Intellectual Property Rights Clauses Checklist for Clinical Trial Agreements

Is your study a Clinical Trial?

Use this Checklist to analyze Clinical Trial intellectual property rights clauses; determine what problems, if any, the clauses contain; and, determine the changes necessary to conform the clauses to the requirements of the Regents’ Rules and Regulations related to Intellectual Property. Because no two deals are identical, the best language for one transaction may not be the best language for another transaction. If in doubt, please contact the Office of General Counsel with any questions.


The following sample clauses for this Checklist can be found here: Intellectual Property Rights Clauses.


You may offer the Sponsor any of Clauses 1 through 9 (Clause 5 is probably the most comprehensive). If the Sponsor accepts one of these clauses as is, you are finished with the analysis of your intellectual property rights clause.


If you are analyzing a Sponsor-offered clause, complete the Sponsored Research Study/Agreement found here: Intellectual Property Rights Clauses Checklist for Sponsored Research Agreements.


If you are analyzing a Clinical Trial Agreement, complete the Clinical Trial Agreement section below.


1. Did the Investigator participate in drafting the protocol for this Trial?


Offer Sponsor any of Clauses 1 through 9 (Clause 5 is probably the most comprehensive).


Use Clause 10, if Sponsor accepts the clause as is; or, if Sponsor's clause is substantially the same as ours; or, if you are able to edit Sponsor's clause to make it substantially the same. For example, by incorporating the critical elements of our clauses (highlighted in the clause).

2. Is the allocation of ownership of intellectual property in accordance with U.S. Patent Law?

U.S. Patent Law says that if we invent it, we own it; if they invent it, they own it; and, if we jointly invent it--that is, if both an employee of the University and an employee of the Sponsor would be inventors under US Patent Law--then we would own it jointly. You should answer YES, even if the clause does not fully address all possibilities, so long as it does not contradict the above scenario.


The clause is fine as it is in this regard. Leave it alone.


You must conform the allocation of ownership to the U.S. Patent Law. Use language from Clauses 1.1;  2.2;  3.2;  4.3;  5.1;  6;  7;  8.2; or 9.1.

3. Does Sponsor want an option to license?


Offer the Clinical Trial option (Clause 10). If Sponsor accepts the clause as is,do not complete the remainder of this Checklist. If Sponsor will not accept our option and has offered a clause containing a license right, continue to Question 4.


Do not complete remainder of checklist.

4. Regarding new inventions, does the clause grant Sponsor:

a license?

An outright license grant is not appropriate for a clinical trial agreement.

an option?

We may only offer an option to negotiate a license or a right of first refusal to negotiate a license. Further, the license should be royalty-bearing and, in most every case, exclusive. See Clauses 1.1;  2.4;  3.2;  4.3;  5.3;  7;  8.2;  9.3.

a right of first refusal to license?

We may only offer a right of first refusal to negotiate a license or an option to negotiate a license. Further, the license should be royalty-bearing and, in most every case, exclusive. Clauses 1.1;  2.4;  3.2;  4.3;  5.3;  7;  8.2;  9.3.

5. Does the option language include time limits for the option to be exercised and time limits for negotiating terms of the license?


Make sure the time limits are reasonable. Periods in the range of 60-180 days are typical for both an exercise period for an option and for negotiating a license. In either case, longer periods are acceptable on a case-by-case basis, with good reason.


Insert time limits as illustrated in Clauses 1.1;  2.4;  3.2;  4.3;  5.3;  7;  8.2;  9.3.

6. Does the clause require Sponsor to pay patent costs in order to exercise its option to negotiate a license?


Good. Leave clause as it is.


You must make the right to exercise the option contingent upon Sponsor's payment of all patent costs (past, present, and future) associated with protecting the relevant invention. See Clauses 1.2;  2.5;  4.3;  5.5;  9.3.