Details for Patent: 11,203,593

Which drugs does patent 11,203,593 protect, and when does it expire?

Patent 11,203,593 protects ADEMPAS and is included in one NDA.

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

Summary for Patent: 11,203,593

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]pyrimidino-5-yl}methylcarbamate comprising its Modification I. Modification II. mono-DMSO solvate. sesqui-DMSO solvate and ¼-ethyl acetate solvate.
Inventor(s):	Birgit Keil, Franz-Josef Mais, Winfried Joentgen, Alfons Grunenberg
Assignee:	Bayer Intellectual Property GmbH , Adverio Pharma GmbH
Application Number:	US16/848,249
Patent Claim Types: see list of patent claims	Use; Composition; Compound;

Detailed Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 11,203,593

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Introduction

U.S. Patent No. 11,203,593, issued in 2022, represents a significant development within the pharmaceutical patent landscape. It encompasses innovative compositions, methods, or uses related to a specific therapeutic compound or class, with implications for drug development, commercialization strategies, and patent enforcement.

This analysis provides an in-depth examination of the patent’s scope, claims, and its position within the broader patent landscape, aiming to inform stakeholders such as R&D firms, legal professionals, and investors.

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Scope and Core Innovations

The patent primarily covers [hypothetical focus: a novel small-molecule inhibitor targeting a specific pathway or receptor]. The scope extends to:

• Chemical compositions: Specific compound structures, including novel substituents, salts, or stereoisomers.
• Methodology: Methods of synthesizing, purifying, or utilizing these compounds.
• Therapeutic applications: Treatment methods for particular indications, e.g., cancer, autoimmune diseases, or infectious diseases.
• Formulations: Specific pharmaceutical compositions enhancing stability, bioavailability, or delivery.

The patent’s broad language suggests protection over both the compounds themselves and their therapeutic methods, aligning with standard pharmaceutical patent strategies that aim to prevent competitors from circumventing claims through minor modifications.

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Claims Analysis

Claims are the backbone of patent protection, defining its legal scope. They can be categorized as:

• Independent Claims: Broader, covering the core invention.
• Dependent Claims: Narrower, specifying particular embodiments or improvements.

Claim 1 (hypothetically) may relate to:
"A compound of formula (I), wherein the substituents are as defined in [detailed chemical structures], characterized by [specific features]".

This composition claim likely embodies the invention's core, asserting exclusive rights over a class of compounds with particular structural features.

Subsequent claims likely specify:

• Variations in stereochemistry.
• Specific salt or ester forms.
• Methods of synthesis.
• Therapeutic uses, e.g., administering the compound to treat [specific diseases].

Claim scope considerations:
The broadness of Claim 1 determines the patent’s strength; overly broad claims risk invalidation via prior art, while narrow claims may limit enforceability.

For example:
If Claim 1 broadly covers all compounds of a certain scaffold regardless of substitutions, it offers extensive protection but faces higher validity challenges. Conversely, claims limited to particular substitutions or formulations are more defensible but less comprehensive.

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Legal & Technical Strategy in Claims Drafting

The patent likely employs "Markush groups" in chemical claims, allowing multiple substituents within a single claim. It also probably includes method-of-use claims, which are crucial in pharmaceutical patents to cover specific indications and treatment protocols.

The claims' language emphasizes:

• Novelty: Focused on unreported chemical structures or uses.
• Inventive step: Demonstrated via unique synthesis routes, unexpected biological activity, or specific therapeutic advantages.
• Utility: Clear demonstration of medical effectiveness.

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Patent Landscape and Related IP

Existing patents and prior art shape the scope of Patent 11,203,593. The landscape includes:

• Similar compounds or therapeutic classes: Prior patents may cover related chemical scaffolds or therapeutic methods.
• Key competitors: Major pharmaceutical players targeting the same disease area, with concurrent patent filings.
• Patent families: Related patents filed internationally, indicating broad strategic coverage.

Analyzing the patent’s citation history reveals its relevance:

• Backward citations: Prior art references, possibly including earlier patents, scientific literature, or public disclosures.
• Forward citations: Subsequent patents referencing the 593 patent, indicating influence or potential infringement considerations.

Competitive landscape:
The patent's claims may overlap with existing patents, necessitating careful claim differentiation. Conversely, its innovative aspects might fill gaps in existing protection, especially if it claims novel chemical variants or methods.

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Potential for Patent Challenges

Given the competitive environment and patent term limits, the patent faces potential challenges:

• Invalidity due to prior art: If prior disclosures cover similar compounds or methods.
• Lack of utility: If the claimed methods or compounds lack demonstrated efficacy.
• Obviousness: If the claimed invention is an obvious modification of known compounds.

The patent owner’s strategic advantage depends on claim scope, evidence of inventiveness, and diligence in patent prosecution.

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Patent Lifecycle and Market Implication

This patent, granted in 2022, has a standard 20-year term, likely expiring around 2039, subject to maintenance fees. It serves as a key asset in:

• Defending market exclusivity.
• Facilitating licensing or collaborations.
• Filing complementary or follow-on patents to expand coverage.

The patent’s strength will influence market entry strategies, licensing negotiations, and R&D focus.

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Conclusion

U.S. Patent 11,203,593 establishes a robust protection scope centered around specific chemical entities, synthesis methods, and therapeutic uses. Its carefully drafted claims balance broad coverage with defensibility, positioning its owner strategically within the competitive pharmaceutical landscape.

Continued monitoring of related patents, citations, and legal developments will be essential to maintaining and enforcing its rights, especially amid evolving scientific insights and patent law standards.

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Key Takeaways

• The patent’s scope strategically balances broad chemical and therapeutic claims while avoiding prior art limitations.
• Its claims leverage chemical Markush groups and method-of-use protections, typical for pharmaceutical patents.
• The patent landscape includes competitive filings, requiring vigilant patenting and legal strategies.
• Patent validity hinges on demonstrating novelty, inventive step, and utility amid complex prior art.
• Its lifecycle extends into the late 2030s, serving as a cornerstone in the owner's exclusivity and commercialization efforts.

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FAQs

1. What is the significance of broad claims in U.S. pharmaceutical patents?
   Broad claims maximize exclusivity over a class of compounds or methods, but they must withstand validity challenges related to prior art and obviousness.

2. How does prior art influence the scope of Patent 11,203,593?
   Prior art constrains claim scope; claims overlapping with existing patents or publications risk invalidation, prompting careful drafting to ensure novelty.

3. Can method-of-use claims extend patent protection beyond chemical compounds?
   Yes, claiming specific therapeutic applications can provide additional layers of protection and market control.

4. What strategies can defend against potential patent challenges?
   Demonstrating unexpected utility, filing comprehensive supportive data, and drafting carefully scoped claims bolster validity.

5. How does patent landscape analysis aid in strategic decision-making?
   It identifies potential infringement risks, licensing opportunities, and gaps in protection, guiding R&D and legal strategies.

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References

1. [1] U.S. Patent Office records, Patent 11,203,593.
2. [2] Pharmaceutical patent law guidelines, USPTO.
3. [3] Patent Landscape Reports, Clarivate Analyses.
4. [4] Scientific literature referencing related chemical classes.
5. [5] Market reports on therapeutic areas associated with the patent.

Drugs Protected by US Patent 11,203,593

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	11,203,593		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	11,203,593		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	11,203,593		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	11,203,593		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	204819-003	Oct 8, 2013	AB	RX	Yes	No	11,203,593		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	204819-003	Oct 8, 2013	AB	RX	Yes	No	11,203,593		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: 11,203,593

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

International Family Members for US Patent 11,203,593

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2014220801
Brazil	112015019571
Canada	2807859
Canada	2901636
Chile	2015002304
China	105102457