We suggest that the extension of Federal government rights to States and domestic municipal governments be placed on a case-by-case discretionary basis. The rationale for such an extension is believed to be an assurance that inventions in the public health area, such as certain drugs, pharmaceuticals and safety devices, would be made widely available at minimum costs through state or minicipal sponsorship. This is a reasonable requirement. However, by making the extension mandatory many inventions not having such urgent public health benefits would also be included and would seriously impinge on a just return to the contractor and inventor and reduce the incentive to make improvements or further inventions..

Ditto

The matter of state and municipal government rights should
be forth in a separate subsection for both clarity and more
specific definition of these rights. As mentioned pre-
viously such rights should not be mandatory, but decided on
a case-by-case basis. The basis for any decision on these
rights should be set forth in positive language rather
than in the negative sense used in this proposed agreement.
For example, the statement might read:

"The Agency may determine after the invention has been
identified that it is useful in the area of public health
and safety, and, therefore, acquisition of a license for
States and domestic municipal governments is required."
A corresponding change will need to be made in Exhibit A,
Confirmatory Instrument.

Amer.Patent Law Association

1. Whereas, a proposed amendment to the Federal Procurement
Regulations dealing with Institutional Patent Agreements
has been developed by an Ad Hoc Subcommittee of the
United States Government's Committee on Government Patent
Policy; and

Whereas, on page 7 Paragraph IV (a), with respect to Sub-
ject Inventions, a paid-up license is given to State and
Domestic municipal governments unless the Agency deter-
mines after the invention has been identified that it
would not be in the public interest to acquire the
license for State and Domestic municipal governments;
Now Therefore, it is resolved by the American Patent Law
Association that the license to and for State and
Domestic mmicipal governments should be only on an
exception basis where special circumstances justify the
exception; and not automatic, subject to exclusion.

Our concern in both resolutions is that the proposed regulations in question would remove the incentive for competent organizations to accept Research and Development grants or contracts or subcontracts, and that as a result the government will be hampered in carrying out its purposes. Inventions are unlikely to be developed and actually made available to the public without reasonable incentives. Institutional Patent Agreements such as utilized by the Department of Health, Education, and Welfare provide adequate safeguards of the public interest, including march-in rights if the patent owner or licensee is not commercializing.

(b) with respect to each Subject Invention to which the Institution retains principal or exclusive rights, the Institution agrees to grant to responsible applicants, upon request of the Government, a license on terms that are reasonable under the circumstances;

(A) unless the Institution, its licensee, or its assignee, demonstrates to the Government that effective steps have been taken within three (3) years after a patent issues on such invention to bring the invention to the point of practical application or that the invention has been made available for licensing royalty-free or on terms that are reasonable in the circumstances or can show cause why the principal or exclusive rights should be retained for a further period of time; or

Michigan State University

It is our understanding that this section deals with what is generally referred to as "March-in Rights" of the Government. It is suggested that this section be modified to include a provision whereby the institution can request a hearing prior to the Government exercising these rights. This would bring the proposed agreement more closely in line with the DIEW's Institutional Patent Agreement, which we find very acceptable.

Adopted in part,

Redraft provides for hearing and notes designate official responsible.

Cornell University

With regard to "march in rights", it would be helpful if it were possible to develop more specific criteria although we recognize this may be most difficult. We do, however, suggest that the decision on such matters be specified to rest at the highest level within a given agency.

Dittp

Ditto

The general emphasis in the application of Section (b) appears to be the reverse of that in existing like provisions of the Institutional Patent Agreements with both the Department of Ikealth, Education, and Welfare and the National Science Foundation. The format in which this Section has been couched would appear at the outset to shift the burden of proof in the administration of an invention. In other words, it would appear that under the literal language of the proposed provision the Government can request the Institution to grant a license to a third party at any time before the running of the 3-year period after the patent issues. The burden of proof then appears to shift to the Institution to show that effective steps have been taken to bring the invention to the point of practical application, or that the invention has been licensed on reasonable terms or that principle or exclusive rights should be retained the 3-year "incubation" period being available to the Institution by implication.

It would seem more appropriate that the 3-year "incubation" time should be more specifically set out so that there is no misunderstanding of the intent of the whole paragraph (b). We believe the language of Article XII (a) of the Institutional Patent Agreement with the Department of Health, Education, and Welfare would be more appropriate. With regard to paragraph (b) (B) of Article IV the decision (see comments under Scope of Agreement above) can be an arbitrary one. No guidelines or criteria are established upon which such a decision can be based. Moreover, the decision to license others can be made under this provision without even giving the Institution an opportunity to be heard. That opportunity, at the very least, should be included in the provision. The format of the