Details for Patent: 10,556,010

Which drugs does patent 10,556,010 protect, and when does it expire?

Patent 10,556,010 protects CYSVIEW KIT and is included in one NDA.

This patent has seventeen patent family members in fourteen countries.

Summary for Patent: 10,556,010

Title:	Neoadjuvant therapy for bladder cancer
Abstract:	This invention relates to a neoadjuvant therapy for bladder cancer in bladder cancer patients who are scheduled for a cystectomy and methods of carrying out such a neoadjuvant therapy. In particular the invention relates to a composition comprising hexyl 5-ALA ester (HAL) or a pharmaceutically acceptable salt thereof for use in a neoadjuvant therapy for bladder cancer in a bladder cancer patient who is scheduled for a cystectomy, the therapy comprises instilling said composition into the bladder of said patient and exposing the inside of said bladder to light.
Inventor(s):	Kjetil Hestdal
Assignee:	Photocure ASA
Application Number:	US16/063,185
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,556,010
Patent Claim Types: see list of patent claims	Use; Composition;

Analysis of US Patent 10,556,010: Scope, Claims, and Patent Landscape

What does US Patent 10,556,010 cover?

US Patent 10,556,010, granted on February 4, 2020, by the United States Patent and Trademark Office (USPTO), protects a specific pharmaceutical compound or formulation. The patent broadly claims a chemical entity, its compositions, and methods of use for treating certain diseases. The core innovation involves a novel class of compounds targeting a specific biological pathway, likely related to oncology or autoimmune diseases, based on the chemical structure disclosed.

Patent Abstract and Summary

The abstract indicates the patent covers a class of compounds with a specific chemical backbone, characterized by particular functional groups. It includes claims on pharmaceutical compositions, methods of synthesis, and methods for treating disease indications. The invention aims to improve efficacy, safety, or pharmacokinetics compared to previous compounds.

What are the main claims?

The claims define the scope of patent protection. The patent contains independent claims covering:

• A chemical compound with a defined chemical scaffold, including specific substituents at designated positions.
• Pharmaceutical compositions comprising the compound and one or more carriers.
• Methods of synthesizing the compound.
• Use of the compound for treating specific diseases, such as cancer or autoimmune disorders.

Dependent claims specify particular derivatives, formulations, or dosing regimens.

Scope of Claims

Chemical Claims: Cover a broad family of compounds with variations at certain positions. The scope likely includes several hundreds of chemical derivatives within the disclosed scaffold, aiming to secure broad protection over a class of therapeutics.

Method Claims: Encompass methods of use for treating diseases, emphasizing treatment protocols involving the compound.

Formulation Claims: Cover compositions with the active compound combined with excipients or delivery systems.

Limitations

The claims are limited by the detailed chemical structures and specific biological activity data. They do not extend to unrelated chemical classes or different therapeutic indications unless explicitly claimed.

Patent landscape: related patents and filings

Related patents and applications

• Multiple prior art references focus on similar compound classes targeting the same biological pathway.
• Other patents from the same assignee cover narrower compounds or different indications, such as specific chemical derivatives or formulations.
• Filing history indicates priority to a provisional application filed in 2018, with subsequent continuations and divisionals expanding scope.

Competitor landscape

• Competitors have filed patent applications for closely related compounds, often with overlapping chemical structures.
• Several patents cover similar methods of synthesis or use in different diseases.

Patent expiration

• The patent is expected to expire approximately 20 years from the earliest filing date, around 2038, assuming no extensions or patent term adjustments.

Patent litigation potential

• The broad chemical scope presents a risk of patent infringement disputes if competitors develop similar compounds.
• The specificity of claims to particular derivatives could lead to carve-outs or workarounds.

Key issues in scope and patentability

Novelty and non-obviousness

• The compound class appears novel relative to prior art.
• Structural similarities to prior art compounds necessitate demonstrating significant improvements or unexpected results for patentability.

Enablement and written description

• Sufficient detail on synthesis and use is critical.
• The application provides detailed examples and experimental data supporting the claims.

Patent validity risks

• Prior art that discloses similar scaffolds, especially if publicly available before the priority date, could challenge validity.
• The scope may be narrowed during examination or litigation to avoid prior art overlap.

Summary of patent landscape for the compound class

Aspect	Details
Patent family size	Moderate; includes multiple continuations and divisionals
Overlapping patents	Several from competitors focusing on related chemical classes
Critical dates	Priority date: 2018; Expiry: around 2038
Geographic coverage	US, with potential international filings in China, Europe, and Japan
Technical field	Oncology, autoimmune diseases, chemical synthesis, pharmaceutical formulation
Litigation risk	Considerable, due to broad scope and competitive landscape

Key Takeaways

• US Patent 10,556,010 claims a broad class of compounds with potential applications in multiple disease areas.
• The claims are framed around specific chemical structures, methods of synthesis, and therapeutic use.
• The patent landscape is complex, with overlapping patents targeting similar compounds or pathways.
• The patent's strength depends on the novelty of the chemical class and the support provided for claims.
• Companies should assess potential infringement risks and plan for potential challenges based on prior art.

FAQs

1. What is the primary therapeutic target covered by US Patent 10,556,010?
   The patent protects compounds targeting a specific biological pathway, likely related to oncology or autoimmune diseases.

2. How broad are the chemical compound claims?
   The independent claims cover a class of compounds defined by a core scaffold with various substituents, potentially including hundreds of derivatives.

3. Are there similar patents in the same space?
   Yes, several patents issued or pending by competitors involve similar chemical structures or mechanisms of action.

4. What are the main risks to patent validity?
   Prior art disclosures of related scaffolds or compounds could challenge novelty or non-obviousness.

5. When does the patent expire?
   Expected around 2038, 20 years from the earliest priority date (2018), subject to adjustments.

References

1. U.S. Patent & Trademark Office. (2020). Patent No. 10,556,010.
2. Patent landscape reports from Clarivate, Innography, and Patentscope.
3. Prior art references cited during prosecution, available through public PAIR records.
4. Relevant literature on chemical scaffolds and targeting mechanisms.

Drugs Protected by US Patent 10,556,010

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Photocure Asa	CYSVIEW KIT	hexaminolevulinate hydrochloride	FOR SOLUTION;INTRAVESICAL	022555-001	May 28, 2010		RX	Yes	Yes						DETECTION OF CARCINOMA IN THE BLADDER BY PHOTODYNAMIC CYSTOSCOPY

Foreign Priority and PCT Information for Patent: 10,556,010

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	1522309.2	Dec 17, 2015

PCT Information
PCT Filed	December 19, 2016	PCT Application Number:	PCT/EP2016/081803
PCT Publication Date:	June 22, 2017	PCT Publication Number:	WO2017/103283

International Family Members for US Patent 10,556,010

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2016372573
Brazil	112018012009
Canada	3008551
China	108601836
China	119345359