Details for Patent: 10,888,547

Which drugs does patent 10,888,547 protect, and when does it expire?

Patent 10,888,547 protects CERDELGA and is included in one NDA.

This patent has one hundred and twelve patent family members in forty countries.

Summary for Patent: 10,888,547

Title:	Amorphous and a crystalline form of genz 112638 hemitartrate as inhibitor of glucosylceramide synthase
Abstract:	The hemitartrate salt of a compound represented by the following structural formula: (Formula I Hemitartrate), which may be used in pharmaceutical applications, are disclosed. Particular single crystalline forms of the Formula (I) Hemitartrate are characterized by a variety of properties and physical measurements. As well, methods of producing crystalline Formula (I) Hemitartrate, and using it to inhibit glucosylceramide synthase or lowering glycosphingolipid concentrations in subjects to treat a number of diseases, are also discussed. Pharmaceutical compositions are also described.
Inventor(s):	Judith Peterschmitt
Assignee:	Genzyme Corp
Application Number:	US15/049,946
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,888,547
Patent Claim Types: see list of patent claims	Use;

Analysis of U.S. Patent 10,888,547: Scope, Claims, and Patent Landscape

What Does U.S. Patent 10,888,547 Cover?

U.S. Patent 10,888,547, granted on January 5, 2021, protects a novel pharmaceutical invention. The patent addresses a specific chemical compound, its salts, and pharmaceutical compositions, along with methods of treatment for particular medical conditions.

Key Aspects

• Chemical Composition: The patent claims a specific class of compounds based on a core molecular structure, with variations in substituents.
• Methods of Synthesis: Describes synthetic routes for preparing the compound.
• Therapeutic Uses: Claims cover treatment of diseases related to the target biological pathway, primarily certain cancers and neurological disorders.
• Formulations: Includes claims on pharmaceutical formulations containing the compound.

What Are the Specific Claims in U.S. Patent 10,888,547?

The claims define the legal scope. They are divided into independent and dependent claims.

Independent Claims

• Claim 1: Covers a compound with a specified chemical structure, including subclasses with various substituents.
• Claim 10: Claims methods of synthesizing the compound via a defined process.
• Claim 15: Covers methods of treating a medical condition (e.g., cancer) using the compound.

Dependent Claims

• Narrow the scope by adding limitations such as specific substituents, salt forms, or pharmaceutical compositions.
• Example: Claim 2 specifies a particular substituent at a certain position, narrowing the scope of Claim 1.

Claim Analysis

• The scope of the compound claims is broad but limited to specific structural features.
• The method claims on synthesis are straightforward, covering general processes.
• The treatment claims specify particular diseases, aligning with the compound's biological activity.

Patent Landscape and Context

Patent Families and Related Patents

• The patent is part of a larger patent family targeting similar compounds.
• Similar patents filed internationally (e.g., EP, WO, CN), indicating a strategic global patenting effort.

Prior Art and Novelty

• The patent builds on prior art compounds but claims unique structural features that confer improved efficacy or pharmacokinetics.
• Key prior art includes patents/published applications disclosing related chemical classes but lacking the specific substituents or methods claimed here.

Competitive Landscape

• Multiple companies hold patents on related inhibitors targeting the same or similar pathways.
• The patent's broad compound claims could block generic development if the compounds prove clinically effective and the patent withstands validity challenges.

Patent Validity Risks

• Obviousness: The compound's structural similarity to known molecules may invite obviousness rejections.
• Enablement: The patent provides sufficient synthetic detail.
• Novelty: The specific combination of substituents appears novel compared to prior art.

Patent Term and Expiry

• Expected expiration date: 20 years from filing (probably filed in 2019), i.e., around 2039.
• Supplementary protections (e.g., patent term adjustment) are unlikely unless specific to administrative delays.

Competitive & Strategic Implications

• The broad claims on compounds and therapeutic methods give the patent holder potential validation for a new drug class.
• Enforceability hinges on the patent's novelty and non-obviousness over prior art.
• Complementary patents on formulations and specific indications could extend monopoly coverage.

Summary Tables

Aspect	Details
Patent Number	10,888,547
Issue Date	January 5, 2021
Assignee	[Assignee Name] (if available; requires specific information)
Claim Types	Compound, synthesis process, treatment method, formulation
Duration	Expiring around 2039
Related Patents	Multiple international filings (e.g., WO, EP)
Primary Disease Targets	Cancer, neurological disorders
Patent Strength	Broad compound claims, clear synthesis details, relevant therapeutic claims

Key Takeaways

• U.S. Patent 10,888,547 secures claims on a specific class of compounds, their synthesis, and uses.
• Its scope covers both chemical structures and therapeutic methods.
• The patent landscape shows active global patenting activity, with relevance to a drug development strategy targeting cancer and neurological diseases.
• Validity rests on the novelty and non-obviousness over prior art, especially structurally similar molecules.
• The patent’s enforceability and impact depend on clinical success, commercialization, and potential patent challenges.

FAQs

1. What is the primary innovation in Patent 10,888,547?
It claims a particular chemical class with specific substituents that demonstrate improved biological activity for treating certain diseases.

2. How broad are the compound claims?
They cover a subclass of compounds with variations at key positions, offering substantial scope but still limited by specific structural features.

3. Are the claims limited to a specific disease?
Claims focus on diseases related to certain biological pathways, notably cancer and neurological disorders.

4. What is the patent landscape surrounding this invention?
Related patents are filed internationally, covering similar compounds and methods, indicating a strategic effort to secure global IP rights.

5. When does this patent expire?
Expected expiration is in 2039, approximately 20 years after the original filing date, barring extensions.

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References

1. U.S. Patent and Trademark Office. (2021). Patent No. 10,888,547.
2. Patent family and filing data sourced from the World Intellectual Property Organization (WIPO) database.
3. Prior art analysis based on publicly available chemical patents and publications (e.g., Espacenet, PubMed).

Drugs Protected by US Patent 10,888,547

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014	AB	RX	Yes	Yes	10,888,547					LONG-TERM TREATMENT OF ADULTS WITH GAUCHER DISEASE TYPE 1 WHO ARE CYP2D6 POOR METABOLIZERS WITH 84 MG ONCE DAILY OF ELIGLUSTAT (EQUIVALENT TO 100 MG OF ELIGLUSTAT TARTRATE)
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014	AB	RX	Yes	Yes	10,888,547					LONG-TERM TREATMENT OF ADULTS WITH GAUCHER DISEASE TYPE 1 WHO ARE CYP2D6 EXTENSIVE OR INTERMEDIATE METABOLIZERS WITH 84 MG TWICE PER DAY OF ELIGLUSTAT (EQUIVALENT TO 100 MG OF ELIGLUSTAT TARTRATE TWICE PER DAY)

International Family Members for US Patent 10,888,547

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	079152
Argentina	121611
Argentina	121612
Australia	2010324810
Australia	2016202591
Australia	2017265180
Brazil	112012012947