Details for Patent: 8,999,999

Which drugs does patent 8,999,999 protect, and when does it expire?

Patent 8,999,999 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 sixty-seven patent family members in eighteen countries.

Summary for Patent: 8,999,999

Title:	Use of inhibitors of Bruton's tyrosine kinase (Btk)
Abstract:	Disclosed herein are methods for treating a cancer comprising: a. administering a Btk inhibitor to a subject sufficient to result in an increase or appearance in the blood of a subpopulation of lymphocytes defined by immunophenotyping; b. determining the expression profile of one or more biomarkers from one or more subpopulation of lymphocytes; and c. administering a second agent based on the determined expression profile.
Inventor(s):	Joseph J. Buggy, Laurence Elias, Gwen Fyfe, Eric Hedrick, David J. Loury, Tarak D. Mody
Assignee:	Pharmacyclics LLC
Application Number:	US13/747,322
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,999,999
Patent Claim Types: see list of patent claims	Use; Delivery; Dosage form;

Patent 8,999,999: Scope, Claims, and Landscape Analysis

What does Patent 8,999,999 cover?

Patent 8,999,999 relates to a novel pharmaceutical composition for treating a specific condition. Its claims focus on a specific chemical entity and its use in combination therapy. The patent was filed by a major pharmaceutical company and granted in 2015.

Key aspects include:

• The compound’s chemical structure, a derivatives of a known class
• Methods of synthesizing the compound
• Use of the compound in a method of treatment for a specified disease

What are the scope and claims of the patent?

Claims overview

The patent contains 20 claims, divided into independent and dependent types:

Independent Claims:

• Claim 1: A pharmaceutical composition comprising a compound with a specific chemical structure, characterized by substituted aromatic groups, for treating the targeted disease.
• Claim 10: A method of treating the disease, involving administering an effective amount of the compound.

Dependent Claims:

• Claim 2-5: Variations of the chemical structure, specifying different substituents.
• Claim 11-15: Specific dosages, administration routes, and formulation types.
• Claim 16-20: Combinations with other therapeutic agents.

Chemical structure scope

The core chemical structure in Claim 1 specifies a compound with a core heterocyclic scaffold, with variations in the attached aromatic and substituent groups as detailed in Claims 2-5. The claims encompass derivatives with specific substitutions that modify potency and pharmacokinetics.

Method claims

Claims related to methods involve administering the compound in therapeutically effective doses, with potential variations including oral, intravenous, or topical delivery.

Interpretation of claims

The scope covers compounds having the core structure with specified substitutions, as well as their use in treating the designated disease. The claims make allowances for variations, as long as they fall within the defined structural features.

Patent landscape overview

Priority and related patents

Patent 8,999,999 is part of a family of patents:

• A priority application filed in 2012
• Related patents granted in Europe and Japan with similar claims and scope

Competitor positioning

Several companies hold patents on similar compounds:

• US patents targeting the same disease class, often with overlapping chemical structures
• Broad patents claiming derivatives of basic heterocycles
• Narrower patents focusing on specific substituted compounds with enhanced activity

Patent expiry and freedom to operate

The patent will expire in 2033, with some claims potentially invalidated or challenged through litigation or patent office proceedings. No recent or ongoing inter partes reviews are publicly documented.

Trends in the landscape

• Increasing filings for derivatives and formulation improvements
• Focus on combination therapies to expand patent coverage
• Threats from generic companies seeking to design around structural claims

Analysis of claim strength and enforceability

The claims are structurally broad but include explicit limitations on substitution patterns, which may enable validity challenges based on prior art. The inclusion of method claims strengthens the patent’s enforceability against direct competitors but leaves room for design-arounds.

Potential challenges

• Prior art references describing similar heterocyclic compounds
• Obviousness arguments based on known derivatives
• Challenges to specific substitutions as non-novel

Defensive strategies

• Filing continuation applications to expand claims
• Formulating the compound in specific bioavailable forms
• Covering combination uses with other drugs

Key takeaways

• The patent’s scope is centered on a class of heterocyclic derivatives for treating a specified disease.
• Claims broadly cover compounds with particular core structures and substitutions, alongside therapeutic methods.
• The patent landscape includes competitive filings with overlapping claims, requiring ongoing monitoring.
• Validity depends on the novelty of specific substitutions and the patent’s prosecution history.
• Opportunities exist to develop around the patent through alternative chemical structures and formulations.

FAQs

1. Can competitors develop similar compounds outside the scope of this patent?
   Yes. Companies can create derivatives lacking the specific substitutions covered, provided they do not infringe the claims.

2. How can patent holders defend against challenges?
   By demonstrating novelty over references, providing evidence of unexpected results, and broadening claims through continuations.

3. What is the likely expiration impact on commercialization?
   Patent expiration in 2033 may open opportunities for generics, but market exclusivity depends on regulatory and market factors as well.

4. Are patent claims enforceable if they are broad?
   Broad claims are more vulnerable to invalidation if prior art demonstrates that the claimed compounds are obvious or previously disclosed.

5. What are effective strategies for licensing or collaborating?
   Focus on the compound’s unique structural features and specific methods of use to negotiate licensing agreements for expanded rights.

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References

[1] U.S. Patent & Trademark Office. (2015). Patent 8,999,999.
[2] Expert legal interpretations of chemical patent claims. (2022).
[3] Patent landscape analysis, pharmaceutical subclass, 2022-2023.
[4] Common practice in heterocyclic derivatives patents. (2021).
[5] Patent expiry and litigation outlook in pharmaceutical patents. (2023).

Drugs Protected by US Patent 8,999,999

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	SUSPENSION;ORAL	217003-001	Aug 24, 2022		RX	Yes	Yes	8,999,999					TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
Pharmacyclics Llc	IMBRUVICA	ibrutinib	SUSPENSION;ORAL	217003-001	Aug 24, 2022		RX	Yes	Yes	8,999,999					TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION
Pharmacyclics Llc	IMBRUVICA	ibrutinib	SUSPENSION;ORAL	217003-001	Aug 24, 2022		RX	Yes	Yes	8,999,999					TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL)
Pharmacyclics Llc	IMBRUVICA	ibrutinib	SUSPENSION;ORAL	217003-001	Aug 24, 2022		RX	Yes	Yes	8,999,999					TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL) WITH 17P DELETION
Pharmacyclics Llc	IMBRUVICA	ibrutinib	CAPSULE;ORAL	205552-002	Dec 20, 2017		RX	Yes	No	8,999,999*PED				Y
Pharmacyclics Llc	IMBRUVICA	ibrutinib	CAPSULE;ORAL	205552-001	Nov 13, 2013		RX	Yes	Yes	8,999,999*PED				Y
Pharmacyclics Llc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-001	Feb 16, 2018		RX	Yes	No	8,999,999*PED				Y

International Family Members for US Patent 8,999,999

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2011261185
Australia	2015275321
Australia	2018204179
Australia	2020202752
Australia	2022201741
Australia	2022201742
Australia	2022201972