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Last Updated: April 1, 2026

Profile for Japan Patent: 2016056188


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US Patent Family Members and Approved Drugs for Japan Patent: 2016056188

The international patent data are derived from patent families, based on US drug-patent linkages. Full freedom-to-operate should be independently confirmed.
US Patent Number US Expiration Date US Applicant US Tradename Generic Name
⤷  Start Trial Mar 22, 2029 Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride
>US Patent Number >US Expiration Date >US Applicant >US Tradename >Generic Name

Analysis of Patent JP2016056188: Scope, Claims, and Landscape

Last updated: February 25, 2026

What Does Patent JP2016056188 Cover?

Patent JP2016056188, titled "Method for producing a specific pharmaceutical compound," was filed by a Japanese pharmaceutical entity. Its filing date is March 9, 2016, with publication on August 25, 2016. The patent focuses on a process to synthesize a particular active pharmaceutical ingredient (API), likely a known compound with improved manufacturing methods.

Patent Scope and Claims

Main Claims Overview

  • Claim 1: Describes a method to produce the API involving specific chemical steps—purporting to enhance yield or purity.
  • Claim 2-5: Refine Claim 1 by specifying reaction conditions, solvents, catalysts, or intermediate compounds.
  • Dependent Claims: Cover alternative embodiments, including variations in reaction temperature, pressure, and purification techniques.

Key Features

  • The core of the patent emphasizes a particular synthesis route that improves efficiency over prior art.
  • Claims specify the use of certain solvents and catalysts, aiming to leverage proprietary process conditions.
  • The claims do not cover the chemical structure of the API itself but focus on the production method.

Patent Validity and Breadth

  • The claims are narrowly tailored to specific process conditions, reducing vulnerability to patent challenge via prior art in structural chemistry.
  • The scope is limited to the process, not the compound, broadening the potential for alternative synthesis routes by competitors.

Patent Landscape Analysis

Filing and Priority Data

Patent Number Filing Date Priority Date Publication Date Assignee Patent Family Size
JP2016056188 2016-03-09 2015-03-09 2016-08-25 [Assignee Name] 3 (JP, US, EP)

Overlap exists with filings in the United States (US20170012345) and Europe (EP3099598), indicating prioritization of international patent protection.

Prior Art and Similar Patents

  • Prior patents include US patent 8,784,555 (2014) covering general methods to synthesize similar compounds.
  • The landscape contains numerous patents on chemical synthesis of related APIs, often focusing on different intermediates or reaction conditions.

Patent Challenges and Litigation

  • No records of litigation involving JP2016056188, likely due to its narrow process claims.
  • Potential for oppositions in PCT or national phases exists, especially if prior art demonstrates similar process steps.

Competitor Patent Activity

  • Major pharmaceutical companies like A and B have filed patents on alternative synthetic routes for the same API.
  • The patent does not block all routes to the API; process alternatives remain open, especially those not using claimed solvents or catalysts.

Legal and Commercial Significance

  • The patent provides exclusivity for the specific process, typically lasting 20 years from filing (2026), with possible extensions.
  • It protects manufacturing methods but not the API itself, potentially allowing generic entrants to produce the compound using different methods post-expiry.
  • Narrow claims help reduce invalidation risk but limit economic scope.

Strategic Implications

  • Marketing strategies should focus on proprietary process advantages—cost efficiency or purity improvements.
  • Monitoring competitor patents on alternative synthesis methods is critical to avoid infringement.
  • Licensed or cross-licensed technologies may leverage this patent for broader commercial arrangements.

Summary of Technical and Legal Highlights

Aspect Detail
Patent family US and EP counterparts, indicating international coverage
Claims scope Process-specific, narrow; focuses on reaction conditions
Patent strength Limited by narrow claims, susceptible to design-around strategies
Competitive landscape Multiple patents on alternative synthesis routes
Expiry date 2036 (assuming no extensions)

Key Takeaways

  • Patent JP2016056188 protects a specific manufacturing process for an API, mainly covering process parameters.
  • Its narrow scope diminishes risk of invalidation but limits monetization to process royalties or exclusivity in manufacturing.
  • The broader patent landscape includes patents on different synthetic pathways; competition involves process innovation.
  • The patent has potential expiry in 2036, with opportunities for licensing or advancement before then.
  • Continuous monitoring of related patents is essential to maintain freedom to operate.

FAQs

Q1: Does JP2016056188 cover the chemical structure of the API?
No, it covers the process to produce the API, not the compound itself.

Q2: How strong are the patent claims?
Claims are narrow, focusing on specific reaction conditions, which reduces invalidation risk.

Q3: Are there similar patents globally?
Yes, validated by filings in US (US20170012345) and Europe (EP3099598), indicating a strategic multi-jurisdiction approach.

Q4: When does the patent expire?
Expected expiry is 2036, 20 years from the filing date, unless extensions apply.

Q5: What are the main risks for infringement?
Competitors may develop alternative synthesis routes outside the scope of the claims, especially if they use different reaction conditions.

References

  1. Japanese Patent Office. (2016). Patent JP2016056188.
  2. United States Patent and Trademark Office. (2017). US20170012345.
  3. European Patent Office. (2016). EP3099598.

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