Understanding the Scope and Claims of United States Patent 10,975,046
Introduction
Patents are a crucial component of the pharmaceutical industry, providing exclusive rights to inventors and manufacturers for their innovations. The United States Patent 10,975,046 is one such patent that has significant implications for the drug market. Here, we will delve into the details of this patent, including its scope, claims, and the broader patent landscape it operates within.
Patent Overview
United States Patent 10,975,046 is associated with the drug Bylvay, which is used for the treatment of pruritus (severe itching) in patients with progressive familial intrahepatic cholestasis (PFIC), a rare genetic disorder affecting the liver.
Patent Expiration Dates
The patent is set to expire on June 20, 2039[2].
Scope of the Patent
The scope of a patent defines the boundaries of what is protected under the patent. For US Patent 10,975,046, the scope includes:
Drug Formulation
The patent covers the proprietary chemical formulation of Bylvay, specifically the active ingredient odevixibat. Odevixibat is an ileal sodium/bile acid cotransporter inhibitor, which helps in reducing bile acid reabsorption and thereby alleviating the symptoms of PFIC[4].
Manufacturing Process
The patent may also include the manufacturing process for odevixibat, ensuring that the method of production is protected and exclusive to the patent holder.
Dosage and Administration
The patent details the specific dosage forms and administration methods for Bylvay, which are critical for its efficacy and safety.
Claims of the Patent
The claims section of a patent is the most critical part as it defines what is legally protected. Here are some key aspects of the claims for US Patent 10,975,046:
Independent Claims
Independent claims are those that stand alone and define the invention without reference to other claims. For this patent, the independent claims likely focus on the unique chemical structure of odevixibat, its therapeutic use, and the specific formulation used in Bylvay[2].
Dependent Claims
Dependent claims build upon the independent claims and provide additional details or limitations. These might include specific dosages, administration routes, or other aspects that further define the invention.
Patent Landscape
The patent landscape for Bylvay and odevixibat is complex and involves multiple patents.
Multiple Patents
There are several patents associated with odevixibat, each with different expiration dates. For example, some patents expire on November 8, 2031, while others, like US Patent 10,975,046, expire on June 20, 2039[2][4].
Exclusivity Periods
In addition to patent protection, Bylvay may also have exclusivity periods granted by the FDA. These periods can run concurrently with the patent and provide additional market protection[2].
Impact on the Pharmaceutical Industry
The expiration of patents like US Patent 10,975,046 has significant implications for the pharmaceutical industry.
Generic Competition
Once the patent expires, generic versions of Bylvay can enter the market, potentially reducing the market share and revenue of the original drug. However, as of now, there is no generic version of Bylvay approved in the United States[2].
Innovation and R&D
The protection provided by patents like US Patent 10,975,046 incentivizes innovation and research and development in the pharmaceutical sector. Companies are more likely to invest in new drug development when they have a period of exclusivity to recoup their investments.
Challenges and Controversies
Patents in the pharmaceutical industry are often subject to controversies and challenges.
Patent Scope and Quality
There is ongoing debate about the scope and quality of patents, with some arguing that overly broad patents can stifle innovation and increase litigation costs[3].
Litigation and Licensing
Patent litigation and licensing agreements are common in the pharmaceutical industry. These can be complex and costly, affecting the overall profitability of a drug.
Conclusion
United States Patent 10,975,046 is a critical component of the intellectual property portfolio for Bylvay, protecting the exclusive rights to the drug's formulation, manufacturing process, and therapeutic use. Understanding the scope and claims of this patent, as well as the broader patent landscape, is essential for navigating the complex world of pharmaceutical patents.
Key Takeaways
- US Patent 10,975,046 protects the proprietary formulation of Bylvay (odevixibat) and expires on June 20, 2039.
- The patent includes independent and dependent claims that define the invention.
- The patent landscape for odevixibat involves multiple patents with different expiration dates.
- Exclusivity periods granted by the FDA can provide additional market protection.
- The expiration of this patent will open the market to generic competition.
- Patents play a crucial role in incentivizing innovation in the pharmaceutical industry.
FAQs
Q: What is the main purpose of US Patent 10,975,046?
A: The main purpose of US Patent 10,975,046 is to protect the proprietary formulation and therapeutic use of Bylvay (odevixibat) for the treatment of pruritus in patients with progressive familial intrahepatic cholestasis (PFIC).
Q: When does US Patent 10,975,046 expire?
A: US Patent 10,975,046 is set to expire on June 20, 2039[2].
Q: What is the active ingredient protected by this patent?
A: The active ingredient protected by this patent is odevixibat, an ileal sodium/bile acid cotransporter inhibitor[4].
Q: Are there any generic versions of Bylvay available?
A: As of now, there are no generic versions of Bylvay approved in the United States[2].
Q: How do exclusivity periods affect the patent protection of Bylvay?
A: Exclusivity periods granted by the FDA can run concurrently with the patent and provide additional market protection, preventing other manufacturers from marketing the same drug during this period[2].
Sources
- GreyB, "Drug Patents Expiring between 2020 to 2022", GreyB Blog.
- Drugs.com, "Generic Bylvay Availability", Drugs.com.
- Hoover Institution, "Patent Claims and Patent Scope", Hoover Institution Working Paper Series.
- DrugBank, "Odevixibat: Uses, Interactions, Mechanism of Action", DrugBank Online.
