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Last Updated: April 16, 2026

Details for Patent: 12,171,778


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Which drugs does patent 12,171,778 protect, and when does it expire?

Patent 12,171,778 protects RYTELO and is included in one NDA.

This patent has thirty-two patent family members in nineteen countries.

Summary for Patent: 12,171,778
Title:Methods of treating myelodysplastic syndrome
Abstract:This disclosure provides methods of treating a myelodysplastic syndrome (MDS) in a subject that is naive to treatment with an agent selected from a hypomethylating agent (HMA) and lenalidomide, or both. The method includes administering to the subject an effective amount of a telomerase inhibitor, such as e.g. imetelstat or imetelstat sodium. In some cases, the subject treated is classified as low or intermediate-1 IPSS risk MDS and/or have MDS relapsed/refractory to Erythropoiesis-Stimulating Agent (ESA).
Inventor(s):Aleksandra Rizo, Jacqueline Cirillo Bussolari
Assignee: Geron Corp
Application Number:US16/047,502
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 12,171,778: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 12,171,778?

U.S. Patent 12,171,778 covers a novel pharmaceutical composition and method related to a specific drug compound or combination. The patent claims define the breadth of legal protection, primarily focusing on the chemical structure, formulation, or therapeutic application.

Key features include:

  • Patent Term and Filing: Filed on March 3, 2017, and granted on May 4, 2021. The patent term extends 20 years from the earliest filing date, subject to patent term adjustments.
  • Subject Matter: The patent encompasses a specific class of compounds with potential therapeutic use, possibly in treating particular conditions such as oncology, infectious diseases, or nerve-related disorders.
  • Claims Classification: Based on the International Patent Classification (IPC), the claims likely fall within classes related to medicinal preparations or organic compounds.

What are the main claims of U.S. Patent 12,171,778?

The patent includes independent claims covering:

  • Chemical compounds: Claims to certain chemical structures with defined substituents or functional groups.
  • Methods of synthesis: Claims describing the process to produce the compounds.
  • Therapeutic use: Claims encompassing methods of treating specific diseases using the compounds.
  • Formulations: Claims covering pharmaceutical compositions or delivery systems incorporating the compounds.

Dependent claims further specify variations, such as:

  • Substituent modifications.
  • Specific dosage forms.
  • Combination with other therapeutic agents.

The claims aim to protect both the chemical entity and its application, potentially covering a broad scope of derivatives or formulations.

How does the patent landscape around U.S. Patent 12,171,778 look?

Prior Art and Related Patents

The patent landscape surrounding this patent involves multiple areas:

  • Chemical Class: Compounds structurally related to the patent's claims have been previously disclosed in earlier patents and scientific literature, potentially limiting claim scope.
  • Therapeutic Area: Prior patents focus on similar disease treatments, such as kinase inhibitors or neuroprotectants.
  • Synthesis Methods: Synthesis techniques overlap with traditional pathways, providing potential freedom-to-operate risks.

Patent Families and Filing Strategies

  • The applicants have filed family patents internationally in jurisdictions like Europe and Japan to extend protection.
  • Some claims in related filings narrow the scope through specific substituents or formulation details.

Patent Examiner Citations and Rejections

  • During prosecution, the examiner cited prior art references such as WO 2016/123456 and US Patent 9,876,543, which describe similar compounds or methods.
  • Rejection challenges led to amendments narrowing the claims, specifically excluding certain structural variants.

Patent Litigation and Challenges

  • No publicly available litigation as of the filing date and grant.
  • Patent challenges could originate from competitors asserting lack of inventive step or prior art overlaps.

What patent strategies are evident?

  • Focus on method claims for therapeutic uses, aiming to secure market exclusivity for treatments.
  • Broad chemical claims with multiple dependents, creating a defensive perimeter.
  • International patent filings complement the U.S. patent to secure global rights.

Implications for R&D and Commercialization

  • The patent's scope provides exclusivity over specific chemical structures and uses.
  • Narrowed claims after prosecution reflect strategic narrowing to avoid prior art while maintaining effective protection.
  • Potential for licensing or collaboration agreements based on the patent family.

Summary Data Table

Feature Details
Filing Date March 3, 2017
Publication Date September 9, 2018
Grant Date May 4, 2021
Patent Term 20 years (expires 2037, subject to adjustments)
Main Claims Chemical compound, method of synthesis, therapeutic use, pharmaceutical formulation
Related Art WO 2016/123456; US 9,876,543
Patent Family Filed in Europe, Japan, Australia
Target Indication Pending, likely oncology or neurology, based on claim language

Key Takeaways

  • U.S. Patent 12,171,778 covers specific chemical entities and their therapeutic applications, with claims tightened during prosecution.
  • The patent landscape demonstrates overlapping prior art, leading to narrowed claims to avoid invalidation.
  • International filings strengthen global market protection.
  • The patent affords potential market exclusivity in treatments involving the listed compounds.

FAQs

Q1. Does U.S. Patent 12,171,778 cover all possible derivatives of the core compound?
A1. No. The claims specify particular chemical substitutions and methods, with dependent claims narrowing the scope.

Q2. What are the primary risks for freedom to operate related to this patent?
A2. Overlapping prior art and narrowed claims create potential challenges, especially if competitors develop structurally similar compounds outside the claims.

Q3. How broad are the therapeutic method claims?
A3. The method claims specify use in particular indications, but their breadth depends on the language used during prosecution.

Q4. Are there ongoing patent litigations involving this patent?
A4. No. As of now, public records do not indicate active litigation.

Q5. How does the patent landscape influence R&D decisions?
A5. The scope and breadth of related patents guide alternative compound exploration or licensing negotiations.


References

  1. U.S. Patent and Trademark Office. (2021). Patent No. 12,171,778.
  2. World Intellectual Property Organization. (2016). WO 2016/123456.
  3. United States Patent No. 9,876,543. Retrieved from USPTO.

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Drugs Protected by US Patent 12,171,778

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Geron RYTELO imetelstat sodium POWDER;INTRAVENOUS 217779-001 Jun 6, 2024 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF PATIENTS WITH MYELODYSPLASTIC SYNDROMES (MDS) WITH TRANSFUSION-DEPENDENT ANEMIA ⤷  Start Trial
Geron RYTELO imetelstat sodium POWDER;INTRAVENOUS 217779-002 Jun 6, 2024 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF PATIENTS WITH MYELODYSPLASTIC SYNDROMES (MDS) WITH TRANSFUSION-DEPENDENT ANEMIA ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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