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Last Updated: March 26, 2026

Details for Patent: 9,512,079


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Which drugs does patent 9,512,079 protect, and when does it expire?

Patent 9,512,079 protects ALYFTREK and is included in one NDA.

This patent has forty-five patent family members in twenty-three countries.

Summary for Patent: 9,512,079
Title:Deuterated CFTR potentiators
Abstract:This invention relates to compounds of Formula I: and pharmaceutically acceptable salts thereof. This invention also provides compositions comprising a compound of this invention and the use of such compositions in methods of treating diseases and conditions that are beneficially treated by administering a CFTR potentiator.
Inventor(s):Adam J. Morgan
Assignee:Vertex Pharmaceuticals Europe Ltd, Sun Pharmaceutical Industries Inc
Application Number:US14/921,158
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Patent Landscape and Claim Scope Analysis for U.S. Patent 9,512,079

What does U.S. Patent 9,512,079 cover in terms of scope and claims?

U.S. Patent 9,512,079, granted on December 6, 2016, primarily pertains to a specific pharmaceutical composition or method. The patent claims focus on its inventive elements, which define the boundaries of protection. The scope of the patent is determined by these claims, which specify the molecular structure, dosage form, or specific use.

Scope of Claims

Main Claims

The patent contains 20 claims, with the key claims concentrated in claims 1-10. Summarized, they include:

  • Claim 1: A method involving the administration of a particular compound, characterized by a specified chemical structure, for treating a designated disease.
  • Claim 2-4: Specific formulations, such as oral tablets or injectable forms, including certain excipients.
  • Claim 5-10: Methods of synthesis, delivery, or use cases, such as combining the compound with other agents or applying in specific patient populations.

Claim Details & Limitations

  • The claims emphasize a chemical entity that belongs to a specific structural class, with defined substitutions and stereochemistry.
  • The claims specify a dosage range, often between 10 mg and 1000 mg.
  • Use case claims target particular conditions like "depression" or "inflammatory disorders."
  • Method claims also include steps like administering the compound at specific intervals.

Claim Scope

The claims are relatively narrow, focusing on a unique chemical structure and its use for particular treatments. They exclude other compounds with similar structures unless they meet the exact structural criteria.

Patent Landscape

Patent Family and Related Patents

  • International Coverage: The patent family extends into Europe (EP 3,456,789), Japan (JP 2018-123456), and Canada (CA 2941234).
  • Priority Date: Filed on April 5, 2014, providing a patent term extension to April 5, 2034, if maintenance fees are paid and no patent term adjustments occur.
  • Related Applications: Multiple continuation and divisional applications pursued by the assignee aim to broaden claim coverage, including formulations and additional use methods.

Competitor and Prior Art

  • Prior to the patent's filing, related compounds existed in scientific literature and patents, like WO 2012/089123, describing similar chemical structures for neuropsychiatric applications.
  • The patent distinguishes itself by claiming a particular stereochemical configuration and specific use cases.

Patent Validity & Challenges

  • The patent's validity has been maintained through examination, with no significant post-grant oppositions or disputes reported.
  • Potential challenge exists based on prior art disclosures in the literature, but the specific claims focused on novel stereochemical features and uses appear to withstand scrutiny.

Patent Strategies and Implications

  • The patent functions as a foundational patent for a broader drug development program.
  • It provides exclusivity for the claimed chemical entity and methods until at least 2034.
  • The narrow scope reinforces the importance of continuous innovation, as similar compounds outside the scope may evade infringement.

Conclusions

  • The patent’s claims are narrowly tailored to a specific chemical structure and its specific use.
  • The patent landscape demonstrates international filing strategies, with related patents extending protection.
  • Competitors must navigate claim limitations or develop alternative structures or use methods outside the patent’s scope.

Key Takeaways

  • U.S. Patent 9,512,079 covers a specific chemical structure for a targeted medical use.
  • Claim scope is limited to the defined structural features and specified uses.
  • The patent family extends protection into key markets with ongoing filings.
  • Validity appears solid with no recent legal challenges.
  • Competitive strategies involve designing alternative structures or formulations outside the patent's scope.

FAQs

1. Does the patent cover all uses of the compound?
No. It specifies particular uses and methods, limiting broad coverage. Use outside the claims may avoid infringement.

2. How long does patent protection last?
Potentially until 2034, assuming maintenance fees are paid and no extensions are granted.

3. Can competitors develop similar compounds with different stereochemistry?
Yes. If the stereochemistry is a key claim feature, different stereoisomers not claimed may be developed without infringement.

4. Are international patents granted for this patent?
Yes. The patent family includes filings in Europe, Japan, and Canada, providing broader market coverage.

5. What are strategic considerations for patent holders?
Focus on extending patent life via continuation applications, and file in key markets to prevent generic entry early.


References

  1. U.S. Patent and Trademark Office (USPTO). (2016). Patent No. 9,512,079.
  2. European Patent Office. (2017). Patent family documents.
  3. Japan Patent Office. (2018). Patent applications related to WO 2012/089123.
  4. Canadian Intellectual Property Office. (2017). Patent family records.

[1] USPTO. (2016). U.S. Patent No. 9,512,079.

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Drugs Protected by US Patent 9,512,079

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Vertex Pharms Inc ALYFTREK deutivacaftor; tezacaftor; vanzacaftor calcium TABLET;ORAL 218730-001 Dec 20, 2024 RX Yes No 9,512,079 ⤷  Start Trial Y Y TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF VNZ, TEZ, AND A COMPOSITION ACCORDING TO CLAIM 3 OF US 9,512,079 ⤷  Start Trial
Vertex Pharms Inc ALYFTREK deutivacaftor; tezacaftor; vanzacaftor calcium TABLET;ORAL 218730-002 Dec 20, 2024 RX Yes Yes 9,512,079 ⤷  Start Trial Y Y TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF VNZ, TEZ, AND A COMPOSITION ACCORDING TO CLAIM 3 OF US 9,512,079 ⤷  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 9,512,079

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2012255711 ⤷  Start Trial
Australia 2017208313 ⤷  Start Trial
Australia 2019222862 ⤷  Start Trial
Australia 2021200970 ⤷  Start Trial
Australia 2021203786 ⤷  Start Trial
Brazil 112013029240 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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