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 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):	Casado; Rosa Lamarca (Barcelona, ES), Serra; Gonzalo De Miquel (Barcelona, ES)
Assignee:	Almirall, S.A. (Barcelona, ES)
Application Number:	13/692,032
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Delivery; Device; Dosage form;

Understanding the Scope and Claims of United States Patent 10,085,974

Introduction

United States Patent 10,085,974, titled "Dosage and formulation," is a significant patent in the pharmaceutical industry, particularly for inhalation therapies. This patent is associated with the drug aclidinium, a muscarinic antagonist used in the treatment of chronic obstructive pulmonary disease (COPD).

Patent Overview

Publication Details

• Publication Number: US10085974B2
• Filing Date: December 21, 2012
• Grant Date: October 2, 2018
• Authority: United States Patent and Trademark Office (USPTO)[4].

Scope of the Patent

The patent focuses on pharmaceutical compositions for inhalation, specifically those containing aclidinium in the form of a dry powder.

Key Components

• Active Ingredient: Aclidinium, a muscarinic receptor antagonist.
• Formulation: Dry powder formulation designed for inhalation.
• Dosage: The patent specifies the dosage ranges and formulations of aclidinium, including the microgram doses and the delivery mechanism[4].

Claims of the Patent

The claims of the patent are crucial as they define the legal boundaries of what is protected.

Independent Claims

• The patent includes independent claims that describe the composition of the dry powder, the dosage forms, and the method of administration. For example, Claim 1 might describe a pharmaceutical composition comprising aclidinium in a specific dosage range, formulated as a dry powder for inhalation[4].

Dependent Claims

• Dependent claims further specify the details of the independent claims, such as the particle size of the powder, the excipients used, and the inhaler device characteristics.

Patent Landscape

Understanding the broader patent landscape is essential for strategizing market entry and generic launch.

Family Patents

• The patent is part of a larger family of patents that protect various aspects of the drug, including the active ingredient, dosage forms, and delivery devices. For instance, other patents in the family might cover different formulations or additional uses of aclidinium[5].

Exclusivity and Generic Launch

• The patent's exclusivity period is critical for determining when generic versions can be launched. As of the current date, the patent is still active, with an expected expiry in 2029, assuming no term extensions or amendments that could alter the expiry date[5].

Legal Activities and Status

Tracking legal activities on the patent is vital for understanding its current status and potential changes.

Recent Activities

• Activities such as maintenance fee payments, oppositions, and any amendments to the claims can affect the patent's lifespan and exclusivity. For example, recent maintenance fee payments and reminders indicate that the patent is being actively maintained[5].

Oppositions and Litigations

• The patent may be subject to oppositions or litigations, which can impact its validity and scope. Understanding these legal challenges is crucial for both the patent holder and potential generic entrants[5].

Metrics for Measuring Patent Scope

The scope of a patent can be measured using various metrics.

Claim Length and Count

• Research suggests that the length and count of independent claims can be indicative of the patent's scope. Narrower claims with fewer words and fewer claims tend to have a higher probability of grant and a shorter examination process[3].

Forward Citations and Patent Maintenance Payments

• The number of forward citations and patent maintenance payments can also reflect the patent's scope and importance. Patents with more forward citations and higher maintenance payments often indicate broader and more valuable intellectual property[3].

Impact on Innovation and Market Entry

The scope and claims of the patent can significantly impact innovation and market entry strategies.

Innovation Incentives

• Broad patents with unclear or overly broad claims can deter innovation by increasing licensing and litigation costs. In contrast, narrower, well-defined claims can encourage innovation by providing clear boundaries and reducing legal uncertainties[3].

Generic Entry Points

• Understanding the patent landscape, including the scope and claims of patents like US10085974B2, helps identify potential generic entry points. Markets with weaker patent protection or nearing patent expiry can be ideal for generic drug launches[5].

Key Takeaways

• Patent Scope: The patent covers specific formulations and dosages of aclidinium for inhalation.
• Claims: Independent and dependent claims define the protected intellectual property.
• Patent Landscape: Part of a larger family of patents protecting various aspects of the drug.
• Exclusivity: Active until 2029, subject to legal activities and potential changes.
• Metrics: Claim length, count, forward citations, and maintenance payments are important metrics.
• Impact: Affects innovation and market entry strategies, particularly for generic drugs.

FAQs

1. What is the main subject of United States Patent 10,085,974?

   • The patent is focused on pharmaceutical compositions for inhalation, specifically those containing aclidinium in the form of a dry powder.

2. When is the patent expected to expire?

   • The patent is expected to expire in March 2029, assuming no term extensions or amendments.

3. What are the key components of the patent claims?

   • The claims include descriptions of the composition, dosage forms, and method of administration of aclidinium as a dry powder.

4. How does the patent landscape impact generic drug launches?

   • Understanding the patent landscape helps identify markets with weaker patent protection or nearing patent expiry, which can be ideal for generic drug launches.

5. What metrics are used to measure the scope of a patent?

   • Metrics such as claim length, claim count, forward citations, and patent maintenance payments are used to measure the scope of a patent.

Sources

1. US Patent and Trademark Office. US10085974B2 - Dosage and formulation.
2. Pharsight. Tudorza Pressair patent expiration.
3. SSRN. Patent Claims and Patent Scope.
4. Google Patents. US10085974B2 - Dosage and formulation.
5. Pharsight. Tudorza Pressair's Family Patents.

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	10,085,974		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	10,085,974		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