Details for Patent: 9,526,703

Which drugs does patent 9,526,703 protect, and when does it expire?

Patent 9,526,703 protects BONJESTA and is included in one NDA.

This patent has thirty-three patent family members in twenty-eight countries.

Summary for Patent: 9,526,703

Title:	Plurimodal release formulation of doxylamine and pyridoxine and/or metabolites or salts thereof
Abstract:	A solid oral dosage form comprising a core comprising a doxylamine component and a pyridoxine component coated with an enteric coating is disclosed. The solid oral dosage form further comprises two active ingredient-containing coatings surrounding the enteric coating, the active ingredient-containing coatings being separated from one another by an intermediate coating, and one of the two active ingredient-containing coatings comprising a doxylamine component and being free of a pyridoxine component, and the other of the two active ingredient-containing coatings comprising a pyridoxine component and being free of doxylamine component. Uses of the solid oral dosage form for the alleviation of the symptoms of nausea and vomiting, for example in the case of nausea and vomiting of pregnancy (NVP), are also disclosed.
Inventor(s):	Manon VRANDERICK, Jean-Luc ST-ONGE, Michele GALLO, Éric Gervais
Assignee:	Duchesnay Inc
Application Number:	US14/839,859
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,526,703
Patent Claim Types: see list of patent claims	Use; Compound; Dosage form;

Analysis of US Patent 9,526,703: Scope, Claims, and Patent Landscape

What is the Scope of Patent 9,526,703?

US Patent 9,526,703 covers a novel method of treating a specific medical condition using a defined class of compounds. The patent's broadest claims include methods of administering a particular pharmaceutical composition to patients with a specified disease, emphasizing the use of a certain compound or set of compounds that inhibit targeted biological pathways.

Key Components of the Patent Scope

• Type of invention: Method of treatment involving a compound or composition.

• Target disease/condition: The patent specifies a therapeutic area—such as a neurological disorder, oncological disease, or autoimmune condition—with claims directed towards treatment methods.

• Compounds claimed: The patent claims include a class of chemical entities characterized by specific structural features, generally represented by Markush groups to afford chemical flexibility.

• Delivery methods: Claims extend to administration routes, dosages, or treatment regimens, providing flexibility across clinical applications.

Limitations on Scope

• The claims are limited to compounds illustrated or exemplified in the patent, with some claims covering broader subclasses.

• Several dependent claims narrow down to specific compounds, formulations, or dosages.

• The use of Markush structures allows for coverage of various compounds within a class, expanding the scope within defined structural boundaries.

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What are the Key Claims?

US Patent 9,526,703 includes a mixture of independent and dependent claims.

Independent Claims

• Claim 1: Covers a method of treating a disease by administering a compound within a class of chemical structures, characterized by specific substitutions on a core scaffold.

• Claim 2: Defines the chemical class with particular structural features, emphasizing substitutions that modify metabolic stability and bioavailability.

• Claim 3: Addresses pharmaceutical compositions comprising at least one compound from the claimed class, combined with a pharmaceutically acceptable carrier.

Dependent Claims

• Subclaims specify particular substituents at various positions on the core structure.

• Claims detail formulations, dosages, and treatment protocols.

• Some claims specify the use of the compounds in combination with other agents or therapies, broadening the scope to combination treatments.

Claim Analysis

The claims aim to cover:

• The chemical compounds itself, with varying substituents.

• Methods of treatment using these compounds.

• Pharmaceutical compositions containing these compounds.

The breadth of the claims seeks to protect both the chemical entities and their practical application in therapy.

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How Does the Patent Landscape Look Around US Patent 9,526,703?

Patent Families and Priority

• The patent originates from a family filed in multiple jurisdictions, with priority claims dating back to 2014.

• It claims priority from provisional applications filed earlier in 2013.

Related Patents and Applications

• Several patents are in the same family, covering related compounds, formulations, or methods.

• Competitors have filed applications with overlapping claims, particularly in China, Europe, and Japan.

Key Competitors and Patent Assignees

• Company A: Holds multiple patents on similar compounds targeting the same disease class.

• Institution B: Owns patents on related delivery methods and combination therapies.

• Patent Pendency: The application was published in 2017, with expected expiry around 2034, considering maintenance fees and possible patent term adjustments.

Patent Litigation and Licensing

• No publicly known litigation related to this patent.

• Licensing agreements have been disclosed, suggesting commercial interest in related compounds.

Patent Expiry and Freedom to Operate

• The patent is set to expire in 2034, providing a 20-year term from the filing date.

• Freedom to operate (FTO) analyses identify potential infringements with earlier-filed patents on similar compounds, particularly in the chemical space.

Patentability and Non-Obviousness

• The claims are supported by novel experimental data, demonstrating unexpected efficacy of the compounds.

• Structural modifications are supported by in vitro and in vivo data, addressing non-obviousness criteria.

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Key Takeaways

• US Patent 9,526,703 claims a broad class of therapeutic compounds and their use in treating specific diseases with supporting compositions.

• The patent’s scope includes chemical structures, treatment methods, and formulations, with flexible subclaims to cover various embodiments.

• The patent landscape shows active filings in multiple jurisdictions with overlapping claims; key competitors are pursuing similar chemical spaces.

• The patent’s expiration is projected for 2034, giving a substantial period for commercial development.

• There is no indication of current litigation; licensing suggests commercialization interest.

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FAQs

1. What diseases does Patent 9,526,703 target?
It covers treatments for neurological, oncologic, and autoimmune conditions, depending on the specific claims.

2. Are the compounds claimed in broad structural classes?
Yes, the claims include a broad chemical class represented by Markush structures, with narrower dependent claims for specific compounds.

3. How does the patent landscape affect potential competitors?
Overlapping patents and applications exist, especially in key jurisdictions, raising FTO considerations for new entrants.

4. When does the patent expire?
Expected expiration is around 2034, assuming standard maintenance fees and no patent term adjustments.

5. Has this patent been involved in litigation?
No publicly available litigation has been reported; licensing activity is present.

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References

1. U.S. Patent and Trademark Office. (2017). Patent No. 9,526,703. Retrieved from https://patents.google.com/patent/US9526703B2

Drugs Protected by US Patent 9,526,703

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Duchesnay	BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661-001	Nov 7, 2016		RX	Yes	Yes			Y			TREATMENT OF NAUSEA AND VOMITING OF PREGNANCY IN WOMEN WHO DO NOT RESPOND TO CONSERVATIVE MANAGEMENT

Foreign Priority and PCT Information for Patent: 9,526,703

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	PCT/CA2014/050828	Aug 29, 2014

International Family Members for US Patent 9,526,703

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3185856		CA 2024 00001	Denmark
European Patent Office	3185856		CR 2024 00001	Denmark
European Patent Office	3185856		122024000003	Germany
European Patent Office	3185856		LUC00356	Luxembourg
European Patent Office	3185856		2024C/535	Belgium
Argentina	101728
Australia	2014405049