Procedure: Intellectual Property Rights Protection
Country: Global Procedure
Version #: 11/28/2023
Author: Daria Kostiuchenko
Editor: Daria Kostiuchenko

ID: GP-PhR-IP-SR
Category: Pharmaceuticals/MD&IVD/Others
Validity: IP Rights Expiration Date
Certified by: Vlad Reznikov
Copyright: Pattern of USA Inc.

SUMMARY

Intellectual Property Rights Protection in pharmaceuticals registrations refers to the legal mechanisms and regulations in place to safeguard the intellectual property of pharmaceutical companies. This includes patents, trademarks, copyrights, and trade secrets related to pharmaceutical products and processes. The protection of these rights is crucial in the pharmaceutical industry to safeguard research and development, as well as to prevent unauthorized use, infringement, smuggling, counterfeit or re-export issues.

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Must-Have Requirements, Recognized Standards, and Certifications:

  • Original documentation for IP rights protection

Nice-to-have: IP Class code/s or Cooperative Patent Classification (CPC), International IP Rights protection

Typical Gaps and Deficiencies: International IP Rights infringement, lack of international harmonization

Implementation Period: Immediately after approval

Deliverables: Country-specific IP Search Report, Certificate of Copyright (©), Trademark (™) or Patent Registration

PHASE

TASK

TASK

START

DURATION

 

Fee

 

KPI

NUMBER

TITLE

OWNER

W/M/Q/Y

in weeks

3rd Party 

Service 

State

 

0

In-house Pre-Submission Activity

       

  0.1

NDA signing or validation

Executor

week 1

1

    

  0.2

Contract Closing

MAH

week 1

1

    

  0.3

POA issuance and shipping

MAH

week 1

1

    

  0.4

Invoice is sent to MAH and paid

Executor

week 1

1

    

  0.5

Document processing

Executor

week 2

1

    

  0.6

Translations, Notary and Apostilles 

3rd party

week 2

2

    

  0.7

SOW is approved by MAH

Executor

week 4

1

   

SOW

I

IP Rights Search

       

  I.1

Copyright Search

Executor

week 5

2

    

  I.2

Trademark Search

Executor

week 5

2

    

  I.3

Patent Search

Executor

week 5

2

    

  I.4

Reporting to MAH

Executor

week 7

1

   

Search Report

II

Application to NRA

       

  II.1

Filing a copyright application/s

Executor

week 8

2

   

Application

  II.2

Filing a trademark application/s

Executor

week 8

2

   

Application

  II.3

Filing a patent application/s

Executor

week 8

2

   

Application

  II.4

Communication with NRA

Executor

week 10

1

   

Q&A

III

Approval and Market Exclusivity

       

  III.1

Obtaining apporval/s from NRA

Executor

week 11

4

    

  III.2

Reporting to MAH

MAH

week 15

1

   

Approval

F

Final Phase In-house Post-Authorization Activity

       

  F.1

Service Acceptance Certificate signing

MAH

week 16

1

    

  F.2

Final Invoice

Executor

week 17

1

    

  F.3

Final Payment

MAH

week 18

1

    

  F.4

Contract Termination

Executor

week 19

1

    

  F.5

Archiving and limiting access

Executor

week 19

1

   

Archiving

 

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