United States Patent Extensions
Have others noted discrepancies among sources for term extension data?
Which is authoritative or most reliable?
Origin of the Data
The Food and Drug Administration (FDA) publishes in the
Federal Register the time the extension is applied for.
When the extension is granted the United States Patent and Trademark
Office (USPTO) puts the information in the Official Gazette (OG).
Sources for the Data
- The USPTO lists of extensions is at
The USPTO adds expiration to its list whenever an extension is granted.
- The FDA posts the entire Orange Book (APPROVED DRUG
PRODUCTS with Therapeutic Equivalence Evaluations) on its website.
The "Patent and Exclusivity Lists" chapter from the 17th edition of April,
1997, is at
In addition, there's a series of cumulative supplements. The 7th supplement
patent and exclusivity list is at
Those documents list the generic drug names with patent numbers, dates, and
exclusivity codes. They don't have the information the OG publishes about
the numbers of days the patents are extended. And the FDA lists only
current exclusivity data. An extended patent that expired in the past isn't
listed. Patent numbers are provided by the owner of the approved drugs, not
collected by anyone at the FDA. The expiration dates are intended as
warnings to potential infringers. If the patent were to be extended, the
patentee would have to notify the FDA if it wanted the extended date to be
listed. "One of our attorneys has told me that there's no provision of the
law or regulations that requires the patentee to notify the FDA about the
extension. The bottom line seems to be that the Orange Book shouldn't be
used as the exclusive source of information about patent expiration dates."
- FOI's Drugs Under Patent
FOI gets its information from the annual FDA listing, and doesn't publish
supplements. FOI lists only current exclusivity data.
- IFI/Plenum gets the data from the weekly hard copy of
the USPTO OG and posts it shortly thereafter to the CLAIMS
Reassignment/Reexam file. Whenever there's an extension in the OG it would
be posted to the file.
- Drug Patents International (DPIN)
- Scrip
- PROMT
Edlyn Simmons actually did a little test: As of Nov 5, 1997, an extension
granted September 9, 1997, reported in the October 21, 1997, OG, is online
in the Orange Book supplement and the Claims Reassignment etc. file. The
DPIN record for that patent doesn't have the extension data yet.
Answers contributed by:
Kenneth J. Allison
Information Management & Technology
R.W. Johnson PRI - 2263 OMP Admin
Route 202; PO Box 300
Raritan NJ 08869-0602
Tel: (908) 704-4079
Fax: (908) 704-9058
Anne E. Backman
Senior Research Information Scientist
Zeneca Pharmaceuticals
1800 Concord Pike
Wilmington DE 19850-5437
anne.backman@phwilm.zeneca.com
Phone: 302-886-8211 fax: 302-886-5369
Edlyn Simmons
Hoechst Marion Roussel, Inc.
Cincinnati, OH 45215-6300
edlyn.simmons@hmrag.com
Last edited: Elyse Turner
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