[Ip-health] FTC Amicus brief in Buspirone patent case

[James Love]

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-------- Original Message --------
Date: Wed, 9 Jan 2002 12:27:15 -0500
Sender: Antitrust Section Intellectual Property Committee 
<AT-IP@MAIL.ABANET.ORG>
From: David Balto <DBalto@washdc.whitecase.com>
Subject: [AT-IP] FTC Amicus brief
Comments: To: j.anthony.chavez@exxonmobil.com

FTC Files Amicus brief in In re Buspirone Patent Litigation  (MDL Dkt No 
1410 (SDNY Jan 10, 2002)

I thought you should know that yesterday the FTC filed an amicus brief 
in the BuSpar case in the SDNY.  As you know this case involves patent 
and antitrust challenges to Bristol Myers filing of a patent and 
subsequent listing of the patent in the FDA's Orange Book  for BuSpar. 
The defendant argued that its listing of the patent in the  Orange Book 
is immune under the Noerr- Pennington doctrine as valid petitioning 
incidental to litigation. The FTC opposed that extension of Noerr 
immunity, noting that

  "the necessary implication of BMS's position is that neither the FDA 
nor courts enforcing the antitrust laws can provide any remedy if a 
pharmaceutical company fraudulently abuses the regulatory procedures of 
the Hatch-Waxman Act, in order to wrongfully extend a drug product's 
monopoly beyond its lawful limits, to the substantial detriment of 
consumers.
  A ruling in BMS's favor would potentially give a branded drug 
manufacturer an almost unlimited ability to stifle generic competition, 
a result that could cost American consumers billions of dollars annually 
and would be plainly at odds with Congress'=s intent, in enacting the 
Hatch-Waxman Act...."


  The FTC brief notes that the Noerr doctrine protects legitimate 
efforts at influencing government to adopt a particular course of 
action.  Orange Book filings are not petitions, but merely requests for 
a ministerial act by the FDA (just listing the patent).  Nor is an 
Orange Book filing analogous to a pre-litigation threat letter, because 
they are pro forma communications with the FDA -- not a litigant.  Nor 
are they compelled by the statute since a patent holder can bring the 
same claims regardless if its patents are listed in the Orange Book.

Finally,   the FTC notes that even if the filings may be petitioning 
under Noerr they may fall under the sham exception (actually a 
misrepresentation exception), since in this case there may have been 
misrepresentation in BMS' filings with the PTO and FDA.


Please e mail me if you would like a copy of the brief

Many thanks

David Balto

David Balto
White & Case
601 13th St N.W.
Washington, D.C.  20005

phone:  202-626-3617

email:  dbalto@whitecase.com


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