[Ip-health] FDA request for comments on Listing of Patent Information in the Orange Book

James Love james.love at keionline.org
Sat May 30 14:33:33 PDT 2020

This is an opportunity to advocate for some useful changes in the FDA
orange book, such as retaining the listing of expired patents in the Orange
Book, web page, providing information on government rights in the listed
patents, including the relevant grants or research contracts, and
information regarding USPTO IPR or court litigation over patent claims, as
well as the name of holder of the patent rights, and other things, people
think would be useful.



Document Citation: 85 FR 33169
Agency/Docket Number:
Docket No. FDA-2020-N-1127
Submit either electronic or written comments by August 31, 2020.

The Food and Drug Administration (FDA or Agency) is announcing the
establishment of a docket to solicit comments on the listing of patent
information in the FDA publication, “Approved Drug Products With
Therapeutic Equivalence Evaluations” (commonly known as the “Orange Book”).
We are soliciting comments on the types of patents currently listed in the
Orange Book and the impact that any change to current patent listing
practices may have on drug product development. This notice is not intended
to communicate our regulatory expectations on these issues but is instead
intended to seek early input from the public to inform further regulatory
action if determined to be appropriate.

FDA is establishing a docket for public comments on this document. The
docket number is Docket No. FDA-2020-N-1127. The docket will close on
August 31, 2020. Submit either electronic or written comments by that date.
Please note that late, untimely filed comments will not be considered.
Electronic comments must be submitted on or before August 31, 2020. The
https://www.regulations.gov electronic filing system will accept comments
until 11:59 p.m. Eastern Time at the end of August 31, 2020. Comments
received by mail/hand delivery/courier (for written/paper submissions) will
be considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

You may submit comments as follows:

Electronic Submissions
Submit electronic comments in the following way:

Federal eRulemaking Portal: https://www.regulations.gov. Follow the
instructions for submitting comments. Comments submitted electronically,
including attachments, to https://www.regulations.gov will be posted to the
docket unchanged. Because your comment will be made public, you are solely
responsible for ensuring that your comment does not include any
confidential information that you or a third party may not wish to be
posted, such as medical information, your or anyone else's Social Security
number, or confidential business information, such as a manufacturing
process. Please note that if you include your name, contact information, or
other information that identifies you in the body of your comments, that
information will be posted on https://www.regulations.gov.


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