Details for Patent: 10,716,785

Which drugs does patent 10,716,785 protect, and when does it expire?

Patent 10,716,785 protects LYBALVI and is included in one NDA.

This patent has thirty-five patent family members in nineteen countries.

Summary for Patent: 10,716,785

Title:	Methods for treating antipsychotic-induced weight gain
Abstract:	The present invention relates to the discovery of a novel opioid modulator effective in reducing pharmacologically induced weight gain associated with atypical antipsychotic use. The present invention provides methods of reducing antipsychotic induced weight gain, methods for suppressing food intake and reducing ghrelin levels induced by atypical antipsychotic medications in a patient.
Inventor(s):	Deaver; Daniel (Wilmington, MA), Todtenkopf; Mark (Franklin, MA)
Assignee:	Alkermes Pharma Ireland Limited (Dublin, IE)
Application Number:	16/390,531
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Analyzing the Scope and Claims of United States Patent 10,716,785

Overview of the Patent

United States Patent 10,716,785, titled "Methods for treating antipsychotic-induced weight gain," is a patent that addresses a significant medical issue related to the side effects of antipsychotic medications. Here is a detailed analysis of its scope, claims, and the broader patent landscape.

Patent Structure and Sections

Cover Page

The patent begins with a cover page that provides bibliographic information, including the publication number, application number, and prior art keywords. This section is crucial for identifying the patent and its context within the broader patent database[2].

Specification

The specification section describes the invention in detail. It includes background information, a summary of the invention, and a detailed description of the methods and processes involved. For US10716785B2, the specification outlines the discovery of a novel opioid modulator effective in reducing pharmacologically induced weight gain associated with antipsychotic medications[4].

Claims

The claims section is the most critical part of the patent, as it defines the scope of the invention and what the patentee has the right to exclude others from making, using, or selling. Here’s a breakdown of the claims in US10716785B2:

• Claim Structure: Each claim consists of a preamble and a body, connected by a transition word or phrase. For example, a claim might start with "A method for treating antipsychotic-induced weight gain" followed by the specific steps or elements of the method[2].

• Claim Scope: The claims in US10716785B2 specifically outline the methods for using the novel opioid modulator to treat weight gain. These claims must be clear and distinct to ensure that potential infringers understand what is protected and what is not[2].

Key Claims and Their Implications

Method Claims

The patent includes method claims that describe the steps involved in treating antipsychotic-induced weight gain. These claims are detailed to ensure that the method is clearly defined and distinguishable from other treatments.

• Example Claim: A method for treating antipsychotic-induced weight gain in a patient, comprising administering a therapeutically effective amount of a novel opioid modulator. This claim specifies the action (administering) and the subject matter (novel opioid modulator) to protect the invention[4].

Composition Claims

In addition to method claims, the patent may include composition claims that describe the novel opioid modulator itself. These claims define the chemical structure or composition of the modulator.

• Example Claim: A composition comprising a novel opioid modulator, wherein the modulator is effective in reducing pharmacologically induced weight gain associated with antipsychotic medications. This claim protects the specific chemical entity and its use[4].

Patent Landscape and Competitive Intelligence

Technology Area

The patent falls within the biotechnology and pharmaceutical sectors, specifically addressing the issue of weight gain induced by antipsychotic medications. This area is highly competitive, with numerous patents and ongoing research aimed at mitigating side effects of psychiatric treatments.

• Competitive Analysis: Using tools like the Patent 300® Dashboard, one can analyze the patent landscape in this technology area. This includes identifying key players, technology gaps, and competitor portfolio metrics to understand the competitive landscape and potential whitespace opportunities[1].

Patent Eligibility

The patent's eligibility under Section 101 of the Patent Act is crucial. Recent judicial and legislative developments have narrowed the scope of patent-eligible subject matter, particularly in areas like biotechnology and AI. The claims must not be directed to ineligible concepts such as natural phenomena, abstract ideas, or laws of nature[5].

• Alice/Mayo Framework: The Supreme Court's decisions in cases like Alice and Mayo have set a framework for determining patent eligibility. The claims in US10716785B2 must pass the two-step test outlined in these decisions to ensure they are patent-eligible[5].

Economic and Strategic Implications

Market Impact

The patent has significant market implications, particularly in the treatment of psychiatric disorders. The novel opioid modulator offers a potential solution to a common side effect of antipsychotic medications, which could improve patient outcomes and quality of life.

• Market Trends: Analyzing market trends and patenting activities in this area can help identify opportunities for innovation, licensing, and potential mergers and acquisitions. Tools like the Patent 300® Dashboard can provide insights into market, technology, and patent trends[1].

Litigation and Licensing

The detailed technology overlap and whitespace data from the patent can inform litigation or infringement decisions. It can also identify potential candidates for licensing opportunities, which is crucial for maximizing the value of the patent.

• Litigation Preparation: Understanding the claims and the scope of the patent is essential for preparing for potential litigation. This includes reviewing the detailed technology overlap and whitespace data to identify potential infringers and to defend against infringement claims[1].

Key Takeaways

• Clear Claims: The claims in US10716785B2 must be clear and distinct to define the scope of the invention and protect the novel opioid modulator.
• Patent Eligibility: The patent must comply with the standards for patent-eligible subject matter under Section 101 of the Patent Act.
• Competitive Landscape: Analyzing the patent landscape using tools like the Patent 300® Dashboard is crucial for understanding the competitive environment and identifying opportunities.
• Market Impact: The patent has significant market implications, offering a potential solution to a common side effect of antipsychotic medications.

FAQs

Q: What is the main focus of United States Patent 10,716,785?

A: The main focus of US10716785B2 is on methods for treating antipsychotic-induced weight gain using a novel opioid modulator.

Q: How are the claims structured in this patent?

A: The claims are structured with a preamble and a body, connected by a transition word or phrase, to clearly define the scope of the invention.

Q: What is the significance of the Alice/Mayo framework in patent eligibility?

A: The Alice/Mayo framework is a two-step test used to determine if a patent claim is directed to an ineligible concept, such as an abstract idea or a law of nature, which is crucial for ensuring the patent's eligibility under Section 101 of the Patent Act.

Q: How can tools like the Patent 300® Dashboard help in analyzing this patent?

A: The Patent 300® Dashboard can help in analyzing the patent landscape, identifying key players, technology gaps, and competitor portfolio metrics, which is essential for competitive intelligence and strategic decision-making.

Q: What are the potential market implications of this patent?

A: The patent has significant market implications, offering a potential solution to a common side effect of antipsychotic medications, which could improve patient outcomes and quality of life.

Sources

1. Patent 300® Dashboard - Harrity LLP, Interactive Dashboard Report
2. How To Read a Patent - The Lens, Roadmap of U.S. Patent No. 5,723,765
3. Patent Claims Research Dataset - USPTO, Detailed information on claims from US patents
4. US10716785B2 - Google Patents, Methods for treating antipsychotic-induced weight gain
5. Patent-Eligible Subject Matter Reform: An Overview - CRS Reports, Recent judicial, administrative, and legislative developments

Drugs Protected by US Patent 10,716,785

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-001	May 28, 2021		RX	Yes	Yes						METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-001	May 28, 2021		RX	Yes	Yes						METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-002	May 28, 2021		RX	Yes	No						METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-002	May 28, 2021		RX	Yes	No						METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-003	May 28, 2021		RX	Yes	No						METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-003	May 28, 2021		RX	Yes	No						METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-004	May 28, 2021		RX	Yes	No						METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN

International Family Members for US Patent 10,716,785

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2011293502
Australia	2015201907
Australia	2017200396
Australia	2018202410
Canada	2807965
Cyprus	1121128
Denmark	2608670