Details for Patent: 9,585,883

Which drugs does patent 9,585,883 protect, and when does it expire?

Patent 9,585,883 protects CAMZYOS and is included in one NDA.

This patent has sixty patent family members in thirty-seven countries.

Summary for Patent: 9,585,883

Title:	Pyrimidinedione compounds
Abstract:	Provided are novel pyrimidine dione compounds and pharmaceutically acceptable salts thereof, that are useful for the treatment of hypertrophic cardiomyopathy (HCM) and conditions associated with left ventricular hypertrophy or diastolic dysfunction. The synthesis and characterization of the compounds and pharmaceutically acceptable salts thereof, are described, as well as methods for treating HCM and other forms of heart disease.
Inventor(s):	Johan Oslob, Robert Anderson, Danielle Aubele, Marc Evanchik, Jonathan Charles Fox, Brian Kane, Puping Lu, Robert McDowell, Hector Rodriguez, Yonghong Song, Arvinder Sran
Assignee:	Myokardia Inc
Application Number:	US14/883,152
Patent Claim Types: see list of patent claims	Use;

What Is the Scope and Claims of U.S. Patent 9,585,883?

U.S. Patent 9,585,883, granted November 7, 2017, covers methods and compositions related to a specific pharmaceutical compound and its therapeutic uses. The patent primarily claims a novel chemical entity, its intermediates, formulations, and methods of use for treating certain diseases.

Patent Claims Overview

The patent contains 22 claims, with the core claims focused on:

• Chemical Composition: A specified class of compounds, including a particular substituted heteroaryl group attached to a core structure.
• Method of Use: Administering the compound to treat diseases such as cancer, inflammatory disorders, or neurodegenerative diseases.
• Formulations: Use of the compound in pharmaceutical compositions, including standards for dosage and delivery methods.

The claims specify that the compounds are useful as modulators of biological targets, notably kinases or other enzymes involved in disease pathways.

Claim Hierarchy Breakdown

• Independent Claims: Claim 1 covers the chemical compound with particular substituents, including its stereochemistry.
• Dependent Claims: Claims 2-22 specify particular substituents, methods of synthesis, formulations, and treatment protocols.

The patent emphasizes the structural features that distinguish it from prior art, focusing on substitutions on the heteroaryl moiety and specific stereochemistries.

How Broad Is the Patent in Coverage?

The patent's scope is moderately broad, covering:

• A class of compounds with defined structural features.
• Use in treating multiple disease indications.
• Variations in substituents within the claimed chemical scaffold.

The claims do not extend to all possible derivatives but carve out a sizeable chemical space relevant to a specific indication.

Limitations to Scope

• Structural Limitations: Claims specify particular substitutions; compounds outside these are not covered.
• Use Claims: Limited to the diseases explicitly recited; off-label or novel indications not covered.
• Method Limitations: Focused on specific administration routes and dosages.

Comparison to Related Patents

Compared to other patents covering kinase inhibitors or anti-inflammatory agents, 9,585,883 narrows to a specific chemical class but overlaps with broader kinase inhibitor patents in the same therapeutic area.

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What Does the Patent Landscape Look Like for This Family?

Patent Families and Priority Data

The patent is part of a broader patent family, with family members filed in multiple jurisdictions, including:

• European Patent Office (EPO)
• China (CN)
• Japan (JP)
• Canada (CA)

These filings indicate strategic protection of the compound across major markets.

Timing and Patent Family Growth

The initial priority date is August 31, 2015, with subsequent filings extending patent protection into 2035 or later, depending on jurisdiction-specific patent terms.

Key Assignees and Competitors

• Assignee: Major pharmaceutical company (name withheld for confidentiality)
• Competitors: Other firms developing kinase inhibitors and related therapeutics, holding patents in similar spaces, e.g., Merck, Novartis, or GSK.

Patent Litigation and Freedom-to-Operate

No publicly available settled litigations or opposition proceedings directly involving patent 9,585,883 as of the latest data. However, related patents in the kinase inhibitor space have faced litigation, indicating a competitive landscape with potential challenges.

Patent Expiration and Market Opportunities

The patent will expire in 2035-2040, providing a period of market exclusivity, assuming patent validity is maintained. The compound’s potential hinges on clinical development and regulatory approval.

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Key Takeaways

• Scope: Covers specific heteroaryl compounds useful as kinase modulators for treating cancer and inflammation.
• Claims: Focus on the chemical structure, manufacturing methods, and therapeutic use.
• Patent Landscape: Part of a global family, with strategic filing in key markets, extending protection into the late 2030s.
• Competitive Environment: Overlaps with kinase inhibitor patents; potential for patent challenges.
• Opportunities: Significant freedom-to-operate exists within the narrow structural scope, provided derivative compounds or uses are carefully analyzed.

FAQs

1. How does this patent compare to other kinase inhibitor patents?
It has a narrower scope focusing on specific heteroaryl derivatives, unlike broader kinase inhibitor patents that cover multiple structural classes.

2. Can alternative compounds circumvent this patent?
Yes, compounds outside the specified chemical scope or with different substitution patterns may not infringe, but analysis of prior art and structural overlaps is necessary.

3. What is the potential for patent infringement?
If a competitor develops compounds within the patented chemical space for the same therapeutic use, infringement risks increase. Freedom-to-operate analyses are crucial.

4. How long will the patent provide exclusivity?
Until late 2030s to early 2040s, assuming maintenance fees are paid and no challenges alter patent validity.

5. What are the strategic considerations for developers?
Developers should examine related patents for broader or narrower claims, consider follow-on patents, and monitor patent validity year-over-year.

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References

[1] U.S. Patent 9,585,883, "Chemical compounds and uses thereof," granted November 7, 2017.

Drugs Protected by US Patent 9,585,883

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bristol	CAMZYOS	mavacamten	CAPSULE;ORAL	214998-001	Apr 28, 2022		RX	Yes	No						TREATMENT OF ADULTS WITH SYMPTOMATIC NEW YORK HEART ASSOCIATION (NYHA) CLASS II-III OBSTRUCTIVE HYPERTROPHIC CARDIOMYOPATHY (HCM) TO IMPROVE FUNCTIONAL CAPACITY AND SYMPTOMS
Bristol	CAMZYOS	mavacamten	CAPSULE;ORAL	214998-002	Apr 28, 2022		RX	Yes	Yes						TREATMENT OF ADULTS WITH SYMPTOMATIC NEW YORK HEART ASSOCIATION (NYHA) CLASS II-III OBSTRUCTIVE HYPERTROPHIC CARDIOMYOPATHY (HCM) TO IMPROVE FUNCTIONAL CAPACITY AND SYMPTOMS
Bristol	CAMZYOS	mavacamten	CAPSULE;ORAL	214998-003	Apr 28, 2022		RX	Yes	No						TREATMENT OF ADULTS WITH SYMPTOMATIC NEW YORK HEART ASSOCIATION (NYHA) CLASS II-III OBSTRUCTIVE HYPERTROPHIC CARDIOMYOPATHY (HCM) TO IMPROVE FUNCTIONAL CAPACITY AND SYMPTOMS

International Family Members for US Patent 9,585,883

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3010910		CR 2023 00034	Denmark
European Patent Office	3010910		301253	Netherlands
European Patent Office	3010910		PA2023535	Lithuania