[Pharm-policy] Patent News: Help Thailand doctors bust Bristol Myers DDI patent

[James Love]

Subject: PATNEWS: Help Thailand doctors bust Bristol Myers DDI patent
     Date: Tue, 30 May 2000 12:54:08 -0400 (EDT)
    From: Gregory Aharonian <srctran@world.std.com>
      To: patent-news@world.std.com


!20000530  Help Thailand doctors bust Bristol Myers DDI patent

    Some groups in Thailand are trying to bust a ddI formulation patent
assigned to Bristol Myers Squibb.  They sent me the following request
for information.  Anyone familiar with this chain of patent applications
and with information that might help the Thailand groups, please send it
to me, and I will forward it to them.  The groups are mostly charitable
and relief organizations, so if it will cost a few bucks to provide them
with information (or to get someone to help), I'll cover the costs.

Thanks
Greg Aharonian
Internet Patent News Service
                              ====================

Gregory,

    I am writing from Thailand seeking your help with the patent for
ddI - didanosine.

    Here in Thailand we have been fighting for cheaper access to this HIV
medication.  ddI has been the focus of our efforts: it was developed by
the US National Institutes of Health and then licensed to Bristol Myers
Squibb. The license agreement included 5% royalty and a fair pricing
clause. Despite our requests, the NIH never tried to enforce the fair
pricing clause.

    The patent for the original substance, ddI is held by the US government.
This patent does not exist in Thailand because it was patented abroad
before Thai product patent law came into effect in 1992.

    Our obstacle has been a formulation patent held by Bristol Myers Squibb
(BMS). After failing to get the Thai government to use compulsory license
we are now in preparation to challenge the patent both on inventive steps
and novelty in a Thai Intellectual Property Court.

    It would strenghten our case enormously if you could have a look at
the US (or even other) versions of the patent. The US patent is 5,880,106.

    BMS claims that they invented an improved formulation involving the
composition of ddI (well known) and a (well known) buffer.  They claim
reduced antacid mass and improved bioavailability.

    Together with Thai pharmacists we have looked at the US patent file
wrapper and my understanding is now the following (please bear in mind
that I don't know anything about patents):

    The first application (# 07/733,547) was filed on July 22, 1991; no
copy of this application is in the file wrapper.

    The second application (# 07/882,204) was filed on May 13, 1992.
All claims were rejected by patent examiner Moody on January 23, 1995 for
obviousness (not new in the art). She concludes that "dose optimization
for efficient acid neutralization would have been routine and well
within the ordinary level of skill in this art".

    BMS then filed a similar, third application (#8/942,660) on Oct 2, 1997
(abandoning the second application only much later).  All claims were
again rejected for obviousness, this time by examiner Crane on February 2,
1998.  Fortunate for BMS this time the reasons for rejection were not as
far reaching Moody's. 

    Crane points out that the combination of ddI with antacids is well
known in the art but he forgets to point out - as Moody did - that reduced
mass of the buffer was also readily calculable. BMS lawyer Ryan therefore
responded by saying that the unobviousness was based on their "new buffer
system" with reduced antacid component etc. 

    After a telephone conversation with the BMS lawyer in August 1998,
examiner Crane accepted the claims after small amendments: "the instant
claims are allowable in view of prior art because the composition is now
narrowly defined to specifically include the ingredients and proportions
which applicant has disclosed to be most appropriate to yield improved
bioavailability of the anti-viral agents ddA, ddI and ddG, and limited
with a proviso excluding compositions which cause specific undesirable
effects".

    When I look at the amended claims the following proviso seems indeed
to be the only "significant" change: "the proviso that the formulation
does not act like a bulk laxative, cause constipation, or cause either
physiological pH or electrolyte imbalances in the host following
administration". This proviso is based on the theoretical assumption that
more side effects will occur the greater the mass of the involved buffer -
but BMS never proved this.

    This patent also exists in Australia (# 657337) and in Europe
(#EP 0 524 579 B 1). It seems that the claims of both the Thai and
Australian patents are identical with the rejected US application
#08/942660 (they were never amended as the US application was).

    Our impression is that this is a completely ridiculous patent.
Unfortunately this patent has been instrumental in denying HIV patients
in Thailand a life saving medicine, and probably other countries as well.
Any advice you can provide would be appreciated.


-- 
=======================================================
James Love, Director           | http://www.cptech.org
Consumer Project on Technology | mailto:love@cptech.org 
P.O. Box 19367                 | voice: 1.202.387.8030
Washington, DC 20036           | fax:   1.202.234.5176
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