RE: [PIUG List] Orange Book - dates Patents published

Laurie,
 
For current information on submission date(from 2004), your question is add=
ressed in § 314.53 (e). [This means that only month of submission could b=
e identified from online information, but not specific date]
 
§ 314.53 Submission of patent information.

(a) Who must submit patent information. This section applies to any applica=
nt who submits to FDA a new drug application or an amendment to it under se=
ction 505(b) of the act and § 314.50 or a supplement to an approved appli=
cation under § 314.70, except as provided in paragraph (d)(2) of this sec=
tion.

(e) Public disclosure of patent information.
FDA will publish in the list the patent number and expiration date of each =
patent that is required to be, and is, submitted to FDA by an applicant, an=
d for each use patent, the approved indications or other conditions of use =
covered by a patent. FDA will publish such patent information upon approval=
 of the application, or, if the patent information is submitted by the appl=
icant after approval of an application as provided under paragraph (d)(2) o=
f this section, as soon as possible after the submission to the agency of t=
he patent information. Patent information submitted by the last working day=
 of a month will be published in that month's supplement to the list. Paten=
t information received by the agency between monthly publication of supplem=
ents to the list will be placed on public display in FDA's Freedom of Infor=
mation Staff. A request for copies of the file shall be sent in writing to =
the Freedom of Information Staff (HFI-35), Food and Drug Administration, rm=
.12A-16, 5600 Fishers Lane, Rockville, MD 20857

http://edocket.access.gpo.gov/cfr_2007/aprqtr/pdf/21cfr314.53.pdf, or
http://www.kenyon.com/Resources/WaxmanHatchRH/HTMLHelp/!SSL!/WebHelp/Waxman=
%20Hatch.htm
 
The last cumulative supplement is available there:
http://www.fda.gov/cder/orange/obcs.pdf (In current July 2008 Supplement, n=
ew patent listing could be found in Appendix A, from pages A-1 (page 94 of =
pdf file July 2008 Supplement).
 
See Footnote on the end of the section (Appendix A):
Patents are published upon receipt by the Orange Book Staff and may not ref=
lect the official receipt date as described in 21 CFR 314.53(d)(5).
[21 CFR 314.53(d)(5)."Submission date. Patent information shall be consider=
ed to be submitted to FDA as of the date the information is received by the=
 Central Document Room"]

A few archival copies are retrievable through Internet Archive www.archive.=
org <http://www.archive.org> http://web.archive.org/web/*/http://www.fda.=
gov/cder/orange/obcs.pdf <http://web.archive.org/web/*/http://www.fda.gov/c=
der/orange/obcs.pdf> (2005-2007)
and at http://web.archive.org/web/*/http://www.fda.gov/cder/orange/suppleme=
nt/patents.pdf (1999-2007) (not all monthly supplements are archived)
<http://www.archive.org>
Alternatively, Before mid 2004, daily updates are listed in DOCKET NUMBER *=
95S-0117 (PATENT TERM EXTENSION AND NEW PATENTS). Patent updates are publis=
hed monthly. Electronic copies of these update is available at Docket Manag=
ement at FDA site, from Jan 2000-June 2004). For example: June 2004 list ht=
tp://www.fda.gov/ohrms/dockets/dailys/04/June04/062304/95s-0117-lst00093-vo=
l7.pdf (Tips for searching: use FDA Advanced Search (http://www.fda.gov/adv=
search.html <http://www.fda.gov/advsearch.html> ) limit to dockets and sear=
ch for drug name AND *95S-0117)
 
Regards,
 
Aleksandr Belinskiy
Patent Information Scientist
Patent Department
sanofi-aventis
  
1041 Routes 202/206
 P.O. Box. 6800, Mail Stop BW-D-203A,
Bridgewater, NJ 08807-0800
Phone : (908) 231-3294 Fax: (908) 231-4766
E-mail: aleksandr.belinskiy (at) sanofi-aventis.com <mailto:aleksandr.belin=
skiy_at_sanofi-aventis.com>
 

________________________________

From: Cameron, Laurie [mailto:laurie.cameron_at_dechert.com]
Sent: Friday, August 22, 2008 3:04 PM
To: PIUG Discussion List @ Listbox
Subject: [PIUG List] Orange Book - dates Patents published



I am trying to determine how one would find the official date of receipt of=
 patents by the office of generic drugs and also the date that the Orange B=
ook staff enter the information into the electronic orange book. I can't f=
ind a definitive answer on the Office of Generic Drugs website. Does anyon=
e of knowledge about this area.

Thank you.

Laurie A. Cameron
West Coast Librarian
Dechert LLP
+1 650 813 4994 Direct
+1 650 813 4848 Fax
laurie.cameron_at_dechert.com
www.dechert.com <file://www.dechert.com>


 
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Received on Sat Aug 23 2008 - 15:54:51