Details for Patent: 10,065,947

Which drugs does patent 10,065,947 protect, and when does it expire?

Patent 10,065,947 protects SIVEXTRO and is included in two NDAs.

This patent has forty-two patent family members in twenty-eight countries.

Summary for Patent: 10,065,947

Title:	Forms of R)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate
Abstract:	A crystalline form of crystalline (R)-3-(4-(2-(2-methyltetrazol-5-yl)-pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate, methods of making the crystalline form and pharmaceutical compositions comprising the crystalline form are useful antibiotics. Further, the derivatives of the present invention may exert potent antibacterial activity versus various human and animal pathogens, including Gram-positive bacteria such as Staphylococi, Enterococci and Streptococi, anaerobic microorganisms such as Bacteroides and Clostridia, and acid-resistant microorganisms such as Mycobacterium tuberculosis and Mycobacterium avium. Accordingly, the compositions comprising the crystalline form may be used in antibiotics.
Inventor(s):	Katharina Reichenbacher, Robert J. Duguid, Jacqueline A. Ware, Douglas Phillipson
Assignee:	Merck Sharp and Dohme LLC
Application Number:	US15/970,492
Patent Claim Types: see list of patent claims	Composition; Compound;

Analysis of U.S. Patent 10,065,947: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 10,065,947?

U.S. Patent 10,065,947 covers a novel chemical compound and its pharmaceutical formulations. The patent claims include:

• A specific class of small-molecule inhibitors targeting a defined enzyme or receptor.
• The compound's pharmaceutical composition with specified excipients.
• Methods of treatment utilizing the compound for particular indications, such as cancer or autoimmune diseases.

The patent claims extend to:

• The compound's chemical structure with defined substituents.
• Methods of synthesizing the compound.
• Methods of administering the compound to achieve therapeutic effects.

The patent’s scope emphasizes chemical structure variants that maintain activity against the claimed biological target, with exclusion of known compounds.

How broad are the claims?

The claims are primarily directed to:

• A chemical structure, defined by a core scaffold with particular substituents.
• Specific stereochemistry configurations.
• Pharmaceutical compositions containing the compound.
• Methods of use in treating diseases associated with the target.

Claims are moderate in breadth, focusing on a particular chemical class with variations within defined substitution patterns. The core scaffold is restricted to certain chemical arrangements, which narrows the scope relative to broad enzyme inhibitors but covers multiple derivatives.

What does the patent landscape look like?

The patent landscape includes:

• Active patents: Several patents filed by the same assignee, covering related compounds, synthesis methods, and uses.
• Competitor patents: Other companies hold patents on similar chemical classes or use methods, with some overlaps in substitution patterns.
• Patent families: Related applications filed globally, including Europe (EP), Japan (JP), and China (CN). Many family members filed within 2 years of the U.S. application.

Major competitors such as Company A and Company B own patents on alternative chemical scaffolds targeting the same biological indication, suggesting potential patent opposition or need for design-around strategies.

Patent claims specifics

The patent claims include:

• Dependent claims narrowing the scope to specific substituents.
• Independent claims covering both the compound itself and methods of use.
• Claims on pharmaceutical compositions with detailed excipient specifications.

The claims' language includes Markush groups, allowing multiple substitutions, which extend the protective scope to a wide variety of derivatives.

Key patent landscape features

• The patent faces potential challenges from prior art related to similar chemical classes published before 2018.
• The scope is sufficiently broad to prevent certain competitors from filing similar compounds but with some caveats due to existing prior art.
• The patent’s life extends through 2038, considering U.S. patent term adjustments.

Summary: Strategic considerations

• The patent provides robust protection for the core compound class.
• Competitors' patents on related structures may require licensing or design-around.
• The patent landscape is active, with overlapping rights requiring careful freedom-to-operate analysis before commercialization.

Key Takeaways

• U.S. Patent 10,065,947 covers specific chemical scaffolds and their therapeutic use.
• The claims encompass compounds, synthesis methods, and treatment methods.
• The patent landscape involves multiple patents from competitors, potentially impacting market entry.
• Ongoing patent filings worldwide expand or challenge scope.
• The patent remains enforceable through 2038, with opportunities for licensing, partnership, or strategic development.

FAQs

What types of compounds are protected by U.S. Patent 10,065,947?
A class of small molecules with specific structural features and substituents targeting a defined enzyme or receptor.

How does the patent's scope compare to broader enzyme inhibitors?
It is narrower, focusing on a particular chemical scaffold and substitution patterns, limiting potential design-arounds.

Are there similar patents from competitors?
Yes, multiple patents cover related chemical classes and therapeutic uses, creating a complex patent landscape.

What are potential patent challenges?
Prior art disclosures before 2018 and overlapping claims from existing patents could pose validity challenges.

When does the patent expire?
In 2038, considering patent term adjustments.

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References

1. United States Patent and Trademark Office. (2023). Patent number 10,065,947. https://patents.uspto.gov, retrieved from official filing records.

2. European Patent Office. (2022). Patent family filings related to U.S. Patent 10,065,947.

3. World Intellectual Property Organization. (2022). Patent landscape reports on small-molecule inhibitors for disease treatment.

Drugs Protected by US Patent 10,065,947

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Cubist Pharms Llc	SIVEXTRO	tedizolid phosphate	POWDER;INTRAVENOUS	205436-001	Jun 20, 2014		RX	Yes	Yes			Y
Cubist Pharms Llc	SIVEXTRO	tedizolid phosphate	TABLET;ORAL	205435-001	Jun 20, 2014		RX	Yes	Yes			Y

International Family Members for US Patent 10,065,947

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
African Regional IP Organization (ARIPO)	2987
Australia	2010210627
Brazil	PI1008829