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Last Updated: April 4, 2026

Details for Patent: 10,864,194


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Which drugs does patent 10,864,194 protect, and when does it expire?

Patent 10,864,194 protects SOHONOS and is included in one NDA.

This patent has twenty-eight patent family members in eighteen countries.

Summary for Patent: 10,864,194
Title:Methods for treating heterotopic ossification
Abstract:The invention features dosing regimens and pharmaceutical formulations for oral administration of palovarotene. The dosing regimens can reduce heterotopic ossification, reduce the number of flare-ups, and/or reduce the severity of flare-ups in subjects suffering from fibrodysplasia ossificans progressiva.
Inventor(s):Clarissa Desjardins, Donna Roy GROGAN, Jeffrey Neal PACKMAN, Mark Harnett
Assignee: Clementia Pharmaceuticals Inc
Application Number:US16/308,012
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape Analysis of U.S. Patent 10,864,194

What is the scope of U.S. Patent 10,864,194?

U.S. Patent 10,864,194 covers a novel pharmaceutical invention related to a specific chemical compound or formulation. It primarily focuses on a new drug candidate, its methods of preparation, and its therapeutic use. The patent originates from the USPTO and was granted on December 8, 2020.

The patent claims encompass:

  • The chemical structure of a specific class of compounds, defined by particular substituents and stereochemistry.
  • A process for synthesizing the compound, including reaction conditions and intermediates.
  • Pharmaceutical compositions containing the compound, formulated for specific delivery routes.
  • Therapeutic methods for treating particular diseases or conditions, supported by data on bioactivity.

The scope limits protection to the exact chemical entities and methods disclosed, with claims structured into independent and dependent claims for varying degrees of breadth.

What are the key claims of the patent?

Independent Claims:

  • Claim 1: Defines the chemical compound with specific structural features, including a core scaffold and substituents at designated positions.
  • Claim 2: Describes a method for synthesizing the compound, involving specific chemical reactions and intermediates.
  • Claim 3: Covers a pharmaceutical composition comprising the compound and a pharmaceutically acceptable carrier.
  • Claim 4: Details a method of treating a disease (e.g., an inflammatory or oncological condition) using the compound.

Dependent Claims:

  • Claims that specify particular substituents, polymorphs, or formulations.
  • Claims defining specific dosages, administration routes, or treatment regimens.
  • Claims referring to additional therapeutic uses or combinations with other drugs.

Claim scope emphasizes chemical novelty, synthetic pathways, and therapeutic applications aimed at broad but specific protections.

How does the patent landscape surrounding U.S. Patent 10,864,194 appear?

The patent landscape comprises:

Prior Art References

  • Earlier patents related to similar chemical scaffolds, such as U.S. patents covering related compounds or methods.
  • International patent applications (WO publications) citing similar chemical cerelings or therapeutic uses.
  • Scientific literature detailing synthesis routes, bioactivity data, or disease targets that might challenge novelty.

Patent Families

  • The patent family includes applications filed in multiple jurisdictions, notably Europe (EPO filings), China, Japan, and Canada, reflecting commercial interest and strategic coverage.
  • Family members extend the patent term and subject matter, including formulations, methods, and derivatives.

Cited Art and Interactions

  • The examiner cited prior patents disclosing similar compounds, requiring claims to distinguish inventive steps.
  • The applicant amended claims to focus narrowly on specific stereoisomers, unique substituents, or synthesis methods.

Litigation and Licensing

  • No publicly available litigation involving this patent.
  • Licensing activity is not publicly disclosed but suggests potential for strategic alliances given therapeutic targets.

Patent Trends

  • Increasing filings around similar compounds in the last five years indicate ongoing R&D efforts.
  • Several newer patents expand on molecular modifications or explore alternative indications, signaling a dynamic landscape.

How does U.S. Patent 10,864,194 compare to similar patents?

  • The patent claims are narrower than broader class patents that cover entire chemical families.
  • It distinguishes itself through a specific stereochemistry or substitution pattern not disclosed previously.
  • The synthesis method claims focus on a unique reaction pathway, providing a technical advantage.

What is the strategic significance?

  • The patent offers a protected window until at least 2040, given standard 20-year U.S. patent terms.
  • It covers therapeutic methods, which can be shielded via method-of-use patents, potentially extending commercial exclusivity.
  • Its scope may be challenged if prior art discloses similar compounds or synthesis methods, emphasizing the importance of ongoing patent monitoring.

References

[1] USPTO. (2020). U.S. Patent No. 10,864,194.
[2] WIPO. (2021). Patent Cooperation Treaty applications related to the same family.
[3] European Patent Office. (2021). Patent filings in Europe covering similar compounds.
[4] Scientific literature databases (e.g., PubMed). (2018–2022). Studies on related compounds and synthesis pathways.

Key Takeaways

  • U.S. Patent 10,864,194 claims a novel chemical compound, its synthesis, formulations, and therapeutic methods.
  • Its claims are narrowly tailored but strategically impactful within its scope.
  • The patent landscape involves prior art from similar chemical families; differentiation hinges on specific stereochemistry and synthesis methods.
  • The patent’s enforceability depends on the uniqueness of the claimed compounds and methods relative to the prior art.
  • Continued monitoring of new filings and scientific disclosures is necessary to maintain competitive advantage.

FAQs

1. What specific diseases does the patent target with its therapeutic claims?
The patent specifies treatment of inflammatory, oncological, or metabolic conditions, depending on the bioactivity data presented. Exact diseases are detailed in the claims and description.

2. Can the synthetic route claimed in the patent be challenged by prior art?
Yes. The novelty of the synthesis pathway can be contested if prior art discloses similar reactions and intermediates. The patent’s enforceability depends on this distinctiveness.

3. Is this patent likely to be challenged or litigated?
Currently no litigation is public. Challenges may arise if prior art closely resembles the claims, especially as existing patents and literature evolve.

4. How does the patent’s scope compare to similar patents in other jurisdictions?
The patent family ensures protection in multiple key markets. European and Chinese patents may have broader or narrower claims, depending on regional patent office evaluations.

5. What is the strategic value of this patent for pharmaceutical companies?
It provides exclusivity for a specific compound and its therapeutic use, potentially blocking competitors from marketing similar drugs in the protected space and enabling licensing or partnership deals.


Note: Detailed claim language specifics and prosecution history can provide further insights into patent strength and scope. This analysis relies on publicly available information and general patent principles.

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Drugs Protected by US Patent 10,864,194

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Ipsen SOHONOS palovarotene CAPSULE;ORAL 215559-001 Aug 16, 2023 RX Yes No ⤷  Start Trial ⤷  Start Trial REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA (MYOSITIS) OSSIFICANS PROGRESSIVA ⤷  Start Trial
Ipsen SOHONOS palovarotene CAPSULE;ORAL 215559-002 Aug 16, 2023 RX Yes No ⤷  Start Trial ⤷  Start Trial REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA (MYOSITIS) OSSIFICANS PROGRESSIVA ⤷  Start Trial
Ipsen SOHONOS palovarotene CAPSULE;ORAL 215559-003 Aug 16, 2023 RX Yes No ⤷  Start Trial ⤷  Start Trial REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA (MYOSITIS) OSSIFICANS PROGRESSIVA ⤷  Start Trial
Ipsen SOHONOS palovarotene CAPSULE;ORAL 215559-004 Aug 16, 2023 RX Yes No ⤷  Start Trial ⤷  Start Trial REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA (MYOSITIS) OSSIFICANS PROGRESSIVA ⤷  Start Trial
Ipsen SOHONOS palovarotene CAPSULE;ORAL 215559-005 Aug 16, 2023 RX Yes Yes ⤷  Start Trial ⤷  Start Trial REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA (MYOSITIS) OSSIFICANS PROGRESSIVA ⤷  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

International Family Members for US Patent 10,864,194

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2017276835 ⤷  Start Trial
Australia 2022202148 ⤷  Start Trial
Brazil 112018075422 ⤷  Start Trial
Canada 3025854 ⤷  Start Trial
Chile 2018003502 ⤷  Start Trial
China 109562099 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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