of multiple sclerosis (RMS). It works by blocking de novo pyrimidine synthesis, thereby inhibiting the replication and function of activated lymphocytes[1].
Scope of the Patent
The patent focuses on methods to reduce the risk of adverse interactions between teriflunomide and substrates of breast cancer resistance protein (BCRP) and/or organic anion transporting polypeptide B1 and B3 (OATP1B1/B3), particularly rosuvastatin. Rosuvastatin, a statin used to lower cholesterol, can interact with teriflunomide due to their shared transport mechanisms, potentially leading to increased levels of rosuvastatin and associated adverse effects[1].
Claims of the Patent
The patent includes several claims that outline the specific methods and conditions for reducing the risk of adverse interactions:
- Claim 1: A method for managing the risk of an adverse interaction between teriflunomide and a substrate of BCRP and/or OATP1B1/B3, involving the administration of teriflunomide and monitoring or adjusting the dose of the substrate based on the patient's genetic profile or other factors[1].
- Claim 5: A method involving the co-administration of teriflunomide with a reduced dose of rosuvastatin to minimize the risk of adverse effects[2][5].
Patent Landscape
The patent landscape surrounding U.S. Patent 9,186,346 is complex and involves several key aspects:
Related Patents
- U.S. Patent 6,794,410: This patent, also held by Sanofi, covers the composition and use of teriflunomide. It is often cited in conjunction with the '346 patent in litigation related to generic versions of Aubagio[2][5].
- U.S. Patent 8,802,735: This patent pertains to tablet formulations of teriflunomide with improved stability. It is another critical patent in the suite of protections for Aubagio[5].
Litigation and Enforcement
Sanofi has been actively involved in litigation to protect the '346 patent against generic manufacturers. For example, Sanofi has sued companies like Impax Laboratories and Mylan Pharmaceuticals for infringement related to their Abbreviated New Drug Applications (ANDAs) for generic versions of Aubagio[2][5].
Patent Expiration
The '346 patent is set to expire in February 2034, which marks a significant milestone in the patent lifecycle. After this date, generic versions of the drug could enter the market, potentially altering the competitive landscape for MS treatments[4].
Impact on Multiple Sclerosis Treatment
The methods described in this patent are crucial for ensuring the safe co-administration of teriflunomide with other medications, particularly those that are substrates of BCRP and OATP1B1/B3. This is vital for patients with multiple sclerosis who may require concurrent treatment with statins like rosuvastatin.
Industry and Economic Implications
The protection afforded by this patent helps Sanofi maintain market exclusivity for Aubagio, which is a significant revenue generator. The expiration of this patent could lead to increased competition from generic manufacturers, potentially reducing the market share and revenue for Sanofi.
Conclusion
United States Patent 9,186,346 is a critical component of Sanofi's intellectual property portfolio related to Aubagio. It addresses a specific clinical need by providing methods to manage drug interactions, ensuring safer treatment options for patients with multiple sclerosis. The patent's claims and the surrounding patent landscape highlight the complexities and strategic importance of intellectual property in the pharmaceutical industry.
Key Takeaways
- The patent focuses on reducing the risk of adverse interactions between teriflunomide and substrates of BCRP and OATP1B1/B3.
- It includes claims for specific methods of managing these interactions, particularly with rosuvastatin.
- The patent is part of a broader suite of patents protecting Aubagio.
- Litigation has been ongoing to enforce this patent against generic manufacturers.
- The patent is set to expire in February 2034, which could significantly impact the market for MS treatments.
Frequently Asked Questions (FAQs)
What is the primary focus of U.S. Patent 9,186,346?
The primary focus is on methods to reduce the risk of adverse interactions between teriflunomide and substrates of BCRP and OATP1B1/B3, particularly rosuvastatin.
Why is this patent important for multiple sclerosis treatment?
This patent ensures the safe co-administration of teriflunomide with other medications, which is crucial for patients with multiple sclerosis who may require concurrent treatments.
What are the key claims of the patent?
The key claims include methods for managing the risk of adverse interactions by monitoring or adjusting the dose of the substrate and co-administering teriflunomide with a reduced dose of rosuvastatin.
When is the patent set to expire?
The patent is set to expire in February 2034.
How has Sanofi enforced this patent?
Sanofi has been involved in litigation against generic manufacturers to protect this patent, citing infringement related to their ANDAs for generic versions of Aubagio.
Sources:
- United States Patent and Trademark Office, Methods for reducing the risk of an adverse teriflunomide and rosuvastatin interaction in multiple sclerosis patients, US009186346B2.
- RPX Corporation, IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE SANOFI-AVENTIS U.S. LLC, AVENTISUB LLC, SANOFI, and GENZYME CORPORATION, Plaintiffs, v. IMPAX LABORATORIES, INC., Defendant.
- United States Patent and Trademark Office, 2018–2022 Strategic Plan.
- Pharsight, Aubagio patent expiration.
- RPX Corporation, IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE SANOFI-AVENTIS U.S. LLC, AVENTISUB LLC, SANOFI, and GENZYME CORPORATION, Plaintiffs, v. MYLAN PHARMACEUTICALS INC. and MYLAN INC., Defendants.
