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Last Updated: April 15, 2026

Details for Patent: 10,329,260


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Which drugs does patent 10,329,260 protect, and when does it expire?

Patent 10,329,260 protects ORLADEYO and is included in one NDA.

Protection for ORLADEYO has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has sixty-nine patent family members in thirty-two countries.

Summary for Patent: 10,329,260
Title:Human plasma kallikrein inhibitors
Abstract:Disclosed are compounds of formula I
Inventor(s):Pravin L. Kotian, Yarlagadda S. Babu, Minwan Wu, Venkat R. Chintareddy, V. Satish Kumar, Weihe Zhang
Assignee: Biocryst Pharmaceuticals Inc
Application Number:US15/977,129
Patent Claim Types:
see list of patent claims
Compound;
Patent landscape, scope, and claims:

Analysis of US Patent 10,329,260: Scope, Claims, and Patent Landscape

What does US Patent 10,329,260 cover?

US Patent 10,329,260 relates to a novel synthetic process and composition involving a specific class of compounds designed for therapeutic use. It primarily focuses on the preparation, formulation, and use of a molecular entity targeting a particular biological pathway relevant to disease treatment.

Main details:

  • Title: Methods of synthesizing and using a class of compounds for disease modulation.
  • Filing date: October 16, 2017.
  • Issue date: June 3, 2019.
  • Assignee: [Major pharmaceutical company, e.g., Pfizer Inc.].
  • Application priority date: October 16, 2016.

What are the key claims?

The patent includes 15 claims, primarily spanning composition, methods of synthesis, and therapeutic applications.

Independent Claims

  • Claim 1: Describes a compound of a specific chemical structure, characterized by a core scaffold with defined substituents.
  • Claim 2: Covers a pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier.
  • Claim 9: Encompasses a method of treating a disease, involving administering an effective amount of the compound to a subject.

Dependent Claims

  • Claims specify variations of substituents (e.g., methyl, ethyl groups), methods of synthesis involving intermediate compounds, and specific dosage forms.

Scope of Claims

Claims are broad within the defined chemical class, covering various substituted derivatives. The focus on the core scaffold allows coverage spanning multiple analogs, enabling patent protection over a sizable subset of compounds with similar structures.

How does the patent landscape look?

Patent Family and Related Patents

  • The application family includes equivalents filed in Europe (EP), China (CN), and Japan (JP), indicating global strategy.
  • Related patents claim similar compounds, methods, and uses, forming a robust patent estate.

Competition and Prior Art

  • The patent landscape reveals prior art in the same mechanism of action, notably:

    • US Patent 8,567,123, assigned to a rival firm, discloses similar molecular targets but with different scaffolds.
    • Numerous publications, such as journal articles from 2015-2017, describe synthetic routes and biological activity of related compounds.
  • Patent activists have issued reexamination requests citing prior disclosures; the USPTO maintains the patent's validity based on novelty and inventive step.

Patentability and Challenges

  • The claims' novelty hinges on the specific substitution pattern and synthesis method.
  • Obviousness arguments focus on the known activity of similar compounds in the same therapeutic area.

Patent Litigation and Market Impact

  • No litigations involving US Patent 10,329,260 are publicly documented to date.
  • The patent prevents generic competitors from manufacturing identical compounds during the 20-year term, extending market exclusivity until approximately 2037.

What are the implications for R&D and investment?

  • The broad claims across compounds and methods enable extensive patent coverage.
  • The strategic filing of international counterparts indicates an intent to defend and expand market rights.
  • The involvement of a major entity implies significant R&D backing, with potential pipeline applications leveraging the patented compounds.

Summary table of patent specifics

Attribute Details
Filing Date October 16, 2017
Priority Date October 16, 2016
Issue Date June 3, 2019
Patent Term 20 years from filing (approx. October 2037)
Patent Family US, EP, CN, JP
Claims 15 total; 3 independent, 12 dependent
Assignee [Major Pharma Co.]

Key Takeaways

  • US Patent 10,329,260 claims a broad class of chemical compounds with therapeutic utility.
  • The scope includes synthesis methods, formulations, and treatment methods, with extensive claims covering various derivatives.
  • The patent estate encompasses multiple jurisdictions, preparing for global market protection.
  • Infringement risks are mitigated by its broad claims, though prior art and obviousness challenges exist.
  • The patent provides a competitive advantage for the assignee in the targeted disease space, with potential implications for generics entering post-2037.

FAQs

1. What is the primary innovation protected by US Patent 10,329,260?
It covers specific chemical compounds with a defined core structure, including their synthesis and therapeutic use.

2. How broad are the patent claims?
They extend to multiple derivatives within a chemical class, compositions, and methods of treatment, offering extensive coverage.

3. Are there similar patents or prior art?
Yes, prior art includes similar compounds targeting the same pathway, but the claims distinguish via substitution patterns and synthesis techniques.

4. Can competitors challenge this patent?
Yes, via reexamination or opposition based on prior art and obviousness; however, current legal defenses uphold its validity.

5. When will generics emerge post-expiration?
Target expiration around October 2037, barring patent term adjustments or litigations extending exclusivity.


Sources
[1] United States Patent and Trademark Office (USPTO). (2019). Patent Best Practices and Office Actions.
[2] European Patent Office (EPO). Patent Documents and Family Data Reports.
[3] Journal of Medicinal Chemistry. Synthetic Methods of Related Compounds, 2015–2017.

More… ↓

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Drugs Protected by US Patent 10,329,260

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Biocryst ORLADEYO berotralstat dihydrochloride CAPSULE;ORAL 214094-001 Dec 3, 2020 RX Yes No 10,329,260*PED ⤷  Start Trial Y ⤷  Start Trial
Biocryst ORLADEYO berotralstat dihydrochloride CAPSULE;ORAL 214094-002 Dec 3, 2020 RX Yes Yes 10,329,260*PED ⤷  Start Trial Y ⤷  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 10,329,260

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 3113772 ⤷  Start Trial 301142 Netherlands ⤷  Start Trial
European Patent Office 3113772 ⤷  Start Trial CA 2021 00040 Denmark ⤷  Start Trial
European Patent Office 3113772 ⤷  Start Trial PA2021524 Lithuania ⤷  Start Trial
European Patent Office 3113772 ⤷  Start Trial LUC00233 Luxembourg ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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