Details for Patent: 10,662,188

Which drugs does patent 10,662,188 protect, and when does it expire?

Patent 10,662,188 protects ADEMPAS and is included in one NDA.

This patent has twenty-four patent family members in twenty-one countries.

Summary for Patent: 10,662,188

Title:	Forms of methyl {4,6-diamino-2-[1 (2-fluorobenzyl)-1H-pyrazolo[3-4-b]pyridino-3-yl]pyrimidino-5-yl} methyl carbamate
Abstract:	This present invention relates to forms of methyl {4.6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo[3.4-b]pyridino-3-yl]pyrimi- dino-5-yl}methylcarbamate comprising its Modification I. Modification II. mono-DMSO solvate. sesqui-DMSO solvate and 1/4-ethyl acetate solvate.
Inventor(s):	Keil; Birgit (Duesseldorf, DE), Mais; Franz-Josef (Duesseldorf, DE), Joentgen; Winfried (Cologne, DE), Grunenberg; Alfons (Wuppertal, DE)
Assignee:	ADVERIO PHARMA GmbH (Schoenefeld, DE)
Application Number:	16/119,671
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Compound; Dosage form;

United States Patent 10,662,188: A Detailed Analysis

Introduction

The United States Patent 10,662,188, titled "Forms of methyl {4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridino-3-yl]pyrimidino-5-yl}methylcarbamate," is a patent that covers specific forms of a pharmaceutical compound. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Scope of the Patent

The patent US10662188B2 pertains to various forms of a complex organic compound, specifically methyl {4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridino-3-yl]pyrimidino-5-yl}methylcarbamate. This compound is likely intended for pharmaceutical use, given the detailed descriptions of its chemical structure, synthesis methods, and potential applications.

Chemical Structure and Synthesis

The patent describes the chemical structure and various methods for synthesizing the compound. It includes detailed formulas, reaction schemes, and conditions necessary for producing the desired forms of the compound. This level of detail is crucial for ensuring the reproducibility and consistency of the compound, which is essential in pharmaceutical development[1].

Claims of the Patent

The claims section of the patent outlines the specific aspects of the invention that are protected by law. Here are some key points:

Compound Forms

The patent claims various forms of the compound, including crystalline forms, solvates, and pharmaceutical compositions. These forms are critical because they can affect the compound's stability, solubility, and bioavailability[1].

Pharmaceutical Compositions

The patent includes claims related to pharmaceutical compositions that contain the compound. These compositions can be in various forms such as tablets, capsules, solutions, and suspensions. The claims also cover the use of pharmaceutical excipients and the methods for preparing these compositions[1].

Therapeutic Uses

While the patent does not explicitly state the therapeutic uses, it implies potential applications in treating diseases or conditions by mentioning "diseases, disorders, signs and symptoms" and "prophylaxis" methods. The specific therapeutic areas would typically be determined through clinical trials and further research[1].

Patent Landscape

Related Patents and Litigation

In the broader patent landscape, pharmaceutical patents often face complex litigation and settlement scenarios. For example, patents related to pharmaceutical compositions and methods of treatment are frequently involved in ANDA (Abbreviated New Drug Application) litigation, as seen in cases like those involving Ozempic® (semaglutide injection) and Ocaliva® (obeticholic acid tablets)[2].

Patent Assertion Entities (PAEs)

The patent landscape is also influenced by Patent Assertion Entities (PAEs), which often target pharmaceutical companies with patent infringement suits. PAEs can significantly impact the development and commercialization of pharmaceuticals by asserting broad and sometimes ambiguous patent claims[3].

Valuation and Economic Impact

The value of a patent like US10662188B2 can be substantial, given the potential market size and the exclusive rights it grants. The valuation of pharmaceutical patents typically involves the income approach, considering the future benefits such as revenue from sales and cost savings. The market value can range widely, from hundreds of thousands to millions of dollars, depending on the compound's therapeutic potential and market demand[4].

Regulatory Environment

The Leahy-Smith America Invents Act (AIA) has introduced several provisions that affect the patent landscape, including faster patent processing, post-grant review of issued patents, and increased patent quality standards. These changes aim to reduce the backlog and improve the efficiency of the patent system, which can impact the enforcement and validity of patents like US10662188B2[3].

Challenges and Opportunities

Patent Litigation and Settlements

Pharmaceutical companies often face challenges related to patent litigation and settlements. The terms of these settlements can significantly impact the market entry of generic drugs and the exclusivity period of the patented compound[2].

Innovation and Competition

The patent protects the innovation and investment made in developing the compound, allowing the patent holder to recoup their investment and incentivizing further research and development. However, it also creates a barrier to entry for competitors, which can affect market competition and drug prices[3].

Key Takeaways

• Specific Forms Protected: The patent protects various forms of the compound, including crystalline forms and pharmaceutical compositions.
• Therapeutic Potential: The compound has potential therapeutic uses, although specific indications are not detailed in the patent.
• Regulatory and Litigation Landscape: The patent operates within a complex regulatory and litigation environment, influenced by PAEs and ANDA litigation.
• Economic Value: The patent's value is significant, reflecting the potential market and therapeutic benefits.
• Innovation and Competition: The patent balances innovation incentives with market competition, affecting the availability and pricing of pharmaceuticals.

FAQs

What is the main subject of United States Patent 10,662,188?

The main subject is various forms of the compound methyl {4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridino-3-yl]pyrimidino-5-yl}methylcarbamate.

What types of pharmaceutical compositions are covered by the patent?

The patent covers various pharmaceutical compositions, including tablets, capsules, solutions, and suspensions.

How does the patent impact the therapeutic use of the compound?

The patent protects the compound's forms and compositions, ensuring the patent holder's exclusivity in its therapeutic use until the patent expires.

What is the role of PAEs in the patent landscape?

PAEs assert patent claims to enforce rights and often target companies with infringement suits, which can impact the development and commercialization of pharmaceuticals.

How is the value of a pharmaceutical patent typically determined?

The value is typically determined using the income approach, considering future benefits such as revenue from sales and cost savings, as well as market and cost valuation methods.

Cited Sources

1. US10662188B2 - Forms of methyl {4,6-diamino-2-[1 (2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridino-3-yl]pyrimidino-5-yl}methylcarbamate.
2. ANDA Litigation Settlements | Hatch-Waxman - Robins Kaplan.
3. PATENT ASSERTION AND U.S. INNOVATION - Obama White House.
4. The value of a patent - Perpetual Motion Patents.

Drugs Protected by US Patent 10,662,188

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 Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-001	Oct 8, 2013	AB	RX	Yes	No			Y	Y		TREATMENT OF ADULTS WITH PERSISTENT/RECURRENT CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION (CTEPH), (WHO GROUP 4) AFTER SURGICAL TREATMENT, OR INOPERABLE CTEPH, TO IMPROVE EXERCISE CAPACITY AND WHO FUNCTIONAL CLASS
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-001	Oct 8, 2013	AB	RX	Yes	No			Y	Y		TREATMENT OF ADULTS WITH PULMONARY HYPERTENSION (PAH), (WHO GROUP 1), TO IMPROVE EXERCISE CAPACITY, WHO FUNCTIONAL CLASS AND TO DELAY CLINICAL WORSENING
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-002	Oct 8, 2013	AB	RX	Yes	No			Y	Y		TREATMENT OF ADULTS WITH PERSISTENT/RECURRENT CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION (CTEPH), (WHO GROUP 4) AFTER SURGICAL TREATMENT, OR INOPERABLE CTEPH, TO IMPROVE EXERCISE CAPACITY AND WHO FUNCTIONAL CLASS
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-002	Oct 8, 2013	AB	RX	Yes	No			Y	Y		TREATMENT OF ADULTS WITH PULMONARY HYPERTENSION (PAH), (WHO GROUP 1), TO IMPROVE EXERCISE CAPACITY, WHO FUNCTIONAL CLASS AND TO DELAY CLINICAL WORSENING

Foreign Priority and PCT Information for Patent: 10,662,188

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Canada	2806895	Feb 21, 2013
Canada	2807859	Feb 21, 2013

International Family Members for US Patent 10,662,188

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2014220801
Brazil	112015019571
Canada	2807859
Canada	2901636