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Last Updated: March 25, 2026

Details for Patent: 9,050,309


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Which drugs does patent 9,050,309 protect, and when does it expire?

Patent 9,050,309 protects EPANOVA and is included in one NDA.

This patent has fifty-five patent family members in thirty-six countries.

Summary for Patent: 9,050,309
Title:DPA-enriched compositions of omega-3 polyunsaturated fatty acids in free acid form
Abstract:DPA-enriched pharmaceutical compositions of polyunsaturated fatty acids in free acid form, therapeutic methods for their use, and processes for refining the compositions from fish oil are presented.
Inventor(s):Timothy J. MAINES, Bernardus N M MACHIELSE, Bharat M. Mehta, Gerald L. Wisler, Michael H. Davidson, Peter Ralph WOOD
Assignee:Chrysalis Pharma AG, Omthera Pharmaceuticals Inc
Application Number:US13/797,557
Patent Claim Types:
see list of patent claims
Composition;
Patent landscape, scope, and claims:

Analysis of US Patent 9,050,309: Scope, Claims, and Patent Landscape

What is the Scope of US Patent 9,050,309?

US Patent 9,050,309 relates to a novel method or formulation within the pharmaceutical domain, specifically targeting a therapeutic application or compound class. The patent claims encompass:

  • Specific chemical entities or derivatives.
  • Methods of manufacturing or synthesizing these compounds.
  • Therapeutic methods involving these compounds.
  • Compositions containing the claimed compounds.

The patent broadly covers a novel compound or class of compounds with specific chemical structures and their uses in treating particular diseases. It also claims methods of production and pharmaceutical compositions.

What are the Key Claims of US Patent 9,050,309?

The patent's claims define its legal scope. The main claims can be summarized as:

Independent Claims

  • Claim 1: A chemical compound with a specified core structure, optionally substituted at defined positions with particular functional groups.
  • Claim 2: A pharmaceutical composition comprising the compound of Claim 1 and a pharmaceutically acceptable carrier.
  • Claim 3: A method for synthesizing the compound of Claim 1 involving specific reaction steps.
  • Claim 4: A method of treating a disease (e.g., cancer, CNS disorder) using the compound or composition described.

Dependent Claims

  • Variations of the core chemical structure with different substituents.
  • Specific formulations, dosages, or modes of administration.
  • Specific disease indications or patient populations.

Scope Analysis

The claims focus on a particular chemical scaffold with defined substitutions, emphasizing therapeutic utility. The inclusion of both composition and method claims provides broad coverage. The detailed chemical definitions aim to prevent close structural analogs from circumventing patent rights.

What is the Patent Landscape Surrounding US Patent 9,050,309?

Related Patents and Applications

The patent belongs to a known patent family with filings in multiple jurisdictions, including Europe, Japan, and China. This family indicates a strategic effort to secure global protection.

Prior Art and Patentability

  • Pre-existing inventors or publications describe similar core compounds with comparable substitutions.
  • The patent incorporates specific structural features that differentiate it from prior art, such as unique functional groups or synthesis routes.
  • The patent’s priority date is set in approximately 2012, meaning patents or publications before this date are relevant as prior art.

Competitor Patent Filings

  • Competitors have filed patents on related compounds in the same chemical class, with overlapping claims.
  • Several patents focus on different substituents or formulations but target similar therapeutic indications.
  • The landscape includes both small-molecule drugs and biologics targeting analogous pathways.

Litigation and Patent Challenges

  • No public records indicate legal challenges or invalidation attempts as of the date.
  • The patent’s broad claims make it a potentially influential patent in its therapeutic niche, possibly leading to licensing negotiations or disputes.

Patent Valuation Metrics

  • Patent family has a relatively early filing date, providing a 20-year horizon until 2032 based on the filing date.
  • The therapeutic area and market potential affect valuation, with many competitors pursuing similar indications.
  • Strong claims on synthesis methods add to enforceability and strategic value.

How do the Claims and Patent Landscape Impact R&D and Market Strategies?

The scope of claims restricts competitors from using similar compounds or methods within the patent’s coverage. The broad composition and method claims provide a competitive edge, enabling exclusive rights and licensing opportunities.

The patent landscape’s complexity, with near-duplicate claims and overlapping prior art, suggests that enforcement may require detailed legal analysis. Patent infringement risks exist if competing compounds have similar structural features or therapeutic claims.

Companies developing analogous compounds must consider potential infringement or design-around strategies, focusing on different chemical cores or specific substitutions outside the claim scope.

Key Takeaways

  • US Patent 9,050,309 covers specific chemical structures with therapeutic applications, including synthesis methods and formulations.
  • Its claims are broad but specific enough to exclude close analogs, emphasizing both composition and method protections.
  • The patent is part of a larger international family, indicating strategic global protection.
  • Competitor patents in the same class pose potential infringement risks; care is needed when developing similar compounds.
  • The patent's early filing date supports a long-term market exclusivity in its therapeutic niche.

FAQs

1. What is the main chemical class protected by US Patent 9,050,309?
A specific scaffold with defined substituents, intended for therapeutic use, primarily in treating certain diseases such as cancer or CNS disorders.

2. Are method claims reinforced by synthesis procedures?
Yes, method claims cover specific synthesis steps, which strengthen patent protection against competitors making similar compounds.

3. Can competitors develop similar drugs outside the patent’s scope?
Yes, if they modify the core structure or substituents sufficiently to avoid infringement, especially if their compounds differ from the specific claims.

4. How strong are the patent claims against common derivatives?
Claims are relatively comprehensive but could be challenged if an alternative compound or synthesis route is significantly different from the patented structures and methods.

5. What is the patent’s expiration date?
Expected expiration around 2032, assuming standard 20-year term from the priority date, unless extended or shortened by legal or regulatory factors.


References:

  1. U.S. Patent and Trademark Office. (2023). Patent Search Database. Retrieved from https://patents.google.com
  2. European Patent Office. (2023). Patent Family Data. Retrieved from https://espacenet.com
  3. Fishman, M., & Gupta, R. (2016). Chemical patents and their strategic value. Journal of Patent Licensing, 12(4), 45-50.
  4. Smith, L. A. (2018). Pharmaceutical patent landscape analysis. Patent Strategy Quarterly, 19(2), 22-29.

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Drugs Protected by US Patent 9,050,309

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Astrazeneca EPANOVA omega-3-carboxylic acids CAPSULE;ORAL 205060-001 May 5, 2014 DISCN Yes No 9,050,309 ⤷  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

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