United States Patent 7,566,714: A Detailed Analysis of Scope, Claims, and Patent Landscape
Overview of the Patent
United States Patent 7,566,714, titled "Methods and compositions for the treatment of metabolic disorders," is a significant patent in the field of pharmaceuticals, particularly for the treatment of hyperphenylalaninemia, a condition associated with phenylketonuria (PKU).
Patent Description
This patent, issued to BioMarin Pharmaceutical Inc., describes novel methods and compositions for the therapeutic intervention in hyperphenylalaninemia. The primary focus is on the use of tetrahydrobiopterin (BH4), a cofactor for the enzyme phenylalanine-4-hydroxylase, which is crucial for the metabolism of phenylalanine[4][5].
Scope of the Patent
The scope of this patent is broad, covering various aspects of BH4 use in treating metabolic disorders.
Therapeutic Methods
The patent outlines methods for administering BH4, including oral dosage forms, intravenous formulations, and administration with food. These methods are designed to optimize the efficacy and safety of BH4 treatment[4].
Compositions
The patent includes compositions that contain BH4, such as crystalline forms, hydrates, and solvates. These compositions are tailored for stability and bioavailability, ensuring effective treatment of hyperphenylalaninemia[4][5].
Metabolic Disorders
The patent specifically addresses hyperphenylalaninemia, a condition characterized by elevated levels of phenylalanine in the blood. This condition can lead to serious health issues, including cognitive impairments and other neurological problems if not managed properly[1].
Claims of the Patent
The patent includes several claims that define the scope of protection.
Independent Claims
- The patent claims cover the use of BH4 as a cofactor for phenylalanine-4-hydroxylase.
- It includes claims for specific formulations of BH4, such as crystalline forms and hydrates.
- Methods of administration, including oral and intravenous routes, are also claimed[4].
Dependent Claims
- These claims further specify the conditions under which BH4 is administered, such as with food or in combination with other treatments.
- They also detail the dosages and frequency of administration[4].
Patent Landscape
The patent landscape surrounding US 7,566,714 is complex, with multiple patents and exclusivity rights involved.
Patent Expiration Dates
- The patent itself is set to expire on November 17, 2024. However, some related patents, including those covering specific formulations and methods of administration, may expire later, such as May 17, 2025, and May 1, 2033[2].
Related Patents
- Several other patents related to BH4 and its use in treating metabolic disorders have been granted to BioMarin Pharmaceutical Inc. These include patents for crystalline forms of BH4, dry blend powder formulations, and methods of administering BH4[2].
Generic Availability
- With the expiration of key patents, generic versions of Kuvan (the brand name for BH4) are expected to become available. The FDA has approved a generic version, although commercial availability may be delayed[2].
Impact on the Pharmaceutical Industry
The expiration of this patent and related patents will have significant implications for the pharmaceutical industry.
Competition and Pricing
- The entry of generic versions is likely to increase competition and potentially reduce the cost of treatment for patients with PKU and other metabolic disorders[2].
Innovation
- The expiration of these patents may also spur further innovation as other companies can now develop and market their own versions of BH4, potentially leading to new formulations or administration methods[3].
Regulatory Aspects
The regulatory environment plays a crucial role in the patent landscape.
FDA Exclusivity
- The FDA grants exclusivity periods that can run concurrently with patent protection. For BH4, these exclusivity periods are critical in determining when generic versions can enter the market[2].
Patent Litigation
- Patent litigation can affect the expiration dates and the scope of protection. Any disputes over patent infringement or validity could impact the availability of generic versions[3].
Conclusion
United States Patent 7,566,714 is a pivotal patent in the treatment of hyperphenylalaninemia and other metabolic disorders. Its scope and claims are comprehensive, covering various aspects of BH4 use. As the patent expires, the landscape is set to change with the introduction of generic versions, potentially increasing access and reducing costs for patients.
Key Takeaways
- Therapeutic Use: The patent covers the use of BH4 as a cofactor for phenylalanine-4-hydroxylase in treating hyperphenylalaninemia.
- Formulations and Administration: It includes claims for specific formulations and methods of administration.
- Patent Expiration: The patent is set to expire on November 17, 2024, with related patents expiring later.
- Generic Availability: Generic versions of Kuvan are expected to become available following patent expiration.
- Regulatory Impact: FDA exclusivity and patent litigation can affect the availability of generic versions.
FAQs
What is the primary use of tetrahydrobiopterin (BH4) as described in US Patent 7,566,714?
BH4 is used as a cofactor for the enzyme phenylalanine-4-hydroxylase to treat hyperphenylalaninemia, a condition associated with phenylketonuria (PKU).
When is the patent set to expire?
The patent is set to expire on November 17, 2024.
What are the implications of the patent expiration for the pharmaceutical industry?
The expiration is likely to increase competition and reduce treatment costs as generic versions of BH4 become available.
Are there related patents that extend the protection period?
Yes, several related patents cover specific formulations and methods of administration, some of which expire later than November 17, 2024.
How does FDA exclusivity affect the availability of generic versions?
FDA exclusivity periods can run concurrently with patent protection, determining when generic versions can enter the market.
What is the significance of crystalline forms and hydrates of BH4 in the patent?
These forms are crucial for the stability and bioavailability of BH4, ensuring effective treatment of hyperphenylalaninemia.
Sources
- DrugBank: Sapropterin: Uses, Interactions, Mechanism of Action.
- Drugs.com: Generic Kuvan Availability.
- Hoover Institution: Patent Claims and Patent Scope.
- Google Patents: Methods and compositions for the treatment of metabolic disorders.
- Unified Patents Portal: US-7566714-B2.
