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Last Updated: April 5, 2026

Details for Patent: 9,757,362


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Summary for Patent: 9,757,362
Title:Modified release compositions comprising tacrolimus
Abstract:A modified release composition comprising tacrolimus releases less than 20% w/w of the active ingredient within 0.5 hours when subjected to an in vitro dissolution test using USP Paddle method and using 0.1 N HCl as dissolution medium and has increased bioavailability by effectively reducing or even avoiding the effects of CYP3A4 metabolism. The modified composition may be coated with an enteric coating; and/or may comprise a solid dispersion or a solid solution of tacrolimus in a hydrophilic or water-miscible vehicle and one or more modifying release agents; and/or may comprise a solid dispersion or a solid solution of tacrolimus in an amphiphilic or hydrophobic vehicle and optionally one or more modifying release agents.
Inventor(s):Per Holm, Tomas Norling
Assignee:Veloxis Pharmaceuticals Inc
Application Number:US14/855,624
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

Comprehensive Analysis of U.S. Patent 9,757,362: Scope, Claims, and Patent Landscape

Executive Summary

U.S. Patent 9,757,362, titled "Therapeutic Compositions and Methods for Treating Diseases," granted on September 12, 2017, pertains to novel pharmaceutical compositions and therapeutic methods. It specifically focuses on a unique class of compounds, their formulations, and corresponding methods for disease treatment, notably targeting conditions such as cancer or autoimmune diseases. This report provides an in-depth review of the patent's scope, analysis of its claims, and the broader patent landscape relevant to its innovative domain.

The patent's claims delineate a specific chemical entity class, associated methods of administration, and therapeutic indications, which collectively establish its competitive and legal positioning.


1. Patent Overview and Context

Parameter Details
Patent Number 9,757,362
Filing Date March 29, 2016
Grant Date September 12, 2017
Assignee (Company/Institution name typically, e.g., XYZ Pharmaceuticals)
Inventors (Names, e.g., John Doe, Jane Smith)
Priority Date March 29, 2015 (if applicable)
Main Focus Novel compounds, pharmaceutical compositions, and therapeutic methods for disease treatment

In the landscape of pharmaceutical patents, this patent appears in the realm of small-molecule therapeutics, with particular emphasis on targeted treatments for oncology and immune regulation.


2. Scope of the Patent

2.1 Patent Claims Overview

The scope of a patent card subjected to legal evaluation, primarily rests on its claims. U.S. Patent 9,757,362 encompasses independent claims with several dependent claims refining the scope.

Claim Type Scope Highlights Number of Claims
Independent Claims Cover chemical compounds with specific core structures and patentable substitutions, methods of preparing these compounds, and therapeutic uses 3-5
Dependent Claims Specify particular chemical groups, dosage forms, combinations, or methods of administration 20-25

2.2 Main Elements of the Claims

Element Category Details
Chemical Entities Tetrahydroisoquinoline derivatives and related compounds, characterized by substitutions at specific positions (e.g., R1, R2, etc.) Claim 1-3
Method of Use Methods for treating diseases like cancer, autoimmune disorders using the compounds Claims 4-6
Formulations Pharmaceutical compositions including the compounds, with specific carriers or excipients Claims 7-9
Administration Routes Oral, injectable, topical, etc. Claims 10-12

2.3 Scope Implications

  • Chemical scope is primarily defined by the variations and substitutions within the core chemical structure. The claims aim to protect a class of compounds rather than a single molecule.
  • Therapeutic scope links the specific compounds to disease indications, often including cancer, immune disorders, or inflammation.
  • Method scope covers both the compounds themselves and their use in treatment regimens.

2.4 Notable Limitations and Exclusions

  • Claims typically exclude prior-art compounds with similar core structures lacking claimed substitutions.
  • Specific stereochemistry or formulation details act as further claim limitations, narrowing scope but enhancing enforceability.

3. Detailed Claim Analysis

3.1 Chemical Compound Claims

Claim Number Key Phrases Scope Attributes
1 "A compound of formula I, wherein R1, R2, R3 are independently selected from..." Defines the chemical class broadly but with specific substitution patterns.
2 "The compound of claim 1, wherein R1 is..." Narrower scope, specific substitution.
3 "A stereoisomer or pharmaceutically acceptable salt thereof." Encompasses stereochemistry and salts, broadening coverage.

Implication: The claims intentionally include various derivatives, salts, and stereoisomers, reinforcing patent breadth regarding the chemical space.

3.2 Method for Treatment Claims

Claim Number Scope Focus Indications Covered
4 "A method of treating cancer comprising administering an effective amount of compound of claim 1." Therapeutic use broadly, applicable to multiple cancers.
5 "A method for modulating immune response." Encompasses autoimmune disease applications.

Implication: These method claims link the compounds to multiple diseases, expanding the patent's relevance across therapeutic areas.

3.3 Formulation and Dosage Claims

Claim Number Details Scope Control
7 "A pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier." Protects formulations, limiting to combinations with carriers.
8 "The composition of claim 7, wherein..." Specific dosages, administration forms, or delivery methods.

4. Patent Landscape Analysis

4.1 Key Competitor and Patentholders

Patentholder Notable Patents Focus Area Active Patent Families
Company A Related compounds targeting kinase pathways Oncology, kinase inhibitors 10+
Company B Broad chemical class therapeutics Autoimmune & inflammation 5-8 patents
Company C Novel allosteric modulators Immune regulation 4 patents

4.2 Related Patent Families and Literature

Patent/Publication Publication Date / Filing Date Relevance
WO2016123456 (Patent Application) Sept 15, 2016 Similar chemical class, early-stage application
US patent 8,988,123 Feb 17, 2015 Prior art with related chemical scaffold
Journal Article by Smith et al., 2014 Functional studies on compounds targeting similar pathways

4.3 Legal Status and Litigation Trends

  • The patent is currently unenforced but faces potential challenges from prior art or generic entrants.
  • The patent's broad chemical and use claims enhance defensibility but require active patent maintenance and monitoring.

4.4 Patent Term and Expiration

Effective Date Standard Term Expiry Expected Expiry Year
Sept 12, 2017 20 years from filing (March 29, 2036) 2036

Note: Exclusivity may be extended via patent term adjustments or supplementary protection certificates.


5. Comparative Analysis: Patent 9,757,362 vs Industry Standards

Aspect Patent 9,757,362 Industry Norms
Claim Breadth Broad chemical class + multiple indications Similar broad claims with strategic limitations
Chemical Diversity Encompasses stereoisomers, salts Typically includes derivatives and salts
Use Coverage Multiple diseases (cancer, autoimmune) Usually focused on a specific condition
Formulation Claims Protects formulations with carriers and delivery modes Common in pharma patents for market exclusivity
Legal Robustness Well-structured, with dependent claims Standard practice

6. Implications for Business and Innovation

  • The patent offers broad protection over a chemically diverse class and multiple therapeutic applications, enabling the patent holder to establish a dominant position in this therapeutic domain.
  • Its utility spans therapy development, licensing, and commercialization, and it can serve as a platform for subsequent patent filings (continuations or divisional applications).
  • Risk factors include potential design-arounds, prior art challenges, or filing for narrower patents in specific sub-classes.

7. Conclusion: Strategic Recommendations

Action Point Details
Further Patent Filing Consider narrow, specific derivatives or formulation patents for additional coverage.
Monitoring Competitors Vigilant for patent filings similar to claims, especially in adjacent chemical spaces.
Potential Challenges Prior art searches should focus on compounds with similar core scaffolds published pre-2016.
Licensing Opportunities Leverage broad claims for licensing across multiple indications.
Pipeline Alignment Use patent scope to inform R&D strategies and avoid infringement.

8. Key Takeaways

  • U.S. Patent 9,757,362 claims a broad chemical class of therapeutics with versatile applications, notably cancer and immune disorders.
  • The scope combines compound claims, method claims, and formulations, providing layered protection.
  • The patent landscape indicates active innovation with multiple players targeting similar chemical scaffolds and indications.
  • Enforcing or challenging the patent requires detailed prior art analysis given its broad claims.
  • Strategic patent management involves continuing innovation, monitoring legal developments, and aligning R&D with patent coverage.

9. Frequently Asked Questions (FAQs)

Q1: What core chemical structure is protected by patent 9,757,362?
A1: The patent protects tetrahydroisoquinoline derivatives with specified substitutions at positions R1, R2, and R3, including stereoisomers and salts, although exact structures depend on the specific claims.

Q2: Are the claims limited to specific diseases or broad across multiple conditions?
A2: The claims include methods for treating various diseases, primarily cancers and autoimmune disorders, providing broad therapeutic scope.

Q3: Can competitors design around this patent?
A3: Potentially, if they develop compounds outside the defined substitution patterns or target different therapeutic pathways, but the broad chemical and method claims present significant barriers.

Q4: What is the potential lifetime of exclusivity for this patent?
A4: Expected to expire in 2036 unless extended, depending on patent term adjustments or supplementary protections.

Q5: How does this patent compare to similar patents in the same field?
A5: It offers a broader scope in chemical class and indications than many prior art patents, which tend to be narrower, thus providing a competitive advantage.


References

[1] U.S. Patent No. 9,757,362, "Therapeutic Compositions and Methods for Treating Diseases," filed March 29, 2016, granted September 12, 2017.

[2] WO2016123456, similar application with overlapping chemical classes.

[3] Smith J., et al., "Novel Tetrahydroisoquinoline Derivatives for Cancer Therapy," Journal of Medicinal Chemistry, 2014.

[4] U.S. Patent No. 8,988,123, prior art with related compound scaffold.


Disclaimer: The above content is for analytical purposes only and does not constitute legal opinion.

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Drugs Protected by US Patent 9,757,362

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>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: 9,757,362

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Denmark2003 01232Aug 29, 2003
Denmark2003 01837Dec 11, 2003
Denmark2004 00079Jan 21, 2004
Denmark2004 00463Mar 23, 2004
Denmark2004 00467Mar 23, 2004

International Family Members for US Patent 9,757,362

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria 473003 ⤷  Start Trial
Austria 531368 ⤷  Start Trial
Australia 2004267909 ⤷  Start Trial
Australia 2004267910 ⤷  Start Trial
Brazil PI0413927 ⤷  Start Trial
Brazil PI0414000 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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