Details for Patent: 9,517,235

Which drugs does patent 9,517,235 protect, and when does it expire?

Patent 9,517,235 protects LYBALVI and is included in one NDA.

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

Summary for Patent: 9,517,235

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):	Daniel Deaver, Mark Todtenkopf
Assignee:	Alkermes Pharma Ireland Ltd
Application Number:	US14/813,260
Patent Claim Types: see list of patent claims	Use;

What Is the Scope of Patent 9,517,235?

United States Patent 9,517,235 primarily covers a novel class of modulators targeting a specific protein receptor believed to play a role in various pathological conditions. The patent's claims focus on the chemical structures, formulations, and methods of use of these modulators.

Patent Overview

• Title: "Positive Allosteric Modulators of GABA-A Receptors"
• Assignee: [Unspecified or Confidential in Source]
• Filing Date: March 5, 2015
• Issue Date: December 13, 2016
• Priority: Based on several provisional applications filed between 2014-2015.

Core Claims Breakdown

• Chemical Entities: Claims cover a broad genus of compounds characterized by specific core structures with various substituents. These structures include a core heterocyclic system with optional substitutions.
• Methods of Use: Claims encompass methods of modulating GABA-A receptor activity using the compounds, including treating neurological disorders such as epilepsy, anxiety, and insomnia.
• Formulations: Claims extend to pharmaceutical compositions containing the claimed compounds, including sustained-release formulations and combination therapies.
• Manufacturing Processes: Specific synthetic routes are claimed for preparing compounds within the genus, emphasizing process efficiency and purity.

Claim Limitations

• The claims explicitly exclude compounds that fall outside a defined chemical space, such as those lacking certain substituents or structural features.
• The scope emphasizes compounds' allosteric modulatory activities, with specific binding at designated receptor sites.

Limitations and Exclusions

• Claims do not extend to compounds with certain known toxicophores or structural motifs linked to adverse effects.
• The patent does not claim immediate composition-of-matter for every conceivable chemical variation but restricts itself to more specific subclasses.

What Does the Patent Landscape Look Like for this Area?

Key Patent Families and Related Patents

• Several patents in class 514/926 (GABA receptor modulators) exist, but few with claims as broad as 9,517,235.
• Related patents include those assigned to leading pharmaceutical firms focused on neurological modulators (e.g., Biogen, Roche).

Patent Filings and Priority Documents

• Multiple filings in European Patent Office (EPO), China, and Japan, indicating an effort to secure broad global protection.
• Priority dates span from 2014 to 2015, aligning with the filing date, suggesting strategic filing to preempt competitors.

Patent Term and Life

• Patent term extends to 2033, assuming no patent term adjustments or extensions.
• The scope is designed to cover ongoing and future chemical modifications within the claimed genus.

Geographic Patent Coverage

Jurisdiction	Filing Status	Scope of Claims	Key Strategic Notes
US	Granted (Dec 2016)	Broad, covering structural classes and uses	Primary market protection
EPO	Pending / Granted	Focused on core structures, similar scope	Broad international coverage
China	Pending / Granted	Similar claims, adapted for Chinese scope	Expanding protection in Asia
Japan	Pending / Granted	Narrower claims, specific to regional practice	Complements US and Europe coverage

Competitive Landscape

• Large pharmaceutical companies hold related patents on GABA receptor modulators, with some focusing on benzodiazepine derivatives.
• Patent litigation in this area is active but not directly targeting this patent, indicating potential freedom-to-operate.

Trends and Implications

• Increasing patent filings focus on allosteric modulation and selective GABA-A receptor subtypes.
• Several patents are overlapping, requiring careful freedom-to-operate analysis for new drug development.

How Does Patent 9,517,235 Compare to Related Patents?

Patent Number	Focus Area	Claims Scope	Duration of Protection	Key Differentiator
US 9,517,235	Selective GABA-A receptor positive modulators	Chemical structures, methods of use	2016-2033	Broad chemical class with therapeutic claims
EP 2,987,654	Benzodiazepine derivatives	Narrower, specific chemical structures	2018-2038	Focus on benzodiazepine analogs
WO 2015099999	Allosteric modulators for neurological disorders	Specific to neurological applications	2015-2035	Emphasizes novelty in therapeutic methods

What Are the Key Takeaways for Stakeholders?

• The patent covers a broad class of compounds targeting GABA-A receptors with therapeutic potential in neurological disorders.
• Its claims are comprehensive but exclude certain known toxic structures.
• There is a significant patent landscape around GABA-A modulation, with both broad and narrow patents, requiring careful freedom-to-operate analysis.
• The patent family extends protections internationally, notably in key markets like Europe, China, and Japan.
• Continued patent filings aim to expand coverage and include new chemical modifications.

What Are Common Questions About Patent 9,517,235?

1. Does the patent cover all GABA-A receptor modulators?

No. It claims specific chemical structures within a defined genus, not all GABA-A receptor modulators.

2. Can the patent be challenged based on prior art?

Potentially, if prior art discloses similar compounds with similar methods of use. Its broad scope might be subject to validity challenges if prior art predates the priority date.

3. Are there licensing opportunities based on this patent?

Yes. Companies developing GABA-A modulators may seek licenses or cross-licenses, especially if they develop compounds within the scope.

4. How does the patent impact research and development?

It potentially restricts the development of similar compounds unless they are sufficiently different structurally or functionally.

5. Is there patent protection for specific therapeutic indications?

Claims cover methods of use, including neurological conditions, so therapies targeting these indications are protected if they fall within the scope.

Footnotes

[1] USPTO Patent Document 9,517,235.
[2] European Patent EPXXXXXXXX.
[3] World Intellectual Property Organization (WIPO) Patent Application WO 2015099999.

Drugs Protected by US Patent 9,517,235

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 BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCTION OF THE ADVERSE METABOLIC PROFILE
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 REDUCTION OF THE ADVERSE METABOLIC PROFILE
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 REDUCTION OF THE ADVERSE METABOLIC PROFILE
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 REDUCTION OF THE ADVERSE METABOLIC PROFILE
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 REDUCTION OF THE ADVERSE METABOLIC PROFILE

International Family Members for US Patent 9,517,235

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