[Ip-health] KEI Comments to NIST on Interagency Edison System for Reporting Federally Funded Inventions, 84 FR 68128, Docket No. 191126-0092

James Love james.love at keionline.org
Tue Jan 28 06:00:16 PST 2020


For those keeping track of such things, these are measures a President can
implement without legislation.

https://www.keionline.org/32199

Filed in 84 FR 68128, Docket No. 191126-0092.

-------------------------------
Knowledge Ecology International (KEI), 1621 Connecticut Avenue, NW, Suite
500, Washington, DC 20009, http://keionline.org

January 27, 2020

Dr. Courtney Silverthorn
Deputy Director, Technology Partnerships Office,
National Institute of Standards and Technology
Technology Partnerships Office
100 Bureau Drive, MS 2200, Gaithersburg, MD 20899,
mailto:courtney.silverthorn at nist.gov

Re: Request for Information Regarding the Interagency Edison System for
Reporting Federally Funded Inventions, 84 FR 68128, Docket No. 191126-0092

NIST has published a request for comments regarding the iEdison reporting
system that asks the following three questions:

1. What, if any, current features of iEdison does your organization believe
should be retained in any updated version?

2. What challenges, if any, is your organization experiencing in reporting
inventions in the iEdison system? Where practicable, please provide
specific descriptions and/or screenshots of user interface screens or error
messages.

3. What improvements could be made to the iEdison system that would reduce
your organization's reporting burdens, improve its experience, and
facilitate your organization's ability to comply with reporting
requirements?

The notice appears to be directly primarily at awardees who use the
web-accessible program to report federally-funded subject inventions, elect
rights, request extensions of time requirements, request waivers,
demonstrate progress, inform the government of its limited use rights,
upload requested documents, and perform other reporting tasks as required
by their funding agency.

KEI is offering comments from the point of view of the general public and
the taxpayers who fund the grants. In particular, KEI requests certain
enhancements to the iEdison system, including reporting regarding several
patent-related issues, economic data on the costs of government-funded
clinical trials, and the creation of opportunities for the public to query
the iEdison database for some information that is of public interest.


1.Reporting regarding several patent-related issues.

a. At present, companies often fail to make disclosures of public funding
on initial patent applications. In some cases, such omissions are addressed
via late reports to the iEdison system, or the United States Patent and
Trademark Office (USPTO). The USPTO notices may include a formal
Certificate of Correction (CofC), and/or a modified assignment of rights.
The iEdison system should have a complete record of any CofC or modified
assignments of rights.

b. The iEdison system should include data regarding the listing of patents
in the FDA Orange Book.

c. The iEdison system should include data regarding any patents that are
asserted to be relevant to the sale of a specific biologic drug, cell or
gene therapy, vaccine or biomedical diagnostic test.

d. The iEdison system should include copies of both the full text and a
version redacted for public viewing, of any license to any federally funded
patents.

e. The iEdison system should indicate if any patented invention is related
to any human-use clinical trial of a drug, vaccine, cell or gene therapy or
biomedical diagnostic test, and identify the trial by clinicaltrials.gov
identifier (NCT Number).


2. Economic data on the costs of government-funded clinical trials

When any grant is used to fund a clinical trial, the awardee should provide
the following information:

a. The name and clinicaltrials.gov identifier (NCT Number) for the trial.

b. The expected total cost of the trial.

c. The federal government’s contribution, in that year, to the costs of the
trial.

d. The contribution, if any, to the cost of the trial, by any other parties.

e. Any actual or expected reimbursements/cost sharing, by U.S. or foreign
health care reimbursement entities, such as those under PHS Act section
2709(a), as added by the Affordable Care Act, to the costs of the trials.

f. The number of subjects enrolled in the trial, for that year.


3. Creation of opportunities for the public to query the iEdison database
for some information that is of public interest.

At present, iEdison is designed for use by federal employees and federal
grantees or contractors. The database should be enhanced to permit the
public to search and submit queries to iEdison directly, on topics of
public interest, or arrangements should be made to make some information
available through the NIH RePORT or RePORTER databases.

The following are some of the items the public should have access to:

a. The dates that a subject invention was disclosed via the iEdison system.

b. Copies of any USPTO Certificate of Correction or changes in assignments
of interest that correct earlier failures to disclose federal funding.

c. Copies of all licenses and assignments of interest in the patents.

d. Request for waivers of U.S. manufacturing, and subsequent determination
on the waiver request by the funding organization.

e. Whether or not any specific drug, vaccine, cell or gene therapy or
biomedical diagnostic test that uses the subject invention under a patent
license has been approved for marketing by the FDA.

f. An estimate of the annual cost to the federal government health programs
for purchasing any product or service identified in e.

g. All data on the costs of clinical trials, described in 2, above.

h. Information about the geographical scope of the patent rights, including
the names of the countries where twin applications have been filed or
granted; numbers, dates, and other identifiers for patents or published
applications filed in other countries; and whether a Patent Cooperation
Treaty (PCT) application has been filed, and its application or publication
number.

i. Legal events that have occurred following the issuance of the patent,
such as patent term extensions and term adjustments; granted pediatric
exclusivity; as well as any judicial or administrative proceeding relating
to the issued patent.

j.  Any request by or to the federal government for exercise of the
government’s royalty free right in the patents, or to use the Bayh-Dole
march-in rights in the patents.


Sincerely,

James Love
Knowledge Ecology International
james.love at keionline.org


Luis Gil Abinador
Knowledge Ecology International


-- 
James Love.  Knowledge Ecology International
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