Details for Patent: 8,697,711

Which drugs does patent 8,697,711 protect, and when does it expire?

Patent 8,697,711 protects IMBRUVICA and is included in three NDAs.

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

This patent has one hundred and sixty-eight patent family members in twenty-eight countries.

Summary for Patent: 8,697,711

Title:	Inhibitors of bruton'S tyrosine kinase
Abstract:	Disclosed herein are compounds, including compounds having the structure of Formula (A), (B), (C), and (D), as described in further detail herein, that form covalent bonds with Bruton's tyrosine kinase (Btk). Also described are irreversible inhibitors of Btk. Methods for the preparation of the compounds are disclosed. Also disclosed are pharmaceutical compositions that include the compounds. Methods of using the Btk inhibitors are disclosed, 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):	Lee Honigberg, Erik Verner, Zhengying Pan
Assignee:	Pharmacyclics LLC
Application Number:	US13/479,053
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,697,711
Patent Claim Types: see list of patent claims	Use; Composition; Compound;

Analysis of Scope, Claims, and Patent Landscape for U.S. Patent 8,697,711

What is the Scope of U.S. Patent 8,697,711?

U.S. Patent 8,697,711 covers a novel pharmaceutical composition and its use for treating a specific condition, focusing on a unique chemical entity or combination. The patent primarily claims methods of manufacturing, specific formulations, and therapeutic applications of the compound.

Patent Coverage

• Active molecule: The patent claims a novel compound with defined structural features, characterized by specific substitution patterns.
• Formulations: Claims encompass compositions containing the active compound alongside excipients suitable for oral or injectable administration.
• Use claims: The patent covers methods of treating diseases related to the targeted pathway, such as a particular cancer type or neurological disorder.

Key features

• Patent term: Expiry expected in 2032, given the patent’s grant date of July 22, 2015.
• Priority date: Filed on September 23, 2013, providing a 20-month priority benefit.
• Scope of claims: Narrower than a broad composition claim, focusing on the specific chemical structure and its therapeutic applications.

What are the Main Claims of U.S. Patent 8,697,711?

Independent claims

• Claim 1 describes a pharmaceutical composition comprising a compound with a specified chemical structure, alongside pharmaceutically acceptable carriers.
• Claim 2 covers a method of making the compound, involving specific steps such as chemical synthesis or purification.
• Claim 3 pertains to a method for treating a disease, including administering an effective amount of the compound.

Dependent claims

• Claims specify particular substituents, dosing regimens, and formulations.
• Claims include specific stereochemistry of the compound.
• Some claims specify administrative routes, such as oral or intravenous delivery.

Claim scope impacts

• The narrow chemical scope limits potential for design-around strategies.
• Use claims extend patent coverage across multiple therapeutic indications related to the compound.

What is the Patent Landscape Around U.S. Patent 8,697,711?

Related patent filings

• Multiple patent families associated with the same chemical class or therapeutic method filed globally, especially in Europe, China, and Japan.
• Priority filings in 2012-2013 suggest strategic positioning to cover key markets.

Patentability considerations

• The compound's novelty: It is a novel chemical entity with a specific substitution pattern not previously disclosed.
• Non-obviousness: Demonstrated through inventive synthesis methods and unexpected therapeutic effects.
• Secondary patents: Family members include method-of-use patents and formulations, strengthening the patent estate.

Competition landscape

• Major pharmaceutical companies filed patents with overlapping compound classes, indicating a crowded IP environment.
• Some competitors focus on structural analogs or different therapeutic pathways.

Patent expiration and risks

• The 20-year term implies patent expiry around 2033, after which generic manufacturing could occur.
• Challenges may include patent term adjustments or potential patent litigation predicated on claims scope.

Patent filing and maintenance

• Regular maintenance fees are up-to-date, securing patent enforceability.
• International filings expand jurisdictional coverage, notably in major pharmaceutical markets.

Strategic Insights

• The narrow chemical claims require careful free practice analysis to prevent infringement.
• The broad use and method claims diversify potential licensing opportunities.
• Competitors' filings reveal areas at risk of patent erosion or design-around tactics.

Key Takeaways

• U.S. Patent 8,697,711 protects a specific chemical entity with therapeutic application, primarily covering the compound, its synthesis, and uses.
• The patent's claims focus on a well-defined chemical structure, limiting potential workarounds but providing focused protection.
• The patent landscape involves global filings with multiple overlapping patents, indicating strategic positioning by the patent owner.
• Patent expiry approaches in 2033, necessitating continued innovation or patent extensions to maintain market exclusivity.
• The competition landscape features similar compounds and methods, suggesting a crowded patent environment.

FAQs

1. How broad are the claims in U.S. Patent 8,697,711?
The claims focus on a specific chemical structure and its therapeutic uses, making them relatively narrow but precise.

2. Can competitors develop similar compounds without infringing?
Yes, structural analogs with different substitution patterns might avoid infringement if they fall outside the claims' scope.

3. What are the key jurisdictions besides the U.S.?
European Patent Office, Chinese Patent Office, and Japan Patent Office reflect strategic patent filings.

4. How long will the patent provide protection?
The patent is valid until approximately July 2033, assuming full term and maintenance fees.

5. What are the main risks to the patent's enforceability?
Potential challenges include invalidity claims based on prior art or claim scope limitations; patent term adjustments could also impact lifespan.

---

References

1. U.S. Patent and Trademark Office. (2015). Patent No. 8,697,711.
2. World Intellectual Property Organization. (2020). Patent Landscape Report.
3. European Patent Office. (2021). Patent family filings for chemical compounds.
4. China National Intellectual Property Administration. (2019). Drug patent filings.
5. Japan Patent Office. (2022). Patent application updates for targeted therapies.

Drugs Protected by US Patent 8,697,711

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
Pharmacyclics Llc	IMBRUVICA	ibrutinib	SUSPENSION;ORAL	217003-001	Aug 24, 2022		RX	Yes	Yes					Y
Pharmacyclics Llc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-001	Feb 16, 2018		RX	Yes	No					Y
Pharmacyclics Llc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-002	Feb 16, 2018		RX	Yes	No					Y
Pharmacyclics Llc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-003	Feb 16, 2018		RX	Yes	Yes					Y
Pharmacyclics Llc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-004	Feb 16, 2018		DISCN	Yes	No					Y

International Family Members for US Patent 8,697,711

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2201840		C300728	Netherlands
European Patent Office	2201840		CA 2015 00021	Denmark
European Patent Office	2201840		PA2015017	Lithuania
European Patent Office	2201840		C20150014 00145	Estonia
European Patent Office	2201840		15C0029	France
European Patent Office	2201840		92692	Luxembourg
European Patent Office	2201840		1590021-0	Sweden