[Pharm-policy] ddI patents, WSJ story on BMS action

[love@cptech.org]

This is the Waldholtz, Zimmerman, Block report in the WSJ. One omission
from the report is any acknowledgement that there was pressure on (from
students and activitist) and probably from Yale (responding) on the d4T
patent, or last week's CIPLA request for compulsory license on the d4T
patent in South Africa.  With respect to the the ddI patent, which the
WJS says is not in effect in Africa, here is what UNAIDS says about the
patent.

Patents on didanosine
 Wellcome Foundation
  Origin date  
  Europe Expiry date May 14 2006
   Countries where similiar patents have been filed:
 Australia, Canada, Denmark, EP (AT, BE, CH, DE, FR, GB, IT, LI, LU, NL,
SE), Finland, Greece, Hungary, Japan, New Zealand, Portugal, South
Africa, Spain, US

 
US Government Patent on ddI
 Origin datea 26 Aug 85
 US expiration date  29 Aug 2006 
 EP expiration date  21 Aug 20061
 French extention date until 4 May 2009
 
Countries were similar patents were filed: Australia, Canada, Cyprus, EP
(AT, BE, CH, DE, FR, GB, IT, LI, LU, NL, SE), Hong Kong, Ireland,
Israel, Japan, Mexico, New Zealand, Singapore, US
 
Note also that UNAIDS report does not include any discussion of the BMS
formulation patent in Thailand or other countries.  Nor does the WSJ (or
any others) press BMS on whether or not it will drop its opposition to
the Thai GPO selling ddI pills in Thailand, where there is a well known
dispute, but also a good medical infrastructure for treatment, but not
so much international press attention.  Perhaps Dr. Tido from MSF or
someone from the Thai Drug Study Group could get a comment from BMS in
Thailand on this.   Jamie

http://interactive.wsj.com/articles/SB984593017713172966.htm

March 15, 2001  

Bristol-Myers Squibb Offers to Sell
AIDS Drugs in Africa at Below Cost
By MICHAEL WALDHOLZ and RACHEL ZIMMERMAN 
Staff Reporters of THE WALL STREET JOURNAL

     [snip]

The New York pharmaceutical giant says it will sell its AIDS drug Zerit
for 15 cents a day, or $54 a patient for a year's worth of therapy. That
price is about one-fifth the already discounted amount Bristol-Myers
began charging in Africa for Zerit since last summer. Zerit sells in the
U.S. and Europe for about $3,589 per patient per year.

   [snip]

Bristol-Myers officials also say the company won't use its patent on
Zerit in South Africa to block that country's efforts to buy less
expensive versions of the drug from generic makers in India. In fact,
Bristol-Myers is publicly acknowledging that it has almost no patent
protection for its AIDS drugs in sub-Saharan Africa. It has a Zerit
patent only in South Africa. And it has no patent for Videx in any
sub-Saharan country. That means that right now any nation or medical
center in the region could legally buy generic copies of those drugs if
it chose to make such an effort.
  
   [note: I was told that this was *not* true, but we shall soon find
out]

Bristol-Myers's announcement follows an offer from Merck & Co. last week
to sell two of its AIDS drugs at cost, or at about 45% to 55% less than
the discounted price it offered last year. It also comes on the heels of
significant price reductions by two Indian generic-drug makers.

    [snip]

Even at the newly reduced prices, the drug therapy will remain far
beyond the economic reach of most in Africa. Bristol-Myers says that as
part of its new proposal, it will sell Zerit and Videx for a combined
price of $1 a day, or $365 a year. But those two drugs must still be
combined with a third to complete the AIDS regimen. Merck's new reduced
price for its drug Crixivan is $600 a year, and its new price for
Stocrin is $500 a year. Adding either of those drugs to Bristol-Myers's
two medicines will bring the annual price of a three-drug regimen in
Africa to about $865 to $965. If, instead, Bristol-Myers's two drugs are
combined with Viramune, a drug from Germany's Boehringer-Ingelheim GmbH
that costs about $438 a year, the annual price of a three-drug
combination will be $803.

Those prices are still slightly higher than an offer made in February by
drug-maker Cipla Ltd. of Bombay, India, to sell a different combination
of three AIDS drugs in Africa for $600. Suddenly, with the new round of
price cuts from Merck, Bristol-Myers, Cipla and another Indian company,
Hetero International Ltd., a pricing battle seems to be emerging in
Africa. Indeed, Bristol-Myers's new price for Zerit undercuts by $16 a
year the price Cipla is offering for its version of the same drug.

Some drug companies worry that selling at sharply reduced prices in
Africa may lead to a black market for the drugs in the U.S. But
Bristol-Myers says it isn't overly concerned about that at present.

In any case, it is unclear if the new prices will get to people in
Africa quickly, or at all, unless employers and governments in the
region and wealthy donors from abroad begin subsidizing some of the
drugs' costs. "It's pretty dramatic, a major, major step forward," says
Harvard economist Jeffrey Sachs of the new price reductions. But Mr.
Sachs, who has been aggressively lobbying the U.S. government and others
to commit large resources to the AIDS problem in Africa, adds: "The
limiting factor is international donor support to help buy these drugs
at the discount and to provide training to make these drugs effective."

Indeed, it isn't even clear whether many of the African nations are
prepared to take advantage of the new drug prices. The president of
Botswana said this week that the lowered prices may make it possible for
his country, using donations and its own funds, to begin offering drugs
to those who want them. But the government of South Africa, where four
million people are infected with HIV, has yet to meet with drug makers
to discuss the discounts offered last May. It had arranged for such a
meeting for the end of this month, but it was canceled because of
scheduling conflicts. Meanwhile, South African officials say they are
skeptical of the drug makers' sincerity, especially because 39 drug
companies, including Bristol and Merck, are suing the government to
block it from buying generic versions of patented drugs.

In an interview, Ayanda Ntsaluba, director general of South Africa's
health ministry, said that while he doesn't "doubt the good intentions
of Merck," he was "suspicious" of the recent offer because he first
heard about it in press reports rather than from the company.

Meanwhile, two drug companies -- Boehringer-Ingelheim and Roche Holding
AG -- that joined in the offer to reduce prices last May have been
reluctant to join Merck and Bristol-Myers in a new series of price
reductions. John Wecker, program coordinator for Boehringer-Ingelheim's
drug-access program, says the company's current annual price for
Viramune represents a 90% reduction from its price in the U.S. and the
company doesn't plan further cuts. But he says talks are under way to
see if such cuts might be possible.

And while Roche was part of the group that promised to cut its drug
prices last May, it offered a set of reduced prices only recently. On
Feb. 27, Roche sent a letter to UNAIDS, the U.N. agency coordinating
AIDS activities, announcing "improved conditions" related to the cost of
two of its AIDS medicines, Viracept and Fortovase, to take effect March
1. It claims to have cut the price in half for Fortovase and reduced the
price of Viracept by 15%, but that reduction is only available as a
rebate. In addition, those prices, while lower than those charged in the
U.S., are still way above what is affordable in Africa or what Merck is
charging for its similar drug, Crixivan.


--------------------------------------------------------------------------------

-- Robert Block contributed to this article.

Write to Michael Waldholz at michael.waldholz@wsj.com and Rachel
Zimmerman at rachel.zimmerman@wsj.com