United States Patent 10,076,555: A Detailed Analysis of Scope, Claims, and Patent Landscape
Overview of the Patent
United States Patent 10,076,555, titled "Methods of inducing melanogenesis in a subject," is a significant patent that outlines methods and compositions for stimulating melanogenesis, the process of melanin production, in human subjects. This patent is crucial for understanding the therapeutic and cosmetic applications of melanogenesis induction.
Scope of the Patent
Methods and Compositions
The patent describes methods for inducing melanogenesis by administering alpha-melanocyte-stimulating hormone (alpha-MSH) or its analogues to a subject. These methods involve various modes of administration, including local delivery, systemic delivery, intravenous injection, bolus delivery, or continuous infusion[1].
Alpha-MSH Analogues
The patent specifies the use of alpha-MSH analogues, which are compounds designed to mimic the action of natural alpha-MSH. These analogues can be tailored with specific modifications, such as different N-terminal and C-terminal sequences, to enhance their efficacy and stability. For example, the patent mentions analogues with specific sequences like Ac-Gly-, Ac-Met-Glu-, Ac-Nle-Glu-, or Ac-Tyr-Glu- at the N-terminal and modifications at the C-terminal[1].
Therapeutic Applications
The primary therapeutic application of this patent is in the treatment of conditions where increased melanin production is beneficial, such as photodermatoses and erythropoietic protoporphyria (EPP). For instance, afamelanotide, an alpha-MSH analogue, is used to prevent sun-induced skin damage in patients with EPP[4].
Claims of the Patent
Key Claims
- Administration Methods: The patent claims various methods of administering alpha-MSH or its analogues, including subcutaneous implantation, intravenous injection, and continuous infusion[1].
- Composition Formulations: It includes claims for different formulations of alpha-MSH analogues, such as biodegradable polymers and specific weight ratios of components[1].
- Therapeutic Effects: The patent claims the therapeutic effects of inducing melanogenesis, including the prevention of sun-induced skin damage and the treatment of photodermatoses[1].
Specific Claim Details
- The patent specifies that the alpha-MSH analogue may be a compound with particular sequences and modifications, such as R1 being Ac-Gly-, Ac-Met-Glu-, Ac-Nle-Glu-, or Ac-Tyr-Glu-, and Y being -Arg- or -D-Arg-[1].
Patent Landscape
Patent Status and Expiry
As of the current date, the patent (US10076555B2) is set to expire in February 2025. This expiry date is subject to change based on legal activities such as patent term extensions or amendments to the claims[2].
Related Patents and Technologies
The patent landscape surrounding US10076555B2 includes other patents related to the treatment of photodermatoses and the use of alpha-MSH analogues. For example, another patent (US8334265) focuses on the method of treatment of photodermatoses and is set to expire in March 2029[2].
Competitive Environment
The competitive environment involves other pharmaceutical companies and research institutions working on similar technologies. For instance, Galderma Labs LP and Janssen Biotech have patents related to different therapeutic areas but may intersect with melanogenesis research in terms of skin health and dermatological treatments[5].
Legal and Regulatory Activities
Maintenance Fees and Term Extensions
The patent has undergone various legal activities, including the payment of maintenance fees and the issuance of a patent term extension certificate. These activities are crucial for maintaining the patent's validity and extending its lifespan[2].
FDA Determinations
The FDA has been involved in determining the regulatory review period for related patents, such as US8334265, which indicates ongoing regulatory scrutiny and potential for future extensions or amendments[2].
Impact on Industry and Research
Therapeutic Implications
The methods and compositions described in this patent have significant therapeutic implications, particularly for patients with rare disorders like EPP. The ability to induce melanogenesis can provide protective benefits against sun-induced skin damage, improving the quality of life for these patients[4].
Cosmetic Applications
Beyond therapeutic uses, the patent's scope extends to cosmetic applications, where inducing melanogenesis can be beneficial for skin tanning and protection against UV radiation.
Key Takeaways
- Methods and Compositions: The patent outlines specific methods and compositions for inducing melanogenesis using alpha-MSH and its analogues.
- Therapeutic Applications: It has therapeutic applications in treating photodermatoses and EPP.
- Patent Status: The patent is set to expire in February 2025, subject to legal activities.
- Competitive Environment: The patent landscape includes other related patents and technologies from various pharmaceutical companies.
- Regulatory Activities: Ongoing legal and regulatory activities are crucial for maintaining and extending the patent's validity.
FAQs
Q: What is the primary therapeutic application of the methods described in US10076555B2?
A: The primary therapeutic application is in the treatment of conditions like photodermatoses and erythropoietic protoporphyria (EPP) by inducing melanogenesis.
Q: How are alpha-MSH analogues administered according to the patent?
A: Alpha-MSH analogues can be administered through various methods, including subcutaneous implantation, intravenous injection, and continuous infusion.
Q: What is the current status of the patent?
A: The patent is set to expire in February 2025 but is subject to change based on ongoing legal activities.
Q: Are there other related patents in the same therapeutic area?
A: Yes, there are other patents, such as US8334265, which focus on the treatment of photodermatoses and are set to expire in March 2029.
Q: What are the potential cosmetic applications of the patent?
A: The methods described can be used for cosmetic purposes, such as skin tanning and protection against UV radiation.
Sources
- US10076555B2 - Methods of inducing melanogenesis in a subject - Google Patents
- Scenesse patent expiration - Pharsight - GreyB
- Topic 1: Patent landscaping, mapping & analytics - WIPO
- Afamelanotide: Uses, Interactions, Mechanism of Action - DrugBank
- Drugs facing NCE-1 in 2023 - Pharsight - GreyB
