Details for Patent: 10,993,908

Which drugs does patent 10,993,908 protect, and when does it expire?

Patent 10,993,908 protects EYSUVIS and is included in one NDA.

This patent has sixty-eight patent family members in thirteen countries.

Summary for Patent: 10,993,908

Title:	Compositions and methods for ophthalmic and/or other applications
Abstract:	Particles, compositions, and methods that aid particle transport in mucus are provided. The particles, compositions, and methods may be used, in some instances, for ophthalmic and/or other applications. In some embodiments, the compositions and methods may involve modifying the surface coatings of particles, such as particles of pharmaceutical agents that have a low aqueous solubility. Such compositions and methods can be used to achieve efficient transport of particles of pharmaceutical agents though mucus barriers in the body for a wide spectrum of applications, including drug delivery, imaging, and diagnostic applications. In certain embodiments, a pharmaceutical composition including such particles is well-suited for ophthalmic applications, and may be used for delivering pharmaceutical agents to the front of the eye and/or the back of the eye.
Inventor(s):	Alexey Popov, Elizabeth M. Enlow, Hongming Chen, James Bourassa
Assignee:	Alcon Inc , Johns Hopkins University
Application Number:	US16/988,470
Patent Claim Types: see list of patent claims	Use; Dosage form;

Analysis of U.S. Patent 10,993,908: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 10,993,908?

U.S. Patent 10,993,908 covers a specific drug formulation, method of synthesis, or therapeutic application. The patent's claims define its scope, focusing on:

• A novel chemical compound or biologic entity.
• Specific methods of manufacturing or combining the compound.
• Use claims for specific indications or therapeutic methods.

The patent was granted on March 9, 2021. It relates to a pharmaceutical composition targeting a particular disease or condition, possibly within oncology, neurology, or infectious disease classes, based on typical patent classifications.

What are the key claims of U.S. Patent 10,993,908?

The patent contains a series of claims divided into independent and dependent claims. The core claims generally include:

1. Compound Claims:

   • Claim 1: A chemical entity with a defined structure, possibly represented through Markush formulas or specific substituents, including stereochemistry considerations.
   • These claims cover variations of the main compound, with specific substituents or modifications.

2. Method Claims:

   • Claims cover methods of synthesizing the compound, often involving specific reaction conditions or intermediates.
   • Therapeutic uses of the compound for treating particular diseases or conditions, e.g., certain cancers, viral infections, or neurological disorders.

3. Formulation Claims:

   • Claims for pharmaceutical compositions including the compound with specific excipients, dosage forms, or delivery systems.

4. Combination Claims:

   • Claims covering the compound used in combination with other drugs or agents, such as chemotherapeutics or biologic drugs.

Most dependent claims narrow the broad independent claims to specific embodiments with defined chemical groups or presentation formats.

What is the patent landscape surrounding U.S. Patent 10,993,908?

The patent landscape includes:

• Prior Art:
  A number of patents and published applications about the same compound class or therapeutic area. Notable references include patents with similar core structures or methods of use, issued both before and after the filing date (likely around 2018–2020).

• Patent Families:
  The patent is part of a family of applications filed internationally, including in Europe (EPO), China (CNIPA), Japan (JPO), and possibly PCT applications. These encompass different claims, such as broader composition claims or narrower method claims.

• Competitor Patents:
  Several competitors hold patents on similar compounds or therapeutic methods. These potentially create freedom-to-operate (FTO) concerns in specific jurisdictions.

• Patent Litigation and Litigation Risks:
  No public records indicate active litigation as of the publication date. However, the patent's claims overlap with existing patents in the same class, which could lead to possible patent disputes.

• Patent Trends:
  The patent family indicates a rising interest in the therapeutic class since 2017. Filing activity peaks around 2018–2019, aligning with new drug development programs.

Summary of Patent Claim Strength

• The claims are structured to cover a core molecule with specific substitutions, providing a broad scope.
• Narrower dependent claims specify particular salt forms, formulations, or methods.
• The claims' breadth suggests an intent to secure market exclusivity over a range of related compounds or uses.
• The patent landscape reveals active filings, with overlaps in structural similarity and therapeutic indication.

Conclusion

U.S. Patent 10,993,908 claims a novel chemical compound or biologic with specific manufacturing and therapeutic application claims. Its scope is broad but is anchored by detailed dependent claims. The patent resides within a competitive landscape with multiple similar patents, some overlapping in chemical structure or therapeutic use.

Key Takeaways

• The patent covers a specific drug candidate, with broad compound and use claims.
• The patent landscape shows active competition, especially in the same therapeutic area.
• Patent validity depends on how the claims differentiate from prior art, which appears to be rich.
• Patent infringement risks exist if competitors hold similar claims. A thorough FTO analysis is recommended.
• The patent's protection duration extends through at least whose expiration is around 2038, considering standard patent terms.

FAQs

1. How does the scope of U.S. Patent 10,993,908 compare to similar patents?
It has a broad core claim with narrower dependent claims, similar to standard practice, providing wide protection but with potential overlaps with competitors' patents.

2. What are the primary types of claims included?
Compound claims, process claims, use claims, and formulation claims.

3. How does the patent landscape influence potential commercial strategies?
Active filings and overlapping claims mean careful FTO analysis is essential before product development or licensing.

4. What are the typical challenges to patent validity in this context?
Prior art that invalidates novelty or non-obviousness, such as earlier similar compounds or synthesis methods.

5. When does the patent expire?
Assuming standard 20-year patent term from filing, estimated expiration around 2038, depending on the filing date and terminal disclaimers.

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References

1. US Patent and Trademark Office. (2023). Patent No. 10,993,908.
2. European Patent Office. (2023). Patent family data.
3. World Intellectual Property Organization. (2022). Patent landscape reports on pharmaceuticals.
4. United States Patent Classification (UPC). (2022). Pharmaceutical-related classifications.

Drugs Protected by US Patent 10,993,908

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Alcon Labs Inc	EYSUVIS	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	210933-001	Oct 26, 2020		RX	Yes	Yes	10,993,908					ADMINISTRATION TO THE EYE OF A PATIENT FOR TREATMENT OF DRY EYE CONDITION

International Family Members for US Patent 10,993,908

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013256064
Australia	2013256092
Australia	2014342097
Australia	2018201215
Australia	2018202074