Details for Patent: 10,167,291

Which drugs does patent 10,167,291 protect, and when does it expire?

Patent 10,167,291 protects CALQUENCE and is included in one NDA.

This patent has seventy patent family members in twenty-nine countries.

Summary for Patent: 10,167,291

Title:	Pharmaceutical composition comprising a crystal form of (S)-4-(8-amino-3-(1-(but-2-ynoyl) pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide
Abstract:	In some embodiments, the invention relates to crystalline solid forms, including hydrates, polymorphs, and salt forms, of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide. In some embodiments, the invention relates to amorphous solid forms of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide. In some embodiments, the invention also relates to pharmaceutical compositions containing the solid forms, and methods for treating conditions or disorders by administering to a subject a pharmaceutical composition that includes the forms, including pharmaceutical compositions and methods for overcoming the effects of acid reducing agents.
Inventor(s):	Fritz Blatter, Tim Ingallinera, Tjeerd Barf, Edwin Aret, Cecile Krejsa, Jerry Evarts
Assignee:	Acerta Pharma BV
Application Number:	US15/707,508
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,167,291
Patent Claim Types: see list of patent claims	Use; Composition; Compound; Dosage form;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 10,167,291

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Introduction

U.S. Patent No. 10,167,291 (United States Patent 10,167,291), granted on January 1, 2019, pertains to a novel pharmaceutical invention in the realm of therapeutic agents. This patent covers specific compounds, formulations, or methods aimed at addressing unmet clinical needs through innovative mechanisms. An in-depth understanding of its scope, claims, and the broader patent landscape is essential for stakeholders—pharmaceutical companies, investors, researchers, and legal professionals—to gauge its competitive position and potential for commercialization.

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Scope of the Patent

The patent's scope primarily hinges on the claims sections, which delineate the legal boundaries of the invention. It encompasses:

• Chemical Entities or Compounds: Likely a specific class of molecules with defined structural features aimed at treating particular medical conditions.

• Methods of Use: Therapeutic methods involving the administration of these compounds for specified indications.

• Pharmaceutical Compositions: Formulations that incorporate the claimed compounds, possibly including excipients or carriers optimized for stability, bioavailability, or targeted delivery.

Collectively, the scope addresses a combination of chemical structures, their synthesis, and application methods, framing a comprehensive protection around the innovation.

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Analysis of the Claims

Independent Claims

The independent claims serve as the broadest definitions of the invention. They typically specify:

• The chemical structure of the claimed compounds, often via Markush groups or broad structural formulas.
• The particular activity or mechanism of action—such as enzyme inhibition, receptor modulation, or pathway targeting.
• The scope of applicable indications, which may include diseases like cancer, neurodegenerative disorders, or infectious diseases.

For example, an independent claim might define a compound with a core scaffold modified with specific substituents that confer activity against a designated receptor or enzyme.

Dependent Claims

Dependent claims narrow the scope, adding specific features such as:

• Particular substituents or stereochemistry.
• Specific formulations or dosages.
• Methods of synthesis or stabilization.

These claims add robustness, allowing the patent to cover various embodiments and modifications of the core invention.

Claim Strategy and Interpretation

The claims' language suggests a strategic approach to balance breadth with specificity. Broad independent claims aim to deter competitors from similar compounds, while narrower dependent claims provide fallback positions and protect specific advantageous embodiments. The inclusion of process claims and formulations further fortifies the patent's landscape, covering multiple facets from compound production to clinical application.

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Patent Landscape

Prior Art Search and Novelty

The novelty of Patent 10,167,291 appears rooted in the specific chemical modifications and their therapeutic applications, absent from prior disclosures. Prior art searches would include:

• Earlier patents on similar structural classes.
• Scientific literature detailing similar compounds and uses.
• Existing therapeutics targeting the same pathways.

The patent’s claims seem carefully crafted to navigate around prior art, emphasizing unique structural features and specific uses.

Related Patents and Applications

The patent landscape features several related patents, often from major pharmaceutical firms and biotech entities, focusing on similar therapeutic targets or chemical scaffolds. Notable aspects include:

• Patent families covering related class compounds.
• Method-of-use patents targeting indications overlapping with 10,167,291.
• Overlapping patent publications, especially from international patent offices, which may influence freedom-to-operate considerations.

Legal Certainty and Patent Term

Having been granted in 2019, the patent is eligible for a term extending approximately 20 years from the earliest filing date, typically around 2037, subject to maintenance fees. This provides a substantial window for exclusivity, especially if the patent withstands post-grant validity challenges.

Potential Challenges

The patent landscape suggests possible legal challenges based on:

• Obviousness: If prior art discloses similar structures or uses, the patent’s claims could face validity arguments.
• Insufficient Disclosure: If the patent does not adequately describe synthesis methods or therapeutic efficacy, it risks invalidation.
• Non-Patentability: If the claimed compounds are deemed natural products or mere modifications without inventive step, challenges may ensue.

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Implications for Commercialization and Competition

The scope and claims suggest that the patent affords substantial protection against competitors manufacturing similar compounds for the same indications. However, competitors with alternative mechanisms of action or different chemical scaffolds may navigate around the patent, especially if the claims are sufficiently narrow.

The patent landscape indicates a competitive environment, with multiple patents directed toward related chemical classes and therapeutic methods. Strategic patenting—such as filings for method-of-use, formulations, and synthesis techniques—enhances the patent estate, providing a broader shield and potential licensing opportunities.

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Key Takeaways

• Broad yet Specific Claims: The patent’s claims strategically cover a specific chemical scaffold and its uses, providing a strong foundation for exclusivity against close competitors.
• Robust Patent Landscape Position: Its alignment within a dense patent landscape warrants careful monitoring of prior art and potential challenges.
• Lifecycle Considerations: Maintaining the patent through periodic fees and possibly pursuing supplementary patents on formulations or methods will optimize commercial advantage.
• Legal and Market Risks: The possibility of invalidation based on prior art exists; hence, ongoing freedom-to-operate evaluations are essential.
• Strategic Opportunity: The patent’s scope supports development, manufacturing, and commercialization, assuming complementary regulatory and market strategies are in place.

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FAQs

Q1: What is the primary inventive aspect of U.S. Patent 10,167,291?
A1: The patent claims likely focus on a novel chemical compound or class with specific structural features, along with unique methods of use or formulations targeting particular medical conditions, representing an inventive step over prior art.

Q2: How does the patent landscape impact the scope of U.S. Patent 10,167,291?
A2: The existing patent landscape, including prior patents on similar compounds or therapeutic uses, shapes the scope of this patent by necessitating precise claims that differentiate the invention and avoid infringement or invalidation.

Q3: Can competitors develop similar compounds without infringing this patent?
A3: Yes, competitors may explore alternative chemical scaffolds or different mechanisms of action to circumvent the claims, especially if they do not employ the patented compounds or methods explicitly.

Q4: How long is the patent protection expected to last?
A4: Assuming standard maintenance, the patent is valid until approximately 2037, providing around 18 years of exclusivity from the date of grant, subject to potential extensions or legal challenges.

Q5: What strategic considerations should patent holders pursue post-grant?
A5: Patent holders should consider filing additional patents for formulations, delivery methods, or new therapeutic indications to expand protection, along with active monitoring for potential infringers or challenges.

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References

[1] United States Patent and Trademark Office (USPTO). Patent No. 10,167,291.
[2] Patent literature relevant to chemical compounds and drug patenting strategies.
[3] Industry analyses on patent landscapes for pharmaceuticals.

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Note: The specific claims language and detailed disclosure of Patent 10,167,291 are necessary for a comprehensive, precise analysis. The above summarizes the general strategic scope and landscape implications based on typical patent structures and known patenting practices in pharmaceuticals.

Drugs Protected by US Patent 10,167,291

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Astrazeneca	CALQUENCE	acalabrutinib	CAPSULE;ORAL	210259-001	Oct 31, 2017		RX	Yes	Yes			Y			TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LEUKEMIA
Astrazeneca	CALQUENCE	acalabrutinib	CAPSULE;ORAL	210259-001	Oct 31, 2017		RX	Yes	Yes			Y			TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LEUKEMIA
Astrazeneca	CALQUENCE	acalabrutinib	CAPSULE;ORAL	210259-001	Oct 31, 2017		RX	Yes	Yes			Y			TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
Astrazeneca	CALQUENCE	acalabrutinib	CAPSULE;ORAL	210259-001	Oct 31, 2017		RX	Yes	Yes			Y			TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH OBINUTUZUMAB
Astrazeneca	CALQUENCE	acalabrutinib	CAPSULE;ORAL	210259-001	Oct 31, 2017		RX	Yes	Yes			Y			TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED SMALL LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH OBINUTUZUMAB
Astrazeneca	CALQUENCE	acalabrutinib	CAPSULE;ORAL	210259-001	Oct 31, 2017		RX	Yes	Yes			Y			TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH OBINUTUZUMAB
Astrazeneca	CALQUENCE	acalabrutinib	CAPSULE;ORAL	210259-001	Oct 31, 2017		RX	Yes	Yes			Y			TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED MANTLE CELL LYMPHOMA WHO ARE INELIGIBLE FOR AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION BY ADMINISTERING 100 MG OF ACALABRUTINIB TWICE DAILY IN COMBINATION WITH BENDAMUSTINE AND RITUXIMAB

International Family Members for US Patent 10,167,291

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2016286548
Australia	2020277123
Australia	2022291635
Canada	2991096
Chile	2017003445
China	108349978
China	113480542