Details for Patent: RE48839

Which drugs does patent RE48839 protect, and when does it expire?

Patent RE48839 protects CAPLYTA and is included in one NDA.

This patent has twenty-one patent family members in nine countries.

Summary for Patent: RE48839

Title:	Methods and compositions for sleep disorders and other disorders
Abstract:	Use of particular substituted heterocycle fused gamma-carboline compounds as pharmaceuticals and pharmaceutical compositions comprising them for the treatment of one or more disorders involving the 5-HT2A, SERT and/or dopamine D2 pathways are disclosed. In addition, the compounds may be combined with other therapeutic agents for the treatment of one or more sleep disorders, depression, psychosis, dyskinesias, and/or Parkinson's disease or any combinations.
Inventor(s):	Mates; Sharon (New York, NY), Fienberg; Allen (New York, NY), Wennogle; Lawrence (Hillsborough, NJ)
Assignee:	Intra-Cellular Therapies, Inc (New York, NY)
Application Number:	16/784,112
Patent Claim Types: see list of patent claims	Use;

Understanding the Scope and Claims of United States Patent RE48839

Introduction

The United States Patent RE48839, titled "Methods and compositions for sleep disorders and other disorders," is a reissue patent that covers a range of pharmaceutical compositions and methods for treating various disorders. Here, we will delve into the details of the patent, including its scope, claims, and the broader patent landscape.

Patent Overview

Patent Number and Type

• The patent number is USRE48839E1, indicating it is a reissue patent, which is a re-examination of an original patent with potential modifications or clarifications[1].

Publication and Prior Art

• The patent was published with a prior art date, indicating the earliest known date when the invention was publicly disclosed or patented. This is crucial for determining the novelty and non-obviousness of the invention[1].

Scope of the Patent

Covered Disorders

• The patent encompasses methods and compositions for treating sleep disorders, as well as other disorders such as psychotic diseases, Parkinson's disease, dyskinesia, and schizophrenia. This broad scope indicates the versatility of the compounds and methods described[1].

Compounds and Compositions

• The patent focuses on specific substituted heterocycle fused gamma-carboline compounds. These compounds are detailed in the claims and description, highlighting their chemical structures and therapeutic applications[1].

Claims Analysis

Claim Structure

• The claims in the patent are structured to define the matter for which protection is sought clearly and concisely. They must be fully supported by the description, as per the requirements outlined in the Manual of Patent Examining Procedure (MPEP)[2].

Types of Claims

• The patent includes various types of claims, such as composition claims, method claims, and use claims. For example, claims might cover the specific compounds, their pharmaceutical compositions, and the methods of treating various disorders using these compounds[1].

Enablement Requirement

• The patent must meet the enablement requirement under 35 U.S.C. § 112(a), which means the specification must enable a person skilled in the art to practice the full scope of the claimed invention. The Amgen v. Sanofi decision emphasizes that the specification must provide sufficient guidance to make and use the entire class of claimed inventions, not just specific embodiments[3].

Key Compounds and Therapeutic Agents

Gamma-Carboline Compounds

• The patent highlights the use of particular substituted heterocycle fused gamma-carboline compounds. These compounds are described in detail, including their chemical formulas and therapeutic applications[1].

Other Therapeutic Agents

• The patent also mentions other therapeutic agents such as melatonin, nefazodone, trazodone, and fluoxetine, which are relevant in the context of treating sleep and other related disorders[1].

Patent Landscape and Implications

Nonstatutory Double Patenting

• The patent landscape is influenced by the doctrine of nonstatutory double patenting, which prevents the extension of patent terms by claiming essentially the same invention in multiple patents. Terminal disclaimers can be used to overcome such rejections, ensuring that the patent term does not extend beyond the original patent[5].

Competitive Impact

• The use of terminal disclaimers and the practice of filing multiple patents with overlapping claims can create patent thickets, which can stifle competition. For example, the FTC has noted that such practices can impose significant costs on potential competitors, as seen in cases like AbbVie’s Humira[5].

Legal and Regulatory Considerations

Enablement and Scope

• The Amgen v. Sanofi decision has significant implications for the scope of claims in patents. It emphasizes that the specification must enable the full scope of the claimed invention, which can affect the validity of broad claims if they cannot be enabled across their entire range[3].

Terminal Disclaimers

• The proposed rule changes regarding terminal disclaimers aim to prevent the misuse of these disclaimers to extend market exclusivity improperly. This includes ensuring that patents tied by terminal disclaimers are enforceable only if the original patent claims remain valid and unchallenged[5].

Industry Impact and Examples

Pharmaceutical Industry

• The patent has significant implications for the pharmaceutical industry, particularly in the development and marketing of drugs for sleep disorders and other related conditions. Companies must navigate the complex patent landscape to avoid infringement and ensure their products are novel and non-obvious[1].

Case Studies

• The Humira example illustrates how extensive patent portfolios, including reissue patents and terminal disclaimers, can affect market competition. Such strategies can delay the entry of biosimilars and generic drugs, impacting patient access and healthcare costs[5].

Key Takeaways

• Broad Scope: The patent covers a wide range of disorders and compounds, highlighting its versatility.
• Enablement Requirement: The specification must enable the full scope of the claimed invention, a critical aspect emphasized by recent court decisions.
• Patent Landscape: The use of terminal disclaimers and the doctrine of nonstatutory double patenting are crucial in understanding the competitive implications.
• Regulatory Changes: Proposed rule changes aim to prevent the misuse of terminal disclaimers and ensure fair competition.

FAQs

Q: What is the main focus of United States Patent RE48839?

• The main focus is on methods and compositions for treating sleep disorders and other related disorders using specific substituted heterocycle fused gamma-carboline compounds.

Q: What is the significance of the enablement requirement in this patent?

• The enablement requirement ensures that the specification provides sufficient guidance for a person skilled in the art to practice the full scope of the claimed invention, as emphasized by the Amgen v. Sanofi decision.

Q: How do terminal disclaimers impact the patent landscape?

• Terminal disclaimers prevent the extension of patent terms by ensuring that the patent term does not exceed that of the original patent, but they can also create patent thickets that stifle competition.

Q: What are the implications of the proposed rule changes regarding terminal disclaimers?

• The proposed changes aim to ensure that patents tied by terminal disclaimers are enforceable only if the original patent claims remain valid, reducing the barriers to market entry for competitors.

Q: How does this patent affect the pharmaceutical industry?

• The patent influences the development and marketing of drugs for sleep disorders and other related conditions, requiring companies to navigate a complex patent landscape to avoid infringement and ensure novelty and non-obviousness.

Sources

1. USRE48839E1 - Methods and compositions for sleep disorders and other disorders - Google Patents
2. 1824-The Claims - USPTO
3. Amgen v. Sanofi: Seven Months In, Has Anything About Patent Enablement Changed? - IPWatchdog
4. USRE48839E1 - Methods and compositions for sleep disorders and other disorders - Google Patents
5. FTC Comment to the USPTO on Terminal Disclaimer Practice - FTC

Drugs Protected by US Patent RE48839

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-002	Apr 22, 2022		RX	Yes	No						TREATMENT OF BIPOLAR DEPRESSION
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-002	Apr 22, 2022		RX	Yes	No						TREATMENT OF SCHIZOPHRENIA
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-003	Apr 22, 2022		RX	Yes	No						TREATMENT OF SCHIZOPHRENIA
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-003	Apr 22, 2022		RX	Yes	No						TREATMENT OF BIPOLAR DEPRESSION
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-001	Dec 20, 2019		RX	Yes	Yes						TREATMENT OF BIPOLAR DEPRESSION
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-001	Dec 20, 2019		RX	Yes	Yes						TREATMENT OF SCHIZOPHRENIA

Foreign Priority and PCT Information for Patent: RE48839

PCT Information
PCT Filed	May 27, 2009	PCT Application Number:	PCT/US2009/003261
PCT Publication Date:	December 03, 2009	PCT Publication Number:	WO2009/145900

International Family Members for US Patent RE48839

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2009251816
Australia	2015218433
Canada	2725342
China	102105059
China	105168219
European Patent Office	2320731
European Patent Office	3085231