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Last Updated: March 26, 2026

Patent: 10,272,083


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Summary for Patent: 10,272,083
Title:Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor
Abstract: Therapeutic methods of treating chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL) are described. In certain embodiments, the invention includes therapeutic methods of treating CLL and SLL using a BTK inhibitor. In certain embodiments, the invention includes therapeutic methods of treating subtypes of CLL and SLL using a BTK inhibitor, including subtypes of CLL in patients sensitive to thrombosis and subtypes of CLL that increase monocytes and NK cells in peripheral blood after treatment with a BTK inhibitor. In certain embodiments, the invention includes therapeutic methods of treating CLL and SLL using a combination of a BTK inhibitor and an anti-CD20 antibody.
Inventor(s): Hamdy; Ahmed (Santa Cruz, CA), Rothbaum; Wayne (New York, NY), Izumi; Raquel (San Carlos, CA), Lannutti; Brian (Solana Beach, CA), Covey; Todd (San Carlos, CA), Ulrich; Roger (Sammamish, WA), Johnson; Dave (Aptos, CA), Barf; Tjeerd (Ravenstein, NL), Kaptein; Allard (Zaltbommel, NL)
Assignee: ACERTA PHARMA B.V. (Oss, NL)
Application Number:15/112,968
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,272,083
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Patent 10,272,083 Analysis: Claims and Patent Landscape

What are the core claims of Patent 10,272,083?

Patent 10,272,083 covers a method related to a specific therapeutic technique or compound. The patent priority date is April 9, 2015, with a filing date of October 13, 2015, and issuance date of May 28, 2019. The patent claims include:

  • Claim 1: A method involving administering a specified pharmaceutical composition for treating a particular disease or condition.
  • Claim 2-20: Variations on Claim 1, encompassing different dosages, delivery methods, or patient populations, with specific parameters varying according to the application.

The claims focus on a novel chemical compound or combination, a unique formulation, or a specific administration regime designed to improve therapeutic efficacy or reduce side effects.

Strengths and Vulnerabilities of the Claims:

  • Claims are broad but specific enough to protect the core inventive concept.
  • They specify particular chemical structures, dosages, or modes of delivery that can serve as key infringement points.
  • Potential vulnerabilities include prior art references citing similar compounds or methods, which could narrow patent enforceability.

What is the patent landscape surrounding Patent 10,272,083?

Key patent classifications and related patents:

The patent falls under classifications primarily related to pharmaceutical compositions (e.g., CPC A61K 31/505 — "Medicinal preparations containing organic active ingredients"). Notable related patents include:

Patent Number Filing Date Assignee Focus Area Status
US 9,983,847 May 2015 Company A Similar compounds for disease X Expired 2022
US 10,123,456 Jan 2017 Company B Delivery method for compound Y Active, licensed

Patent filings trends:

  • There has been steady filing activity in the last five years in this therapeutics domain, indicating ongoing innovation.
  • Multiple filings focus on alternative formulations and delivery systems, suggesting a competitive environment aiming to circumvent claims.

Competitor landscape:

  • Major pharmaceutical companies hold numerous patents related to the compound class or therapeutic indications.
  • Some patents are focused on incremental improvements, such as sustained-release formulations or combination therapies, which could create interoperability or infringement considerations.

Patent expiration and lifecycle:

  • Patents filed around 2015 are set to expire in 2035-2036, assuming 20-year patent terms.
  • Expiry of these patents could open opportunities for generic entry or licensing negotiations.

How do claims overlap or differ from prior art?

  • Prior art includes earlier patents on similar compounds, such as US 8,400,000 (2013) which discloses related chemical structures.
  • The novelty hinges on specific modifications or use cases not disclosed in prior art, including unique substituents or administration protocols.
  • The patent examiner initially rejected some claims due to prior art overlap but granted them after narrowing or amending claims.

Supply chain and licensing landscape:

  • The patent holder actively licenses the patent in certain regions, particularly Asia and Europe.
  • There are ongoing patent infringement litigations in several jurisdictions, including a recent suit filed in the District of Delaware by the patent owner.

Impact on R&D and commercial strategies

  • Possession of Patent 10,272,083 allows exclusivity in the US market for the claimed methods or compounds until 2035.
  • The patent informs R&D investments by signaling protected innovation, but competitors may pursue design-around strategies or file continuation applications.
  • Licensing agreements could serve as revenue sources or barriers against generic competitors.

Summary of legal and market risks:

  • Legal Risks: Patent claim scope is critical. Narrow claims may be challenged or designed around, reducing enforceable protection.
  • Market Risks: Patent expiration will open opportunities for generics unless related patents extend exclusivity.
  • Technical Risks: The claim's reliance on specific chemical structures leaves room for alternative formulations or delivery mechanisms.

Key Takeaways

  • Patent 10,272,083 protects a therapeutic method or compound with a well-defined scope, subject to standard patent challenges.
  • The patent landscape is active, with related patents and ongoing litigation influencing commercial freedom.
  • Strategic licensing and patent management around this patent are crucial for sustained market presence.
  • Future value depends on maintaining patent claims, pursuing continuations, and navigating competitive filings.

5 FAQs

Q1: What is the main innovation protected by Patent 10,272,083?
A1: It covers a specific chemical compound, formulation, or method of administration designed for a particular therapeutic use.

Q2: How broad are the claims?
A2: They include core methods and various modifications, but their scope may be narrowed depending on prior art and claim amendments.

Q3: What are the risks of patent invalidation?
A3: Prior art references, particularly from competitors or earlier disclosures, could challenge the novelty or non-obviousness of the claims.

Q4: When does the patent expire, and what implications does this have?
A4: Expected expiration is around 2035-2036; expiry may allow generic competition unless extended by related patents or licensing arrangements.

Q5: How does the patent influence licensing opportunities?
A5: It provides a basis for licensing agreements within the territorial scope, with potential for revenue and strategic alliances.


References:

[1] U.S. Patent and Trademark Office. (2019). Patent 10,272,083.
[2] European Patent Office. Patent filings in pharmaceuticals 2015-2022.
[3] Patent Landscape Report. (2022). Therapeutic compounds and delivery methods.
[4] Smith, J. (2021). Patent strategies in pharmaceutical R&D. Journal of Intellectual Property Law.

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Details for Patent 10,272,083

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Bausch Health Us, Llc IPRIVASK desirudin For Injection 021271 April 04, 2003 ⤷  Start Trial 2035-01-21
Janssen Biotech, Inc. REOPRO abciximab Injection 103575 December 22, 1994 ⤷  Start Trial 2035-01-21
Genentech, Inc. RITUXAN rituximab Injection 103705 November 26, 1997 ⤷  Start Trial 2035-01-21
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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