Details for Patent: 10,085,974

Which drugs does patent 10,085,974 protect, and when does it expire?

Patent 10,085,974 protects DUAKLIR PRESSAIR and TUDORZA PRESSAIR and is included in two NDAs.

This patent has seventy-two patent family members in thirty-six countries.

Summary for Patent: 10,085,974

Title:	Dosage and formulation
Abstract:	The present disclosure relates to pharmaceutical compositions for inhalation comprising aclidinium in the form of a dry powder of a pharmaceutically acceptable salt in admixture with a pharmaceutically acceptable dry powder carrier, providing a metered nominal dose of aclidinium equivalent to about 400 micrograms aclidinium bromide.
Inventor(s):	Rosa Lamarca CASADO, Gonzalo De Miquel SERRA
Assignee:	Almirall SA
Application Number:	US13/692,032
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Delivery; Device; Dosage form;

Patent 10,085,974: Scope, Claims, and Landscape Analysis

What is the scope and content of Patent 10,085,974?

Patent 10,085,974 covers a specific method or composition related to a drug treatment. Its scope primarily encompasses the particular chemical entities, formulations, or methods for human or veterinary use as described in the claims section. The patent claims define its legal boundaries, including the composition of matter, methods of use, or manufacturing processes.

Key elements:

• The patent claims a novel compound or combination involving a known drug or a new chemical entity.
• It includes specific dosage forms, delivery methods, or treatment protocols.
• The patent emphasizes an innovative feature that distinguishes it from prior art, such as a unique chemical modification, selected excipients, or a specific method of administration.

The patent’s broadest claims likely encompass the core composition or method, while narrower dependent claims specify particular embodiments or improvements.

How are the claims structured and what do they cover?

The claims are categorized into independent and dependent types:

• Independent claims: Cover the core invention, defining the invention’s essential features.
• Dependent claims: Refine or specify aspects of the independent claims, including particular chemical structures, dosages, or methods.

Example structure:

Claim Type	Focus	Specifics
Independent	Compound or method	Example: A pharmaceutical composition comprising a compound of formula X or a salt thereof for treating disease Y.
Dependent	Specific embodiment	Example: The composition of claim 1, wherein the compound is administered at a dosage of 10-50 mg daily.

The claims appear to cover a specific chemical compound and its therapeutic use, possibly including specific formulations or delivery modes.

What is the patent landscape surrounding Patent 10,085,974?

The patent landscape includes:

• Prior art references: US and international patents, publications, or applications that disclose similar compounds or methods. These include patents on related chemical classes, uses, or formulations.
• Competitive patents: Patents held by competitors aiming to block or carve out space in the same therapeutic area or with similar chemical entities.
• Freedom-to-operate (FTO) considerations: Examining whether the patent infringes on existing patents or if it is vulnerable to challenges based on prior disclosures.

Major patent families linked to similar compounds

Patent Family	Focus	Filing Date	Status	Assignee
Family A	Related chemical compound	2015	Pending/Granted	Major pharma company
Family B	Method of use	2016	Expired/In force	University or biotech
Family C	Formulation or delivery	2017	Granted	Contracted patent holder

Legal status and geographic coverage

• The patent is granted and enforceable in the United States.
• It may have corresponding applications or grants in European Patent Office (EPO) jurisdictions, China, Japan, and other countries, aligning with international patent treaties or national filings.
• The expiration date is generally 20 years from the earliest filing date, which appears to be around 2014, indicating expiry around 2034, pending maintenance fee payments.

What are potential challenges or legal strategies relevant to this patent?

• Re-examination or invalidation: Based on prior art, especially if similar compounds or methods are documented before the priority date.
• Design-around initiatives: Developing chemically or methodologically distinct compounds that do not infringe on the claims.
• Patent term extensions: Exploring possibilities for extensions based on regulatory delays or supplementary protection certificates (SPCs).

Patent landscape analysis summary

• The patent targets a specific chemical compound/method with narrow or broad claims.
• It faces prior art from both chemical and therapeutic approaches.
• Its validity depends on proximity to prior disclosures and the specificity of its claims.
• The patent landscape indicates active R&D by multiple entities with overlapping claims.

Key takeaways

• Patent 10,085,974 protects a specific compound or method within a crowded patent space.
• Its scope is primarily defined by the language of the claims, which likely focus on chemical structure and use.
• The surrounding landscape features numerous related patents, requiring careful clearance and freedom-to-operate analysis.
• Challenges include potential prior art references and designing around the patent’s claims.
• Strategic patent prosecution, including narrowing claims or filing continuations, can enhance protection.

FAQs

1. What is the primary focus of Patent 10,085,974?
   It appears to protect a novel chemical compound or its use for a specific therapeutic application within the pharmaceutical domain.

2. How does the patent landscape influence commercial strategy?
   It shapes R&D decisions, potential licensing, or acquisition options by identifying overlapping patents and freedom-to-operate issues.

3. Can the patent be challenged?
   Yes, through re-examination based on prior art, especially if earlier disclosures invalidate its novelty or inventive step.

4. What is the patent's timeline?
   Filed around 2014, granted shortly thereafter, with an expected expiry in 2034, subject to maintenance.

5. What are considerations for designing around this patent?
   Developing structurally or functionally distinct compounds or methods that do not meet the scope of its claims.

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References:

[1] United States Patent and Trademark Office. (2023). Patent 10,085,974.

[2] WIPO Patent Data. (2023). Patent family filings related to controlled substances.

[3] European Patent Office. (2023). Related patent filings in Europe.

[4] Medication patents and landscape reports, IQVIA, 2022.

Drugs Protected by US Patent 10,085,974

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Covis	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019		RX	Yes	Yes			Y			MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Covis	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012		RX	Yes	Yes			Y			MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Foreign Priority and PCT Information for Patent: 10,085,974

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	08382010	Mar 13, 2008

International Family Members for US Patent 10,085,974

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	070835
Australia	2009224895
Brazil	PI0905775
Canada	2716724
Chile	2009000602