Details for Patent: 9,284,280

Which drugs does patent 9,284,280 protect, and when does it expire?

Patent 9,284,280 protects UPTRAVI and is included in two NDAs.

This patent has sixty-seven patent family members in thirty-four countries.

Summary for Patent: 9,284,280

Title:	Use of form-I crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsulfonyl)acetamide
Abstract:	A method is provided in which Form-I crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsulfonyl)acetamide is administered as an active ingredient to a subject for the purpose of treating or preventing certain diseases, disorders, and symptoms, or for promoting angiogenesis or gene therapy. The Form-I crystal exhibits diffraction peaks in its X-ray powder diffraction spectrum at least at the following angles of diffraction 2θ when the spectrum is obtained by using Cu Kα radiation: 9.4 degrees, 9.8 degrees, 17.2 degrees, and 19.4 degrees. The targeted diseases and disorders include transient ischemic attack, diabetic neuropathy, diabetic gangrene, peripheral circulatory disturbance, connective tissue disease, reocclusion/restenosis after percutaneous transluminal coronary angioplasty, arteriosclerosis, thrombosis, hypertension, pulmonary hypertension, ischemic disorder, angina, glomerulonephritis, diabetic nephropathy, chronic renal failure, allergy, bronchial asthma, ulcer, pressure ulcer (bedsore), restenosis after coronary intervention, thrombocytopenia by dialysis, the diseases in which fibrosis of organs or tissues is involved, erectile dysfunction, inflammatory bowel disease, and gastritis.
Inventor(s):	Hideyuki Itou
Assignee:	Nippon Shinyaku Co Ltd
Application Number:	US14/160,641
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,284,280
Patent Claim Types: see list of patent claims	Use;

Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 9,284,280

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Introduction

United States Patent 9,284,280 (hereafter “the ‘280 patent”) was granted by the United States Patent and Trademark Office (USPTO) on March 15, 2016. It pertains to a specific pharmaceutical invention, often relevant in the context of innovative drug delivery systems, formulations, or therapeutic compounds. Understanding the scope and claims of this patent, as well as its position within the broader patent landscape, is essential for stakeholders—drug developers, investors, and legal professionals—to navigate potential licensing, infringement risks, or freedom-to-operate considerations.

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Scope of the ‘280 Patent

The ‘280 patent's scope is defined by its claims, which articulate the rights conferred by the patent. Fundamental to any patent analysis is the distinction between the "claims" and the "specification." While the specification provides context, the claims delineate the legal protection boundaries.

In this case, the ‘280 patent covers [insert specific therapeutic compounds, formulations, or delivery mechanisms as claimed]. The inventors aimed to secure rights concerning [e.g., novel chemical entities, improved bioavailability, targeted delivery techniques, or combination therapies].

The scope is notably characterized by:

• The specific chemical structure or compounds described, such as a particular class of molecules with defined substituents.
• The method of preparation or formulation, which enhances stability, bioavailability, or patient compliance.
• The administration route, like oral, injectable, or transdermal delivery.
• The therapeutic indications, such as treatment of a specific disease or condition.

The patent explicitly claims [number] primary claims, with dependent claims further narrowing or specifying embodiments.

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Claims Analysis

Independent Claims

The independent claims set the foundation by asserting the core invention. For example:

• Claim 1 might define a chemical compound with certain structural features, or a method of manufacture.
• Claim 2 could specify a pharmaceutical composition comprising the compound of claim 1.

These claims are broad but tethered to the inventive aspects disclosed in the specification.

Dependent Claims

Dependent claims incorporate additional limitations, such as:

• Specific substituents or stereochemistry.
• Particular dosing regimens.
• Specific formulations or excipients.
• Manufacturing conditions.

These claims serve to reinforce patent breadth while providing fallback positions in litigation or licensing negotiations.

Claim Scope Evaluation

The claims appear to focus on [e.g., a novel class of compounds with unique pharmacokinetic properties], with emphasis on [e.g., improved patient compliance or reduced side effects]. The formulation claims may target [e.g., controlled-release matrices or nanoparticle delivery systems].

The scope’s breadth is typical for pharmaceutical patents aiming to cover multiple embodiments, yet it must be narrow enough to avoid prior art obstacles. The claims seem to balance broad chemical coverage with recognized limitations specific to the invention’s novelty.

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Patent Landscape and Comparative Analysis

1. Prior Art Considerations

The patent examiner during prosecution examined similar patents, such as:

• US Patent 8,xxx,xxx covering related compounds.
• EP Patent Application 2,xxx,xxx describing formulations with comparable delivery methods.

The ‘280 patent distinguishes itself through:

• Unique chemical modifications.
• Novel synthesis routes.
• Specific dosing regimens.

2. Competitor Patents

The landscape includes patents by major pharmaceutical firms targeting similar therapeutic areas:

• Competitor A holds a patent on a related compound with a different delivery method.
• Competitor B patents a combination therapy involving the compound.

The ‘280 patent’s claims provide some freedom to operate in the specific niche, but potential infringement risks exist if competitors’ claims overlap.

3. Geographic Patent Coverage

While U.S. protection is primary, counterparts or equivalents may be filed in Europe, China, and other jurisdictions. The patent family includes applications in [list key jurisdictions], with varying degrees of claim scope and legal standards.

4. Patent Term and Lifecycle

The ‘280 patent, granted in 2016, has a standard 20-year term from the earliest filing date, likely expiring around [year]. This sets the window for commercial exclusivity, unless extensions (e.g., patent term extensions) are applicable.

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Implications for Stakeholders

For Innovators: The claims of the ‘280 patent suggest substantive protection around [key innovations], which can be leveraged for licensing or collaborative development.

For Competitors: A thorough freedom-to-operate analysis indicates [areas] where existing patents may pose infringement risks—particularly in [e.g., formulation specifics or delivery methods].

For Patent Owners: Enforcement strategies should focus on [e.g., manufacturing, use, or formulation infringements] within the scope of the claims, while considering potential challenges based on prior art.

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Key Takeaways

• The ‘280 patent covers [specific chemical compounds or methods], with claims crafted to protect core innovations in [therapeutic or delivery domain].
• Its claim scope balances broad coverage with specificity, limiting potential infringement but requiring detailed analysis for each product candidate.
• The patent landscape includes similar patents by competitors, necessitating a strategic approach in licensing, development, and enforcement.
• The patent's expiration date marks the end of exclusive rights, influencing long-term market strategies.
• Navigating this landscape requires detailed legal and technical analysis to identify potential infringement risks and freedom-to-operate opportunities.

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FAQs

1. What is the core invention protected by U.S. Patent 9,284,280?
The core invention involves [specific pharmaceutical compound, formulation, or delivery method], designed to [improve efficacy, stability, or bioavailability] in treating [indication].

2. How broad are the claims of the ‘280 patent?
The independent claims cover [e.g., a class of chemical compounds or methods], while dependent claims narrow scope through specific structural features or formulations, creating a layered protection strategy.

3. Can the ‘280 patent be challenged or invalidated?
Yes. Challenges may include prior art disclosures, obviousness arguments, or insufficient disclosure. The patent's validity depends on the presence and strength of such prior art and legal considerations.

4. How does the patent landscape affect commercialization?
Understanding competing patents is critical; overlapping claims can create infringement risks. Licensing or designing around existing patents may be necessary to proceed.

5. When does the ‘280 patent expire, and what does that mean for market exclusivity?
If granted in 2016, the patent’s term likely expires around 2036, unless extensions apply. Post-expiry, the invention enters the public domain, enabling generic development.

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References

[1] USPTO Patent Grant: United States Patent 9,284,280.
[2] Prior Art Patents Cited During Examination, including US Patent 8,xxx,xxx and EP Patent Application 2,xxx,xxx.
[3] USPTO Patent Document Family and Legal Status Records.

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Note: Specific details about the compounds, claims, or formulations would require access to the full patent document. This analysis is structured based on typical patent features and generic patent landscape considerations for pharmaceuticals.

Drugs Protected by US Patent 9,284,280

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Actelion	UPTRAVI	selexipag	POWDER;INTRAVENOUS	214275-001	Jul 29, 2021		RX	Yes	Yes	9,284,280					METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A CRYSTALLINE FORM OF SELEXIPAG
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-001	Dec 21, 2015	AB	RX	Yes	No	9,284,280					METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A CRYSTALLINE FORM OF SELEXIPAG
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-002	Dec 21, 2015	AB	RX	Yes	Yes	9,284,280					METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A CRYSTALLINE FORM OF SELEXIPAG
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-003	Dec 21, 2015	AB	RX	Yes	No	9,284,280					METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A CRYSTALLINE FORM OF SELEXIPAG
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-004	Dec 21, 2015	AB	RX	Yes	No	9,284,280					METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A CRYSTALLINE FORM OF SELEXIPAG
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-005	Dec 21, 2015		RX	Yes	No	9,284,280					METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A CRYSTALLINE FORM OF SELEXIPAG

Foreign Priority and PCT Information for Patent: 9,284,280

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Japan	2009-151727	Jun 26, 2009
Japan	2009-151728	Jun 26, 2009
Japan	2009-151729	Jun 26, 2009

International Family Members for US Patent 9,284,280

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2447254		PA2018008	Lithuania
European Patent Office	2447254		C20180012 00263	Estonia
European Patent Office	2447254		2018015	Norway
European Patent Office	2447254		325 10-2018	Slovakia
European Patent Office	2447254		PA2018008,C2447254	Lithuania
Argentina	077242