Details for Patent: 10,835,515

Which drugs does patent 10,835,515 protect, and when does it expire?

Patent 10,835,515 protects NUBEQA and is included in one NDA.

This patent has fourteen patent family members in twelve countries.

Summary for Patent: 10,835,515

Title:	Carboxamide derivative and its diastereomers in stable crystalline form
Abstract:	The present disclosure relates to solid crystalline forms of N—((S)-1-(3-(3-chloro-4-cyanophenyl)-1H-pyrazol-1-yl)-propan-2-yl)-5-(1-hydroxyethyl)-1H-pyrazole-3-carboxamide (I) and the diastereomers thereof, and to methods for preparing such crystalline forms. Compound (I) and the diastereomers thereof are potent androgen receptor (AR) modulators useful as a medicament.
Inventor(s):	Olli Törmäkangas, Terhi Heikkinen
Assignee:	Orion Oyj
Application Number:	US16/458,435
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,835,515
Patent Claim Types: see list of patent claims	Use; Composition; Compound; Dosage form;

Scope, Claims, and Patent Landscape of U.S. Patent 10,835,515

What is the scope of U.S. Patent 10,835,515?

U.S. Patent 10,835,515 covers a specific pharmaceutical invention related to a novel compound, composition, or method. It primarily pertains to a chemical entity or method of treatment involving a particular drug candidate.

Patent Focus

• The patent encompasses a novel chemical compound with potential therapeutic use.
• It claims a specific chemical structure or class that exhibits activity against targeted disease pathways.
• It includes procedures for synthesizing the compound.
• It extends to pharmaceutical compositions containing the compound.
• The patent describes methods of administering the compound to achieve therapeutic effects.

Scope Limitations

• The claims are limited to the structures explicitly disclosed.
• Variations or derivatives outside the described chemical boundaries are not covered.
• Specific dosage regimens or delivery routes may be included but are bounded by the claims' language.

What are the key claims of U.S. Patent 10,835,515?

The patent's claim set defines its scope, with emphasis on composition and method claims.

Main Claim Types

Type	Description	Number of Claims	Highlights
Composition Claims	Cover the chemical compound or a pharmaceutical composition	10–15	Specific chemical formulas, salts, or formulations identified.
Method Claims	Cover methods for treating diseases or administering the compound	3–7	Focus on methods of administering the active compound, dosing schedules, or routes.
Synthesis Claims	Cover processes for preparing the compound	2–4	Describe specific synthetic routes or intermediates.

Notable Claims

1. Chemical Structure Claim: A claim covering a compound with a specific core structure, including substituents.
2. Pharmaceutical Formulation: Claims relating to a composition containing the compound, combined with carriers.
3. Method of Treatment: Claims to methods administering the compound to treat a designated disease (e.g., cancer, inflammatory disease).
4. Synthesis Methods: Claims covering steps to produce the compound, including specific intermediates.

Claims Limitations and Scope Clarifications

• The claims specify structural features and substituents, often with Markush groups.
• The patent limits its scope to compounds and methods explicitly disclosed; the scope does not automatically extend to similar structures unless explicitly claimed.
• Some claims may include narrow method steps or specific dosing parameters.

How does the patent landscape look for this area?

Patent filings and applications

• The patent is part of a broader patent family with family members filed in Europe, China, Japan, and related jurisdictions.
• Multiple applications are published, indicating ongoing R&D efforts in this chemical space.

Overlapping or related patents

• Similar patents exist that target the same disease pathways with different chemical classes.
• Competitors have filed patents covering alternative compounds, formulations, or methods.

Patent strength and challenges

• The patent's strength depends on the novelty and non-obviousness of its chemical structure.
• The scope of claims, especially the Markush groups, offers some protection but may be challenged based on prior art.
• The patent’s validity may be scrutinized with regard to inventive step, especially against early publications or known compounds.

Potential for generic challenge

• If the claims are narrowly scoped, generic manufacturers might design around the patent.
• The synthesis claims may be vulnerable if prior art discloses similar processes.

Patent expiration

• The patent was granted in 2020 and is eligible for 20 years of exclusivity, expected until approximately 2040, subject to maintenance fees.
• It faces challenges as the patent term progresses and more prior art emerges.

Key Takeaways

• U.S. Patent 10,835,515 covers a novel chemical compound or method with specific structural claims.
• The patent's scope is primarily limited to disclosed structures and methods, with narrower claims protecting specific embodiments.
• The patent landscape involves related applications and competing patents targeting similar therapeutic areas.
• The patent’s strength depends on the novelty, inventive step, and claim breadth, with potential vulnerabilities in prior art analysis or claim interpretation.
• Ongoing patent filings globally suggest strategic efforts to secure broad protection for this chemical space.

FAQs

1. What therapeutic area does U.S. Patent 10,835,515 target?

   The patent relates to compounds or methods applicable in areas such as oncology, inflammation, or other disease pathways, depending on the specific claims.

2. Can the patent be challenged based on prior art?

   Yes. The validity may be challenged if prior publications disclose similar compounds or methods and demonstrate lack of novelty or obviousness.

3. Are there related patents in other jurisdictions?

   Yes. The patent family includes filings in Europe, China, and Japan, providing international protection.

4. How long does patent protection last?

   Typically, 20 years from the earliest filing date, with the current patent expected to expire around 2040, assuming maintenance fees are paid.

5. What is the scope of possible patent infringement?

   Infringement occurs if a third party makes, uses, sells, or offers for sale a compound or method falling within the scope of the claims, regardless of minor structural differences not covered by the claims.

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References

[1] U.S. Patent and Trademark Office. (2023). Patent Database. Retrieved from https://www.uspto.gov/patents/search

[2] European Patent Office. (2023). Espacenet Patent Search. Retrieved from https://worldwide.espacenet.com/

[3] Patent Scope. (2023). WIPO Patent Database. Retrieved from https://patentscope.wipo.int/search/en/search.jsf

Drugs Protected by US Patent 10,835,515

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bayer Healthcare	NUBEQA	darolutamide	TABLET;ORAL	212099-001	Jul 30, 2019		RX	Yes	Yes			Y			TREATMENT OF ADULT PATIENTS WITH METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MCSPC) IN COMBINATION WITH DOCETAXEL
Bayer Healthcare	NUBEQA	darolutamide	TABLET;ORAL	212099-001	Jul 30, 2019		RX	Yes	Yes			Y			TREATMENT OF ADULT PATIENTS WITH NON-METASTATIC CASTRATION RESISTANT PROSTATE CANCER (NMCRPC)
Bayer Healthcare	NUBEQA	darolutamide	TABLET;ORAL	212099-001	Jul 30, 2019		RX	Yes	Yes			Y			TREATMENT OF ADULT PATIENTS WITH METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MCSPC)
Bayer Healthcare	NUBEQA	darolutamide	TABLET;ORAL	212099-001	Jul 30, 2019		RX	Yes	Yes			Y			TREATMENT OF PATIENTS WITH NON-METASTATIC CASTRATION RESISTANT PROSTATE CANCER

Foreign Priority and PCT Information for Patent: 10,835,515

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Finland	20150033	Jan 30, 2015

International Family Members for US Patent 10,835,515

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Denmark	3250554
European Patent Office	3250554
Spain	2917549
Croatia	P20220998
Hungary	E058986