Patent management: regulatory affairs scope of practice

"Are patent management and research activities part of Regulatory affairs department responsibilities at your company or not? If not, which department?". That's a question I posted on LinkedIn and RegEx trying to figure out the scope of practice of "Patent management" with respect to the regulatory affairs professionals.

Surprisingly, I think the answers to one question have revealed to me how variable the scope of practice is, depending on the company main activities and its location!

Generally, we can say the "patent management and research activities" are shared between the following "functional" departments in a company:

1. Legal/ IP legal
2. R&D
3. Regulatory affairs
4. Marketing/Brand management

In the following table, I summarized the relative contribution of functional departments to the patent management and research activities in different types of pharmaceutical companies. That's according to the feedback I obtained in the previous few days regarding my above question. Definitely, this relative contribution is itself relative and may vary from one company to another!

Research companies

In research, originators or brands companies, R&D department is the main responsible functional unit for developing patents. Patent prosecution is mostly outsourced to a patent attorney. The corporate R&D and legal departments work in harmony to support the patent attorney mission.

RA department roles

In research companies, the RA department may have the following roles:

1. filing the relevant patents to the drug authority to protect the company innovations from the copycat developers either generics or biosimilars.
2. raising internal awareness regarding the patent regulations issued by the drug authority and keeping the corporate updated for effected or foreseen changes. This task could be outsourced to a patent attorney who is professional in the pharmaceutical field. This is considered as a part of the IP risk management plan.
3. referring to the R&D department to clarify any technical issues related to the patents.
4. raising flags regarding the milestone dates of any patent term extension requests.

Affiliates of research companies

For regional affiliates of research companies, the regional patent prosecution is accomplished through the cooperation of the global and regional legal departments to support the mission of the company regional patent attorney.

RA department roles

The regional RA department has the responsibility of:

1. obtaining the patent information that support their new submissions from either the regional legal department or the corporate RA department.
2. raising internal awareness regarding the regional patent regulations issued by the regional drug authority and keeping the corporate updated for effected or foreseen changes.

Generic/biosimilar companies

Many generic/biosimilar companies have setup a dedicated unit that is responsible for the IPR (Intellectual Property Rights) studies and research. The unit studies the patent clauses in the regulations and guidelines of each relevant country/region and recommends the suitable product filing strategy.

RA department roles

The generic RA department is also responsible for raising internal awareness regarding the patent regulations issued by the different drug authorities globally and regionally; and keeping the corporate updated for effected or foreseen changes. This task is very important to reveal any opportunities and to plan the global submission strategy.

Many companies are currently utilizing the services of regulatory intelligence companies to help in portraying the best strategies and achieving the optimum outcomes.

I hope this summary helps our colleagues who share with me the same point of curiosity! I'll be very pleased to receive your comments and thoughts to enrich this summary.

Thanks to all who spent minutes of their precious time to drop an answer to my question.