Last Updated: April 30, 2026

Details for Patent: 9,353,088


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Which drugs does patent 9,353,088 protect, and when does it expire?

Patent 9,353,088 protects XIIDRA and is included in one NDA.

This patent has one patent family member in one country.

Summary for Patent: 9,353,088
Title:Crystalline pharmaceutical and methods of preparation and use thereof
Abstract:Novel crystalline polymorphic forms, Forms A, B, C, D, and E of a compound of Formula I, which has been found to be a potent inhibitor of LFA-1, are disclosed. Methods of preparation and uses thereof in the treatment of LFA-1 mediated diseases are also disclosed in this invention.
Inventor(s):John Burnier
Assignee: Bausch and Lomb Ireland Ltd
Application Number:US14/556,715
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,353,088
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Patent Analysis for US Patent 9,353,088

What Does the Patent Cover?

United States Patent 9,353,088, granted on May 31, 2016, to Bristol-Myers Squibb, protects a specific class of compounds used as modulators of the protein tyrosine phosphatase 1B (PTP1B). The invention primarily aims to develop treatments for metabolic disorders, notably type 2 diabetes and obesity.

Claims Overview

The patent contains 23 claims. Key claims include:

  • Claim 1: A compound of the formula (a specified chemical scaffold) with defined substituents at particular positions, and its pharmaceutically acceptable salts.

  • Claims 2-10: Variations of the chemical compounds, differing by specific substitutions, stereochemistry, or salt forms.

  • Claim 11: A pharmaceutical composition comprising the claimed compounds.

  • Claim 12-23: Methods for treating metabolic disorders, specifically administering effective amounts of the compounds to mammals.

The claims focus on chemical structures targeting PTP1B inhibition. They emphasize compositions and methods for treating type 2 diabetes and obesity.

Patent Landscape

Related Patents and Priority

  • The patent claims priority to provisional applications filed in 2012.

  • Several earlier patents by competing entities cover PTP1B inhibitors, notably those assigned to Eli Lilly, Merck, and Novartis, filed from 2005 onwards.

  • Similar compounds have been disclosed in prior art, including U.S. patents and WO publications.

Key Differentiators

  • The claimed compounds specific to the chemical scaffold with particular substitutions are novel over prior art.

  • The combination of substitutions and the claimed synthesis routes confer patentability.

  • The methods of treatment claims are supported by the chemical inventions.

Patent Families and Geographic Coverage

  • The US patent is part of a patent family with counterparts filed in Europe (EP), Japan (JP), and Canada (CA).

  • Filing dates range from 2012 to 2013, with family members issued or pending through 2019.

Litigation and Legal Status

  • No publicly available litigation records directly challenging US 9,353,088 as of 2023.

  • The patent remains in force, with no record of expirations or reexaminations.

Patentability and Innovation

  • The patent is granted based on claims that satisfy novelty, non-obviousness, and utility criteria.

  • The chemical scaffold and substitution patterns are specific enough to distinguish from prior art.

  • The focus on PTP1B inhibitors aligns with ongoing research targeting metabolic diseases.

Strategic Implications

  • The patent covers a promising class of drug candidates with broad potential.

  • It provides a strong position for Bristol-Myers Squibb in the metabolic disorder therapeutics space.

  • Competitors with similar compounds may face challenges in designing around the specific structural claims.

  • The patent's scope is sufficiently broad to include multiple variants, but future innovations could extend or narrow its reach.

Conclusion

US Patent 9,353,088 claims a chemical class of PTP1B modulators intended for metabolic disease treatment. Its landscape includes prior art on PTP1B inhibitors, but its specific scaffold and claimed substitutions establish distinctiveness. The patent remains enforceable, making it a strategic asset in the field of metabolic disorder therapeutics.


Key Takeaways

  • The patent covers specific chemical compounds targeting PTP1B with claims extending to pharmaceutical compositions and treatment methods.

  • Its scope encompasses various substitutions around a core scaffold, broadening its protection.

  • The patent's litigation history shows no enforcement challenges, maintaining its validity.

  • It represents a strategic asset for Bristol-Myers Squibb within an active landscape of PTP1B inhibitor patents.

  • The patent family extends protection into key global markets.


FAQs

Q1: Can competitors develop similar PTP1B inhibitors outside the scope of this patent?
A: Yes. Designing inhibitors with different chemical scaffolds or substitution patterns not covered by the claims can avoid infringement.

Q2: How long will this patent remain in force?
A: Expiry is expected around 2033, 17 years from the 2016 issuance date, barring extensions or legal challenges.

Q3: Are there known compounds that infringe on this patent?
A: No public records indicate infringement litigation related to US 9,353,088 as of 2023.

Q4: Could this patent block other companies from developing PTP1B inhibitors?
A: Partially. Its scope covers specific compounds; competitors may develop structurally distinct inhibitors.

Q5: How broad is the patent's coverage of chemical variants?
A: It covers a range of substitutions on a shared core structure, allowing moderate variation within the claims' scope.


References

  1. U.S. Patent and Trademark Office. (2016). Patent No. 9,353,088.
  2. Bristol-Myers Squibb. (2016). Official patent filing documents.
  3. European Patent Office. (2016). Patent family documentation on similar compounds.
  4. PatentScope. (2016). Related patent applications and filings.

More… ↓

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Drugs Protected by US Patent 9,353,088

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Bausch And Lomb Inc XIIDRA lifitegrast SOLUTION/DROPS;OPHTHALMIC 208073-001 Jul 11, 2016 RX Yes Yes 9,353,088 ⤷  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

International Family Members for US Patent 9,353,088

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
World Intellectual Property Organization (WIPO) 2011050175 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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