United States Patent 9,433,624: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,433,624, titled "Methods and Compositions for the Treatment of Hyperphenylalaninemia," is a crucial patent in the pharmaceutical industry, particularly for the treatment of phenylketonuria (PKU) and other metabolic disorders. This patent is owned by BioMarin Pharmaceutical Inc. and is part of a broader patent portfolio related to the drug Kuvan®.
Background on Kuvan®
Kuvan® is a pharmaceutical drug used to treat hyperphenylalaninemia, a condition characterized by elevated levels of phenylalanine in the blood. The drug is a formulation of sapropterin dihydrochloride, which helps reduce phenylalanine levels in patients with PKU[4].
Patent Overview
Issuance and Ownership
The U.S. Patent and Trademark Office (USPTO) issued the '624 patent on September 6, 2016, to BioMarin Pharmaceutical Inc. BioMarin is the sole owner of all rights, title, and interest in this patent[1][4].
Patent Claims
The '624 patent includes multiple claims that cover various aspects of the methods and compositions for treating hyperphenylalaninemia. Here are some key claims:
- Claim 1: This claim covers a method for treating hyperphenylalaninemia in a patient, comprising administering a therapeutically effective amount of sapropterin dihydrochloride.
- Claim 2: This claim pertains to a composition comprising sapropterin dihydrochloride and a pharmaceutically acceptable carrier.
- Claim 3: This claim describes a method for reducing phenylalanine levels in a patient with hyperphenylalaninemia, involving the administration of sapropterin dihydrochloride in combination with a dietary restriction of phenylalanine[5].
Scope of Protection
The '624 patent provides broad protection for BioMarin's proprietary methods and compositions related to the treatment of hyperphenylalaninemia. This includes not only the specific formulation of sapropterin dihydrochloride but also the therapeutic regimens and dosing schedules associated with its use.
Patent Landscape
Related Patents
The '624 patent is part of a larger family of patents related to Kuvan®. Other significant patents in this family include:
- U.S. Patent 7,566,462: Expired on November 16, 2025, this patent covers stable tablet formulations of sapropterin dihydrochloride[2].
- U.S. Patent 7,566,714: Expired on November 17, 2024, this patent covers methods and compositions for the treatment of metabolic disorders[2].
- U.S. Patent 7,612,073: Expired on November 17, 2024, this patent also pertains to methods and compositions for treating metabolic disorders[2].
Patent Expiration Dates
The '624 patent is set to expire on November 16, 2025, which is a critical date for generic manufacturers seeking to enter the market with their own versions of the drug. Other related patents have already expired or are set to expire around the same time, which could impact the competitive landscape[2].
Litigation and Enforcement
BioMarin has been actively enforcing its patent rights against generic manufacturers. For instance:
- Teva Pharmaceuticals: BioMarin and Merck have filed a lawsuit against Teva for patent infringement related to Teva's filing of an Abbreviated New Drug Application (ANDA) for a generic version of Kuvan®. The lawsuit alleges infringement of several patents, including the '624 patent[1].
- Dr. Reddy’s Laboratories: BioMarin has also sued Dr. Reddy’s Laboratories for similar reasons, alleging infringement of the '624 patent among others[4].
These legal actions highlight the importance of the '624 patent in protecting BioMarin's intellectual property and market position.
Impact on Generic Competition
The approval of generic versions of Kuvan® is contingent upon the expiration of the relevant patents. Although a generic version has been approved by the FDA, its commercial availability is delayed due to ongoing patent litigation[2].
Generic Approval and Commercial Availability
Despite FDA approval, the commercial launch of generic Kuvan® is pending due to patent disputes. This delay allows BioMarin to maintain its market exclusivity for a longer period.
Key Takeaways
- Patent Ownership: BioMarin Pharmaceutical Inc. is the sole owner of the '624 patent.
- Claims and Scope: The patent covers methods and compositions for treating hyperphenylalaninemia using sapropterin dihydrochloride.
- Patent Landscape: Part of a broader family of patents related to Kuvan®, with several related patents expiring around the same time.
- Litigation: BioMarin is actively enforcing its patent rights against generic manufacturers.
- Generic Competition: The commercial availability of generic Kuvan® is delayed due to ongoing patent litigation.
FAQs
What is the primary use of the drug covered by U.S. Patent 9,433,624?
The primary use is for the treatment of hyperphenylalaninemia, a condition characterized by elevated levels of phenylalanine in the blood.
Who is the owner of U.S. Patent 9,433,624?
BioMarin Pharmaceutical Inc. is the sole owner of this patent.
What are the key claims of U.S. Patent 9,433,624?
The key claims include methods for treating hyperphenylalaninemia using sapropterin dihydrochloride and compositions comprising this compound.
When does U.S. Patent 9,433,624 expire?
The patent is set to expire on November 16, 2025.
Why is the commercial availability of generic Kuvan® delayed?
The commercial availability is delayed due to ongoing patent litigation between BioMarin and generic manufacturers.
What other patents are related to U.S. Patent 9,433,624?
Other related patents include U.S. Patents 7,566,462, 7,566,714, and 7,612,073, among others.
