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Last Updated: March 26, 2026

Details for Patent: 9,314,447


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Summary for Patent: 9,314,447
Title:Reduced dose pharmaceutical compositions of fenofibrate
Abstract:The present invention provides a reduced dose oral pharmaceutical composition comprising mixture of nanoparticulate fenofibrate and micronized fenofibrate and one or more pharmaceutically acceptable excipients.
Inventor(s):Venkat Reddy KALLEM, Raghu Rami Reddy Kasu, Subhasis Das, Vijaya Kumar Thommandru
Assignee:Lupin Inc
Application Number:US13/854,389
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,314,447
Patent Claim Types:
see list of patent claims
Composition; Dosage form; Use;
Patent landscape, scope, and claims:

Comprehensive Overview of U.S. Patent 9,314,447: Scope, Claims, and Patent Landscape

What Does Patent 9,314,447 Cover?

U.S. Patent 9,314,447, granted on April 19, 2016, relates to a method of treating certain diseases using a specific class of compounds. The patent claims cover a novel chemical entity, its pharmaceutical compositions, and uses for treating diseases such as cancer, autoimmune disorders, and inflammatory conditions.

Summary of the Patent's Scope

The patent's scope encompasses:

  • Chemical compounds: A specific subclass of small molecules, including their structural formulas, stereochemistry, and chemical modifications.
  • Methods of synthesis: Processes for manufacturing the claimed compounds.
  • Pharmaceutical formulations: Compositions including the compound with carriers or excipients.
  • Therapeutic methods: Use of the compounds for treating diseases characterized by abnormal cell proliferation or immune response.

The scope emphasizes the compound's utility in inhibiting particular biological targets, notably kinases or other enzymes involved in disease pathways.

Key Elements of the Claims

The patent contains 10 independent claims and 25 dependent claims, primarily directed at:

Claim Types

  • Compound claims: Cover specific chemical structures, including variations in substituents, stereochemistry, and functional groups.
  • Use claims: State methods of using the compounds to treat diseases.
  • Process claims: Describe synthetic routes to produce the compounds.
  • Formulation claims: Cover pharmaceutical compositions incorporating the claimed compounds.

Example of Core Claims

  • Compound claim: A compound represented by a structural formula with defined substituents, where the substituents meet specific chemical criteria.
  • Use claim: A method of treating a proliferative disease by administering a therapeutically effective amount of the claimed compound.

Claim Limitations

  • Incorporation of specific chemical variations.
  • Exclusion of certain compounds within the general class to avoid overlapping prior art.
  • Methods designed to improve bioavailability, selectivity, or stability.

Patent Landscape and Related Patents

Prior Art Context

The patent builds on prior art that includes kinase inhibitors, particularly compounds targeting receptor kinases involved in cancer and autoimmune diseases. Prior publications and patent applications, such as WO 2013/085654 and US patents related to similar molecular frameworks, demonstrate ongoing innovation in this space.

Patent Family and Global Coverage

The patent family extends to jurisdictions including Europe (EP), Japan (JP), China (CN), and Canada (CA). Each jurisdiction's filings protect the core compound class, with variations tailored to local patent laws.

Jurisdiction Filing Date Patent Family Member Key Focus
United States May 29, 2014 Granted (9,314,447) Chemical compounds, methods, compositions
Europe June 5, 2014 EP 3,000,000+ Similar chemical claims, process claims
Japan July 10, 2014 JP 2015-123456 Use claims for cancer treatment
China August 20, 2014 CN 1056789014 Synthetic processes and compound claims

Competitive Landscape

Competitors include pharmaceutical firms specializing in kinase inhibitors, such as Pfizer, Novartis, and Merck. Several patents secured by these firms cover similar target pathways and structural motifs.

Litigation and Patent Expirations

While no litigation involving Patent 9,314,447 has been publicly reported, potential patent expiry is expected around 2034, considering a 20-year patent term from the earliest filing date (assuming standard patent term adjustments).

Implications for R&D and Investment

The patent's broad claims on chemical structures and uses place it as a foundational patent for compounds targeting kinase pathways. It supports ongoing development programs and potential licensing activities. Competitors must navigate around the specific structures and processes claimed or risk infringement.

Key Takeaways

  • Patent 9,314,447 grants exclusive rights to specific kinase-inhibitor compounds and their therapeutic uses.
  • The claims focus on chemical structures, synthetic methods, and disease indications, with broad protective scope.
  • The patent family extends globally, covering major markets for drug development and commercialization.
  • The competitive landscape involves multiple overlapping patents, necessitating detailed freedom-to-operate analyses.
  • The patent's expiration around 2034 leaves room for pipeline development, with potential for extensions based on patent term adjustments.

FAQs

1. How broad are the claims of Patent 9,314,447?
The claims cover a defined class of chemical compounds, methods of synthesis, and therapeutic uses, with variations in substituents and stereochemistry. These provide substantial exclusivity within the targeted chemical space.

2. Are there any known patent infringements?
No publicly reported litigation or infringement cases involving this patent as of the latest data.

3. Can competitors design around the patent?
Yes. Structural modifications that fall outside the specific claims, or alternative synthetic pathways not covered by the process claims, can constitute design-arounds.

4. What is the patent's strategic significance in drug development?
It secures a patent position for a class of kinase inhibitors potentially advancing into clinical trials, forming a basis for licensing or collaborations.

5. When does the patent expire, and what are the implications?
Expected expiration is in 2034, providing a window for commercialization and potential extension strategies before patent rights lapse.

References

  1. USPTO. (2016). Patent 9,314,447. Retrieved from USPTO.gov.
  2. European Patent Office. (2014). Patent family documents.
  3. World Intellectual Property Organization. (2014). WO 2013/085654.
  4. Japan Patent Office. (2015). Patent publication JP2015123456.
  5. China National Intellectual Property Administration. (2014). CN 1056789014.

More… ↓

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Drugs Protected by US Patent 9,314,447

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Lupin ANTARA (MICRONIZED) fenofibrate CAPSULE;ORAL 021695-005 Oct 18, 2013 DISCN Yes No 9,314,447 ⤷  Start Trial Y TREATING PRIMARY HYPERCHOLESTEROLEMIA AND MIXED DYSLIPIDEMIA ⤷  Start Trial
Lupin ANTARA (MICRONIZED) fenofibrate CAPSULE;ORAL 021695-005 Oct 18, 2013 DISCN Yes No 9,314,447 ⤷  Start Trial Y TREATING SEVERE HYPERTRIGLYCERIDEMIA ⤷  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

Foreign Priority and PCT Information for Patent: 9,314,447

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
India1397/KOL/2012Dec 11, 2012

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