I think this is a very interesting topic that you have raised. However, I do not agree that whoever writes the protocol or pays for the study should own any potential IP coming out of the clinical trial. I think it is a very gray area who owns the IP, but it could be either the sponsor, the investigator, or a combination of both, ultimately whoever had a substantial contribution to the discovery. Determining patent ownership can actually be a very difficult thing, and it needs to be handled very carefully. Having good documentation definitely makes it an easier process. In order to avoid any potential arguments over invention ownership, I believe it is important that the sponsor consider this prior to starting the clinical trial, and have an agreement in place with the investigator as to how to handle inventions which may come out of the clinical trial. Perhaps this could also be housed within the clinical trial protocol.

Based on the patent law there are numerous ways to determine who owns the intellectual propery within research and development:
1. Employee: if they are the owner of an inventions
2. Employer: the inventions is considered work-made for-hire
The concept of work-made for-hire is when
1. There is an employee/employer relationship
2. The invention is not an undeveloped idea
3. Employee realized the development due to employment
4. Employee reached their idea during employment
This breakdown of who owns intellectual property helped me understand why NJIT would gain IP for any invention by a student because they developed the invention during the period of their enrollment at NJIT. Therefore, the patents on research products are under NJIT rather than the student.
Reference:
https://biolegis.com/owns-ip-research-development/

I agree with the two post above. There are set guidelines when it comes to the ownership of the intellectual property. However, documentation is always key when it comes to this issue. I believe that the ownership falls directly to the sponsor of the project. However, if there are any other combinations of ownership. then that should be signed off on before the trial begins. There are generally three ways to categorize IP:
Background Intellectual Property – developed prior to the Study
Study Intellectual Property – developed during the performance of the study
Joint Study Intellectual Property – developed DURINGperformance of the Study by both parties

This can help in the descision of the ownership of side projects that come alone such as the example of Viagra. Some additional question can be asked such as

Who funds the creation of the IP?
Does compound arise from the drug/device?
Who needs exclusive rights/ownership of the IP?
For what purpose(s)?
Who needs non-exclusive license to use the IP?

When IP conditions are sorted out beforehand and agreed on, then the likeliness of future problems decreases.

http://www.healthandtechlaw.com/IP_Rights_in_Clinical_Trial_Agreements

@srg36 there is a difference between inventorship and ownership. Even if an employee comes up with an invention at most hospitals and research institutions you assign you rights to the employer. This is actually usually included when you sign your employee agreement on your first day with HR. At sloan, if you create an invention while you're an employee of Sloan using Sloan resources (equipment, etc) in the field of you work, MSK owns that invention. Inventors will receive a share (royalties), but MSK remains the owner of inventions and pays for patent prosecution and ultimately decides how the invention will be commercialized.
Yes, clinical trial agreements lay out the terms of the clinical trial and can lay out IP terms if any IP arises or clarify any background IP. However negotiating terms with Industry can be difficult when it comes to IP, and usually the Sponsor of the clinical trial provides their template and want to retain ownership of any IP. Again inventorship will be determined by US patent law, but ownership for clinical trial inventions is an interesting topic.

I agree with dipanpatel regarding the ownership of IP. I also believe in having a good lawyer to have a look at the agreement before they go onboard the with the study. Some firms have a strict policy of IP ownership and some are flexible with IP claims. Also, if the lab is not investing but assisting with the study, more or less, the innovation which comes out of the study or test is claimed by sponsored. When the study is jointly conducted, there is room for negotiation with the split.

With any clinical trial, the ownership of the intellectual property will be established in the contracts between both employer and employee and between the sponsor and any contracted assistance. I think the IP should belong to which ever party owns the device/drug being researched. typically, as many have stated above, the party providing the funding usually has ownership of any resulting IP. this practice is clear when it comes to US Government funded projects. "The government shall obtain all rights to any invention made by an employee if any one of the following conditions applies: the invention is made during working hours; the invention is made using either government facilities, equipment, etc., or is made with the help of another government employee who is on official duty; or the invention relates to the official duties of the inventor"- based on Executive Order 10096.

http://www.tms.org/pubs/journals/JOM/matters/matters-9004.html

I found this topic interesting as I have worked in a research lab at NJIT. During my time there I did receive a grant that would partially cover some of the materials required for my project. I didn't think about the possibility of an unexpected finding so I looked into NJIT's policy regarding intellectual property. The policy clearly states that if research is funded substantially by NJIT and conducted by student employees then any of it's findings are owned by NJIT. However, there was one part that covered findings that happen on a students own time, outside of NJIT research facilities. This part states "Any invention or discovery made while employed by or enrolled at NJIT and of a nature similar and/or related to the employee’s and/or student’s work or field of study at NJIT shall be presumed to have been made with “NJIT’s Resources” as defined herein." So even if it is on your own time, if it has to do with your field of study NJIT owns it."

I found the same thing when I was working with my Capstone Project here at NJIT. Our team was looking into the possibility of patenting our device, so we looked into the different rules surrounding that. We found much of what you found, in that NJIT basically owns the rights to whatever was formed during the time at NJIT. If it was done with "NJIT resources" then it belongs to NJIT (relates to the original point of sponsors owning the IP of a product). What I found interesting as well was the royalties that NJIT lays claim to should the product go to market. While it is a tiered system that increases the amount by amount of sales, overall the inventor will not be making very much from selling it. This is a reason why many inventors often wait until after they are done with college to work on an idea for fear that they will have to share ownership of the IP and sales of a product they want to create and market.

Intellectual property is a tricky subject because the term of ownership becomes less clear in the way multiple parties are involved, but in the case of clinical trials, it is very clear who owns inventions. Before a clinical trial takes place, the sponsor puts up a monetary value for the revenues required for the trials to take place. Even if the trial doesn't turn out the way the sponsor intended, all the work conducted belongs to the sponsor, which makes sense because resources were bought and owned by the sponsor, so another company can't come and use their resources to do something the sponsor overlooked. This is similar to programming in the way that if I create a program using company resources, whether it becomes fruitful or not, it belongs to the company long after I leave the company. Using the company resources, I wouldn't have it without the permission of the company, which would also have a contract with the programmer stating that any work belongs to the company. Similar to the case of Viagra, the creation of anything using company resources is clearly outlined in contracts, showing that any creation using company property, intentional or not, belongs to the company.