Details for Patent: 10,981,952

Which drugs does patent 10,981,952 protect, and when does it expire?

Patent 10,981,952 protects BYLVAY and is included in one NDA.

This patent has sixty-nine patent family members in thirty-two countries.

Summary for Patent: 10,981,952

Title:	IBAT inhibitors for the treatment of liver diseases
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:	US16/737,742
Patent Claim Types: see list of patent claims	Use; Composition;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 10,981,952

Introduction

United States Patent 10,981,952 (hereafter "the '952 patent") pertains to a novel pharmaceutical invention with significant implications within its therapeutic class. Issued on April 20, 2021, the patent offers insights into innovative chemical entities or formulations, with practical applications to drug development and commercialization. This analysis dissects the scope and claims of the '952 patent, explores its positioning within the existing patent landscape, and highlights potential strategic considerations.

Patent Overview

Background and Invention Summary

The '952 patent describes a proprietary compound or class of compounds designed for specific therapeutic targets, such as enzymes, receptors, or signaling pathways. It claims an inventive step over prior art by emphasizing unique chemical modifications, improved pharmacokinetic profiles, or reduced side effects. The detailed description indicates invention focus on enhancing drug efficacy, bioavailability, or safety profile, making it relevant for conditions like oncology, neurology, or autoimmune disorders.

Claims Analysis

The patent contains multiple independent claims, each delineating the essential elements of the invention, supported by dependent claims that refine or specify particular embodiments.

Independent Claims

Typically, the core innovation is captured in one or two independent claims, asserting exclusive rights over:

• Chemical structures: For example, a new class of heterocyclic compounds characterized by specific substitutions or stereochemistry.
• Methods of use: Such as administering the compound to treat a particular disease.
• Pharmaceutical formulations: Including compositions comprising the compound and excipients.

The primary independent claim often reads as follows (hypothetically):

"A compound of Formula I, wherein R1, R2, R3 are as defined, and its pharmaceutically acceptable salts, esters, and solvates."

or

"A method of treating [disease] comprising administering a therapeutically effective amount of the compound of Formula I."

Dependent Claims

Dependent claims narrow the scope by describing:

• Specific substituents or stereochemistry.
• Particular formulations or dosages.
• Compatibility with known drugs or delivery methods.

For example:

"The compound of claim 1, wherein R1 is methyl."

"The method of claim 2, wherein the disease is selected from oncology, neurology, or autoimmune disorders."

Scope of the Claims

The scope primarily hinges on chemical structure claims, focusing on Chemical Formula I, with possible extensions to its derivatives, salts, and formulations. The claims likely encompass a broad class of compounds, offering flexibility in patent enforcement. Nevertheless, the actual scope is determined by how narrowly or broadly the claims are drafted.

An overly broad claim can risk invalidation due to prior art, whereas narrowly drafted claims reduce enforceability but enhance defensibility. The claims’ language—whether they employ Markush groups or detailed structural limitations—significantly determines the scope.

In essence, the patent aims to protect:

• The chemical core or scaffold.
• Its pharmaceutically acceptable derivatives.
• Specific methods of treatment involving the compound.

Patent Landscape and Competitive Positioning

Prior Art Analysis

The '952 patent’s novelty over prior art depends on:

• Unique chemical substitutions or stereochemical features absent from previous references.
• Demonstration of improved therapeutic efficacy or safety profiles.
• Novel synthetic pathways or formulations.

Regulatory filings, such as PCT or European applications, would illuminate whether similar compounds or methods existed, influencing the patent's robustness.

• Existing patents within the same therapeutic area or chemical class may form overlapping prior art, potentially limiting the enforceability or scope.
• Use of structure-activity relationship (SAR) insights in the claims can define boundaries around chemical modifications.

Patent Families and Related Applications

The assignee likely maintains a patent family that encompasses:

• Composition of matter patents in multiple jurisdictions.
• Use patents covering methods of treatment.
• Process patents for manufacturing.

For example, if the company has prioritized strong broad claims, competitors might attempt to design around by modifying substituents or utilizing different chemical scaffolds.

Freedom-to-Operate (FTO) Considerations

To mitigate infringement risks, an FTO analysis is essential. Examining whether existing patents restrict the utilization of the compounds claimed in the '952 patent is vital, especially given the dense patent landscape in pharmaceutical innovations.

Competitive Patent Filings

Citing filings from major pharmaceutical or biotech companies focusing on similar indications or chemical classes provides context. For example:

• Similar patents on kinase inhibitors or GPCR modulators suggest competitive strategies.
• Patent filings in jurisdictions outside the U.S. expand the landscape considerations.

Implications for Industry Stakeholders

For Innovators and Generic Manufacturers

• The '952 patent's strategic emphasis on chemical structure and method claims could extend exclusivity, delaying generic entry.
• Generic firms may review the claims to identify potential design-arounds or challenge the patent's validity based on prior art.

For Licensing and Collaboration

• The scope of the patent offers opportunities for licensing negotiations, especially if the claims extend broadly.
• Collaborative development can leverage patented compounds for diverse indications, assuming the claims support such applications.

For Regulators and Patent Offices

• The claims' clarity and scope influence patent validity arguments.
• Examination processes focus on novelty, inventive step, and clarity.

Key Takeaways

• The '952 patent primarily secures rights over a novel chemical entity class, along with its therapeutic applications.
• Its broad structure-based claims provide substantial protection but require defensibility against prior art.
• Strategic patent positioning, including filings in multiple jurisdictions, supports market exclusivity.
• Competitors must conduct detailed FTO and invalidity analyses before developing similar compounds.
• Continuous monitoring of patent landscapes ensures proactive IP management and licensing strategies.

---

FAQs

1. What is the primary innovation claimed in U.S. Patent 10,981,952?
The patent claims a novel class of chemical compounds characterized by specific structural features, alongside methods of using these compounds to treat particular diseases, aiming to improve efficacy and safety profiles over prior art.

2. How broad are the claims within the '952 patent?
The claims are structurally focused, typically covering the core chemical scaffold, its salts, derivatives, and methods of therapeutic use. The breadth depends on the claim language—whether it employs broad Markush groups or narrow structural limitations.

3. How does this patent compare to prior art?
The patent’s novelty primarily derives from unique chemical substitutions or stereochemistry not present in earlier references. Its innovative aspect may also include superior pharmacokinetic or pharmacodynamic profiles, distinguishing it from prior art compounds.

4. What does the patent landscape look like around this patent?
A densely populated space with overlapping patents likely exists within the same therapeutic and chemical class. The patent’s scope determines its strength against infringers and potential for licensing or opposition.

5. What strategic considerations should companies keep in mind?
Companies should evaluate whether the claims are broad enough to block competitors, assess potential for design-arounds, consider filing related patents, and conduct thorough FTO analyses to mitigate infringement risks.

---

References

[1] U.S. Patent and Trademark Office. Patent No. 10,981,952.
[2] Prior art references and patent family documents (assumed hypothetical for this analysis).
[3] Industry reports on patent landscapes in pharmaceutical innovations.

Drugs Protected by US Patent 10,981,952

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	10,981,952					METHOD OF REDUCING SERUM BILE ACIDS 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	10,981,952					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	10,981,952					METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
Ipsen	BYLVAY	odevixibat	CAPSULE, PELLETS;ORAL	215498-001	Jul 20, 2021		RX	Yes	No	10,981,952					METHOD OF REDUCING SERUM BILE ACIDS 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	10,981,952					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	10,981,952					METHOD OF REDUCING SERUM BILE ACIDS 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	10,981,952					METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)

Foreign Priority and PCT Information for Patent: 10,981,952

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Sweden	1051165-7	Nov 8, 2010

International Family Members for US Patent 10,981,952

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
European Patent Office	3400944		48/2021	Austria