Re: Patent Term Extension

Louise,

You may wish to complement your search on patents for which extensions ha=
ve been granted by search for patents for which applications for patent =
term restoration (extension) are pending. This information could be found=
 on FDA web-site (not in the Orange Book)

As you mention the Federal Register, it publishes notices "Determination =
of Regulatory Review Period for Purposes of Patent
Extension". The most recent Notice dated Apr. 29, 2005 is related to U.S.=
 Patent No. 4,831,031 for GEODON (Pfizer). http://frwebgate5.access.gpo.g=
ov/cgi-bin/waisgate.cgi?WAISdocID=297699324635+0+0+0&WAISaction=retri=
eve

USPTO have not granted yet an extension for GEODON, and waits for FDA's =
response regulatory review period (a subject of above Notice in the Feder=
al Register).
   [Eventually, USPTO will make it final determination and make it availa=
ble to public through publication in the Official Gazette or through "FOI=
A Reading Room", http://www.uspto.gov/web/offices/com/sol/foia/comm/pte/p=
te.htm), cf. a list "Patent Terms Extended Under 35 USC §156", for info=
rmational purposes only http://www.uspto.gov/web/offices/pac/dapp/opla/te=
rm/156.html)]


Information about pending applications for extension of patent term befor=
e a date of publication an above-mentioned notice in the Federal Register=
 is available in FDA's Dockets Management files. This files are searchabl=
e on Dockets Management site http://www.fda.gov/ohrms/dockets/default.htm=
 or through FDA Advanced search limited by "Dockets" http://www.fda.gov/=
advsearch.html)

You can find information on a patent number(s) applications for patent te=
rm restoration is pending for a specific drug. For example, for GEODON su=
ch information was added for a docket June 09, 2003 (about 2 years earli=
er of publication of the Notice in the Federal Register) See http://www=
.fda.gov/ohrms/dockets/dailys/03/Jun03/060903/060903.htm, Docket 2003E-02=
59.

There is a good summary of information about patent term extension applic=
ation available FDA web-site:
a browsable docket for a patent term extension application for Zometa (No=
vartis) Pat. No. 4,939,130 [Docket 2002e-0020]
http://www.fda.gov/ohrms/dockets/dockets/02e0020/02e0020.htm (the unique=
 example?)



For a sake of completeness, I want also to mention that some drugs which =
are subject to the "Virus-Serum-Toxin Act" (veterinary biologics). For th=
ese drugs Regulatory Review Period for Purposes of Patent Extension are =
determined by US Department of Agriculture [Animal and Plant Health Insp=
ection Service, APHIS, http://www.aphis.usda.gov/vs/cvb/). I was interest=
ed how many veterinary biologics patents patent term was extended. I foun=
d only records for 2 vaccines for which patent term extension has been r=
equested [Poulvac ST Vaccine and Fel-O-Vax[ FIV Vaccine]. (I searched No=
tices in the Federal Register 1995-2005 ("Regulatory Review Period" AND =
(APHIS or vaccine)]
Did I miss something or there were only 2 extensions granted for patents =
for drugs which are subject to the "Virus-Serum-Toxin Act" ?



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 @ sanofi-aventis.com

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PS. This is duplicate posting. An original posting was sent Thu, Jun. 9, =
2005 but did not show up. AB


-----Original Message-----
From: owner-piug-l_at_derwent.co.uk [mailto:owner-piug-l_at_derwent.co.uk]On
Behalf Of louise Franco
Sent: Wednesday, June 08, 2005 8:24 AM
To: piug-l_at_derwent.co.uk
Subject: Patent Term Extension


Dear PIUG:

I'm trying to verify if a patent was granted an extension. I checked
the following sources:

Federal Register
Orange Book
IFI files
USPTO
IMSPATENTS

Is this a comprehensive search or is there a source that I'm missing?

Any help would be greatly appreciated.

Kind regards,

Louise Franco
Patent Librarian
Scully, Scott, Murphy & Presser
400 Garden City Plaza Ste 300
Garden City, New York 11530
(516) 742-4343 (telephone)
(516) 742-4366 (facsimile)
intprop_at_ssmp.com

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Received on Fri Jun 10 2005 - 16:40:22