[Ip-health] PUBPAT challenges 8 ritonavir patents

Kajal Bhardwaj k0b0 at yahoo.com
Fri Sep 3 06:39:08 PDT 2010


Abbott Laboratories Patents on Ritonavir are  Undeserved 

New York, NY -- August 10, 2010 -- The Public Patent Foundation (PUBPAT)  
announced today that it has formally asked the United States Patent and  
Trademark Office to reexamine eight patents held by Abbott Laboratories  (NYSE: 
ABT)  relating to the critical HIV/AIDS drug ritonavir, which is marketed by  
the Chicago, Illinois pharmaceutical giant under the name brand Norvir.

In  its requests, PUBPAT submitted previously unforeseen prior art proving  that 
the patents should not have been granted.  PUBPAT also cited recent  Federal 
Circuit case law that supports its detailed arguments for  nullification of the 
eight patents.

The challenged patents, U.S. Patents Nos. 5,541,206, 5,635,523, 5,648,497, 
5,674,882, 6,037,157, 6,703,403, 7,148,359, and 7,364,752, are the eight patents 
listed in the FDA's Orange Book  for the 100mg ritonavir tablet approved on 
February 10, 2010.   This tablet is heat stable and does not need to be 
refrigerated like  prior versions of the drug, making it much more convenient 
for patients.

Among  a class of drugs called protease inhibitors, ritonavir was originally  
developed for its antiviral properties in the treatment of HIV infection  and 
AIDS.  However, it is now more widely used for its ability to  enhance the 
efficacy of other protease inhibitors by inhibiting the  enzyme that breaks down 
those drugs.  It thus remains a critical drug  for HIV/AIDS treatment.

This is not the first time Abbott's  popular HIV/AIDS drug has caused 
controversy.  In December 2003, Abbott  raised the price of its Norvir brand 
version of ritonavir from $1.71 a  day to $8.57 a day.  In response, a consumer 
group petitioned the NIH to  override the then existing patents on ritonavir, 
because the research  underlying those patents had been paid for by government 
tax-payer  funds.  Abbott settled a class action antitrust lawsuit regarding the  
Norvir price raise for $10 million in 2009.

Today over 30 million  people worldwide are infected with HIV/AIDS, including 
more than one  million Americans.  "Abbott is using these eight patents to 
prevent  anyone else from offering ritonavir to HIV/AIDS patients in the United  
States," said Dan Ravicher, PUBPAT's Executive Director.  "Since the  patents 
are undeserved, they are illegal barriers to the medical  treatment that 
American HIV and AIDS patients need and deserve."

The  U.S. Food and Drug Administration will not allow anyone other than  Abbott 
to distribute ritonavir in the United States because Abbott  claims the 
exclusive right to do so via its patents.  If PUBPAT's  request is granted and 
the United States Patent and Trademark Office  agrees with PUBPAT that the 
challenged patents are invalid, Abbott will  lose the legal right to prevent 
anyone else from making, using, or  selling the subject matter of those patents. 

The Requests for Reexamination filed by PUBPAT against the eight ritonavir 
patents held by Abbott Laboratories can be found at PUBPAT > Ritonavir HIV/AIDS 
Drug Patents. 


More information about the Ip-health mailing list