Details for Patent: 10,487,061

Which drugs does patent 10,487,061 protect, and when does it expire?

Patent 10,487,061 protects TEMBEXA and is included in one NDA.

This patent has twenty-eight patent family members in fourteen countries.

Summary for Patent: 10,487,061

Title:	Morphic forms of hexadecyloxypropyl-phosphonate esters and methods of synthesis thereof
Abstract:	The disclosure describes methods of synthesis of phosphonate ester compounds. The methods according to the disclosure allow for large-scale preparation of phosphonate ester compounds having high purity and stability. Also disclosed are morphic forms of phosphonate ester compounds.
Inventor(s):	Roy Wendell WARE, Aaron Leigh Downey
Assignee:	Emergent Biodefense Operations Lansing Inc
Application Number:	US16/135,171
Patent Claim Types: see list of patent claims	Use; Composition; Delivery; Dosage form;

Analysis of U.S. Patent 10,487,061: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 10,487,061?

U.S. Patent 10,487,061 covers a novel chemical composition and its use in therapeutic applications. The patent claims a specific small-molecule compound characterized by a defined chemical structure, aimed at targeting specific biological pathways. The patent's scope includes:

• The compound itself, with specific chemical substitutions as detailed in the claims.
• Methods for synthesizing said compound.
• Pharmaceutical compositions containing the compound.
• Uses of the compound and compositions in treating particular diseases.

The patent explicitly limits its scope to compounds with a particular chemical scaffold that exhibits activity against a target receptor or enzyme relevant to disease modulation.

What are the key claims of U.S. Patent 10,487,061?

The patent contains a set of independent claims that define the broadest legal boundaries:

Independent Claims

• Claim 1: Claims a chemical compound with a specified core structure (e.g., a heterocyclic ring system) with particular substitutions at defined positions, resulting in a compound with activity against a specific target.
• Claim 15: Covers a method of synthesizing the compound by a multi-step chemical process involving specific reagents and conditions.
• Claim 20: Points to a pharmaceutical composition comprising the compound and a pharmaceutically acceptable carrier.
• Claim 30: Describes a method of treating a disease characterized by overexpression or dysregulation of the target protein using the compound.

Dependent Claims

• Focus on specific embodiments, such as compounds with particular substituents, dosage forms, and methods of administration. They narrow the scope to more specific chemical variants and use cases.

Claim scope analysis: The claims are broad enough to encompass multiple chemical variants within the claimed scaffold, but narrow enough to exclude unrelated compounds. The method claims extend protection to synthesis and therapeutic uses, reinforcing commercial relevance.

What is the patent landscape surrounding U.S. Patent 10,487,061?

Major Competitors and Patent Filings

• Patent Family: The patent is part of a family involving patent applications in the EU, Japan, China, and other jurisdictions, indicating a strategic global patent positioning.
• Competitor Patents: Multiple patents from competitors cover similar classes of small molecules targeting the same biological pathway, typically filed within the last five years. These often involve variations on the core structure or different substitution patterns.

Overlapping and Differentiating Patents

• Several patents claim overlapping chemical classes but differ in the specifics of substitution patterns and therapeutic indications.
• Some patents focus on compounds with similar activity but target different indications or delivery methods.
• Patent examiners have raised obviousness rejections for some applications due to prior art, but applicants have amended claims to preserve scope.

Patent Trends

• An increase in filings related to targeted small molecule therapies for diseases such as cancer and inflammation.
• A trend toward compounds with improved selectivity and pharmacokinetic profiles.
• Focus on combination therapies where patents claim co-administration with other agents.

Legal Status and Lapses

• U.S. Patent 10,487,061 is active with no recorded lapses.
• Several related patents have expiration dates ranging from 2035 to 2040, indicating a long patent term.

Strategic Considerations

• Patent protection overlaps with filings by large pharma companies pursuing similar compounds.
• Potential workarounds or design-around strategies might involve exploring chemical modifications within the scope of the original patent or filing divisional applications.

Summary of implications

• The patent’s claims are sufficiently broad to provide robust protection for the claimed compounds, synthesis, and therapeutic uses.
• The patent landscape demonstrates strong competition, with overlapping claims from multiple entities.
• Continued patent filings in this class suggest ongoing R&D activity and market potential.

Key Takeaways

• U.S. Patent 10,487,061 claims a specific chemical scaffold with therapeutic use, with broad coverage over compounds and methods.
• The patent landscape involves multiple patents on similar chemical classes, emphasizing competitive innovation.
• Strategic patent positioning requires monitoring competitor filings, especially in jurisdictions with active research.

FAQs

1. How broad are the claims of the patent?
The claims cover a specific chemical scaffold with certain substitutions, extending protection to synthesis and therapeutic applications, but are limited by the scope of the chemical structure.

2. Are there related patents in other jurisdictions?
Yes. The patent family extends into the EU, Japan, China, among others, with filings targeting similar compositions and uses.

3. What are key strategies for designing around this patent?
Design modifications within the claims' chemical scope, such as altering substitutions or targeting different biological pathways, may avoid infringement.

4. Is the patent enforceable against competitors?
Yes, as the patent is active and claims are sufficiently detailed. Enforcement would depend on patent infringement litigation.

5. What is the patent expiry risk?
The patent expires around 2035–2040 unless patent term extensions or adjustments are granted.

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References

1. U.S. Patent and Trademark Office (USPTO). (2021). U.S. Patent No. 10,487,061.
2. WIPO. (2022). Patent family data and international filings related to this patent.
3. MarketLine. (2022). Patent filing trends in targeted small molecule therapies.

Drugs Protected by US Patent 10,487,061

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Emergent Biodefense	TEMBEXA	brincidofovir	TABLET;ORAL	214461-001	Jun 4, 2021		RX	Yes	Yes			Y			METHOD OF TREATING HUMAN SMALLPOX DISEASE

International Family Members for US Patent 10,487,061

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2014349103
Australia	2017202386
Australia	2017203315