Assuming a company has at least the following divisions (some of these might be combined):
* R&D
* Operations (including manufacturing)
* Quality
* Sales
* Marketing
* Regulatory
* Clinical
R&D should have primary responsibility for generating patents and typically works with outside patent attorneys to prosecute patents while internal corporate legal might be responsible for the administrative aspects. At larger companies legal will take more responsibility for IP, but the internal corporate legal departments at most companies don't have a patent attorney or a patent agent on staff.
R&D should have primary responsibility for technical research related to the product, including collaborative research conducted with outside experts, but in most cases should be working closely with Marketing.
Marketing should have primary responsibility for research related to customer needs while working in concert with R&D.
Clinical is responsible for clinical research related questions while working closely with R&D and Marketing.
At any competent, functional company there would be cooperation between functional roles so Regulatory would be in the loop on most research being conducted, but there are strong reasons why distinct functional roles exist with clear delineations of responsibility.
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Thomas Hoegh
Edina MN
United States
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Original Message:
Sent: 13-Feb-2021 12:46
From: Alaa El Kazak
Subject: Patent Management
Dear Pharma folks,
Are patent management and research activities are part of Regulatory affairs department responsibilities at your company or not? If not which department?
The question applies to both Brand and generic companies.
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Alaa El Kazak Msc., RAC
Jeddah
Saudi Arabia
https://www.linkedin.com/in/alaaelkazak/
http://bcert.me/snztdjygk
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