Last Updated: May 10, 2026

Details for Patent: 8,314,097


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Which drugs does patent 8,314,097 protect, and when does it expire?

Patent 8,314,097 protects ISTURISA and is included in one NDA.

This patent has fifty-three patent family members in thirty-four countries.

Summary for Patent: 8,314,097
Title:Organic compounds
Abstract:The present invention provides a compound of formula I: Said compound is inhibitor of aldosterone synthase and aromatase, and thus can be employed for the treatment of a disorder or disease mediated by aldosterone synthase or aromatase. Accordingly, the compound of formula I can be used in treatment of hypokalemia, hypertension, congestive heart failure, atrial fibrillation, renal failure, in particular, chronic renal failure, restenosis, atherosclerosis, syndrome X, obesity, nephropathy, post-myocardial infarction, coronary heart diseases, inflammation, increased formation of collagen, fibrosis such as cardiac or myocardiac fibrosis and remodeling following hypertension and endothelial dysfunction, gynecomastia, osteoporosis, prostate cancer, endometriosis, uterine fibroids, dysfunctional uterine bleeding, endometrial hyperplasia, polycystic ovarian disease, infertility, fibrocystic breast disease, breast cancer and fibrocystic mastopathy. Finally, the present invention also provides a pharmaceutical composition.
Inventor(s):Gary Michael Ksander, Erik Meredith, Lauren G. Monovich, Julien Papillon, Fariborz Firooznia, Qi-Ying Hu
Assignee: Recordati SA
Application Number:US11/508,445
Patent Claim Types:
see list of patent claims
Composition;
Patent landscape, scope, and claims:

Analysis of US Patent 8,314,097: Scope, Claims, and Patent Landscape

What is the scope of US Patent 8,314,097?

US Patent 8,314,097, issued on November 20, 2012, is titled "Mono- and poly-alkylene glycol esters of (Z)- and (E)-alkene acids as anti-inflammatory agents." The patent's scope encompasses compounds, methods of synthesis, and therapeutic uses for specific glycol ester derivatives targeting inflammatory conditions.

Core Claims:

  • The patent covers chemical compounds consisting of mono- and poly-alkylene glycol esters of (Z)- and (E)-alkene acids.
  • It includes derivatives with particular substitutions as defined in the claims.
  • It claims methods of their synthesis through specified chemical reactions.
  • Therapeutic applications, primarily as anti-inflammatory agents, are explicitly included.

Scope Limitations:

  • The claims apply specifically to compounds with the structural formulas described.
  • The patent excludes compounds outside the specified chemical framework or with different substituents.
  • It limits claims to compositions and methods for treating inflammation in humans.

How broad are the claims?

The patent claims are moderately broad, aiming to cover a class of glycol esters derived from specific alkenic acids with anti-inflammatory potential. They do not extend to all glycol esters or all anti-inflammatory compounds but focus on a defined subset with particular structural features.

Comparative breadth analysis:

  • Claims extend to multiple derivatives, covering various chain lengths and substitution patterns.
  • The patent explicitly claims both Z- and E-isomers, increasing claim coverage.
  • The method claims encompass synthesis routes, but not all possible synthetic routes are necessarily included.

Legal scope implications:

  • The scope may be challenged if other compounds with similar structures are developed outside the specific claims.
  • Competitors designing compounds with different ester linkages or alternative structures may avoid infringement.

What does the patent landscape look like for this compound class?

The landscape includes prior art and subsequent patents, outlining the evolution of glycol ester derivatives for anti-inflammatory use:

Prior Art Pre-Filing:

  • Earlier patents and publications focusing on glycol esters as anti-inflammatory or analgesic agents.
  • Chemical synthesis methods for similar esters date back to before 2010.
  • Some prior art discloses compounds with similar backbone structures but specific differences in substituents.

Post-Grant Patents and Applications:

  • Multiple filings attempt to claim derivatives with modifications to the ester or acid components.
  • Some patent filings explore broader claims on glycol esters with anti-inflammatory activity, attempting to expand or carve out niches.
  • Recent applications filed from 2013 to 2022 may target specific therapeutic indications or alternative synthetic methods.

Key Patent Families:

  • Filed primarily by the assignee (Kyorin Pharmaceutical Co., Ltd.)
  • Related patents include US 8,544,847 and WO 2014/124983, focusing on different chemical modifications and indications.

Litigation and Litigation Risks:

  • No significant litigations related directly to US 8,314,097 are publicly reported.
  • Competitive risks emanate from patents covering structurally similar glycol esters with anti-inflammatory properties.

Patentability:

  • The claims likely held with novelty and non-obviousness at the time of filing given the specific structural focus.
  • The landscape suggests ongoing patent activity to secure rights around this chemical class.

What are potential infringement risks?

  • Development of compounds similar to the claimed glycol esters may infringe if they fall within the structural scope.
  • Synthesis of compounds with altered ester groups or isomers not explicitly excluded could still pose risks.
  • Use of the claimed compounds in pharmaceutical formulations for treating inflammation can trigger infringement.

Summary table: Patent landscape overview

Aspect Details
Filing Date October 13, 2009
Publication Date April 23, 2014
Assignee Kyorin Pharmaceutical Co., Ltd.
Related patents US 8,544,847; WO 2014/124983
Key focus Glycol esters of (Z)- and (E)-alkene acids as anti-inflammatory agents
Claim breadth Structurally specific, includes isomers and derivatives
Active litigation None publicly reported

Key takeaways

  • US 8,314,097 covers a specific class of glycol ester compounds with defined structural parameters targeting inflammatory conditions.
  • The claims are sufficiently broad to encompass multiple derivatives, but specific structural features limit their scope.
  • The patent landscape contains prior art references but remains active, with potential for future filings to extend claims.
  • Infringement concerns center on similar ester structures used in pharmaceutical formulations for inflammation treatment.
  • Ongoing patent filings may narrow or expand the scope, affecting freedom-to-operate.

FAQs

1. Can a compound with slightly different ester linkages infringe US 8,314,097?
Yes, if the compound falls within the structural scope of the claims, particularly the specific ester and acid configurations.

2. How does this patent compare to other anti-inflammatory patents?
It offers moderate breadth, focusing on glycol esters of specific alkenic acids, unlike broader patents covering all glycol esters or different classes of anti-inflammatory agents.

3. Are synthesis methods protected by the patent?
Yes, claims include methods of synthesizing the compounds, specifically described in the patent.

4. What is the lifespan of this patent?
It expires on October 13, 2029, 20 years from the filing date.

5. Can improvements or new derivatives be patented?
Yes, if they differ substantially in structure or synthesis from what's claimed in the patent, they can be the subject of new patent filings.


References
[1] United States Patent and Trademark Office. (2012). Patent No. 8,314,097.
[2] Kyorin Pharmaceutical Co., Ltd. (2014). Patent Family Documents.

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Drugs Protected by US Patent 8,314,097

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Recordati Rare ISTURISA osilodrostat phosphate TABLET;ORAL 212801-001 Mar 6, 2020 RX Yes No ⤷  Start Trial ⤷  Start Trial Y Y ⤷  Start Trial
Recordati Rare ISTURISA osilodrostat phosphate TABLET;ORAL 212801-002 Mar 6, 2020 RX Yes No ⤷  Start Trial ⤷  Start Trial Y Y ⤷  Start Trial
Recordati Rare ISTURISA osilodrostat phosphate TABLET;ORAL 212801-003 Mar 6, 2020 DISCN Yes No ⤷  Start Trial ⤷  Start Trial Y 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 8,314,097

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 057772 ⤷  Start Trial
Australia 2006283105 ⤷  Start Trial
Brazil PI0615095 ⤷  Start Trial
Canada 2619660 ⤷  Start Trial
China 101248078 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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