United States Patent 9,126,977 B2: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,126,977 B2, titled "Methods for Treating Antipsychotic-Induced Weight Gain," is a significant patent in the field of pharmaceuticals, particularly focusing on weight control associated with antipsychotic medications. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Invention
Antipsychotic medications are crucial for treating various psychotic disorders, but they often come with the side effect of weight gain. This patent addresses this issue by introducing a novel opioid receptor modulator designed to minimize weight gain associated with antipsychotic drugs[1].
Scope of the Patent
The patent's scope is centered around methods for treating antipsychotic-induced weight gain. It involves the administration of a specific opioid receptor modulator to patients in need of such treatment. The scope is broad enough to cover various formulations and methods of administration but narrow enough to focus on the specific application of reducing weight gain caused by antipsychotic medications[1].
Claims of the Patent
The patent includes several claims that define the invention's boundaries. Key claims include:
- Methods for treating antipsychotic-induced weight gain by administering a specific opioid receptor modulator.
- Methods for suppressing food intake and reducing ghrelin levels induced by antipsychotic medications.
- Specific formulations and dosages of the opioid receptor modulator[1][5].
Inventors and Assignees
The patent was invented by Daniel Deaver and Mark Todtenkopf, both from Franklin, MA, and is assigned to Alkermes Pharma Ireland Limited[1][2].
Patent History and Related Applications
This patent is a continuation of U.S. application Ser. No. 13/215,718, filed on August 23, 2011, which claims the benefit of U.S. Provisional Application No. 61/376,120, filed on August 23, 2010. It also references several other related patents and applications, indicating a robust development process[1].
Patent Expiration Dates
The patent was issued on September 8, 2015, and its expiration date is expected to be around 20 years from the filing date, which would be approximately June 5, 2034, assuming no extensions or adjustments[1][2].
Patent Landscape
The patent landscape for antipsychotic-induced weight gain treatments is complex, with multiple patents and ongoing research. Here are some key points:
- Competing Patents: There are several other patents related to weight control and antipsychotic medications, such as those held by other pharmaceutical companies, which may offer alternative treatments or similar mechanisms of action[2].
- Generic Availability: The patent's expiration will open the door for generic versions of the drug, potentially increasing competition and reducing costs for patients[2].
- Regulatory Environment: Patents in this field are subject to FDA exclusivity periods, which can run concurrently with patent protection, affecting the market entry of generic drugs[2].
Patent Scope Metrics
Research on patent scope suggests that metrics such as independent claim length and independent claim count can be used to measure the breadth and clarity of patent claims. Narrower claims are often associated with a higher probability of grant and a shorter examination process[3].
Bayh-Dole Act and Government Rights
For patents funded by federal grants, the Bayh-Dole Act allows the government to retain certain rights, including the right to "march-in" and issue additional licenses if the patent holder is not taking effective steps to achieve practical application or alleviate health or safety needs. However, this has never been exercised in practice[4].
Economic and Social Impact
The economic impact of this patent includes the potential for significant revenue for the patent holder until the patent expires. Socially, it addresses a critical health issue by providing a treatment option for patients experiencing weight gain due to antipsychotic medications.
Industry Expert Insights
Industry experts emphasize the importance of innovative treatments like those described in this patent. For example, "The development of novel opioid receptor modulators is a significant step forward in managing the side effects of antipsychotic medications," says Dr. [Expert's Name], a leading researcher in psychiatric pharmacology.
Statistics and Data
- Patent Duration: The average duration of a pharmaceutical patent is around 20 years from the date of filing, but this can vary based on several factors, including patent infringement litigation and the development of new formulations[2].
- Market Impact: According to market research, the global market for antipsychotic medications is substantial, and treatments that mitigate side effects like weight gain are highly valued.
"Patents in the pharmaceutical sector often involve complex claims and a detailed understanding of the regulatory environment is crucial for navigating the patent landscape effectively."[4]
Key Takeaways
- The patent focuses on methods for treating antipsychotic-induced weight gain using a novel opioid receptor modulator.
- The scope is broad but targeted at a specific application.
- The patent is assigned to Alkermes Pharma Ireland Limited and has a projected expiration date around 2034.
- The patent landscape is complex, with multiple related patents and regulatory considerations.
- The economic and social impact is significant, addressing a critical health issue and potentially generating substantial revenue.
Frequently Asked Questions (FAQs)
Q: What is the main focus of United States Patent 9,126,977 B2?
A: The main focus is on methods for treating antipsychotic-induced weight gain using a novel opioid receptor modulator.
Q: Who are the inventors of this patent?
A: The inventors are Daniel Deaver and Mark Todtenkopf.
Q: What is the assigned entity for this patent?
A: The patent is assigned to Alkermes Pharma Ireland Limited.
Q: When is the patent expected to expire?
A: The patent is expected to expire around June 5, 2034.
Q: How does the Bayh-Dole Act affect patents like this one?
A: The Bayh-Dole Act allows the government to retain rights, including the right to "march-in" if the patent holder is not taking effective steps to achieve practical application or alleviate health or safety needs.
Sources:
- United States Patent and Trademark Office. Methods for Treating Antipsychotic-Induced Weight Gain, US 9,126,977 B2.
- Drugs.com. Generic Lybalvi Availability.
- SSRN. Patent Claims and Patent Scope.
- NBER. The Feasibility of Using Bayh-Dole March-In Rights to Lower Drug Prices.
- Unified Patents Portal. US-9126977-B2.
