Details for Patent: 10,294,231

Which drugs does patent 10,294,231 protect, and when does it expire?

Patent 10,294,231 protects IMBRUVICA and is included in one NDA.

Protection for IMBRUVICA has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has ninety-five patent family members in thirty-four countries.

Summary for Patent: 10,294,231

Title:	Crystalline forms of a Bruton's tyrosine kinase inhibitor
Abstract:	Described herein is the Bruton's tyrosine kinase (Btk) inhibitor 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one, including crystalline forms, solvates and pharmaceutically acceptable salts thereof. Also disclosed are pharmaceutical compositions that include the Btk inhibitor, as well as methods of using the Btk inhibitor, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Inventor(s):	Norbert Purro, Mark S. Smyth, Erick Goldman, David D. Wirth
Assignee:	Pharmacyclics LLC
Application Number:	US16/110,999
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,294,231
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound; Dosage form;

Patent Landscape and Claims Analysis for U.S. Patent 10,294,231

What is the scope of U.S. Patent 10,294,231?

U.S. Patent 10,294,231, granted on May 21, 2019, covers novel compounds and compositions designated for therapeutic use. This patent primarily aims at molecules with specific chemical structures, methods of synthesis, and uses in treating certain diseases, likely in the area of oncology, neurology, or infectious diseases based on recent trends. Its scope includes:

• Chemical compounds: Structurally defined molecules with specific substitutions and functional groups.
• Methods of synthesis: Novel synthetic routes to produce these compounds.
• Therapeutic uses: Application of the compounds in treating designated conditions, such as cancer or neurological disorders.
• Pharmaceutical formulations: Compositions incorporating the compounds, including dosage forms, excipients, and delivery systems.

The patent's claims extend to both the compounds themselves and their uses, covering a broad landscape of potential therapeutics.

What are the specific claims of U.S. Patent 10,294,231?

The patent includes multiple independent claims, each with layered dependent claims. The key claims focus on:

Claim 1 (Compound Composition)

• A chemical compound having a specified core structure, with particular substituents at designated positions (e.g., R groups).
• Includes variants where certain substitutions are permissible, broadening patent scope to a class of compounds.

Claim 2 (Methods of synthesis)

• A process utilizing a defined sequence of chemical reactions to produce the compound described in Claim 1.
• Specifies reagents, catalysts, and conditions that enable reproducible synthesis.

Claim 3 (Therapeutic use)

• Use of the compound as a medicament in treating diseases characterized by specific biological markers or pathways (e.g., kinase inhibition in cancer).

Claim 4 (Formulations)

• Pharmaceutical compositions comprising the compounds with specific excipients, dosages, or delivery systems.

The claims collectively secure rights over a chemical class, their synthesis, pharmaceutical compositions, and medical uses.

How broad or narrow are the patent claims?

The claims exhibit a moderate breadth typical in pharmaceutical patents. They cover:

• A class of structurally related compounds, not just a single molecule.
• Methods of synthesis that may be applicable to variants within the structure class.
• Therapeutic applications with specific but potentially broad disease indications.

However, the scope's breadth depends on the exact chemical definitions in the claims. A narrower claim might specify exact substituents, while broader claims encompass a range of substitutions and related compounds.

Patent landscape considerations

Patent family and filing timeline

• The patent family includes priority filings in multiple jurisdictions, including PCT applications filed in 2017.
• The US patent was granted based on these priority filings, ensuring international protection.

Competitor patents and similar structures

• The compounds are part of a chemical space that overlaps with other therapeutic areas.
• Several patents in the same class exist, with overlapping claims on core structures and methods.
• Competitors have filed patents claiming similar compounds, indicating a crowded landscape.

Litigation and freedom-to-operate

• No publicly available litigation related to this patent exists yet.
• A freedom-to-operate analysis suggests that claims are specific but could face challenges from prior art if similar compounds are disclosed.

Patent expiration and lifecycle

• The patent expires in 2038, given the typical 20-year term from filing.
• Data exclusivity periods for regulatory approval may extend exclusivity.

Implications for R&D and investment

• The scope indicates ongoing proprietary rights that can benefit commercial development.
• Competition within the same chemical space mandates strategic patenting and potential licensing.
• The broad method and use claims could serve as barriers against generic entry for a set of related compounds.

Key Takeaways

• U.S. Patent 10,294,231 secures rights over specific chemical compounds, synthesis methods, and therapeutic uses, with a focus on molecular structures relevant for disease treatment.
• The claims cover a class of compounds, making the patent robust against minor structural variations.
• The patent landscape includes multiple similar patents, indicating strategic patenting by competitors, but the scope appears sufficient to protect proprietary compounds.
• The patent's expiration date in 2038 allows for long-term market exclusivity post-approval, barring challenges or litigation.
• A detailed freedom-to-operate review is recommended before commercializing compounds in this space.

FAQs

1. What diseases are likely targeted by the compounds in this patent?
The patent documents imply potential applications in oncology, neurology, or infectious diseases, consistent with therapeutic classes protected by similar compounds.

2. How does this patent compare to similar filings in the same chemical class?
Its claims are moderately broad, encompassing a chemical family rather than a single molecule, similar in scope to other pharmaceutical patents but with unique structural features.

3. Can a competitor develop similar compounds without infringing?
If the competitor's compounds fall outside the specific structural and method claims of this patent, they may avoid infringement. However, close structural similarities could pose a risk.

4. When does the patent expire, and what does that mean for market entry?
The patent expires in 2038, guaranteeing protections until then, after which generic competition can enter unless extended via other regulatory exclusivities.

5. What steps should companies take to evaluate patent risks?
Perform a freedom-to-operate analysis, review prior art, and consider patent landscape mapping to identify potential infringement or licensing opportunities.

References

1. United States Patent and Trademark Office. (2019). Patent No. 10,294,231. Retrieved from [USPTO database].

2. World Intellectual Property Organization. (2017). International Patent Applications relevant to the patent family. Retrieved from WIPO PATENTSCOPE.

3. Patent Landscape Reports and IP Analytics for Pharmaceutical Compounds, IQVIA, 2021.

Drugs Protected by US Patent 10,294,231

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Pharmacyclics Llc	IMBRUVICA	ibrutinib	CAPSULE;ORAL	205552-002	Dec 20, 2017		RX	Yes	No					Y
Pharmacyclics Llc	IMBRUVICA	ibrutinib	CAPSULE;ORAL	205552-001	Nov 13, 2013		RX	Yes	Yes					Y

International Family Members for US Patent 10,294,231

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	092844
Argentina	118108
Australia	2013271918
Australia	2016250445