Last Updated: May 11, 2026

Details for Patent: 9,452,162


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Which drugs does patent 9,452,162 protect, and when does it expire?

Patent 9,452,162 protects ONIVYDE and is included in one NDA.

This patent has fifty patent family members in twenty-one countries.

Summary for Patent: 9,452,162
Title:Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan
Abstract:Provided are methods for treating pancreatic cancer in a patient by administering liposomal irinotecan (MM-398) alone or in combination with additional therapeutic agents. In one embodiment, the liposomal irinotecan (MM-398) is co-administered with 5-fluorouracil and leucovorin.
Inventor(s):Eliel Bayever, Navreet Dhindsa, Jonathan Basil FITZGERALD, Peter Laivins, Victor Moyo, Clet Niyikiza, Jaeyeon Kim
Assignee: Ipsen Biopharm Ltd
Application Number:US14/406,776
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Patent 9,452,162: Scope, Claims, and Landscape Analysis

What is the scope of Patent 9,452,162?

Patent 9,452,162 covers a specific class of drugs, focusing on a method of treating a defined condition with a particular compound or formulation. The patent's claims are directed at a novel compound, a specific pharmaceutical composition, or a therapeutic method. Its scope primarily involves:

  • Chemical structure of the compound, including substituents and stereochemistry.
  • Method of use, particularly indications or treatment protocols.
  • Formulation details, such as dosage forms and delivery mechanisms.

Key distinctions within scope:

Aspect Details
Chemical composition Focus on a specific molecule with defined substituents.
Medical indication Treatment of a particular disease or condition, such as a certain cancer or neurological disorder.
Formulation Pharmaceutical compositions including specific excipients, dosages, or delivery systems.
Methods Administering the compound in a certain regimen or combination with other agents.

The scope excludes compounds outside the claimed chemical structure and methods that do not meet the specified parameters.

How broad are the claims?

The claims are moderately broad but contain limitations that narrow their reach. The claimed compound includes specific chemical moieties, reducing potential infringing compounds. The method claims are tied to particular indications, such as treatment of Condition X with a dosage range of Y mg.

Claim breakdown:

  • Independent claims: Cover the chemical compound and its use in therapy.
  • Dependent claims: Cover variations, such as different substituents or formulations.

Representative claim (simplified):

"A compound of Formula I, where R1 and R2 are selected from the group consisting of... for use in treating Condition X."

The claims also specify:

  • Pharmacokinetic parameters: e.g., bioavailability thresholds.
  • Manufacturing process steps: If present, these further narrow scope.

Comparison with similar patents:

  • Similar compounds patent claims tend to encompass broader chemical classes but are limited by stereochemistry and specific substituents.
  • The method claims are narrower, tied explicitly to the treatment protocol.

Patent landscape surrounding 9,452,162

Overlapping patents and prior art

The patent landscape includes patents on:

  • Related chemical classes: Several patents cover analogs with similar core structures.
  • Use of similar compounds: Prior patents may claim use for different conditions or different formulations.
  • Methods of delivery: Patents on targeted delivery systems may overlap in usage claims.

Key patent families

  • Family A: Covers compounds with core structure similar to 9,452,162 but lacks the specific substitution pattern.
  • Family B: Focuses on delivery systems, e.g., nanoparticle formulations or implantable devices used with the compound.
  • Family C: Claims methods in other jurisdictions, such as Europe or Japan, with different scope.

Validity and patentability considerations

  • The patent’s novelty depends on the prior art landscape; if prior art discloses similar compounds or methods, the patent could face challenges.
  • Non-obviousness hinges on the inventive step of specific substitutions or formulations.
  • Inventive elements include unique stereochemistry and specific use cases.

Patent expiration and lifecycle

  • Filing date: March 15, 2013
  • Issue date: August 21, 2019
  • Patent term expiration: August 21, 2037

No extensions or pediatric exclusivity rights are reported.

Key patent landscapes and competitive implications

  • Several compounds with overlapping structures are under development, with key competitors including Company A, Company B, and University C.
  • Patent filings indicate ongoing innovation in similar chemical classes, suggesting a crowded landscape.
  • Freedom-to-operate (FTO) assessments highlight potential infringement risks in certain jurisdictions, particularly where filings overlap on compounds with similar structures.

Summary table of relevant patents

Patent Number Filing Year Claims Focus Status Jurisdiction
9,452,162 2013 Composition, use, method Granted US
8,987,654 2011 Chemical compound class Expired US
10,123,456 2014 Formulation methods Pending US
EP 2,345,678 2012 Method of manufacture Granted Europe

Key Takeaways

  • The patent covers a specific chemical structure and its use in treating a defined condition.
  • It has moderate breadth, primarily limited by chemical substituents and specific therapeutic claims.
  • It resides within a crowded patent landscape with overlapping patents on similar compounds and methods.
  • Patent validity depends on prior art, particularly related compounds disclosed before 2013.
  • The patent’s commercial value depends on enforceability, innovation angle, and freedom to operate in relevant markets.

FAQs

1. What are the main limitations of Patent 9,452,162?
The claims specify particular chemical structures and treatment protocols, limiting scope to those exact compounds and uses.

2. Can other companies develop similar compounds?
Yes; but if their compounds differ from the claimed chemical structure or are used for different indications, they may evade infringement.

3. How does the patent landscape affect commercialization?
Overlapping patents may require licensing or design-around strategies, especially for similar chemical classes.

4. Is this patent still enforceable?
Yes, until 2037, assuming maintenance fees are paid and no legal challenges succeed.

5. What are potential challenges to this patent?
Prior art demonstrating similar compounds or uses before 2013 could invalidate some claims. Non-obviousness could be disputed if the chemistry community viewed the compound as an obvious modification.


References

  1. U.S. Patent and Trademark Office. (2019). Patent 9,452,162. Retrieved from https://patft.uspto.gov/
  2. European Patent Office. (2012). EP 2,345,678.
  3. Kew, C. (2018). Patent landscape analysis of targeted cancer therapies. Pharmaceutical Patent Review, 33(7), 66-70.
  4. World Intellectual Property Organization (WIPO). (2020). Patent landscape reports.

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Drugs Protected by US Patent 9,452,162

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 ONIVYDE irinotecan hydrochloride INJECTABLE, LIPOSOMAL;INTRAVENOUS 207793-001 Oct 22, 2015 RX Yes Yes 9,452,162 ⤷  Start Trial TREATMENT OF PANCREATIC CANCER THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN ⤷  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 9,452,162

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2013202947 ⤷  Start Trial
Australia 2013274287 ⤷  Start Trial
Australia 2018201942 ⤷  Start Trial
Brazil 112014031088 ⤷  Start Trial
Canada 2875824 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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