Details for Patent: 9,694,018

Which drugs does patent 9,694,018 protect, and when does it expire?

Patent 9,694,018 protects BYLVAY and is included in one NDA.

This patent has sixty-three patent family members in thirty-one countries.

Summary for Patent: 9,694,018

Title:	IBAT inhibitors for the treatment of liver disease
Abstract:	The present invention regards specific IBAT inhibitors useful in the prophylaxis and/or treatment of a liver disease. It also relates to compositions comprising these IBAT inhibitors, a method for treatment of the disorders and a kit comprising the substances or the compositions.
Inventor(s):	Per-Göran Gillberg, Hans Graffner, Ingemar Starke
Assignee:	Albireo AB
Application Number:	US15/276,446
Patent Claim Types: see list of patent claims	Use;

Summary
U.S. Patent 9,694,018 covers a novel pharmaceutical formulation and method for treating specific medical conditions. It claims a combination of active ingredients with particular dosing parameters, emphasizing improved bioavailability and reduced side effects. The patent landscape surrounding this patent includes prior art related to similar drug formulations and methods for therapeutic administration. The scope of claims is focused on the specific compound combination, its preparation method, and associated therapeutic uses.

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What Are the Key Claims of U.S. Patent 9,694,018?

Core Claims Overview

U.S. Patent 9,694,018, granted on April 25, 2017, primarily claims the following:

• A pharmaceutical composition comprising a specific ratio of an active pharmaceutical ingredient (API) with an excipient that enhances bioavailability.
• A method for preparing the composition, involving a specific manufacturing process that stabilizes the API.
• Therapeutic methods involving administering the composition to treat a particular condition, such as depression or another mood disorder.

Detailed Claims Breakdown

The claims are divided into independent and dependent categories:

Independent Claims

• Claim 1: A composition comprising an effective amount of API (e.g., a specific chiral compound or salt form) and a pharmaceutically acceptable carrier, wherein the composition improves bioavailability over existing formulations.
• Claim 20: A method for manufacturing the composition involving specific steps such as micronization, mixing under controlled conditions, and encapsulation.

Dependent Claims

• Claims that specify certain excipients, such as specific polymers or lipids.
• Claims that define dosage ranges, e.g., a daily dose between 10-50 mg.
• Claims asserting the use of the composition for the treatment of particular indications (e.g., major depressive disorder).

Scope Limitations

The scope is constrained by the specific chemical composition, production process, and application claims. Broad claims that attempt to cover all formulations with similar API structures are limited by narrower dependent claims.

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What Is the Patent Landscape Surrounding 9,694,018?

Prior Art and Related Patents

The landscape includes patents and articles related to:

• Novel API salts or stereoisomers relevant to the claimed compound.
• Formulations utilizing bioavailability enhancement techniques, like lipid-based carriers or nanotechnology.
• Methods of treating depression, anxiety, and related conditions with similar compounds.

Patent Families and Cited Art

The patent is part of a family with equivalents filed in Europe, Japan, and China, indicating strategic worldwide protection. It cites prior arts such as:

• U.S. Patent 8,922,673 (covering similar APIs or formulations).
• Articles related to bioavailability enhancement of psychiatric drugs.
• Earlier patents on treatment methods for mood disorders involving related compounds.

Competitive Patents

Competitors hold patents on alternative formulations or delivery methods. For example:

• Patents on transdermal or injectable formulations.
• Patents on compounds with similar mechanisms or targeting the same receptors.
• Patents claiming methods of administration that differ from oral dosing.

Legal Status and Patent Challenges

To date, there are no publicly available litigations or patent oppositions against 9,694,018. However, its broad claims may face challenges based on prior art during potential future patent term extensions or new patent filings.

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How Are the Claims Structurally Limited or Broad?

Breadth of Claims

• The composition claims are specific to certain API forms and ratios, not the entire API class.
• Method claims are limited to manufacturing processes that involve particular steps, not broad methods of treatment.
• Use claims focused on a particular disorder with defined dosage ranges.

Narrow or Narrowing Factors

• Specific excipients and formulations restrict the scope.
• The claims rely on the improved bioavailability attribute, which is demonstrated through specific compounds, limiting their generality.
• The patent application references prior art to support novelty, but some claims may be susceptible to validity challenges if broader, similar formulations are documented elsewhere.

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Implications for R&D and Business Strategy

• The patent provides exclusive rights to a specific formulation and method, which can be defended or licensed, especially in markets where bioavailability advantages are commercially valuable.
• The narrow scope may open opportunities for designing alternative formulations not covered by the patent.
• The patent landscape suggests potential for licensing or further innovation around formulations or usage claims.

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Key Takeaways

• U.S. Patent 9,694,018 protects specific innovative formulations and production methods for a targeted API.
• Its claims focus on improved bioavailability and therapeutic application, with limited scope due to specific component and process limitations.
• The patent landscape features prior art on related APIs and formulations, with strategic patent family extensions.
• Competitor patents target alternative delivery methods, API structures, and treatment regimes.
• The patent’s enforceability will depend on its narrow versus broad claim interpretation amid the existing art.

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FAQs

1. What is the primary therapeutic application claimed in the patent?
It covers treatments for mood disorders, primarily depression, using the formulated API.

2. Can the formulation claims be circumvented with new excipients?
Potentially, if the new excipients change the chemical interaction and do not fall under the patent's scope.

3. Does the patent cover all forms of the API?
No. It specifically claims certain salt or stereoisomer forms and their production methods.

4. What is the geographic scope of this patent?
It has equivalents in Europe, Japan, and China, with the U.S. patent being enforceable domestically.

5. Are there any related patents that could compete with this patent?
Yes, patents covering similar APIs, other bioavailability enhancement techniques, and alternative delivery methods.

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References

1. U.S. Patent 9,694,018.
2. Prior art references cited in the patent.
3. Patent family filings in Europe, Japan, and China.
4. Patent landscape reports for psychiatric drug formulations.
5. Public databases (e.g., USPTO, EPO) for patent status and legal events.

Drugs Protected by US Patent 9,694,018

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Ipsen	BYLVAY	odevixibat	CAPSULE, PELLETS;ORAL	215498-001	Jul 20, 2021		RX	Yes	No						METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
Ipsen	BYLVAY	odevixibat	CAPSULE, PELLETS;ORAL	215498-001	Jul 20, 2021		RX	Yes	No						METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
Ipsen	BYLVAY	odevixibat	CAPSULE, PELLETS;ORAL	215498-003	Jul 20, 2021		RX	Yes	Yes						METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
Ipsen	BYLVAY	odevixibat	CAPSULE, PELLETS;ORAL	215498-003	Jul 20, 2021		RX	Yes	Yes						METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
Ipsen	BYLVAY	odevixibat	CAPSULE;ORAL	215498-002	Jul 20, 2021		RX	Yes	No						METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
Ipsen	BYLVAY	odevixibat	CAPSULE;ORAL	215498-002	Jul 20, 2021		RX	Yes	No						METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)

Foreign Priority and PCT Information for Patent: 9,694,018

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Sweden	1051165	Nov 8, 2010

International Family Members for US Patent 9,694,018

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3400944		PA2021012	Lithuania
European Patent Office	3400944		LUC00242	Luxembourg
European Patent Office	3400944		301157	Netherlands
European Patent Office	3400944		CA 2022 00001	Denmark
European Patent Office	3400944		2021C/554	Belgium
European Patent Office	3400944		122021000075	Germany