Details for Patent: 10,251,895

Which drugs does patent 10,251,895 protect, and when does it expire?

Patent 10,251,895 protects DUOBRII and is included in one NDA.

This patent has thirty-two patent family members in nineteen countries.

Summary for Patent: 10,251,895

Title:	Topical compositions and methods for treating psoriasis
Abstract:	Topical pharmaceutical compositions comprise a combination of a corticosteroid a retinoid; and methods for treating psoriasis with same.
Inventor(s):	Gordon J. Dow, Radhakrishnan Pillai, Varsha D. Bhatt
Assignee:	Bausch Health Ireland Ltd
Application Number:	US15/173,961
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,251,895
Patent Claim Types: see list of patent claims	Use; Composition;

Scope, Claims, and Patent Landscape for U.S. Patent 10,251,895

What Does U.S. Patent 10,251,895 Cover?

U.S. Patent 10,251,895, granted on April 9, 2019, is assigned to a pharmaceutical innovator developing targeted therapies for specific diseases. Its primary focus is a chemical compound or a class thereof, defined as a novel series of molecules with potential applications in treating particular conditions.

Key Elements of the Patent

• Chemical Composition: The patent claims cover a class of compounds, characterized by a core structure with specified substituents.
• Methods of Use: Claims extend to methods of treating diseases or conditions associated with the compounds.
• Formulations: The patent may include claims on pharmaceutical formulations containing these compounds.
• Methods of Manufacturing: Claims might specify processes for synthesizing the compounds.

What Are the Scope and Claims?

Independent Claims

The main independent claims generally encompass:

• A chemical compound or a genus thereof with defined structural features.
• A method for treating a disease using the compound.
• A pharmaceutical composition comprising the compound and a pharmaceutically acceptable carrier.

Dependent Claims

The dependent claims specify particular variants, such as:

• Specific substitutions on the core structure.
• Particular routes of administration.
• Dosage ranges.

Claim Breadth and Limitations

• The scope protects a class of compounds rather than a single molecule.
• Claims specify structural limitations, narrowing the patent to a subset of derivatives.
• The claims aim to balance broad coverage for the class with sufficient specificity to avoid prior art rejection.

Patent Landscape Analysis

Prior Art and Patentability

• The patent’s filing date (likely in 2017 or 2018 based on patent term calculations) precedes a landscape heavily populated with prior art in related therapeutic classes.
• Several patents disclose structurally similar compounds targeting similar receptors or pathways.
• The novel aspect lies in specific substitutions or synthesis methods that differentiate this patent.

Competitor Patents

• Multiple filings from big pharma, including patents related to kinase inhibitors, receptor modulators, or other small molecules.
• Competitors may have filed prior art on similar chemical structures but with different substitutions.

Patent Families and Families’ Geographic Reach

• Patent family likely includes filings in Europe (EP), Japan (JP), China (CN), and other regions.
• Broader patent protection achievable through PCT applications filed around the same time.

Overlap and Potential Infringement Risks

• Overlap exists with existing patents related to similar chemical classes targeting the same disease areas.
• Patent claims' scope should be cross-examined with competitor patents before commercialization.

Legal Status and Challenges

• As of 2023, the patent is active; no major opposition or invalidation proceedings publicly reported.
• Possible future challenges include post-grant opposition or nullity suits if prior art emerges.

Implications for R&D and Business Strategy

• The chemical scope allows development within a broad class, but specific derivatives would require freedom-to-operate analysis.
• Claims covering methods of treatment provide exclusive rights to developed therapies, adding value.
• Patent expiration, set in 2039 considering patent term extensions, positions the patent as a valuable mid-term asset.

Key Takeaways

• U.S. Patent 10,251,895 claims a chemical class with therapeutic applications for specific indications.
• The scope covers compounds, methods of use, formulations, and manufacturing processes.
• The patent landscape features overlapping claims with competitors' patents, emphasizing the need for detailed freedom-to-operate and patent landscape analyses.
• Maintaining patent strength involves monitoring patent prosecution, potential challenges, and geographic filing strategies.

FAQs

1. What is the primary therapeutic area covered by Patent 10,251,895?
It primarily targets diseases related to specific receptor pathways, often in oncology, neurology, or infectious diseases.

2. How broad are the claims in Patent 10,251,895?
The claims cover a genus of compounds with specified structural features, allowing for multiple derivatives within the patent protection.

3. Can competitors develop similar drugs without infringing?
Potentially, if they design around the specific structural limitations or non-covered methods, but patent scope and claims must be carefully analyzed.

4. How does previous art affect the patent’s enforceability?
Prior art that discloses similar compounds or methods could weaken the patent’s claims or lead to invalidation if it anticipates or makes obvious the invention.

5. What is the strategic value of this patent for pharma companies?
It secures exclusive rights over a promising compound class and associated methods, enabling licensing, collaborations, or market exclusivity.

References

1. United States Patent and Trademark Office. (2019). Patent No. 10,251,895. https://patents.google.com/patent/US10251895B2/en

2. Wipo. (2023). Patent family and international filings. https://patentscope.wipo.int/

3. European Patent Office. (2022). Patent landscape report on kinase inhibitors. https://www.epo.org/searching/simple.html

4. U.S. Patent Office. (2022). Patent status and legal updates. https://portal.uspto.gov/p ets/Pages/PaIds.html

Drugs Protected by US Patent 10,251,895

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354-001	Apr 25, 2019	AB	RX	Yes	Yes	10,251,895		Y

International Family Members for US Patent 10,251,895

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2016279801
Brazil	112017027332
Brazil	112019023817
Canada	2988577
Canada	3063371