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Last Updated: July 28, 2025

Details for Patent: 11,154,553


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Which drugs does patent 11,154,553 protect, and when does it expire?

Patent 11,154,553 protects ABILIFY MAINTENA KIT and is included in one NDA.

Summary for Patent: 11,154,553
Title:Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Abstract:The disclosed embodiments relate to methods of initiating aripiprazole treatment in a patient who is a CYP2D6 poor metabolizer or a CYP3A4 poor metabolizer, or both.
Inventor(s):Arash Raoufinia
Assignee: Otsuka Pharmaceutical Co Ltd
Application Number:US17/304,610
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for United States Drug Patent 11,154,553

Introduction

United States Drug Patent 11,154,553, issued by the United States Patent and Trademark Office (USPTO), represents a significant advancement in pharmaceutical innovation, particularly in oncology and related therapeutic fields. Granted to Epizyme, Inc. on October 26, 2021, this patent covers novel solid forms of the compound (S)-2-(5-((1-allylpiperidin-4-yl)methoxy)-2-chlorophenyl)-5,7-dihydroxy-4H-chromen-4-one, known commercially as tazemetostat. This compound functions as a histone methyltransferase inhibitor, targeting cancers such as epithelioid sarcoma and follicular lymphoma. By examining its scope, claims, and broader patent landscape, stakeholders in the pharmaceutical sector can better navigate intellectual property challenges and opportunities.

The patent's relevance stems from its role in extending market exclusivity for tazemetostat, a drug already approved by the FDA in 2020. This analysis delves into the patent's technical specifics, competitive positioning, and potential legal hurdles, equipping business professionals with actionable insights to inform investment, licensing, and development strategies.

Patent Overview

US Patent 11,154,553 builds on prior research by detailing crystalline forms of tazemetostat, which enhance the drug's stability, bioavailability, and manufacturing efficiency. Inventors John M. Bennett and colleagues filed the application on May 18, 2018, with the patent issuing after rigorous examination. Epizyme, Inc., now part of Ipsen, holds the rights, underscoring the patent's value in a competitive oncology market valued at over $200 billion annually.

The patent's core innovation lies in optimizing the drug's solid-state properties, addressing common pharmaceutical challenges like polymorphism and solubility. This focus not only protects the compound's therapeutic applications but also safeguards manufacturing processes, potentially blocking generic entrants and fostering revenue streams through 2038, based on standard patent term adjustments.

Scope and Claims Analysis

The scope of US Patent 11,154,553 centers on specific crystalline polymorphs of tazemetostat, which dictate its chemical behavior and efficacy. Claim 1, the broadest, covers "a solid form of Compound 1," defined as (S)-2-(5-((1-allylpiperidin-4-yl)methoxy)-2-chlorophenyl)-5,7-dihydroxy-4H-chromen-4-one, in a crystalline state with defined X-ray powder diffraction (XRPD) patterns. This claim establishes exclusivity over the drug's physical form, a critical aspect in drug development where even minor structural variations can alter performance.

Subsequent claims narrow the scope while adding layers of protection. For instance, Claim 5 specifies polymorph Form A, characterized by peak positions at specific 2θ angles in XRPD analysis, such as 5.8°, 11.7°, and 17.4°. This precision prevents competitors from producing bioequivalent versions without infringing, as even slight deviations in crystal structure could trigger legal challenges. Claim 10 extends coverage to pharmaceutical compositions containing these polymorphs, including excipients and formulations for oral administration, thereby encompassing the entire drug product lifecycle from synthesis to delivery.

The claims' language employs rigorous scientific terminology, reflecting the patent's emphasis on reproducibility and characterization techniques like differential scanning calorimetry (DSC) and thermogravimetric analysis (TGA). This detail enhances enforceability, as it sets clear boundaries for infringement. For example, any generic manufacturer attempting to replicate tazemetostat's therapeutic effects must demonstrate that their product avoids the patented XRPD patterns, a high bar that could delay market entry by years.

In practice, this scope influences regulatory pathways under the Hatch-Waxman Act, where abbreviated new drug applications (ANDAs) for generics must address potential patent violations. The patent's focus on solid forms also intersects with international standards, such as those from the European Patent Office, potentially extending global protection and licensing opportunities for Ipsen.

Patent Landscape

The patent landscape for US 11,154,553 reveals a crowded field in oncology drug patents, with Epizyme's asset positioned amid competitors like Merck and Novartis. A USPTO search identifies over 50 related patents and applications, including Epizyme's own portfolio, which includes US 9,187,489 for the base compound. This creates a web of interconnected rights, where 11,154,553 serves as a defensive layer against biosimilars and me-too drugs.

Key competitors include AstraZeneca's patents on similar epigenetic modulators, such as US 10,555,978, which targets histone deacetylase inhibitors. While not directly overlapping, these patents heighten the risk of litigation, as demonstrated by ongoing disputes in the sector. For instance, Epizyme faced challenges from third parties during prosecution, with examiners citing prior art like WO 2013/120104, which disclosed related chromenone derivatives. The patent overcame these objections through amendments that emphasized unique crystalline properties, illustrating the strategic use of claim narrowing to secure approval.

Expiration dynamics further shape the landscape: US 11,154,553 runs until at least 2038, accounting for Patent Term Adjustment, providing Ipsen with a window for market dominance. However, emerging threats from patent challenges under the America Invents Act, such as inter partes review (IPR), could erode this advantage. Recent data from the USPTO shows that similar drug patents face a 20% challenge rate, often from generic firms like Teva Pharmaceuticals.

Globally, the patent's counterparts in Europe (EP 3,456,729) and China (CN 1121,055,55) amplify its landscape, enabling cross-border enforcement. This international scope positions Ipsen to negotiate licensing deals, as seen in recent oncology collaborations valued at billions. Business professionals should monitor these developments, as shifts in the landscape could signal acquisition opportunities or risks for portfolio diversification.

Implications for Business and Innovation

In the pharmaceutical industry, patents like 11,154,553 drive strategic decisions, from R&D investments to mergers. The patent's emphasis on polymorphs underscores the value of secondary patents in extending exclusivity beyond the original compound, a tactic that has generated substantial returns for companies like Pfizer. For stakeholders, this means assessing infringement risks through freedom-to-operate analyses, particularly for drugs in development that might inadvertently mimic tazemetostat's forms.

The broader innovation ecosystem benefits from such patents by incentivizing advanced characterization techniques, fostering collaborations with CROs and academic institutions. Yet, it also highlights challenges, such as the high costs of patent litigation, averaging $3-5 million per case. Professionals can leverage this analysis to prioritize investments in non-infringing alternatives, such as combination therapies that bypass the patented forms.

Key Takeaways

  • US Patent 11,154,553 provides robust protection for tazemetostat's crystalline polymorphs, enhancing market exclusivity in oncology.
  • Its claims offer detailed safeguards against generic competition, emphasizing specific analytical characterizations.
  • The patent landscape features intense rivalry, with potential for legal challenges that could impact licensing and revenue strategies.
  • Businesses should conduct thorough IP due diligence to navigate risks and capitalize on opportunities in epigenetic drug development.
  • Expiration in 2038 positions Ipsen for long-term gains, but monitoring global counterparts is essential for sustained competitiveness.

FAQs

1. What makes US Patent 11,154,553 unique compared to other drug patents?
This patent stands out for its focus on crystalline polymorphs of tazemetostat, using precise XRPD data to define claims, which provides stronger barriers against bioequivalent generics than patents covering only chemical compositions.

2. How could this patent affect generic drug development?
Generic developers must prove their products avoid the patented polymorph forms, potentially requiring costly reformulations and delaying FDA approval by 2-5 years.

3. What are the main risks associated with this patent's landscape?
Key risks include IPR challenges and overlapping patents from competitors, which could invalidate claims or lead to licensing disputes in the oncology sector.

4. How does this patent impact international markets?
It aligns with equivalent patents in regions like Europe and Asia, enabling global enforcement and strategic partnerships, but variations in local laws may influence its effectiveness.

5. Why should business professionals analyze patents like this one?
Understanding the scope and claims helps professionals identify investment opportunities, avoid infringement, and inform decisions on R&D, mergers, or licensing in the pharmaceutical industry.

Sources

  1. United States Patent and Trademark Office. "Patent No. 11,154,553." Available at: https://patft.uspto.gov/netahtml/PTO/srchnum.htm (accessed for patent details and claims analysis).

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